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Evolving Biotech Patent Landscape in Brazil: Challenges and Opportunities

This document outlines the changing patent landscape for biotechnology in Brazil since the TRIPS agreement implemented in 1995. It highlights the historical context of patenting in the country, with a ban on pharmaceutical and agrochemical product patents until 1945, the criteria for patentability of genetically modified microorganisms, and the limitations on living matter patenting. It discusses ANVISA's role in pharmaceutical patents, the scope of patentable and non-patentable biotechnological inventions in Brazil, and recent regulatory actions impacting the biotech sector.

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Evolving Biotech Patent Landscape in Brazil: Challenges and Opportunities

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  1. Biotech IP issues in Brazil Gustavo Morais May 2011

  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)

  3. Agrochemical patents • Patentability of GM microorganisms and of several inventions involving living matter • Waive of transition periods • Pipeline patents • Criteria for damage calculation

  4. Preliminary injunctions • Civil and criminal penalties against infringers • Infringement by equivalency • Patentterm: 20 years as offilingor 10 yearsfromgrant, whichever expires later • Problem: ANVISA’s intervention – pharmaceutical products and processes

  5. Patent basics • Patentabilitycriteria • Novelty • Inventivestep • Industrial applicability • Enablement • Brazil not a member of Budapest Treaty • Biological material may be filed in any IDA

  6. Notpatentable: Living beingsandpartsthereof, includingcellsevenifmodified TRIPS 27.3(b) allowsexclusionofpatentabilityonly “plantsandanimals” Naturallyoccurringbiologicalmaterial (evenifisolated, purifiedorsynthesized) and natural biologic processes PatentsSubject matter

  7. Notpatentable: • 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. Patentable: • Microorganismsgeneticallymodifiedthroughhumanintervention • Modified DNA/RNA sequencesandgenes • Considered as chemicalcompounds • Anyprocessofgenomemodification

  9. Patentable: • Chemicalcompositionscharacterizedby its intrinsicfeatures, evenifincludingnaturallyoccurringbiological material • Processes for obtaining, isolating, modifying, manufacturingandusingbiologicalmaterialsand living beings • Excepthumans (biosafetylaw)

  10. Polynucleotides epolypeptides • Allowableclaims: • DNA sequencecharacterizedbypresenting ... Sequence • DNA sequencecharacterizedbybeing Seq. ID nº • Recombinantproteincharacterizedbybeing Seq. ID nº • Notallowableclaims: • DNA sequencecharacterizedbycodifyingprotein X • Proteincharacterizedbypresentingactivity Y

  11. Polynucleotides epolypeptides • Naturallyoccuringbiological material – notpatentable • A compositionincludingsuch material maybeif its onlydistinctivefeature is notthepresenceofofthe material • Purifyingandisolationmethods - patentable

  12. Antibodies • Patentable • Monoclonal antibodycharacterizedby its hybridoma • Notpatentable • Polyclonalantibodiessincetheyconsidered a by-productof natural biological processes

  13. Methodsoftreatmentanddiagnosis • Notpatentable per se • Swisstypeclaims • Patentable - methodsofobtaining data outsidethehumanor animal bodysuch as measuringbloodpressure, X-rayexamination, hemograms, etc. • Notpatentable - methodsofdiagnosisperformed in thehumanor animal body (e.g, to determine anallergy)

  14. Stemcells • Notpatentable per se • Patentable - methodsofobtainingstemcellsandusingthem, exceptifmethodoftreatmentordiagnosis

  15. IP in agriculture • Plantsnotpatentable, evenif GM • Onlythe genes • Plantvarietyprotection • Examplesofallowableclaims: • Methodofpestorweedcontrolusingcertainagrochemicalsand/orplants • Process to confer to plantsresistance to XYZ pesticide

  16. Access to Brazilianbiodiversity • 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. Thankyou!Obrigado!gustavo@dannemann.com.br

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