1. 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

2. Background General Intellectual property rights in living matter
Teaching agricultural biotechnology since 1995
Expanded into three hour course in 2000
Three 1-hour components
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
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

3. United States Novelty Distinctiveness Non-Obviousness
Plant Patent Act of 1930
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
New
Distinct
Uniform
Stable
Seed Deposit
Plant Variety Certificate – sub-patent IPR -- USDA
Exemptions from infringement
Public Interest Exemption
Research Exemption
Farmer’s Exemption

4. United States Patent Act of 1952 – the general utility patent law
Scope: useful process, machine, manufacture, composition of matter
Requirements
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

5. European Union UPOV ‘61, ’78, ’91 European Patent Convention (1977)
1961 European Convention
Requirements:
New
Distinct
Stable
Uniform
Biological deposit
1991 UPOV
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
European Patent Convention (1977)
Scope: Not patentable
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
New
Inventive Step
Industrial Application
Description

6. European Union
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
Art. 53(b) interpreted to establish demarcation to prevent dual coverage
Patent granted to Novartis for anti-pathogenic transgenic plants and processes for producing the transgenic plants
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

7. Canada Adapted from U.S. Patent Act of 1952 UPOV ver. 1978
Plant Breeder’s Rights Act of 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
Harvard/Oncomouse
Patent Office (1995)
Process claims for creation of transgenic embryo allowed
Product claims for the mammal (rodent) disallowed
Supreme Court Canada (2002)
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.

8. Canada 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 (2004)
Siebrasse, The Innocent Bystander Problem in the Patenting of Higher Life Forms, 49 McGill L. J (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 Benefit-Based Approach to the Innocent User Problem in the Patenting of Higher Life Forms, 20 Can. Intell. Prop. Rev (2003)

9. 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 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

10. Monsanto v. McFarling (2002)
Facts:
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
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

11. Monsanto v. McFarling (2002)
Legal Issue
McFarling argued that contractual prohibition on saving seed violated the doctrines of patent exhaustion and first sale
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

12. Monsanto v Trantham (2001)
Facts
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
Trantham argued that the Technology Agreement violated the Sherman Anti-trust laws prohibiting monopolization and unreasonable restraint of trade
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