Brajilian Patent office rejects patentof Gilead on HIV drug

The Brazilian Patent Office has rejected a patent application filed by Gilead Sciences for its Viread medication (Generic name tenofovir disoproxil fumarate [TDF]). This is the first time that a patent related to an antiretroviral (ARV) medicine has been rejected as a result of a pre-grant opposition in Brazil And Doctors Without Borders (DWB) is saying the move could increase access to a key AIDS drug across the developing world.

Tido von Schoen-Angier, executive director of DWB’s Access Campaign, says in a statement that Viread “is a cornerstone drug, recommended by the World Health Organization both for patients starting treatment and for those whose medications aren’t working anymore. In the past, Brazil’s production of anti-retroviral drugs has helped to bring down prices of ARVs globally. We hope this will happen again.”

According to the non-profit, Viread can now be made by Brazilian generic companies or imported from abroad. Around 31,000 people currently receive Viread through Brazil’s universal AIDS treatment program, and an estimated 37,000 by the end of 2008, which would translate into considerable savings. Companies in India make a WHO-approved version for $158 for one patient’s yearly treatment, compared to the $1,387 charged by Gilead in Brazil.

A Gilead spokeswoman says that this patent has been issued in countries around the world, including most recently in China, and has been reissued in the United States following a thorough evaluation during the re-examination process that the U.S. Patent and Trademark Office concluded earlier this year. We remain confident in the strength of our intellectual property for Viread and plan to vigorously defend the patent and the scientific innovation on which it is based. If necessary, appealing a final decision will remain an option in Brazil.

The patent application filed by Gilead Sciences was opposed by a coalition of Brazilian NGOs and a government pharmaceutical laboratory. The patent office in Brazil rejected it on the grounds that it lacks inventiveness – one of the key requirements for a patent in Brazilian and international patent law.