Mark D. Janis Professor 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 Licensing: Seed bag “technology agreements”

Utility Patents for Plants

INBRED MAIZE LINE PH4TW SOYBEAN CULTIVAR CASSETTES FOR THE EXPRESSION OF STORABLE PROTEINS IN PLANTS VITAMIN B METABOLISM PROTEINS FERTILE TRANSGENIC MAIZE PLANTS CONTAINING A GENE ENCODING THE PAT PROTEIN SOYBEAN AGROBACTERIUM TRANSFORMATION METHOD METHOD OF INSERTING VIRAL DNA INTO PLANT MATERIAL ORAL IMMUNIZATION WITH TRANSGENIC PLANTS Conventionally Bred Plants Plant Genetic Elements Transgenic Plants Transgenic Methodologies Therapeutic Applications Title U.S. Pat. # Sample: Plant-Related Utility Patents (2002)

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

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?

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?

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 (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.

Plant Variety Protection

Sample: PVP Certificates DeKalb Genetics Soybean variety CX433RR PVP Cert. No Pioneer Hi-Bred Soybean Variety 92B14 PVP Cert. No Pioneer Hi-Bred Field Corn Variety PH3HH PVP Cert. No Delta & Pine Land Cotton Variety PM 2200 RR PVP Cert. No

Ownership of Corn PVP Certificates

Ownership of Soybean PVP Certificates

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 yrs. from issue date

Plant Patents

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 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 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