MDL No. 3138
J.P.M.L.Feb 6, 2025Background
- Amgen Inc. and Amgen Manufacturing Limited LLC sought to centralize four patent infringement actions regarding their drugs Prolia® and XGEVA® under the Biologics Price Competition and Innovation Act (BPCIA).
- The litigation involves several defendants across the District of New Jersey, Northern District of Illinois, and Eastern District of North Carolina, all of whom allegedly infringed multiple Amgen patents by seeking to market biosimilar products.
- Defendants opposed centralization, arguing significant non-overlap among patents and unique manufacturing methods, as well as concerns about competitively sensitive information and the manageability of a multidistrict litigation (MDL).
- Amgen argued that centralization would be efficient due to overlapping factual and legal issues, including claim construction and patent validity, and previous related proceedings in the District of New Jersey.
- The case was assigned to the Honorable Christine P. O’Hearn in the District of New Jersey, who has experience presiding over related matters and has gained familiarity with the drugs and technology involved.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether to centralize the actions in the District of New Jersey | Centralization avoids duplicative discovery and inconsistent rulings | Differences among patents and methods make centralization inefficient | Granted centralization in District of NJ |
| Overlap and management of patent issues among cases | Significant overlap in patents and factual issues | Patents and manufacturing methods are distinct | Overlap sufficient to merit centralization |
| Handling of confidential information and competitive concerns | One judge can efficiently coordinate confidentiality | Competitors need special protections for secrets | Centralization does not preclude protections |
| Appropriateness given the number of actions involved | Even with few cases, centralization serves efficiency | Few cases; complexity makes MDL unwieldy | Centralization appropriate for efficiency |
Key Cases Cited
- In re Aflibercept Patent Litigation, 730 F. Supp. 3d 1374 (J.P.M.L. 2024) (Panel previously rejected arguments against centralization in complex BPCIA cases)
- Sandoz Inc. v. Amgen Inc., 582 U.S. 1 (2017) (aBLA filing constitutes act of infringement under the BPCIA)