Court Sides with AbbVie by Blocking Biosimilar Patent Dismissal Bid

In an opinion issued on Monday, a Chicago court sided with drug maker AbbVie in its lawsuit against Icelandic biotechnology company Alvotech h.f. The broader case is an effort by AbbVie to block Alvotech’s bid to create a generic version of Humana, a biologic produced by the plaintiff. The judge sided with AbbVie in rejecting Alvotech’s motion to dismiss, which argued that the plaintiff must sue Alvotech’s American subsidiary, instead of its Icelandic parent.

The opinion, authored by Judge John Lee of the Northern District of Illinois, explained the procedure for submitting an abbreviated biologics license application (aBLA), whereupon the applicant must allege that the original drugmaker’s patents protecting the biologic are invalid or unenforceable. Afterward, the court explained, the two parties engage in a “patent dance,” where they collaboratively establish what patent law issues must be litigated.

In arguing for dismissal, Alvotech h.f. argued that the court does not have jurisidcition to hear the case, and that AbbVie has failed to state a claim that can be redressed, as it is not the party that “submitted” the aBLA.

The court rejected these arguments, finding that case law supports the argument that the submitting party conceptually includes parties that are “actively involved” in the process, drawing analogy to a nearly identical, parallel procedure used for pharmaceuticals, the Abbreviated New Drug Application. Because Icelandic Alvotech began to work on the aBLA prior to its American subsidiary’s existence, the court found that both companies were found to have “submitted” the application.

The court also rejected other jurisdictional and venue-based arguemnts for dismissal. AbbVie is represented by Latham & Watkins, LLP and Finnegan, Henderson, Farabow, Garrett & Dunner, LLP. Alvotech is represented by Fish & Richardson and Jenner & Block.