AIDS non-profit takes Gilead fight to SCOTUS
A non-profit called AIDS Healthcare Foundation (AHF) has filed a petition for certiorari with the US Supreme Court in a patent dispute with Gilead.
AHF has asked the court to clarify the ‘actual controversy’ requirement when parties seek declaratory judgment in cases concerning pharmaceutical patents and generic drugs.
It stems from a lawsuit AHF filed against Gilead in January 2016. The non-profit accused Gilead of drug patent manipulation and antitrust violations regarding different formulations of tenofovir alafenamide (TAF), an HIV/AIDS treatment.
AHF brought the declaratory action to clear out allegedly invalid patents for the drug so that it could partner with generic makers and purchase generic TAF.
Genvoya, Gilead’s first drug product containing TAF, received Food and Drug Administration (FDA) approval in November 2015. It is a combination drug product incorporating TAF and other specified antiviral agents.
In 2016, the FDA approved two additional TAF-containing combination products—Descovy and Odefesey—each of which contains at least one other antiviral agent.
Six months after AHF filed the suit, in July 2016, the US District Court for the Northern District of California granted Gilead’s motion to dismiss the claims, before the US Court of Appeals for the Federal Circuit affirmed the decision.
The district court concluded that AHF’s actions in encouraging others to produce generic products and its interest in purchasing such products didn’t create a case of actual controversy in terms of the Declaratory Judgment Act.
On appeal, the Federal Circuit said the district court had correctly held that AHF had not established a case of actual controversy.
AHF has now filed a petition for certiorari with the US Supreme Court, asking: “In the context of patent cases involving pharmaceutical products, does the ‘actual controversy’ requirement of the Declaratory Judgment Act, 28 USC section 2201(a) require a party seeking to introduce a generic drug product to file an application for FDA approval of that generic drug product before it can file suit for declaratory relief for patent invalidity?”
Michael Weinstein, AHF president, said that at the time of the 2016 ruling, AHF vowed that it would appeal to the Supreme Court if necessary, “to prevent Gilead from using a faulty patent process to game the system and garner more profits at the expense of patient health”.
AHF is the largest global AIDS organisation, providing medical care and services to more than 965,000 people in 41 countries.
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