Intellectual Property Rights
in Living Matter: An
Overview for Bacteria,
Plants & Animals
Drew L. Kershen
Earl Sneed Centennial Professor of Law
University of Oklahoma
Copyright 2004, Drew L. Kershen, all rights reserved
Background
General
 Teaching agricultural
biotechnology since 1995
 Expanded into three hour
course in 2000
 Three 1-hour components
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Intellectual property
rights in living matter
Comparative
regulations – U.S. and
E.U.
International
Conventions and
Treaties
 Handouts – Basic explanation
and science experiment
OkJoLT Founded in 2002 – Julie Short;
Ruth Okediji
2003 Michelle Grasso; Drew Kershen
Spring 2004 – Project on Intellectual
Property in Living Matter– Five students;
five countries
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JoLynn Jeter – US
Jason Naimi – Canada
Katrina McClatchy – EU
Robyn Ott – India
Steven Ruby – Int’l Conv.
3 e-briefs each– accurate,
concise summaries relating to the
project topic
Hopefully five more countries next
fall (e.g Korea, Egypt, Mexico,
Brazil, Australia, New Zealand,
South Africa)
Premiere URL for basic info – APS
www.okjolt.org
United States
 Plant Patent Act of 1930
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Asexually reproduced
plants – cuttings, grafting
– single plant
Requirements
 Novelty
 Distinctiveness
 Non-Obviousness
 Description as
complete as
reasonably possible
Subpart of General
Patent Law – USPTO
Horticultural industry–
flowers, fruits
 Plant Variety Protection Act of
1970, amend. 1994
 Sexually reproduced plants
by pollination, seeds – the
variety
 Requirements
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New
Distinct
Uniform
Stable
Seed Deposit
 Plant Variety Certificate –
sub-patent IPR -- USDA
 Exemptions from infringement
 Public Interest Exemption
 Research Exemption
 Farmer’s Exemption
United States
 Patent Act of 1952 – the general
utility patent law
 Scope: useful process,
machine, manufacture,
composition of matter
 Requirements
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New
Useful
Non-Obvious
Description
 Written description
(reduced to practice)
 Enablement
 Biological deposit
 Funk Brothers Seed Company
v. Kalo Inoculant Company
(1948) – invention v. discovery
 Diamond v. Chakrabarty (1980)
– scope of patents – man-made,
genetically engineered bacteria
for breaking down crude oil
 J.E.M. Ag. Supply, Inv. v.
Pioneer Hi-Bred Int’l, Inc. (2001)
– inbred & hybrid seed corn,
non-transgenic
 Scope of patent
 Relationship to other IPR
laws
 Dual protection
European Union
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UPOV ‘61, ’78, ’91
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1961 European Convention
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Scope: Not patentable
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New
Distinct
Stable
Uniform
Biological deposit
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1991 UPOV
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European Patent Convention (1977)
Requirements:
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Strengthen breeders’ rights
Weakened exemptions to
breeders’ rights, particularly
farmer’s exemption
Removed prohibition on dual
protection
U.S. PVPA patterned after UPOV,
including 1994 amendments
Plant variety certificates
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Discoveries, scientific
theories, mathematical
method
Art. 53(b) – “plant or animal
varieties or essentially
biological processes” but
does not apply to
microbiological processes
and products thereof
“Ordre publique” or morality
Requirements
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New
Inventive Step
Industrial Application
Description
European Union
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Novartis/Transgenic Plant (2000)
 Art. 53(b) – plant variety compared
to genes and plant cells and plants
generally
 Invention embraces plant varieties
but not targeted to plant varieties
 Interrelationship between UPOV and
EPC – no dual coverage
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Art. 53(b) interpreted to
establish demarcation to
prevent dual coverage
Patent granted to Novartis for antipathogenic transgenic plants and
processes for producing the
transgenic plants
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Harvard/Oncomouse (2003)
 Claim for process of introducing
oncogene sequence
 Claim for the transgenic animal
(mammal - rodents) itself
Art. 53(b) – exclusion for animal variety
Technical Board of Appeal (1990)
 Art. 53(b) language does not include
animals in general, only animal
varieties
 Harvard application – for animal
variety? – rodents
Opposition Division (2003)
 EPC Rule 23c(b) – patentable if
technical feasibility not confined to
particular plant or animal variety
 Technical Board 1990 legal rulings
 Compatible with Novartis (2000)
Harvard/Oncomouse patent upheld for
process patent and on transgenic animal
EPO upheld Harvard/Oncomouse patent
but limited it to mice (July 2004) – not yet
published
Canada
 Patent Act of 1985
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Adapted from U.S. Patent
Act of 1952
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 Plant Breeder’s Rights Act of
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1990
UPOV ver. 1978
 Dual protection prohibited
 Patent Commissioner
 Manual of Patent Practice
1990
 “multi-cellular
differentiated organisms
(plants, seeds, and
animals)” are not
considered within scope of
patent act
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Harvard/Oncomouse
Patent Office (1995)
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Process claims for creation of
transgenic embryo allowed
Product claims for the
mammal (rodent) disallowed
Supreme Court Canada (2002)
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Scope: does not include
higher life forms – not a
composition of matter or
manufacture
Canadian parliament must
address issue
Unexpressed concern about
humans
Sixteen jurisdictions grant;
two have analogous case
granting; only Canada has
denied a patent for Harvard
oncomouse.
Canada
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Schmeiser v. Monsanto
 Patented transgenic canola
 Infringement dispute
 Saved seed known or should
have known for 1998 crop – not
an innocent infringer
 Federal Court Trial (2001) and
Federal Court Appeal (2002) –
ruled on all points for
Monsanto, except amount of
damages
 Monsanto claims genes and
cells genetically modified for
herbicide tolerance
Kershen, Of Straying Crops and
Patent Rights, 43 Washburn L. J.
575-610 (2004)
Siebrasse, The Innocent Bystander
Problem in the Patenting of Higher
Life Forms, 49 McGill L. J. 349-392
(2004)
Supreme Court Canada – 2004 SCC 34
(2004)
 Patent Commissioner granted
Monsanto patents; different
burden of proof
 Scope – higher life forms
 Breadth of claims – if genes
and cells, effectively plants –
analogy to product with
incorporated patented part
 Disputes about how to interpret
infringement in self-reproducing
patented plants or animals
 Election of remedies – profits or
royalties – Monsanto lost on
damages
 Siebrasse, A Remedial BenefitBased Approach to the Innocent
User Problem in the Patenting of
Higher Life Forms, 20 Can. Intell.
Prop. Rev. 79-134 (2003)
Infringement Actions
 As of October 10, 2004, 21 reported cases relating to utility
patents and plants with 32 opinions
 Nineteen involve Monsanto Co. – 18 U.S.; 1 Canada
(Schmeiser)
 Two involve Pioneer Hi-bred Int’l Inc.
 Oct. 2004 -- Monsanto Co. reported less than fifty lawsuits total - Canada (2) and U.S. (45) – decisions, settlements, pending
 Allegation in Higginbotham v. Monsanto Co., an anti-trust
lawsuit in Missouri that 475 lawsuits exist – no verification –
Monsanto says has written approx. 500 letters to farmers
 Infringement actions
 PVPA infringement actions – Delta and Pine Land Co.,
Syngenta
 Plant Patent Act infringement actions
 Utility patents in non-biotechnology plants
Monsanto v. McFarling (2002)
 Facts:
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McFarling purchased Round-up Ready soybeans and signed
Technology Use Agreement in 1997
Technology Use Agreement – payment of a license fee per
bag – license authorizes crop for one season and prohibits
saving seed for replanting or supplying seed to anyone for
replanting
McFarling did not dispute that he purposefully saved seed
and replanted seed for the 1998 and 1999 crop years
 Legal Issue
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McFarling argued that prohibition on saved seed was a
tying-arrangement prohibited by anti-trust laws
 Ruling – McFarling not tied to repurchase of RR
soybeans – free to purchase any soybean seed –
superior performance of RR soybeans resulting in desire
to grow again is not tying arrangement
Monsanto v. McFarling (2002)
 Legal Issue
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McFarling argued that contractual prohibition
on saving seed violated the doctrines of patent
exhaustion and first sale
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Ruling – Scope of the patent grant allows
patentee to license only use of the patented
product – patentee by contractual license can
condition the authorization – the Technology Use
Agreement specifically prohibited saving seed
and authorized growth for a single season only
for commercial sale as commodity soybeans
Monsanto v Trantham (2001)
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Facts
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Trantham purchased cottonseed from cotton gin for planting in 1999 –
sprayed the planted cotton with Roundup herbicide – repeated the
same process in 2000 – 93% of samples RR cotton
Trantham purchased soybeans from an authorized dealer but did not
sign the Technology Agreement – 100% of samples RR soybeans
Legal Issues
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Trantham argued that the Technology Agreement violated the Sherman
Anti-trust laws prohibiting monopolization and unreasonable restraint of
trade
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Ruling – the technology agreement as a license does not
violate the anti-trust laws – patent holders are entitled to a
monopoly – technology agreement by itself sets forth legal
restrictions
Ruling – clauses prohibiting seed saving and charging a
technology fee are not unreasonable restraints of trade based
on argument that Monsanto markets RR soybeans without the
restriction and fee in Argentina – Argentina does not allow
patents on plants -- Monsanto’s different marketing strategy
responds to different market conditions