The US Patent & Trademark Office invalidated four HIV/AIDS patents belonging to Gilead Sciences for tenofovir disoproxil fumarate, or TDF, which the drugmaker markets in the US under the brand name Viread and as part of its Atripla combo product. Last summer, the Public Patent Foundation challenged the patents because the FDA won’t allow any other entity to distribute TDF in the US and Gilead claims the four patents offer exclusive rights.

In its filings challenging the patents, PUBPAT, as the advocacy group calls itself, submitted prior art that Gilead had not disclosed to the USPTO during the patent application process. PUBPAT also described how the prior art would have prohibited the patents from being issued in the first place, had the Patent Office had been aware of it. The group also maintains that third-party challenges are successful in causing reviewed patents to be revoked or changed more than two-thirds of the time.

“Every person suffering from HIV/AIDS has a right to get the best medical treatment science can offer, without any unjustified impediments placed in their way,” says Dan Ravicher, PUBPAT’s executive director, in a statement. “This includes Americans infected with HIV/AIDS, who are entitled to the
best pharmaceuticals possible without undeserved patents making them exorbitantly expensive…”This means that we are now well on the way towards ending the harm being caused to the public by Gilead’s use of the patents to prevent anyone else from offering TDF to HIV/AIDS patients in the United States.”

A Gilead spokeswoman, Amy Flood, writes to us with this response: “This step in the process is one that we fully anticipated, and I wanted to note this is non-final rejection. The U.S. Patent and Trademark Office’s action is typical in the re-examination process. We now have the opportunity to address the PTO’s questions. We will vigorously defend each and every claim that supports our patent protection, and we remain confident in the outcome. The process of a challenge - like the one from PUBPAT - may take time, but we do not believe the exclusivity of any of our products is in jeopardy.”