Federal Circuit Affirms Dismissal of Suit Over Humira

February 9, 2018
Kelly Davio

The Federal Circuit on Monday affirmed a previous district court dismissal of drug maker AbbVie’s suit against MedImmune Limited over US Patent 6,248,516 (“the ’516 patent”).

The Federal Circuit on Monday affirmed a previous district court dismissal of drug maker AbbVie’s suit against MedImmune Limited over US Patent 6,248,516 (“the ’516 patent”).

AbbVie had, in 2016, sought a declaratory judgment that the ’516 patent, which relates to single-domain ligands derived from molecules in the immunoglobulin superfamily, was invalid. The district court, in granting MedImmune’s motion to dismiss, said that it lacked jurisdiction under the Declaratory Judgment Act, and further said that it would not exercise its jurisdiction if it existed.

AbbVie had entered into a development and licensing agreement, governed under British law, with MedImmune in 1995, stemming from a research collaboration that resulted in adalimumab, which AbbVie today sells as the blockbuster drug Humira. The agreement allowed AbbVie to practice the ’516 patent, among others, for a royalty on the sales of certain antibodies until the last licensed patent expired, or until 15 years after the date of first sale of the product resulting from those antibodies.

The ’516 patent, which will expire on June 19, 2018, is the last of the group of patents to expire (while 15-year royalty period after the first Humira sales ended in January 2018). By seeking to invalidate the ’516 patent, AbbVie sought to truncate the period for which it would be required to pay royalties on Humira. MedImmune argued that, regardless of whether the patent was ruled valid or invalid, AbbVie would still be obligated to pay royalties until the patent’s expiry date, as stipulated in the parties’ contract.

The district court dismissed AbbVie’s complaint, saying that AbbVie does not practice the ’516 patent in producing Humira, so AbbVie is not at risk of infringement and therefore lacks standing to bring an action. It also stated that, even if AbbVie had standing, the 1995 contractual agreement is governed by British contract law, not US law.

In Monday’s ruling, the appellate court said that district court was in error in saying that AbbVie was not at risk of infringement, saying that this interpretation mischaracterized AbbVie’s claim, which concerned contractual obligations.

However, said the 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.” Because AbbVie has no other pending litigation that would resolve its contractual dispute with MedImmune, the court cannot establish declaratory judgment jurisdiction over the question of the patent’s invalidity.

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