Gilead gets a leg up in dueling Truvada patent feuds with feds

By going on the attack in one Truvada patent case, Gilead Sciences saw a chance to strengthen its position in a separate but related lawsuit. That tactic may be paying off.

In a late November court decision unsealed Wednesday, the U.S. Court of Federal Claims (CFC) sided with Gilead’s argument that the U.S. Centers for Disease Control and Prevention broke certain agreements with the company around its HIV drug for preexposure prophylaxis (PrEP). Gilead advanced its federal claims court lawsuit in 2020 as a sort of parry to the U.S.’s own patent infringement case, which the government filed in a Delaware federal court the year before.

The CFC specifically said the government violated three so-called material transfer agreements (MTAs) by failing to promptly notify Gilead when it filed for patents related to Truvada’s use to prevent HIV, according to court documents made public Wednesday.

Truvada—which fuses earlier Gilead HIV treatments Emtriva and Viread—first won approval to treat HIV in 2004. Soon after that, the CDC and Gilead joined forces to research the drug’s preventative potential. In 2012, Truvada was approved to curb the risk of HIV infection.

The U.S. in its case against Gilead says that the company failed to compensate the CDC for its role in discovering Truvada’s value as an HIV preventative. Gilead, for its part, contends the government breached research agreements when it filed Truvada PrEP patent applications without swiftly alerting the company.

In the latest court decision, senior U.S. Judge Charles Lettow largely agreed with Gilead. The judge pointed out the CDC applied for its first PrEP patent in 2006 but didn’t let Gilead know until “eight years after the filing of the provisional patent” in 2014. Further, Gilead has “sufficiently proven that it suffered reliance, restitution and expectation damages,” Lettow said, without setting a dollar amount.

Alongside the broken MTAs, Gilead alleged the CDC also violated clinical trial agreements (CTAs), but Lettow could not come to a decision on whether the organization had also breached the CTAs.

Meanwhile, in a letter sent to the Delaware court Wednesday, Gilead said its claims court victory bolsters its defense in the other case, where the U.S. government is hounding the company for more than $1 billion in damages over its Truvada PrEP regimen.

“The CFC’s findings are relevant to at least Gilead’s unclean-hands defense here, which is premised, in part, on the government’s breach of the same agreements,” the company’s note reads.

Essentially, Gilead is arguing the government can’t enforce its patents because the CDC may have slipped up.

The Delaware case in which Gilead is the defendant is set to go before a jury in May.

Gilead’s patent dust-up with the U.S. Department of Health and Human Services arose near the end of Truvada’s patent life as the med’s heir, Descovy, was working to carve out a PrEP niche.

The HIV-focused pharma attempted to beat back the government's arguments at the U.S. Patent and Trademark Office, but those efforts ran aground in early 2020. 

Truvada and Descovy have been blockbusters for Gilead. In 2021, the company earned around $16.265 billion from global sales of various products containing either Truvada or Descovy.