Denosumab Patent Litigation
Denosumab is a monoclonal antibody used to treat bone-related conditions such as osteoporosis and bone metastases. It functions by inhibiting osteoclast activity, thereby reducing bone resorption. The patent litigation involves Amgen's patents covering the denosumab antibody, its composition, and methods of use. The core of the dispute centers on whether biosimilar versions infringe upon these patents.
8
Pending actions
12
Total actions filed
Active
Status
02/06/2025
Established
Filing deadline
The general statute of limitations for patent infringement claims in the United States is six years from the date of the alleged infringement. Specific procedural deadlines within MDL-3138 are not explicitly detailed beyond this general statute of limitations. Recent procedural rule changes for MDLs, effective December 1, 2025, aim to streamline proceedings but do not alter the six-year statute of limitations for patent infringement.
Who qualifies
In the context of MDL-3138 Denosumab Patent Litigation, qualifying criteria for plaintiffs (in this case, Amgen as the patent holder) involve demonstrating that the asserted patents are valid and that the defendants' biosimilar products infringe upon these patents. The patents in question cover the denosumab antibody, its composition, and methods of use. Allegations of infringement typically relate to the manufacturing, marketing, and sale of biosimilar denosumab products that compete with Amgen's patented drugs. The litigation focuses on patent validity and infringement, rather than patient-specific injuries or conditions.
Products involved
- Denosumab
- Prolia®
- Xgeva®
- Denosumab biosimilars
Bellwether trials
An expedited trial was scheduled for late February 2025. Multiple court documents from February and September 2025 indicate ongoing litigation, with a consent judgment and injunction issued in September 2025. The case remains active with pending court activity as of November 2025.
Settlement landscape
Multiple cases within MDL-3138 have been resolved through confidential settlements and consent judgments. Specific monetary figures or licensing terms are not publicly disclosed due to the confidential nature of these agreements. For example, settlements have been reached with companies such as Celltrion, Accord Biopharma, Biocon, Hikma, and Richter.
Lead counsel
- Steven J. Horowitz (Sidley Austin LLP)
This page is generated from the official JPML pending-MDL report and public court records, refreshed monthly. It is provided for attorney reference and is not legal advice.
