Gilead sues US govt for breach of contract over antiviral patents
Gilead has escalated its dispute with the US federal government by filing a new lawsuit accusing it of improperly filing for patents covering HIV drug Truvada.
Specifically, the complaint relates to pre-exposure prophylaxis (PrEP), a daily regimen of antivirals which can reduce the risk of contracting HIV by up to 99%. Credit for discovering the use of Gilead’s Truvada (emtricitabine/tenofovir) as PrEP is the subject of a dispute between the company and the federal government.
The government has accused Gilead of infringing four government patents, and profiting from federal research, through its sale of PrEP.
Gilead, which recently unsuccessfully tried to have the patents invalidated, now claims that they were filed improperly.
In a complaint filed last week at the Court of Federal Claims, Gilead said that the government violated four material transfer agreements and a clinical trial agreement (CTA) governing the company’s research collaboration with the government on HIV prevention.
Under these terms, Gilead agreed to provide the federal Centres for Disease Control and Prevention (CDC) with antiviral compounds free of charge, and in exchange the CDC would notify the company of any discoveries that arose from its research into HIV, the complaint stated.
But Gilead says that, despite these agreements, the government filed for patent protection without notifying the drugmaker. The four government patents were granted in 2015, and are at the heart of the government’s infringement lawsuit against Gilead.
Under the terms of the CTA, Gilead said, the government explicitly promised “not to seek patent protection in connection with any alleged inventions that derive from the use of the study drug in the trial”.
“Gilead’s complaint alleges that, as a result of the multiple breaches of contract, Gilead has incurred unnecessary attorneys’ fees and has suffered reputational harm due to the government’s inflammatory and selective allegations asserted in the patent infringement lawsuit,” a company statement said.
The pharmaceutical company also said it believed the government patents to be “invalid”, and that they “should not have been granted”.
The US Patent Trial and Appeal Board rejected this view in February, dismissing all outstanding requests from Gilead to have the government patents for PrEP invalidated.
Gilead wants the federal claims court to declare the government’s conduct a breach of contract and award damages to the company.
