XVIII International AIDS Conference


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Challenging pharmaceutical patent strategies to improve access to ARVs in Brazil: the case of tenofovir

Presented by Francisco Viegas Neves da Silva (Brazil).

F. Viegas Neves da Silva1, R. Reis2, M. Fogaça Vieira3, V. Terto Jr.4, M.C. Pimenta5

1ABIA - Brazilian Interdisciplinary AIDS Association, Working Group of Intellectual Property, Rio de Janeiro, Brazil, 2Brazilian Interdisciplinary AIDS Association ABIA, Working Group of Intellectual Property, Rio de Janeiro, Brazil, 3Conectas Human Rights, Justice Program, São Paulo, Brazil, 4Brazilian Interdisciplinary AIDS Association, General Coordination, Rio de Janeiro, Brazil, 5Brazilian Interdisciplinary AIDS Association ABIA, General Coordination, Rio de Janeiro, Brazil

Issues: Tenofovir is an ARV used in Brazil to treat approximately 20,000 patients. Tenofovir original patent application is for its salt (tenofovir disoproxil fumarate - TDF). It was filed by Gilead Sciences in 1998 (PI9811045- 4 - US5,935,946) and was denied by the Brazilian Patent Office (INPI) in June 2009 because it lacked inventiveness. Although the original patent application was dismissed, Gilead filed a divisional patent application for TDF (PI9816239-0) in July of 2008 - that still has not been examined - aiming to prolong lifespan of patent protection for their product (Viread®). Both these practices are considered anticompetitive because they intend to extend undue monopolies from pharmaceutical companies by delaying the generic entry. This kind of practice was denounced in the Final Report of the European Commission on its competition inquiry into the pharmaceutical sector (2009).
Description: The Brazilian Working Group of Intellectual Property (a network of NGOs) presented a pre-grant opposition petition in December 2006 to the original TDF patent application based on lack of inventiveness. In November 2009, a second pre-grant opposition was presented against the divisional patent application of TDF because it did not fulfill the Brazilian IP Law divisional requirements and because Gilead presented new claims that weren't present in the original patent application.
Lessons learned: It is important to advocate avoiding adoption of different anticompetitive strategies that cause delay in the access to generic versions of medicines. A multisectorial social watch is important to monitor the patent granting process, in order to prevent abuses.
Next steps: The Brazilian civil society will continue to monitor the anticompetitive practices of pharmaceutical companies that impact the access to medicines. More pressure will be put on Brazilian Antitrust Authority (SDE) to control practices such as this, as well as social mobilization and public debate around this issue will be reinforced.

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