On November 6, 2025, Amgen, Inc. (“Amgen”) launched a new round of BPCIA denosumab litigations when it filed two cases in the U.S. District Court for the District of New Jersey, one against Dr. Reddy’s Laboratories (“Dr. Reddy’s”) and Alvotech, and the second against Amneal Pharmaceuticals (“Amneal”). As we previously…
On September 30, 2025, the U.S. District Court for the Northern District of California ordered Biogen MA, Inc. (“Biogen”) to pay Genentech, Inc. (“Genentech”) $88,348,123 in unpaid royalties plus interest. The parties stipulated to $35,903,701 in interest on October 3. As we reported previously, in 2004, Genentech granted a non-exclusive…
On September 5, 2025, the U.S. District Court for the District of New Jersey entered a Consent Order and Judgment resolving the denosumab BPCIA litigation between Amgen, Inc. (“Amgen”) and Samsung Bioepis Co., Ltd. and Samsung Biologics Co., Ltd. (“Samsung”), one day after Amgen and Samsung executed a Confidential Settlement…
On September 30, the U.S. District Court for the Eastern District of Virginia granted in part and denied in part the Motion to Dismiss filed by Amgen, Inc. and Immunex Corporation (“Amgen”) in a class action antitrust lawsuit brought by CareFirst of Maryland, Inc., Group Hospitalization and Medical Services, Inc.,…
The aflibercept multi-district litigation consists of multiple actions consolidated in the Northern District of West Virginia, with Regeneron Pharmaceuticals, Inc. (“Regeneron”) filing suit under the Biologics Price Competition and Innovation Act (“BPCIA”) against Amgen Inc. (“Amgen”), Mylan Pharmaceuticals Inc. (“Mylan”), Biocon Biologics Inc. (“Biocon”), Celltrion, Inc. (“Celltrion”), Formycon AG (“Formycon”),…
On September 26, 2025, Factor Bioscience Inc. (“Factor”) filed a complaint against Cellectis Inc., Cellectis SA, AstraZeneca PLC, AstraZeneca Ireland Limited, and AstraZeneca Holdings B.V., alleging infringement of Factor’s U.S. Patent Nos. 10,662,410, 10,829,738, and 10,982,229. The case was filed in the District Court for the District of Delaware. Factor’s…
As we previously reported, on June 17, 2025, Regeneron filed a complaint against Amgen under the BPCIA, alleging that Amgen’s aflibercept biosimilar, PAVBLU, infringes U.S. Patent No. 12,331,099 (“the ’099 patent”). The ‘099 patent issued on June 17, 2025, almost eight months after Amgen announced the launch of PAVBLU on…
The Bayh-Dole Act provides that the federal government retains certain rights in inventions it funds. Many have sought to use those rights as a way to lower the cost of prescription drugs for consumers and for the federal government. With the increasing market share of more expensive biologic prescriptions, those…
On September 9, 2025, the District Court for the Northern District of West Virginia entered a Stipulation and Order dismissing all claims and counterclaims in view of a settlement agreement between Sandoz, Inc. (“Sandoz”) and Regeneron Pharmaceuticals, Inc. (“Regeneron”) resolving the BPCIA litigation regarding Sandoz’s aflibercept biosimilar, ENZEEVU (aflibercept-abzv). According…
On August 14, 2025, Genentech, Inc. and Hoffman-La Roche Inc. (together, “Genentech”) filed a BPCIA complaint in the U.S. District Court for the District of New Jersey against Shanghai Henlius Biotech, Inc. and Shanghai Henlius Biologics Co., Ltd. (together, “Henlius”) and Organon LLC and Organon & Co. (together, “Organon”) seeking approval…