Gilead claims Truvada patents in HHS’ complaint are invalid
Back in November, the Department of Health and Human Services took the rare step of filing a complaint against Gilead for infringing on government-owned patents related to the HIV drug Truvada (emtricitabine/tenofovir disoproxil fumarate) for pre-exposure prophylaxis (PrEP).
But on Thursday, Gilead filed its own retort, making clear that it does not believe it has infringed on the Centers for Disease Control and Prevention’s (CDC) Truvada patents because they are invalid.
The California-based company denied that the four patents are valid and said they do not “reflect any ‘innovative regimens’ developed by the CDC.” The company also noted that HHS has canceled several of its claims after being faced with Gilead’s invalidity positions, which are pending before the Patent Trial and Appeal Board.
The defense echoes what Gilead CEO Daniel O’Day said before the House Oversight Committee in May 2019, when he noted that the patents are invalid “because the use of Truvada as prophylaxis was widely known at the time the CDC sought these patents.”
Gilead also denied that CDC researchers “succeeded where others had not” and “conceived of and developed” the use of emtricitabine and “tenofovir or a tenofovir prodrug” as PrEP. Other denials focus on CDC researchers using “new” and “precise” animal modeling methods, although the company later admits that, “following the CDC macaque research, researchers changed the methodology of at least one human PrEP trial” in Botswana.
The HHS complaint, by contrast, explained how Gilead had 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.”
On royalties, Gilead further denied that the CDC is entitled to a “reasonable royalty.”
RAPS: First published in Regulatory Focus™ by the Regulatory Affairs Professionals Society, the largest global organization of and for those involved with the regulation of healthcare products. Click here for more information.