US sues Gilead alleging infringement on government-owned patents for Truvada, Descovy for HIV PrEP

The US Department of Health and Human Services (HHS) said it has filed a lawsuit against Gilead Sciences, claiming the company infringed HHS patents related to Truvada (emtricitabine/tenofovir disoproxil fumarate) and Descovy (emtricitabine/tenofovir alafenamide) for pre-exposure prophylaxis (PrEP) to prevent HIV infection. Truvada for PrEP was approved by the FDA in 2012, while Descovy's label was expanded to include PrEP just last month.

Gilead initially obtained FDA approval for Truvada and Descovy for post-infection HIV treatment in combination with other antiretroviral therapies. However, HHS noted that after scientists at the US Centers for Disease Control and Prevention (CDC) conducted "groundbreaking PrEP work" in the mid-2000s and "developed innovative two-drug regimens to effectively prevent HIV infection," Gilead was later granted approvals for the drugs to be used for PrEP.

HHS stated that it holds four patents that cover the PrEP regimens and that it filed the lawsuit in US District Court in Delaware after Gilead "repeatedly refused to obtain licenses" for their use. The department pointed out that two other companies that manufacture generic equivalents of Truvada for PrEP in foreign countries have agreed to licenses with HHS. Health secretary Alex Azar said the government "recognises Gilead's role in selling Truvada and Descovy to patients for prevention of HIV," but the company "must respect the US patent system, the groundbreaking work by CDC researchers, and the substantial taxpayer contributions to the development of these drugs."

In August, Gilead petitioned the US Patent and Trademark Office (PTO) to invalidate the HHS patents through an inter partes review. At the time, Gilead said "published materials clearly show that well before HHS claims to have invented the concepts of PrEP and PEP (post-exposure prophylaxis) in 2006, others had conceived of using an antiretroviral therapy, including Truvada, for both forms of prophylaxis."

Commenting on the lawsuit, Gilead asserted that the patents granted to HHS since 2015 for PrEP and PEP are "not valid" and that it "[rejects] any notion of willful infringement." The company also said it is "surprised that the government has requested that a district court judge and jury look at the same issues of patent validity that the patent office will be deciding," adding that it will ask the district court to stay the litigation until the PTO has an opportunity to undertake the review.

In October, Gilead chief commercial officer Johanna Mercier, who joined the company in July, said that about 224,000 people are taking Truvada for PrEP, a figure that is up 25% year-over-year.

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