Astellas Pharma Inc. et al. v. Hikma Pharmaceuticals USA Inc.
Dismissed- Docket:
- 3:25-cv-00578
- Filed:
- 2025-01-16
The claims and counterclaims in this case were dismissed with prejudice, with each party bearing its own costs.
Plaintiff
3 cases as plaintiff.
Medivation LLC is a biopharmaceutical company that is now a wholly-owned subsidiary of Pfizer Inc. Founded in 2003, the company was headquartered in San Francisco, California. In September 2016, Pfizer acquired Medivation for approximately $14 billion, primarily to gain control of its flagship oncology drug. Prior to its acquisition, Medivation was a publicly traded company on the NASDAQ stock exchange under the ticker MDVN.
Medivation's core business is the development and commercialization of therapies for serious diseases, with a strong focus on oncology. The company's key product is XTANDI® (enzalutamide), an androgen receptor inhibitor used to treat prostate cancer. This drug was developed in collaboration with Astellas Pharma Inc. and has been a major revenue driver. At the time of its acquisition, Medivation's pipeline also included other promising oncology assets like talazoparib, a PARP inhibitor for treating cancers with DNA damage repair mutations, and pidilizumab for immuno-oncology applications.
The company's patent litigation profile shows it as a plaintiff in all three tracked cases, with no instances of being a defendant. This posture is consistent with an operating company enforcing its patent rights, often in connection with its primary commercial products. All listed cases were filed in the U.S. District Court for the District of New Jersey.
The tracked cases are notable for being filed jointly with Astellas Pharma Inc., Medivation's development and commercialization partner for XTANDI®. The lawsuits are directed against generic pharmaceutical manufacturers—Hikma Pharmaceuticals, Haimen Pharma, and Zydus Pharmaceuticals—which is typical of brand-name drug manufacturers seeking to prevent the market entry of generic versions of their patented medicines under the Hatch-Waxman Act. These cases underscore the commercial importance of XTANDI® to Medivation and its parent company, Pfizer.
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The claims and counterclaims in this case were dismissed with prejudice, with each party bearing its own costs.
This case has been consolidated with case 3:24-cv-09748 for all purposes. An amended complaint including the '628 patent was filed on January 3, 2025, and the case appears to be ongoing.
This case has been consolidated with case 3:24-cv-09403 and appears to be ongoing. An amended complaint including US patent 12161628 was filed on January 3, 2025.