Intellectual Property and Biotechnology: A European Perspective.
Dr Margaret Llewelyn
Reader in Intellectual Property Law
Deputy Director
Sheffield Institute for Biotechnology Law and Ethics
Introduction
Data published by the European Patent Office in 2002 indicates a steady growth in patent
applications concerning inventions involving biological material 1. This increase, when taken
together with recent legislative developments such as the adoption of the EU Directive on the
Legal Protection of Biotechnological Inventions, which explicitly states that biological
material is patentable, and the introduction of a EU Community Plant Variety Rights regime
which implements the UPOV Convention 1991, would indicate that the legal situation with
regard to the intellectual property status of genetic material in Europe is now established.
Protection via an intellectual property right is both appropriate and possible for all bar the
least inventive or most ethically sensitive types of genetic material. In this Europe
developments appear to embody the ethos set down in the Agreement on Trade Related
Aspects of Intellectual Property Rights (TRIPs) that patents should be available for all fields
of technology, as required under Article 27(1) TRIPs, with only limited restrictions on the
application of that principle.
However, the actual position is not as clear as might first appear. Less than a handful of EU
member states have implemented the EU biotech directive into national law with the result
that the European Commission is threatening punitive action for non-compliance with a
Community measure. Equally not all EU member states have upgraded their national laws to
comply with the 1991 UPOV Convention meaning that there is continued disparity in
available protection across the EU (see the accompanying tables). In addition bodies such as
the UK’s Nuffield Council on Bioethics and Human Genetics Commission have raised
concerns over the application of the traditional patent granting criteria to genetic material.
Equally patents grants, such as those made to Myriad Genetics in respect of the breast cancer
genes, have been criticised by public and private sector alike because of what is seen as an
inappropriate application of the granting criteria together with an unjustifiably broad scope of
protection affecting public access to ‘best practice’ healthcare. There have also been a
number of high profile patent cases which have seen key patents held by multi-national
companies revoked and media reportage strongly suggesting that stock market confidence in
the bioscience industry, and in the value of the rights granted to market critical products, has
been shaken. Whilst there are some who believe that the intellectual property system will
internally resolve any problems given time, there are others who believe that more
immediate action needs to be taken and not necessarily by those directly involved in patent
acquisition and litigation2.
1
www.european-patent-office.org/epo/facts_figures/facts2000/e/6_e.htm - the EPO has approximately 15,000
‘life-form’ patent applications pending. It is, however, quite difficult to put a precise figure on the number of
bioscience patent applications and grants. The reason is because of the problem of defining ‘an invention
comprising biological material’ - this concept can involve both animate and inanimate material and can also
consist of a number of different genetic confiurations which could include genetic material common to more than
one species.
2
For an example of this debate see White White Gene and Compound per se Claims [2000/2001] 6 Bioscience
Law Review 239. The paper can also be found in the journal of the Chartered Institute of Patent Agents, The CIPA
Journal February 2002 Vol 31 No2 at 80 and March 2002 Vol 31 No 3 at 134. The views sets out by White have
been challenged, although not the principle of a reward for a contribution to the public good, see Crespi Gene and
It is clear that the new bioscience revolution promises a great deal, however, a central issue is
the provision of effective and appropriate intellectual property rights. Despite the recent
intensive legislative activity in Europe, questions remain including those relating to the twin
presumptions of protectability and patentability, the availability of rights and the ability of all
interested parties to acquire and enforce rights (this is a particularly important question for
the majority of European plant breeders which fall within the category of small to medium
sized enterprise, a sector which traditionally does not use intellectual property rights
primarily for reasons of acquisition and enforcement costs, and yet these breeders are
increasingly having to competing against rights-sophisticated multi-nationals) and the scope
of the rights once granted. Of particular important to the UK, for example, is the impact of
intellectual property rights over genomic products and processes on the ability of the national
health service to deliver the most appropriate and effective healthcare - at the heart of this
discussion lies the value of the public interest limitations such as the research exemption and
compulsory licence/Crown Use provisions.
This means that there is a lack of certainty and predictability within the law. Certainty as to
what can be protected and predictability as to the value of the right once granted. If this
situation continues then both society and industry could lose trust in these rights which are
intended to facilitate the creation of inventions for the benefit of society. The issue which
Europe still needs to resolve is how to best achieve the twin goals.
This paper will simply present a broad brush outline of current European legislation. Within
the confines of this paper it is not possible to provide a comprehensive evaluation because
there are differences between a) the protection afforded at the European/EU level and
national levels and b) the types of protection available - for example the fact that there are
two systems of protection available for different types of plant material (the plant variety
rights system which protects plant varieties and the patent system which protects all other
aspects of plant material) means that more than one jurisprudence has developed on the
protection of biological material.
It is against this complex and diverse background that the current European legal framework
needs to be read.
EUROPEAN PATENT LAW
The situation in Europe is slightly complicated in that there are two sources of European
patent law. However, recent attempts to bring the two sources together should serve to make
the legislative framework clearer.
The two sources are:
(1)
European Patent Convention (EPC)
This is not an instrument of the EU, however, all EU countries are members of EPC and all
EU national laws mirror the EPC. The reason for this mirroring is because the function of
the EPC is to enable an applicant to acquire, via a single application, a patent which is
enforceable in as many member states as the applicant wishes. The right once granted has
exactly the same effect as if it had been granted by the local granting office, and it is
enforceable through the national courts. In order to ensure the necessary conformity between
member states, the EPC requires that the patent laws of all member states adhere to its
Compound Claims: Another View The CIPA Journal May 2002, Vol 31, No 5 at 255. Both authors are eminent
patent attorneys yet have very different views on the appropriateness of developments in gene patenting.
provisions. The EPC is overseen by the European Patent Office (EPO) which again falls out
side the purview of the EU.
and
(2)
EU Patent Legislation
With its objective of eradicating national differences which could result in trade barriers and
impede the “proper functioning of the single market”3 the EU introduced the Directive on
the Legal Protection of Biotechnological Inventions 1998 (Directive 44/98). The objective
of the Directive is to ensure the co-ordinated development of the legal protection of
biotechnological inventions. As the national patent laws of each member state are settled by
virtue of membership of the European Patent Organisation, the Directive does not seek to
introduce new laws, but rather seeks to clarify the application and interpretation of the
existing substantive laws, where necessary by appropriate national legislative action. Each
member state had until 30 July 2000 to implement. At this time only five member states,
Denmark, Finland, Ireland, Spain and the United Kingdom, have officially taken action to
implement. Recent information suggests that Sweden has also implemented. There are
numerous reasons for the failures to implement which range from purely political in the sense
of ever changing administrations through the substantive concerns about the patenting of
living material and in particular the patenting of human genetic material. For example, the
French are concerned that the Directive violates the principle enshrined in their law on
bioethics that no commercial gain should result from the use of the human body. The most
strident opposition to the Directive has come from the Netherlands which lodged a challenge
to its validity at the European Court of Justice4. The action was unsuccessful but this has not
prevented a number of political parties in the Netherlands, France and Germany seeking to
have the Directive revised to omit the protection of human genetic material. At present the
situation appears to be one of impasse at the national level. However, the reaction from the
EPO to the Directive has been more positive.
In order to avoid any divergence of application or interpretation between the national
granting offices and courts and the European Patent Office, on 6th June 1999, the
Administrative Council of the EPO voted to amend its Implementing Rules to permit the EU
directive to be used as a Supplementary Means of Interpretation. It is clear from the
amendment that the EPC is now to be read in light of the provisions of the EU directive. Rule
23b also expressly states that “...the Recitals preceding the provisions of the Directive as also
to be taken into account”. (1999 OJ EPO 437). These came into force on the 1st September
1999. These provisions have to be followed unless it can be shown that they are inconsistent
with the Convention. This means that there is now greater cohesion between the policy and
practice of the EU and the EPO.
Recently the EU has proposed the introduction of a EU Patent which would primarily oversee
a more harmonised approach to the enforcement of patents granted under the EPC. This
proposal is still being discussed and it is not proposed to discuss it in any detail within this
Report.
The relevant provisions of the EPC together with the Directive are outlined below.
A) The European Patent Convention (EPC)
3
Directive 98/44/EU, Recital 5
4
http://europa.eu.int/jurisp/cgi-bin/form.pl?lang=en
The EPC came into force in 1973 under the auspices of the Council of Europe. The office is
autonomous with no external review mechanism.
An applicant must submit a patent specification which outlines:
(a) what was known previously;
(b) how his/her invention builds on this prior knowledge in a novel and inventive manner
(the problem/solution approach is used) which identifies a functions for the material;
and
(c) the claims which define the boundaries of protection.
The protection once granted extends to as many countries as the applicant designates in the
application and the right then has local effect in those countries. It is litigated through the
national courts and not by the European Patent Office.
The scope of the patent claims must be such that it is possible to identify the new technical
effect that the applicant is claiming, but the claims must not be so broad that they claim more
than the applicant has actually invented. Where the patent is for a process, then protection
extends to any material that results directly from using the process. Patents are available for
inventions, products or processes which meet the threshold for protection.
I) Threshold for Protection
It should be noted that there may be differences in the interpretation of these requirements
between national granting offices. For reasons of brevity and clarity it is not proposed to
discuss specific national differences within the EU.
1.
Novel
2.
Result from an Inventive Step
3.
Capable of Industrial Application
4.
Not Excluded The key exclusions for biotechnological inventions are:
 Discoveries (Article 52)
 Inventions the commercial exploitation of which would be contrary to ordre
public or morality (Article 53(a))
Plant and animal varieties and essentially biological process for the production of
plants and animals - this does not extend to microbiological processes or the
products thereof (Article 53(b))
5. Sufficiently Disclosed
In brief each requirement can be described as follows.
1.
Novelty
Material which does not form part of the state of the art is deemed to be novel. Article 54(5),
which was introduced following the revision of the EPC in 2000, reads:
“paragraphs 2 and 3 [(2) the state of the art shall be held to comprise everything which is
made available to the public by means of a written or oral description, by use, or in any other
way, before the date of filing of the European patent application; (3) Additionally, the
content of European patent applications as filed, of which the dates of filing are prior to the
date referred to in paragraph 2 and which were published under Article 93 on or after that
date, shall be considered as comprised in the state of the art.] shall not exclude the
patentability of any substance or composition referred to in paragraph 4 [paragraph 3 shall
be applied only in so far as a Contracting State designated in respect of the later application,
was also designated in respect of the earlier application as published] for any specific use in
any method referred to in Article 53(c)[(4)] Methods for treatment of the human or animal
body by surgery or therapy and diagnostic methods practised on the human or animal body
shall not be regarded as inventions which are susceptible of industrial application...This
provision shall not apply to products, in particular substances and compositions, for use in
any of these methods], provided that such use is not comprised in the state of the art.”
2.
Inventive Step
It must not have been obvious to invent. This determined on the basis of what would have
been obvious to a person skilled in the art given the state of the art prior to the invention
being made.
3.
Capable of industrial application
The invention must be capable of being used and, where biological material is involved, the
function of that material must be demonstrated.
Each of these requirements must be demonstrated in the patent specification, which also must
allow a person skilled in the art of reproduce the invention simply by reference to the
specification.
There is no physical examination of the invention.
4. Excluded Material
a.
Discoveries
A discovery is, for patent law purposes, latent information for which a use has yet to be
found. Once a use is found for the information then, provided that use can be shown to be
both novel and inventive, the discovered material, as used in the novel and inventive manner,
may be patentable.
However, biological material which is isolated from its natural
environment or produced by means of a technical process may be patentable even if it
previously occurred in nature (Rule 23c(a))
Article 53 European patents shall not be granted in respect of:
(a)
inventions, the commercial exploitation of which would be contrary to ordre public
or morality, provided that the exploitation shall not be deemed to be so contrary merely
because it is prohibited by law or regulation in some or all of the Contracting States5.
(b)
Plant or animal varieties or essentially biological process for the production of plants
or animals; this provision does not apply to microbiological processes or the products
thereof
The decision in Novartis6 in 1999 demonstrates that this exclusion only applies to plant
varieties as such and a plant variety is determined by reference to the plant variety rights
5
Harvard/Oncomouse [1990] O.J. EPO 476; [1992] O.J. EPO 589.Plant Genetic Systems v Greenpeace
(T356/93) [1995] European Patent Office Reports 357.Howard Florey/Relaxin [1995] European Patent Office
Reports 541. For an academic discussion of the intepretation and application of Article 53(a) see Beyleveld &
Brownsword Mice, Morality and Patents with Armstrong & Davis Patents and Morality in Perspective. [See also
Moufang (1994) 25 IIC 407; Moufang (1995) 24 IIC 487 and Straus (1995) 24 IIC 920; Ford The Morality of
Biotech Patents: Differing Legal Obligations in Europe [1997] 6 European Intellectual Property Review 315;
Sterckx Some Ethically Problematic Aspects of the Proposal for a Directive on the Legal Protection of
Biotechnological Inventions [1998] 4 European Intellectual Property Review 123; Warren A Mouse in Sheep’s
Clothing: The Challenge to the Patent Morality Criterion Posed by “Dolly” [1998] 12 European Intellectual
Property Review 445]. The practical problems which could encountered in trying to bring morality within the
framework of a patent are outlined in Harms Drafting Claims Around Morality [1996] 7 European Intellectual
Property Review 424.
6
Novartis/Transgenic plant (G01/98) [2000] European Patent Office Reports 303
system (see below) any claim not falling within the definition of a plant variety is patentable
even where it encompasses plant varieties - this decision mirrors the principle set down in
Article 4(2) of the EU directive.
Article 52(4) also excludes
(c)
Methods for the treatment of the human or animal body or therapy and diagnostic
methods practised on the human or animal body....This provision shall not apply to
products, in particular substances or composition, for use in any of these methods.
A simple rule of thumb is used - in vivo activity is excluded from protection and in vitro
included.
The Human Body
Whilst there is no specific reference in either the TRIPs Agreement or the EPC to the human
body as a result of adopting the Directive for the purposes of Supplementary Interpretation,
the Implementing Rules of the EPC now specifically exclude from patent protection the
human body and simple discoveries of one of its elements (Rule 23e). However, inventions
which involve human genetic material are patentable provided the threshold for protection is
met and the invention does not fall within the public interest exclusions. Concern remains
over the application of these provisions. In 2000 it was announced that the European Patent
Office had “mistakenly” granted a patent to Edinburgh University over a “method of
preparing a transgenic animal”, the term “animal” being taken to include humans (Patent No
0695351 22/02/2000). The patent has since been amended7.
The categories of excluded material are given a restrictive application8.
5. Sufficiently Disclosed
The patent applicant must disclose the invention sufficiently to enable another person
skilled in the art to reproduce it - it is also necessary for them to demonstrate that the
claims made support the invention described.
Once granted the patent can be enforced in those countries designated by the patentee via the
national courts.
II) Scope of the Right
The scope of the right granted is determined by the language of the claims - what falls within
the claims is covered by the patent, that which falls outside is not covered. Most patent
systems use a purposive construction for claims - what did the patentee intend the claims to
include. But it is important to note that when courts are assessing the scope of the claims they
do so from the basis of assessing the right of the patentee against the rights of third parties.
It is also relevant to note that most patent systems hold that where a patent is granted over
material which can be incorporated into other material, for example a gene, then, provided
that the incorporated material continues to perform the function which is patented, the patent
holder can claim rights over the material into which the material has been placed.
7
EPO Press Release 24th July 2002. In its decision the Opposition Division made it clear that it considers itself
bound by decisions under the EPC and the applicable international and European law, such as the EU
biotechnology directive. It is not bound by national law.
8
See discussion in Novartis, above note 6
Also where a patent has been granted over a process the patent is held to cover any product
which has been directly produced using that process.
III) Derogations from/Limitations to the Right
As the European Patent Convention is solely concerned with the grant of a patent it is silent
on the derogations/limitation to the patent right. It is left to national patent laws to determine
whether there should be any curbs on the rights granted to the patent holder. For reasons of
brevity and clarity it is not proposed to discuss specific national differences within the EU.
Whilst the right granted permits the holder to prevent others from using the protected
material for a period up to 20 years, there are certain derogations which permit use without
necessarily acquiring authorisation from the rights holder. The main derogation for plant
breeders is that relating to research use.
Research Exemption
The EPC makes no mention of any right to use patented material freely for research purposes.
However, the Community Patent Convention (which has never been fully implemented)
permits “acts done for experimental purposes” and this has been adopted by all member
states of the EPC. There is a question over what constitutes experimental purposes with the
determining factor being whether the material is being used with a commercial objective in
mind. If it is being used with a commercial objective in mind then it is unlikely to fall within
the research exemption9.
Compulsory Licences
The primary limitation of the right enjoyed by the patent holder is of the State to grant a
licence in the absence of any agreement from the rights holder.
As with the research exemption, the EPC is silent on the issue of compulsory licences,
however most countries operate a system whereby if a patent holder is shown by a third party
to be abusing the right by an inappropriate anti-competitive strategy then national offices
may, in extremis, grant a compulsory licence. These are usually only granted after the third
party has failed to secure an ordinary licence and only if that third party can show that the
rejection by the patent holder of a offer to take a licence was unreasonable.
B) Directive 44/98/EC10
In 1998 the EU introduced a directive which makes it clear that, with certain limited
exceptions, biological material may form the basis of a patentable invention.
The relationship between the directive and the EPC can be explained as follows.

all member states of the EU are members of the EPC

the EU cannot revise or amend the EPC

member states of the EU would be required to amend their laws to bring them into line
with the directive

if the directive changed any provisions of the EPC then the national laws member
states of the EPC would be inconsistent
9
See Cornish Experimental Use of Patented Inventions in European Community States IIC Vol 29, No 7/1998,
735.
10
Official Journal of the European Communities L 213/13 30/7/98

the substantive provisions of national patent laws remain the same with the objective
of the directive being to provide guidance as to how they should be interpreted and
applied in respect of biotechnological inventions.

As a result the directive builds on the principles set down in the EPC and thus must be read in
conjunction with the EPC. The decision of the EPO in June 1999 to adopt the Directive for
the purposes of supplementary protection means that there is greater coalescence between the
two systems.
1. The Text of the Directive
Article 1 All member states of the EU shall be required to provide patent protection for
biotechnological inventions
Article 3(2) Biological material which is isolated from its natural environment by means of
a technical process may be the subject of an invention even if it previously occurred in
nature
Article 4(1)(a)- Plant and animal varieties are not patentable
Plant varieties are defined according to the Community Plant Variety Rights Regulation
(Article 2(3) - where a claim encompasses more than one variety then this will be patentable
(Article 4(2)) no definition of animal variety is given.
Article 5 The human body and the simple discovery of one of its elements, including the
sequence or partial sequence of a gene, cannot constitute patentable inventions. An element
isolated from the human body may constitute a patentable invention even if that element is
identical to that of a natural element. The industrial application of the gene must be
disclosed in the patent specification.
Recital 26 states that is an invention is based on human genetic material and a patent
application is filed then consent to that application must have been obtained from the person
from whose body the material was taken. This has to be in accordance with national law - to
date only Denmark has implemented this provision.
Article 6 Inventions will only be considered unpatentable where their commercial
exploitation would be contrary to ordre public or morality.
The directive provides a non-exhaustive list of inventions which will automatically be
regarded as immoral; processes for human reproductive cloning; processes for modifying the
germ line genetic identity of human beings; use of human embryos for industrial or
commercial purposes and processes for modifying the genetic identity of animals which
causes greater suffering to the animal than benefit to either man or animal.
Article 7 The Commission’s Group of on Ethics in Science and New Technologies will
evaluate all ethical aspects of biotechnology.
Scope of the Right
Article 8 The protection conferred by the patent extends to any biological material derived
from the protected material which possesses the same characteristics. Where a process is the
subject of a patent then the protection shall extend to any product directly obtained through
that process and to any other material derived from that directly obtained material which
possesses the same characteristics
Article 9 The protection conferred by a patent shall extend to all material (except the human
body) in which the genetic material protected by the patent is contained which performs its
function
Article 10 The extension of protection referred to in Articles 8 and 9 does not apply to the
first multiplication or propagation of the protected material where this multiplication or
propagation necessarily results from the application of the material for which it was
marketed. This right does not extend to any subsequent multiplication or propagation.
Derogations from the right:
Unlike both the US and EPC patent systems the directive specifically permits certain
derogations from the right. Interestingly it makes no mention of any right to use protected
material for research purposes.
Article 11 This permits farmers, in certain instances to retain from one year to the next
reproductive, or breeding, material obtained from a patented plant or animal. This right, often
referred to as the Farm-Saved Seed or Farmers Privilege, is restricted, however in respect of
plant material. The directive makes an explicit reference to the EU Regulation on Community
Plant Variety Rights (see below) .
Article 12 This introduces the concept of compulsory cross-licences between patents and
plant variety rights. These apply where a breeder or inventor cannot exploit a protected
variety or patented invention without infringing another party’s plant variety right or patent.
The breeder/inventor must show
a) that they applied unsuccessfully to the holder of the plant variety right/patent
and
b) that their plant variety or invention constitutes a significant technical progress when
compared with the protected plant variety or invention
Article 12(4) states that each Member State shall designate the authority or authorities
responsible for granting the licence. Where the licence for a plant variety can be granted only
by the Community Plant Variety Office, Article 29 of Regulation (EC) No 2100/94 shall
apply
This provision is the subject of much debate as it is not clear what the requirement that the
plant variety or invention must constitute a significant technical progress means.
Research
The directive is silent on the issue of research.
Article 16 sets down review mechanisms to take account of “any problems encountered with
regard to the relationship between this Directive and international agreements on the
protection of human rights; the implications of this Directive...for basic genetic engineering
research of failure to publish or late publication; and the development and implications of
patent law in the field of biotechnology and genetic engineering.” It is this latter which is
being invoked by those who wish to see a revision of the Directive.
Areas of Concern Include
i) Patenting living material (distinction between discoveries and inventions);
ii) Patents for intermediates, SNPs, ESTs, research tools;
iii) Protection of incremental innovation - level of non-obvious activity;
iv) Research Use - when is a use non-commercial, use for clinical trialling?
v) Relationship between patents and plant variety rights - especially for research purposes;
vi) Scope of protection, broad claims;
vii) Reach through claims - and tie-in requirements (for example, a licence to use a patented
testing kit being conditional on a tie-in obligation to use the diagnostic service provided by
the patent holder);
viii) Role of the Patent Agents;
ix) Compulsory licensing;
x) Crown/Government Use;
xi) Cost of Acquisition and litigation.
There is little agreement as to how these can be resolved both within and outside the patent
community.
EUROPEAN PLANT VARIETY RIGHTS11
At the EU level plant variety rights is governed by the Regulation on Community Plant
Variety Rights (CPVR)12 which came into effect in 1994. The Regulation set up the
Community Plant Variety Rights Office (based in Angers, France) and established a
Community-wide plant variety right enforceable in each member state. The introduction of
the Regulation served two functions, it enabled the EU to put in place a single community
right and it brought EU policy and practice into line with the UPOV Convention 1991.
However, it would not be appropriate for this Report to merely focus on the Community
system nor on the UPOV Convention 1991. The Community-right does not supplant the
national systems of plant variety protection, many of which have been in operation since the
1960s. Instead the Regulation is intended to serve as an alternative right (it is relevant to note
that an applicant must decide which right, national or community, they wish to acquire as
they cannot hold both). The relevance is the fact that whilst the EU has embraced the 1991
UPOV Convention this does not mean that the 1991 Convention has been adopted at the
national level in all EU member states. As can be seen from the table below there is a
11
For a critical view of European plant intellectual property see Llewelyn The Legal Protection of Plant Varieties
in the European Union: A Policy of Consensus, or Confusion?[1997] 2 Bioscience Law Review 50- 61; Llewelyn
European Plant Variety Protection: A Reactionary Time [1998/9] 6 Bioscience Law Review 211 – 219
12
Regulation 2100/94
considerable divergence between member states, with some countries having only ratified the
earliest UPOV Convention, the 1961 Act.
It is relevant, therefore, before discussing the Community Regulation to set out the UPOV
system upon which it is based, and because of the differing forms of the UPOVC currently in
force to look at the two key UPOV Conventions, the 1978 and 1991 Acts.
Background to the UPOV Convention
The International Convention on the Protection of New Varieties of Plants (UPOV) was
adopted in 1961 following extensive discussions over how to most appropriately and
effectively protect the results of plant breeding programmes.
In contrast to the action taken in the US, the view in Europe was that plant material should
not be patented. The reasons for this were that:
a) Plant material would not meet the novelty criterion;
b) Plant breeding programmes could rarely be shown to be inventive;
c) Whilst the results of plant breeding were undoubtedly of industrial application, it would
not be in the public interest to allow plant breeders to have an over extensive monopoly.
d) It would be difficult for plant material to met the disclosure (teaching) requirement namely that a person skilled in the art can reproduce the invention merely by following the
information contained in the specification. Even where a full description is given as to how
the plant material was produced, it does not guarantee that following the same route will give
rise to an identical result (i.e. the plant material could mutate or sport).
The result was the plant variety right as set down by the International Convention on the
Protection of New Plant Varieties (UPOV) which came into force in 1961.
Common Principles under the 1978 and 1991 UPOV Conventions
The UPOV Conventions provide protection for
Plant groupings which are Distinct, Uniform and Stable (DUS) following repeated
reproduction.
Distinct = essential characteristics must be distinct from other varieties within the same
genus or species;
Uniform = these characteristics must reproduce uniformly; and
Stable = these characteristics must reproduce in a stable manner.
The plant variety must also not have been offered for sale prior to the right being applied for this is referred to as the variety being new but it is not the same concept as novelty in patent
law.
The protection is acquired only after a minimum of two years of trialling, undertaken by the
granting office, during which time the plant material is assessed for the DUS criteria against
control varieties from within the same species. This can be contrasted with the patent system
where the examination of the invention pre grant consists of a paper exercise. It should also
be noted that the reproductive material of the variety can be recalled by the granting office at
any time during the period of grant, to ensure that it has remained DUS.
The right extends to the sale or offering for sale of the reproductive material and it is a
lesser monopoly than that provided by a patent.
The right is also premised on a number of derogations.
1) Farmers may retain the reproductive material of a protected variety from one year to the
next for resowing without payment of an additional royalty (this is known as farmers’
privilege)
2) Breeders are able to use protected material for research purposes - where that research
leads to a new variety the breeder of the new variety can claim rights over it without having
to obtain permission from the first breeder (this is known as the breeders exemption).
These derogations have altered during the various revisions of the UPOVC.
The UPOV Convention has been revised three times since 1961 - the two main revisions
taking place in 1978 and 1991. A revision in 1972 was to extend protection to a wider
number of plant varieties (i.e. decorative).
The UPOV Convention 1978.
The protection provided by the 1978 Act is as follows.
1) Rights are granted over varieties which are shown to be distinct, uniform, stable and
commercially new. (One major diversion from the 1961 Act was the removal of the
definition of a plant variety).
2) The right allows the holder to sell, or offer for sale, reproductive material of the protected
variety.
3) The right does not extend to the use of material for research purposes (nor to the products
of that research) nor to farm saved seed (the so-called farmers’ privilege).
4) The Act requires member states to progressively extend protection to more species and
genera;
4) The right lasts for up to 18 years for trees and vines and 15 years for all other varieties.
5) Member states are prevented from permitting patent protection and plant variety protection
over the variety (the dual protection prohibition).
In contrast the 1991 Act strengthens the rights of the breeder and limits the exemptions from
the right.
The UPOV Convention 1991
The substance of 1991 Act is follows.
1) It provides a right over plant groupings which are shown to be commercially novel,
distinct, uniform and stable (Article 5).
2) The definition of a plant variety is reintroduced, and the right extends to any plant
grouping within a single botanical taxon of the lowest known rank which, irrespective of
whether the conditions for a grant of a plant variety right are fully met, is new, distinct,
uniform and stable (Article 1). The fact that the grouping can be identified as a plant variety
irrespective of whether or not it meets the conditions for grant takes account of varieties with
a level of uniformity which is acceptable to industry, but not acceptable for a grant of rights.
It allows these “varieties” to be taken into account when assessing distinctness and novelty.
3) Member states are required to provide protection in respect of all species and genera
within five years of joining (Article 3).
4) Members may, if they wish extend protection to material derived from a protected variety for example essential oils, perfumes, and medicinal products. To date no European country
has extended protection in this way.
5) There is no express derogation from the right in respect of farm saved seed which means
that any farmer engaging in this activity will infringe the rights of the holder (Article 14).
However, in recognition of the sensitivity of this issue, the 1991 Act does allow member
states an option of restrict the breeders right within reasonable limits (Article 15(2)). This
would enable member states to permit the practice of farm saved seed.
It is widely understood that any exercise of this provision should not extend beyond that
which was permitted under the 1978 Act (see below under Article 14 CPVR).
6) Use of protected material for research purposes is permitted (Article 15), but where that
research results in a variety which is “essentially derived” from the protected variety then the
protection will extend to the essentially derived plants as well (Article 14(5). It is not entirely
clear how the term “essentially derived” is to be interpreted and it is likely that this will be
left to the courts to determine which could give rise to vagaries of interpretation.
7) The right lasts for up to 25 years for a tree or vine and 20 years for all other species
(Article 19).
The Community Plant Variety Rights Regulation
As might be expected there is considerable parity between the Community Regulation and
the UPOV Convention 1991. The main differences lie in the manner in which the Regulation
expands upon some of the principles set down in the 1991 UPOVC.
Article 1 states that the system of Community plant variety rights is the sole and exclusive
form of Community industrial property rights for plant varieties.
Article 3 then states that this does not preclude national rights being granted instead of the
Community right.
Article 2 sets down that the rights under the Regulation shall have uniform effect within the
territory of the Community.
Article 5 defines the subject matter protectable under the Regulation. It states that a “variety
shall be taken to mean a plant grouping within a single botanical taxon of the lowest known
rank, which grouping, irrespective of whether the conditions for the grant of a plant variety
right are fully met, can be: defined by the expression of the characteristics that results from a
given genotype or combination of genotypes; distinguished from any other plant grouping by
the expression of at least one of the said characteristics; and considered as a unit with regard
to its suitability for being propagated unchanged. The Article also goes on to say that a plant
grouping consists of entire plants or parts of plant as far as such plants are capable of
producing entire plants - these are collectively called the variety constituents (5(3).
This Article has an additional importance as it is to this definition of a plant variety that the
EPO has looked when determining the scope of its exclusion of plant varieties from patent
protection.
Article 6 sets down the requirements that the variety must be distinct, uniform stable and
new, with Article 7-10 defining these criteria respectively. It is clear from the language used
that the Regulation applies to all types of plant varieties howsoever created.
Article 11 and 12 define entitlement to a Community right.
Article 13 sets down the rights granted under the Regulation and it is here that the first
expansion of the UPOV provisions can be seen.
The following acts require the authorisation of the rights holder, to produce, reproduce,
condition for the purpose of propagation, offer for sale, sell or other marketing, export or
import and stock variety constituents. The Regulation then goes on to state that these rights
also applies to a) varieties which are essentially derived from the protected variety provided
a) that this variety is not itself essentially derived from another variety, b) varieties which are
not distinct from the protected varieties and c) varieties whose production requires the
repeated use of the protected variety.
Essentially Derived (Article 13(6))
For the purposes of the Regulation, a variety is taken to be essentially derived if:
a) it is predominantly derived from the initial variety or from a variety which is itself
predominantly derived from the initial variety;
b) it is distinct in accordance with Article 7 (requiring distinctness ) from the initial variety;
and
c) it confirms essentially to the initial variety in the expression of the characteristics that
results from the genotype or combination of genotypes of the initial variety.
Article 13(8) also states that the exercise of the right may not violate any provisions adopted
on the grounds of public morality, public policy or public security, the protection of health
and life of humans, animals or plants, the protection of the environment, the protection of
industrial or commercial property, or the safeguarding of competition, of trade or of
agricultural production.
This can be compared to the morality provisions within the EPC and Directive where the
issue is one of pre-grant - here it is one of post-grant use and clearly regarded as an external
issue for consideration by the rights holder and other regulatory bodies and not the granting
office.
Article 14 sets down the derogations from the right and these expand upon Article 14 of the
1991 UPOVC. Article 14 of the Regulation states that farmers may use protected material
(other than a hybrid or synthetic variety) for propagating purposes on their own holding
however - this right is limited in that
1) The farmer can only retain propagating material for this purpose from one of the following
categories
a) Fodder plants (chickpea milkvetch, yellow lupin, lucerne, field pea, Berseen/Egyptian
clover, Persian clover, field bean, common vetch and in Portugal only, Italian rye-grass)
b) Cereals (oats, barley, rice, canary grass, rye, triticale, wheat, durum wheat, spelt wheat)
c) Potatoes
d) Oil and fibre plants (swede rape, turnip rape, linseed with the exclusion of flax)
Farmers’ privilege does not apply to any other plant varieties
In addition
2) The farmer must pay an equitable remuneration sensibly lower than the amount originally
charged - the common figure across the EU is 50% of the original price.
The only exemption from this obligation is the small farmer (farmers who do not grow plants
on an area bigger than the area which would be needed to produce 92 tonnes of cereal or, in
respect of other plant species, farmers who meet comparable appropriate criteria) who
remain free to retain seed from one year to the next without making an additional payment
Article 15 permits the use of protected material for acts done privately and for noncommercial purposes; acts done for experimental purposes; acts done for the purpose of
breeding or discovering and developing new varieties, this is subject to the limitations of
Article 13(5).
Article 16 sets out the limits of exhaustion of plant variety rights and Article 17 requires that
any person dealing in the protected material must use a variety denomination pursuant to
Article 63 of the Regulation.
Article 19 states that the right lasts for up to 25 years for all varieties apart from trees and
vines which can be protected for up to 30 years.
Opposition appeals are heard by the CPVRO
Areas of Concern
Most European plant breeders are satisfied with the current plant variety protection - however
they do have some concerns. These are:
 The agricultural bias of the plant variety rights system;
 The definition of an essentially derived variety;
 The definition of ‘significant technical progress’ for the purposes of obtaining a
compulsory licence;
 The balance of power between a patent holder and plant breeder/plant variety rights
holder when determining a compulsory cross licence;
 Policing the Farm Saved Seed provision;
 Determining the “equitable remuneration significantly lower” for the purposes of the farm
saved seed provision.
 Cost of acquisition and litigation;
 The biggest concern however is the lack of awareness and experience of patents.
The distinction between Patents and Plant Variety Rights
There are a number of key differences between patent protection and plant variety rights.
Patents serve to protect novel results which are non-obvious. In order to ascertain whether or
not the invention is obvious to one skilled in the art it is necessary to demonstrate the steps
taken in arriving at the invention. The disclosure of the steps taken in order to arrive at the
final result is requisite if the applicant is to succeed in showing that what s/he has done is
inventive. This is shown by describing what was known before and demonstrating how what
the inventor did was not an obvious step forward given what had been known before.
In contrast the plant variety rights system is not intended to protect non-obvious results. Most
plant breeding activity involves trying the obvious - if breeders were required to show that
what they had done would not be obvious to a person skilled in the art then few if any rights
would be granted. The rationale for the grant of a plant variety right is therefore not to protect
inventiveness. There is no need for the breeder to disclose information about how the variety
was developed the variety as s/he does not have to prove that their decision to pursue a
particular line of research was unobvious. The key rationale for the grant of a plant variety
right is the protection of the time invested in producing a new variety which is distinct from
others of the same species, and which, over time, remains uniform and stable following
reproduction.
There are three other main points of distinction between patent protection and plant variety
rights.
The first is that the right is generally administered by governmental agencies responsible for
agricultural matters and not by offices concerned with trade and industry, as is the practice
with patents.
The second is that the rights are subject to a number of derogations on the basis of public
interest. In order to ensure that the protection granted does not restrict ongoing research or
interfere with the legitimate interests of the agricultural community UPOVC explicitly states:
i) that use of protected material for research purposes and the results of that research are not
covered by the right; and
ii) that farmers can continue their practice of retaining seed from one year to the next without
necessity of an additional payment to the breeder.
The third distinction is that, in contrast to the paper assessment undertaken to determine
whether an invention is patentable, a plant variety is subjected to two years of practical trials
before the right is granted. These serve to show whether or not the variety is actually distinct,
uniform and stable as opposed to simply relying on a written description provided by the
breeder. The trials are undertaken by the granting offices in conjunction with breeding
institutes, such as the UK’s National Institute of Agricultural Botany (NIAB).
Dual Protection
Both the 1961 and 1978 UPOV Acts stated that
Article 2(1)
Member states must provide either patent or plant variety protection in accordance with
the provisions of this Convention but not both.
This was taken to mean that Member States could not provide both an ordinary patent and a
plant variety right in accordance with UPOV and this meaning was given weight by the
specific exclusion of plant varieties in the European Patent Convention.
According to the UPOV Office the dual protection ban only applied to those situations where
the member state provided patent and plant variety protection both of which were in
accordance with its provisions - i.e. the patent grant depended on the variety being shown to
be distinct, uniform and stable. It did not apply to situations where the member state provided
ordinary patent protection which was not in accordance with UPOV. This explained the
ability of the US to join UPOV despite the fact that it provided both patents and plant variety
rights.
When the UPOV Convention was revised in 1991 the dual protection prohibition was
removed to enable member states to provide either or both forms of protection. The only bar
to protecting plant varieties which now remains is that contained in patent law13.
Indeed the EU Council Regulation on the Protection of New Plant Varieties this states in
Article 92, headed ‘Cumulative Protection Prohibited’, that Any variety which is the subject
matter of a Community plant variety right shall not be the subject of a national plant variety
right or any patent for that variety.
This clearly shows that within Community plant variety right there is the possibility for
patent protection to be available for plant varieties.
Conclusion
Whilst there has been extensive legislative activity providing a relatively coherent system of
protection for all type of genetic material, the situation in Europe remains an uncertain one.
There is uncertainty as to provision at the national level in the absence of any impetus in
many EU member states to implement either the EU Directive or the UPOV Convention 91.
In addition whilst the framework for grant is in place, the issue of the proper scope of the
rights will remain unclear until tested in the courts. To date there has only been limited
litigation and until such time as the courts develop a coherent jurisprudence at the national
and EU levels it is not possible to state with certainty and predictability as to exactly what is
protectable and what, on the ground of public interest, maybe excluded from protection.
13
see Greengrass The 1991 Act of the UPOV Convention [1991] 12 EIPR 467
European Plant Intellectual Property
Who can claim
European Patent Convention
EU Directive
UPOV Convention 1991
Community Plant Variety Rights
14European
EU Directive16
UPOV Convention 1991
Community Plant Variety Rights17
Not stated - as the Directive simply builds
on national patent practice which within
current EU member states is prescribed by
the EPC
a) the person who bred, or discovered and
developed the variety,
The person who bred, or discovered and
developed the variety or his successor in
title (Article 11)
Patent Convention15
The person who is first to file
b) the employer of the breeder
c) the successor in title to either a) or b)
(Article 1)
Protectable subject matter
Any invention which is susceptible of
industrial application, which is new and
which involves an inventive step.
All biotechnological inventions except
those which are specifically excluded
(Article 1)
(Article 52)
The invention must also not fall within the
categories of excluded material
The categories of excluded material are to
be given a restrictive interpretation (see
below)
A variety defined as a
As per the UPOV Convention 1991
plant grouping within a single botanical
taxon of the lowest known rank which
Protection is available over all plant
species and genera irrespective of how the
variety has been created (Article 5(1))
a) is defined by the expression of
characteristics which result from a given
genotype or combination of genotypes,
and
b) these characteristics distinguish the
variety from other plant groupings
c) is considered a unit
(Article 1)
d) meets the granting criteria distinctness, uniformity, stability
? The following is intended for the purposes of guidance only and should not be taken as a definitive statement of the law.
14
Please note that whilst both the EPC and EU Biotech Directive serve to align the substantive elements of patent law, there remain national differences over interpretation and application.
15
Patent applicants can choose whether to apply for national protection (which is only enforceable in the territory of grant) or for a European patent, which is enforceable in exactly the same way as a national patent in all the
countries the applicant has designated.
16
Member states of the European Union must implement the Directive by the end of July 2000 - it is expected that the general principles and requirements of the directive, which are not defined as such within the directive, i.e.
those relating to first to file and the interpretation and application of the substantive principles, will be determined according to existing European patent law practice.
On 16th June 1999 the Administrative Council of the European Patent Office voted to implement the directive via the Implementing Regulations of the European Patent Convention, Part II, Chapter VI, Rules 23b, 23c, 23d and
23e. These came into effect on 1 September 1999.
17
A plant breeder has the choice of either acquiring a national plant variety right or a Community plant variety right. S/he cannot acquire both over the same variety.
17
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EU Directive
UPOV Convention 1991
Community Plant Variety Rights
(Article 5)
Protection is available over all plant
species and genera irrespective of how the
variety has been created
(Article 3(1)(i))
Excluded Material
Yes
Yes
No
No
a) Discoveries - [unutilised information]
a) Plant and animal varieties - inventions
the technical feasibility of which is not
confined to a particular plant or animal
variety are not excluded - e.g. claims
which encompass more than one variety
are permitted
Article 17 states that
(Article 4(1)(a) & (2))
(Article 4(1)(b))
2) When any such restriction has the
effect of authorising a third party to
perform any act for which the breeders’
authorisation is required, the Contracting
Party concerned shall take all measures
necessary to ensure that the breeder
receives equitable remuneration
Article 13(8) serves to remind the breeder
that the exercise of the right may be
subject to external restrictions adopted on
the grounds of morality, public policy,
security, the protection of human, animal
and plant life and health, the protection of
the environment and the protection of
industrial or commercial property
Article 5(c)
Not Applicable
(Article 52(2)(a))
b) Inventions the publication or
exploitation of which would be contrary
to ordre public or morality (the
guidelines to the EPC use the example of
a letter bomb - and defines the concepts of
ordre public or morality on the basis of
that which the public finds abhorrent)
(Article 53(a))
b) Essentially biological processes for the
production of plants and animals
c) Plant or animal varieties and essentially
biological processes for the production of
plants and animals
1) Except where expressly provided in
this Convention, no Contracting Party
may restrict the free exercise of a
breeders’ right for reasons other than of
public interest
(Article 53(b))
Plant variety is defined as a plant
grouping which is eligible for protection
under plant variety rights
Patent protection is available for
transgenic plants, including groupings
which encompass more than one plant
variety
Essentially biological processes are
defined as those processes which are nontechnical in nature and do not involve
any technical intervention by man
Human Genetic Material
Rule 23(e) of the amended Implementing
Rules excludes the human body and
simple discoveries of one of its elements.
However, inventions which involve
Not Applicable
c) The human body and simple
discoveries of human genetic elements
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European Patent Convention
human genetic material are patentable
provided the threshold for protection is
met and the invention does not fall within
the public interest exclusions.
EU Directive
UPOV Convention 1991
Community Plant Variety Rights
No
Yes
d) Inventions the commercial exploitation
of which would be contrary to ordre
public or morality - e.g. processes for
cloning human beings, processes for
modifying the germ line genetic identity
of human beings, industrial or commercial
uses of human embryos, processes for
modifying the genetic identity of animals
which cause suffering without any
substantial benefit to animals or humans
and any animals resulting from such
processes
(Article 6)
Dual Protection
Prohibition
No express prohibition on dual protection
although the exclusion of plant varieties
from protection serves this function.
No express prohibition on dual protection
although the exclusion of plant varieties
from protection serves this function.
A variety which is the subject of a
Community plant variety right shall not
also be
a) the subject of a national plant variety
right
b) the subject of a patent
(Article 92)
Examination
Examination of the patent specification (a
written document)
None specified
Technical Examination of the plant
material - in the course of which the
examining authority may grow the variety,
or carry out other necessary tests,
including taking into account the results
of other growing trials
Technical examination of the plant
material via growing trials etc.
(Chapter II)
(Article 12)
Novelty
Yes
Yes
Yes
Yes
An invention shall be considered to be
new if it does not form part of the state of
the art.
But it is not defined
The variety must not have been sold or
otherwise disposed of to other, either by
or with the consent of the breeder, for the
purposes of exploitation
The variety (including its harvested
material) must not have been offered for
sale by the breeder within the territory of
the Community more than 1 year before
the date of filing or more than four years
The state of the art comprises everything
made available to the public by means of
(Article 3(1))
a) in the territory of the Contracting Party
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EU Directive
a written or oral disclosure, by use or in
any other way, before the date of filing the
application
UPOV Convention 1991
Community Plant Variety Rights
more than one year before filing
(6 for trees and vines) outside the
Community
b) in a territory other than that of the
Contracting Party more than four years (6
for trees and vines) before filing
(Article 54)
(Article 10(1)
(Article 6(1)
Grace Period
Inventive Step
No
No
Yes
Yes
Not available - novelty is assessed as of
the date of filing the patent application
Not available - as per the EPC
As above
As above
Yes
Yes
No
No
An invention shall be considered as
involving an inventive step if, having
regard to the state of the art, it is not
obvious to a person skilled in the art.
But it is not defined
Not a requirement
Not a requirement
(Article 3(1)
(Article 56)
Problem and Solution approachthe invention, as described in the
specification, must provide a solution to
the problem of getting from the prior art
to the new technical effect.
The application is examined to identify
a) the prior art
b) the technical problem - using the
invention as described and the prior art
c) whether a skilled person in the art,
using the prior art, would have arrived at
the same solution
This requirement highlights the problems
caused by national interpretation e.g. the
degree of knowledge and ingenuity
ascribed to the person skilled in the art
Industrial Application
Yes
Yes
No
No
The invention is considered as susceptible
of industrial application if it can be made
or used in any kind of industry, including
But it is not defined
Not a requirement
Not a requirement
(Article 3(1))
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Community Plant Variety Rights
agriculture.
Methods of treatment of
the human or animal body
by surgery or therapy or
diagnostic methods
practised on the human or
animal body
These are excluded on the grounds that
they are not capable of industrial
application. The general rule of thumb is
that if the method needs to be practised on
or in the human body then it is excluded.
Methods which take place outside or away
from the human body may be patentable.
Not mentioned
Not Applicable
Not Applicable
Distinctness
No
No
Yes
Yes
Not a requirement
Not a requirement
The variety must be clearly
distinguishable from any other variety
whose existence is a matter of common
knowledge at the time of filing the
application
The variety must be clearly
distinguishable in its essential
characteristics from other varieties which
are a matter of common knowledge (e.g.
protected by a plant variety right) at the
time of application
(Article 7)
(Article 7)
Uniformity
Stability
Extent of Protection
No
No
Yes
Yes
Not a requirement
Not a requirement
The variety must be sufficiently uniform
in its relevant characteristics (subject to
any variation which may be expected)
The essential characteristics must be
sufficiently uniform in their expression
following repeated reproduction
(Article 8)
(Article 8)
No
No
Yes
Yes
Not a requirement
Not a requirement
The variety must remain stable in its
relevant characteristics following repeated
reproduction
The essential characteristics must remain
unchanged following repeated
reproduction
(Article 9)
(Article 9)
The applicant can specify in which
member states the patent grant is to have
effect
No mentioned as the Directive is intended
to be implemented by Member States at
the national level
Community-wide right enforceable in all
member states
The right is determined by the terms of
the claims, drawings and the description
can be used to interpret the claims.
It is a local right extending only to the
territory of grant
The provisions of the Convention must be
implemented by the Member State at the
local level. The right, once granted, is a
local right extending only to the territory
of grant
(Article 69)
The right allows the holder to prevent all
others from using the material as
Protection extends to all material (except
material falling within Article 5(1)
(which excludes from protection the
human body in its various stages of
The authorisation of the breeder is
required in respect of the following acts
a) production or multiplication
b) conditioning for the purpose of
Right to
a) produce or reproduce
b) condition for the purpose of
propagation
c) offer for sale
d) sell or market
21
European Plant Intellectual Property
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UPOV Convention 1991
Community Plant Variety Rights
described in the patent specification
development and the simple discovery of
one of its elements) in which the patented
product is incorporated and in which the
genetic information is contained and
performs its function
propagation
e) export out of the Community
c) offering for sale
f) import into the Community
d) selling or marketing
g) stock for any of the above purposes the
variety
(Article 9)
f) importing
Broad claims (claims which go beyond
the new technical effect described in the
patent specification) are not permitted
Protection extends to all biological
material, genes to genotypes and includes
plant groupings provided the claims do
not relate to a specific plant variety
e) exporting
g) stocking for any of the above purposes
The right extends to harvested material,
including whole plants, parts of plants and
products made directly from the harvested
material, which has been obtained through
unauthorised use
Right extends to harvested material and
other products obtained directly from
material of the variety provided these
were obtained through unauthorised use.
(Article 13)
(Article 14)
Extension of protection to
Essentially Derived
Varieties
Yes
Yes,
Yes
Yes,
Where the claims encompass the derived
material
a) Protection extends to any biological
material which is derived from the
protected invention provided the derived
material exhibits the same characteristics
as the patented invention
An essentially derived variety is held to
exist where
An essentially derived variety is held to
exist where
a) it is predominantly derided from the
initial (protected) variety
a) it is predominantly derived from the
initial (protected) variety
b) it is distinct from the initial (protected
variety)
b) it is distinct from the initial (protected
variety)
and
and
c) it conforms essentially to the initial
(protected) variety in the expression of its
characteristics
c) it conforms essentially to the initial
(protected) variety in the expression of its
characteristics
(Article 14(5))
(Article 13(5))
Yes
Not as such
Yes
(Articles 11 and 12)
Article 17 states that
b) Protection extends to any biological
material which results from using a
patented process which enables biological
material to be produced which possesses
specific characteristics provided the
derived material exhibits the same specific
characteristics
(Article 8)
c) (as above) protection extends to all
material in which the patented product is
incorporated and in which the genetic
information is contained and performs its
function
(Article 9)
Derogations
No
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Community Plant Variety Rights
1) Except where expressly provided in
this Convention, no Contracting Party
may restrict the free exercise of a
breeders’ right for reasons other than of
public interest
2) When any such restriction has the
effect of authorising a third party to
perform any act for which the breeders’
authorisation is required, the Contracting
Party concerned shall take all measures
necessary to ensure that the breeder
receives equitable remuneration
Farmers Privilege
No
Yes
The provision is identical to that used in
the Community Plant Variety Rights
Regulation (see across)
(Article 11)
Optional
Contracting Parties 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 (including essentially
derived varieties)
(Article 15(2))
Yes Farmers may use protected material (other
than a hybrid or synthetic variety) for
propagating purposes on their own
holding
however - this right is limited in that
1) The farmer can only retain propagating
material for this purpose from one of the
following categories
a) Fodder plants (chickpea milkvetch,
yellow lupin, lucerne, field pea,
Berseen/Egyptian clover, Persian clover,
field bean, common vetch and in Portugal
only, Italian rye-grass)
b) Cereals (oats, barley, rice, canary grass,
rye, triticale, wheat, durum wheat, spelt
wheat)
c) Potatoes
d) Oil and fibre plants (swede rape, turnip
rape, linseed with the exclusion of flax)
The farmers’ privilege does not apply to
any other plant varieties
In addition
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Community Plant Variety Rights
2) The farmer must pay an equitable
remuneration sensibly lower than the
amount originally charged - the common
figure across the EU is 50% of the
original price.
The only exemption from this obligation
is the small farmer (farmers who do not
grow plants on an area bigger than the
area which would be needed to produce
92 tonnes of cereal or, in respect of other
plant species, farmers who meet
comparable appropriate criteria) who
remain free to retain seed from one year to
the next without making an additional
payment
(Article 14)
Breeders’/Inventors’
Research Privilege
Compulsory Licensing
No
Not specified
But such exemptions is usually provided
in the national patent laws of EPC
Member States
Up to national law
Re licensing in general the directive is
silent- but it does contain compulsory
non-exclusive cross-licensing provisions.
These apply where a breeder or inventor
cannot exploit a protected variety or
patented invention without infringing
another party’s plant variety right or
patent. The breeder/inventor must show
a) that they applied unsuccessfully to the
holder of the plant variety right/patent
and
Yes
Yes
Non-infringing acts include
Non-infringing acts include
a) acts done privately and for noncommercial purposes
a) acts done privately and for noncommercial purposes
b) acts done for experimental purposes
b) acts done for experimental purposes
c) acts done for the purpose of breeding or
discovering and developing varieties
c) acts done for the purpose of breeding or
discovering and developing varieties
(Article 15(1))
(Article 15)
Not mentioned as such
Yes
Article 17 states that
The Community Plant Variety Rights
Office can grant a compulsory
exploitation right where it is shown that it
is in the public interest to do so
1) Except where expressly provided in
this Convention, no Contracting Party
may restrict the free exercise of a
breeders’ right for reasons other than of
public interest
2) When any such restriction has the
effect of authorising a third party to
perform any act for which the breeders’
authorisation is required, the Contracting
(Article 29)
Public interest is to be assessed on the
basis of i) the protection of life or health
of humans, animals and plants, ii) the
need to supply the market with material
offering specific features or iii) the need
24
European Plant Intellectual Property
European Patent Convention
EU Directive
UPOV Convention 1991
Community Plant Variety Rights
b) that their plant variety or invention
constitutes a significant technical progress
when compared with the protected plant
variety or invention
Party concerned shall take all measures
necessary to ensure that the breeder
receives equitable remuneration
to maintain the incentive for continued
breeding of new varieties (Article 41
Commission Regulation 1768/95)
(Article 12)
Article 12(4) states that each Member
State shall designate the authority or
authorities responsible for granting the
licence. Where the licence for a plant
variety can be granted only by the
Community Plant Variety Office, Article
29 of Regulation (EC) No 2100/94 shall
apply (see across)
Not a requirement under the Convention,
but where the invention involves a microorganism which is not available to the
public or which cannot be described in the
patent specification then the applicant is
required to deposit the material in a
recognised depository no later than the
date of filing. This is a requirement
imposed by the Budapest Treaty on the
International Recognition of the Deposit
of Micro-organisms for the Purposes of
Patent Protection
Yes
Not as such.
Not as such.
Where an invention involves biological
material which is not available to the
public and which cannot be described in
the patent specification
The breeder is required to submit
reproductive material of the variety to the
granting office at any time during the
period of grant for retesting for
distinctness, uniformity and stability.
The breeder is required to submit
reproductive material of the variety to the
granting office at any time during the
period of grant for retesting for
distinctness, uniformity and stability.
(Article 22)
(Article 64)
Variety Denomination
Requirement
No
No
Yes
Yes
(Chapter VI)
(Article 63)
Geographical Indicator
No
Yes, Recital 27 states that where an
invention is based on biological material
of plant or animal origin, or where it uses
such material, the patent application
should, where appropriate, include
information on the geographical origin of
such material. This does not apply to
human genetic material.
No
No
Deposit
(Article 13)
25
European Plant Intellectual Property
Duration of the Right
European Patent Convention
EU Directive
UPOV Convention 1991
Community Plant Variety Rights
20 years from filing
Not specified
30 years for trees and vines,
30 years for trees and vines,
25 years for all other varieties
25 years for all other varieties
(Article 19)
(Article 19)
Determined at the national level
Application fee 1,000 EUROS.
Examination fees differ according to
whether the variety falls within one of
three groups. Group A (Crops) = 1000
EUROS; Group B (Vegetables) = 800
EUROS; Group C (Ornamentals) = 700
EUROS.
(Article 63)
Average Cost (1999
figures)
4,300 EUROS(including filing,
examination and grant fees). These do not
include translation costs, professional
representation costs or renewal fees.
To be determined at the national level
The average cost of a European Patent,
which is valid in 8 member States and in
force for a 10 year period (including
translation costs, professional
representation fees (but not patent agent
fees) and renewal fees of 8,500 EUROs
per year from the 5th to the 10th year) is
29,800 EUROS(Source: The European
Patent Office)
Who enforces the right
The inventor through the civil courts as
the right is a private right
These figures do not include renewal fees
(which range from 400 EUROs for the
first years to 1,300 for the final year), fees
for taking over reports or lawyers fees.
(Source: The Community Plant Variety
Office)
The inventor through the civil courts as
the right is a private right
The breeder through the civil courts as the
right is a private right
The breeder through the civil courts as the
right is a private right
26
European Patent Convention
EU Directive on the Legal
Protection of Biotechnological
Inventions (implemented)
Austria
X
Belgium
X
Denmark
X
X
Finland
X
X
France
X
Germany
X
Greece
X
Ireland
X
Italy
X
Luxembourg
X
Netherlands
X
Portugal
X
Spain
X
Sweden
X
United Kingdom
X
X
Candidate Countries
European Patent Convention
UPOV Convention 1978
Bulgaria
From 2002
Cyprus
X
Czech Republic
From 2002
Estonia
From 2002
Hungary
Latvia
UPOV Convention 1978
UPOV Convention 1991
X
1961/72 UPOV Conventions
X
X
X
X
X
X
X
X
X
X
1961/72 Conventions - however the Plant
Variety Protection Act 2000 will enable
Spain to ratify the 1991 Convention
X
X
UPOV Convention 1991
X
X
X
X
External State
27
Lithuania
External State
Malta
Poland
X
Romania
External State
Slovenia
External State
Slovak Republic
From 2002
Turkey
X
X
X
X
28