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Biotech IP issues in Brazil

Biotech IP issues in Brazil. Gustavo Morais May 2011. 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

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Biotech IP issues 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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