AbbVie and Boehringer Ingelheim Settle Over Biosimilar Adalimumab

AbbVie announced today that it has settled its patent litigation with Boehringer Ingelheim (BI) over adalimumab.

Under the terms of the settlement, BI’s biosimilar, Cyltezo, will not enter the US market until July 1, 2023. BI will pay royalties to AbbVie for licensing of its patents covering the reference drug, Humira, and BI acknowledged the enforceability of AbbVie’s patents.

“This is an important settlement as it resolves all Humira-related patent litigation in the US and provides access for another biosimilar manufacturer seeking to enter the US,” said Laura Schumacher, vice chairman, external affairs, and chief legal officer at AbbVie, in a statement announcing the settlement. “As an innovation-driven biopharmaceutical company, we will continue to develop novel cures for the toughest health challenges and rely on a robust patent system to protect that investment in innovation.”

AbbVie first sued BI for patent infringement in 2017, saying that BI would infringe on more than 70 patents covering adalimumab in developing its biosimilar, which was approved just months later by the FDA under the brand name Cyltezo.

Then, in June 2018, the court granted BI’s motion to compel discovery in the case after BI argued that it needed relevant documents related to its allegations that AbbVie has “unclean hands”; the unclean hands doctrine is a legal defense that bars a party who is asking for a judgment from receiving the court’s help if that party has behaved unethically with respect to the subject of the lawsuit. According to BI, AbbVie’s strategy of acquiring what BI described at the time as overlapping, noninventive patents that create a patent “thicket” could constitute unclean hands on AbbVie’s part.

The settlement marks a turning point in the US biosimilars market, as BI was the only remaining biosimilar developer with an approved or late-stage product that had not yet reached an agreement with AbbVie. BI had previously told The Center for Biosimilars^® that it was “committed to making [the biosimilar] available to US patients as soon as possible, and certainly before 2023.”

BI follows in the steps of Coherus, Pfizer, Amgen, Mylan, Samsung Bioepis, Sandoz, Fresenius Kabi, and Momenta, which also struck deals with the Humira maker. None of their products will enter the US market before 2023, either. First to enter will be Amgen’s biosimilar, Amjevita, in January 2023.