The AIDS Healthcare Foundation (AHF) has been battling Gilead over its patents on tenofovir alafenamide fumarate (TAF) since January of 2016. When its federal lawsuit alleging the company manipulated the patent system to enrich itself at the expense of patient safety was dismissed, AHF vowed to appeal the case all the way to the Supreme Court if necessary.
AHF has made good on that promise.
The foundation announced Monday night that it has filed a petition for review of the case with the Supreme Court. The 26-page document (PDF) starts by explaining that AHF, which uses Gilead’s HIV drugs in its healthcare centers, "seeks to introduce generic TAF to its patients as soon as possible," but can’t because of the company’s five-year exclusivity period. The foundation is asking the Supreme Court to consider whether it actually has to file for FDA approval of generic TAF before it can file a lawsuit seeking to invalidate Gilead’s patent.
AHF’s original beef with Gilead centered around the timing of TAF’s development and market entry. Tenofovir initially was part of combination medicines like Viread, which as a patented product brought in more than $1 billion in sales. But AHF alleged the company knew as far back as the early 2000s that the drug could work at a fraction of the dose contained in Viread, and thus could cut the risk of side effects such as kidney and bone damage.
AHF claimed Gilead stopped developing the less potent TAF until 2010 and that it didn’t launch its version of it, as part of the combo treatment Genvoya, until late 2015, protecting its market for Viread in "a calculated, anticompetitive manner," the original suit said.
Gilead filed a motion for dismissal with the U.S. District Court for the Northern District of California, which granted it on the grounds that AHF failed to explain how the company’s delayed development effort amounted to unfair competition. A federal circuit court affirmed the decision. Hence the Supreme Court petition.
Gilead did not immediately respond to a request for comment from FiercePharma. But in 2016, then-Chief Scientific Officer Norbert Bischofberger told the Los Angeles Times that Gilead halted development of TAF so it could pour resources into searching for another type of HIV drug. Then the company detected a need for the less-toxic version of the drug to treat aging HIV patients, who are more susceptible to bone and kidney issues.
Maybe so, but Gilead continues to be dogged by ethical questions. Just a few months ago, the company was hit with a lawsuit filed by two patients who allege that after years of taking Gilead’s Truvada and Atripla—both of which contain the original formulation of tenofovir—they now suffer from osteopenia and osteoporosis.
The patients are asking for damages, and they filed a separate suit requesting class action status.
AHF’s Supreme Court petition argues the lower court decisions in favor of Gilead were faulty because they were based on previous cases involving generic drug makers that had not yet finished clinical trials of the products in question. "By contrast, the products AHF seeks to obtain and distribute are generic versions of Respondent Gilead’s TAF-containing products," meaning "there is no uncertainty about whether the products would meet with FDA approval," the request for Supreme Court review says.
In its announcement of the Supreme Court petition, AHF noted that when the district court threw out its original complaint, the judge did say that the issue was "ripe for reconsideration" by a higher court. "AHF firmly believes that pharmaceutical companies should not be permitted to game the patent system to prolong profits at the expense of patient welfare," said Tom Myers, general counsel and spokesman for AHF, in the statement. "That is why we are petitioning the Supreme Court to review this critical question."
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