Plaintiff
4 cases as plaintiff.
Amgen Inc. is an American multinational biopharmaceutical company headquartered in Thousand Oaks, California. Founded on April 8, 1980, originally as Applied Molecular Genetics Inc., it became a public company in 1983 and is traded on Nasdaq under the ticker AMGN, forming a component of the Nasdaq-100, DJIA, and S&P 500 indices. As of December 31, 2025, Amgen reported approximately 31,500 employees and total revenues of $36.8 billion for the full year 2025.
The company discovers, develops, manufactures, and delivers innovative human therapeutics to treat serious illnesses, operating in a single business segment focused on human therapeutics. Amgen's product portfolio addresses various therapeutic areas, including oncology, inflammation, bone diseases, cardiovascular conditions, kidney disease, and rare diseases. Key products include Prolia and Xgeva for bone diseases, Enbrel for autoimmune diseases, Repatha for hyperlipidemia, and various therapies for cancer and anemia. Amgen has a global commercial presence, reaching patients in approximately 100 countries worldwide.
In terms of patent litigation, Amgen Inc. exhibits the posture of an operating company defending its products. The company has been involved in one tracked patent litigation case, in which it appears solely as a defendant. This aligns with its role as a developer and manufacturer of biopharmaceutical products.
The notable tracked case, Regeneron Pharmaceuticals, Inc. v. Amgen Inc., commenced on January 10, 2024. In this litigation, Regeneron Pharmaceuticals, Inc. sued Amgen Inc. for alleged infringement related to Amgen's aflibercept biosimilar, PAVBLU®. The suit involves a dispute over a patent that was issued after Amgen had launched its product. Amgen responded with counterclaims, including allegations of antitrust violations. The case has moved through the U.S. District Court for the Central District of California, subsequently transferred to the U.S. District Court for the Northern District of West Virginia, and has potential appeals to the U.S. Court of Appeals for the Federal Circuit.
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Amgen filed this BPCIA action asserting infringement of several patents, including US Patent 7364736, against Amneal LLC and mAbxience S.A.U. for their proposed denosumab biosimilar products.
This case was resolved through a confidential settlement agreement. A court order found the asserted claims of US Patent 7364736 to be valid, enforceable, and infringed by Sandoz's denosumab biosimilars. The settlement allows Sandoz to launch its biosimilar products on May 31, 2025, or earlier under certain limited conditions.
This BPCIA action is currently pending, with preliminary expedited discovery proceedings related to 29 asserted patents, including US7364736.
A Consent Order and Judgment was entered by stipulation. For the purposes of this action, the asserted claims of all 21 enumerated patents, including US7364736B2, were deemed valid, enforceable, and infringed by Samsung's denosumab biosimilar products.