1. © 2011 Dannemann Siemsen. Todos os direitos reservados. Biotech IP issues in Brazil Gustavo Morais May 2011 Gustavo Morais May 2011

2. © 2011 Dannemann Siemsen. Todos os direitos reservados. 2 Brazil - Patents Changing scenario  No pharmaceutical and agrochemical patents (products) as of 1945 (processes excluded as of 1969)  No provisions concerning living matter  TRIPS - Jan 1, 1995  IP Law Nº 9,279 of May 14, 1996 (IPL)  No pharmaceutical and agrochemical patents (products) as of 1945 (processes excluded as of 1969)  No provisions concerning living matter  TRIPS - Jan 1, 1995  IP Law Nº 9,279 of May 14, 1996 (IPL)

3. © 2011 Dannemann Siemsen. Todos os direitos reservados. 3  Agrochemical patents  Patentability of GM microorganisms and of several inventions involving living matter  Waive of transition periods  Pipeline patents  Criteria for damage calculation  Agrochemical patents  Patentability of GM microorganisms and of several inventions involving living matter  Waive of transition periods  Pipeline patents  Criteria for damage calculation

4. © 2011 Dannemann Siemsen. Todos os direitos reservados. 4  Preliminary injunctions  Civil and criminal penalties against infringers  Infringement by equivalency  Patent term: 20 years as of filing or 10 years from grant, whichever expires later  Problem: ANVISA’s intervention – pharmaceutical products and processes  Preliminary injunctions  Civil and criminal penalties against infringers  Infringement by equivalency  Patent term: 20 years as of filing or 10 years from grant, whichever expires later  Problem: ANVISA’s intervention – pharmaceutical products and processes

5. © 2011 Dannemann Siemsen. Todos os direitos reservados. 5  Patentability criteria  Novelty  Inventive step  Industrial applicability  Enablement  Brazil not a member of Budapest Treaty  Biological material may be filed in any IDA  Patentability criteria  Novelty  Inventive step  Industrial applicability  Enablement  Brazil not a member of Budapest Treaty  Biological material may be filed in any IDA Patent basics

6. © 2011 Dannemann Siemsen. Todos os direitos reservados. 6 Patents Subject matter  Not patentable :  Living beings and parts thereof, including cells even if modified  TRIPS 27.3(b) allows exclusion of patentability only “plants and animals”  Naturally occurring biological material (even if isolated, purified or synthesized) and natural biologic processes

7. © 2011 Dannemann Siemsen. Todos os direitos reservados. 7  Not patentable :  Therapeutic, surgical and diagnostic methods applied to human or animal bodies  Discoveries as opposed to inventions  Genetic Use Restriction Technologies (GURTs)  Crime to use, sell, register, patent and license  Not patentable :  Therapeutic, surgical and diagnostic methods applied to human or animal bodies  Discoveries as opposed to inventions  Genetic Use Restriction Technologies (GURTs)  Crime to use, sell, register, patent and license

8. © 2011 Dannemann Siemsen. Todos os direitos reservados. 8  Patentable:  Microorganisms genetically modified through human intervention  Modified DNA/RNA sequences and genes  Considered as chemical compounds  Any process of genome modification  Patentable:  Microorganisms genetically modified through human intervention  Modified DNA/RNA sequences and genes  Considered as chemical compounds  Any process of genome modification

9. © 2011 Dannemann Siemsen. Todos os direitos reservados. 9  Patentable:  Chemical compositions characterized by its intrinsic features, even if including naturally occurring biological material  Processes for obtaining, isolating, modifying, manufacturing and using biological materials and living beings  Except humans (biosafety law)  Patentable:  Chemical compositions characterized by its intrinsic features, even if including naturally occurring biological material  Processes for obtaining, isolating, modifying, manufacturing and using biological materials and living beings  Except humans (biosafety law)

10. © 2011 Dannemann Siemsen. Todos os direitos reservados. 10 Polynucleotides e polypeptides  Allowable claims:  DNA sequence characterized by presenting... Sequence  DNA sequence characterized by being Seq. ID nº  Recombinant protein characterized by being Seq. ID nº  Not allowable claims:  DNA sequence characterized by codifying protein X  Protein characterized by presenting activity Y  Allowable claims:  DNA sequence characterized by presenting... Sequence  DNA sequence characterized by being Seq. ID nº  Recombinant protein characterized by being Seq. ID nº  Not allowable claims:  DNA sequence characterized by codifying protein X  Protein characterized by presenting activity Y

11. © 2011 Dannemann Siemsen. Todos os direitos reservados. 11 Polynucleotides e polypeptides  Naturally occuring biological material – not patentable  A composition including such material may be if its only distinctive feature is not the presence of of the material  Purifying and isolation methods - patentable  Naturally occuring biological material – not patentable  A composition including such material may be if its only distinctive feature is not the presence of of the material  Purifying and isolation methods - patentable

12. © 2011 Dannemann Siemsen. Todos os direitos reservados. 12 Antibodies  Patentable  Monoclonal antibody characterized by its hybridoma  Not patentable  Polyclonal antibodies since they considered a by-product of natural biological processes  Patentable  Monoclonal antibody characterized by its hybridoma  Not patentable  Polyclonal antibodies since they considered a by-product of natural biological processes

13. © 2011 Dannemann Siemsen. Todos os direitos reservados. 13 Methods of treatment and diagnosis  Not patentable per se  Swiss type claims  Patentable - methods of obtaining data outside the human or animal body such as measuring blood pressure, X-ray examination, hemograms, etc.  Not patentable - methods of diagnosis performed in the human or animal body (e.g, to determine an allergy)  Not patentable per se  Swiss type claims  Patentable - methods of obtaining data outside the human or animal body such as measuring blood pressure, X-ray examination, hemograms, etc.  Not patentable - methods of diagnosis performed in the human or animal body (e.g, to determine an allergy)

14. © 2011 Dannemann Siemsen. Todos os direitos reservados. 14 Stem cells  Not patentable per se  Patentable - methods of obtaining stem cells and using them, except if method of treatment or diagnosis  Not patentable per se  Patentable - methods of obtaining stem cells and using them, except if method of treatment or diagnosis

15. © 2011 Dannemann Siemsen. Todos os direitos reservados. 15 IP in agriculture  Plants not patentable, even if GM  Only the genes  Plant variety protection  Examples of allowable claims:  Method of pest or weed control using certain agrochemicals and/or plants  Process to confer to plants resistance to XYZ pesticide  Plants not patentable, even if GM  Only the genes  Plant variety protection  Examples of allowable claims:  Method of pest or weed control using certain agrochemicals and/or plants  Process to confer to plants resistance to XYZ pesticide

16. © 2011 Dannemann Siemsen. Todos os direitos reservados. 16 Access to Brazilian biodiversity  Authorization to access GRs and associated TK  Indication of source in patent applications filed as of 2007  Components of genetic heritage x biological resources  Recent PTO office actions and fines imposed on companies  Authorization to access GRs and associated TK  Indication of source in patent applications filed as of 2007  Components of genetic heritage x biological resources  Recent PTO office actions and fines imposed on companies

17. © 2011 Dannemann Siemsen. Todos os direitos reservados. Thank you! Obrigado! gustavo@dannemann.com.br