New BPCIA Litigation: AbbVie Files Suit on Sandoz’s HUMIRA (adalimumab) biosimilar

Today, AbbVie sued Sandoz regarding its proposed biosimilar to HUMIRA (adalimumab) in the District of New Jersey. The suit alleges infringement under the BPCIA of U.S. Patent Nos. 9,187,559 and 9,750,808. The ‘559 patent is directed to methods of administration of adalimumab for treatment of idiopathic inflammatory bowel diseases. The ‘808 patent is directed to formulations of adalimumab suitable for subcutaneous injection.

The complaint alleges that Sandoz notified AbbVie on January 12, 2018 that it had submitted an aBLA for an adalimumab biosimilar, which the FDA subsequently accepted on or before January 16, 2018.  AbbVie further alleges the parties began exchanging information in January 2018, but according to AbbVie, Sandoz did not provide information in those exchanges on the process(es) used to manufacture its biosimilar, as required by (l)(2)(A).

The complaint goes on to allege that on March 18, 2018, AbbVie provided Sandoz with its list of potentially infringed patents under (l)(3)(A), which it supplemented under (l)(7) in April and May 2018 to add subsequently issued patents. The complaint states that Sandoz then provided its response under (l)(3)(B) and (l)(7)(B) that the patents AbbVie identified will not be infringed or are invalid. AbbVie states that it responded pursuant to (l)(3)(C) to Sandoz’s assertions as to 84 patents. The complaint further alleges that on August 5, 2018, Sandoz notified AbbVie it would agree to be sued on one patent. As the complaint states, the patent dance then provides that each party can identify one patent each to be litigated. The complaint alleges that “AbbVie will have a second opportunity, when Sandoz provides a 180-day Notice of Commercial Marketing (or as circumstances otherwise warrant), to assert its remaining patents.”

The ‘559 patent was the subject of one of eight IPRs Sandoz filed since July 2017 on patents relating to adalimumab. Sandoz is appealing the denial of Sandoz’s petition on AbbVie’s U.S. Patent No. 9,512,216.

AbbVie has entered into patent licenses with Mylan, Amgen, and Samsung Bioepis regarding their proposed adalimumab biosimilars. Litigation with Boehringer Ingelheim regarding its adalimumab biosimilar is ongoing.