The National Association of Manufacturers’s (NAM) submission (7 February 2014, USTR-2013-0040) to USTR’s 2014 Special 301 Review expressed concerns with aspects of Brazilian IPR policy including patent backlogs, ANVISA’s role in reviewing patents for pharmaceuticals, protection of test data for pharmaceuticals and Brazil’s role in WIPO advancing the use of compulsory licensing and requesting WIPO to develop a manual on the use of exceptions and limitations to the rights conferred by patents.
Brazil
Manufacturers continue to face significant challenges in Brazil, including significant patent backlogs, patentability review by non-intellectual property agencies and discriminatory application of data protection. Brazil’s patent office, INPI, has taken steps to reduce patent approval delays, but additional resources and actions are needed. Delays in excess of ten years still exist and may undermine otherwise valid patent rights and incentives for companies to bring innovative products to Brazil.
Brazil’s health regulatory agency, ANVISA, currently is authorized to review and approve all patent applications for pharmaceutical products. Their review is in addition to and given equal weight as INPI examination. However, ANVISA does not limit its role to review of potential sanitary risks but also reviews patentability requirements. ANVISA and INPI also do not apply the same patentability review standards. This “dual examination” creates considerable uncertainty and appears to be incompatible with Brazil’s TRIPS obligations.
INPI’s role in approving all IPR licensing and technology transfer agreements potentially impinges on the freedom of companies to contract freely for goods and services and may result in the destruction of trade secrets.14 Brazil does not provide data protection to all sectors. Although Brazil has enacted federal laws to ensure adequate data protection for veterinary and crop products, it still does not provide for adequate regulatory data protection for pharmaceuticals.
A recent study by the Center for Strategic Studies and Debates of the Brazilian Chamber of Deputies raises serious concerns about the future direction of Brazil’s IPR policy. Among other things, it recommends new limitations on patent terms and proposes expanding the use of compulsory licensing to promote local production.15 Brazil is advancing such proposals in domestic legislation and international forums. For years, it has blocked discussions on patent quality and pushed WIPO to create a manual on how to use patent exceptions and limitations.16
14 The 1970’s-era law that established INPI (Law 5648/70) also granted authority to approve licensing and technology transfer agreements. That authority was eliminated in 1996, but INPI continues to interfere.
15 Center for Strategic Studies and Debates, Brazil’s Patent Reform: Innovation towards National Competitiveness, July 2013.
16 See, for example, Proposal from Brazil to the World Intellectual Property Organization, Standing Committee on the Law of Patents, Fourteenth Session, January 2010