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The Evolving Landscape of Biotech Intellectual Property in Brazil

This analysis explores the complexities of biotechnology intellectual property (IP) rights in Brazil, tracing historical changes and current legal frameworks. It highlights Brazil's prohibition of pharmaceutical and agrochemical patents since 1945, the impact of the TRIPS agreement since 1995, and the evolution of IP Law No. 9,279. Key topics include patentability criteria for genetically modified microorganisms, issues surrounding ANVISA's intervention, the implications of non-member status to the Budapest Treaty, and limitations on patentability regarding living organisms.

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The Evolving Landscape of Biotech Intellectual Property in Brazil

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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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