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with patents in plant breeding
François
Chrétien
Rhône-Poulenc
Agro
Département
Propriété Industrielle
BP
9163 (Lyon 9)
69263
Lyon Cédex 1
France
Developing
a transgenic plant variety involves two main steps,
first producing a transgenic mother plant (transformation
and regeneration), then transferring this mother plant
for breeding in a breeding programme to create an
elite variety.
- Transgenic
mother plant: patent issues
- Producing
a transgenic mother plant with a novel character
(trait) implies two steps. The first one is transforming
a plant cell with a DNA sequence of interest coding
for herbicide tolerance, insect or disease resistance,
or a quality trait (e.g. oil content modification).
The second step involves the transformation technology
for inserting the DNA of interest. This can take
place by using Agrobacterium (dicots and recently
monocots). Here constructs of DNAs of interest are
used, with regulation elements and bacterial vectors.
Another transformation technology consists of the
bombardment with DNA bearing projectiles (monocots).
Also a combination of these technologies is possible
(recently with monocots).
After
this, the transformed cell should be regenerated
into a plant by embryogenesis comprising three main
steps each involving a specific culture medium:
the induction of embryos from a plant totipotent
issue, growth of embryos, and the obtention of plantlets.
- Compared
to agrochemistry there are more opportunities of
patentable inventions in plant breeding biotechnology,
creating also more complicated drafting, procedures
and overlapping of rights. The main types of inventions
are the product (DNA, protein, as chemical product;
cell; plant), the process of making, and the use.
In order to be able to patent, three patentability
criteria are required: novelty, inventive step and
industrial application (utility). Further, the sufficiency
of disclosure should be adapted to biological material.
For strains of bacterial vectors, cells, and even
seeds a deposit is required by the Budapest Treaty,
organizing the recognition of these deposits (EPC
Rule 28 and directive A13-15 for deposit access
and renewal). For plants the situation is simpler
in the USA than in Europe (EPO case law, EU directive).
Transfer
into a breeding programme: plant breeder issues
Transferring
the mother plant for breeding mentioned above in a breeding
programme is the second phase. Usually license agreements
are used for evaluating the transgenic to create a variety
with a certain trait, i.e. an elite at a commercial
level. In Europe, if there is no agreement and/or no
exploitation: dependancy licence of the EU Directive
for the legal protection of biotechnological inventions
(Article12) and national laws.
What kind
of intellectual property protection is available for
the created variety? The legal general frame is plant
breeder right according to UPOV 1961/1978/1991 (in force
late April 1998). The Plant Variety Certificate (PVC)
covers the morphological expression (now in relation
to the genetic identification according to UPOV 1991)
of the plant genome. A protectable variety should be
Distinct, Homogenous and Stable (DHS). In Europe regulation
2100/94 is in force and national Patent Variety Certificate
(PVC) laws are applicable. In the USA, PVC exists. However,
and although the USA is a member of UPOV, the USA has
further to PVC also plant patents (for vegetative reproducing
plants) and utility patents for sexual reproducing plants
(corn, soybean), including plant varieties.
Patent
protection and Plant Variety Certificate protection
compared
The patent
on plants first covers the plant with the patented transgenic,
i.e. a specific and limited change in the plant genome.
It covers any commercial use of any plant variety with
the patented gene. The transformed plant with the specific
patented gene is protected, but not the basic genome
itself, because a patent on a plant variety is not possible.
Regarding the breeder's exemption, in Europe, the experimental
search on the patented invention is free; in the US
the use for breeding is an infringing act (not an experimental
use). There is no seed saving exemption in plant patents.
In Europe, the farmer’s privilege is introduced
in the EU patent directive (Article 11) under an implicit
licence for the farmer to propagate on its farm with
reduced or no royalty.
Plant
Breeder Rights (or Plant Variety Certificate (PVC))
covers any act with the variety (say V1) itself, but
not the use of this variety as a variation source for
creating new varieties (sayV2) (UPOV). This is the so-called
breeder's exemption with an exception for an "essentially
derived variety" (EDV). Last there is, in the Plant
Breeder Rights, a derogation for self reproducing species:
the saved seed or farmer's privilege. This is an infringing
act under some national laws. This derogation is now
optional under UPOV 1991 and compulsory under Regulation
210094 (Article 13).
In short,
the situation in transgenic plant breeding regarding
intellectual property is as follows:
Patents
on plants dominate, corresponding transgenic varieties
when commercially used. This does give some problems
with patent validity and the scope of the patent in
this field.
In the
EU the breeder’s exemption is saved, there is compulsory
licensing in national laws and the EU patent directive
for biotechnological inventions (Article 12).
In the
USA the protection is more unbalanced, in favour of
the patentee.
In the
practice, in most cases the mutual interest of the patentee
and the breeder is a strong incentive to an agreement
between the parties.
Intellectual
property in the animal field
The
patentability of animals is recognized in the USA
and in Europe (of EU Directive for protection of biotechnological
inventions and EPC with some uncertainty with case law
(the myc mouse case).
Animal
varieties
Animal
varieties are excluded from patentability (EPO Article
53a and EU Directive Article 4).
Is there
any possibility for Patent-Variety-Certificate-like
specific protection (AVC)? No, this is not likely. In
the first place, no scientific definition of "animal
variety" exists. Further, the Distinct, Homogenous
and Stable (DHS) criteria are not applicable to animals.
Last but not least, the implementation of a AVC is very
questionable: heavy controls would be necessary and
all together it would be an expensive procedure. Some
attempts to set up a specific system in France/Germany
and the UK failed.
Is there
really a need for a specific legal protection for animal
varieties? For farm animals and animals for production
of useful products (pharmaceuticals) registration affords
good protection. Basically in animal breeding the ongoing
change of the animal genome gives relative value to
legal protection. Having the lead in the ongoing change
of the animal genome is the best protection.
Thus a
suggestion could be that anyway patent protection exists
on transgenic animal cells and the scope ruled by Article11
in the EU Directive for the protection of biotechnological
inventions combined with registration could be considered
as sufficient.
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