UNIVERSITY OF KENT AT CANTERBURY
KENT LAW SCHOOL
THE IMPLEMENTATION OF THE BIOTECHNOLOGY DIRECTIVE
(98/44/EC) IN FRANCE AND IN THE UK: A COMPARATIVE STUDY
WHICH SHOWS SERIOUS DISPARITIES DESPITE ITS EFFORT OF
HARMONISATION
Supervisor: Alan Story
Words: 20 000
Céline MARQUES
LLM in International Commercial Law
September 2006
1
Abstract
Biotechnology is defined as the use of micro-organisms, such as bacteria or yeasts,
or biological substances, to perform specific industrial or manufacturing processes.
Biotechnological inventions have recently become a really important field of
investments and, thus a worldwide competitive market. The applications of
biotechnologies concern, not only, pharmaceuticals, but also the food industry,
health and agriculture. To attract investments and encourage innovations on this
field, a harmonised regulation was necessary in European law to protect such
inventions. This paper concerns the implementation of the European directive on the
protection of biotechnological inventions, in France, and in the United Kingdom.
After reaching an arduous consensus, Member States appeared to have difficulties to
implement the directive. When studying its implementation in French and UK law,
it comes into sight that the patentability of living organisms, and especially genes, is
at the heart of the difficulties. Furthermore, the monopoly right granted to a patent
holder adds further obstacles in the implementation of the 98/44/EC directive. The
aim of this paper is to explain why, despite an effort of harmonisation, only a step
towards the reconciliation of legislations has been achieved. The purpose is also to
find in which way conflicting interests, but also cultures and legal mentalities of
both countries have influenced the implementation of the directive. It appears that,
biotechnology is not only a legal issue but also a political, economic, moral and
cultural issue and it is the accumulation of these elements which gives all its interest
to this comparative study.
2
DISSERTATION
OUTLINE
3
LIST OF ABBREVIATIONS…………………………………………………..................................8
ACKNOWLEDGEMENTS………………………………………………………….………………9
INTRODUCTION………………………………………………………..........................................10
-
The definition of biotechnologies…………………………………................................10
The reasons of the draft of the Directive 98/44/EC………………….............................12
Problematic………………………………………………………………..…………....15
structure
………………………………………………………………………………………….16
CHAPTER I – THE DIRECTIVE ON THE LEGAL PROTECTION OF
BIOTECHNOLOGICAL INVENTIONS: A LONG AWAITED LEGISLATION…………….17
1.
The need for a harmonisation concerning the legal status and protection of
biotechnological inventions……………………….........................................................17
1.1 The International Context of the protection of biotechnological
inventions…………………………....................................................18
1.1.1
The international regulation on the protection of
Biotechnological Inventions, the incentive for
harmonisation..................................................19
1.1.2
The modern case law calling for a European
harmonisation…………..................................22
1.2 The EPO decisions as a first sign of the necessity of the protection of
biotechnological inventions in the EC……………............................24
1.3. The pressures from businesses and foreign investors waiting for an
efficient protection in Europe………………………………..............25
2.
An awaited directive which has been the course of conflicts during its creation………27
2.1 The tumultuous genesis of the directive……………………………..27
2.2 The creation of the directive 98/44/EC which shows divergent
opinions from the start………..…………..........................................29
3.
The validity of the directive, which can not be questioned any longer, despite the
hostility of some Member states……………..................................................................31
3.1 The ECJ decision (ECJ, October 9th, 2000, C-377/98) or the assertion
of its validity……………………………...........................................31
3.2 A directive which can not be challenged at a national level either and,
which has to be implemented……...………………………………...33
CHAPTER II – THE PATENTABILITY OF LIVING ORGANISMS: A DIFFICULT
DISTINCTION BETWEEN INVENTIONS AND DISCOVERIES……………………..............36
1.
Patent law applied to living organisms: a regime to study..............................................36
4
1.1 The choice of the directive: patent law………………………….......37
1.2. The conditions of patentability applied to living organisms……...38
1.2.1
A patentable subject matter……......................39
1.2.2
An industrial application……..........................41
1.2.3
Novelty………...……………..........................43
1.2.4
An inventive step…………………………….44
2.
The shy implementation of the distinction between inventions and discoveries in French
law…………………………………………………………………………………...…46
2.1. The purpose of the distinction in the directive……........................46
2.1.1. the directive…………………............................46
2.1.2. a distinction preceded by foreign legislation ..48
2.2 The strong opposition of French law to article 5 of the
biotechnology directive……………………………………..…………....50
3.
2.2.1
The patentability of some specific biological
elements: discovery or invention?...................51
2.2.2
The patentability of human elements: a source
of uncertainties in French law which could lead
to its non-conformity with the biotechnology
directive……………………………………...52
2.2.3
The French arguments in favour of a non
compliance with article 5 of the directive……53
A clear implementation as to the patentability of living organisms in UK law which did not
call for a debate………………………………..........................................................................56
3.1 A large discussion on the morality clause despite its clear
implementation………………………………………………………56
3.1.1.
A proper implementation of article 6 of the directive
with however a restrictive interpretation…………57
3.1.2.
The criticisms attached to the nature of the
provision………………………………………….58
3.2 Criticisms and alternatives expressed on its content…………………59
CHAPTER III – THE RIGHTS GRANTED BY PATENTS: ONE DIRECTIVE BUT TWO
DIFFERING IMPLEMENTATIONS…………………………………….......................................64
1. The regular rights granted to a patentee. ………………………………………………...64
1.1. A limited right to exclude others from using, selling or exploiting the
patented inventions…….....................................................................65
1.2. The fear of possible abuses of such rights…………………………...66
1.2.1. The Myriad genetics case………………….......67
1.2.2. The large debate on the merits of such
monopoly……… ……………………………67
5
2.
The limitations granted by the directive to secure the protection of the incentive to
invent and their implementations…………………………………………...……..69
2.1. The
need
of
new
defences
for
biotechnological
inventions……………………………………………………………70
2.1.1. The very specific nature of biotechnological
inventions led to the necessity of including further
limitations…………………….......................................70
2.1.2. Further new limitations motivated by the
expending reproducing nature of living organisms……71
2.2. The additional limitations of French Law and its consequences, an
imperfect implementation which restrict patentee’s rights………….71
2.3. The English implementation of the directive: a faithful reproduction
of the European text but some difficulties with its article 12……….73
3.
The exemptions granted to farmers: difficulties of implementation put in relation
with international agreements……………………………………………………...75
3.1. The exemptions granted to farmers: a limitation to patent rights
essential for agriculture. …………………………………………………76
3.1.1. The economic situation of farmers as to
patents…………………………………………………76
3.1.2. The farmer’s privilege: a well-accepted
consensus………………………………………...……77
3.2. The implementation of the directive in France and in the UK: an
appearance of harmonisation…………………………..…………………78
3.3. The farmer’s privilege: a practice which is likely to be different from
the implementation ……………................................................................80
CHAPTER IV – THE DIVERGENT LEGAL MENTALITIES: A POSSIBLE REASON TO
THE LACK OF HARMONISATION…..........................................................................................84
1.
Is there anything else than the implementations and national provisions to compare
in comparative law……………………....................................................................84
1.1. The modern concept of comparative law and its consequences on our
study………………………………………..………………………..85
1.1.1. P. Legrand and the concept of legal
mentality………….........................................................85
1.1.2. The reasons and interests of taking into account
the legal mentality..........................................................86
1.2. What other factors should be compared as regard to the
implementation of the biotechnology directive to understand the
reasons of its partial success………………………………………...87
2.
The use of legal gaps in the Directive to introduce national politics created by mere
national interests…………………….......................................................................89
6
2.1. Ethical issues and commercial interests: two indivisible elements of
biotechnological
issues
leading
to
different
national
politics…………………………………………………………………....89
2.2. The uncertainties of the directive used by each legislator to encourage
its politics………………………………………………………………...91
3.
The unavoidable function of the “legal mentality” in a climate of “conflicting
cultures” and the alternatives to a partial and dissatisfactory harmonisation……...93
3.1. A divergence as to the legal mentalities: an important but neglected
factor……………………………………..…….........................................94
3.2. The alternatives or what could have been done to have a satisfactory
harmonisation:
the
absence
of
a
simple
and
perfect
answer………………………… …………………………………………95
CONCLUSION………………………………………………………………...................................99
ANNEX 1: glossary………………………………………………………………………..………..103
BIBLIOGRAPHY……………………………………………………………………………….....107
7
List of abbreviations
- CBD ►
Convention on Biological Diversity
- DNA ►
Deoxyribonucleic Acid
- EC ►
European Community
- ECJ ►
European Court of Justice
- EPC ►
European Patent Convention
- EPO ►
European Patent Office
- EU ►
European Union
- IPC ►
Intellectual Property Code
- IPRs ►
Intellectual Property Rights
- GATT ►
General Agreement on Tariffs and Trade
- GMO s ►
Genetically Modified Organisms
- IPRs ►
Intellectual Property Rights
- TRIPs Agreement ►
Agreement on Trade-related Aspects of Intellectual
Property Right
- UK ►
United Kingdom
- UNCTAD ►
United Nations Conference on Trade and
Development
- The UPOV convention ► The International Convention for the Protection
of Varieties of Plants
- WIPO ►
World Intellectual Property Organisation
- WTO ►
World Trade Organisation
8
ACKNOWLEDGEMENTS
During the writing of this dissertation, it has been a real pleasure to benefit from the
knowledge and advice of various persons.
I would like to acknowledge in particular my supervisor, Mr Alan Story, for his
helpful experience in intellectual property law, our useful conversations and his
answers to my enquiries. I would also like to thank him for his academic advice
which helped me to carry out this project till the end.
I would also like to thank my parents and Nathalie for their constant financial and
emotional support throughout the year. I would like to acknowledge their
consideration and patience.
I also thank my closest friends in Canterbury, Véronique Govet and Emilie Braive
for their persistent moral support. To all the persons I have met in Canterbury as
well, and especially in Tyler Court, for what they have taught me during this year,
which means tolerance, compassion and patience.
Last but not least, I am extremely grateful to Christian Krause for his continuous
encouragement, enthusiasm and most importantly for his unlimited understanding.
9
THE IMPLEMENTATION OF THE BIOTECHNOLOGY DIRECTIVE
(98/44/EC) IN FRANCE AND IN THE UNITED KINGDOM: A
COMPARATIVE STUDY WHICH SHOWS SERIOUS DISPARITIES
DESPITE ITS EFFORT OF HARMONISATION
Introduction:
Biotechnology has become one of the most mediatised legal and political issues
during the last decades. Its extremely fast-evolving innovations, which concern the
scientific, as well as the technological and industrial fields, has raised many
questions as to the legal framing of biotechnologies1. Biotechnology is defined as
“the use of living organisms, (eg bacteria), or the enzymes produced by them, in the
industrial manufacture of useful products, or the development of useful processes,
eg in energy production, processing of waste, manufacture of drugs and
hormones”2. Biotechnologies concern a very broad field of processes and
techniques3. With the discovery of the deoxyribonucleic acid (DNA), and its
subsequent isolation in 1869 by Friedrich Miescher, and the discovery of its
structure and function, in 1953 by J. Watson and F. Crick4, biotechnology became a
far more important issue than what it used to be, and opened the door to new kinds
of innovations, as well as new kinds of concerns. By then, biotechnologies were not
only about traditional techniques, such as fermentation processes for the production
1
Bauer M. W. and Gaskell G., Biotechnology, the making of a Global Controversy, (Cambridge
University Press; 2002)
2 Chambers 21st century dictionary, chambers reference online available on
http://www.chambersharrap.co.uk/chambers/chref/chref.py/main?query=biotechnology&title=21st
3
Ilbert H. & Tubiana L., Protection juridique des inventions biotechnologiques : analyse de la
directive européenne et propositions, (SOLAGRAL collection réseaux biotechnologiques, 1992)
4
University of Delaware, DNA History, november 2004, available on
http://www.ocean.udel.edu/extreme2004/genomics/dnahistory.html
10
of bread or beer, or other techniques, such as the selective breeding of plants or
animals5; but it also turned out to be a new era for biotechnologies. Today,
biotechnology concerns especially pharmaceuticals, where micro-organisms are
used to produce medicine. For instance, genetic engineering allowed the production
of insulin, using human cells, instead of cells of pigs6. This innovation, due to
biotechnological research, reduces possible rejections of the insulin by the body, and
increases its efficiency. Thereby nowadays, more than half of the new medicines are
related to biotechnologies7. It also concerns cloning, diagnostics and testing of some
genetic diseases such as breast cancer, gene therapy, xenotransplantation,
genetically modified seeds and foods and some new environmental techniques, such
as the creation of micro-organisms which can degrade hydrocarbons8. Modern
biotechnology gathers many expectations and hopes, mainly in public health and in
the food industry. However, it also raises questions and fears as to the use of genetic
information, biodiversity, the limits and the merit of biotechnology itself9.
Furthermore, they also have an important effect on economy. According to the
European Commission, biotechnologies will represent a market of 2 000 billions
euros in 201010. Furthermore, the field of “human biotechnologies”, which concerns
5
Schley C., 2001, Biotechnology/Gene Patenting, University of Kent at Canterbury, UL3 shelved in
Thesis Collection 4906
6
Ilbert H. & Tubiana L., Protection juridique des inventions biotechnologiques : analyse de la
directive européenne et propositions, (SOLAGRAL collection réseaux biotechnologiques, 1992)
7
Gaumont-Prat H., Brevetabilité du vivant : animal et humain – Inventions biotechnologiques et
contexte socio-juridique, (2004), JurisClasseur Brevets, fasc. 4240
8
Bauer M. W. and Gaskell G., Biotechnology, the making of a Global Controversy, (Cambridge
University Press; 2002) 1
9
Bauer M. W. and Gaskell G., Biotechnology, the making of a Global Controversy, (Cambridge
University Press; 2002) 1
Report of the European Commission to the Council and European Parliament, “development and
implications of patent law in the field of biotechnology and genetic engineering”, commission of the
European Communities, Brussels 7.10.2002, COM (2002) 545 final, 30-32 available on
10
11
mainly genetic therapies, diagnostic and testing processes, and some pharmaceutical
products, is especially active. Its worldwide market is considered to be of about $ 35
billions, and it has known a constant increase of 20 per cent each year, since the start
of 199011. Consequently, biotechnology has become the new field of substantial
investments and competitiveness.
Given the financial importance of this field, investors are competing for the access
to primary materials, such as genes, as well as for their protection, and for the
protection of the innovations coming from the research, based on these materials.
On October 21st, 1988, the Council of the European Community (EC) proposed a
European directive on the protection of biotechnological inventions to assert a
payback in the investments carried out by companies, and to encourage research,
innovations, and the increase of investments in biotechnologies in Europe12. The
purpose of this harmonisation was to face the competition coming from the United
States and Japan. Indeed, the European hindrance, as to the filing and grant of
patents, compared to the United States, started to be substantial. Between 1981 and
1995, 70 per cent of the patents granted by the European Patent Office (EPO)
belonged to American or Japanese firms, whereas only 24 per cent were granted to
European companies13. Since 1988, the European directive proposal had chosen to
http://europa.eu/eur-lex/en/com/rpt/2002/com2002_0545en01.pdf
11
Beverly-Itasse E., la consolidation du secteur mondial des biotechnologies humaines, report
published in october 2004, available on
http://www.eurostaf.fr/fr/catalogue/etudes/sectorielles/pharmaciesante/conso_sect_mondial_biotech/r
esume.html
12
Ilbert H. & Tubiana L., Protection juridique des inventions biotechnologiques : analyse de la
directive européenne et propositions, (SOLAGRAL collection réseaux biotechnologiques, 1992)
13
Gaumont-Prat, les tribualtions en France de la directive n° 98-44 du 6 juillet 1998 relative à la
protection juridique des inventions biotechnologiques, (2001), Rec. Dalloz du 11 octobre 2001, 29932884
12
protect biotechnological inventions through patent law. A patent is usually defined
as an official title granted by a patent office to a person or a business, giving the sole
right, for a limited period of time, to make and sell a particular product or exploit a
particular process14. However, the patent is a right to exclude others, which means,
first of all, competitors, from using, exploiting, selling or producing the invention.
However, it does not give a right to commercialise it.
A consensus on the protection of biotechnological inventions had been reached on
July 6th, 1998, through the adoption of the Biotechnology directive, after 10 years of
parliamentary debates15. The use of a directive to set down a protection for
biotechnological inventions could seem, at first, inappropriate, given the existence
of the Convention of Munich16. However, because of the complexity of the
procedure to amend the said convention, the European Community considered that a
directive would be the quickest and most efficient way to grant such a protection17.
A directive is defined as a legal text drafted by the European Community which
links the Member States as to the results to achieve, and lets them free to implement
it in the way they chose to. The European directive, which was expected by the
scientific and legal communities, should have been implemented by all Member
States by July 30th, 200018. However, in 2002, only six Member States had
14
Davis J., Intellectual property law, (Butterworths, Core text Series, 2001)
15
European Directive 98/44/CE on the protection of biotechnological inventions of July 6th, 1998,
[1998] OJEC L213/13
16
European Patent Convention of 5 October 1973, available on:
http://www.european-patent-office.org/legal/epc/e/ma1.html
Gaumont-Prat H., Brevetabilité du vivant : animal et humain – Inventions biotechnologiques et
contexte socio-juridique, (2004), JurisClasseur Brevets, fasc. 4240
17
18
European Directive 98/44/CE on the protection of biotechnological inventions of July 6th, 1998,
[1998] OJEC L213/13
13
implemented it and had integrated it into their national legal systems 19. The United
Kingdom (UK) had mainly implemented the Biotechnology Directive 98/44/EC in
the Patents Regulations 2000 (SI 2000/2037) as far as sections 1 to 11 were
concerned. They have, then, completed the implementation with the Patents Rules
2001 (SI 2001/1412), and the Patents and Plant Variety Rights (Compulsory
Licensing) Regulations 2002 (SI 2002/247). Contrary to the quick implementation
of the UK, France implemented the Biotechnology Directive with 53 months delay.
The transposition had been made in two parts. A first statute, implementing sections
5 and 6 of the directive, related to the inventions as to the human body and its
elements, had been drafted on August 6th 2004 (statute n° 2004-800). A second,
implementing the other sections of the directive, had been drafted on December 8th,
2004 (statute n° 2004-1338). However, the difference of time which has been
necessary to implement the directive in France and in the UK is not the only
disparity. Indeed, comparing both implementations, some important divergences
appear, and show a quite differing political will from one country to the other. The
interest of this paper is not to challenge the merit of the Biotechnology Directive, or
to explain in every detail its content. The purpose of this paper is not to describe the
implementing statutes from the UK and France. The point, here, is to make a
comparative analysis, between two legal systems, on the implementation of the said
directive. Given the various interests at stake, biotechnology is a particularly
complex issue20. Indeed, Biotechnology does not only involve patent law, but also
Report of the European Commission to the Council and European Parliament, “development and
implications of patent law in the field of biotechnology and genetic engineering”, commission of the
European Communities, Brussels 7.10.2002, COM (2002) 545 final, 6-7 available on
http://europa.eu/eur-lex/en/com/rpt/2002/com2002_0545en01.pdf
19
20
Bauer M. W. and Gaskell G., Biotechnology, the making of a Global Controversy, (Cambridge
University Press; 2002)
14
political and ethical issues. Furthermore, French law has its origin in Civil law, or
more particularly in the European continental system of law, which is primarily
derived from Roman law, and the Germanic tradition. Its codification of abstract
principles and its history are two of its major specificities21. However, the UK is a
Common Law country. Its legal system is divided into two legal fields, Common
Law and Equity. Common law systems have a pragmatic approach to the particular
problems which appear, and are, thus, often reluctant in giving abstract principles.22
These differences of origins imply, therefore, important differences between both
legal systems. Consequently, it can be interesting to understand in which extent a
harmonisation, on such a complex issue, is possible, and how it can actually be
handled between two legal systems, which are apparently very different from one
another.
As previously stated, important divergences appeared in the implementation of the
1998 Biotechnological Directive. The interest here is to explain the reasons of such
differing implementations. On which grounds do the various divergences of
implementations stand? Are such differences due to differing ethical politics, to
differing legal systems or mentalities, or to any other cause? Could the European
community have foreseen these difficulties of implementation, when drafting the
directive? What are the consequences of these disparities for the harmonisation of
the protection of biotechnological inventions?
Indeed, the Biotechnology Directive, which was long awaited by all professionals
concerned, has shown lots of difficulties to be drafted. Actually, despite the
21
Slapper G. and Kelly D., The English legal system, (London, Cavendish, 6th ed., 2003) 3-4
22
Slapper G. and Kelly D., The English legal system, (London, Cavendish, 6th ed., 2003) 3-4
15
necessity to set down a legal protection for biological inventions, ten years have
been necessary to reach a consensus. Moreover, even after its final draft, its legal
validity has been questioned at various levels, and it even appeared necessary to
assert its authority (chapter I). However, this tumultuous genesis of the
Biotechnology Directive did not stop it from having differing implementations, in
French and UK law. Two main issues appeared to be especially sensitive. First of
all, the patentability of living organisms, which is the central point of the directive,
raised some ambiguities. It even reached a real opposition when implementing the
distinction between inventions and discoveries (Chapter II). These disparities went
even further when the rights given to a biotechnological invention patentee were
considered. At this point, two legal approaches emerged facing the French limitation
to the UK protection of such rights (Chapter III). However, these disparities can be
explained through a number of factors. In an atmosphere of conflicting legal
cultures23, the Biotechnology Directive was, both, needed to get a reconciliation
between legislations, and too wide to get a real harmonisation. In its directive, the
European Community tried to lay down the basis of a uniform set of rules. However,
the directive, allowed France and the UK to integrate their own public policy.
Consequently, this study will lead us to determine the different factors which have
prevented a uniform implementation of the Directive. Furthermore, we will have to
examine, with such factors, if a complete harmonisation was possible and which
alternatives existed, at that time, to avoid such difficulties (Chapter 4).
Beyleveld D., Brownsword R. and Llewelyn M. “The morality clauses of the Directive on the
Legal Protection of Biotechnological Inventions: conflict, compromise and the patent community” in
Goldberg R. & Lonbay J. Pharmaceutical Medicine, Biotechnology and European Law, (Cambridge
University Press, 2000)
23
16
CHAPTER I
THE DIRECTIVE ON THE LEGAL PROTECTION OF
BIOTECHNOLOGICAL INVENTIONS: A LONG AWAITED
LEGISLATION
Through the course of nearly half a century, biotechnology has gradually become a
key field of the economy24. Consequently, and because of the lack of legal
harmonisation within the European Community, a piece of legislation was required
to give an answer to the fear of investors. It was necessary to create a harmonised
and safe legal context in Europe, to attract biotechnological companies25. However,
the directive has caused various conflicts. Consequently, ten years have been
necessary to reach a consensus among Member States. This tumultuous genesis of
the Directive shows how sensitive the issue is, not only legally, but also politically,
and economically. Nevertheless, this consensus did not please anyone in particular.
Some Member States even tried to challenge the legality and the authority of the
said legislation. The assertion of the ECJ but also of some constitutional courts, such
as the French Constitutional Court, has, thus, been essential to give some legal
legitimacy to the directive.
1.
The need for a harmonisation, concerning the legal status, and the
protection, of biotechnological inventions.
Report of the European Commission to the Council and European Parliament, “development and
implications of patent law in the field of biotechnology and genetic engineering”, commission of the
European Communities, Brussels 7.10.2002, COM (2002) 545 final, 30-32 available on
http://europa.eu/eur-lex/en/com/rpt/2002/com2002_0545en01.pdf
“ Life science and biotechnology are widely recognised as one of the most promising frontier
technologies in the new knowledge-based economy” 31
24
25
Gaumont-Prat H., Brevetabilité du vivant : animal et humain – Inventions biotechnologiques et
contexte socio-juridique, (2004), JurisClasseur Brevets, fasc. 4240
17
To understand the necessity of drafting a European text able to protect
biotechnological inventions within the EC, it is necessary to consider three
important factors. It appears that the International context played an important role
in the draft of the said directive. Indeed, it has already led the EPO, through its case
law, to protect some biotechnological inventions. This first step of the EC towards
the protection of biotechnological inventions has been seen as one of the most
important signs in Europe, of the necessity to have a harmonised legislation among
Member States. But it is mainly because of the economic pressures carried out by
biotechnological businesses and investors that the draft of the Biotechnology
Directive did not become only necessary but also imperative.
1.1.
The international context of the protection of biotechnological
inventions.
The Biotechnology Directive is not the first piece of legislation dealing with the
protection of biotechnological inventions26. At an international level, several
agreements could be mentioned27. Moreover, the international context is not only
about international legislation but also about foreign case law28.
26
Bellmann C., Dutfield G., Meléndez-Ortiz R., Trading in knowledge: development perspectives on
TRIPS, Trade and sustainability, (Earthscan Publication ltd, London, Sterling VA, 2003) 4 “The
architecture of the global intellectual property regulatory system includes an increasing and, to
some, bewildering diversity of multilateral agreements, regional conventions and instruments, and
bilateral arrangements.”
27
such as the TRIPs agreement, the Convention on Biological Diversity, the Convention on the Grant
of European Patents (the European Patent Convention), the UPOV Convention and the Budapest
Treaty on the International Recognition of the Deposit of Micro-organisms for the Purposes of Patent
Procedure, and many others
28
Dutfield G., Intellectual Property Rights and the Life Science Industries : a twentieth century
history, (Ashgate, 2002) 1-13. This paper does not allow us to talk about all the international or
regional agreements which have been drafted concerning the protection of biotechnological
18
1.1.1
The International Regulation on the protection of
Biotechnological
Inventions
the
incentive
for
harmonisation.
Since the 1970s, Intellectual Property Rights (IPRs) have become increasingly
important29. Maybe the most important and well-known international agreement
dealing with the protection of inventions is the TRIPs agreement, drafted in 1994,
and administered by the World Trade Organisation (WTO)30. It sets down minimum
standards of protection Members need to follow, concerning all the main IPRs31.
This international agreement was particularly expected by industrialists and,
nowadays, it has a substantial authority in International Intellectual Property Law32.
inventions. However, others, such as the Bangui Agreement Establishing an African Intellectual
Property Organisation, or the Andean Community Common Regime on Industrial Property are
important as well.
29
Dutfield G., Intellectual Property Rights and the Life Science Industries : a twentieth century
history, (Ashgate, 2002) 1-13 As previously stated, it was mainly due to the recent and significant
progress in life industries, including biotechnologies
30
THE WTO IN BRIEF: PART 1 The multilateral trading system—past, present and future,
available on
http://www.wto.org/english/thewto_e/whatis_e/inbrief_e/inbr01_e.htm
"The World Trade Organization came into being in 1995. One of the youngest of the international
organizations, the WTO is the successor to the General Agreement on Tariffs and Trade (GATT)
established in the wake of the Second World War".
31
Bellmann C., Dutfield G., Meléndez-Ortiz R., Trading in knowledge: development perspectives on
TRIPS, Trade and sustainability, (Earthscan Publication ltd, London, Sterling VA, 2003) 4
32
Martin Khor, Intellectual Property, Biodiversity and Sustainable Development: resolving the
difficult issues, Zed Books, Third World Network, 2002.
It is important to state that from 1986, which means from the start of the Uruguay Round, the issue of
the protection of intellectual property rights was a concern for a majority of industrials and
members, even if, this issue had been integrated in the agenda of the Uruguay Round at the last
minute. Moreover, according to Martin Khor, the agreement has been greatly influenced by
developed countries, to protect their financial investments on biotechnologies and to promote private
monopoly rights
19
Section 27.333 is particularly interesting as it has been not only the most
controversial section, but also the section which dealt with the patentability of living
organisms, and the exceptions to such patentability34. This section is often called the
“biotechnological clause”35. It shows, first of all, the concern States had and still
have in setting down a protection for biotechnological inventions. Furthermore, the
conflict it arose, especially with the Biodiversity Convention, shows the legal
differences existing between countries and the sensitivity of this legal issue. The
Convention on Biological Diversity was signed by 150 government leaders at the
1992 Rio Earth Summit36 and is dedicated to promoting sustainable development.
Indeed, its objectives are to promote conservation of biodiversity and equitable
benefit sharing37. The convention sets down mechanisms to encourage transfer of
technologies between contracting parties38. While the CBD uses intellectual
property rights (IPRs) to protect biodiversity, and allow developing countries to
access technologies, the TRIPS agreement strengthens IPRs to protect private
33
TRIPs agreement, section 27.3, “Members may also exclude from patentability: plants and
animals other than micro-organisms, and essentially biological processes for the production of
plants or animals other than non-biological and microbiological processes. However, Members shall
provide for the protection of plant varieties either by patents or by an effective sui generis system or
by any combination thereof.(…) “
34
Bellmann C., Dutfield G., Meléndez-Ortiz R., Trading in knowledge: development perspectives on
TRIPS, Trade and sustainability, (Earthscan Publication ltd, London, Sterling VA, 2003) 33
35
UNCTAD-ICTSD Project on IPRs and Sustainable Development, Resource Book on TRIPS and
Development, (Cambridge University Press, 2005) 388 This section describes the inventions
Member States may exclude from patentability but, at the same time, obliges them to protect
microorganisms and some biological processes.
36
United Nations Environment program, How the convention on biological diversity promotes nature
and human well-being available on http://www.biodiv.org/doc/publications/guide.asp
CBD, section 1 The objectives of the CBD “are the conservation of biological diversity, the
sustainable use of its components and the fair and equitable sharing of the benefits arising out of the
utilization of genetic resources, including by appropriate access to genetic resources and by
appropriate transfer of relevant technologies, taking into account all rights over those resources and
to technologies…”
37
The convention on biological diversity, section 16 “Each Contracting Party, recognizing that
technology includes biotechnology, and that both access to and transfer of technology among
Contracting Parties are essential elements for the attainment of the objectives of this Convention”
38
20
investors39. This conflict proves the economic importance of biotechnological
inventions, not only as to the investments done by companies from developed
countries, but also as to the genetic material, or knowledge, incorporated into these
inventions, and which come, most of the time, from developing countries40.
Another essential agreement is the UPOV Convention41. Adopted in 1961, it entered
into force in 1968 and has been regularly revised since then. The UPOV Convention
sets up the International Union for the Protection of New Varieties of Plants, as well
as a sui generis system to protect plant varieties42. One of the main provisions,
especially important, is the one dealing with farmers’ privilege43. This section is
particularly close to section 11 of the European Directive on the protection of
biotechnological inventions where similar rights are granted44.
39
Bellmann C., Dutfield G., Meléndez-Ortiz R., Trading in knowledge: development perspectives on
TRIPS, Trade and sustainability, (Earthscan Publication ltd, London, Sterling VA, 2003) 85
40
Bellmann C., Dutfield G., Meléndez-Ortiz R., Trading in knowledge: development perspectives on
TRIPS, Trade and sustainability, (Earthscan Publication ltd, London, Sterling VA, 2003) 85
The TRIPS agreement and the Convention on Biological Diversity are often said to be conflicting.
This conflict is essentially due to the different interests at stake. While the former tries to secure the
protection of most of the inventions, including biotechnological inventions, to assure benefits to
companies, most of the time located in developed countries, which made large investments; the latter
tries to balance IPRs to encourage the development of countries, where biological elements are
located.
41
The International Convention for the Protection of New Varieties of Plants, adopted on December
2, 1961, by a Diplomatic Conference held in Paris, available on
http://www.upov.int/en/about/upov_convention.htm
42
UNCTAD-ICTSD Project on IPRs and Sustainable Development, Resource Book on TRIPS and
Development, (Cambridge University Press, 2005) 400 « in order to be eligible for protection, a
plant variety must meet the following requirements : novelty (…) dinstinctness (…) uniformity (…)
stability (…) Denomination (…)”
Under this section, farmers, even if they’re not allowed to sell protected seeds, can re-use them for
propagating purposes on their own land
43
44
A similar exemption can be found in the European directive on the protection of biotechnological
inventions in its section 11. The European Directive on the Protection of biotechnological inventions,
section 11 “By way of derogation from Articles 8 and 9, the sale or other form of commercialisation
of plant propagating material to a farmer by the holder of the patent or with his consent for
agricultural use implies authorisation for the farmer to use the product of his harvest for
propagation or multiplication by him on his own farm, the extent and conditions of this derogation
corresponding to those under Article 14 of Regulation (EC) No 2100/94.2. By way of derogation
from Articles 8 and 9, the sale or any other form of commercialisation of breeding stock or other
21
None of these conventions can be considered separately. They are all dependent on
each other. For instance, the UPOV Convention sets down the sui generis system
stated in section 27.3 of the TRIPS Convention. Such Conventions do not only have
effects at an international level, but also at the national level. Doing so, these
conventions tried to weaken all the differences existing between national laws45.
However, despite this minimum standard of protection, many disparities sill existed
between countries before 1998. They were particularly significant within the
European Union despite the creation of the European Patent Office.
Faced with the growing importance of biotechnologies, and the multiplication of
international agreements, members of the EU had, not only, to implement the latter,
but also to harmonise their legislation46. This need became particularly obvious
when facing case law.
1.1.2
The modern case law calling for a European harmonisation as to
the protection of biotechnological inventions.
Many case law in the 1980s and 1990s allowed a protection for inventions
concerning living organisms. It is this case law and the proliferation of international
animal reproductive material to a farmer by the holder of the patent or with his consent implies
authorisation for the farmer to use the protected livestock for an agricultural purpose. This includes
making the animal or other animal reproductive material available for the purposes of pursuing his
agricultural activity but not sale within the framework or for the purpose of a commercial
reproduction activity.”
45
UNCTAD-ICTSD Project on IPRs and Sustainable Development, Resource Book on TRIPS and
Development, (Cambridge University Press, 2005) 400 For instance, many countries created in their
national laws a sui generis system such as the one states in the UPOV convention to implement
article 27.3 of the TRIPS agreement.
46 Report of the European Commission to the Council and European Parliament, “development and
implications of patent law in the field of biotechnology and genetic engineering”, commission of the
European Communities, Brussels 7.10.2002, COM (2002) 545 final, 30-32 available on
http://europa.eu/eur-lex/en/com/rpt/2002/com2002_0545en01.pdf
22
agreements, which led to the necessity of drafting a harmonised regulation within
the European Union, to face both competition and attract investments.
For instance, from the end of the 19th century till the mid 1930s, the patentability on
some biological materials, such as some yeast, has been seen as a normal extension
of patent law47. Furthermore, in the Diamond v. Chakrabarty48 case in 1980, the U.S
Supreme Court, for the first time, accepted a patent on living organisms. However,
this evolution in patent law was limited to micro organisms. It is only at the end of
the 1980s that patents on biologically modified animals appeared. The patent
granted to Harvard University in 1988 for their oncomouse is an example of this
evolution49. Finally, patents have been granted on human materials50. As a
consequence, patents on living organisms started to spread out, not only in the U.S
case law, but also in the EPO decisions, and many other jurisdictions.
However, this case law used to evolve without a uniform legislation in the EU,
which weakened its position as one of the technological leaders. The reaction of the
EPO compared to national laws show even better the necessity of a harmonisation.
47
Gaumont-Prat H., Loi de bioéthique et droit des brevets: alliance féconde ou liaison difficile? La
pénultième péripétie de la transposition de la directive (CE) 98/44, (2005), Les Petites Affiches, 18
février 2005, n° 35, p. 51. A patent has been granted to Louis Pasteur in 1873 by the U.S Patent
Office for yeast which proves to be exempted of any disease.
48
U.S Supreme Court, Diamond v. Chakrabarty, 447 U.S 303 (1980) It recognised the patentability
of a genetically modified oyster. The court held that a patent could be granted for any non-human
multicellular organisms non pre existing in the environment, including animals which are due to
men’s interventions.
In this case, the defendant required a patent for the development of genetically engineered bacteria
with a unique trait. These living organisms could not be found in nature and was clearly due to
human scientific research and interventions.
49
U.S Patent n° 4 736 866. In this case, a cancer-causing genes was inserted into a mouse
50
Patent EP n° 041-313 (1990)
23
1.2
The European Patent Office decisions as the first sign of the necessity of
the protection of biotechnological inventions in the European Community.
In Europe, the patentability of micro organisms has not been a real issue. Section
53b of the European Patent Convention has recognised the patentability of
biotechnological processes and of their products51. Patentability has also been
recognised for micro-organisms isolated from their natural environment. Another
issue is the patentability of animals. In Europe, the patent for the oncomouse of
Harvard University was first refused. However, a second decision held in 1990
stated that the non-patentability of animals as a specie did not apply to the
oncomouse52. Thus, the invention was patentable if it gathered all the requirements.
As for “human material”, the EPO had already granted several patents in the 1980s.
For instance, we could state as an example the patents granted on human purified
proteins to cure haemophilia53. Finally, some questions arose as to the patentability
of genes in the 1990s. The issue became even more important with the creation of
the Human Genome Organisation which aimed at sequencing the DNA54. It thus
appears that the patentability of human genes and the one of human cells are
considered in the same way55.
51
European Patent Convention, article 53b « plant or animal varieties or essentially biological
processes for the production of plants or animals; this provision does not apply to microbiological
processes or the products thereof.”
52
Déc. T. 19/90, Regents de l’Université de Harvard : JOOEB déc 1990, p. 476
53
Patent SCRIPPS EP 83 483
54
The Human Genome Organisation (HUGO) is the international organisation of scientists involved
in human genetics, established in 1989. Further information is available on http://www.hugointernational.org/
55
Gaumont-Prat H., Loi de bioéthique et droit des brevets: alliance féconde ou liaison difficile? La
pénultième péripétie de la transposition de la directive (CE) 98/44, (2005), Les Petites Affiches, 18
février 2005, n° 35, p. 51.
24
Despite this case law from the EPO, there was no uniform regulation to protect
biotechnological inventions. However, faced with the growing importance of these
inventions and the necessity to protect them in order to encourage innovation, some
political measures have been taken. These measures are mainly related to the
creation of the Biological Resources Centre56. Despite this political will in favour of
biotechnologies, investors and companies used to consider any investment in Europe
as a financial risk. This reluctance to invest had negative consequences on the
European economy and was a decisive reason to draft a piece of legislation on the
issue.
1.3
The pressures from businesses and foreign investors waiting for an
efficient protection in Europe
The market of the biotechnological inventions is particularly important for several
reasons. First, it gathers significant investments and second, the innovations at stake
are particularly valuable. Health represents the main application of biotechnologies.
In its report, the European Commission evaluates the total world market potential of
biotechnological applications to more than 2000 billion euros in 201057.
Furthermore, the same report states that, even if investments in biotechnology
within the EU increase gradually during the last decades, it remains remarkably low
compared to investments in the U.S.
56
Gaumont-Prat H., Loi de bioéthique et droit des brevets: alliance féconde ou liaison difficile? La
pénultième péripétie de la transposition de la directive (CE) 98/44, (2005), Les Petites Affiches, 18
février 2005, n° 35, p. 51
.
57 Report of the European Commission to the Council and European Parliament, “development and
implications of patent law in the field of biotechnology and genetic engineering”, commission of the
European Communities, Brussels 7.10.2002, COM (2002) 545 final, 30-32 available on
http://europa.eu/eur-lex/en/com/rpt/2002/com2002_0545en01.pdf
25
For instance in France, it appears that the number of applications for patents of
French origin hardly increased compared to the total number of applications. Indeed,
it comes into view that the main increase of applications is due to foreign
applications58. Furthermore, if we consider only applications for patents on
biotechnologies during the last decade, it has doubled. Given these figures, it
became clear that investors feared making investments in Europe because of the lack
of protection and legal uniformity biotechnological inventions were submitted to.
Indeed, some reports, such as the “rapport Lenoir”59 or the report of the European
Commission60, clearly identifies the lack of an efficient protection of
biotechnological inventions as one of the reasons, which explains the difference of
investments between the U.S and the European Union. It also represents one of the
reasons why less patent applications are registered in the European Union rather
than in the U.S61. The interest of the harmonisation was thus doubled. First, there
was an economic interest to avoid the departure of investors in competing countries,
where the protection of biotechnological inventions is granted. Moreover, there was
also a legal interest not to let Member states set up their own regulation which
would most probably increase legal disparities among them.
58
Gaumont-Prat H., Loi de bioéthique et droit des brevets: alliance féconde ou liaison difficile? La
pénultième péripétie de la transposition de la directive (CE) 98/44, (2005), Les Petites Affiches, 18
février 2005, n° 35, p. 51.
Between 1995 and 2002, the number of applications to be granted a patent increased of 5,3% but only
1,4% are due to “French” applications.
59
Noëlle Lenoir, relever le défi des biotechnologies, March 11 th 2002 available on
http://www.genopole.org/media/pdf/fr/communication/defi-biotechs-noellelenoir.pdf#search=%22le%20rapport%20lenoir%22
60
Report of the European Commission, (COM (2002), 2 final, January 14th, 2002)
61
Report of the European Commission, (COM (2002), 2 final, January 14th, 2002)
26
Given all these elements, a regulation seemed to be necessary to protect
biotechnological inventions. Biotechnologies represent an essential field of the
economy and the pressures created by investors made the draft of a common
regulation even more important. Thus, the EC decided to draft the European
directive on the protection of biotechnological inventions. The Directive was
adopted on July 6th, 1998. However, ten years have been necessary to reach its final
draft. Indeed, despite its necessity, the European Directive has been the course of
large conflicts.
2.
An awaited directive which has been the course of conflicts during its
creation
Consequently, it is necessary to study the tumultuous genesis of the draft of the
directive to understand the different opinions at stake, and why it is such a complex
issue to study and why it led to a differing implementation.
2.1
The tumultuous genesis of the directive.
The Directive on the protection of biotechnological inventions entered into force in
July 30th, 1998. Its genesis has been particularly tumultuous, and its draft difficult.
The first proposal for this directive was drafted in October 21st, 1988. Ten years of
legal arguments have been necessary to find a compromise62. The purpose of this
proposal was to clarify the implementation of patent law on biotechnological
62
Gaumont-Prat H., La laborieuse transposition de la directive n°98/44/CE du 6 juillet 1998 relative
à la protection des inventions biotechnologiques, suite et fin ? , (2005), Propriété Industrielle n° 3,
mars 2005, Etude 5
27
inventions in order to encourage the free movement of new biotechnological
products, and processes, and investments. Many amendments to the proposal have
been recommended, after the first reading by the European Parliament in 199263.
The discussions between the Council and the Commission on the amendments
submitted by the Parliament led to the procedure of conciliation to find a
compromise in September 199464. Divergences of opinions, mainly on three points,
remained despite the numerous discussions and readings65. First, the issue of the
patentability of animals, and more specifically, the distinction between discoveries
and inventions involving living organisms raised many problems. The exclusion of
patentability for “processes of modifying the germ line genetic identity of human
beings”66, and the introduction of the derogation of farmers, have been two other
very important and conflicting issues. The first difficulty, which is mainly the
distinction between discoveries and inventions, has been induced by the concern of
the patentability of human genes. The draft of this section gave rise to many
misunderstandings and discussions. However, the interest of such debate is that it
underlined the necessity to integrate a distinction concerning human biological
elements able to be patented. The second issue concerned first the germinal genetic
therapy and its non-patentability. These issues, which involve mainly economy and
ethics, were solved on August 29th, 1997, when the European Commission adopted
the modified directive proposal, rejecting however its amendment 76. The latter
implemented and even widened the requirements of the CBD, as to the access of
63
JOCE n° C 305, November 23rd, 1992
Common proposal adopted by the Committee of conciliation on January 23 rd, 1995 (Doc.-PE –
COMS 3606/1/95, February 21st, 1995
64
65
Chemtob-Concé M. C. et Gallochat A., Le Brevetabilité des inventions technologiques appliquées
à l’homme. (Ed. Lavoisier, Tech & Doc, Paris 2ème ed., 2004) 48
66
Directive 98/44/EC on the legal protection of biotechnological inventions, section 6 (2) b)
28
biological resources. Doing so, the Parliament was adding conditions of
patentability which were not considered either within the TRIPS agreement, or
within patent law. Consequently, the final draft made by the European Council, has
been adopted by the European Parliament on May 12th, 1998, with 338 votes in
favour of the directive and 110 against67.
However, given these conflicts and hesitations, we could wonder if this consensus
satisfied all parties and all opinions.
2.2
The creation of the directive 98/44/EC which shows, from the start,
some divergent opinions.
The first proposal in 1988 was essentially settling technical principles on
biotechnological inventions, setting down their protection and stating the exclusions
to patentability. It just clarified the application of patent law to biotechnological
inventions. Faced with criticisms and pressures of lobbies, amendments were
proposed in order to introduce ethical elements. After the refusal to adopt the
directive proposal in March 1995, the European Commission proposed a new draft
in December 1995. This latter proposal gathered ethical elements required, as well
as, technical provisions. The Commission had queried the European Group on
Ethics in Science and New Technologies about the compatibility of the directive
with the main ethical principles. Twice, the European Group asserted the said
67
Chemtob-Concé M. C. et Gallochat A., Le Brevetabilité des inventions technologiques appliquées
à l’homme. (Ed. Lavoisier, Tech & Doc, Paris 2ème ed., 2004) 54
29
compatibility68. However, even if, at the European level, the final draft of the
directive seemed to represent a uniform opinion, it appears, when looking at national
and ethical committee reports, that the situation is more complex. On June 8th, 2000,
the French national advisory committee of ethics69 advised the French government
to “start a new discussion about the terms of the directive”. Despite the adoption of
the directive, conflicts and diverging opinions remained. As far as ethical issues are
concerned, the conflict concerned three main points such as the noncommercialisation of the human body, the free access of the knowledge of gene, and
the sharing of this knowledge. In France, this opposition has been strengthened by
the opinion of the Parliamentary Agency on the Evaluation of Scientific and
Technological Choices70. At the judicial level, these diverging opinions and even
criticisms have been expressed by the action for cancellation brought by the
Netherlands, supported by Italy and Norway, before the European Court of Justice
on October 19th, 199871. The most important point is maybe the quickness of the
various reactions. The criticisms did not concern the patent system as such, or its
applications to living organisms. They mostly concerned what could be claimed
saved for the patentability exclusions of human beings, plant and animal varieties72.
Despite ten years of discussions and apparent agreements, signs of oppositions and
disagreements started to rise straight after the adoption of the directive. This paper
68
Opinion n°3 of September 30th 1993 on the ethical questions raised by the commission proposal of
a directive on the legal protection of biotechnological inventions, and the opinion n° 8 of September
25th 1996 as to the ethical aspects of the patentability of inventions based on human elements.
69
Opinion n°64 on the law proposal to implement the European directive on the legal protection of
biotechnological inventions
70
Opinion given on december 20th, 2001
71
ECJ, October 9th, 2001, aff. C-377/98, Kingdom of the Netherlands c/ European Parliament and
Council of the European Union, JCP 2001 éd. E., n°42
72
Ilbert H. & Tubiana L., Protection juridique des inventions biotechnologiques : analyse de la
directive européenne et propositions, (SOLAGRAL collection réseaux biotechnologiques, 1992) 6
30
can not stress all the differing opinions that may have existed after the adoption of
the Directive. However, such differing opinions have been substantial, and prove the
dissatisfaction members felt. This dissatisfaction was, indeed, so deep-seated that
the intervention of various jurisdictions appeared necessary to give further authority
to the directive.
3.
The validity of the directive, which can not be questioned any longer,
despite the hostility of some Member States.
Various Member States tried to challenge the directive, first before the ECJ, and
then before their national constitutional court. However, the legality of the directive
was strengthened and its implementation became unavoidable.
3.1
The ECJ decision (ECJ, October 9th, 2000, C-377/98) or the
assertion of the validity of the directive.
We need to keep in mind that the directive applies patent law to living organisms.
Moreover, article 5 makes genes the legal stand for patentability. This provision has
been at the origin of many disputes73. In a sentence, the compromise found in the
directive failed to satisfy all Member States. Thus, on October 19th, 1998, less than
four months after the adoption of the Biotechnological Directive, the Netherlands
brought an action for cancellation before the ECJ under article 173 of the European
73
Le Gal C., La contestation de la directive relative à la protection des inventions biotechnologiques,
la fin des espérances françaises? , (2005), La Semaine Juridique Edition Générale n°11, 16 mars
2005, I 120
31
Convention (now article 230 of the European Convention)74. Some other countries,
such as Italy, and Norway, intervened in support of the Netherlands75. The
Netherlands brought six pleas76. First, they claimed that the directive was contrary to
the principle of subsidiarity77. Then they argued that it infringed the principle of
legal certainty that it was incompatible with obligations in International Law that it
had not been adopted properly, and finally, they claimed that the directive amounted
to the reification of the human material, and thus did not respect the fundamental
right of human dignity. In its decision, rendered on October 9th, 2001, the ECJ held
that the directive framed patent law in such a rigorous way that the human body
remained inalienable, and thus, human dignity was preserved. Consequently, the
ECJ dismissed the claim and declared the Directive valid. The ECJ also asked
Member States to implement it within the time limit set up to do so. Indeed, on July
10th, 2003, the European Commission decided to take action against the 8 Member
States which had not implemented the directive yet.
However, despite this assertion and this hardening behaviour of the ECJ, many
doubts remained. For instance, in France, political authorities questioned the
The Treaty establishing the European Community, article 230. “The Court of Justice shall review
the legality of acts adopted jointly by the European Parliament and the Council, of acts of the
Council, of the Commission and of the ECB, other than recommendations and opinions, and of acts
of the European Parliament intended to produce legal effects vis-à-vis third parties.” Official Journal
C-325of 24 December 2002
74
75
ECJ,October 9th, 2001, aff. C-377/98, Kingdom of the Netherlands c/ European Parliament and
Council of the European Union, JCP 2001 éd. E., n°42
76
ECJ,October 9th, 2001, aff. C-377/98, Kingdom of the Netherlands c/ European Parliament and
Council of the European Union, JCP 2001 éd. E., n°42
77
According to this principle, the EU may only act (i.e. make laws) where member states agree that
action of individual countries is insufficient. The principle was established in the 1992 Treaty of
Maastricht.
32
European Commission twice about the scope of article 578. The aim was to specify
the scope and authority of claims on sequence or partial sequence of human genes.
Indeed, while taking into account the decision of the ECJ, it appears that the Court
analysed the directive first in relation with the state of biotechnological industry in
Europe, instead of looking at its role in society79. When characterising the directive,
the Court had considered biotechnology primarily as an industrial rather than an
ethical or social issue80. Consequently, this approach raised more questions than
answers about the content of the directive itself. However, this decision enabled the
directive not to be challenged anymore, and to have a complete authority within
European law. Nevertheless, some Member States tried to challenge the validity of
the directive before their constitutional court, recourse which proved to be useless
given the legal force of the directive.
3.2
A directive which can not be challenged at a national level either
and, which has to be implemented.
We can take the example of France and its refractory reaction against the directive
once it was adopted. This example can be interesting and relevant given that during
the 10 years of discussions, France had always supported the European Community
to draft the directive and had always voted in its favour at the European Council.
78
Letters from the French President to the President of the European Commission in June 2000 and
february 2001.
79
MacLaren M., Patently Unsatisfactory ?: community Legislative competence and the ECJ Biotech
Decision, German Law Journal No 18 (01 December 2001) European and international law.
80
MacLaren M., Patently Unsatisfactory ?: community Legislative competence and the ECJ Biotech
Decision, German Law Journal No 18 (01 December 2001) European and international law. “The
Court held that biotechnological innovations was fit for regulation under a conventional intellectual
property regime, that the Directive’s primary intent was harmonisation for the well-functioning of
the internal market and that harmonisation was effected only by clarifying existing national
legislation.”
33
However, the implementation of the directive was carried out with fifty three
months of delay, after a conviction for breach81, and the threat of financial
penalties82 under article 228 of the European Convention. In 2002, fearing the
European sanctions, a bill was introduced to the Parliament. Nonetheless, some
members tried to challenge the said proposal, asking for a judicial review of the bill
implementing the directive. In its decision rendered on July 29th, 2004, the French
Constitutional Court asserted the compatibility and legality of the bill 83.
Thus, despite an attempt to challenge the directive before the ECJ 84, to challenge the
implementing bill before the Constitutional Court85, to have another discussion
before the European commission86, and even despite petitions87 and negative
opinions of national groups of ethics towards some provisions of the directive 88, its
implementation as well as its legal effects appeared to be unavoidable.
The directive entered into force in July 30th, 1998, and despite its non
implementation, started to create national and international effects. At a national
level, the directive had some legal effects even if it had not been implemented
81
ECJ, July 1st, 2004, case C-448/03
82
Letter from the European Commission to the French government on October 5th, 2004
83
Cons. Const., July 29th, 2004, dec. N° 2004-498 DC, JO n° 182 of august 7th, 2004, p.14077
84
ECJ,October 9th, 2001, aff. C-377/98, Kingdom of the Netherlands c/ European Parliament and
Council of the European Union, JCP 2001 éd. E., n°42
85
Cons. Const., July 29th, 2004, dec. N° 2004-498 DC, JO n° 182 of august 7th, 2004, p.14077
86
Opinion n°64 on the law proposal to implement the European directive on the legal protection of
biotechnological inventions
87
Petition draft by the members of parliament Jean-François Mattei and W. Wodarg in April 2000
which wanted to create an opposition to the patentability of human genes
88
Opinion n°64 on the law proposal to implement the European directive on the legal protection of
biotechnological inventions
34
within the time limit, which means within July 30th, 2000. Moreover, according to
the Marleasing case89, national jurisdictions have to construe national legislation
with regard to the European directive even if the latter has not been implemented
yet. Finally, according to the Région Wallonne case90, Member States have to avoid
drafting legislation which could endanger the implementation of the Directive.
Despite all the efforts made either to avoid the implementation of the directive, or to
slow down the mechanism of implementation, the European legal text had to be
implemented.
Through this paper, we have shown the clear reluctance of Member States to
implement the directive. The reasons of such opposition are still obscure; however
the approach of the European Commission and of the ECJ, which is to consider the
protection of biotechnological inventions as more a technical issue than an ethical or
social one, may represent the start of an answer. To know more about this essential
point, it is however necessary to enter more deeply into the content of the directive.
Two main issues have to be studied more carefully, the patentability of living
organisms and the rights granted to the patentee.
89
ECJ, November 13th, 1990, case C-106/89, Marleasing SA, rec. ECJ, I, 4132
90
ECJ, march 31st, 1997, case C-129/96, region wallonne, rec. ECJ, I, 7411
35
CHAPTER II
THE PATENTABILITY OF LIVING ORGANISMS: A DIFFICULT
DISTINCTION BETWEEN INVENTIONS AND DISCOVERIES
The directive 98/44/EC of July 6th, 1998, was greatly motivated by the political will
of the European Union to encourage investments and research in biotechnologies.
Public authorities, whether national or European, considered that patent law
represented the best system to protect biotechnological inventions. To be
competitive in this field, the directive was deemed to be similar to the legislation of
the United States and Japan. Consequently, the European text was drafted to be first
a commercial piece of legislation. However, on July 30th, 2000, time limit to
implement the directive, only Denmark had respected its commitments. This
reluctance was first due to the provisions on the patentability of living organisms.
Two main legal issues appeared particularly sensitive. The distinction between
discoveries and inventions was the first sign of a differing opinion and, thus,
diverging implementation of the directive. Following this sign, the patentability of
inventions including human biological material has been at the heart of the conflict.
1- Patent law applied to living organisms: a regime to study
Genetic manipulations are used in many industrial applications. However, this
evolution towards the development of biotechnologies gave rise to some questions.
To be part of the economic leaders throughout the world, it was necessary to find a
system which could protect the investments made in biotechnological research.
However, to promote innovation, the system should allow the free access to
knowledge. Thus, the European Commission chose the patent system.
36
1.1
The choice of the directive: patent law
Given the substantial sum invested, companies developing biotechnological
processes and products wanted a return of the said investments. Faced to this
economic pressure, the Intellectual property protection was thus considered as the
only efficient system able to give such guarantees. Before the submission of the first
proposal to the European Parliament in 1988, the question was to know which
system had to be chosen. Either the European Community set up a new system, what
we call a “sui generis” system, changing the existing legal principles or creating new
ones, or they applied one of the regimes of intellectual property law. With this latter
possibility, only few modifications were necessary as well as the adding of new
criteria. These new provisions specific to biotechnological inventions would have
nonetheless coexisted with either patent law or law applied to plant varieties.
To face competitiveness and to provide a similar protection of biotechnologies to the
United States and Japan, an intellectual property right was chosen91. Patent law, a
system originally applicable to inert inventions, was identified as the adequate
protection. This opinion was asserted by the International Society for the Protection
of Intellectual Property in Rio in 1985 and by the World Intellectual Property
Organisation92. A patent is defined as the grant of a monopoly, for a limited period
91
Chemtob-Concé M. C. et Gallochat A., Le Brevetabilité des inventions technologiques appliquées
à l’homme. (Ed. Lavoisier, Tech & Doc, Paris 2ème ed., 2004)
92
WIPO, Revised suggested solutions concerning intellectual property protection of biotechnological
inventions, document Biot/ce/IV/3/WIPO, Geneva, 1988
37
of time, to an inventor who has invented something new93. However, even if the
great principles were applicable to biotechnological inventions, some provisions
needed to be added to give a reliable scope to the protection of biotechnologies.
Furthermore, patent law seemed to be the appropriate legal regulation, given the
international agreements already existing in this field94. With major international
agreements using patent law as the legal system regulating and protecting
biotechnologies, creating a sui generis system would have been an awkward choice.
Indeed, this new form of regulation would not have fulfilled the international
requirements. Biotechnologies represent an international economic field, especially
with the strong influence of the United States and Japan. Thus, any legislation
chosen would have had to cover, not only Europe, but also the United States and
Japan. Consequently, a different system from patent law would have probably led
the EC to take the risk to be left aside from the leaders of the new technologies.
Following the international line and giving way to the economic pressure, the
European Commission drafted its first proposal in 1988, stressing patent law as the
legal system deemed to protect biotechnologies. The Biotechnological Directive
adopted in July 1998 clearly applied patent law to biotechnologies to protect them.
Thus, the way patent law may be applied to biotechnological inventions is essential
to examine.
1.2 The conditions of patentability applied to living organisms.
93
Torremans P., Holyoak & Torremans Intellectual Property Law, 4th edition (Oxford University
Press, 2005)
94
Chemtob-Concé M. C. et Gallochat A., Le Brevetabilité des inventions technologiques appliquées à
l’homme. (Ed. Lavoisier, Tech & Doc, Paris 2ème ed., 2004)
38
Patent law is dependent on several conditions. For a patent to be granted, the subject
matter of the invention must be patentable, and the invention must comply with
three major requirements. This rule is common to any legal system applying patent
law95. The patentability of living organisms is an issue which has been dealt with in
the directive and which has been at the origin of many criticisms. Before studying
the main conflicting points of the directive, it seems necessary to explain the basic
principles of patent law, applied to any invention. First of all, the subject matter
must be patentable.
1.2.1. a patentable subject matter
The subject matter patentability, under the European Patent Convention and thus
under the patent act and the French intellectual property code, is restricted by four
requirements.
First of all, in every legal system, patent law provides a non-exhaustive list of
products or processes which are not regarded as inventions and thus can not be
patentable. The list is provided in article 52 of the European Patent Convention.
This section has been introduced into national legislation, among which the French
and British legislation. According to this provision and especially to its paragraph
(b), any “literary, dramatic, musical or artistic work or any aesthetic creation” is
not patentable. This provision can be easily understood given that such creations are
already protected by the copyright system. Consequently, this limitation expressly
avoids an unnecessary additional protection. Moreover, it excludes any “scheme,
rule or method performing a mental act, playing a game or doing business, or a
95
For instance, in English law, this rule is stated in section 1(1) of the 1977 Act and in French law, it
is stated in section L611-10 of the Intellectual Property Code. Both sections are based on section 52
of the European Patent Convention.
39
program for a computer” in its paragraph (c) as well. Within the EU, patents are
deemed to protect any “technical” invention. Consequently, contrary to the U.S, any
rule amounted to a mere abstract method can not be patented. This paragraph can be
related to the first one which states that any “discovery, scientific theory or
mathematical method” is excluded from patentability. These exclusions from
patentability follow directly from the requirement of industrial application,
examined here-under. Patents do not protect abstract and intellectual inventions in
nature, which are not susceptible of any technical and concrete application.96 The
same approach has been retained for any “presentation of information” in paragraph
(d)97.
Moreover, a patent can not be granted for immoral inventions or inventions which
are contrary to public policy98. This section was first applied, in the EPC, in the
Onco-mouse case in 198999. The EPC chose a utilitarian approach to this
requirement. It balanced the sufferance inflicted to animals as well as the harm
caused to the environment with the usefulness of the invention to mankind. This
provision has been subsequently applied in several cases such as in the Relaxin
case100 and in the Plant Genetic System Decision101. Through these cases, it became
particularly clear that the balancing test was not the only approach to article 53 (a).
96
Bentley L, Sherman B, Intellectual Property Law, (Oxford University Press, 2nd edition, 2001)
97
European Patent Convention, article 52. d
98
European Patent Convention, article 53 (a), section L611-10 of the French Intellectual Property
Code, and Patent Act, section 1 (3) introduced by the Patent Regulations 2000 (SI 2000/2037) While
this provision was rarely used in the past, it took a new importance with the emergence of
biotechnologies. The Patent Regulations added some new exclusions relating to immoral biological
inventions, which can not be patented. This provision is strongly related to ethical considerations.
99
Harvard/ Onco-mouse [1990] EPOR 4
100
Howard Florey/ Relaxin, T74/91 [1995] EPOR 541
101
Plant Genetic System [1995] OJEPO 545
40
The biotechnological directive has a significant impact on this section.
Consequently, the said limitation gained another meaning with the emergence of
modern biotechnological inventions. Moreover, this conflict between patent law and
ethics was one of the main reasons of the differing implementation of the directive
in France and in the UK, issue which will be examined later on.
Furthermore, according to the general requirement of patent law, a patent can not be
granted for “any variety of animals or plants, not being a microbiological process
or the product of such process”102. This section points out the fact that patentability
can not be denied because of the solely biological nature of an invention.
Consequently, animals and plants may be patentable as long as it does not amount to
the patentability of a variety. This eventuality was introduced, and clarified with the
biotechnological directive, in section 4 (2). This issue of a patentable subject matter
gave rise to many conflicts within the European Community while drafting the
directive. Indeed, this topic concerns mainly ethical issues, which adds more
complexity to the protection of biotechnological inventions103.
Finally, the invention must be capable of an “industrial application”. However, this
requirement has a special meaning in patent law, especially for biotechnologies.
Given the complexity of the issue at stake, this requirement will be examined in the
following paragraph.
1.2.2
An industrial application
102
European Patent Convention, article 53 (b), section L611-17 of the French Intellectual Property
Code and Patent Act, schedule A2, paragraph 3 (f)
103
L Bentley and B. Sherman, Intellectual Property Law, (Oxford University Press, 2nd edition)
« What is most striking about the interaction of patent law and ethics is how unconfortable the
relationship has been and the difficulties that it has produced »
41
For an invention to be patentable, it must be capable of “industrial application”104.
A patent should not be granted for purely abstract creations. An invention is said to
meet the requirement of industrial application when it can be used or made in any
kind of industry. Industry is construed quite widely including all activities, whether
for profit or not. Moreover, there is no need to show actual use. It means that an
invention must have the potential to be applicable in an activity. This requirement is
clearly applicable to any biotechnological inventions without any difference as to
their specific nature. This last requirement is particularly important for biological
research. For instance, it happens that researchers identify genes belonging to the
human genome without being able to stress the role of such genes. This function is
what we call the useful purpose of the invention. Without the latter, it is most of the
time impossible to determine any industrial application of the invention. In this case,
the invention can not meet the last requirement and is thus not patentable105. This
legal point is reinforced in the Biotechnological Directive 98/44/EC. As recital 23
explains, a mere DNA sequence without any determined function can not be
patentable because it lacks industrial applications106. Far from creating another
requirement, the directive strengthens the one already existing to clarify the status of
biotechnological inventions107. But this requirement still gives rise to criticisms and
104
Patent Act, section 1 (1) (c), section L611-15 of the French Intellectual Property Code, and
European Patent Convention, article 52 (1)
105
Bently L., Sherman B., Intellectual Property Law, (Oxford University Press, 2nd edition, 2001)
385-88
106
Biotechnology Directive, Recital 23
For instance, if a gene is used to produce a protein, the said gene would meet the requirement of
industrial application only if it determines which protein it creates, or the function it performs. Thus,
it would be necessary to show a biological function such as a therapeutic use or another function such
as a diagnostic use.
Icos Corporation/ Seven transmembrane receptor [2002] OJEPO 293. “DNA sequences with
indications of function which are not substantial, specific, and credible shall not be patentable
inventions according to Article 52 (1) EPC” The Opposition Division at the EPO applied this
approach in the Icos Corporation case to deny a patent. In this case, the polynucleotide encoding for
107
42
questions. It is argued that once a specific function was determined, the patentee
was granted IPRs for any function of his patented gene. Authors denounced the lack
of symmetry between the function, and the scope of the monopoly granted to the
patentee. Given that this assessment will be analysed more deeply later on, few
observations will be made on this particular point in this part.
Consequently, it appears that the European Commission has chosen to apply patent
law to biotechnological inventions to secure its protection. Doing so, the directive
left the basic principles untouched and even strengthened them to fit this specific
field of technology. Some key notions have nonetheless generated difficulties. In
this respect, we will keep studying the last requirements such as novelty and the one
of inventive step as well.
1.2.3
novelty
The third requirement is novelty. In English law, it means that “an invention shall
be new if it does not form part of the state of the Art108”. Patents are granted for
products and processes which are not pre-existing. If they were previously available
on the market, they are considered as being part of the state of the art. In other
words, they are considered as being part of common knowledge. The state of the art
is defined in the Patents Act and in the European Patent Convention as representing
all matter which, at the priority date of the application, has been made available to
the amino acid sequence of the V 28 protein, which had been purified and isolated, had not any
industrial application because its function could not be identified.
108
Section 2 (1) of the 1977 Patents Act
43
the public by any means109. The term “all matter” includes any product, any
process, any information or anything else. There is no geographical boundary to the
state in the art, which means it concerns for example any matter in the UK or
anywhere else. Moreover, the said description can be made in any way whether
written or oral. Finally, the priority date is the date on which the application was
made. Consequently, if an invention is not new, with regards to the special meaning
patent law gives to this word, no protection whatsoever can be granted110. This
requirement ensures that patents do not stop people from using and exploiting what
already existed before the grant of the patent111. Even if some provisions have been
modified to fit the specificities of biotechnological inventions, broadly speaking
they are treated in a similar manner to other inventions. This principle can seem
obscure when biotechnological inventions are based on natural materials. In such a
case, surprisingly, a natural substance which has been isolated for the first time will
not lack in novelty even if it is a living, and thus natural, element112. It will be
considered as novel. The artificial nature of the isolated substance shows a sufficient
difference between an invention and the state of the art.
1.2.4
An inventive step
109
Patent Act 1977, section 2 (2) , section L611-11 of the French Intellectual Property Code, and
European Patent Act, article 54 (2)
110
Torremans P., Holyoak & Torremans Intellectual Property Law, 4th edition (Oxford University
Press, 2005) 53
111
See, e.g. Asahi’s Application [1991] RPC 485 (HL)
Howard Florey Institute’s application T74/91 [1995] OJEPO 388. For instance, a polynucleotide
sequence which has been isolated for the first time and which already existed in the human genome
(nature) will still be considered as novel. The main reason is that patent law draws a distinction
between the isolated polynucleotide, considered as an invention, and the natural substance which is
the polynucleotide which exists in the human genome and which is not isolated (natural).
112
44
The forth requirement is the inventive step. To be granted a patent, the invention
must involve an inventive step. This requirement, once again, is generally accepted
in national, European and international law113. An invention is said to involve an
inventive step if it is not obvious for a man skilled in the art. This person is an
ordinary worker in the field. He is supposed to have the attributes, skills,
knowledge, and qualifications to the field in which he works. This requirement of
non-obviousness ensures that only “meritorious” inventions are granted
protection114. To harmonize the differing approaches to obviousness or inventive
step, the European Patent Office (EPO) developed an objective approach to the
assessment of the inventive step which was also economical and transparent. The
approach which has been chosen is “the problem and solution” one. It is based on
the idea that an invention gives a solution to a specific problem. Accordingly, rather
than asking whether an invention is obvious, the EPO asks whether the solution the
invention provides, would have been obvious to the person skills in the art at the
priority date. This approach is not the only one to test the requirement of
obviousness. However, it is used in most cases. Despite some criticisms, the
problem and solution approach is still the “chief way in which inventive step is
determined at the EPO”.115 However, it has to be noted that this approach has not
113
Patent Act, section 1 (1) b , section L611-14 of the French Intellectual Property Code, the
European Patent Convention article 52 (1) and the TRIPS agreement, article 27(1)
114
Bently L., Sherman B., Intellectual Property Law, (Oxford University Press, 2nd edition, 2001)
471-71 For instance, it is commonly accepted that a variant of an old idea which is more or less selfevident can not be provided a protection.
115
Bently L., Sherman B., Intellectual Property Law, (Oxford University Press, 2nd edition, 2001)
471-71
45
been adopted by UK courts116. In spite of this, the requirement remains the same for
any jurisdiction and for any invention, including biotechnological inventions.
Consequently, it appears that the European Commission has chosen to apply patent
law to biotechnological inventions to secure its protection. Doing so, the directive
left the basic principles untouched and even strengthened them to fit this specific
field of technology. Some key notions have nonetheless generated conflicts.
Accordingly, the patentability of living organisms as subject matter, and especially
the patentability of human elements will be examined.
2
The shy implementation of the distinction between discoveries and
inventions in French law.
In this main section, the purpose of the distinction has to be explained. Indeed, the
distinction can be very subtle to make when applying to biotechnological inventions
and especially to genes.
2.1
The purpose of the distinction.
2.1.1
the directive
As it has been previously stated, the first condition an invention has to fulfil in order
to be protected by a patent is the condition of the patentability of its subject matter.
116
Whereas these provisions were deemed to set up a harmonised construction of the said
requirement among EPC states, inventive step appears to be an area of law where British Courts have
taken little notice of EPC case law. See Hallen v. Brabantia [1991] RPC 195, 212
46
The line between inventions and discoveries is one of the main criteria, especially in
biotechnology, to determine if an invention is patentable. This distinction is set up in
article 5 (1) and 5 (2) and recitals 16, 20 and 21 of the biotechnological directive.
The main principle is that discovering is not creating. To have a patent granted, a
human intervention with some creative skills is necessary. Highlighting what
already exists in nature is not invention117. Article 5 first explains that the human
body, at the various stages of its development and the discovery of one of its
elements, including the sequence or partial sequence of gene, are not patentable118.
As the report of the European Commission stresses, neither the human genome in its
natural state, nor mere information about it can be considered as patentable
inventions119. Article 5.2, which leads to many criticisms and complications, sets
down the principle according to which, an element isolated from the human body or
otherwise produced by a human process, may constitute a patentable invention.
According to the European Commission, this rule does not contradict the first
paragraph of the same article120. Indeed, the European Commission construes article
5.2 in the light of recital 21, stating that an element from the human body, including
a sequence or partial sequence of a gene, can be patentable if, and only if, such an
element is the result of technical processes. For instance, to be patentable such
sequence would need to be identified, purified, characterised and multiplied outside
117
For instance, cross breeding without any human intervention can not be considered as an
invention.
118
Biotechnology Directive, article 5
119 Report of the European Commission to the Council and European Parliament, “development and
implications of patent law in the field of biotechnology and genetic engineering”, commission of the
European Communities, Brussels 7.10.2002, COM (2002) 545 final, 16-23 available on
http://europa.eu/eur-lex/en/com/rpt/2002/com2002_0545en01.pdf
Report of the European Commission to the Council and European Parliament, “development and
implications of patent law in the field of biotechnology and genetic engineering”, commission of the
European Communities, Brussels 7.10.2002, COM (2002) 545 final, 17 available on
http://europa.eu/eur-lex/en/com/rpt/2002/com2002_0545en01.pdf
120
47
the human body. Doing so, the sequence or partial sequence at stake would not be a
discovery anymore, because it would not be available in nature as such. Here, the
human intervention is considered as an essential requirement. As the European
Commission assesses, “such techniques can not be found in nature”. It could thus
be said that human elements lose their status of natural elements and become
inventions because of the human intervention. It is because of genetic engineering
and because of the technical processes used on the natural element that this element
changes nature and become artificial. Through man’s intervention, it becomes an
invention.
Many international agreements as well as national legislations draw this legal line
between discovery and invention. Highlighting this distinction, the Biotechnology
Directive tries to comply with further international legal texts and with Member
States legal principles.
2.1.2 A distinction preceded by foreign legislation.
This distinction between discovery and invention, in biotechnology, can be found in
many international agreements. Of course, all these conventions do not concern
patent law, and their legal aim is not to protect biotechnologies, but the interest
given to discoveries is similar. For instance, the directive can be construed as
following article 4 of the UNESCO declaration on the human genome. This
declaration is first aimed at avoiding any financial gain taken from the natural state
48
of the human genome121. In the same way, the distinction made in the biotechnology
directive can be found in the Joint Declaration on the Human Genome made in 2000
by Prime Minister Blair and President Clinton122.
Moreover, this distinction is not a new idea. Case law, from the EPO, the UK, and
France shows this distinction as a prerequisite to any patent. For instance, in its
guideline, the EPO has suggested that an application could succeed in being granted
a patent, only if an invention was disclosed123. In the UK, two main decisions have
set down this distinction. Genentech v. Wellcome124 and Biogen v. Medeva125. Even
if, the question whether the applicant had to show that the subject matter of his
application was an invention has been left unanswered. The interest of the said
distinction and its importance has been highlighted. Consequently, it would be
particularly surprising if a patent would be granted on a material which would turn
out to be nothing more than a mere discovery, or which would give rise to serious
uncertainties as to its “inventive” nature. Consequently, the directive tried to set
down this distinction to secure the integrity and inalienability of natural elements,
especially human elements, given the political sensitivity of the subject. Even before
the draft of the directive, the distinction already existed in practice. For instance, in
121
UNESCO Universal Declaration on the Human Genome and Human Rights, adopted on the
report of commission III at the 26 th plenary meeting, on 11 November 1997, article 4 « The human
genome, on its natural state, shall not give rise to financial gains”
122
Joint Declaration made by videoconference from the White House on March 14, 2000. In this
declaration, Prime Minister Blair and President Clinton promoted the free access to the human
genome in order to have the results of the genetic sequencing available to other scientists. However,
they did not want to challenge the possibility of a patent once the conditions would be gathered.
Once again, the line between inventions and discoveries was underlined to find a balance
between the protection of biotechnological inventions, and thus investments, and the need to
keep discoveries available to the scientific community and encourage further innovations.
123
EPO guideline, C-IV, 1.1, 2.2; EPC rr. 27 and 29
124
Genentech’s Patent [1989] RPC 147, 262 (Mustill LJ)
125
Biogen v. Medeva [1997] RPC 1, 31 (Lord Mustill)
49
the Relaxine case126, the EPO considered that the DNA molecule did not represent
life but was a mere chemical molecule and had to be treated as such by patent law.
The directive tried to strengthen and develop in all Member States the legalisation of
this practice.
However, the line drawn by the Biotechnology Directive led to many difficulties
and uncertainties. Indeed, diverging implementations can be noticed in French and
UK law.
2.2 The strong opposition of French law to article 5 of the biotechnology
directive.
The biotechnological directive was implemented after 53 months delay with two
main statutes. First, the provisions concerning inventions related to the human body,
its elements and products were included in the Intellectual Property Code (IPC) by
the statute of August 6th, 2004.127 This statute mainly implements article 5128 and
6129 of the directive. The other provisions have been implemented in the statute of
December 8th, 2004.130
126
EPO, Relaxine case, December 8th, 1994, D. 1996, p 44
127
Statute of August 6th, 2004, n° 2004-800
Biotechnology directive 98/44/EC of July 6th, 1998, article 5. “ 1. The human body at the various
stage of its formation and development, and the simple discovery of one of its elements, including the
sequence or partial sequence of a gene, cannot constitute patentable inventions.
2. An element isolated from the human body or otherwise produced by means of a technical process,
including the sequence or partial sequence of a gene, may constitute a patentable invention, even if
the structure of that element is identical to that of a natural element.
3. The industrial application of a sequence or a partial sequence of a gene must be disclosed in the
patent application”
128
Biotechnology directive 98/44/EC of July 6th, 1998, article 6 “1 Inventions shall be considered
unpatentable where their commercial exploitation would be contrary to ordre public and morality;
however, exploitation shall not be deemed to be so contrary merely because it is prohibited by law or
regulation.
2.On the basis of paragraph 1, the following, in particular, shall be considered unpatentable:
129
50
2.2.1
The patentability of some specific biological elements:
discovery or invention?
The distinction between discovery and invention was set down in article 5 of the
Biotechnological Directive. The questions coming from the implementation of this
latter article concerned mainly the patents granted for genes or DNA sequences and
other similar biological elements. This difficulty in setting the distinction led to the
non implementation of article 5.2 as well as article 3.2131 of the directive 98/44/EC
in French law. This refusal to implement this part of the directive shows a rejection
of the possibility to grant a patent on a biological element which has been isolated.
This legal loophole in the law of August 6th, 2004 has been said to be in complete
contradiction with the “clear and unconditional” provisions of the directive132.
This reluctance could be partly explained with the statute of July 29th, 1994
concerning the gift and the use of the elements and products of the human body as
well as the knowledge of the sequence or partial sequence of genes 133. According to
this statute, these elements could not, as such, be the subject matter of a patent. This
(a) processes for cloning human beings;
(b) processes for modifying the germ line genetic identity of human beings;
(c ) uses of human embryos for industrial or commercial purposes;
(d) processes for modifying the genetic identity of animals which are likely to cause them suffering
without any substantial medical benefit to man or animal, and also animals resulting from such
processes”
130
Statute of December 8th, 2004, n° 2004-1338
Biotechnology directive 98/44/EC of July 6th, 1998, article 3.2 “Biological material which is
isolated from its natural environment or produced by means of a technical process may be the
subject of an invention even if it previously occurred in nature”
131
132
Cons Const. July 29th, 2004, decision n° 2004-498 DC, JCP 2004, II, 10167
133
Statute of July 29th, 1994, n° 94-653
51
provision which had been included into the IPC was modified with the
implementation of the Biotechnological Directive. Indeed, the new provisions left
aside the exclusions of the products of the human body and its elements. With the
clear formulation of the directive, the statute had to be changed.
Consequently, section 17 of the statute of August 6th, 2004 used article 5.1 of the
directive to exclude the mere discovery of an element of the human body. This
principle includes the sequence or partial sequence of a gene. Thus, even if it
appears that living organisms are mostly patentable; this patentability is strictly
controlled. This scope of limitation led to many questions as to the conformity of
French law with the biotechnological directive on this issue134.
2.2.2
The patentability of human elements: a source of uncertainties
in French law which could lead to its non-conformity with the
Biotechnology directive
Taking into account the elements above, article 17 of the statute of August 6th, 2004
banned what the European text allowed as to the patentability of a sequence or
partial sequence of a gene. In this section, French law suppressed the terms “An
element isolated from the human body or otherwise produced by means of a
technical process”, notions essential to allow the patentability of elements, such as
sequence or partial sequence of genes. As previously mentioned, the term “isolated”
asserts a human and technical intervention on the element. The genetic or other
material coming from this “isolation” would not have anything in common with its
Leca A., La question de la brevetabilité du “matériel génétique” d’origine humaine est-elle réglée
avec l’article 17 de la loi n° 2004-800 du 6 août 2004 ? (2005) , Les Petites Affiches, 18 février 2005,
n° 35, p. 63
134
52
natural state. This material, even similar to the natural element, would not exist in
nature as such and would represent an invention. But article L.611-18 of the IPC
states that the industrial application of an invention based on a function of an
element of the human body have to be precisely and concretely expressed in the
application. Doing so, a patent has effects on an element of the human body so far
that it is necessary to the realisation of a particular industrial application 135. It means
that the patent would be limited to the function of the gene which allows the
industrial application and not to the gene itself. The sequence or partial sequence of
the gene would become only the medium of an industrial application, deduced from
its determined function. Consequently, the suppressions of some notions in the
article 17 of the statute of August 6th, 2004, as well as its additional limitations
distort the meaning of the Biotechnological Directive as explained above. It also
leads to a partial implementation which does not comply with the directive as to the
subject matter which is patentable136.
2.2.3
The French arguments in favour of a non compliance with
article 5 of the Directive.
France was not the only country to contest the merits of the Biotechnological
Directive. However, because of its statute of 1994 on bioethics, French law was
considered to have foreseen the legal evolution of biotechnologies137. The French
135
Le Gal C., La contestation de la directive relative à la protection des inventions
biotechnologiques, la fin des espérances françaises? , (2005), La Semaine Juridique Edition Générale
n°11, 16 mars 2005, I 120
136
Le Gal C., La contestation de la directive relative à la protection des inventions biotechnologiques,
la fin des espérances françaises? , (2005), La Semaine Juridique Edition Générale n°11, 16 mars
2005, I 120
137
Statute of July 29th, 1994, n° 94-653
53
opposition is mainly based on the ethical principles laid down in its statute of 1994.
Indeed, the provisions of the directive contradict the French bioethical principles of
1994. The latter forbids the patentability of “the knowledge of the complete or
partial structure of the human gene as such”. This ban was motivated by public
ordre and good character138. The intent of the French legislator was clearly to
prevent the extension of patentability to genetic sequence139. Faced with these
principles, the 98/44/EC directive created strong opposition. The origins of the draft
of this statute on bioethics and a fortiori of the French opposition to the directive
were technical as well as ethical. The argumentation was based on several points.
The non commercialisation of the human body is a fundamental principle in ethics.
It partly led to a refusal to have a product applicable to genes qualified as an
invention. But we first have to deal with the cornerstone of the arguments which is
the free access to the knowledge of genes seen as a basic principle to protect140.
First of all, the Statute was drafted to avoid a situation of innovation jamming. If a
patent was granted on a sequence or partial sequence of a gene, even isolated and
thus coming from technical processes, companies would have to obtain a licence to
research such elements. Consequently, their research would often have been
dependent on the will of their competitors. Furthermore, additional costs would have
had to be included to pay the licensing fees, which could be extremely expensive. It
138
IPC, section L. 611-17
139
Le Gal C., La contestation de la directive relative à la protection des inventions biotechnologiques,
la fin des espérances françaises? , (2005), La Semaine Juridique Edition Générale n°11, 16 mars
2005, I 120
140
Gaumont-Prat H., Loi de bioéthique et droit des brevets: alliance féconde ou liaison difficile? la
pénultième péripétie de la transposition de la directive (CE) 98/44, (2005), Les Petites Affiches, 18
février 2005, n° 35, p. 51
54
is exactly the debate which arose with the Myriad Genetics case141. The EPO had
granted two patents to Myriad Genetics, an American biotechnology company. They
had identified and sequenced two breast cancer genes. Consequently, any research
and process developed on these genes led to the draft of a licence. The Institute
Curie in Paris alleged to be prevented from finding another maybe more efficient
and cheaper process to detect breast cancer on the said genes because of the
“exceptionally” broad patent granted to Myriad Genetics. This legal impediment
would have as a consequence to hinder innovation instead of encouraging it. With
such a legal barrier, biological elements included in a patent would be under
exploited because of the prohibiting prices of licensing. This obstruction to
innovation would furthermore lower the concerns for public health and increase the
one of private interests.
Furthermore, when considering the basic principles of patent law, French opponents
to the directive alleged that the automatic cloning of a gene became so frequent that
it lost its innovating character142. Moreover, it happens that the industrial application
of the said gene represents a mere deduction or supposition. In such a case, a patent
can not be granted, the subject matter of the “invention” lacking of industrial
applicability.
As a result, this opposition led to the non implementation in French law of articles
3.2 and 5.2 of the Biotechnological directive. Moreover, Recital 21, which explains
141
Jon Henley, Cancer unit fights US gene patent. Special report: the ethics of genetics, The
Guardian, September 8, 2001
142
Le Gal C., La contestation de la directive relative à la protection des inventions biotechnologiques,
la fin des espérances françaises? , (2005), La Semaine Juridique Edition Générale n°11, 16 mars
2005, I 120
55
the distinction between invention and discovery, has not been implemented with the
same strength. When studying the implementation of this part of the directive in UK
law, it appears that the problems were different.
3
A clear implementation as to the patentability of living organisms in UK
law which did not call for a debate
The UK was one of the first countries to implement the Biotechnology directive.
The Patents Regulations 2000143 came into force on July 28th, 2000. It implements
most of the provisions of the EC directive. Actually, it appeared that the
implementation did not bring lots of changes into UK law144. Most of the principles
were already adopted in the Patent Act of 1977. According to a report on the
implementation of the directive, it does not change anything on the scope of the
patentable subject matter. However, it sets down a framework on patent law. A
number of differences concerning the patentability of living organisms can be
noticed between the Regulations and the Directive. However, these differences are
not similar to the one in French law.
3.1 A large discussion on the morality clause despite its clear
implementation.
143
Patents Regulations 2000 (S.I 2000, n° 2037) available at
http://www.hmso.uk/si/si2000/20002037.htm
144
The patent office, legal protection of biotechnological inventions : a consultation paper on
implementation in the United Kingdom of EC Directive 98/44/EC, April 5th 2000, available at
http://www.patent.gov.uk/media/pressrelease/2000/0504.htm
56
As it has been previously said, the implementation of the EC directive did not
change much in UK law145. Consequently, articles 1 to 11 have been implemented
properly and quickly in the Patents Regulations. However, many discussions and
arguments arose on the issue of the morality clause and its merits in such legislation.
3.1.1
A proper implementation of article 6 of the EC Directive with
however a restrictive interpretation.
The first principle, which already existed in UK law before the directive, is that
biotechnology inventions are not to be treated differently from any other invention
submitted to patent law. However, the specificity of biotechnologies can not be dealt
without the consideration of ethical issues. For some British authors, the question
whether patents should be excluded on moral grounds was the most controversial
one during the draft of the directive146. Inventions are excluded from patentability
on moral or public policy grounds by the provisions of section 1(3) of the Patents
Act 1977147. Consequently, article 6(1) of the EC directive did not need any
implementation in UK law. In this respect, the EC directive did not change anything
in UK law and the morality provision was introduced without any difficulty148.
145
Actually, only some slight modifications can be noticed. For instance, concerning article 6 of the
Biotechnology Directive 98/44/EC, while implementing it, the Regulations talk about “public policy
or morality” instead of “ordre public”. Both terms have a specific meaning but it does not mean that
their application is different. Without any existing case law on this point, it will not be detailed in this
paper.
146
Beyleveld D., Brownsword R. and Llewelyn M., the morality clauses of the directive on the legal
protection of Biotechnological Inventions: conflicts, compromise and patent community, paper from
Goldberg R. & Lonbay J. Pharmaceutical Medicine, Biotechnology and European Law, (Cambridge
University Press, 2000)
The Patents act 1977, section 1(3) states that “A patent shall not be granted for an invention the
commercial exploitation of which would be contrary to public policy or morality.”
147
148
Graeme L., Patenting Stem Cells of Human Origin,(2004), European Intellectual Property
Review, 2004, 26 (2), 59-66
57
Nonetheless, it was not the same for article 6(2) of the EC directive149. With regard
to this part of the article, a slight difference from the EC directive can be noticed.
While the EC directive excludes some inventions from patentability and states that
these exclusions are mere examples, the UK regulations state that “the following are
not patentable”150, which means the UK list is exhaustive. The consequence of such
provision is that the list of UK exclusions from patentability is more restrictive than
the EC directive, and does not really leave room for additional exclusions in patent
law. Even if the UK implementation of the directive did not lead to any difficulties,
and the articles related to the patentability of living organisms were the first to be
introduced to UK law151, some reluctance in giving a large scope to article 6 of the
EC directive can be noticed.
This reluctance to give a broader scope to the
exclusions stated in the directive could be the result of legal discussions on the merit
of the morality clause in itself.
3.1.2
The criticisms attached to the nature of the provision.
Many authors questioned the merits of the place of article 6 within the EC directive.
One of the main objections was that morality, as such, should not intervene within
The biotechnology directive of July 6th 1998, 98/44/EC, article 6.2 “On the basis of paragraph
1, the following, in particular, shall be considered unpatentable: (a) processes for cloning human
beings;
149
(b) processes for modifying the germ line genetic identity of human beings;
(c) uses of human embryos for industrial or commercial purposes;
(d) processes for modifying the genetic identity of animals which are likely to cause them
suffering without any substantial medical benefit to man or animal, and also animals resulting
from such processes.”
150
Patents Regulations 2000 (S.I 2000, n° 2037) available at
http://www.hmso.uk/si/si2000/20002037.htm
151
The Patents Regulations 2000 concern article 1-11 of the EC directive
58
the patent system152. This criticism was mainly supported by the practitioners of the
field such as patent officers. According to opponents, it should not be up to patent
officers to give moral judgments on an invention. They have neither the authority
nor the experience to make such moral analysis. Moreover, the intent to harmonise
moral values was said to be unable to reach a uniform legislation. Morality is a
notion which evolves through time and territories. It is commonly said that a legal
intervention on morality does not occur in a cultural vacuum. Already within the
British legal system, different cultures and moral values can be found153.
Consequently, seeking a harmonisation appeared to be extremely hard to settle.
3.2 The criticisms and alternatives expressed on the content of article 6.
But criticisms did not concern only the nature of the morality clause. Discussions
appeared on the content of article 6 itself154. When reading article 6(1) of the EC
directive, it appears that to grant patentability, the article considers whether
“commercial exploitation” of the invention would be immoral. However, Recital
14, which defines the purpose of a patent, states that a patent does not give any right
to its holder to implement the invention. It just entitles him to ban others from
exploiting it for industrial and commercial purposes. Consequently, the patent does
not give a right to exploit the patent but gives a monopoly control of the invention.
152
Beyleveld D., Brownsword R. and Llewelyn M., the morality clauses of the directive on the legal
protection of Biotechnological Inventions: conflicts, compromise and patent community, paper from
Goldberg R. & Lonbay J. Pharmaceutical Medicine, Biotechnology and European Law, (Cambridge
University Press, 2000)
153
Adams J.N, Brownsword R, Understanding law (2nd ed, London, Sweet and Maxwell, 1999) ch.4
154
Beyleveld D., Brownsword R. and Llewelyn M., the morality clauses of the directive on the legal
protection of Biotechnological Inventions: conflicts, compromise and patent community, paper from
Goldberg R. & Lonbay J. Pharmaceutical Medicine, Biotechnology and European Law, (Cambridge
University Press, 2000) 164-169
59
Keeping this in mind, opponents to the draft of article 6(1) discussed its merits on
the grounds that the fact that the commercial exploitation of an invention would not
be immoral as such does not mean that the grant of a monopoly right would not be
immoral as well155. For instance, the monopoly right granted on the function of
genes could deprive other genetic companies from developing parallel technics to
identify cells holding cancer. Even if, it is not related to a commercial exploitation,
this could be immoral. Consequently, article 6, despite its quick and straight forward
implementation, has been said by its opponents to restrict the grounds on which
patent officers can deny a patent. These restrictions as well as the technical nature of
the analysis made by patent officers have been perceived as not being efficient
enough to determine the immorality of various inventions. In other words,
commercial exploitation is not the only reason why a patent should be denied
whereas it is the only point highlighted by the EC directive156.
As a consequence, article 6(1) has been seen, by some British authors157, as
encouraging a narrow reading of exclusionary reasons to patentability by
considering mainly the commercial exploitation of the future invention and by
giving this morality test to technicians who are not deemed to give such judgments.
155
Jon Heyley, Cancer unit fights US gene patent. Special report: the ethics of genetics, The
Guardian, September 8, 2001. For instance, this argument could be supported with the Myriad
Genetics case where the commercial exploitation of the test applied to specific gene to detect breast
cancer was not immoral
156
Beyleveld D., Brownsword R. and Llewelyn M., the morality clauses of the directive on the legal
protection of Biotechnological Inventions: conflicts, compromise and patent community, paper from
Goldberg R. & Lonbay J. Pharmaceutical Medicine, Biotechnology and European Law, (Cambridge
University Press, 2000)
157
Beyleveld D., Brownsword R. and Llewelyn M., the morality clauses of the directive on the legal
protection of Biotechnological Inventions: conflicts, compromise and patent community, paper from
Goldberg R. & Lonbay J. Pharmaceutical Medicine, Biotechnology and European Law, (Cambridge
University Press, 2000)
60
Some weaknesses have also been noticed in article 6(2) of the EC directive.
According to Recital 38, article 6(2) has been drafted “to provide national courts
and patent offices with a general guide to interpreting the reference to ordre public
and morality”. Consequently, article 6(2) assesses four products, processes which
have to be considered as unpatentable. However, this list remains non-exhaustive,
which is not the case in UK law. Despite this slight difference, the implementation
has been done quickly and efficiently. However this paragraph has been
criticised158. Research using human embryo and especially embryo stem cells has
raised many ethical issues in many countries. This kind of research has received
some answers in national law. However, provisions vary from a legal system to
another and range from no law at all (Italy) to outright ban (Germany) to provisions
which allow the creation of embryos for controlled research purposes (the UK)159. In
such a disparate legal view, the morality provision becomes particularly importance.
Article 6(2) states that “shall be considered unpatentable (…) uses of embryos for
industrial or commercial purposes.” This provision has been criticised on several
grounds. First, it does not give any definition of the term “embryo”. The recent legal
disputes in the UK show that this term is far from being obvious and needs to be
defined160. The lack of definition in the European Directive could lead to a narrow
158
Graeme L., Patenting Stem Cells of Human Origin,(2004), European Intellectual Property
Review, 2004, 26 (2), 59-66 “Art 6 of the biotechnological directive fails to provide us with sufficient
clarity or consistency of approach within European patent law” In this sentence, Laurie Greame
makes reference especially to the second paragraph of article 6.
159
Graeme L., Patenting Stem Cells of Human Origin,(2004), European Intellectual Property
Review, 2004, 26 (2), 59-66
160
R v. Secretary of State for Health, [2003] UKHL 13, [2003] 2 All E.R 113 The matter was about
the definition which has to be given to the word “embryo” as stated in the 1990 Human Fertilisation
and Embryology Act. The issue was to decide whether an embryo produced without the need for
fertilisation, which means produced by Cell Nuclear Replacement, could be defined as an embryo
within the scope of the said Act. It was not clear. Indeed, the Act at stake defined an embryo as a
“live human embryo where fertilisation is complete” The House of Lords took a purposive
interpretation of the Act including such embryo produced by Cell Nuclear Replacement in the Act.
61
definition of terms such as “embryo” or “human being” and would thus exclude
organisms such as embryos produced by Cell Nuclear Replacement or
parthenogenesis from the Act. Moreover, it does not give any answer to research
made on in vitro organisms which have no potential for an independent life.
However, could it be excluded from the scope of “human beings” or “embryos” for
this reason? According to Laurie Greame, article 6 and especially the list of its
second paragraph does not give any clear and precise limits. Consequently, the said
list has been considered by some authors as creating confusion between inventions
which should be unpatentable because their commercial exploitation would be
contrary to public ordre and morality, and inventions which should be unpatentable
because of their nature. At the end, even if this provision has been properly
implemented, it has nonetheless been considered as vague. Last but not least, the
fact that the principle of respect for human dignity has been introduced in Recital
38161 rather than in article 6(2) led to some questions.
Consequently, even if UK law implemented article 6 of the EC directive quickly, the
limitative interpretation of article 6(2) and the numerous criticisms show a debate on
the merits of the morality clause. However, we can regret that the morality clause
has not been more detailed in its draft. For instance we can regret that the directive
did not include the criteria of monopoly right in addition to the one of commercial
exploitation to judge the immorality of an invention. Furthermore, we can regret that
the EC directive does not expressly make references to international agreements to
161
The biotechnology directive of July 6th 1998, 98/44/EC, Recital 38 Whereas the operative part of
this Directive should also include an illustrative list of inventions excluded from patentability so as to
provide national courts and patent offices with a general guide to interpreting the reference to ordre
public and morality; whereas this list obviously cannot presume to be exhaustive; whereas processes,
the use of which offend against human dignity, such as processes to produce chimeras from germ
cells or totipotent cells of humans and animals, are obviously also excluded from patentability”
62
give clearer guidance to National Patent Offices162. Indeed, maybe it would have
been simpler to follow, and thus have an agreement, on moral criteria shared
throughout the world rather than trying to define unknown European moral notions
which have a tendency to highlight the cultural differences between Members.
Consequently, it appears that this directive led to many questions and problems in its
implementation in UK and French law. However, concerns and issues have not been
the same in each country. But these differences of implementation, of issues and of
interests in the biotechnology Directive did not stop there. Indeed, we need to
consider the patent rights arising from the patentability of living organisms.
162
Such as the European Convention on Human Rights (done in Rome, November 4, 1950) available
on http://www.hri.org/docs/ECHR50.html or,
The Convention on Human Rights and Biomedicine (done at Oviedo, Spain, April 4, 1997), available
on
http://www.oup.co.uk/pdf/bt/cassese/cases/part3/ch16/1121.pdf#search=%22convention%20on%20h
uman%20rights%20and%20biomedicine%22
63
CHAPTER III
THE RIGHTS GRANTED BY PATENTS: ONE DIRECTIVE BUT TWO
DIFFERING IMPLEMENTATIONS.
Surprisingly, whereas France was the most opposed to the patentability of living
organisms, especially to human organisms, the implementation of the provisions
concerning the rights and their limitations granted for biotechnological patents led to
as many problems in UK law as in French law. However, concerns in both
countries, once more, were not the same. Consequently, not only the implementation
but also arguments and concerns from both legal systems were differing. To
understand these divergences, it is important to explain the rights which are
normally granted to a patentee, and the problems which can arise from them
concerning biotechnological inventions. It is only under this condition, that we will
be able to understand the choices made by the French legislator in its
implementation and the arguments given by English legal authors. However, despite
an apparent harmonisation, it is mainly the exemptions granted to farmers which led
to some difficulties.
1.
The regular rights granted to a patentee.
“A patent is a limited monopoly that is granted in return for the disclosure of
technical information”163.Consequently, a patent is a right to exclude others from
selling, exploiting, commercialising and using the invention which is patented.
However, this right is limited. The rights granted to a patentee have a real interest
and importance for biotechnological inventions because of the debates and eventual
dangers for innovation they can lead to.
163
Bently L., Sherman B., Intellectual Property law, 2nd edition (oxford University Press, 2003) 519
64
1.1 A limited right to exclude others from using, selling, exploiting the
patented inventions
A patent right protects its holder from any kind of infringement, whether direct or
indirect. Some conditions must be gathered to have an infringement. The activity,
whether of exploitation, selling, using or, of importing must be carried out without
the consent of the patentee, the activity must not be covered by a licence, it must
occur on the territory where the patent has been granted and within the duration of
the patent, which means within 20 years from the grant of the patent 164. The aim
here is to explain the scope of these rights to understand the fears generated
concerning biotechnological inventions. Looking at the provisions of patent law,
whether in France165 or in the UK166, it appears that most of the commercial
valuable activities available on a patented invention are controlled by the patent
holder. The rights given to a patentee are different given the nature of an invention.
For instance, concerning products, the owner is given the right to make, dispose of,
offer to dispose of, use, or keep the product whether for disposal or otherwise167.
Consequently, the owner has a real monopoly on the product, in case of an
infringement; the liability of the infringer is absolute168. Concerning inventions
which are processes, liability is not absolute. To qualify an action of infringement, it
164
Bently L., Sherman B., Intellectual Property law, 2nd edition (oxford University Press, 2003) 519533
165
CPI, article L615-1 and L613-3 to L613-6.
166
Patents Act, 1977, section 60
167
PA s. 60 (1) (a)
168
It means that the knowledge of the defendant is not relevant to qualify an infringement
65
must be shown that the defendant knew, or should have known given the
circumstances, that the unauthorised use of the process amounted to an infringement
of the patent. Patent rights are especially broad. For instance, a patent is infringed
where a person contributes to, but does not directly take part in, the infringement169.
However, the monopoly right is limited. First, the activity which is alleged to
infringe the patent must be expressly protected by the patent. Moreover, some
activities are not considered as infringement behaviour and are protected by law170.
For instance, immunity is provided for acts which are done privately and for noncommercial purposes171 and for acts done for experimental purposes relating to the
subject matter of the invention172. These were the basic exemptions which existed
prior to the biotechnological directive and which were used to limit the monopoly
rights of the patent holder.
However, taking into account the scope of the rights granted to a patent owner and
these exemptions, some fears started to appear among member states while drafting
the directive.
1.2 The fear of possible abuses of such rights.
169
PA s.60 (2), CPC 26 (1). Dow Chemical v. Spence Bryson [1982] FSR 598, 628-30 and Bently L.,
Sherman B., Intellectual Property law, 2nd edition (oxford University Press, 2003) 519-533 For
instance, a patent for a glue, which is composed by putting together two elements such as A and B. If
a producer supplies A to a person who manufacture the glue, infringing the patent, the producer is
liable of indirect infringement
170
Bently L., Sherman B., Intellectual Property law, 2nd edition (oxford University Press, 2003) 519533
171
CPC, art. 31 and PA s.60 (5)a and section L613-6 (a) of the French Intellectual Property Code
172
CPC art.27 (b) and PA s. 5(b), section L613-6 (b) of the French Intellectual Property Code, this
exemption is motivated by the principle that patent monopoly should not stop scientific development.
66
The reluctance to grant someone such a monopoly arose with the specific nature of
living organisms. However, this reluctance became, in some way, an opposition
with the myriad genetics case. Consequently, a large debate on the merits of such
monopoly appeared and led to differing implementations.
1.2.1
The Myriad Genetics case
The Myriad genetics case173 summarizes perfectly all the concerns that patents on
biotechnological inventions lead to. In this case, Mary-Claire King found out that
breast cancer was a hereditary disease. In October 1990, she managed to determine
the location of a gene related to breast cancer. Following this discovery, many
companies, whether private or public, tried to isolate the gene. It is the Myriad
Genetics Company which did it first. Myriad genetics applied for a “composition of
matter” patent as well as a “method of use” one concerning the breast and ovarian
cancer gene at stake174. The scope of this patent, especially broad led to many
criticisms and worldwide protests. It is these protests which represent best the
modern concerns on the rights granted to biotechnological patent holders.
1.2.2
The large debate on the merits of such monopoly
In France, the Institute Curie initiated an opposition procedure to contest the patent
granted to Myriad Genetics for a method for diagnosing a predisposition for breast
173
Rimmer M., MYRIAD GENETICS, Patent law and genetic testing, (2003), European Intellectual
Property Review, EIPR 2003, 25(1), 20-33
174
EP 0699754
67
and ovarian cancer associated with the said gene175. This paper will not discuss the
grounds on which this procedure was based. What matters here is to determine the
real criticisms and fears such monopoly creates. The fear of the Institute was that
such monopoly would “jeopardise the development of research, hinder access to
testing, and disrupt the national health system, which is based on a commitment to
the comprehensive and multi-disciplinary care of high-risk patients176.” This
monopoly was said to be contrary to the aim of patent law and discouraged
additional inventive progress.
This criticism was supported by an additional
argument according to which the scope of the patent granted to Myriad Genetics
was excessively broad given its active contribution to the invention. At the time, the
gene had already been located and some information had already been made
available. The patent was said to grant a monopoly right to a company whose work
had represented only a part of the whole research177. Furthermore, the Institute Curie
claimed that the grant of a monopoly would block the transfer of information
between scientists and researchers. Because of the patent, they would not be allowed
to improve diagnostic technologies and methods178. This argument can be agreed
upon given the Margaret Reece case179 and the figures collected by John Merz180.
175
Institut Curie, « The Institut Curie is initiating an opposition procedure with the European Office »
(Paris :Institut Curie, September 12, 2001)
176
Rimmer M., MYRIAD GENETICS, Patent law and genetic testing, (2003), European Intellectual
Property Review, EIPR 2003, 25(1), 20-33
177
CBC, « The impact of Gene Patents on Health Care and Medical Research : The case of breast
cancer genetic screening » (march 21, 2000)
www.radio.cbc.ca/programs/thismorning/features/life_2.htlm
Michael Stratton, the professor of cancer genetics at the Institute of Cancer Research said “the
identification of a gene like BRCA1 and 2 is the culmination of many years of work requiring the
input of activities and information from many, many different groups. (….) And awarding the patent,
in other words brick in the wall, is unfair because it does not recognise the contribution of others.”
178
Institut Curie, « The Institut Curie is initiating an opposition procedure with the European Office »
(Paris :Institut Curie, September 12, 2001)
179
K. Blanton, “Corporate Takeover”, Boston Globe, February 24 th, 2002,
68
The Institute further argued that the consequence of such monopoly on the
“invention” would be that the costs of commercial testing would be a barrier to
patient care. It would lead to a health care with two speeds, where only some
patients could benefit from specific diagnostic techniques181.
These arguments summarize the fears and the reasons of the protests against patents.
However, the monopoly is not unlimited and to secure the benefit sharing of
information on living organisms, the European directive set down some limits to the
monopoly right. These additional limits and the diverging implementation on this
point prove the sensitivity of the issue, the dissatisfaction of each country with this
directive and the specificity of each legal system.
2
The limitations granted by the directive to secure the protection of the
incentive to invent and their implementation.
Due to the very specific nature of biotechnological inventions, three new defences
have been set up by the European directive182. However, these limitations to a
This argument is even strengthened by the example taken from Reece’s buccalcell techniques.
Margaret Reece found a quick means of screening for BRCA mutations.However, for her research to
be reliable, her results needed to be compared with Myriad’s clinical test. The Baystate Medical
Centre which employed Margaret Reece obtained a patent on this new technique. However, they’re
afraid that the exploitation of the said patent leads to an infringement of the Myriad Genetics Patent.
J. Merz, A. Kriss, D. Leonard, and M. Cho, “Diagnostic testing fails the test” (2002) 415 Nature
577. According to figures found, 48 laboratory physicians up to 74 admitted they had not developed a
clinical test because they were afraid of infringing a patent.
180
181
The consequence of a monopoly is that usually that the techniques offered by the patent are more
expensive than if some alternatives and competition existed. In such circumstance, the additional cost
would have to be supported by medical insurance schemes and hospital budgets which would require
more expenses for the patient as well.
182
Biotechnology directive 98/44/EC, article 10 and 11.
69
monopoly right on biotechnologies inventions have not been implemented in the
same way in French and UK law despite their apparent simplicity.
2.1 The need of new defences for biotechnological inventions.
Article 10 and 11 of the biotechnological directive deals with some specific
limitations to patent rights granted to the holder of a biotechnological patent. These
defences, which have never been necessary for other type of inventions, became
essentials for products or processes involving living organisms.
2.1.1
The very specific nature of biotechnological inventions led to
the necessity of including further limitations.
The scope of protection granted for biotechnological inventions is particularly broad
given the nature of such products or processes. Indeed, this reality is dealt with
article 8 and 9 of the directive183. However, this very broad protection could give to
the patentee control of subsequent uses of the subject matter of the invention on
scientific area they did not envision184. The solution to this problem would be to
limit the patent rights on the function expressly stated in the patent. This vision is
supported by Recital 25 of the Biotechnological Directive. However, what is
183
The biotechnology directive 98/44/EC of July 6th, 1998, articles 8 and 9.
These articles provide that the protection granted on a biotechnological invention extends to any
biological material derived from it by propagation or multiplication in an identical or divergent
form. They also provide that the protection provided on an invention including genetic information
extends to any material, save as those expressly stated in article 5(1), in which the product is
incorporated and in which the genetic information is contained and performs its function
184
Bently L., Sherman B., Intellectual Property law, 2nd edition (Oxford University Press, 2003) 519533 For instance, if a laboratory found out that the gene Z was the cause of acne and isolated them,
they could ask for a patent. If a patent was granted to them and subsequently another laboratory
found out that it is also the source of some skin cancer, it would maybe be covered by the earlier
patent.
70
important here are the concerns created by the specific nature of biological
elements.
2.1.2
Further new limitations motivated by the expending
reproducing nature of living organisms
As mentioned above, the expending and reproducing nature of living organisms led
to new concerns as to the scope of patent rights. Consequently, article 10 and 11 of
the European directive set out some new limitations. The first limitation consists in a
new form of exhaustion for biological patents. According to it, the patent protection
can not extend to any biological material obtained by the propagation or
multiplication of the patented biological material if it was due to its normal use185.
For instance, if yeast was sold in a shop for the purpose of beer-making and this
activity involves the multiplication of the yeasts, the beer maker would not infringe
the patent. It was the normal use of the yeast to have its multiplication while
producing beer186. This limitation, which does not seem essential at first sight, has a
prominent role in agriculture and the food industry. Other limitations specific to
Farmers have been introduced to the European directive. However, given its
importance and the discussions on this legal field, this point will be dealt later on.
2.2 The additional limitations of French law and its consequences, an
imperfect implementation which restrict patentees’ right
185
The biotechnology directive, 98/44/EC of July 6th, 1998, article 10
186
Bently L., Sherman B., Intellectual Property law, 2nd edition (Oxford University Press, 2003) 519533
71
The provisions related to the patent rights were implemented in French law by the
statute of December 8th, 2004187. As previously stated, the self reproductive nature
of living organisms led to the restriction of patent rights applied to biotechnological
inventions. The French legislator introduced three limitations leading to the
exhaustion of patent rights whereas only one was expressly stated in the directive.
Indeed, article L613-2-1 CPI taken from the statute of august 6th, 2004, limits the
rights of the owner of a biotechnological patent due to its specific character. In other
words, a patent claim on a gene sequence is limited to the part which is directly
related to the specific function expressly stated in the patent description. Moreover,
a patent on a gene sequence does not stop other researchers from requesting a patent
on the same gene for another function and industrial application. The French
legislator, while adding this provision, tried to limit the monopoly granted to the
patent holder in order to avoid the hindrance of research on the said sequence188.
When comparing with the European directive, it appears that its article 9 states the
“function” of the gene but it does not construe it as an essential and direct limit to
the monopoly right granted to the patent holder. Furthermore, according to article
L613-5-3 CPI, any person who uses a plant variety protected under a patent in order
to develop a new variety can not be held liable of having infringed the rights of the
patent holder. The last limitation, included in the European directive is the Farmer’s
privilege but this point will be studied later on.
The implementation of the European directive and thus the addition of these
limitations to patent rights look like a concrete answer to the fear commonly shared
187
Statute n° 2004-1338 of December 8th, 2004
188
Caron C., La loi n° 2004-1338 du 8 décembre 2004 relative à la protection des inventions
biotechnologiques, (2005), La Semaine Juridique Entreprise et Affaires n°8, 24 février 2005, art. 42
72
among laboratories, scientists and plant producers. It becomes clear that the French
legislator used the European directive as a basis he worked on to answer to some
concrete issues and to national protests. We can regret however that during the 10
years of European debate, the French representatives did not lead the discussions
towards a draft which could have been compatible with the mentioned concerns. In
other words, we can regret the lack of reaction of the French representatives during
these 10 years of discussions.
The European directive, in its article 12, also considered the case of licensing.
Surprisingly, this point did not create any difficulties in French law but did in UK
law. Indeed, this article was implemented in UK law in 2002 only, whereas most of
the directive had been implemented two years before. The question is why this point
raised more difficulties than any others in the directive? Why did not it raise any
difficulties in French law but did in UK law?
2.3 The English implementation of the directive: a faithful reproduction of
the European text but some difficulties with its article 12.
Article 12 of the European directive was implemented by The Patents and Plant
Variety
Rights
(Compulsory
Licensing)
Regulations
in
2002189.
This
implementation came more than two years after the implementation of articles 1 to
11. Furthermore, it was the last article of the European directive to be implemented.
Article 12 allows compulsory licences when the existence of the patent blocks the
exploitation or the acquisition of another right. This possibility is however
189
The Patents and Plant Variety Rights (Compulsory Licensing) Regulations, SI 2002/247
73
dependent on some conditions. First, the applicant to such licence must prove that
he applied for a contractual licence but did not reach any agreement. Secondly, he
must show that the subject matter of the patent, for which a licence is asked,
represents a significant technical progress of considerable economical interest
compared with the invention claimed in the patent190. To find out the reason of such
delay in the implementation, it would maybe be useful to look at the changes it
induces in UK law. According to The Patent Office, it brings three main changes191.
Here, the author decided to talk only about two given their relevance. First, some
restrictions to applications which existed have disappeared as far as compulsory
licences on biotechnological inventions are concerned. For instance, an applicant
had to wait three years after the grant of the patent to apply for a compulsory
licence. Moreover, an applicant had to wait two years after the grant of plant
breeders’ rights before asking for a compulsory licence. With article 12 of the
Biotechnological directive, these limitations to apply to a compulsory licence
disappeared. Moreover, concerning cross-licensing, the patent office adds “Rules
will allow for representations to be made on the terms of cross-licences, and the
grant of a cross-licence is part of the conditions of grant of the compulsory licence
applied for”192. In other words, applications for compulsory licences appear to be
less restricted, which amounts to a limitation of the patent holder monopoly.
While French law took time and was concerned in limiting patent holder’s rights, it
appears that the UK legislator needed two more years to implement a restriction to
190
The biotechnology directive 98/44/EC of July 6th, 1998, article 12
191
The patent office, Implementation of article 12 of Directive 98/44/EC on the legal protection of
biotechnological inventions, January 21st, 2002 (E-NOTICE IPPD/08/2002)
192
patent office, Implementation of article 12 of Directive 98/44/EC on the legal protection of
biotechnological inventions, January 21st, 2002 (E-NOTICE IPPD/08/2002)
74
patent rights. Of course, at least for UK law, the implementation was completed in
compliance with the European directive. However, these diverging implementations,
due to diverging interests and concerns are likely to be the cause of diverging
interpretations and thus application of the provisions.
The main issue concerning the rights granted to a patent holder was the privilege
granted to farmers. This has been at the origin of many discussions. Apparently, this
point seemed to be the best compromise found among members. However, once
more, when looking at the implementations in both countries and when looking
carefully at both legal systems, this provision is nothing more than a façade of
faithful implementation.
3.The exemptions granted to farmers: difficulties of implementation put in
relation with international agreements.
The farmer’s privilege is one of the rights which have led to many discussions
among Member states. Given its economic importance, we will examine this point
separately and explain why this issue appeared essential during the draft of the
directive. Even after its coming into force, the farmer’s privilege is one of the rare
provisions which have been properly implemented by both the French and the UK
legislator. However, when studying more carefully both legal systems, it appears
that even on this point, which was essential, the uniform implementation was just a
façade and hid other divergences.
75
3.1
The exemptions granted to farmers: a limitation to patent rights
essential for agriculture.
Before stressing the difference of implementation, this paper will explain the interest
of the farmer’s privilege.
3.1.1
The economic situation of farmers as to patents
During the various talks surrounding the draft of the directive, the Member states
were afraid that such a monopoly on a biotechnological invention would threaten
traditional farming practices193. The risk was that farmers would not be able to use
the seeds they produced from their crops to continue their production. Indeed, the
use of such seeds, obtained by a patented element, would lead to the infringement of
the said patent. To fully understand the importance of this eventual infringement, it
is important to keep in mind the difference between breeding and farming. From
early times, farmers used to set aside harvested seeds for replanting. They used to
make a selection based on the qualities of the plant they were looking for (disease
resistance, froze tolerance…)194. Consequently, it led to the creation of many
varieties. However, given the ever more scientific character of crop improvement
throughout the years, a separation occurred between breeders and farmers. This
splitting up of both activities led to some financial obligations for farmers. For
instance, in Canada where the farmer’s privilege does not exist, any buyer of
particular patented seeds has to use them only once for production and has to sell his
193
Bently L., Sherman B., Intellectual Property law, 2nd edition (Oxford University Press, 2003) 542-
49
194
G. Dutfield, Intellectual Property Rights and the life science industries: a twentieth century
history, (ASHGATE, 2003) 175-205
76
crops to authorised buyers195. Thus, in a case such as the Monsanto case, a farmer
would need to spend $15 000 a year to use the seeds for his production and he
would not be allowed to sell freely his crops at the end, or to keep some seeds for
further production196. Faced with this negative effect on agriculture, Member States
have decided to limit the monopoly right of patent holder. They thus created an
exception for farmers to allow them to set apart some seeds, even patented, to use
them for the following harvesting. The aim was to avoid small farms to stop their
activities.
3.1.2
The farmer’s privilege: a well-accepted consensus
Article 11(1) and (2) of the Biotechnology directive gave to farmers a particular
right which limits the monopoly of a patent holder. According to this provision,
when there has been a sale or any other commercialisation of a plant-propagating
material to a farmer, the latter is allowed to use the products of his harvest for
propagating or multiplying them. This means that the farmer would have the right to
keep some seeds he would have produced to sow crops in the following year. The
same provision was provided for animal breeders. According to article 11(2), he can
freely reproduce the protected cattle if and only if, he does not sell it afterwards. In
this case, it is a legal licence. Thus, even if the patent holder can not protest against
the reproduction of the said cattle, he can ask for a fair compensation from its
commercialisation197.
Passa J., La protection par brevet des semences génétiquement modifiées. A propos de l’arrêt
Monsanto de la Cour suprême de Canada, (2005), Propriété Industrielle n°5, mai 2005, Etude 13
195
196
Monsanto Canada Inc. v. Schmeiser, Supreme Court of Canada, May 21st, 2004, [2004] 1 R.C.S
902
77
However, the emergence of a practice to limit the use of such privilege must be
noted. Indeed, the patent holders may make genetic manipulations of their seeds in
order to reduce the yield of the next harvest or to make it completely sterile. In such
a case, the farmer would have to buy further patented seeds or material to continue
his production198. We can regret that the compromise reached by Member States did
not avoid the additional cost that patent holders, which means companies, put on
farmers to increase their financial benefits. Indeed, even if the European parliament
thought about preventing any legal barriers to farmers, they have forgotten or they
have been unable to foresee the technical barriers. As a consequence, it is likely that
the financial costs it induces will weight heavily on some farmers.
However, so far, the farmer’s privilege is one of the best compromises which have
been found, while drafting the directive. The best evidence is its faithful
implementation both in UK and French law. Of course, this compliance with the
European text has other reasons we are going to explore.
3.2 The implementation of the directive in France and in the UK: an
appearance of harmonisation
In UK law, the farmer’s privilege provisions were implemented in 2000 by sections
60(5) (g) and 60(5) (h) of the 1977 Patent Act199. When reading these sections, it
197
The Biotechnology Directive 98/44/EC, of July 6 th 1998, Article 11(2)
Passa J., La protection par brevet des semences génétiquement modifiées. A propos de l’arrêt
Monsanto de la Cour suprême de Canada, (2005), Propriété Industrielle n°5, mai 2005, Etude 13
198
199
Patents Regulations 2000 (S.I 2000, n° 2037)
78
appears that they perfectly respect the European provisions. In French law, this
privilege was implemented word for word by article L.613-5-1 CPI200. To this
extent, the directive seemed to have achieved a real reconciliation. However, several
reasons can be found. As it has been previously said, the situation of farmers was an
important concern for all Members. Agriculture is a significant part of the economy
and it has a considerable weight in Europe. To this extent, France and the UK had
the same interest despite their differing legal systems. Both needed to protect
farmer’s financial resources, especially small farmers. However, a common
economic interest was not the only reason. It has to be noted that this EC provision
did not change many things in UK law. Furthermore, this right has long been
discussed and taken into account in international agreements201. The UPOV
convention does not expressly recognise the farmer’s privilege. However, it lets free
States to set up rights such as farmers putting away seeds for the following season.
This eventuality was put into practice through the draft of the Council Regulation
for a Community Plant Variety Right. This regulation allowed small farmers to keep
seeds from one year to the next without paying any additional cost to the patent
holder of the said seeds202. However, this right was restricted only to some specific
seeds and plants. Furthermore, only farmers considered as “small” could benefit
200
Statute of December 8th, 2004, n° 2004-1338
201
1991 UPOV Convention
”Article 15: Exceptions to the breeder's right [Optional exception] Notwithstanding Article 14, each
Contracting Party may, within reasonable limits and subject to the safeguarding of the legitimate
interests of the breeder, restrict the breeder's right in relation to any variety in order to permit
farmers to use for propagating purposes, on their own holdings, the product of the harvest which
they have obtained by planting, on their own holdings, the protected variety or a variety covered by
Article 14(5)(a)(i) or (ii).”
202
The Council Regulation for a Community Plant Variety Right (1994)
”Article 14: Derogation from Community plant variety right. Notwithstanding Article 13 (2), and for
the purposes of safeguarding agricultural production, farmers are authorised to use for propagating
purposes in the field, on their own holding the product of the harvest which they have obtained by
planting, on their own holding, propagating material of a variety other than a hybrid or synthetic
variety, which is covered by a Community plant variety right”
79
from this exception. The others could not avoid the payment of seeds from one year
to another. Consequently, the European directive did not bring a new issue, but
strengthened and and finally fulfilled a loophole which existed in the EPC. Indeed,
whereas this convention proved to be essential in settling several patent issues
before the EPO, such privilege for farmers proved to be absent from its draft203. A
final factor helped to obtain a well-accepted compromise. The putting into practice
of this right is provided in article 14 of the European regulation of July 27 th, 1994,
on the European protection of plant varieties. This already existent provision was
already suitable to apply to the farmer’s privilege.
However, implementing properly an important provision of a directive does not
mean that its application will be unique among several countries.
3.3 The farmer’s privilege: a practice which is likely to be different from
the implementation
An identical implementation does not necessarily provide for a clear and unique
application of the principle. Indeed, even though the scope and the mode of
enforcement of the farmer’s privilege were detailed in the European regulation of
July 27th, 1994, hesitations and questions did not disappear. Between 2003 and
2004, the ECJ held three decisions to construe paragraph three of the said
regulation204. Even if these cases involved neither France nor the UK, it nonetheless
proves that a successful implementation does not only amount in a faithful
203
S. Chaturvedi, The Public-Private Debate in Agricultural biotechnology and New Trends in the
IPR regimes: Challenges before developing countries, available on http://ris.org.in/dp17_pap.pdf
204
ECJ, April 23rd, 2003, case C-305/00 ; ECJ, March 11th, 2004, case C-182/01 and; ECJ, October
14th, 2004, case C-336/02
80
integration of a directive into a national law. The application and the legal system
which surrounds the provisions which has been integrated are also essential. It is in
respect to this that the implementation, at least in French law of the farmer’s
privilege has only been apparently satisfactory. In fact, when considering the French
legal system, it comes into sight that such privilege might not be granted when seeds
are both protected by patent law and a sui generis system protecting plant variety as
provided in the TRIPS agreement205. The privilege is provided in the European and
national patent law and on the European regulation on the protection of plant
variety. However, such right is not allowed in the domestic law on the protection of
plant varieties206. In fact, France has not ratified the review of the UPOV convention
expressly introducing the farmer’s privilege. Consequently, according to patent law,
a farmer can use seeds obtained in one year for the next season, but he can not do it
under the sui generis system on the protection of plant variety207. In this case, the
farmer would not be protected by patent law, and the farmer’s privilege provided by
the biotechnological directive and implemented in French law, would be useless.
Even today, no legal initiatives have been taken to change the domestic regime on
the protection of plant variety to make it compatible with the provisions of the
directive. More than a mere reluctance of the French legislator, it mostly shows the
difficulty of combining several IPRs on the same subject matter. The current
concern of the French legislator to put its domestic law in conformity with both the
UPOV convention and the European directive is evidence of such difficulty to
205
TRIPS agreement, article 27 (3)
206
Statute of June 11th, 1970, codified in article L.623-1 and R.623-1 CPI
207
Two decisions can be taken as examples of such liability : CA Nancy (the Court of appeal of
Nancy), September 13th, 1988 (PIBD 1988, III, p.572) and TGI Paris (High Court of Paris), October
26th, 1989 (PIBD 1990, III, p.91) In other words, if a farmer uses seeds, protected both by patent law
and by a sui generis protection of plant variety, of one year for the next season, he will be held liable
of infringement
81
combine several legal regimes on the same subject matter. Indeed, a bill was
brought before the French parliament in December 11th, 1996208; however, it is still
pending. The implementation of the directive and the express introduction of the
farmer’s privilege into French patent law are likely to bring a change to this
situation. Thus, despite an implementation without any discrepancies of article 11 in
French and UK law, the application of the farmer’s privilege will be probably
different from one country to another. Once again, given the differences between
legal systems, the step towards a harmonisation on the protection of
biotechnological inventions was merely half-successful.
Indeed, as it has been seen, most of the provisions studied by the author have not
been implemented in the same way in France and UK. Instead of providing a
uniform protection which would have been available in any member of the EC, the
directive set down principles, legal framework, rights and limitations to those rights,
which have been at the origin of some reluctance from the Member States. Of
course, the directive is not a failure and has reached some of its objectives, such as,
bringing into light some issues on the patenting of living organisms, and setting
down a legal framework for such inventions. However, after 10 years of
parliamentary debates, it has to be noted that the results are only partly satisfactory.
We have already observed that the interests at stake were not the same in France and
UK as regard to biotechnological inventions and that the content of both legal
systems were also different. This would easily explain the differing and sometimes
contradictory implementation of the same legal text. However, it would also mean
that no matter the years spent working towards a compromise, a real harmonisation
208
Bill n°145 introduced by A. Juppé and P. Vasseur
82
would not be possible. But is it the case? Are there other reasons which could
explain such a lack of uniformity after such long parliamentary debates? More
importantly, is there any other solution or any factor the EC should have taken into
account in drafting the directive? What has been forgotten and how could these
elements have changed the way the directed was perceived by the States?
83
CHAPTER IV
THE DIVERGENT LEGAL MENTALITIES: A POSSIBLE REASON TO
THE LACK OF HARMONISATION
Through this paper, the circumstances of the draft of the Biotechnology directive, as
well as its implementation in French and UK law have been studied. Some obvious
differences have been pointed out. The arguments of each legislator supporting their
national provisions have been explored to try and find some explanations to such
discrepancies. However, only two factors have arisen. Apparently, the differing
interests and national legal systems would be at the origin of the partial failure of the
directive. But is there any other reason which could explain this only semicompleted harmonisation? Given that our main question is “what are the reasons of
the differing implementations of the directive 98/44/EC?”, and that we have already
compared the implementations of the directive in both countries; is there anything
else we should compare to find answers to our main question? How much have
national economic interests and politics been involved in the introduction of this
biotechnological directive in national law? Finally, what does the expression
«differing legal mentalities” really mean, and is it the final answer to our question?
1.
Is there anything else than the actual implementations and
national provisions to compare in comparative law?
84
Most comparatists used to compare norms and the way they used to be introduced
and enforced in a said legal system. However, this very formal view of comparative
law, supported mainly by Zweigert and Kötz209, has recently been changed.
1.1.The modern concept of comparative law and its consequences on
our study.
As explained above, the formal and traditional concept of comparative law was
mainly to compare positive rules and the way they were enforced through case law.
Comparative law was about comparing norms, rules and the facts of cases210.
However, the new concept of comparative law, supported mainly by P. Legrand,
allows us to go deeper in our work.
1.1.1
P. Legrand and the concept of legal mentality.
According to P. Legrand211, taking into consideration rules, norms and facts is not
enough. The purpose of comparative law is to compare different legal systems and a
legal system does not exist on its own. As Sacco212 argues, law is an answer given
by the society to a need for social order. Thus, such comparison should include
history, culture, sociology, economy, and politics. A legal system is the sign of a
209
Zweigert and Kötz, the history of comparative law, an introduction to comparative law,
Clarendon Paperbacks, 2nd edition, 1992
210
Zweigert and Kötz, the history of comparative law, an introduction to comparative law,
Clarendon Paperbacks, 2nd edition, 1992
211
P. Legrand, How to compare now (1995) 16 Legal studies 232
212
Rodolfo Sacco, legal formants: a dynamic approach to comparative law, American Journal of
Comparative Law, vol. 39, 1991
85
legal mentality the comparatist must determine to understand it. This amount of
"subjects" the comparatist must take into account is important because "it (the law)
operates within a society"213. It is this context, this tradition and mentality which
will allow him to understand the norms and make some criticisms on them. These
elements would allow him to develop a thought not only about the legal rules and
the way they're applied in practice, but also an understanding of the reasons of such
rules. This content of comparative law can seem very broad and very difficult to
achieve. However it is not contrary to the conception of Zweigert and Kötz. It is not
a difference of content; it is most of all a difference of degree in the comparison,
which is justified by the purpose of the comparison.
1.1.2
The reasons and interests of taking into account the legal
mentality.
The aim of comparative law is to bring further knowledge both on the foreign legal
system and on the domestic legal system214. The purpose is to study the alternatives
of a same legal issue. But to determine all these points, P. Legrand 215 clearly states
that studying rules and facts is not enough for several reasons.
Firstly, each society has its own culture and traditions216. Such traditions have an
effect on the rules of the said legal system. Law does not exist on its own but is
shaped by the context which can be economical, political, sociological, and of
213
P. Legrand, How to compare now (1995) 16 Legal studies 232
214
P. Legrand, How to compare now (1995) 16 Legal studies 232, "the comparatist can make sense
about why things are the way they are"
215
P. Legrand, How to compare now (1995) 16 Legal studies 232
216
Patrick Glenn, legal cultures and legal traditions, in Mark Van Hoecke, epistemology and
methodology of comparative law, oxford and portland oregon, 2004
86
course cultural. Consequently, the comparatist can't understand a foreign legal
system if he does not research why such rules have been created and how they're
perceived within the legal system. Secondly, Sacco217 argues that even when terms
seem to be the same and are translatable, as is the case for the implementation of the
biotechnological directive, they're not identical. They differ and they may not lead to
the same operative rules. Louise Rayar218 also points out that you can't translate
rules without involving the culture of the legal system which is translated. Each rule,
each principle and each legal concept involves an interpretation and the culture of
the country. For that reason, a simple comparison of legal rules can not be sufficient.
Consequently, the comparatist should not make his comparison as if the law existed
on its own but should consider it as being influenced by everything surrounding it,
such as, politics, culture, traditions and economy. He should take into consideration
everything related to the life of the society, to its "legal mentality"219.
1.2 What other factors should be compared as regard to the implementation
of the biotechnology directive to understand the reasons of its partial
success
It becomes clear that norms and the actual implementation in both countries are not
enough to understand the reasons of the discrepancies. However, to reach an answer,
some choices have to be done.
217
Rodolfo Sacco, legal formants: a dynamic approach to comparative law, american journal of
comparative law, vol. 39, 1991
218
L.Rayar, Translating Legal Texts: a methodology (1993) 47Euroforum conference paper.
219
P. Legrand, How to compare now (1995) 16 Legal studies 232
87
Sacco writes that220 the purpose of comparative law is the acquisition of knowledge.
However this knowledge varies according to what the comparatist has to compare.
P. Legrand221 insists on the point that the comparatist should study the legal
mentality of the foreign legal system to understand it. However, the legal mentality
is not uniform within the same legal system. It evolves and changes according to the
professionals who consider it222. Consequently, even if the comparatist should
compare the culture and the "legal mentality", the content of his comparison will
depend on what the comparatist will look for. Frederick Pollock further says223 that
"comparison is profitable after the several things to be compared have been
ascertained. If attempted earlier, it is hazardous at best". In this way, the aims of
the comparatist drive and influence the scope of his study and direct, in some extent,
what he should compare to reach such aims224. Whether he wants to explain the
divergences between two legal systems or to deepen the knowledge as to his
domestic law through the study of a foreign legal system, the elements which will be
taken into account will be different from one study to another.
The comparatist needs to be flexible, to be able to adapt to each new legal system
and each issue he's facing. It is what we’re going to do taking into account the
national politics and interests which might have motivated a different reading and
220
Rodolfo Sacco, legal formants: a dynamic approach to comparative law, american journal of
comparative law, vol. 39, 1991
221
P. Legrand, European Legal Systems are not converging (1996) 45, International and comparative
law quarterly 52
222
223
G. Samuel, epistemology and method in law, Ashgate, 2003
Frederick Pollock and Samuel Wright, an essay on possession in the common law, 1988
224
Reimann, progress and failure of comparative law in the second half of the 20th century, The
American Journal of Comparative Law, 2002, p. 671
88
implementation of the directive.
2
The use of legal gaps in the Directive to introduce national politics created
by mere national interests.
The first choice to make in such a comparison and enquiry is to deepen what has
already been found. Apparently, criticisms and/or changes operated while
implementing the directive have been motivated by national politics. This diverging
national politics are the sign of diverging national interests.
2.1 Ethical issues and commercial interests, two indivisible elements of
biotechnological issues leading to different national politics.
National politics of the French and the UK governments are not opposed. However
some differences may be distinguished. For instance, in both countries, ethical and
economic issues are closely related to biotechnologies. However, the clash of ethical
concerns with economic imperatives does not lead to the same balance. For instance,
when considering the various talks and speeches while drafting the French law
implementing the directive, the opinion of the French national ethics committee
created in 1983225 as well as the Bioethics law of 1994226 played a very important
role. With these factors, the issue on the patentability of living organisms turned out
225
Decree of February 23rd, 1983, n° 83-132, creating the French national committee on ethics.
226
Statute n° 94-548 of July 1st, 1994
89
to be mostly a public debate227. Of course, it was still an economic issue. However,
the importance of the public opinion could not be neglected and took a new
importance. France has a long history of “administrative consultancy”228. In every
sectors of its competence, the French government has often asked for the opinion of
a committee specialized in the particular field of law. Given the importance of the
public opinion on the issues related to biotechnologies and especially on the
implementation of the directive 98/44/EC, the French legislator was seeking for
moral legitimacy. In other words, the enforcement of the law depended upon the
legitimacy to do so as regard to both the scientific community and the public
opinion. Consequently, even if the economic pressure was a really strong element to
be taken into account, it was not the decisive one. In the UK, the situation was
slightly different. Ethical provisions were introduced in patent law with the Patents
Act 1977 and with the provisions of the EPC. However, as Charles Foster points
out, issues on biotechnologies, such as the implementation of the European directive
at stake, have not led to a large public debate229. Of course, discussions have arisen
while drafting the Patents Regulations of 2000. However, Charles Foster further
says that “Obvious and important questions about human dignity and autonomy
arise, but have featured little in the public debate. That debate has been rather
crudely pragmatic… and…there has been no real national discussion about these
matters”230. In other words, the debate has mainly been led by biotechnology
227
J-C Galloux, A. T. Mortensen, S de Chveigné, A. Allansdottir, A Chatjouli and G. Sakellaris, The
Institutions of bioethics, in M. W. Bauer and G. Gaskell, biotechnology: the making of a global
controversy (Cambridge University Press, 2002)
228
J-C Galloux, A. T. Mortensen, S de Chveigné, A. Allansdottir, A Chatjouli and G. Sakellaris, The
Institutions of bioethics, in M. W. Bauer and G. Gaskell, biotechnology: the making of a global
controversy (Cambridge University Press, 2002) 138-45
229
C. Foster, current issues in the law of genetics, January 10th, 2003, New Law Journal 153.7062
(29)
90
companies highlighting their needs to see their innovations protected by patent
rights to secure and encourage further investments. Lobbies and economic pressures
were especially strong. Consequently, the UK was not faced with the same national
interests and concerns. Even if ethical issues were important and were to play an
important role in patent law, this lesser pressure of the public opinion led the
government to consider the European directive in another way.
Thus, it is a certainty that both ethical issues and economic interests had an
important role to play in both States, and consequently, in both implementations.
However, the balance between these two elements was not the same in each country.
But, how did these different interactions influence concretely the implementation of
the directive?
2.2 The uncertainties of the Directive used by each legislator to encourage
its politics.
Within the European directive, like within most legal texts, some loopholes are
noticeable. Even if they are not substantial, they have been sufficiently important for
legal systems to use them to introduce their national politics. The first and maybe
simplest omission is the lack of definitions. When studying the Biotechnological
directive, it appears that none of the terms such as “embryo” or “living organisms”
or “variety” are defined. However, they limit the scope of patentability and represent
the subject matter of the directive. In a legal system where case law is fundamental
230
C. Foster, current issues in the law of genetics, January 10th, 2003, New Law Journal 153.7062
(29)
91
like in the UK231, this lack of definition could allow a divergence in the
implementation of the directive; not in the text itself but in its enforcement.
Moreover, the ethical provisions and exclusions of patentability on moral or public
ordre grounds have been seen by most authors as inappropriate in a European
directive232. Indeed, such criteria might lead to problems of implementation or even
interpretation. As it has been explained, each legal system has its own perception of
what morality is. For instance, article 6 (2) (d) declares that are not patentable
“processes for modifying the genetic identity of animals which are likely to cause
them suffering without any substantial medical benefit to man or animal, and also
animals resulting from such processes.233” This provision looks like a proportional
test national patent offices would have to do, to know if a process is patentable.
However, how could two distinct national legal systems quantify in the same way
the “sufferance of an animal”? To take a more relevant example, how can two
national legal systems, in two different States, with different economic situations
and different levels of scientific improvements quantify, in the same way, a
“substantial medical benefit”? This is even more striking if we keep in mind that the
Biotechnology Directive does not lay down any clear fundamental principle to
support these patent exclusions or moral limitations. This legal gap means that
national legislators will have to implement these limitations and exemptions and
make them be in compliance with their own fundamental principles, which might
not be the same everywhere. This European directive is mostly a technical text
setting down a protection for biotechnological inventions. Given the conflicts and
231
Slapper G. and Kelly D., The English legal system, (London, Cavendish, 6th ed., 2003)
232
Chemtob-Concé M. C. et Gallochat A., Le Brevetabilité des inventions technologiques appliquées
à l’homme. (Ed. Lavoisier, Tech & Doc, Paris 2ème ed. 2004)
233
The Biotechnology directive, 98/44/EC of July 6th, 1998
92
concerns its draft led to, some ethical provisions have been introduced to find a
compromise. However, the ethical provisions of the directive are not sufficiently
clear. It gave a chance to the French legislator to base his implementation on his
own ethical statutes and principles, setting aside major provisions of the directive234
and adding some further limitations to the patentability of living organisms235. As
for the UK legislator, this lack of precision in the Directive did not have any effect
on the implementation itself. However, given the criticisms expressed towards the
European text already explored in this paper, it would be surprising not to find
similar criticisms, thoughts, or interpretations in rulings opinions. At the end, it
would probably emphasize the disparities between both implementations.
Consequently, it appears that it might be the legal loopholes in the directive itself
combined with the different legal imperatives and public policies of both States
which led to a lack of harmonisation in the protection of biotechnological
inventions. Of course, some other factors have played a role in this partial-success.
However, the importance of the legal mentality of a legal system should not be
neglected while drafting a European piece of legislation.
3
The unavoidable function of the “legal mentality” in a climate of
“conflicting cultures” and the alternatives to a partial and dissatisfactory
harmonisation.
Consequently, it appears impossible, when drafting such a directive with economic,
scientific, political, moral and legal implications, not to take into consideration the
234
The Biotechnology directive, 98/44/EC, of July 6th 1998, article 5.2.
235
The biotechnology directive, 98/44/EC of July 6th 1998, article 11
93
legal mentality of each State. Given this element, it appears that the European
parliament neglected to contemplate some alternatives.
3.1 A divergence as to the legal mentalities, an important but neglected
factor.
The purpose of the directive was to set up clear, efficient and harmonised principles
on the protection of biotechnological inventions. This harmonisation was deemed to
encourage the innovation on this important scientific field236. During parliamentary
talks, legal mentalities have been expressed through disagreements and opinions in
order to find a compromise. The European directive is a gathering of these legal
mentalities, put together to reach an acceptable agreement for all. But, what if such
an agreement was not possible? The important information to bear in mind is that
the draft of the directive has needed 10 years of parliamentary talks. As explained in
the first part of this paper, the European directive has had a tumultuous genesis.
However, by desperately looking for a solution and a consensus among such amount
of diversity, the European Parliament has forgotten to look at other available
alternatives237. Even if this directive is an important step forward for the protection
of biotechnological inventions, its legal loopholes allowing Member States to
introduce their national politics, as well as its difficult articulation or even
236 Report of the European Commission to the Council and European Parliament, “development and
implications of patent law in the field of biotechnology and genetic engineering”, commission of the
European Communities, Brussels 7.10.2002, COM (2002) 545 final, available on
http://europa.eu/eur-lex/en/com/rpt/2002/com2002_0545en01.pdf
237
Chemtob-Concé M. C. et Gallochat A., Le Brevetabilité des inventions technologiques appliquées
à l’homme. (Ed. Lavoisier, Tech & Doc, Paris 2ème ed. 2004)
94
incompatibility with some of them238, make it a dissatisfactory and an incomplete
piece of legislation.
For this reason, it might seem necessary to look at some of the alternatives which
could have been chosen to remedy the defects explored throughout this work. The
reference to these alternatives could help us to complete our study with an answer to
our final answer. In such a case, with such circumstances, was a harmonisation
possible?
3.2 The alternatives or what could have been done to have a satisfactory
harmonisation: the absence of a simple and perfect answer.
In this paper, the main problems of the implementation of the 98/44/EC directive in
UK law and French law have been studied. When considering the criticisms which
led to such discrepancies, some alternatives arise as to what could have been done to
avoid them.
First, the basic modification would have been to define some controversial terms
such as “embryo” or, “industrial or commercial purposes”, or “substantial medical
benefit” or even “reproduction or multiplication” of a biological material239. Article
238
The Convention on Biological Diversity represents the international agreement with which the
European Directive 98/44/EC had the most difficulties to comply with. The Directive has tried to
take the former agreement into account. However, to reach a consensus, the obligation to ask the
consent of the donor to the filing of a product derived directly from material taken from the donor has
been introduced to the directive by a Recital and as a matter of fact does not represent a kind of
guideline in the reading of the directive and the law which required to be implemented. In doing so,
the European directive gave a chance to members not to implement that principle (like in the UK).
Consequently, even if this principle is introduced in the directive, it is hard to understand how such a
weak and elusive introduction could comply with the spirit and purpose of the Convention on the
Biological Diversity.
95
2 of the directive gives some definitions. However, the omission of some essential
terms could lead to a severe imprecision as to the scope of the directive, and thus, as
to its implementation and enforcement. Of course, the national jurisdictions would
probably ask the ECJ some precisions as to the said scope240. However, it would just
delay a proper reading of the directive and would complicate the harmonisation of
patent law.
The second change would have been to take advantage of the disparities among
national legal systems instead of looking for a consensus by all means. We have
already seen that the consensus, reached after 10 years of parliamentary debates, did
not satisfy everyone on many issues, especially on articles 5 and 6 of the
directive241. As far as article 6 is concerned, its first paragraph could have been
completed. Indeed, as explained by English authors, the main interest of the
patentability of living organisms, such as gene sequences, is the monopoly right
which is granted to the patent holder.242 Consequently, an alternative would have
been to add the criteria of an immoral monopoly right to the one of an immoral
commercial exploitation to limit patentability243.
239
Chemtob-Concé M. C. et Gallochat A., Le Brevetabilité des inventions technologiques appliquées
à l’homme. (Ed. Lavoisier, Tech & Doc, Paris 2ème ed., 2004).
L. Bentley, B. Sherman, Intellectual Property law, (Oxford University Press, 2nd edition, 2003) 43843
240
Three decisions have been held by the European Court of Justice on the interpretation of the
farmer’s privilege (ECJ, April 10th, 2003, case C-305/00; ECJ, March 11th, 2004, case C-182-01;
ECJ, October 14th, 2004, case C-336/02). Such request to interlocutory question is likely to be done
as to the scope which has to be given of some technical terms.
241
The Biotechnology Directive 98/44/EC of July 6 th, 1998, article 5 and 6
242
Beyleveld D., Brownsword R. and Llewelyn M., the morality clauses of the directive on the legal
protection of Biotechnological Inventions: conflicts, compromise and patent community, paper from
Goldberg R. & Lonbay J. Pharmaceutical Medicine, Biotechnology and European Law, (Cambridge
University Press, 2000) 164-169
243
See chapter 2
96
Furthermore, another possible solution would have been to let Member States free to
apply their own moral provisions instead of creating a common and European
morality clause on the protection of biotechnologies nobody managed to recognise.
Of course, the biotechnological directive, given the political and ethical
sensitiveness of its subject matter, could not remain only technical. For this reason,
it would have probably been useful so set down and assert some fundamental
principles acknowledged by all members in various international agreements244. It
would have represented a strong basis for patent limitations.
However, even with these modifications, article 5 of the directive and articles
related to the scope of the monopoly right would still have created lots of
difficulties. Biotechnologies involve legal, political, ethical, economic, cultural and
international issues. Doing so, it is extremely complicated, or even impossible, to set
down a harmonisation straight away with only one text; no matter the time
necessary to do so.
Maybe the last alternative, which would avoid a race to the patentability of living
organisms, and which would avoid challenging important ethical principles, would
be to draft an international agreement ratified by the major protagonists of the
biotechnological research. As studied in chapter one, there are already several
international conventions dealing with biotechnologies. However, none of them are
244
Beyleveld D., Brownsword R. and Llewelyn M., the morality clauses of the directive on the legal
protection of Biotechnological Inventions: conflicts, compromise and patent community, paper from
Goldberg R. & Lonbay J. Pharmaceutical Medicine, Biotechnology and European Law, (Cambridge
University Press, 2000) 164-169. When talking about international agreements, the author makes
reference to the European Convention on Human Rights or the Convention on Human Rights and
Biomedicine.
97
global. They concern either the economic side of the issue like the TRIPS
agreement, or the protection of the raw material and traditional knowledge allowing
the research on biotechnologies like the Biodiversity Convention, or some other
conventions dealing with the ethical and political problems the research and
discoveries in this field arise. However, none of them are global enough to
conciliate all these interests together and set up a satisfactory protection of the
biotechnological inventions, while protecting the traditional knowledge, biological
diversity and the research itself. Instead of looking for a compromise between
members of the EC, to face the United States and Japan, trying to comply at the
same time with international agreements, maybe the solution would have been to
give some limits to this competition and avoid it to become a race for patentability.
Even if this idea would have been extremely hard to put into practice, given first, the
amount of states which would have been involved –States from developed as well as
developing countries involved in any stage of biotechnological research- given the
differing interests of each of this protagonists – some protecting the invention itself
through a patent, others protecting the living material and traditional knowledge
involved in such invention- , maybe it would have been more useful to gather the
piecemeal legislation which already exist, and which is acknowledged by most of
the international community, to draft a strong and global international convention.
With principles already accepted, legal mentalities would not need to conflict in this
context. The latter would not replace the already existing texts, but would act as a
strong basis, with well determined principles, to any legislative work, and would
probably slow down the competition, and be a strong authority for any limitation
imposed on patents.
98
Conclusion:
Given the expanding financial investments on the biotechnological research focused
on living elements, the EC has seen the protection of inventions related to such
research as a necessity. Many industries are involved with such inventions such as
the pharmaceutical industry, the food industry and even health care. It has also been
considered as an important issue to face competition coming from the US and Japan.
As a result, the European directive 98/44/EC on the protection of biotechnological
inventions has been signed in July 6th, 1998. 10 years of compromises were needed
to be agreed upon. Despite these efforts from all Member States, this directive had
many difficulties in its implementation. Of course, these difficulties did not start
only when the directive was already drafted and needed to be implemented. Its
genesis shows clearly the impact of the disagreements. The action brought by
Netherlands before the European Court of Justice245 was a further element showing
how difficult a harmonisation on the protection of biotechnological inventions
would be, despite its necessity.
However, even if some parliamentary debates were expected, nobody ever thought
that the implementation of the directive would have been so difficult after the arrival
to a compromise. France and the UK are two different examples of this difficulty.
Implementing the directive, the French legislator chose to omit some provisions of
it. Article 5 has been particularly set aside, as well as article 3.2. The issue
concerned the patentability of gene sequences and other human living organisms.
The main argument of the French parliamentarians was that instead of encouraging
245
ECJ,October 9th, 2001, aff. C-377/98, Kingdom of the Netherlands c/ European Parliament and
Council of the European Union, JCP 2001 éd. E., n°42
99
innovation, a strong patent protection would lead to the contrary. The Myriad
Genetics case and the arguments supported by the Institute Curie summarised these
concerns and fears that a monopoly right on a gene sequence, far from encouraging
further research and innovation would most probably block other laboratories from
innovating. This concern has been further expressed in the additional limitations
which can be found in the French law implementing the European Directive. In the
UK, the concerns were different. The implementation has been done without any
discrepancies, except for some light changes which have been studied throughout
this paper. However, many criticisms have been formulated against the directive by
several UK legal professionals. These criticisms were especially focused on article 6
of the Biotechnology Directive and its merits challenged. Of course, the
implementation of the directive did not lead to an important public debate within the
UK, as has been explained previously. However, despite the quick and efficient
implementation, serious criticisms have been formulated in a legal system where
case law and court opinions have an extremely important role. Consequently, only
the application of the implementing statute on actual facts could tell us to what
extent the biotechnology directive has been integrated to UK law.
This study taught us several things. First of all, the analysis of both implementations
highlighted all the discrepancies and the divergences which still remained among
countries. It showed us the dissatisfaction which arose from the compromise reached
after 10 years of parliamentary debates. It becomes clear that the harmonisation
hoped for has been only partially achieved. The consideration of this partial success
raised several questions. The first of them was to know the reasons of such
dissatisfaction. It appeared obvious that several members, among which France and
100
the UK, did not have neither the same economic interests, nor the same public
policies. The reasons of such differences among both legal systems appeared to be
quite complex. The legal mentality as explained by P. Legrand 246 could be one of
the possible answers. With different histories, different legislative legitimacy,
different legal, political and economic concerns and a different balance between
ethical and economic concerns, the way to perceive such a complicated and
compound issue – the protection of biotechnological inventions – could not lead to
the same result. Studying both systems, it came into view that they had different
legal mentalities, each composed of a multitude of factors. Among so much
diversity, the next question was to know if a harmonisation on such a complex issue
was possible. Several alternatives have been examined. Some of them were related
directly to the draft of the directive and others were related to the merits of the
directive itself. However, these are only alternatives and options. In other words,
there is not any evidence which could show us that any of these alternatives would
have led to a better result and to a real and complete harmonisation. However, there
is no evidence of the contrary either.
Now, even if a complete harmonisation has not been reached, it must be underlined
that nearly all authors agree on the point that the Biotechnology directive represents
an important step for the protection of biotechnological inventions. Furthermore, it
is one of the rare global texts which took into consideration economic and non
economic concerns such as ethical and moral issues. However, to have a workable
harmonisation, each legal mentality and national specificities need to be taken into
consideration. We have seen that the search for a perfect and absolute harmonisation
246
P. Legrand, How to compare now (1995) 16 Legal studies 232
101
would cause more conflicts than unity. Consequently, only an acceptable degree of
harmonisation, which means a harmonisation which would give rise to the trust of
financial investors and laboratories, would be desirable. It will be probably the
future case law, in each legal system, which will lead to this acceptable degree of
legal uniformity.
Even if the directive could and should have been drafted otherwise, it will be up to
each state, including France and the UK, to apply their implementing legislation in
such a way to reach an acceptable degree of harmonisation. Actually, this European
text, even imperfect, even leading to many disagreements, is unlikely to lead to any
substantial danger on its own. However, the same can not be asserted for the
international piecemeal legislation, each of its elements showing conflicting
interests. Indeed, this important amount of international conventions could be likely
to increase a race to biotechnological patents capable of having negative effects on
the research and on the innovation itself. This reality could consequently lead to the
next important stage in the protection of biotechnological inventions, which we now
wait for.
102
ANNEX 1: GLOSSARY
A:
Atom: noun, the smallest unit of a chemical element that can display the properties
of that element, and which is capable of combining with other atoms to form
molecules.
The American Heritage® Dictionary of the English Language, Fourth Edition
Copyright © 2000 by Houghton Mifflin Company.
C:
Cancer: noun, Any of various malignant neoplasms characterized by the
proliferation of anaplastic cells that tend to invade surrounding tissue and
metastasize to new body sites.
The American Heritage® Dictionary of the English Language, Fourth Edition
Copyright © 2000 by Houghton Mifflin Company.
Cell: noun, the basic structural unit of all living organisms, consisting of a mass of
protein material.
Chambers 21st century dictionary, chambers reference online available on
http://www.chambersharrap.co.uk/chambers/chref/chref.py/main?query=biotechnology&title=21st
Cloning: The fact of reproducing genetically identical cells or organisms derived
from a single parent cell or organism by asexual reproduction.
Chambers 21st century dictionary, chambers reference online available on
http://www.chambersharrap.co.uk/chambers/chref/chref.py/main?query=biotechnology&title=21st
D:
DNA: deoxyribonucleic acid noun, biochem (abbreviation DNA) the nucleic
acid that forms the material of which the chromosomes and genes of almost all
living organisms are composed, containing coded instructions for the transmission
of genetic information from one generation to the next and for the manufacture of all
the proteins that are required for the growth and development of a whole new
organism.
Chambers 21st century dictionary, chambers reference online available on
http://www.chambersharrap.co.uk/chambers/chref/chref.py/main?query=biotechnology&title=21st
G:
103
Gene: noun the basic unit of inheritance, consisting of a sequence of DNA that
occupies a specific position on a chromosome. It is the means by which one or more
specific characteristics are passed on from parents to offspring.
Chambers 21st century dictionary, chambers reference online available on
http://www.chambersharrap.co.uk/chambers/chref/chref.py/main?query=biotechnology&title=21st
Genetic code: noun, the form in which genetic instructions for the manufacture of
proteins in the cells of living organisms are encoded.
Chambers 21st century dictionary, chambers reference online available on
http://www.chambersharrap.co.uk/chambers/chref/chref.py/main?query=biotechnology&title=21st
Genetic engineering: noun a form of biotechnology in which the genes of an
organism are deliberately altered by a method other than conventional breeding in
order to change one or more characteristics of the organism.
Chambers 21st century dictionary, chambers reference online available on
http://www.chambersharrap.co.uk/chambers/chref/chref.py/main?query=biotechnology&title=21st
Genetic therapy: noun the application of genetic engineering techniques to alter or
replace a defective gene or genes. The procedures are still at the experimental stage,
but it is hoped that they could lead to the prevention of hereditary diseases such as
haemophilia.
Chambers 21st century dictionary, chambers reference online available on
http://www.chambersharrap.co.uk/chambers/chref/chref.py/main?query=biotechnology&title=21st
Genetically Modified Organisms: noun (abbreviation GMOs) Organisms that
carry genes modified by techniques such as genetic engineering and recombinant
DNA techniques. It includes Genetically Modified Seeds and Genetically Modified
Food.
Bauer M. W. and Gaskell G., Biotechnology, the making of a Global Controversy, (Cambridge
University Press; 2002) 25
Germinal Genetic Therapy: noun, the aim of this therapy is to cure a genetic
disease fixing the damaged gene which is the cause of such disease. The process
consists in introducing a normal copy of the gene in the cell where the damaged
gene is located.
Chambers
21st
century
dictionary,
chambers
reference
online
available
on
http://www.chambersharrap.co.uk/chambers/chref/chref.py/main?query=biotechnology&title=21st
H:
Haemophilia: noun, medicine a hereditary disease, usually only affecting males, in
which the normal clotting ability of blood is lost or impaired due to a deficiency of
factor 8
104
Chambers 21st century dictionary, chambers reference online available on
http://www.chambersharrap.co.uk/chambers/chref/chref.py/main?query=biotechnology&title=21st
Hormone: noun, substance, produced by one tissue and conveyed by the
bloodstream to another to effect physiological activity, such as growth or
metabolism.
The American Heritage® Dictionary of the English Language, Fourth Edition
Copyright © 2000 by Houghton Mifflin Company.Published by Houghton Mifflin Company
Hydrocarbon: noun, chem any of a large group of organic chemical compounds
that contain only carbon and hydrogen, occurring notably in oil, natural gas and
coal.
Chambers 21st century dictionary, chambers reference online available on
http://www.chambersharrap.co.uk/chambers/chref/chref.py/main?query=biotechnology&title=21st
I:
Insulin: noun, a hormone secreted by the islets of Langerhans in the pancreas,
which controls the concentration of sugar in the blood. A lack of it causes diabetes.
Chambers 21st century dictionary, chambers reference online available on
http://www.chambersharrap.co.uk/chambers/chref/chref.py/main?query=biotechnology&title=21st
Islets of Langerhans: noun, small groups of specialized cells scattered throughout
the pancreas, which control the level of glucose in the blood by secreting the
hormones insulin and glucagons.
Chambers 21st century dictionary, chambers reference online available on
http://www.chambersharrap.co.uk/chambers/chref/chref.py/main?query=biotechnology&title=21st
M:
Molecule: noun 1 chem, physics the smallest particle of an element or compound
that can exist independently and participate in a reaction, consisting of two or more
atoms bonded together.
Chambers
21st
century
dictionary,
chambers
reference
online
available
on
http://www.chambersharrap.co.uk/chambers/chref/chref.py/main?query=biotechnology&title=21st
N:
Nucleotide: noun, an organic compound consisting of a purine or pyrimidine base,
a sugar molecule, and a phosphate group bonded together, four of which in DNA are
combined in numerous permutations to form the genetic code.
105
Chambers 21st century dictionary, chambers reference online available on
http://www.chambersharrap.co.uk/chambers/chref/chref.py/main?query=biotechnology&title=21st
P:
Purine: noun, a nitrogenous base with a double ring structure, the most important
derivatives of which are major constituents of the nucleic acids DNA and RNA.
Chambers 21st century dictionary, chambers reference online available on
http://www.chambersharrap.co.uk/chambers/chref/chref.py/main?query=biotechnology&title=21st
Pyrimidine: noun, a nitrogenous base with a single ring structure, the most
important derivatives of which are major components of the nucleic acids DNA or
RNA.
Chambers 21st century dictionary, chambers reference online available on
http://www.chambersharrap.co.uk/chambers/chref/chref.py/main?query=biotechnology&title=21st
R:
Recombinant DNA techniques: noun, Combination of methods for splitting,
sequencing, spicing and constructing genes.
Bauer M. W. and Gaskell G., Biotechnology, the making of a Global Controversy, (Cambridge
University Press; 2002) 25
S:
Sequencing: noun, (in full, gene sequencing) the process of determining the order
of nucleotides in DNA or RNA.
Chambers 21st century dictionary, chambers reference online available on
http://www.chambersharrap.co.uk/chambers/chref/chref.py/main?query=biotechnology&title=21st
X:
Xenotransplantation: noun, technique used to “overcome rejection of transplanted
animal tissues”. It would “reduce the problem of many more organs being required
for transplantation than are currently available”.
Brownsword R., Cornish W.R, Llewelyn M., law and human genetics: regulating a revolution,
(Oxford Portland. Cavendish publishing; 1999) 26
106
BIBLIOGRAPHY
Treaties, European legislative instruments and national legislation:
- Treaties:
- The Convention on Biological Diversity of 1992
- The Trade Related aspects of Intellectual Property Rights agreement of 1994
- The UPOV Convention adopted on December 2, 1961, by a Diplomatic
Conference
held
in
Paris,
available
on
http://www.upov.int/en/about/upov_convention.htm
- The UNESCO declaration on the Human Genome and Human Rights, adopted on
the report of commission III at the 26th plenary meeting, on 11 November 1997
- European legislative instruments:
- The Treaty establishing the European Community (consolidated text) of December
24th, 2002
- The European Patent Convention of October 5th, 1973
- The European Patent Office Guideline C-IV, 1.1, 2.2; EPC rr. 27 and 29
- European Directive 98/44/CE on the protection of biotechnological inventions of
July 6th, 1998, [1998] OJEC L213/13
- European regulation on the European protection of plant varieties of July 27th,
1994
- National legislation:
- French Statute of December 8th, 2004, n° 2004-1338, on the protection of
biotechnological inventions, “Journal Officiel” of December 9th, 2004 – N° 2004
- French Statute of August 6th, 2004, n° 2004-800, published in the “Journal
Officiel” of August 7th, 2004
- French Statute of July 29th, 1994 on Bioethics, n° 94-653
- Patents Regulations 2000 (S.I 2000, n° 2037)
- Patents Rules 2001 (SI 2001/1412),
- Patents and Plant Variety Rights (Compulsory Licensing) Regulations 2002 (SI
2002/247
107
Reports :
- Report of the European Commission to the Council and European Parliament,
“development and implications of patent law in the field of biotechnology and
genetic engineering”, commission of the European Communities, Brussels
7.10.2002, COM (2002) 545 final, 30-32 available on
http://europa.eu/eur-lex/en/com/rpt/2002/com2002_0545en01.pdf
- Beverly-Itasse E., la consolidation du secteur mondial des biotechnologies
humaines, report published in october 2004, available on
http://www.eurostaf.fr/fr/catalogue/etudes/sectorielles/pharmaciesante/conso_sect_
mondial_biotech/resume.html
- The patent office, legal protection of biotechnological inventions : a consultation
paper on implementation in the United Kingdom of EC Directive 98/44/EC, April
5th 2000, available at http://www.patent.gov.uk/media/pressrelease/2000/0504.htm
Parliamentary and governmental documents:
- Common proposal adopted by the Committee of conciliation on January 23rd, 1995
(Doc.-PE – COMS 3606/1/95, February 21st, 1995
- The European Group on Ethics in Science and New Technologies Opinion n°3 of
September 30th 1993 on the ethical questions raised by the commission proposal of a
directive on the legal protection of biotechnological inventions,
- The European Group on Ethics in Science and New Technologies opinion n° 8 of
September 25th 1996 as to the ethical aspects of the patentability of inventions based
on human elements.
- The French national advisory committee of ethics, Opinion n°64 of July 8th, 2000,
on the law proposal to implement the European directive on the legal protection of
biotechnological inventions
- The French Parliamentary Agency on the Evaluation of Scientific and
Technological Choices, Opinion n°116 [2001-2002] of December 20th, 2001 on the
patentability of inventions based on human elements
- Bill n°145 introduced by A. Juppé and P. Vasseur to the French parliament on
December 11th, 1996
Books :
- Adams J.N, Brownsword R, Understanding law (2nd ed, London, Sweet and
Maxwell, 1999) ch.4
- Bauer M. W. and Gaskell G., Biotechnology, the making of a Global Controversy,
(Cambridge University Press; 2002)
108
- Bellmann C., Dutfield G., Meléndez-Ortiz R., Trading in knowledge: development
perspectives on TRIPS, Trade and sustainability, (Earthscan Publication ltd,
London, Sterling VA, 2003) 4
- Bentley L, Sherman B, Intellectual Property Law, (Oxford University Press, 2nd
edition, 2001)
- Brownsword R., Cornish W.R, Llewelyn M., law and human genetics: regulating
a revolution, (Oxford Portland. Cavendish publishing; 1999)
- Chemtob-Concé M. C. et Gallochat A., Le Brevetabilité des inventions
technologiques appliquées à l’homme. (Ed. Lavoisier, Tech & Doc, Paris 2ème ed.,
2004)
- Davis J., Intellectual property law, (Butterworths, Core text Series, 2001)
- Dutfield G., Intellectual Property Rights and the Life Science Industries : a
twentieth century history, (Ashgate, 2002) 1-13.
- Franceschi M., Droit et marchandisation de la connaissance sur les gènes
humains, (CNRS édition, Paris 2004)
- Goldberg R. & Lonbay J. Pharmaceutical Medicine, Biotechnology and European
Law, (Cambridge University Press, 2000)
- Ilbert H. & Tubiana L., Protection juridique des inventions biotechnologiques :
analyse de la directive européenne et propositions, (SOLAGRAL collection réseaux
biotechnologiques, 1992)
- Martin Khor, Intellectual Property, Biodiversity and Sustainable Development:
resolving the difficult issues, Zed Books, Third World Network, 2002.
- Frederick Pollock and Samuel Wright, an essay on possession in the common law,
1988
- Meléndez-Ortiz R. and Sánchez V., Trading in genes, development perspectives on
biotechnology trade and sustainability, (Earthscan: London, 2005)
- Slapper G. and Kelly D., The English legal system, (London, Cavendish, 6th ed.,
2003)
- UNCTAD-ICTSD Project on IPRs and Sustainable Development, Resource Book
on TRIPS and Development, (Cambridge University Press, 2005)
- G. Samuel, epistemology and method in law, Ashgate, 2003
- Torremans P., Holyoak & Torremans Intellectual Property Law, 4th edition
(Oxford University Press, 2005)
109
- Van Hoecke M. , epistemology and methodology of comparative law, oxford and
portland oregon, 2004
- Wall Wilson (Dr), Genetics and DNA technology: legal aspects, (Cavendish
Publishing Limited, 2002)
- Zweigert and Kötz, the history of comparative law, an introduction to comparative
law, Clarendon Paperbacks, 2nd edition, 1992
Articles :
- Caron C., La loi n° 2004-1338 du 8 décembre 2004 relative à la protection des
inventions biotechnologiques, (2005), La Semaine Juridique Entreprise et Affaires
n°8, 24 février 2005, art. 42
- CCNE, Avis sur l’avant-projet de loi portant sur la transposition dans le Code de
propriété intellectuelle de la directive 98/44/CE, avis n°64 du 8 juin 2000.
- S. Chaturvedi, The Public-Private Debate in Agricultural biotechnology and New
Trends in the IPR regimes: Challenges before developing countries, available on
http://ris.org.in/dp17_pap.pdf
- Foster C., Current issues in the law of genetics, (2003), New Law Journal, NLJ
153.7062 (29), 10 January 2003
- Galloux J.-C., la loi n°2004-1338 du 8 décembre 2004 relative à la protection des
inventions biotechnologiques : un point d’orgue ou des points de suspension ? ,
(2005), Dalloz Recueil Doctrine, 2005
- Gaumont-Prat, les tribualtions en France de la directive n° 98-44 du 6 juillet 1998
relative à la protection juridique des inventions biotechnologiques, (2001), Rec.
Dalloz du 11 octobre 2001, 2993-2884
- Gaumont-Prat H., La laborieuse transposition de la directive n°98/44/CE du 6
juillet 1998 relative à la protection des inventions biotechnologiques, suite et fin ? ,
(2005), Propriété Industrielle n° 3, mars 2005, Etude 5
- Gaumont-Prat H., Loi de bioéthique et droit des brevets: alliance féconde ou
liaison difficile? la pénultième péripétie de la transposition de la directive (CE)
98/44, (2005), Les Petites Affiches, 18 février 2005, n° 35, p. 51
- Gaumont-Prat H., Brevetabilité du vivant : animal et humain – Inventions
biotechnologiques et contexte socio-juridique, (2004), JurisClasseur Brevets, fasc.
4240
- Graeme L., Patenting Stem Cells of Human Origin,(2004), European Intellectual
Property Review, 2004, 26 (2), 59-66
- Institut Curie, « The Institut Curie is initiating an opposition procedure with the
European Office » (Paris :Institut Curie, September 12, 2001)
110
- J. Henley, Cancer unit fights US gene patent. Special report: the ethics of genetics,
The Guardian, September 8, 2001
- Lawton Smith H., Regulating Science and Technology: The Case of the UK
Biotechnology Industry, (2005), LAW & POLICY, Vol 27. No.1, January 2005
- Leca A., La question de la brevetabilité du “matériel génétique” d’origine humaine
est-elle réglée avec l’article 17 de la loi n° 2004-800 du 6 août 2004 ? (2005) , Les
Petites Affiches, 18 février 2005, n° 35, p. 63
- P. Legrand, European Legal Systems are not converging (1996) 45, International
and comparative law quarterly 52
- P. Legrand, How to compare now (1995) 16 Legal studies 232
- Le Gal C., La contestation de la directive relative à la protection des inventions
biotechnologiques, la fin des espérances françaises? , (2005), La Semaine Juridique
Edition Générale n°11, 16 mars 2005, I 120
- MacLaren M., Patently Unsatisfactory ?: community Legislative competence and
the ECJ Biotech Decision, German Law Journal No 18 (01 December 2001)
European and international law
- J. Merz, A. Kriss, D. Leonard, and M. Cho, “Diagnostic testing fails the test”
(2002) 415 Nature 577.
- Passa J., La protection par brevet des semences génétiquement modifiées. A
propos de l’arrêt Monsanto de la Cour suprême de Canada, (2005), Propriété
Industrielle n°5, mai 2005, Etude 13
- L.Rayar, Translating Legal Texts: a methodology (1993) 47Euroforum conference
paper.
- Reimann, progress and failure of comparative law in the second half of the 20th
century, The American Journal of Comparative Law, 2002, p. 671
- Rimmer M., MYRIAD GENETICS, Patent law and genetic testing, (2003),
European Intellectual Property Review, EIPR 2003, 25(1), 20-33
- Rodolfo Sacco, legal formants: a dynamic approach to comparative law, american
journal of comparative law, vol. 39, 1991
- Schertenleib D., The Patentability and Protection of living organisms in the
European Union, (2004), European Intellectual Property Review, 2004, 26 (5), 203213
- Warren-Jones A., Patenting DNA: a lot of controversy over a little intangibility,
(2004), Med. Law. Rev. 2004. 12 (97)
111
Thesis and Dissertations:
- Guibret F., 1999, la directive du 6 juillet 1998 relative à la protection des
inventions biotechnologiques et ses conséquences en droit français, Mémoire DESS
propriété industrielle (université Paris II)
- Nuňez Duran J. E., 1997, International protection for biotechnological inventions,
University of Kent at Canterbury, UL3 shelved in Thesis Collection 4498
- Schley C., 2001, Biotechnology/ Gene Patenting, University of Kent at
Canterbury, UL3 shelved in Thesis Collection 4906
Case law:
European Case Law:
- ECJ,October 9th, 2001, aff. C-377/98, Kingdom of the Netherlands c/ European
Parliament and Council of the European Union, JCP 2001 éd. E., n°42
- ECJ, November 13th, 1990, 106/89, Req. CJCE 1990, I, p. 4135
- ECJ, December 18th, 1997, C-129/96, Req. CJCE 1997, I, p. 7411
- ECJ, April 23rd, 2003, case C-305/00
- ECJ, March 11th, 2004, case C-182/01
- ECJ, October 14th, 2004, case C-336/02
European Patent Office decisions:
- EPO, Relaxine case, December 8th, 1994, D. 1996, p 44
- Howard Florey Institute’s application T74/91 [1995] OJEPO 388
- Icos Corporation/ Seven transmembrane receptor [2002] OJEPO 293.
- Plant Genetic System [1995] OJEPO 545
- Harvard/ Onco-mouse [1990] EPOR 4; Déc. T. 19/90, Regents de l’Université de
Harvard : JOOEB déc 1990, p. 476
UK case law :
- Asahi’s Application [1991] RPC 485 (HL)
- Hallen v. Brabantia [1991] RPC 195, 212
- Genentech’s Patent [1989] RPC 147, 262 (Mustill LJ)
112
- Biogen v. Medeva [1997] RPC 1, 31 (Lord Mustill)
- R v. Secretary of State for Health, [2003] UKHL 13, [2003] 2 All E.R 113
- Dow Chemical v. Spence Bryson [1982] FSR 598, 628-30
French case law:
- Cons. Const., July 29th, 2004, dec. N° 2004-498 DC, JO n° 182 of august 7th,
2004, p.14077
- CA Nancy (the Court of appeal of Nancy), September 13th, 1988 (PIBD 1988, III,
p.572)
- TGI Paris (High Court of Paris), October 26th, 1989 (PIBD 1990, III, p.91)
U.S Case Law :
- U.S Supreme Court, Diamond v. Chakrabarty, 447 U.S 303 (1980)
Canadian case law:
- Monsanto Canada Inc. v. Schmeiser, Supreme Court of Canada, May 21st, 2004,
[2004] 1 R.C.S 902
Websites:
http://www.chambersharrap.co.uk/chambers/chref/chref.py/main?query=biotechnolo
gy&title=21st
http://www.ocean.udel.edu/extreme2004/genomics/dnahistory.html
http://europa.eu/eur-lex/en/com
http://www.european-patent-office.org/
http://www.wto.org
http://www.biodiv.org/doc/publications/guide.asp
http://www.upov.int/en/about/upov_convention.htm
http://www.hugo-international.org/
http://www.patent.gov.uk/media/pressrelease/2000/0504.htm
http://www.hri.org/docs/ECHR50.html
113