Federal Circuit backs dismissal of AIDS drug suit
The US Court of Appeals for the Federal Circuit has affirmed the dismissal of a clash between a non-profit organisation and Gilead over patents covering HIV drugs.
On Friday, May 10, the Federal Circuit issued its precedential holding, backing a ruling by the US District Court for the Northern District of California which had found that AIDS Healthcare Foundation hadn’t met the criteria for declaratory judgment on its claims.
AIDS Healthcare, a non-profit focusing on HIV prevention services, testing and healthcare, had requested declarations of invalidity of five patents covering the antiviral agent tenofovir alafenamide fumarate (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.
According to the Federal Circuit, AIDS Healthcare told the district court that it brought the declaratory action to “clear out the invalid patents” so that it would have the ability to then partner with generic makers and purchase generic TAF “as soon as it could become available”.
In January 2016, two months after the FDA approved Genvoya, AIDS Healthcare filed its declaratory action.
The California court concluded that AIDS Healthcare’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.
AIDS Healthcare appealed against the decision, claiming that several of its grounds met the declaratory judgment criteria.
The arguments included that AIDS Healthcare is an indirect infringer of the TAF patents and that Gilead’s lack of response to the non-profit’s request for a covenant not to sue has created a controversy.
But the Federal Circuit disagreed with AIDS Healthcare’s contentions, finding that the district court had correctly held that AIDS Healthcare had not established a case of actual controversy.
“The district court concluded that Healthcare’s role as an encourager of others to provide infringing product in the future, and its role as a future purchaser of such product, fell short of the declaratory judgment requirements of immediacy and reality,” said Circuit Judge Pauline Newman, on behalf of the court.
AIDS Healthcare’s other arguments were dismissed and the California court’s dismissal was affirmed.
The non-profit intends to appeal against the judgment.
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