1. Protection of biotechnology innovations in Brazil Leonor Galvão de Botton, Ph.D. AIPLA Spring Meeting May, 2013

2. 2 I. Introduction II. Plant Varieties Protection III. Patent Protection of Biotechnology Inventions Patentability Requirements Natural substances Genes, biological pharmaceuticals and biosimilars Cells and living organisms Diagnostic methods and methods of treatment Access to genetic resources and the disclosure of origin requirement ANVISA´s role in pharmaceutical patent review Patent Prosecution at the BPTO IV. Patent enforcement V. Conclusions 2 Agenda

3. 3 I. Introduction II. Plant Varieties Protection III. Patent Protection of Biotechnology Inventions Patentability Requirements Natural substances Genes, biological pharmaceuticals and biosimilars Cells and living organisms Diagnostic methods and methods of treatment Access to genetic resources and the disclosure of origin requirement ANVISA´s role in pharmaceutical patent review Patent Prosecution at the BPTO IV. Patent enforcement V. Conclusions 3 Agenda

4. 44 I. Introduction

5. 55 International Monetary Fund, 2010.

6. 6 International Treaties UPOV Convention (1978) Paris Convention - 1883 Patent Cooperation Treaty - 1978 TRIPS Agreement Brazilian IP Laws & Regulations Plant Variety Protection Law No. 9.456/1997 Industrial Property Law 9.279/1996 Law 10.196/2001, Regulas ANVISA´s role in pharmaceutical patent review Provisional Act 2.186/2001, Regulates the Convention on Biological Diversity BPTO Normative Act 127 6 I. Introduction

7. 7 II. Plant Varieties Protection III. Patent Protection of Biotechnology Inventions Patentability Requirements Natural substances Genes, biological pharmaceuticals and biosimilars Cells and living organisms Diagnostic methods and methods of treatment Access to genetic resources and the disclosure of origin requirement ANVISA´s role in pharmaceutical patent review Patent Prosecution at the BPTO IV. Patent enforcement V. Conclusions 7 Agenda

8. 8 Legislation Industrial Property Law, No. 9,279/96: According to article 18 (III), do not allow the patentability of plants, in whole or in parts, natural or transgenic: “ Article 18 - The following are not patentable (…): III - living beings, in whole or in part, except transgenic micro-organisms meeting the three patentability requirements - novelty, inventive activity and industrial application – provided for in article 8 and which are not mere discoveries ”. Plant Variety Protection Law, No. 9.456/97 Member of the International Union for the Protection of New Varieties of Plants (UPOV), version of 1978. “ Essentially Derived Plant Variety ” : concept derived from the 1991 UPOV Act. 8 II. Plant Varieties Protection

9. 9 Subject Matter of Protection Right of Protection 9 To be susceptible of protection, the plant variety must be new, homogeneous, and stable; it must have its own denomination and distinctiveness and it must be useful. The protection shall afford its holder the right to commercial reproduction on the territory of Brazil, third parties being prohibited during the term of protection from producing for commercial purposes, offering for sale or marketing propagating material of the plant variety without his authorization. II. Plant Varieties Protection

10. 10 Plant Variety Protection Application Plant Variety Protection Certificate; The National Service for Plant Variety Protection – SNPC 10 Term of Protection 18 years15 years Grapevines, fruit trees, forestal trees and ornamental trees, including, in each case, their graft- holder Other plant varieties II. Plant Varieties Protection

11. 11 I. Introduction II. Plant Varieties Protection III. Patent Protection of Biotechnology Inventions Patentability Requirements Natural substances Genes, biological pharmaceuticals and biosimilars Cells and living organisms Diagnostic methods and methods of treatment Access to genetic resources and the disclosure of origin requirement ANVISA´s role in pharmaceutical patent review Patent Prosecution at the BPTO IV. Patent enforcement V. Conclusions 11 Agenda

12. 12 Natural substances Article 10 of the Brazilian Industrial Property Law: “ The following are not considered to be inventions or utility models: (…) IX - natural living beings, in whole or in part, and biological material, including the genome or germ plasm of any natural living being, when found in nature or isolated therefrom, and natural biological processes ”. New bill (4,961/05) by House of Representatives to allow the patenting of natural substances isolated from nature -> File now! 12 III. Patent Protection of Biotechnology Inventions: Patentability Requirements

13. 13 Genes, biological pharmaceuticals and biosimilars Natural substances even if purified and isolated: not allowed. Synthetic polynucleotides, polypeptides and antibodies: allowed. If structure is not known, the compound may be defined in terms of its physical, chemical or biological properties. % homology and ability to hybridize under certain conditions: objected due to insufficient disclosure/lack of enablement Recombinant DNA structures and vectors: allowed. Compositions comprising natural substances: allowed. Need to define components of the vector/composition: limiting 13 III. Patent Protection of Biotechnology Inventions: Patentability Requirements

14. 14 Cells and living organisms “ Art. 10 of the Brazilian Industrial Property Law – The following are not considered to be inventions or utility models: (…) IX - natural living beings, in whole or in part, and biological material, including the genome or germ plasm of any natural living being, when found in nature or isolated therefrom, and natural biological processes ”. “ Article 18 of the Brazilian Industrial Property Law - The following are not patentable (…): III - living beings, in whole or in part, except transgenic microorganisms meeting the three patentability requirements - novelty, inventive activity and industrial application – provided for in article 8 and which are not mere discoveries ”. “ Sole Paragraph – For the purposes of this law, transgenic microorganisms are organisms, except the whole or part of plants or animals, that exhibit, due to direct human intervention in their genetic composition, a characteristic that can not normally be attained by the species under natural conditions ”. III. Patent Protection of Biotechnology Inventions: Patentability Requirements

15. 15 Cells and living organisms Modified microorganisms/ microorganism cells: allowed. Plant/animal cells: are not considered microorganisms and are not allowed. Modified animals /plants: not allowed. Processes of modifying and producing microorganisms, plants and animals and their cells are allowed (not human cells or embryos). Host cells: the same considerations used for microorganisms, excluding plant/animal cells from patentability. III. Patent Protection of Biotechnology Inventions: Patentability Requirements

16. 16 Diagnostic methods, methods of treatment and medical uses Methods of surgical, therapeutic or diagnostic treatment applicable to the human body or to animals : not allowed. Products destined to put methods into practice: allowed. Methods outside the body and/or non-therapeutic: allowed. 1 st and 2 nd medical uses allowed as Swiss-type if inserted into the claim set prior to the request for examination. 16 III. Patent Protection of Biotechnology Inventions: Patentability Requirements

17. 17 Patentability of Biotechnology Inventions Compound X isolated from nature (gene, protein, antibody etc). Modified DNA, RNA, gene, protein, antibody, vector, etc. Vaccines, medicaments, formulations comprising natural compounds Natural biological processes Processes to isolate, modify and synthesize natural substances Use of gene, protein or compound X isolated from nature (non-therapeutic) Modified microorganisms/ microorganism cells Modified animals/plants or their cells Processes of modifying and producing microorganisms Processes of modifying and producing plants and animals Surgical, therapeutic, diagnostic methods applic. to the human body or animals First and second medical use – Swiss-type claim Allowed Allowed with restrictions Not allowed III. Patent Protection of Biotechnology Inventions: Patentability Requirements

18. 18 I. Introduction II. Plant Varieties Protection III. Patent Protection of Biotechnology Inventions Patentability Requirements Natural substances Genes, biological pharmaceuticals and biosimilars Cells and living organisms Diagnostic methods and methods of treatment Access to genetic resources and the disclosure of origin requirement ANVISA´s role in pharmaceutical patent review Patent Prosecution at the BPTO IV. Patent enforcement V. Conclusions 18 Agenda

19. 19 Provisional Act No. 2,186/2001 - Regulates the CBD. Determines the need for Access Authorization & benefit sharing. If access was contrary to the PA patent rights may be null. BPTO´s resolution 207 /2009 Retroactive for applications filed after June 30, 2000. No BPTO fee. Office actions issued for all applications in relevant classes Must inform origin of the genetic material and associated traditional knowledge and corresponding Access Authorization number issued by CGEN. Information provided preferably in the start of examination. Legal uncertainty: Brazilian mango bought at Walmart? New bill being proposed – less sanctions = more benefit sharing. III. Patent Protection of Biotechnology Inventions: Disclosure of Origin Requirement

20. 20 I. Introduction II. Plant Varieties Protection III. Patent Protection of Biotechnology Inventions Patentability Requirements Natural substances Genes, biological pharmaceuticals and biosimilars Cells and living organisms Diagnostic methods and methods of treatment Access to genetic resources and the disclosure of origin requirement ANVISA´s role in pharmaceutical patent review Patent Prosecution at the BPTO IV. Patent enforcement V. Conclusions 20 Agenda

21. 21 Art. 229-C of IP Law 9.279/96 states that: “ The grant of patents to pharmaceutical products and processes will depend on the previous approval of the National Health Surveillance Agency (ANVISA). ” Interministerial Working Group Decision (May/2012): “ Prior allowance should occur even before the BPTO examination. Procedure BPTO/ANVISA 1. BPTO will exam the formal aspects. 2. Files go to ANVISA for the technical examination. 3. Files return to the BPO for patenteabilty examination. 4. If the ANVISA does not allow the granting of the application, the BPTO will not exam it, and will publish its shelving. III. Patent Protection of Biotechnology Inventions: ANVISA ’ s role in pharmaceutical patent review

22. 22 Federal Attorney General ’ s legal opinion (Jan/2011): “ ANVISA ’ s responsibility is to proceed with the analysis of the sanitary risks of the patented drug to the health. ” Resolution – RDC nº 21 of April 10, 2019 "The patent application is deemed contrary to public health in 2 cases: If the claimed pharmaceutical product or process presents a health risk; If the pharmaceutical product or process refer to substances included in the Brazilian National List of Essential Medicines (RENAME) or are declared of interest for the medicine policies within the Unified Health System (SUS) through an Ordinance of the Ministry of Health." Controversies in the public hearing of March 20, 2013. Legal uncertainty. III. Patent Protection of Biotechnology Inventions: ANVISA ’ s role in pharmaceutical patent review

23. 23 I. Introduction II. Plant Varieties Protection III. Patent Protection of Biotechnology Inventions Patentability Requirements Natural substances Genes, biological pharmaceuticals and biosimilars Cells and living organisms Diagnostic methods and methods of treatment Access to genetic resources and the disclosure of origin requirement ANVISA´s role in pharmaceutical patent review Patent Prosecution at the BPTO IV. Patent enforcement V. Conclusions 23 Agenda

24. 24 More & better qualified examiners and prosecutors – stronger patents Increased productivity (approx. 12-18 months once examination begins) Implementation of the e-Patents system (2011-2013) Examination time down to 4 yrs by 2016. Higher BPTO fees. Consistent exams - NEW GUIDELINES UNDER PUBLIC CONSULTATION 24 YearExaminersApplications filed Patents Granted Examination time 200511221,8472,81910 201025328,1413,6178,1 201125331,7653,801- 201232033,7803,137- 2015600--4 III. Patent Protection of Biotechnology Inventions: Patent Prosecution at the BPTO

25. 25 I. Introduction II. Plant Varieties Protection III. Patent Protection of Biotechnology Inventions Patentability Requirements Natural substances Genes, biological pharmaceuticals and biosimilars Cells and living organisms Diagnostic methods and methods of treatment Access to genetic resources and the disclosure of origin requirement ANVISA´s role in pharmaceutical patent review Patent Prosecution at the BPTO IV. Patent enforcement V. Conclusions 25 Agenda

26. 26 Legal proceedings are regulated by the Brazilian Civil Procedure Code. No distinction as to the procedure of lawsuits involving patents or other IP rights. IP Law is recent and there is a limited number of granted patents, comparing to the United States or Europe. Brazil is a civil law country, i.e. Court precedents are not binding. Any patent litigation precedents are more a directive and/or interpretation concept than an actual source of law. Patent infringment lawsuits are filed before the State Court. Patent nullitylawsuits are filed before the Federal Court. Infringement and Nullity actions may not be litigated together. 26 IV. Patent enforcement

27. 27 Specialised IP Courts Better qualified judges and technical experts. Federal and State IP courts in Rio de Janeiro. Increase in Patent Nullity Actions Patents that are granted without meeting all legal and formal requirements; Nullity of the patent may be partial (i.e. only certain claims are null). Claim may not be re-written. Increase in Patent Infringement Actions Infringement acts (literal and by equivalence); Indirect infringement acts. Effective remedies Injunctions Cessation of the infringement (daily penalty); Destruction of the products; Loss and damages compensation, ex: loss of profits. 27 IV. Patent enforcement

28. 28 I. Introduction II. Plant Varieties Protection III. Patent Protection of Biotechnology Inventions Patentability Requirements Natural substances Genes, biological pharmaceuticals and biosimilars Cells and living organisms Diagnostic methods and methods of treatment Access to genetic resources and the disclosure of origin requirement ANVISA´s role in pharmaceutical patent review Patent Prosecution at the BPTO IV. Patent enforcement V. Conclusions 28 Agenda

29. 29 Growing IP awareness & efficiency 562 PCT applications filed in 2012. Improved prosecution, backlog etc. Improved IP enforcement. Less conservative legislative trends Bill (4,961/05) – Patentability of natural substances. Reduction ANVISA ’ s role in pharmaceutical patent review. Brazil ’ s boom is driving the need for an improved IP system 29 V. Conclusions

30. 30 22 Thank you. Obrigada. Leonor Galvão de Botton, Ph.D. leonor.galvao@murtagoyanes.com.br