Blog Big Molecule Watch January 12, 2022

AbbVie Inc. et al. v. Alvotech hf. Updates

We have previously reported on AbbVie’s first and second wave suits against Alvotech hf. (Alvotech) in the Northern District of Illinois regarding an adalimumab biosimilar.  In the second wave suit, on December 21, 2021, AbbVie filed a Second Amended ComplaintOn December 29, Alvotech filed a Renewed Motion to Dismiss AbbVie’s Second Amended Complaint under Rules 12(b)(1), 12(b)(2), 12(b)(6) and 12(b)(7) for lack of subject matter jurisdiction, lack of personal jurisdiction, failure to state a claim, and failure to join a necessary party, respectively.  AbbVie filed its Opposition on January 3, 2022.  As indicated in a January 7, 2022 joint status report (see below), those papers merely incorporate by reference previously filed memoranda in support and opposition to the motion filed with respect to the original complaint.  The Court previously denied Alvotech’s motion to dismiss in the first wave suit.  In the second wave suit, Alvotech’s motion to dismiss AbbVie’s First Amended Complaint remained pending when AbbVie filed its Second Amended Complaint.  On January 5, 2022, Alvotech filed its Answer and Counterclaims to AbbVie’s Second Amended Complaint, including counterclaims for unclean hands, patent misuse and inequitable conduct.

On January 7, 2022, AbbVie filed a Notice of Narrowing of Claim Construction Issues in the first and second wave suits.  In this notice, AbbVie stated that it will no longer assert seven claims of U.S. Patent No. 11,083,792 (“the ’792 patent”) and three claims of U.S. Patent No. 8,961,973 (“the ’973 patent”).  Dropping these claims made it unnecessary for the court to consider one disputed claim term from each of the ’792 and ’973 patents.

On January 7, 2022, AbbVie and Alvotech Hf. filed a Joint Status Report in the first and second wave suits.  Among other things, the status report addressed the following:  (a) discovery is ongoing with fact depositions beginning this month; (b) the parties requested that the Court take up AbbVie’s fully briefed Motion to Dismiss and Strike Defendant’s Counterclaims and Affirmative Defenses of Inequitable Conduct, Unclean Hands and Patent Misuse; and (c) the parties noted (as described above) that briefing is complete on Alvotech Hf.’s motion to dismiss AbbVie’s Second Amended Complaint.  In addition, the parties requested a hearing on January 13, 2022, the same day as the claim construction hearing, to address AbbVie’s potential future request for a case deadline extension and Alvotech Hf.’s request for a limited increase in the number of prior art invalidity grounds it may include with its Final Invalidity Contentions.  On January 10, 2022, the Court cancelled the January 13 Markman hearing and asked the parties to provide availability during the weeks of January 18 and January 24, 2022.

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