US govt argues Gilead’s patent claims are ‘insufficient’
The US government has urged a Delaware federal court to throw out patent infringement claims from Gilead Sciences over HIV prevention medicines.
The federal government sued Gilead last year for infringing four state-owned patents covering pre-exposure prophylaxis (PrEP) for HIV.
According to the Department of Health and Human Services (HSS), the use of Gilead’s flagship HIV drugs Truvada and Descovy as PrEP was discovered through publicly-funded research, and should not be subject to a Gilead monopoly.
Gilead responded with patent infringement counterclaims of its own, arguing that the government patents were invalid and should not have been granted in the first place.
HSS now wants the US District Court for the District of Delaware to dismiss Gilead’s counterclaims. In a motion filed on Friday, May 15, lawyers for the US government wrote that “every one of Gilead’s counterclaims is insufficiently pled”, and offer “no facts relating to noninfringement or invalidity beyond a bare allegation that Gilead does not infringe and that the patents-in-suit are invalid.”
According to the government, Gilead’s counterclaims add nothing beyond what was contained in its unsuccessful petitions for inter partes review of the patents at the US Patent Trial and Appeal Board (PTAB).
Gilead had asked the PTAB to review and cancel the patents, but the board ruled that Gilead had little chance of proving its invalidity claims.
In addition to the alleged weakness of Gilead’s patent claims, the government said it is protected from lawsuits by the principle of sovereign immunity.
According to the HSS motion, Gilead failed to prove the US had waived its sovereign immunity, a requirement plaintiffs must meet when suing the government.
Gilead is facing a separate antitrust suit alleging that it, as well as Bristol-Myers Squibb, Japan Tobacco, and Johnson & Johnson, restricted competition in the HIV drug market.
The case is set to go ahead after the US District Court for the District of Florida refused to throw out all of the claims in March.
