MINUTES WEEK 5 w/Prof. Sven Bostyn (Monday-Wednesday):
“Human Biotechnological Inventions”
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DNA is essentially a combination of molecules containing information coding for proteins
… the building blocks of living biological organisms. Human DNA sequences in genes have
all been patented now (or are under examination to be patented) – now focus is on use.
Some diseases are caused by single genes – some by multiple genes – and some diseases
again by post-transcriptional and –translational DNA regulation, and finally environmental
forces. Parkinson’s seems to be genetically caused; women have the predominant factor
of passing it on, albeit very infrequently suffering from it themselves. Incidences of
breast cancer are increasing amongst men.
Large discussion in Europe if DNA should/could be patentable, since it is simply a
discovery of information found in nature already. An example given was the fungus found
in nature alone (no refinement) (small inventive step, and industrial utility is speculated –
seldom described in an actual embodiment). NB: EPO Guidelines C.IV.2.3. Isolation of
element + disclosure of industrial application is important to make it patentable (Art. 5
Directive 98/44/EC Rule 29 EPC2000, 23e EPC1973). Case:
o First: fungus found in nature alone => discovery
o Second: fungus found in nature, but active compound isolated in garage =>
invention.
In US it is different from Europe (i.e. US Chakrabarty: “Everything under the sun made by
man is patentable”).Most famous DNA patent case is BRCA1+2 gene for prediction of
effect of chemotherapy in women with breast cancer.
When making a claim, the applicant leaves out the non-coding parts of the DNA, thus
validating the claim as patentable (i.e. you do not claim it as it exist in nature)
Various countries have implemented limitation in scope of protection by “Purpose-bound
protection” NB: Directive 98/44/EC.23.
o For:
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limits are better than full protection due to stifling innovation
justified in view of the specific nature of DNA, which is valuable not for its
chemical nature, but for the information it carries
o Against:
 too small inventive steps, hence multiple narrow patents, leading to
royalty stacking problems (owners of these narrow patents could end up
charging too much in terms of licensing fees)
 owing to the above narrowness in definition/scope, it becomes easy for a
court to decide that a new purpose to which the invention is being put is
sufficiently similar as to be considered an equivalent use (doctrine/concept
of equivalence)
 why should chemical patents have absolute product protection, and
biotechnology ones not?.
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Tip for patent claim language: choosing a specific quality (range) among a number of
options (larger range). How to patent genes: make a claim on hypothetical industrial
applicability.
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EPC:
o Articles: prevails over rules (when inconsistency).
o Guidelines: Just for examination of application by Examiners (similar to US MPEP);
not binding on anyone else; some are based on case law.
EU Biotech Directive – 98/44/EC/Rule 29): create harmonization. Implemented by EPO +
member states.
Under EPC 2000, Article 54.4, product protection is now granted for any further medical
use of a known medicament (hence limited to medicament/medicine); purpose-bound
product claim (i.e. do not need novelty, but DO need inventive step (problem-solution
process)). Usually composition of matter on 1st claim, and 1st medication (purpose-bound)
in the last claims … in the same patent application.
Novelty – it is absolute, under patent law – however, in the case of pharmaceuticals,
something that is not necessarily new can be tatented e.g. a claim can be made for
compound X, and later a similar claim made this time using compound X as a medication
(hence the meaning of a product-bound claim). Thus, essentially a claim on a compound
can be made just once, the second time the claim would have to be in connection with its
use.
Claim law: old EPC 54.5 (only 1st medical indication, based only on use (vs Swiss-type
claim “use of the substance, or composition comprising the substance, in the
manufacture of a medicine for the treatment of a disease” – hence covering the 1st, 2nd
and subsequent use of the substance). Revised 54.5: applications for 2nd and subsequent
medical indications now allowed (new dosage, new indication, new administration);
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Reach-through claims: e.g. a claim that also covers earlier found compounds by screening
(since the screening claims not only covers new but also old compounds found)
Reach-through effect: all future use (e.g. not only screened compounds, but also new
compounds screened later).
Industrial Application requirement: usually exceptional to fail on this. NB: Rule 23e(3) EPC
2000
Low added-value patents: 2-5% royalty.
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Excluded from patentability are processes for cloning human beings, modifying germ line,
and genetic manipulation causing suffering in man or animals. NB: Art 6 Directive
98/44/EC. PS: stem cells from human embryos in Wisconsin Alumni Research Foundation
WARF application (Note: it is left-over embryos from in-vitro fertilization (IVF) treatments,
that are used)
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Prior Informed Consent: from individual from whom human cells or tissues has been
extracted and potentially deposited and used in future to currently unknown use. NB:
Recital 26 of Biotech Directive.
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Scope of rights in biotech inventions: included are products where the patented biotech
element is present, although it might not do its “function” (case: grain grown in Americas
(non-infringing) but sold in EU (infringing)). NB: Art. 9 Biotech Directive.
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Oncomouse (suffers from spontaneous frequent cancers for study purposes):
o NB: Rule 23d(d) EPC:
 Animal suffering likely?
 Likely substantial medical benefit established
 Both Benefit and suffering in same animal use
o NB: Art 53(a) EPC:
 Suffering of animals & risk to environment … against usefulness to
mankind (which is broader than “medical benefit” from 23(d))
Plant Variety and Patent Protection
0-Concepts
1,The definition of breeding
DNA accelerated the process of the improvement of plants – DNA fragments coding for
particular traits are inserted into plant cells e.g. DNA coding for enzyme responsible for herbicide
resistance
2, taxonomy ---classificaton
1, Plant Variety Protection(PVP)
Plant variety rights
 Not patents (Patent law on the other hand claims plants (higher level than
varieties)
 Are purely concerned with plant breeding, which is predominantly through
biotech methods these days
o food production
o ornamental plants
1.1- UPOV 1991 (an update of UPOV 1978)
1) all species can be protected
2) farmer’s privilege
3) essentially derived varieties (UPOV 1978 did not extend protection to these)
4) double protection (with UPOV 1978 this was not allowed)
1. 2- Definition of plant variety 1991
-By the expression of the characteristic resulting from genotype(s) – genetic information of
the group must be identical
-distinguishment
-stability
1. 3- Requirement fro protection
1. 3.1 DUS requirements (for phenotype characteristic); different from patent protection;
DUS = Distinctness, Uniformity and Stability1)Distinctness (need not be inventive, i.e. because these are not patents, nonobviousness not a requirement)
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- be distinguished from other variety at the time of filing
- identified
- essential distance
2) uniformity
-within the same generation, the variety should be sufficiently uniform in its relevant
characteristics
3) stability
- Its relevant characteristic remain unchanged – sustenance of the uniformity over several
generations
- Hybrids are very stable due to their short propagation cycles
1.3.2-Novelty
- Materials not sold, or disposed of in any other manner, within:
-one year (in the contracting party in which application has been filed)
-4 years(territory other than contracting party in which application has been filed)
- if above thresholds exceeded – action novelty-destructive
- private.non-commercial,experimental use – not novelty-destructive
1.3.3 - duration :20 years; for trees protection is longer term because they grow slower
1.3.4-scope of protection 1978
1.3.5 ESSENTIALLY DERIVED VARIETY
1.3.6 -Farmer’s privilege
Optional
1.3.7 Exhaustion of rights
1) sold or otherwise marketed
2) Restriction -further propagation
-counterattacking export to countries which does not protect varieties for propagation but
not for final consumption
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Article 14(5) UPOV 1991 – some countries refuse to ratify because of this article, since it
gives a patent-type of scope
 Plant variety rights 2nd degree rights, when compared to patents, hence not so appealing,
thus the scope was increased
 Big markets however opt for patent protection e.g. the Round-up ready trait (herbicide
resistance)
 A lot of developing countries have refused to ratify UPOV 1991 – hence flexibility to use
plant varieties freely; however, countries such as Argentina, which have no patent
protection on plants, would rather opt for UPOV, where they find it suitable
2. Europe
 Does not protect variety of plants or animals through patent
 Neither protects the essentially biological process – there has to be direct
relationship – no protection for a plant that is derived from one that is itself
derived from another
3.Norvatis case
P64 definition
4.US IP Protection
-Utility patents
-Plant Protection Act
-Plant Variety Protection Act
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5. Case: Monsanto V McFarling
Slide 37 Breeders’ rights and research exemption
 UPOV 1991
o Breeder’s rights
o Research exemption
o Farmer’s privilege
 Farmer’s privilege
o where no mention of it, farmers are not allowed to re-use seed (i.e. as opposed to
UPOV 1978, in UPOV 1991 the discretion whether or not to grant this is left to
individual countries)
 Central community plant variety right system
 Europe EC Reg 2100/94 – farmer’s privilege with compulsory payment based on size of
holdings
 Research exemption – in Europe it is in the law (the Patent Act has it, hence UPOV
recognized it as well)
 Exhaustion of breeder’s rights – Art. 16 UPOV 1991;
o exhaustion doesn’t cover propagation (i.e. if the seed is used in propagation
activities, the breeder’s rights subsist/continue to exist);
o Art. 16 (1) protects against reproduction of seed by non-protection country –
hence also protects against the disadvantages of possible re-importation into
countries where there is protection
From Slide 42 (on Patent Protection for Plants in Europe)
 UPOV used, but very rarely litigated
 Original UPOV did not allow double protection (i.e. both patent and plant variety rights)
 Rule 27 EPC2000 (23c EPC 1973) allows for claiming of a variety comprising a specific
gene sequence, but not the plant type as a whole e.g. insertion of a herbicide-resistant
gene in soya, maize, etc. does not create a new variety of the plant (the plants do not
have a common genotype), but just brings about a trait that is not specific to that type of
plant alone (Rule 27(b): [no protection regarding] plants or animals if the technical
feasibility of the invention is not confined to a particular plant or animal variety
 Europe vs. US
o Europe
 Individual plant varieties per se not patentable
 Plant that is characterized by a particular gene e.g. herbicide resistance, vis
a vis the plant’s whole genome, is not considered to be a plant variety, and
is thus patentable
 Transgenic plants are patentable if they are not restricted to a specific
plant variety, but represent a broader plant grouping
o US – three models of protection
 Plant variety rights
 Plant patent rights
 Utility rights
 Biological, Microbiological and Technical Processes for the Production of Plants (Slide 64)
o Essentially biological processes not patentable
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o Art. 2 Directive 98/44/EC
 (2) “A process for the production of plants or animals is essentially
biological if it consists entirely of natural phenomena such as crossing or
selection” – what is the significance of the word ‘essentially’ here, when
the processes being referred to are entirely biological, is the word
therefore not redundant in this context?
New referral to the European Board of Appeal
o T 0083/05 → G 2/07 – does a non-microbiological process (the molecular marker
step, thus human intervention) escape the exclusion of Art. 53b of European
Patent Convention)?
European Patent #1,211,926
o Wrinkled skin tomatoes – Method for breeding Tomatoes having reduced water
content and product of the method
o Israeli application; granted, despite process being essentially biological
o Not much technical procedure – proof that patenting of plant material does not
demand much
o With regard to the novelty requirement, one can say that the procedure used in
breeding the tomatoes is common general knowledge, despite the fact that the
novelty aspect would normally be met as long as there is no written proof (i.e. no
relevant records) with regard to the prior art
o Addition of steps that require human intervention (i.e. arguably not “essentially
biological”) allows for application for patents, hence initial decision to grant the
patent
Scope of protection of process patents
o Products derived from biological materials are protectable
o Plants derived from the directly-derived materials are patentable
o Plant patents are hardly ever used anymore, due to their limited scope (limited to
one type, or genome); traditionally no concept of equivalence (i.e. no
determination of whether certain features in the new variety might be equivalent
to those in an already existing one)
“Substantive Patent Law Treaty (SPLT)”
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Harmonization – such that a patent in one country is recognized in another – more
realistic than the concept of a world-wide patent
Challenges with harmonization though
o Which will be the common provisions?
o Application of the standards e.g. stronger prior art searches in Europe than in the
US
o Filing in the EPO or US – the patent is valid all over the world? This would block
open innovation in countries that have not entered into agreements e.g. in the
developing world
“University Inventions”
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Goal of university regimes
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o The basis of evaluation of universities includes patents and financial aid
applications (ability to offer assistance to less financially privileged students)
o Subsidies of universities are also based on the number of patents that they file
o Universities license out or sell their patents
Employee inventions in Europe
o Dated lab notebooks as evidence of being an inventor; important especially in the
US, where 1st to invent, is the system (proof in lab book dates and records); for
Europe, where the system is 1st to file, individuals can indeed claim to have
invented, because such records do not necessarily have to be produced (although
an interrogation process should normally effectively decide who the rightful
owner of the work is)
o Very often inventor different from applicant (e.g. who might be a university), who
becomes the rights-holder – the ownership is that of the university, otherwise
properly assigned to inventor
o For inventor to be mentioned in the application, the university’s technology
transfer department has to have mentioned it in the application
o Inventors in universities usually get paid through a compensatory scheme; some
money goes to the laboratory, some to the department, and the rest to the
university’s central fund
o Inventors would normally opt to be co-applicants, rather than just being
mentioned; that way they have more control with regard to the rights, and they
stand to gain more money from the proceeds of the invention
o Some countries, e.g. Germany, actually have an employees’ inventions act
o In cases where the above act does not exist, and there is a dispute between
university and inventor, entitlement proceedings take place
o Presenting at conferences
 Presenting at a public forum such as a conference, material intended for a
patent, is disadvantages to the novelty aspect because the material
immediately falls into prior art; however the applicant can try and file
quickly just before the conference
 The prospective applicant may also present the material under full
confidentiality, where conference participants sign confidentiality
agreement – but of course how practical this is, is a different issue
 Otherwise, normally a patent applicant will delay publication of his/her
findings i.e. researchers are advised to delay publication in journals, etc.,
until filing has been done
o Commercializing university research
 For general research, commercialization of research might not necessarily
be beneficial to society, and governments are gradually decreasing
subsidies for universities
 Applied research, seeking to answer questions from industry, has more
potential for university financing
 Thus, for specific projects in applied research, yes indeed
commercialization could be beneficial; for example, the EU through its
research programme, gets to fund a lot of such projects where it sees
justification in terms of the benefits emanating from the findings
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Basic research departments thus get to suffer a lot, since they are not the
subject of focus
. - END OF MINUTES –
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“Independent Research” (Thursday-Friday):
a)
“200 years that changed the world”: LINK
Comparison between maps of left patents granted and right population size map (2002):
“Crisis narrows China-UK gap”: LINK
b) We thank Daphne and Alberto for nice class-get-togethers the last couple of weekends!
Regards,
Lei, Selalelo, Thomas
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