Just as Gilead Sciences gets underway with a closely watched drug launch for a long-acting HIV medicine in Europe, the company has been dealt a legal setback in the U.S.
A judge in California on Friday ruled that Gilead must face a lawsuit alleging anticompetitive conduct in its 2014 patent settlement with generic rival Cipla. In 2012, Cipla notified Gilead that it planned to market generic versions of antivirals Emtriva and Viread, prompting Gilead to sue the generics maker for infringement.
Then, in 2014, the companies inked a deal that prohibited Cipla from marketing copycats to Gilead's Emtriva, Atripla and Truvada before certain patent expirations. Such "pay-for-delay" deals have often come under legal scrutiny and criticism from pharma watchers.
Atripla and Truvada generics eventually hit the U.S. market in October 2020. Emtriva generics debuted in August 2020.
In its 2020 antitrust lawsuit, the Jacksonville Police Officers and Fire Fighters Health Insurance Trust said that Gilead for years "employed several unlawful strategies to stave off competition for its HIV medications." The plaintiffs said that despite "glaring weaknesses," Gilead's patents were never fully litigated.
Further, the plaintiffs questioned whether Gilead and Cipla's separate hepatitis C antiviral licensing agreement in 2014 was one of the terms of their private patent settlement.
In the Friday ruling, U.S. District Judge Jeffrey White allowed the case to proceed but ordered the plaintiffs to finalize their case by Sept. 9. Gilead and Cipla had moved to dismiss the case, but the judge didn't grant their request.
Gilead is no stranger to legal wranglings for its antivirals. In a separate case, a group of HIV patients from nearly three dozen states alleged the company sidelined next-gen HIV meds for years to reap profits from a slate of older drugs.