Mark D. Janis Professor of Law University of Iowa College of Law

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