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Brazil Rejects Gilead Patent On HIV Drug
  By Ed Silverman // September 3rd, 2008 // 2:30 pm
The Brazilian Patent Office has rejected a patent application filed by Gilead Sciences for its Viread medication. And Doctors Without Borders is saying the move could increase access to a key AIDS drug across the developing world.
"Securing wider access to (Viread) is absolutely crucial," Tido von Schoen-Angerer, executive director of DWB's Access Campaign, says in a statement sent us. 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.
But a Gilead spokeswoman writes us to say: "Although the terminology would appear to make it as such, this is not the efinal' step. It is typical in this process for a rejection to be issued and for the company to then provide detail and background on the patent. This was the process we followed during the recent re-examination proceedings with the US Patent & Trademark Office, resulting in the confirmation of Viread patents, and we would envision following a similar process in this situation (back story). If necessary, appealing a final decision will remain an option in Brazil.
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.
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. 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, according to DWB.
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