“Accessibility of Protected Inventions and Plant varieties for Further Innovations”

1. “Accessibility of Protected Inventions and Plant varieties for Further Innovations” Victoria Henson-Apollonio, Ph.D.,Manager, the CGIAR Central Advisory Service on IP

2. Introduction • Patent Protection for Plant Inventions • Exceptions to Infringement

3. Patent options for protection of plant material • Plant Patents • Utility Patents • Standard Patents

4. Plant Patent option • Unique to U.S. • Oldest type of statutory IP protection for living material, --Townsend-Parnell Plant Patent Act, 46 Stat. 376 (May 23, 1930, ch. 312, §1).

5. Plant Patent option • One claim, describing unique new characteristics • Protects asexually reproduced plants • Favored for protection of new horticultural varieties, as well as fruit and nut trees • No Tuberous plants

6. Utility Patent option • Original Patent Act, 1790 • U.S. option for inventions- process, machine, manufacture, composition of matter • Right to exclude others from making, using, selling, (importing), the claimed invention –in/into the U.S.

7. Utility Patent option • Invention must be novel, non-obvious and useful • Inventions involving living material, --Chakrabarty case –U.S. Supreme Court ruling in 1980, –”..anything under the sun that is made by man.”

8. Utility Patent option • Multiple aspects of a plant invention can be claimed • “Best mode disclosure” and “enablement” requirements • Often met by deposit of propagative material into a “Budapest” –certified depository

9. Utility Patent option • Applicant can file applications for rights on the same variety, under both the utility patent regulations as well as under the Plant Variety Protection Act

10. Standard Patent option- EPO • European Patent Office practice (European Patent Convention) • National laws interpret European Parliament Directives

11. Standard Patent option-EPO • Original EPO interpretation of Directive 98/44/EC –no basis for patents on living plants • Overturned by decision in late 1999, that a claim directed to transgenic plants of more that one variety, that does not claim an individual plant variety, is permissible.

12. Standard Patent option-Japan • Japan allows claims directed to plants and to the genetic engineering of plants • Claims tend to be very narrow

13. Standard Patent --Australia • Claims can be directed to new plant varieties, plants components, reproductive material, products from plants and plant materials used in industrial processes

14. Standard/Utility Patent –New Zealand • Claims can be directed to new transgenic plant varieties, plants components

15. Exceptions to Infringement-U.S. • Plant Patents (U.S.) —can be used as breeding material (Judicial) • Utility Patents (U.S.) –Very narrow interpretation • Further-narrowed by recent (Oct 10, 2002) ruling --Madey v Duke University

16. Exceptions to Infringement—U.S. • Madey v. Duke University also narrowed the definition of “non-commercial” • Pharmaceutical industry in U.S. enjoys a “safe harbor” provided by the U.S. Legislature–the Bolar Amendment (Section 271(e))—allows generic drug makers to test versions of patented drug for regulatory approval

17. Exceptions to Infringement-EU • Community Patent Convention Article 27(b) (currently, non-binding),provides that, “the rights conferred by a patent shall not extend to acts done for experimental purposes relating to the subject matter of the patented invention.”

18. Exceptions to Infringement-EU • Standard Patents- Experimental use exception in U.K. patent law (Section 60(5)(b) • German Courts have interpreted the experimental use clause in the patent law, quite liberally –at least in pharma cases

19. Exceptions to Infringement-Japan • Experimental use exception provided by Section 69 (1) of the Japanese Patent Law. • Scant case law, so far, to aid in interpretation of experimental use exception dealing with plants

20. Contract options for “enlarging” research exemption • Through collaborative agreements–Collaborator may have license • Bilateral contract/license with patent owner

21. Contract options for “enlarging” research exemption • Cross-licensing • “Patent Pooling”/”Clearing-House” mechanisms

22. Summary • Several patent instruments covering plant inventions – • Primarily used by inventors in developed countries • Experimental use/Research exceptions to infringement do exist

23. Summary • Exceptions is U.S. are mainly judicially created • U.S. exceptions are very narrow • European and Japanese exceptions tend to be legislated and are interpreted fairly broadly

24. Summary • “Research only” licenses are usually, but not always, available to public institutions • Other contract options/arrangements have been used

25. The CGIAR Central Advisory Service on Intellectual Property,Housed at ISNAR in The Haguev.henson-apollonio@cgiar.org