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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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