Intellectual Property Rights
in Living Matter
Drew L. Kershen
Earl Sneed Centennial Professor
University of Oklahoma College of Law
© 2006 Drew L. Kershen, all rights reserved
Legal Foundation -Fundamentals
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U.S. Const. Art. I, Sec. 8: “The Congress shall have the Power
[cl. 8] To promote the Progress of Science and useful Arts by
securing for limited Times to Authors and Inventors the
exclusive Right to the respective Writings and Discoveries.”
Federal
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State
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Copyrights, Trademarks, Patents, Plant Variety Certificates
Trade Secrets: e.g. parental lines for hybrids
Geographical Designations: e.g. Hawaiian Kona coffee
Patents on living organisms
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Canada, European Union, Japan, Australia
UPOV (1961/1991)
TRIPs Agreement of the World Trade Organization (WTO)
There are no international patents -- WIPO
United States
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Plant Patent Act of 1930
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Asexually reproduced plants
– cuttings, grafting
Single plant – one claim,
clones
Requirements
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Novelty
Distinctiveness
Non-Obviousness
Description as complete as
reasonably possible
Biological deposit
Subpart of General Patent
Law – USPTO
Horticultural industry–
flowers, fruits
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Plant Variety Protection Act of
1970, amend. 1994
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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
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Public Interest Exemption
Research Exemption
Farmer’s Exemption
United States
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Patent Act of 1952 (1791) – the
general utility patent law
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Scope: useful process, machine,
manufacture, composition of
matter
Requirements
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New
Useful
Non-Obvious
Description
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Written description (reduced
to practice)
Enablement
Biological deposit
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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
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Scope of patent
Relationship to other IPR laws
Dual protection
Legal Issues:
Infringement
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Protection of intellectual property (seed breeding)
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All crops, not just transgenic crops
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J.E.M. Ag Supply v. Pioneer Hi-Bred
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Plant variety certificates, Plant Patent Act (asexually reproduced), Utility Patents
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Trade Secrets (hybrids) – parental lines
Saving seeds
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For own farm only for plant varieties (only PVPA)
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Contractual prohibition for patented plants
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For agronomic reasons not feasible for hybrids
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Self-pollinated crops: Soybeans, wheat, canola (rarely)
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Farmers quite capable on economic calculation about seed costs
Infringement Litigation
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As of Jan 2005, 98 lawsuits Monsanto and farmers
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Monsanto has won 73 of 73 resolved lawsuits
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Numerous other settlements; in fact, most settle quickly
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Bin run, not brown bag or seed exchange
Legal Issues:
Infringement of Patents
All infringement cases, both conventional and transgenic, except two,
farmers admitted that they saved patented seeds intentionally.
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Schmeiser v. Monsanto Canada, Inc.
 In 1997 Schmeiser sprayed canola with Round-up; purposefully
harvested seed from surviving plants; purposefully segregated
the harvested seed; purposefully used the harvested,
segregated seed for the 1998 crop – approximately three acres
 Tests on 1998 seed sample from Humbolt Elevator divided into
three portions and sent directly to Schmeiser, Monsanto, and
an independent expert; Schmeiser subdivided his portion and
sent half to the independent expert
 Results: S65%; M95-98%; IES 65%; IEH 95-98%
 The Canadian courts (trial, appellate, and Supreme Court)
found factually that he purposefully saved and planted
patented seed that he knew or should have know contained a
patented gene for herbicide tolerance.
 Canadian judges concluded that Schmeiser’s explanations for
1997 presence were not plausible – legally irrelevant because
1998 claim
References:
Infringement
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Adventitious presence should not create legal liability for
infringement under patents.
Patent law will protect the truly innocent infringer
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Trace levels of patented trait are commercially irrelevant at trace
levels
Seed developers have no incentive to pursue innocent infringer
Company pledges to pursue only intentional infringers
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)
Siebrasse, A Remedial Benefit-Based Approach to the Innocent User Problem in
the Patenting of Higher Life Forms, 20 Can. Intell. Prop. Rev. 79-134 (2003)
University of Hawaii
Taro Patents
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Three patents obtained in 2002
Plant patents, not utility patents
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Palauan and Hawaiian varieties as parental lines
Conventional sexual breeding from which the
single plant selected
Single plant claimed from asexual reproduction by
tissue culture and stem (huli) propagation
No claim to taro as taro; no claim to taro by
sexual reproduction – these are not legally
possible
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Stem (huli) exchange would be prohibited by the law
Common prohibition in the horticultural industry
Taro Patent Questions
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University of Hawaii owns the patents
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Can grant a license to whomever and under
whatever conditions
Prudential judgments
How to distinguish from other “sacred”
plants?
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Unique to Hawaiian culture
First Amendment – establishment of religion
questions
Taro Patent Questions
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How to deal with escalating demands? The charge of
biopiracy
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Permission from Palau Women’s Council (oversight of lo’I
kalo) and Palauan government in 1993; collection in 1994
No need for permission in the United States – plants within
the United States are basically common heritage
Convention on Biological Diversity – 1992/1993
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Art. 15 Access to Genetic Resources
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prior informed consent on mutually agreed terms
aim of sharing fairly and equitably the commercial utilization
Art. 16 Access to and Transfer of Technology – clear recognition
of intellectual property
Palau is a member of CBD
Taro Patent Questions
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Charge of Biopiracy continued
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FAO & Consultative Group on International Agricultural Research
(CGIAR) – 1994
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Materials Transfer Agreement
Intellectual Property Rights recognized and protected
Plant Genetic Resources for Food & Agriculture Treaty (PGRFA) –
2002/2004
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Art. 12 Facilitated access to plant genetic resources
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Art. 13 Benefit-sharing
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Purpose of treaty is to create multilateral system of exchange
no IPRs “in the form received” but IPRs for plant genetic resources that
have undergone innovation
information, technology transfer, capacity building, sharing of monetary
benefits of commercialization
mandatory trigger comes from IPRs
Palua is not a member of PGRFA Treaty
Charge of Biopiracy rejected; praise for UH and its scientists
Taro Patent Questions
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What impact on the Samoan farmers?
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Samoan farmers requested help due to disease
infestation (leaf blight and root rot)
Agreement that only commercial Samoan farmers
will pay any royalty
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Differentiation endorsed by PGRFA Art. 13.d(ii)
Native Hawaiian group with patent could prevent
Samoan farmers from growing the taro developed
for them
Palau and Hawaii gave lost nothing and gained
knowledge and three excellent taro varieties
Thank you.
I look forward to answering questions
about IPRs in living matter or other
questions about agricultural
biotechnology law and policy