Recently, AbbVie, Inc. and AbbVie Biotechnology, LTD (collectively “AbbVie” or “Plaintiffs”) filed a Complaint in the United States District Court for the District of Delaware against Boehringer Ingelheim International GMBH, Boehringer Ingelheim Pharmaceuticals, Inc., and Boehringer Ingelheim Fremont, Inc. (collectively “Boehringer Ingelheim” or “Defendant”) related to Boehringer Ingelheim’s adalimumab product, a proposed biosimilar to AbbVie’s Humira®. The Complaint, filed on August 2, 2017, alleges that Boehringer Ingelheim’s filing of a biologics license application (“BLA”) for adalimumab under the abbreviated section (k) pathway of the BPCIA constitutes an artificial action of statutory patent infringement pursuant to 35 U.S.C. §271(e)(2)(C).
Boehringer Ingelheim announced in January of this year that the FDA had accepted for review its abbreviated biologics license application for BI 695501, a proposed adalimumab biosimilar. The FDA’s BSUFA date (target goal) for Boehringer’s adalimumab application is estimated to be in September 2017. Adalimumab is a TNF (tumor necrosis factor) inhibitor that binds to TNF-alpha (TNF-α), preventing it from activating TNF receptors, which cause the inflammatory reactions associated with autoimmune diseases. Humira® is indicated for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, psoriasis, and ulcerative colitis.
AbbVie alleges in the Complaint that “Boehringer seeks to copy AbbVie’s work and ignore AbbVie’s patents.” According to the Complaint, AbbVie has identified 74 patents related to Humira, which “AbbVie has identified as infringed” by Defendants. However, the current complaint asserts infringement of only eight patents, including: U.S. Patent No. 8,926,975; U.S. Patent No. 9,018,361; U.S. Patent No. 9,090,867; U.S. Patent No. 9,096,666; U.S. Patent No. 9,255,143; U.S. Patent No. 9,266,949; U.S. Patent No. 9,272,041; and U.S. Patent No. 9,546,212.
According to AbbVie, after the parties exchanged patent lists in accordance with the BPCIA’s patent dance, “Boehringer selected the number of patents … each side could litigate in this first wave.” See Complaint. Boehringer selected five patents per side, and “the eight patents-in-suit constitute the compilation of the two lists” after accounting for the fact that two patents appeared on both side’s subsequent list. Id. AbbVie further notes that it “will have the opportunity to assert the remainder of the patents” later in the case “if and when Boehringer provides its 180-day Notice of Commercial Marketing, and as circumstances otherwise warrant.” Id.
The new Boehringer Ingelheim litigation is Civ. No. 17-cv-00165, and the case has not yet been assigned to a specific judge. According to the court’s docket system, Defendants currently have until August 23, 2017, to file an Answer or otherwise respond to the Complaint.
This is not the only litigation involving adalimumab. AbbVie previously filed an infringement suit against Amgen in Delaware related to its proposed biosimilar adalimumab therapeutic. Other manufacturers have also filed IPRs on patents related to Humira® (adalimumab), as reported here and here.