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

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

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

44 I. Introduction

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

6 II. Patentability Requirements of Biotechnology Inventions Natural substances Genes, biological pharmaceuticals and biosimilars Cells and living organisms Diagnostic methods and methods of treatment III. Access to genetic resources and the disclosure of origin requirement IV. ANVISA´s role in pharmaceutical patent review V. Patent Prosecution at the BPTO VI. Patent enforcement VII. Conclusions 6 Agenda

7 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 II. Patent Protection of Biotechnology Inventions: Patentability Requirements

8 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 II. Patent Protection of Biotechnology Inventions: Patentability Requirements

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

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

11 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. 11 II. Patent Protection of Biotechnology Inventions: Patentability Requirements

12 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 II. Patent Protection of Biotechnology Inventions: Patentability Requirements

13 I. Introduction II. Patentability Requirements of Biotechnology Inventions Natural substances Genes, biological pharmaceuticals and biosimilars Cells and living organisms Diagnostic methods and methods of treatment III. Access to genetic resources and the disclosure of origin requirement IV. ANVISA´s role in pharmaceutical patent review V. Patent Prosecution at the BPTO VI. Patent enforcement VII. Conclusions 13 Agenda

14 Provisional Act No. 2,186/ 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, 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. Access to Genetic Resources and the Disclosure of Origin Requirement

15 I. Introduction II. Patentability Requirements of Biotechnology Inventions Natural substances Genes, biological pharmaceuticals and biosimilars Cells and living organisms Diagnostic methods and methods of treatment III. Access to genetic resources and the disclosure of origin requirement IV. ANVISA´s role in pharmaceutical patent review V. Patent Prosecution at the BPTO VI. Patent enforcement VII. Conclusions 15 Agenda

16 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. IV. ANVISA ’ s role in pharmaceutical patent review

17 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, Legal uncertainty. IV. ANVISA ’ s role in pharmaceutical patent review

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

19 More & better qualified examiners and prosecutors – stronger patents Increased productivity (approx months once examination begins) Implementation of the e-Patents system ( ) Examination time down to 4 yrs by Higher BPTO fees. Consistent exams - NEW GUIDELINES UNDER PUBLIC CONSULTATION 19 YearExaminersApplications filed Patents Granted Examination time ,8472, ,1413,6178, ,7653, ,7803, V. Patent Prosecution at the BPTO

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

21 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. 21 VI. Patent enforcement

22 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 IV. Patent enforcement

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

24 Growing IP awareness & efficiency 562 PCT applications filed in 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 VII. Conclusions

25 22 Thank you. Obrigada. Leonor Galvão de Botton, Ph.D.