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US denied dismissal of contract breach claims in Gilead patent dispute

Truvada tablets that are color blue
January 6, 2021

A federal judge has ruled that the US government needs to face claims by drugmaker Gilead that it was in breach of contract with the company after it obtained patents related to Gilead’s drug Truvada and sued the company over them. 

The patent lawsuit against Gilead alleges that the company infringed patents of the Department of Health and Human Services (HHS) patents related to pre-exposure prophylaxis (or PrEP) and stated that the company refused to obtain licenses for the use of the HHS patents in its products Truvada and Descovy. 

Truvada, an HIV preventative drug, is the subject of a dispute concerning five breaches of contracts by the US government, according to Gilead. Four of the contracts reportedly refer to material transfer agreements from 2004 to 2014 wherein Gilead provided the Centers for Disease Control and Prevention (CDC) with drugs for research. The fifth contract was an agreement where Gilead provided the CDC with Truvada for clinical trial use in Botswana.  

Gilead filed for damages in the Court of Federal Claims in April 2020, months after the US government sued the company for patent infringement. Gilead claims that it suffered damages in the form of potential less favorable license terms and reputational harm. 

The government allegedly previously agreed to give consideration to Gilead’s requests for licenses to IP from the material transfer agreements and that the government also agreed not to seek IP protection for any inventions from the Truvada trial. 

The company also stated that the government’s patent application used information from the clinical trial and was obtained secretly, without providing Gilead a chance to acquire a license.

The US Court of Federal Claims ruled last December 30 that Gilead’s claims were not limited by the pending lawsuit against the drugmaker, denying the government’s motion to dismiss the case.

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