Big Molecule Watch
September 28, 2021

Litigation and Regulatory Update for Alvotech’s Adalimumab Biosimilar

On September 20, 2021, the District Court for the Northern District of Illinois entered a scheduling order in AbbVie v. Alvotech, No. 21-2258, 21-2899 (N.D. Ill.).  As we previously reported, AbbVie Inc. (“AbbVie”) brought an action on April 27, 2021, in the Northern District of Illinois for patent infringement against Alvotech hf. under the BPCIA in connection with Alvotech’s proposed biosimilar version of HUMIRA® (adalimumab).  On June 2, 2021, Alvotech hf. moved to dismiss the complaint for lack of subject matter jurisdiction, lack of personal jurisdiction, failure to state a claim, and failure to join an indispensable party.  On August 23, 2021, the Court denied the motion to dismiss.  The September 20, 2021 scheduling order sets trial for August 2022 on the infringement, validity and enforceability of the following ten patents (“the Ten Patents”):  U.S. Patent Nos. 6,805,686; 8,926,975; 8,961,973; 8,999,337; 9,067,992; 9,085,619; 9,187,559; 9,512,216; 11,083,792; and the patent issuing from U.S. Patent Application No. 17/137,201.  Litigation of the other patents asserted by AbbVie is stayed.  According to the scheduling order, AbbVie “will not seek a preliminary injunction on any patents other than the Ten Patents” and “shall not seek a preliminary injunction on any patent before the Court’s decision.”  The scheduling order further states:  “[T]he Court plans to issue its trial decision by the end of October 2022.  In light of that, Defendant agreed not to launch AVT02 in the United States prior to the issuance of the Court’s decision.”  The parties will file a joint written status report by January 7, 2022.

Also on September 20, 2021, Alvotech announced that the FDA is deferring action on the application for AVT02 until facility assessments can be completed.  Alvotech stated that:  “The FDA can defer action when no deficiencies have been identified and the application otherwise satisfies the requirements for approval, but an inspection(s) is necessary yet cannot be completed due to factors including travel restrictions. Alvotech continues to work with the FDA to coordinate the required inspection(s) in a safe and adequate manner.”  Alvotech further stated that “Alvotech is the only known company that has both submitted a Biologics License Application (BLA) for a high-concentration biosimilar candidate to Humira, the most commonly utilized strength of the product on the market, and has successfully conducted a switching study in support of an FDA designation of interchangeability and correspondingly the potential for product substitution at the pharmacy level.”

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