Federal Circuit affirms Humira licence decision
Yesterday, the US Court of Appeals for the Federal Circuit backed a lower court’s decision to dismiss a declaratory judgment lawsuit filed by AbbVie over its drug Humira (adalimumab).
The decision, which was delivered by Circuit Judge Timothy Dyk, centred on a development and licensing agreement entered into by predecessors to AbbVie and MedImmune in 1995.
Antibody adalimumab was the result of the agreement, which is governed by UK law.
Under the agreement, AbbVie was licensed to practise US patent number 6,248,516 (owned by MedImmune), but the company was also required to pay royalties to MedImmune.
AbbVie’s obligation to pay royalties either ceased in January 2018 (if the period is measured from the first commercial sale in January 2003) or will end in June 2018 (if measured from the expiration date of the ‘516 patent).
According to the Federal Circuit, in a bid to hasten the end of its royalty obligations, AbbVie filed against MedImmune at the US District Court for the Eastern District of Virginia, seeking declaratory judgment that the patent was invalid.
AbbVie argued that a declaration of invalidity would constitute the patent’s expiration under the 1995 agreement, while MedImmune claimed that the district court lacked declaratory judgment jurisdiction or, if it had jurisdiction, should decline to exercise it.
The Virginia court dismissed the complaint on two grounds.
First, because AbbVie doesn’t practise the ‘516 patent, it is not at risk of an infringement suit, so AbbVie lacks standing.
Second, if AbbVie had standing, the interpretation of the 1995 agreement was governed by UK law, so deciding the invalidity question wouldn’t resolve the parties’ ultimate dispute, and would raise additional concerns.
AbbVie appealed against the decision, but the Federal Court backed the lower court.
“AbbVie’s problem is that it did not seek a declaration of its contractual obligations. Rather, AbbVie’s complaint only sought a declaration of invalidity with respect to the ‘516 patent. And as MedImmune argues and the district court held, such a declaration would not actually resolve the parties’ contractual dispute,” said Dyk.
He noted that the court has occasionally permitted an exception to the rule against piecemeal adjudication where litigation that would resolve the remaining questions is pending.
But in this case, AbbVie has no other pending litigation that would “conclusively resolve” its contractual dispute with MedImmune.
“Without taking at least that step, in either the American or British courts, it cannot establish declaratory judgment jurisdiction over the question of invalidity,” noted the Federal Circuit.
Did you enjoy reading this story? Sign up to our free daily newsletters and get stories sent like this straight to your inbox.
Do you work in a pharma or biotech company? Save $275 when you join us at LSPN Boston on April 26 at the special in-house early-bird rate of $525. Find out more here.
