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Mark D. JanisProfessor of Law
University of Iowa College of Law
Mark D. JanisProfessor of Law
University of Iowa College of Law
IP Regimes Relevant to Plants & Plant Biotech
• Utility Patents
(2) Plant Variety Protection
(3) Plant Patents
(4) Trade Secrets
IP Issues in Plant Breeding & Plant Biotechnology
IP Issues in Plant Breeding & Plant Biotechnology
IP Licensing: Seed bag “technology agreements”
Utility Patents for PlantsUtility Patents for Plants
INBRED MAIZE LINE PH4TW 6388179
SOYBEAN CULTIVAR 9323639517206 6388176
CASSETTES FOR THE EXPRESSION OF STORABLE PROTEINS 6403371 IN PLANTS
VITAMIN B METABOLISM PROTEINS 6403859
FERTILE TRANSGENIC MAIZE PLANTS CONTAINING A GENE 6395966ENCODING THE PAT PROTEIN
SOYBEAN AGROBACTERIUM TRANSFORMATION METHOD 6384301
METHOD OF INSERTING VIRAL DNA INTO PLANT MATERIAL 6376234
ORAL IMMUNIZATION WITH TRANSGENIC PLANTS 6395964
ConventionallyBred Plants
Plant Genetic Elements
Transgenic Plants
Transgenic Methodologies
Therapeutic Applications
Title U.S. Pat. #
Sample: Plant-Related Utility Patents (2002)Sample: Plant-Related Utility Patents (2002)
Utility Patent Litigation in the US Seed IndustryUtility Patent Litigation in the US Seed Industry
Mycogen v. Monsanto (Bt corn)
Syngenta v. everyone (Bt corn and cotton; RR cotton; transgenic methodologies) (filed July 2002)
Monsanto/Pioneer settlement (RR corn & soybeans; rootworm-resistant corn, etc.) (announced April 2002)
Acquiring patent rights:
-eligible class of subject matter
-utility
-adequate description
-novel
-non-obvious
Administered by the U.S. Patent and Trademark Office
Acquiring patent rights:
-eligible class of subject matter
-utility
-adequate description
-novel
-non-obvious
Yes, with evidence of at least minimal intervention by man (e.g., purification; isolation; conventional breeding; genetic alteration).
Diamond v. Chakrabarty
(US Sup Ct 1980)
Are utility patents available for biological subject matter?
Are utility patents available for biological subject matter?
Yes.
J.E.M. Ag Supply v. Pioneer Hi-Bred
(US Sup Ct December 2001)
Are utility patents available for plants even though other forms of IP
protection also may be available?
Are utility patents available for plants even though other forms of IP
protection also may be available?
Enforcing patent rights:
-rights to exclude others from making, using, selling. . .
-compensatory damages = reasonable royalty (minimum)
-enforceable for 20 yrs. from filing date
-effective only in the US
May innocent (as well as willful) infringers be held liable for patent
infringement?
May innocent (as well as willful) infringers be held liable for patent
infringement?
Yes.
Unintentional infringement by genetic drift?
Alleged in Monsanto Canada v. Schmeiser (Fed. Ct. 2001) (Canada)
May innocent (as well as willful) infringers be held liable for patent
infringement?
May innocent (as well as willful) infringers be held liable for patent
infringement?
Yes.
Unintentional infringement by genetic drift?
Alleged in Monsanto Canada v. Schmeiser (Fed. Ct. 2001) (Canada)
North Dakota House Bill No. 1442 (Spring 2001)
Is the use of a patented plant in research to develop a new variety
an act of patent infringement?
Is the use of a patented plant in research to develop a new variety
an act of patent infringement?
Yes, unless there is no evidence of commercial motivation.
If a grower plants patented seed, saves seed from the harvest, and
plants the saved seed, does the use of the saved seed constitute patent
infringement?
If a grower plants patented seed, saves seed from the harvest, and
plants the saved seed, does the use of the saved seed constitute patent
infringement?
Yes; no “saved seed” exemption in utility patent statute.
Outcome likely to be governed by language of technology agreement between seed producer and grower.
Plant Variety ProtectionPlant Variety Protection
Sample: PVP CertificatesSample: PVP Certificates
DeKalb Genetics Soybean variety CX433RR
PVP Cert. No. 9900276
Pioneer Hi-Bred Soybean Variety 92B14
PVP Cert. No. 200200131
Pioneer Hi-Bred Field Corn Variety PH3HH
PVP Cert. No. 200000241
Delta & Pine Land Cotton Variety PM 2200 RR
PVP Cert. No. 9700140
Companies with Less than Ten PVP Certificates, 49, 8%
NDSU Research Foundation, 12, 2%
United AgriSeeds, Inc., 16, 3%
The Standard Oil Company, 16, 3%
Novartis Seeds, Inc., 34, 6%
DEKALB Plant Genetics, 26, 4%
DeKalb-Pfizer Genetics, 18, 3%
Zenco (No. 4) Limited, 17, 3%Pioneer Hi-Bred
International, Inc., 269, 44%
Holden's Foundation Seeds L.L.C., 110,
18%
DEKALB Genetics Corporation, 37, 6%
Note: Figures show Numbers of Applications and Percentage Shares of the Applications.
Ownership of Corn PVP CertificatesOwnership of Corn PVP Certificates
Ownership of Soybean PVP Certificates
Ownership of Soybean PVP Certificates
Novartis Seeds, Inc., 100, 13%
Pioneer Hi-Bred International, Inc.,
206, 27%
Minnesota Agricultural
Experiment Station, 28, 4%
Asgrow Seed Company, 100, 13%
DEKALB Genetics Corporation, 23, 3%
Jacob Hartz Seed Company, Inc., 28,
4%
Advanta USA, Inc., 21, 3%
Delta and Pine Land Company, 22, 3%
Ohio Agricultural Research and Development
Center, 20, 3%
Institutions with Eleven Certificates,
22, 3%
FFR Cooperative, 19, 3%
Institutions with Ten Certificates, 20, 3%Institutions with Less
than 10 Certificate, 138, 18%
Note: Figures show Numbers of Applications and Percentage Share of the Applications.
Acquiring PVP rights:
-eligible subject matter: plant “variety”
-new
- “DUS” criteria
Administered by the PVP Office of USDA
Enforcing PVP rights:
-weak protection: exclusive rights are subject to exceptions for non-commercial uses, breeding research, saved seed, etc.
- enforceable for 20-25 yrs. from issue date
Plant PatentsPlant Patents
Sample: Plant Patents (issued Sept. 2002)Sample: Plant Patents (issued Sept. 2002)
FLORIBUNDA ROSE PLANT
NAMED ' POULBELLA', US PAT PP12904
APPLE TREE
NAMED "BULL MACINTOSH', US PAT PP12900
STRAWBERRY PLANT
NAMED "SAN JUAN', US PAT PP12899
WALNUT TREE
NAMED "DOMOTO', US PAT PP12898
Trade SecretsTrade Secrets
Acquiring trade secret rights:
-eligible subject matter: info that has value due to its secret nature, and is the subject of efforts to maintain its secret nature.
Governed by state law.
Enforcing trade secret rights:
-protection against misappropriation, with exceptions for independent development and reverse engineering
IP Licensing: Seed Bag Technology AgreementsIP Licensing: Seed Bag
Technology Agreements
Monsanto v. McFarling (Court of Appeals, Federal Circuit, Aug. 23, 2002)
Monsanto’s technology agreement was enforceable against a grower who saved and replanted seed without paying license fees for the replanted seed.
-no violation of antitrust laws
-no violation of patent law doctrine
-no violation of PVPA