AbbVie Denies Overlapping Patents in Most Recent Adalimumab Litigation

The Center for Biosimilars Staff

In an ongoing litigation over biosimilar adalimumab, AbbVie, maker of the blockbuster reference adalimumab (Humira), denied biosimilar developer Boehringer Ingelheim’s claims that the company has been padding its patent estate with overlapping patents in an effort to protect its drug from competition.

In an ongoing litigation over biosimilar adalimumab, AbbVie, maker of the blockbuster reference adalimumab (Humira), denied biosimilar developer Boehringer Ingelheim’s (BI) claims that the company has been padding its patent estate with overlapping patents in an effort to protect its drug from competition.

In September, BI claimed that “[AbbVie] engaged in a pattern of pursuing numerous overlapping and non-inventive patents for the purpose of developing a ‘patent thicket,’ using the patenting process itself as a means to seek to delay competition against its expensive and lucrative adalimumab product.”

BI went on to claim that the alleged patenting strategy had produced more than 100 adalimumab patents for AbbVie, and that all 74 such patents under dispute in the current case “stem from less than half as many patent families.” BI said that, while adalimumab itself is a “true scientific achievement,” what AbbVie has patented—namely formulations, production processes, and dosing regimens—do not represent such scientific achievements. The biosimilar developer pointed to recent inter partes review (IPR) proceedings before the Patent Trial and Appeal board that found that the reference Humira’s success was not due to methods of treatment, but due to the innovative nature of the adalimumab antibody.

In its answer, AbbVie put forth a number of affirmative defenses against BI’s counterclaims, including the assertion that relief could not be granted for any of BI’s counterclaims, and that BI has not complied with the Biologics Price Competition and Innovation Act. AbbVie asked the court to deny all relief sought by BI and to dismiss all counterclaims in the suit.

AbbVie originally filed suit against BI in August, seeking a judgment that the biosimilar developer has infringed or will infringe on 1 or more of AbbVie’s patents by manufacturing or offering its product, Cyltezo, for sale in the United States. AbbVie also seeks a preliminary and permanent injunction to prevent BI from infringing on patents covering Humira.

BI is the second biosimilar developer to gain FDA approval for a biosimilar adalimumab and face extensive patent litigation with AbbVie; in September 2016, Amgen gained US regulatory approval for its adalimumab biosimilar, Amjevita. Last month, Amgen announced that it had reached a settlement with AbbVie that will allow it to begin marketing the biosimilar in January 2023. The settlement also provided for the European launch of the drug, under the slightly altered name Amgevita, in October 2018.