Transcript Diapositiva 1 - LL.M. in Intellectual Property — LL.M

Subject matter of patents
-Louis Pasteur’s U.S. patent 135,245 for
"Improvement in Brewing Beer and Ale
Pasteurization" (1873)
IP protection of plants
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Plant Patents USA 1930
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PVP Netherlands 1942, Germany 1953
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Revision of the Paris Convention, Lisbon (1958)
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UPOV 1961
European Patent Convention
Article 53
Exceptions to patentability
European patents shall not be granted in respect of:
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(b) plant or animal varieties or essentially biological processes for
the production of plants or animals...
Limits to patent protection of plants
 UPOV
1978: non-accumulation of
patents and PVP (article 2)
Expansion of patent protection of
biological materials
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US Supreme Court in re Chakrabarty (1980):
patentability of ‘anything under the sun that is
made by man“
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Isolated natural gene + function patentable:
discovery or invention?
European Directive on Biotechnological
Inventions (98/44/EC )
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Article 3
1. ‘…inventions… shall be patentable even if they
concern a product consisting of or containing biological
material or a process by means of which biological
material is produced, processed or used.
2. Biological material which is isolated from its natural
environment or produced by means of a technical
process may be the subject of an invention even if it
previously occurred in nature.
DNA-related patents
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DNA sequence (complete or partial gene)
promoters
enhancers
transit peptides
individual exons
cloning vectors
expression vectors
amino acid sequences (proteins)
nucleic acid probes
isolated host cells transformed with expression vectors
modified plants
Gene patents: “a lawyer’s trick”
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“The chemical structure of native human genes
is a product of nature, and it is no less a product
of nature when that structure is ‘isolated’ from
its natural environment than are cotton fibers
that have been separated from cotton seeds or
coal that has been extracted from the earth,”
US Department of Justice-Amicus curiae in Myriads
Europe: genetically modified
plants
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The exclusion of plant varieties from patenting
does not apply to plant types in general that are
modified by patentable biotechnological
processes.
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EPO Enlarged Board of Appeal, Novartis (2000)
Process to obtain a hybrid
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A novel combination of traditional plant
breeding techniques that results in plants and
seeds
Decision T320/87, Lubrizol (1990)
Patent proliferation: barriers to competition
and research
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Multiplicity of claims
Legal fictions on novelty (materials existing in
nature)
Low inventive step
Scope of protection
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Claims’ scope in gene patents (‘species
patents’; functional claims-next slides)
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Unintentional infringement
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The farmers’ privilege
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Research and breeding (next slide)
Species-wide patents
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EP 0301749
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All genetically engineered plant species and
especially soybeans modified by a ‘particle gun’
method used to introduce foreign genes into
plant material
Functional claims
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Hibberd increase in tryptophan content
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Syngenta’s EP 1587933 on melons with a certain
citric acid and sugar content as well as a specific
pH-value
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Dow Agrosciences WO2010053541 Indian
mustard (Brassica juncea) having a certain
quality of oil
Article L613-2-1, French Industrial Property
Code, as amended in 2004
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The scope of a claim on a gene sequence is
limited to that part of the sequence directly
linked to the function specifically disclosed in
the specifications
Research exemption
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PVP: use of protected varieties for further
breeding—new variety may be independently
commercialized
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Patents: research or experimentation on the
invention---improved plant/variety cannot be
independently commercialized
Interface patent-PVP: compulsory
license
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Breeder cannot commercialize a plant variety
without infringing a patent
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Patentee cannot commercialize an invention
without infringing a PVP
Implications of plant patents
 Extension
of protection to derivatives:
the Monsanto case
Are derivatives subject to a patent
over a trait?
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Customs’ detainment of soya meal shipments
from Argentina
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Spain, UK: first instance; Netherlands:
intervention of European Court of Justice
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European Commission: no infringement
What is inventive?
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‘A new device, to be patentable, must
reveal a flash of creative genius’
Juez Douglas en Cuno Engineering Corp., 314 U.S. 84, 51 U.S.P.Q. 1, 1941)
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‘The only valid patents are those this
Court has not put its hands on …
Juez Jackson en Junguersen v. Ostby & Barton Co., 335 U.S. 560, 80 U.S.P.Q. 32
(1949)dissenting opinion
What is inventive? The ‘Enola’
bean patent
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US patent 5894079 April 13, 1999 on a ‘new
field bean variety that produces distinctly
colored yellow seed which remain relatively
unchanged by season’ and a method for
producing it.
Sealed crustless sandwich: US
6,004,596 (1999)
Mouth Appliance for Assisting in Weight Control
Patent Number: 4,883,072
Date of Patent. Nov. 28, 1989
Inventor: Edward W. Bessler, Fort Mitchell, KY
Animal Hat Apparatus and Metbod
Patent Number: 4,969,317
Date of Patent: Nov. 13, 1990
Inventor: April Ode, Lake Havasu City, AZ
British Patent of Sam Houghton
New developments: a turning point?
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Patent applications relating to ‘native’ traits and
conventional breeding methods
(e.g. EP 1069819 on broccoli and EP 1211926
on tomatoes)
A method for the production of Brassica oleracea
EP 1069819
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A method for the production of Brassica oleracea
(...) which comprises:
(a) crossing wild Brassica oleracea species with
Brassica oleracea breeding lines; and
(b) selecting hybrids with levels of 4methylsulfinylbutyl glucosinolates, or 3methylsulfinylpropyl glucosinolates, or both,
elevated above that initially found in Brassica
oleracea breeding lines.
Method for breeding tomatoes having reduced water
content and product of the method (EP 1211926 B1)
A method for breeding tomato plants that produce tomatoes with reduced
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fruit water content comprising the steps of:
crossing at least one Lycopersicon esculentum plant with a
Lycopersicon spp. to produce hybrid seed;
collecting the first generation of hybrid seeds;
growing plants from the first generation of hybrid seeds;
pollinating the plants of the most recent hybrid generation;
collecting the seeds produced by the most recent hybrid generation;
growing plants from the seeds of the most hybrid generation;
allowing plants to remain on the vine past the point of normal ripening;
and
screening for reduced fruit water as indicated by extended preservation
of the ripe fruit and wrinkling of the fruit skin.
Policies on plant patents (1)
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Exclusion of plants (whether genetically
modified or not) and biological processes
Clear distinction between discovery and
invention
Rigorous examination of novelty and inventive
step
Use-bound protection (only the function of the
gene specified in the claim)
Policies on plant patents (2)
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Research exemption + commercialization of
new variety (?)
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Interface patent-PVP: compulsory license