September 21, 2006 DePaul University, Chicago, IL

1. APLF- DePaul University College of Law 2006 Symposium on Intellectual Property Law September 21, 2006 DePaul University, Chicago, IL

2. Protection of Biochemical Inventions in Argentina. Alicia Alvarez Berkenwald, Chem. Eng. Patent Attorney

3. Overview of Patentable Subject Matter

4. Country Features • Argentina: agricultural country • Agriculture: competitive advantage • Factors: - Direct sowing - Agribiotech APLF- DePaul University College of Law 2006 Symposium on Intellectual Property Law

5. The Legal Frame • Agribiotech: main protection systems - Plant Breeders’ Rights - Patent Law APLF- DePaul University College of Law 2006 Symposium on Intellectual Property Law

6. Patent Law • 1995: New Patent Law • - Specific provisions on living matter • 1996: Regulatory Decree • - More restrictive than PL APLF- DePaul University College of Law 2006 Symposium on Intellectual Property Law

7. Patent Law • 2002: Permanent working team • - Secretary of Agriculture / Patent Office • 2003: Guidelines for patentability • - Restrictive interpretation of PL and regulatory • decree APLF- DePaul University College of Law 2006 Symposium on Intellectual Property Law

8. Invention • An invention is everything created by man which allows the transformation of matter or energy for exploitation by man APLF- DePaul University College of Law 2006 Symposium on Intellectual Property Law

9. Patentability Criteria • Not considered inventions: - Discoveries - Any kind of living matter and substances … … pre-existing in nature or identical to a natural element -- Even purified and isolated APLF- DePaul University College of Law 2006 Symposium on Intellectual Property Law

10. Patentability Criteria • Not considered inventions: - Animals, parts or components that lead to a whole individual APLF- DePaul University College of Law 2006 Symposium on Intellectual Property Law

11. Patentability Criteria • Not considered inventions: - Plants, propagation materials, parts or components that lead to a whole individual APLF- DePaul University College of Law 2006 Symposium on Intellectual Property Law

12. Patentability Criteria • Not patentable: - Microorganisms pre-existing in nature -- even isolated and purified • Patentable: - Modified microorganisms APLF- DePaul University College of Law 2006 Symposium on Intellectual Property Law

13. Patentability Criteria • Not patentable: - Cells that may lead to a plant or animal • However, any cell component is considered a substance APLF- DePaul University College of Law 2006 Symposium on Intellectual Property Law

14. Patentability Criteria • Patentable: - Modified substances - Synthetic substances different from natural ones - DNA, plasmids, proteins, sequences,etc.,which are not identical to a naturalelement APLF- DePaul University College of Law 2006 Symposium on Intellectual Property Law

15. Patentability Criteria • Not patentable: - Essentially biological processes - “Series of steps that result in the obtention of plants or animals and that are accomplished to a great extent by action of phenomena existing in nature e.g.Selection and Cross-Breeding” APLF- DePaul University College of Law 2006 Symposium on Intellectual Property Law

16. Patentability Criteria • Patentable - Microbiological processes - “Industrial processes that use, apply or result in a microorganism” APLF- DePaul University College of Law 2006 Symposium on Intellectual Property Law

17. The Sunflower Seed Ruling

18. The Sunflower Seed Ruling • First decision concerning biochemical inventions • Dealt with for the first time: - Clarity of claims - Enablement requirement APLF- DePaul University College of Law 2006 Symposium on Intellectual Property Law

19. The Sunflower Seed Ruling • CIC applied for a patent claiming a sunflower seed comprising an oil with a greater content of stearic acid, obtainable by treating parent seeds with a mutagenic agent, germinatingseeds, culturing plants, collecting and selecting seeds, optionally repeating stages APLF- DePaul University College of Law 2006 Symposium on Intellectual Property Law

20. The Sunflower Seed Ruling • First office action: seeds cannot constitute patentable subject matter • Seeds and plant varieties can be protected by Plant Breeders’ Rights • UPOV 78: no double protection allowed APLF- DePaul University College of Law 2006 Symposium on Intellectual Property Law

21. The Sunflower Seed Ruling • New Claims: - Product Claim: a sunflower oil characterized for having a content of stearic acid 12% greater that the content of stearic acid in the oil obtained from wild seeds APLF- DePaul University College of Law 2006 Symposium on Intellectual Property Law

22. The Sunflower Seed Ruling • New Claims: - Method Claim: method for preparing a sunflower oil by treating parent seeds with a mutagenic agent,germinating seeds, culturing plants, collecting and selecting seeds, optionally repeating stages APLF- DePaul University College of Law 2006 Symposium on Intellectual Property Law

23. The Sunflower Seed Ruling • After 3 office actions, the application was rejected • The applicant judicially requested the reversal of the PTO decision • The Lower Court and the Federal Court of Appeals confirmed the PTO decision on the following basis... APLF- DePaul University College of Law 2006 Symposium on Intellectual Property Law

24. The Sunflower Seed Ruling • The applicant defined the product (oil) by the content of stearic acid in relation to the content of stearic acid of the oil obtained from wild seeds • The applicant failed to define the stearic acid content of the oil obtained from wild seeds • Claim is indefinite APLF- DePaul University College of Law 2006 Symposium on Intellectual Property Law

25. The Sunflower Seed Ruling • Method Claims: the proposed method leads to obtain a sunflower seed or plant (plant variety) • Seeds and plants are protected by Plant Breeders’ Rights • Double protection is not allowed • A method to obtain the oil was not disclosed APLF- DePaul University College of Law 2006 Symposium on Intellectual Property Law

26. The Sunflower Seed Ruling • The result of the method is fortuitous since it depends on selecting the appropriate seeds • Reproducibility is not guaranteed • The applicant failed to provide enough explanatory information APLF- DePaul University College of Law 2006 Symposium on Intellectual Property Law

27. The Sunflower Seed Ruling • Understanding what went wrong: -The sunflower seed should have been protected through Plant Breeders’ Rights. -The oil could have been protected by a Patent if the claim had been properly drafted. APLF- DePaul University College of Law 2006 Symposium on Intellectual Property Law

28. Conclusions

29. Conclusion • Plant Breeders’ Rights: • - Plants or seeds, even genetically modified • - Propagation materials APLF- DePaul University College of Law 2006 Symposium on Intellectual Property Law

30. Conclusion • Patents: • - Plants and animals: No • - Plant or animal parts: No, if a variety is hidden • - Plant or animal cells: No, if a variety is hidden • - MO, DNA, genes, vectors, proteins, sequences: Yes, • if not identical to a natural element APLF- DePaul University College of Law 2006 Symposium on Intellectual Property Law

31. Conclusion • Patents: • - Process for the production of plants or animals: No, if • essentially biological • - Process for the production of a plant or animal: Yes, if • it includes a technical step • - Process for treating plants or seeds: Yes, if new features • are non-inheritable APLF- DePaul University College of Law 2006 Symposium on Intellectual Property Law

32. Conclusion • IP system in AR is still developing • Litigation is increasing and decisions are favoring IP • Plant Breeders’ Rights can be supplemented by • Patent Rights APLF- DePaul University College of Law 2006 Symposium on Intellectual Property Law

33. Thank you. E-mail: aalvarez@goberal.com.ar Web:www.goberal.com.ar