On July 29, 2026, Genentech, Inc. (“Genentech”) and Hoffmann-La Roche Inc. filed a complaint in the U.S. District Court for the District of New Jersey against Biocon Biologics Inc. (“Biocon”) and related entities, alleging infringement of 28 patents relating to Genentech’s PERJETA and Biocon’s proposed biosimilar, Bmab1500. As we previously…
The U.S. Food and Drug Administration (“FDA”) recently released its congressional justification for the 2027 Fiscal Year budget. Overall, the FDA proposed a total budget of $7.2 billion, an overall increase of 3.3% above the 2026 Fiscal Year enacted level. As part of the legislative proposals, the FDA included a…
As we reported last week, Janssen Biotech, Inc. and Janssen Sciences Ireland UC (collectively, “Janssen”) filed under seal a BPCIA complaint in the U.S. District Court for the District of Delaware against Accord BioPharma, Inc. and Bio-Thera Solutions, Ltd. (collectively, “Defendants”), alleging that Accord and Bio-Thera infringe 17 patents in…
On November 12, 2025, Regeneron filed a Motion to Strike Certain Affirmative Defenses and Dismiss Certain Counterclaims against Amgen in the aflibercept patent litigation in the U.S. District Court for the Northern District of West Virginia. The dispute centers on Amgen’s aflibercept biosimilar, PAVBLU®. As we have previously reported, in…
On September 30, 2025, the U.S. District Court for the District of New Jersey entered a Consent Judgment and Injunction resolving the denosumab BPCIA litigation between Amgen, Inc. (“Amgen”) and Biocon Biologics, Inc., Biocon Biologics UK Limited, Biocon Biologics Limited, and Biosimilars Newco Limited (collectively, “Biocon”) after Amgen and Biocon executed a Confidential…
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…
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 July 24, 2025, Acting Director of the USPTO, Coke Morgan Stewart, denied institution of inter partes review in IPR2025-00601 and IPR2025-00602, but referred the petition in IPR2025-00603 to the Board in Amgen Inc. v. Bristol-Myers Squibb Co. The Bristol-Myers Squibb (“BMS”) patents, challenged by Petitioner Amgen, relate to methods of…
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…
In the last week, Amgen, Inc and Amgen Manufacturing Ltd, LLC (“Amgen”) filed three more BPCIA complaints against companies seeking approval for a denosumab biosimilar. On June 25, 2025, Amgen filed a complaint in the U.S. District Court for the District of New Jersey against Hikma Pharmaceuticals USA Inc. (“Hikma”),…