Federal Circuit Affirms Dismissal of Case Against Gilead Sciences

05.2018

On May 11, 2018, the U.S. Court of Appeals for the Federal Circuit affirmed the dismissal Irell secured on behalf of Gilead Sciences in 2016 in AIDS Healthcare Foundation v. Gilead Sciences.

AHF filed its lawsuit in January 2016 alleging that Gilead unlawfully manipulated federal patent and drug-regulatory laws to monopolize the market for Gilead’s newest HIV drugs. AHF challenged Gilead’s patents covering its newest generation antiviral medicine, known as tenofivir alafenamide or TAF, which makes up one key component in each of three recently approved multi-drug combination products: Genvoya, Odefsey and Descovy. The FDA has described such single-pill combination products as the new standard of care for HIV treatment. AHF nevertheless challenged the very notion that Gilead could lawfully develop and launch new combination products without wasting years of effort and resources first developing and obtaining FDA approval of each new drug individually. 

After extensive briefing and oral argument on June 23, 2016, Irell secured a complete dismissal of AHF’s complaint on July 6, 2016.

Irell then represented Gilead in the appeal in June 2017. The Federal Circuit affirmed in a 3-0 decision. The team included Keith Orso and Jason Sheasby.