1. Biotech Inventions in Latin America Argentina Ignacio Sánchez Echagüe Marval, O’Farrell & Mairal

2. MARVAL, O'FARRELL & MAIRAL 2 AGENDA 1.Importance of biotech in Argentina 2.Plant variety protection 3.Patents 4.Registration of biotech products 5.Data exclusivity and biotech products 6.Summary

3. MARVAL, O'FARRELL & MAIRAL 3 AGENDA 1.Importance of biotech in Argentina 2.Plant variety protection 3.Patents 4.Registration of biotech products 5.Data exclusivity and biotech products 6.Summary

4. MARVAL, O'FARRELL & MAIRAL 4 Importance of biotech in Argentina Pharma Agribusiness

5. MARVAL, O'FARRELL & MAIRAL 5 Importance of biotech in Argentina Pharma industry Argentine pharmaceutical industry Great importance in Argentina Mainly devoted to small molecules – Moving to biotech field Employing: 27,000 (directly) and 100,000 (indirectly)

6. MARVAL, O'FARRELL & MAIRAL 6 Importance of biotech in Argentina Pharma industry Argentine pharmaceutical industry 250 laboratories Market: 55% local – 45% international 88% branded products 90% (value) prescription drugs

7. MARVAL, O'FARRELL & MAIRAL 7 Importance of biotech in Argentina Pharma industry Argentine pharmaceutical industry $ 3,220 M (2008) 7% of the Argentine industry Imports Exports Negative trade balance: Government encouraging pharma exports

8. MARVAL, O'FARRELL & MAIRAL 8 Importance of biotech in Argentina Pharma industry - Exports

9. MARVAL, O'FARRELL & MAIRAL 9 Importance of biotech in Argentina Agribusiness industry

10. MARVAL, O'FARRELL & MAIRAL 10 Importance of biotech in Argentina Agribusiness industry Agribusiness 19% of GDP 54% of Argentine exports 36% of registered workers

11. MARVAL, O'FARRELL & MAIRAL 11 AGENDA 1.Importance of biotech in Argentina 2.Plant variety protection 3.Patents 4.Registration of biotech products 5.Data exclusivity and biotech products 6.Summary

12. MARVAL, O'FARRELL & MAIRAL 12 Plant Variety Protection Current Seeds and PVP Law: 40 years old Extended use of farmer’s exemption Widespread agreement on the need to amend the PVP Law Bill drafted by the National Institute of Seeds – INASE- (enforcing agency of the current PVP law)

13. MARVAL, O'FARRELL & MAIRAL 13 Plant Variety Protection INASE’s bill Essentially derived variety Farmer’s exemption Provisional protection Scope of PVP rights

14. MARVAL, O'FARRELL & MAIRAL 14 AGENDA 1.Importance of biotech in Argentina 2.Plant variety protection 3.Patents 4.Registration of biotech products 5.Data exclusivity and biotech products 6.Summary

15. MARVAL, O'FARRELL & MAIRAL 15 Patents Patentable subject matter  Restrictive approach compared to the US Plants Proteins, genes and/or DNA sequences Methods for obtaining plants Diagnostics and gene patenting

16. MARVAL, O'FARRELL & MAIRAL 16 Patents - Patentable subject matter Plants Not patentable: Plants and animals (even if they are modified) Plant parts and components that can derive in a complete individual, including seeds Plant cells capable of regenerating a complete organism

17. MARVAL, O'FARRELL & MAIRAL 17 Patents - Patentable subject matter Proteins Not patentable: Isolated proteins or their fragments, since they are considered to be natural substances Recombinant proteins encoded by a sequence identical to the natural counterpart Patentable: Modified proteins Compositions comprising an isolated protein (even when the sequence is not modified)

18. MARVAL, O'FARRELL & MAIRAL 18 Patents - Patentable subject matter DNA sequences Not patentable: Isolated genes or their fragments: considered to be natural substances Patentable: Modified genes or promoters

19. MARVAL, O'FARRELL & MAIRAL 19 Patents - Patentable subject matter Methods for obtaining plants Not patentable: Essentially biological processes (e.g. process for generating a plant by breeding and selection) Patentable: Biotechnological processes for producing a protein, gene or transgenic organism (eg. recombinant protein production, cloning, transforming methods) Plant Breeding methods with a significant human intervention?

20. MARVAL, O'FARRELL & MAIRAL 20 Patents - Patentable subject matter Diagnostics and gene patenting Not patentable: Medical treatment methods Isolated and/or purified matter Totipotential cells Patentable: In vitro (cultured) human-modified cells

21. MARVAL, O'FARRELL & MAIRAL 21 Patents - Patentable subject matter In re: Pfizer (2013) Pharma case related to selection inventions Selection inventions: Patentable subject matter. A generic disclosure does not affect the novelty of a specific description Support: Allows an obvious generalization of the originally disclosed subject matter. It is possible to amend and include obvious information and examples Possible implications to the biotech industry: 1.Patentable subject matter: Selection of a specific product from a generic disclosure 2.Support: Identity percentages should be allowed

22. MARVAL, O'FARRELL & MAIRAL 22 Patents - Enforcement Biotech patents can be enforced in Argentina Judge – lacks technical background: Scientific evidence of greater importance – Independent expert appointed by the court In re: Syngenta – GA21 Public acknowledgement of infringement Damages License agreement Agreement

23. MARVAL, O'FARRELL & MAIRAL 23 AGENDA 1.Importance of biotech in Argentina 2.Plant variety protection 3.Patents 4.Registration of biotech products 5.Data exclusivity and biotech products 6.Summary

24. MARVAL, O'FARRELL & MAIRAL 24 Registration of biotech products Newly issued regulations for approving biotech products Biological products: Proteins, nucleic acids, sugars or complex combination of such substances, or living entities such as cells or tissues or are derivatives from them, that may be isolated from a variety of natural sources originated from humans, animals or microorganisms, or obtained by biotechnology methods or other technologies, thereby being more complex to characterize, requiring a more detailed description of structure and its manufacturing process Approving a biotech product: 1.First worldwide approval in Argentina 2.Abbreviated approval in Argentina

25. MARVAL, O'FARRELL & MAIRAL 25 Registration of biotech products First worldwide approval in Argentina Full dossier including: 1.Applicant and manufacturer general data, 2.Quality Information 3.Preclinical Information Toxicity studies, toxicological evaluation of pollutants and impurities. 4.Clinical Information Product’s pharmacological properties, pharmacological efficacy and safety. Post-grant surveillance plan and duty of informing any adverse effect Requirements in line with international standards

26. MARVAL, O'FARRELL & MAIRAL 26 Registration of biotech products Abbreviated approval in Argentina The abbreviated procedure is available for products having an equivalent product, which has been commercialized in Argentina or abroad Equivalent products: same qualitative and quantitative composition, therapeutic indication and way of administration Only for products containing well characterized proteins and products manufactured under the same processes General regulation: Product-specific guidelines to be issued

27. MARVAL, O'FARRELL & MAIRAL 27 Registration of biotech products Abbreviated approval in Argentina Abbreviated dossier including: 1.Applicant and manufacturer general data, 2.Quality Information No pre-clinical and clinical information required Post-grant surveillance plan and duty of informing any adverse effect

28. MARVAL, O'FARRELL & MAIRAL 28 AGENDA 1.Importance of biotech in Argentina 2.Plant variety protection 3.Patents 4.Registration of biotech products 5.Data exclusivity and biotech products 6.Summary

29. MARVAL, O'FARRELL & MAIRAL 29 Data Protection Data Protection under the TRIPS Agreement Section 39.3 of the TRIPS Agreement provides: “Members, when requiring, as a condition of approving the marketing of pharmaceutical or of agricultural chemical products which utilize new chemical entities, the submission of undisclosed test or other data, the origination of which involves a considerable effort, shall protect such data against unfair commercial use…”

30. MARVAL, O'FARRELL & MAIRAL 30 Data Protection Data Protection under the Argentine Law Health approval system allows third parties to indirectly rely on confidential information produced by the originator of the product The third party obtains a free ride

31. MARVAL, O'FARRELL & MAIRAL Data Protection 31 Current state of data protection in Argentina Lack of effective data protection In re: Novartis (2011). The Federal Court of Appeals stated, obiter, in a data protection case that the Argentine approval system was not contrary to article 39.3 of the TRIPS Agreement 4 cases still remaining

32. MARVAL, O'FARRELL & MAIRAL 32 AGENDA 1.Importance of biotech in Argentina 2.Plant variety protection 3.Patents 4.Registration of biotech products 5.Data exclusivity and biotech products 6.Summary

33. MARVAL, O'FARRELL & MAIRAL 33 Summary 1.Plant variety protection 1.Currently, inefficient law 2.Bill addressing and correcting some difficulties of the current law 2.Patents 1.Patentable subject matter: Currently, restrictive approach. May change in the future 2.Enforceable patents 3.Registration of Biotech products 1.Newly issued regulations. Allows third party’s free ride 4.Data exclusivity and biotech products 1.Lack of data exclusivity

34. MARVAL, O'FARRELL & MAIRAL 34 Thank you!