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Regulatory Focus™ > News Articles > 2019 > 11 > US Sues Gilead Over HIV Drug Patents

US Sues Gilead Over HIV Drug Patents

Posted 07 November 2019 | By Zachary Brennan 

US Sues Gilead Over HIV Drug Patents

The US government late Wednesday took the rare step of suing Gilead for infringing on four government-owned patents related to the HIV drug Truvada (emtricitabine/tenofovir disoproxil fumarate) for pre-exposure prophylaxis (PrEP), according to a complaint filed in Delaware’s district court.

The patents at issue were the result of the Centers for Disease Control and Prevention’s (CDC) research on emtricitabine (FTC)/tenofovir and FTC/tenofovir prodrug regimens for PrEP. But the complaint alleges that not only did the offices within the National Institutes of Health try to enter into a licensing agreement with Gilead in 2017 and 2018 and fail to reach a deal, but Gilead acted in a questionable manner throughout.

“Gilead’s conduct was malicious, wanton, deliberate, consciously wrongful, flagrant, and in bad faith. This is especially true because, as set forth herein, the Government has attempted to negotiate in good faith an appropriate license,” the complaint says.

The complaint also explains how Gilead’s public statements emphasize the amount of money it has spent to “support the clinical trials that led to the approval of Truvada for PrEP,” but the complaint alleges, “that claim is disingenuous. Its support of early clinical trials was typically limited to only the donation of study drugs.”

And only after the commercial success of Truvada for PrEP did Gilead increase its funding of PrEP clinical trials, and in particular, trials related to Descovy for PrEP. What's more is that following CDC’s decision to recommend daily PrEP in 2014, “sales for Truvada for PrEP skyrocketed, both in the United States and worldwide. In 2016, there were 77,120 PrEP users in the United States, as compared to 8,768 PrEP users in 2012.”

The organization PrEP4All said in a statement: "If HHS is truly invested in ending the HIV epidemic, it will use these patents as leverage to ensure that everyone who needs PrEP can get it."

The price for Truvada also rose from about $1,250 per month to about $1,800 per month in the US as demand began to increase, the complaint says.

“Gilead has failed to address the fact that CDC is widely acknowledged as being the first to demonstrate that FTC/tenofovir prodrug regimens are highly effective in preventing HIV infections and resulted in immediate changes to large human trials related to Truvada for PrEP. These trials directly led to FDA approval of that regimen. Gilead’s validity assertions likewise ignore the wide acclaim and recognition of the innovative and breakthrough CDC research leading to the Patents-in-Suit,” the complaint adds.

Gilead CEO Daniel O’Day also said at a House committee hearing in May that: “Using Truvada for PrEP was well known in the scientific community, long before CDC claimed it as an invention,” but despite this position, Gilead has “chosen not to challenge those patents because we value our collaborative relationship with the agency.” However, just three months after O’Day’s statement, Gilead challenged the validity of all four CDC patents by petitioning for inter partes review (IPR) at the US Patent and Trademark Office.

Now, the government is seeking, among other awards, damages adequate to compensate for Gilead’s  infringement on CDC's patents and an ongoing royalty for continued infringement.

“Gilead has never denied that it infringes CDC’s patents. Nonetheless, by 2019, it became clear that Gilead would not take a license to the Patents-in-Suit on any reasonable terms,” the complaint adds.

Meanwhile, Teva is expected to launch its generic version of Truvada in the US next year, although the complaint notes that Gilead has already won approval for its successor PrEP drug Descovy (emtricitabine and tenofovir alafenamide).

Outside the US, Mylan, which is currently selling its generic Truvada in Australia, Canada, Germany, France, and the UK, entered into a settlement agreement in 2016 with CDC after losing a court case. Mylan agreed to pay royalties for generics sold or manufactured in those countries.

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