Federal claims court rules in favor of Gilead in CDC Truvada patent case

 Gilead pulled a win last week in its ongoing patent battle with the CDC over the HIV drug Truvada for pre-exposure prophylaxis (PrEP).

The US Court of Federal Claims ruled on Nov. 21 that the government breached certain agreements with Gilead by failing to promptly notify the company of its patent applications for Truvada for PrEP, according to documents unsealed on Wednesday.

The issue traces back to around 2004 when Truvada won an accelerated approval to treat HIV. Because HIV is known to develop resistance to therapy, patients at the time were often required to take more than one drug at a time. Truvada combines Gilead’s prior HIV drugs, Emtriva and Viread, making life easier for patients who were taking separate pills daily. Shortly after, the CDC and Gilead struck up a partnership to research Truvada’s use as a preventative measure prior to exposure.

The duo inked multiple material transfer and clinical trial agreements, referred to as MTAs and CTAs in the court documents.

Truvada won a label expansion in 2012 for PrEP, allowing individuals at high risk for HIV to take medicine daily to lower their chances of contracting HIV. In 2016, the government notified Gilead that it had acquired patents for Truvada’s use in PrEP, and three years later, it sued Gilead in Delaware court for infringing on those patents by marketing Truvada and its follow-on drug, Descovy, for PrEP. The Yale Global Health Justice Partnership published a report that year finding that CDC scientists were the first to determine that the drugs comprising Gilead’s Truvada could be used to prevent HIV transmission.

Gilead CEO Daniel O’Day has refuted those claims, arguing before the House Oversight Committee in May 2019 that the patents are invalid “because the use of Truvada as prophylaxis was widely known at the time the CDC sought these patents.”

In addition to challenging the validity of the patents, Gilead took the issue to federal claims court in 2020, alleging that the government breached its MTAs and CTAs with Gilead.

The court sided with Gilead last week, finding that the government failed to notify Gilead of its patent applications in a timely manner. The email notification in 2016 came a year after the first patent was granted.

“To be able to exercise its rights under the MTAs, Gilead would need to know about the government’s patent application,” the court said. Under the MTAs, the government must give Gilead “serious and reasonable consideration to [a] request for a . . . license,” the opinion states. “Gilead’s ability to exercise this right is forestalled if it does not know a patent application exists, especially in a timely manner.”

The Delaware case is set to go to trial in May 2023. The federal claims court did not come to a decision on whether the CTAs were breached.

https://endpts.com/federal-claims-court-rules-in-favor-of-gilead-in-cdc-truvada-patent-case/