The National Institute on Industrial Property (INPI, acronym in Portuguese) published on June 30th the patent rejection for Tenofovir (Viread), produced by Gilead, which is used for HIV/AIDS treatment. According to data from the Ministry of Health’s STD and AIDS Department, Tenofovir accounts for 14,94% of the budget for the purchase of antiretrovirals (ARVs), being one of the most expensive medicines for treatment. The Brazilian government had already declared its public interest in Tenofovir in April 2008, considering it to be an essential drug.

Not only have Tenofovir’s active pharmaceutical ingredient and its antiretroviral activity been known since 1985, but also the additional patent applications filed by Gilead do not fulfill the requirements of inventiveness and novelty – basic requirements for the grant of a patent in Brazil. The application for Tenofovir’s patent in Brazil has been contested by several civil society organizations, members of the Working Group on Intellectual Property (GTPI) of REBRIP and also by Farmanguinhos (Technological Institute in Medicines) of the Oswaldo Cruz Foundation since 2006. The laboratory as well as civil society organizations presented arguments to support INPI’s examination, pointing out the problems in the patent application and the grant’s potential impact on the sustainability of the universal access to ARVs policy.

The rejection of a patent that does not fulfill the legal requirements is an important achievement for society as a whole because it prevents a single company from having exclusive rights for 20 years. With the decision adopted by INPI, the country gains the option to buy affordable generic versions through importation or through local production.

In India, the Tenofovir patent is also being contested by civil society organizations. In 2008, The Indian NGO Sahara Centre for Residential Care & Rehabilitation (SAHARA) and the Brazilian Interdisciplinary Association for AIDS (ABIA) submitted a pre-granted opposition in India against the grant of two other patent applications for Tenofovir, based on the arguments that this medicine is a known compound and should not be considered an invention according to the Indian Patent Law. These patents, contested in India and Brazil, have also been contested in the USA and the USPTO have also published decisions against its granting.

Tenofovir’s case is a clear example of how the patent system is being used by companies to obtain unjustified monopolies of essential products. Even if these products do not fulfill the minimum requirements for a patent grant, the mere expectation of a grant denotes a monopoly and has made the purchase of affordable versions through the public health system unviable. Utilizing this strategy, the pharmaceutical company Gilead, on July 10th, 2008, filed a divison patent application for Tenofovir, which had been previously deferred (PI9816239-0). The application not yet been analyzed by the INPI. It is expected that this application will not be granted , reinforcing the sustainability of the national policy on universal access to ARVs.

For more information: + 55 21 22231040 (Renata Reis). E-mail: abia at abiaids.org.br .