IP Issues in Plant Breeding & Plant Biotechnology • IP Regimes Relevant to Plants & Plant Biotech • Utility Patents • Plant Variety Protection • Plant Patents • (4) Trade Secrets IP Licensing: Seed bag “technology agreements”
Sample: Plant-Related Utility Patents (2002) Title U.S. Pat. # Conventionally Bred Plants Plant Genetic Elements Transgenic Plants Transgenic Methodologies Therapeutic Applications 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 6395966 ENCODING THE PAT PROTEIN SOYBEAN AGROBACTERIUM TRANSFORMATION METHOD 6384301 METHOD OF INSERTING VIRAL DNA INTO PLANT MATERIAL 6376234 ORAL IMMUNIZATION WITH TRANSGENIC PLANTS 6395964
Utility 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
Are utility patents available for biological subject matter? 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 plants even though other forms of IP protection also may be available? Yes. J.E.M. Ag Supply v. Pioneer Hi-Bred (US Sup Ct December 2001)
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? 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? 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? 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? Yes; no “saved seed” exemption in utility patent statute. Outcome likely to be governed by language of technology agreement between seed producer and grower.
Sample: 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
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
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
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
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