On November 29, 2022, Janssen filed a BPCIA complaint in the District of Delaware against Amgen related to Amgen’s ustekinumb biosimilar ABP 654 of Janssen’s STELARA. This is Janssen’s first BPCIA case filed with respect to an ustekinumab biosimilar. Janssen alleges that its “scientists and clinicians spent decades developing STELARA…
Mylan Pharmaceuticals Inc. recently filed an IPR petition, PTAB-IPR2023-00099, seeking cancellation of claims 1-3 of U.S. Patent No. 10,857,205, assigned to Regeneron Pharmaceuticals, Inc. According to the petition, the claims “are drawn to monthly dosing [of aflibercept] to treat an angiogenic eye disorder.” The Petition sets forth three anticipation grounds and…
Biogen seeks a preliminary injunction in its BPCIA case against Sandoz related to Sandoz’s proposed biosimilar of TYSABRI (natalizumab). On October 20, 2022, the Court issued a sealed order on the parties’ joint stipulation and proposed schedule for a preliminary injunction motion. A redacted version of the parties’ proposed schedule…
We previously reported on Regeneron’s antitrust suit against Amgen in the U.S. District Court for the District of Delaware. Amgen recently filed a motion to dismiss Regeneron’s Complaint and a motion to stay the case. The case concerns Regeneron’s allegation that Amgen has violated antitrust law by engaging “in a…
The Seventh Circuit issued this week a long-awaited opinion in the HUMIRA antitrust litigation, UFCW Local 1500 Welfare Fund v. AbbVie Inc., Case No. 20-2402. The appeal is from the Northern District of Illinois’s dismissal of a proposed class action alleging that AbbVie, Inc. created a “patent thicket” around HUMIRA to block…
On March 19, 2022, the parties in the Amgen Inc. v. Hospira Inc. (D. Del., No. 20-201) NEULASTA®/pegfilgrastim litigation submitted a stipulation to dismiss all claims and counterclaims in the litigation with prejudice. The Court (Judge Connolly) entered the order of dismissal on Monday. The case has been pending since February…
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 Complaint. On December 29, Alvotech filed a Renewed Motion to Dismiss…
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 first wave suit, on October 5, 2021 AbbVie moved to dismiss Alvotech’s counterclaims and affirmative defenses of inequitable conduct, unclean hands, and patent…
The New Jersey district court in the Immunex v. Samsung Bioepis BPCIA litigation entered a Final Judgment and Order of Permanent Injunction on November 3, 2021. As we previously reported, the litigation pertains to ETICOVO (etanercept-ykro), Samsung Bioepis’s biosimilar of ENBREL. The case had been administratively stayed since January 2020. Judgment…
On September 2, 2021, the parties in the Amgen v. Hospira (D. Del., No. 18-1064) Neupogen®/filgrastim litigation submitted a stipulation and proposed order to dismiss all claims and counterclaims in the litigation, with prejudice. The Court (Judge Connolly) has not yet entered the order of dismissal on the docket. The…