Global Innovation Policy Center

March 15, 2017

Brazil


Primary Sources

  • AGREEMENT ON TRADE AND ECONOMIC COOPERATION BETWEEN THE GOVERNMENT OF THE UNITED STATES OF AMERICA AND THE GOVERNMENT OF THE FEDERATIVE REPUBLIC OF BRAZIL (2011)
  • Decree 4.830, On Compulsory Licenses (2003)
  • Decree 6.041, Política de Desenvolvimento da Biotecnologia, (2007)
  • Decree No 7709, Pharmaceutical preference margins, (2012)
  • Decree No 7713, Pharmaceutical preference margins, (2012)
  • Decree No 8.415, Local content requirements, (2014)
  • Decree No. 2.848, Penal Code (1940)
  • Decree No. 3.201, On Compulsory Licenses (1999)
  • Decree No. 6.759, Regulates the management of customs activities (2009)
  • Draft Decree for Law 12.965 (Marco da Civil), Ministry of Justice, (2016)
  • Draft Internet Bill (2011) EMI Nº 00086 – MJ/MP/MCT/MC
  • Draft IP Law, PROJETO DE LEI N.º 5.402, DE 2013, (2013)
  • Draft Law 5402/2013, Opposition proceedings (2013)
  • INPI Normative Act No. 131, Trademark Registration Procedure (1997)
  • Instituto Nacional da Propriedade Industrial, Diretoria de Patentes, Diretrizes de Exame de Patentes (2002)
  • Instituto Nacional da Propriedade Industrial, Diretoria de Patentes, Diretrizes de Exame de Patentes (2002)
  • Instituto Nacional da Propriedade Industrial, Diretoria de Patentes, Diretrizes de Exame de Pedidos de Patente na Área de Biotecnologia (2015)
  • Instituto Nacional da Propriedade Industrial, Diretoria de Patentes, DIRETRIZES DE EXAME DE PEDIDOS DE PATENTE, Bloco II, Patenteabilidade (2016)
  • JOINT STATEMENT BETWEEN THE GOVERNMENT OF THE UNITED STATES AND THE GOVERNMENT OF THE FEDERATIVE REPUBLIC OF BRAZIL ON PATENT WORK SHARING BETWEEN PATENT OFFICES, Penny Pritzker and AM Neto, June 30 2015
  • JURISPRUDÊNCIA, ANVISA: COMPETÊNCIA PARA ANUIR EM PEDIDOS DE PATENTES, 1006 – ORDINÁRIA/PROPRIEDADE INDUSTRIAL 30 – 0050402-91.2015.4.02.5101 (2015.51.01.050402-4) (PROCESSO ELETRONICO) ABBVIE INC. (ADVOGADO: RJ176183 – CAIO RICHA DE RIBEIRO, RJ133459 – ROBERTA DE MAGALHAES FONTELES CABRAL.) x AGENCIA NACIONAL DE VIGILANCIA SANITARIA – ANVISA. CONCLUSAO Processo: 0050402- 91.2015.4.02.5101 (2015.51.01.050402-4), PIDCC, Aracaju, Ano IV, Volume 09 nº 02, p.329 a 348 Jul/2015
  • Law 10.603, Protection of non-divulged information submitted for approval for the commercialisation of products and other provisions, (2002)
  • Law 12.349, Local preferences, (2010)
  • Law 12.853, Copyright Amendments, (2013)
  • Law 7.735, Biodiversity and biotechnology (2014)
  • Law 8,866, Procurement (1993, 2012)
  • Law No. 10.196, Amendments to the Law on Industrial Property, (2001)
  • Law No. 10.406, Civil Code, (2010)
  • Law No. 10.753, National Book Policy, (2003)
  • Law No. 10.941, Rio 2016 Olympics and Paralympics (2016)
  • Law No. 10.973, Innovation and Research in Science and Technology, (2004, 2010)
  • Law No. 12.035/09, Olympic Act, (2009)
  • Law No. 12.663, General Law of the World Cup, (2012)
  • Law No. 12.965 Principles, Guarantees, Rights and Obligations for the Use of the Internet, (2014)
  • Law No. 13.123, Access and Benefits Sharing of Genetic Resources and Associated Traditional Knowledge, (2015)
  • Law No. 13.565, Rio 2016 Olympics and Paralympics (2016)
  • Law No. 5.648, National Institute of Industrial Property (1998)
  • Law No. 5.869, Code of Civil Procedure (2011)
  • Law No. 9.279, Industrial Property Law (2001)
  • Law No. 9.609, Law on Protection of Intellectual Property of Software, its Commercialization in the Country, and Other Provisions, (1998)
  • Law No. 9.610, Law on Copyright and Neighboring Rights, (1998)
  • Law No. 9.615, General Rules on Sport and other Measures (1998)
  • Law No. 9610, Copyright and Neighboring Rights (1998)
  • Mercosul CMC/DEC. Nº 27/10, “CODIGO ADUANERO DEL MERCOSUR”, Customs Code (2010)
  • Ministério do Planejamento, Desenvolvimento e Gestão, INSTRUÇÃO NORMATIVA No. 01, January 17, Software procurement, (2011)
  • Ordinance 2.531, “Partnerships for Productive Development” (PDPs), (2014)
  • Regulation 55, ANVISA, automatic substitution, (2010)
  • Resolution CMED 2/04, Pharmaceutical pricing policy, (2004)

Secondary Sources

  • ABES Software (2015) “ABES removes more than 36,000 links to websites and ads with access to illegal software downloads in 1st half”, July 16 2015, http://www.abessoftware.com.br/noticias
  • ABRACRO (2015), “New ANVISA Clinical Research Regulations”, April 23 2015
  • ABRASCO (2015) “Clinical Trials and ANVISA, an Inverted Prioritization” , February 24 2015
  • Agencia Brasil EBC (2016), “Brazil to Become Innovation Exporter”, January 14 2016
  • AH Oikawa (2013), “IP Licensing In Brazil: What You Need To Know”, World Intellectual Property Review, June 6 1 2011; and F. Oliveira do Prado et al. (2010), “Technology Transfer In A Public Brazilian University”, Triple Helix in the Development of Cities of Knowledge, Expanding Communities and Connecting Regions, conference proceedings, October 20 2010
  • AIPPI (2009) “Border Measures and other means of Customs Intervention against Infringers”, Question Q208, Brazil, Marcelo Inglez de Souza, Rafael Lacaz Amaral, Elisabeth Kaznar Fekete, March 10 2009
  • AIPPI (2010) “Protection against the dilution of a trade mark”, Q 214, Brazil, Letícia Provedel, Álvaro Loureiro , Adriana Shimabukuro, Deliane Flausino, Renata Hohl, Adriane Bonato
  • AIPPI (2010) “Protection of trade secrets through IPR and unfair competition law”, Q215, Brazil, Elisabeth Kasznar Fekete, Tatiana Campello, Karin Klempp, Marcelo Inglez de Souza, Rafael Lacaz Amaral, Maria Carmen Maria Carmen Britto, Ana Paula Celidonio
  • AIPPI (2011) “Injunctions in cases of infringement of IPRs”, Q 219, Brazil, Rafael Lacaz do Amaral, Marcelo Inglez de Souza, Pedro Barroso, David Rodrigues
  • AIPPI (2012) “Infringement of trademarks by goods in transit”, Q230, Brazil, Mr. Igor D. de ARAÙJO; Mr. Daniel PITANGA BASTOS DE SOUZA
  • AIPPI (2013) “Plain Packaging Questionnaire”, Brazil, August 13 2013
  • AIPPI (2013), “”Relevant public for determining the degree of recognition
    of famous marks, well-known marks and marks with reputation””, Q 234, Laetitia D’HANENS and Alvaro LOUREIRO
  • AIPPI (not dated) “Damages for infringement, counterfeiting and piracy of Trademarks”, Q203, Brazil, Angela FAN CHI KUNG, Claudio Roberto BARBOSA, Flavia MARINA DE BARROS MONTEIRO, Larissa GALIMBERTI, Maitê Cecilia FABBRI MORO, Márcio JUNGUEIRA LEITE, Natália BOVENZO ALVES, Pedro BARROSO and Luiza SATO PEREIRA DIAS
  • AIPPI, “Damages for infringement, counterfeiting and piracy of Trademarks”, Report Q203, Brazil, Angela FAN CHI KUNG, Claudio Roberto BARBOSA, Flavia MARINA DE BARROS MONTEIRO, Larissa GALIMBERTI, Maitê Cecilia FABBRI MORO, Márcio JUNGUEIRA LEITE, Natália BOVENZO ALVES, Pedro BARROSO and Luiza SATO PEREIRA DIAS
  • AIPPI, “The Patentability of Business Methods”, Report Q 158, Brazil, Esther M. FLESCH, Lelio SCHMIDT, Rana GOSAIN, Antonio Mauricio P. Arnaud, Manoel J. Pereira SANTOS and Dirceu P. de Santa ROSA
  • Amaral, RL (2014) “The building blocks of change”, World Trademark Review, June/July 2014
  • ARIBONI, FABBRI, SCHMIDT E ADVOGADOS ASSOCIADOS (2010) INTELLECTUAL PROPERTY PROTECTION IN BRAZIL, Produced for the New Zealand Government, Ministry of Foreign Affairs and Trade
  • Associação Brasileira de Televisão por Assinatura (ABTA) & Sindicato Nacional das Empresas Operadoras de Sistemas de TV por Assinatura (SETA) (2014) “Pesquisa Sobre Furto De Sinal”, slide presentation, August 6 2014
  • Bellingall, AJ (2014) “Brazil prepares for IP battle”, WIPR, April 1 2014
  • Bhering, P and J Maurer (2013) “Brazil”, Latin Lawyer, latinlawyer.com/reference/topics/52/jurisdictions/6/brazil/, April 12 2013
  • Binsfeld, PC (2012) “The use of compulsory license as patent related flexibility – The Brazilian Experience in Health”, WIPO Seminar, Latin America, February 6-8 2012, powerpoint presentation
  • BIO (2012) 2012 Special 301 Submission, Washington DC
  • BIO (2012) BIO Comments on Public Consultation N°66 of October 16, 2012, December 19, 2012, Washington DC
  • BIO (2012), “Proposal for Reform of Brazil’s Bioprospecting and Genetic Resources, Regulations 18 November 2013”
  • BIO (2013) “Comments of the Biotechnology Industry Organization (BIO) to the National Institute of Industrial Property (INPI) of Brazil February 1, 2013 Re: Guidelines for Examination of Patent Applications in Biotechnology”
  • BNDES, Press Room, News, “BNDES approves R$ 250 million for a factory to produce biopharmaceuticals against cancer”, March 19 2014.
  • BNDES, Press Room, News, “BNDES renews Profarma and expands support to biotechnology”, November 4 2011.
  • BRIC Wall (2016), “ Brazilian Patent Office and the Patent Prosecution Highway Program”, February 16 2016
  • BRIC Wall blog (2014), “The Brazilian Patent Office Places The Fight Against The Patent Application Backlog As Its Top Priority”
  • BRIC Wall Blog (2016), “Expediting Patent Prosecution in Brazil”, March 29 2016
  • BSA (2016) “Consulta Pública sobre a Minuta de Decreto que regulamentará a Lei n° 12.965, de 23 de abril de 2014”, February 29 2016
  • C Aboim (2015) “Brazilian Patent Statute under attack: an overview of potential changes (Part V) – ANVISA’s “prior approval” on pharmaceutical patents”, Licks Attorneys, http://lickslegal.com/publications/articles/brazilianpatentstatuteunderattackanoverviewofpotentialchangespartvanvisaspriorapprovalonpharmaceut
  • C Rolli (2015) “Pirataria online causa perda de R$ 800 mi”, Folha De S Paulo, April 1 2015
  • Calliari, MA & L Roriz (2013) “A welcome modernisation of the Brazilian patent office”, WIPR, April 1 2013
  • Ciencia Estado Blogs (2016), “Legal Framework for Science and Technology: What changes in the lives of investigators?”, January 13 2016, http://ciencia.estadao.com.br/blogs/herton-escobar/marco-legal-de-ciencia-e-tecnologia-o-que-muda-na-vida-dos-pesquisadores/
  • Clarke, Modet & Co (2012) “Global Patent Developments A general overview on Brazil”, powerpoint presentation
  • Confederação Nacional de Dirigentes Lojistas (CNDL) & SPC (2016) CONSUMO DE ITENS DE FUTEBOL OFICIAIS X FALSIFICADOS: CRITÉRIOS DE ESCOLHA DO TORCEDOR BRASILEIRO, October 2016
  • Consultor Juridico (2013) “MercadoLivre não precisa verificar origem de produtos”, Noticias, September 14 2013
  • Dannemann Siemsen Bigler & Ipanema Moreira (2009) “Brazil”, World Trademark Review, February/March 2009
  • de Aguiar, RSB (2014) “New rules at the INPI”, WIPR, May 1 2014
  • Del Bianco, A (2013) “Who has never heard of Absolut?”, March 21 2013, Dannemann Siemsen, Website library, articles
  • Deloitte (2015), “2015 Global Survey of R&D Incentives”, October 2015
  • Di Blasi, G “AN OVERVIEW OF PHARMACEUTICAL AND AGROCHEMICAL DATA PROTECTION, Brazilian and Latin American Cases”, Di Blasi, Parente, Vez e Dias & Associados, not dated powerpoint presentation
  • Duff, A (2014) “Nike World Cup Jersey Price Cut 35% as Fakes Abound in Brazil”, Bloomberg, July 7 2014
  • E Kimball (2014), “Brazil: Opportunities and Challenges in Latin America’s Largest Pharmaceutical Market”, Thomson Reuters, July 10 2014
  • Efor Patent (2014) “Effects of the 2014 World Cup Law on Brazilian Trademark Law”, Eforpatent, December 2 2014
  • F Mesquita & L Cotia (2015 “New draft guidelines for patent examination”, WIPR, May 1 2015
  • Fish & Richardson (2008) International trade secrets law, overview
  • Folha de S. Paulo (2014), “Group Launches Initiative to Develop Clinical Trials in Brazil’ (translated), October 2014
  • Gorini, A & RB Carneiro (2010) “Well-known and famous marks: Brazil”, World Trademark Review and Dannemann Siemsen, Website library, articles, February 23 2010
  • IFPMA (2011) Data Exclusivity: Encouraging Development of New Medicines, Geneva
  • IHS (2016), “Brazilian States Increase ICMS Tax on Medicines”, February 19 2016
  • INPI (2015) “Prazo de validade de patente para remédio contra gripe é mantido”, Notícias, Decisão judicial, June 1 2015 http://www.inpi.gov.br/noticias/decisaojudicial
  • INTERNATIONAL INTELLECTUAL PROPERTY ALLIANCE, 2001-2016, “SPECIAL 301 REPORT ON COPYRIGHT PROTECTION AND ENFORCEMENT”, Washington DC
  • IPO & ZCBS (2014) Intellectual Property Guide Brazil 2014, UK IPO, London
  • Israel, C (2012) “Statement of Chris Israel”, Partner American Continental Group (Former U.S. Coordinator for International Intellectual Property Enforcement) before the HOUSE COMMITTEE ON THE JUDICIARY, SUBCOMMITTEE ON INTELLECTUAL PROPERTY, COMPETITION AND THE INTERNET, on “INTERNATIONAL PATENT ISSUES: PROMOTING A LEVEL PLAYING FIELD FOR AMERICAN INDUSTRY ABROAD”, April 26, 2012
  • IT Forum 365 (2016) “Lei de Propriedade Industrial precisa ser atualizada para ampliar proteção ao conhecimento”, June 22 2016
  • L Mueller and R Rodrigues (2014), “Brazil: An Update of the Most Relevant Events for Pharmaceutical Companies in 2014: Part 3 of a 5-Part Series”, BRIC Wall blog, November 28 2014
  • L Tresca (2015) “Um ano de Marco Civil em vigor, um ano sem regulamentação”, Carta Capital, June 23 2015
  • Licks Attorneys (2015) “Court of Appeals decides first mailbox patent cases”, April 28 2015, http://lickslegal.com/publications/articles/courtofappealsdecidesfirstmailboxpatentcases/
  • Licks Attorneys (2015) “Preliminary injunction on infringement of SEPs upheld by Brazil’s Superior Court of Justice (STJ)”, November 26 2015
  • Licks Attorneys (2015) “Rule 44/2015”, translation, (processing of registration applications of industrial design), December 2015
  • Licks Attorneys (2015) “ZTE do Brasil Ltda (Appellant) v. Vringo Infrastructure Inc (Appellee) Superior Court of Justice Third Panel Interlocutory Appeal on Appeal before the Superior Court of Justice # 594.155”, translation, November 13 2015
  • Licks Attorneys (2015), “Brazilian Patent Statute Under Attack: An Overview Of Potential Changes”, part 3, May 2015.
  • Licks Attorneys (2016) “Rule 167/2016”, translation,(fast-track procedure for examination of industrial design registration for sports products) June 2016
  • Licks Attorneys (2016) “The Brazilian PTO (BRPTO) published today Rule # 154/2015 implementing the Patent Prosecution Highway (PPH) Pilot Program limited to the first 150 applications”, January 5 2016
  • Licks Attorneys (2016) “The BRPTO published Rule #169/2016 implementing the Guidelines for the Examination of Patent Applications”, July 26 2016
  • Licks, O & ML Cotia (2014) “The patent backlog for agrichemical inventions”, WIPR, April 1 2014
  • Licks, O (2014) “What to expect in 2014”, WIPR, Feburary 1 2014
  • Licks, O et al (2014) “Pharmaceutical patent holders benefit as judiciary asserts its independence”, International Law Office, Healthcare & Life Sciences – Brazil, April 30 2014
  • LR Castro (2016) “BRPTO stands up to ANVISA for pharmaceuticals”, Larke Modet & Co, March 15 2016
  • LV Mueller (2015) “13th Federal District Court of Rio de Janeiro Holds that ANVISA Can Examine Patentability Requirements of Patent Applications Claiming Pharmaceutical Inventions”, BRIC Wall Blog, Micheal Best & Friedrich LLP, June 26 2015
  • Massalli, F (2014) “STF faz audiencia publica para discutir lei dos direitos autorais”, Agencia Brazil, EBC, March 17 2014
  • Miller, EC (2012) “Patent term extensions and regulatory exclusivities for pharmaceuticals in Asia and South America”, Lexology June 27 2012
  • Moncau, LF & PN Mzukami (2014) “Brazilian Chamber of Deputies Approves Marco Civil Bill”, infojustice.org, March 25 2014
  • MSF (2013) “MSF welcomes Brazil Parliamentary Committee recommendation to reform patent law”, October 9 2013, MSF Press releases
  • Mueller, L et al (2013) “The Problem of Mailbox Patents and Patent Term in Brazil”, BRIC Wall Blog, Micheal Best & Friedrich LLP, October 1 2013
  • Mulrenan, S (2008) “New approaches to protecting software”, Managing IP, AIPPI Congress News, 10 September 2008
  • NATIONAL CONFEDERATION OF INDUSTRY – CNI (2014) Intellectual property: changes in industry and the new agenda, Brasilia
  • Palmer, E (2013) “Brazil to build Protalix a plant as part of sophisticated tech transfer”, FiercePharma Manufacturing, June 20 2013
  • Paranaguá, P (2013) BRAZIL’S PATENT REFORM: INNOVATION TOWARDS NATIONAL COMPETITIVENESS, Center for Strategic Studies and Debates, Câmara dos Deputados, Brasilia
  • Peralta, E (2014) “Brazil Becomes One Of The First To Adopt Internet ‘Bill Of Rights'”, NPR, April 23 2014
  • R Gosain et al (not dated) “Brazil, Legal framework”, Daniel Advogados (overview of industrial design rights)
  • R Nunes (2015) “Brazilian Patent Statute under attack (Part IV) Proposal for pre-grant opposition mechanism in respect of patent applications”, Prevail, Licks Attorneys Monthly Newsletter, June 2015
  • R. Rezaie et al (2008), “Brazilian health biotech—fostering crosstalk between public and private sectors”, Nature Biotechnology, VOLUME 26 NUMBER 6 JUNE 2008
  • Rana Gosain, Daniel Advogados/Intellectual Property Magazine (2014), “The Pharma Saga”, 28 April 2014
  • Rodrigues, W. C. V. & O Soler (2009) “Licença compulsória do efavirenz no Brasil em 2007: contextualização”, Rev Panam Salud Publica. 2009;26(6):553–9.
  • S Perlmutter (2015) “Joint Communique Between U.S. and Brazil on Patent Work Sharing”, Director’s Forum: A Blog from USPTO’s Leadership, July 20 2015
  • Science and Development Network (2006), “Brazil’s innovation law: lessons for Latin America”, August 3 2006
  • Shaver, L (eds) (2008) BRAZIL NEW RESEARCH ON INTELLECTUAL PROPERTY, INNOVATION AND DEVELOPMENT, Information Society Project 2008
  • Sherwood, RM (2008) “Trade Secret Protection: Help for a Treacherous Journey”, Washburn Law Journal, Vol 48
  • Sieverding, M (2008) “Choice in Government Software Procurement: A Winning Combination”, Journal of Public Procurement,Vol 8, Issue 1, 70-87
  • thepharmaletter (2013), “BNDES invests 804 million real in Novartis’ new Brazil biotechnology unit”, December 7 2013.
  • Thomson Reuters (2010) The grown-up BRIC, innovation & brand expansion in Brazil, London
  • UKIPO & UK Trade & Investment (2008) “Intellectual Property Rights Primer for Brazil”, June 2008, London
  • Werner, J (2014) “Doing battle on and off the pitch, A review of IP disputes in Brazil during the FIFA World Cup and the lessons learnt.” World Trademark Review, October 2014
  • World Customs Organization (2014) “THOUSANDS OF FAKE SPORTING GOODS INTERCEPTED AHEAD OF 2014 WORLD CUP”, WCO IPM Website, http://ipmpromo.wcoomdpublications.org/Contents/Item/Display/460
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