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

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

3. Overview of Patentable Subject Matter

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

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

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

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

8. 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 Invention

9. 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 Patentability Criteria

10. 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 Patentability Criteria

11. 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 Patentability Criteria

12. 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 Patentability Criteria

13. 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 Patentability Criteria

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

15. 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 Patentability Criteria

16. 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 Patentability Criteria

17. The Sunflower Seed Ruling

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

19. APLF- DePaul University College of Law 2006 Symposium on Intellectual Property Law 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, germinating seeds, culturing plants, collecting and selecting seeds, optionally repeating stages The Sunflower Seed Ruling

20. APLF- DePaul University College of Law 2006 Symposium on Intellectual Property Law 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 The Sunflower Seed Ruling

21. APLF- DePaul University College of Law 2006 Symposium on Intellectual Property Law 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 The Sunflower Seed Ruling

22. APLF- DePaul University College of Law 2006 Symposium on Intellectual Property Law 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 The Sunflower Seed Ruling

23. APLF- DePaul University College of Law 2006 Symposium on Intellectual Property Law 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... The Sunflower Seed Ruling

24. APLF- DePaul University College of Law 2006 Symposium on Intellectual Property Law 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 The Sunflower Seed Ruling

25. APLF- DePaul University College of Law 2006 Symposium on Intellectual Property Law 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 The Sunflower Seed Ruling

26. APLF- DePaul University College of Law 2006 Symposium on Intellectual Property Law 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 The Sunflower Seed Ruling

27. APLF- DePaul University College of Law 2006 Symposium on Intellectual Property Law 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. The Sunflower Seed Ruling

28. Conclusions

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

30. 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 Conclusion

31. 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 Conclusion

32. 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 Conclusion

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