Federal Circuit Affirms Dismissal of AbbVie’s Humira License Suit

The Federal Circuit has ruled that AbbVie’s declaratory judgment action seeking to invalidate a patent licensed from MedImmune will not go forward. AbbVie licensed several patents stemming from a research collaboration that produced adalimumab, the active ingredient in Humira. The license provides for royalties until the later of expiry of the last patent or 15 years from the first sales of a product by AbbVie’s predecessor. The 15-year mark was January 2018, and the last patent expires in June 2018. AbbVie tried to invalidate the last patent to cut off its royalty obligations earlier.

In its decision, the Federal Circuit held that the suit would not resolve the license dispute between the companies because a decision on validity would not necessarily resolve whether AbbVie would have to continue to pay royalties under the license. The license is governed by British law, and British courts have not determined whether invalidation of the underlying patent would discharge AbbVie’s license obligations pursuant to the contract.

The Federal Circuit also held that the district court erred in ruling that AbbVie lacked standing to pursue such a claim. The parties had agreed that AbbVie did not practice the patent. On that basis, the district court found there could be no declaratory judgment claim of patent invalidity for which AbbVie had standing. The Federal Circuit disagreed. According to the Federal Circuit, AbbVie’s invalidity argument was unrelated to the issue of infringement and thus, the contractual dispute could confer jurisdiction to determine patent validity. Ultimately though, the court noted, “AbbVie’s problem is that it did not seek a declaration of its contractual obligations.”

Big Molecule watch will continue to follow litigation involving biologics, so check back for the latest news and analysis.