Gilead defeats US govt in billion-dollar HIV drug patent suit
Jury finds three US government patents over PrEP to be invalid | Case thought to be the first time US government has sued a pharmaceutical firm over patents.
Yesterday (May 9) a Delaware jury handed a victory to Gilead Sciences in its unusual lawsuit with the US government over alleged patent infringement, resulting in the biopharma firm avoiding a potentially billion-dollar payout over HIV drugs Truvada and Descovy.
The jury at the US District Court for the District of Delaware found three patents the government had accused Gilead of infringing over the drugs to be invalid. The government had said it was owed up to $691 million in damages from Truvada sales and $311 million from Descovy.
In an apparent first, the US government sued the drugmaker in 2019, following a dispute over research between Gilead and the Centers for Disease Control and Prevention (CDC) into methods for preventing HIV infection known as pre-exposure prophylaxis, or PrEP. This involved testing whether Truvada could prevent infection by the virus as well as treating it.
The government then obtained patents for the CDC’s work and claimed that Gilead “exaggerated” its role in developing PrEP and refused to license the CDC’s patents.
In August 2019, Gilead asked the US Patent and Trademark Office (USPTO) to review the patents granted to the government covering the preventative use of the drug.
“Published materials clearly show that well before HHS [the US Department of Health and Human Services] 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 (emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg tablets), for both forms of prophylaxis,” the firm argued at the time.
Gilead filed its own lawsuit against the US in 2020, claiming that the government had breached research agreements by applying for the patents without giving sufficient notice—a case that also went in favour of the California-based drugmaker.
No infringement
Following a five-day trial, the jury in Delware found that Gilead had not infringed any of the three patents in the dispute—US Patents numbers 9,579,333 and 9,937,191 and 10,335,423. All three were found to be invalid as anticipated and obvious, and the ‘423 additionally found to be invalid as not enabled.
The jury also found that Gilead would not have infringed the patents through sales of Truvada and Descovy even if they were valid.
Commenting on the verdict, Deborah Telman, Gilead’s general counsel and executive vice president of corporate affairs, said: “Today’s decision confirms our longstanding belief that we have always had the rights to make Truvada and Descovy for PrEP available to all who need it.
“Gilead will continue to champion collaborations, including our efforts with the US Health and Human Services Department (HHS) and CDC that span more than 15 years, as we all work together toward our common goal to end the HIV epidemic for everyone, everywhere.”
Representatives for the CDC and the US Department of Health and Human Services had not immediately responded to requests for comment.
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