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Patent protection of biotechnology inventions in Brazil. Leonor Galvão de Botton, Ph.D . AIPLA Webinar June 27, 2013. Agenda. Introduction Patentability Requirements of Biotechnology Inventions Natural substances Genes, biological pharmaceuticals and biosimilars

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Patent protection of biotechnology inventions in Brazil


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    1. Patent protection of biotechnology inventions in Brazil Leonor Galvão de Botton, Ph.D. AIPLA Webinar June 27, 2013

    2. Agenda • Introduction • Patentability Requirements of Biotechnology Inventions • 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 • Patent enforcement • Conclusions 2

    3. Agenda • Introduction • Patentability Requirements of Biotechnology Inventions • 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 • Patent enforcement • Conclusions 3

    4. I. Introduction 4

    5. I. Introduction 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 5

    6. Agenda • Introduction • Patentability Requirements of Biotechnology Inventions • 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 • Patent enforcement • Conclusions 6

    7. II. Patent Protection of Biotechnology Inventions:Patentability Requirements 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! 7

    8. II. Patent Protection of Biotechnology Inventions:Patentability Requirements 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 8

    9. II. Patent Protection of Biotechnology Inventions:Patentability Requirements 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”. 9

    10. II. Patent Protection of Biotechnology Inventions:Patentability Requirements 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. 10

    11. II. Patent Protection of Biotechnology Inventions:Patentability Requirements 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. • 1st and 2nd medical uses allowed as Swiss-type if inserted into the claim set prior to the request for examination. 11

    12. II. Patent Protection of Biotechnology Inventions:Patentability Requirements Allowed Allowed with restrictions Not allowed 12

    13. Agenda • Introduction • Patentability Requirements of Biotechnology Inventions • 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 • Patent enforcement • Conclusions 13

    14. III. Access to Genetic Resources and the Disclosure of Origin Requirement • 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. 14

    15. Agenda • Introduction • Patentability Requirements of Biotechnology Inventions • 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 • Patent enforcement • Conclusions 15

    16. IV. ANVISA’s role in pharmaceutical patent review • Art. 229-C of IP Law 9.279/96 states that: • “The grant of patents to pharmaceutical products and processes willdepend 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 • BPTO will exam the formal aspects. • Files go to ANVISA for the technical examination. • Files return to the BPO for patenteabilty examination. • If the ANVISA does not allow the granting of the application, the BPTO will not exam it, and will publish its shelving. 16

    17. IV. ANVISA’s role in pharmaceutical patent review • 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, 2013 • "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. 17

    18. Agenda • Introduction • Patentability Requirements of Biotechnology Inventions • 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 • Patent enforcement • Conclusions 18

    19. V. Patent Prosecution at the BPTO • 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 19

    20. Agenda • Introduction • Patentability Requirements of Biotechnology Inventions • 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 • Patent enforcement • Conclusions 20

    21. VI. Patent enforcement • 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 lawsuitsare filed before the State Court. • Patent nullitylawsuits are filed before the Federal Court. • Infringement and Nullity actions may not be litigated together. 21

    22. IV. Patent enforcement 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. 22

    23. Agenda • Introduction • Patentability Requirements of Biotechnology Inventions • 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 • Patent enforcement • Conclusions 23

    24. VII. Conclusions 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 24

    25. Thank you. Obrigada. Leonor Galvão de Botton, Ph.D. leonor.galvao@murtagoyanes.com.br 22 25