Plaintiff
3 cases as plaintiff.
Astellas Pharma US, Inc. is the U.S. affiliate of the Tokyo-based global pharmaceutical company, Astellas Pharma Inc. (TSE: 4503). The parent company was formed in 2005 through the merger of Yamanouchi Pharmaceutical Co., Ltd. and Fujisawa Pharmaceutical Co., Ltd. The U.S. headquarters are in Northbrook, Illinois, and the company employs several thousand people in the U.S. as part of a global workforce of over 14,000. Astellas Pharma Inc. reported revenues of over $11 billion in recent fiscal years.
Astellas is an operating company focused on developing and commercializing pharmaceuticals across several therapeutic areas, including oncology, urology, ophthalmology, immunology, and women's health. Its major products include Xtandi (prostate cancer), Padcev (urothelial cancer), Myrbetriq (overactive bladder), and Prograf (immunosuppressant for organ transplants). The company's business model is based on in-house research and development, as well as a history of strategic acquisitions of biotechnology companies to expand its pipeline and technology platforms.
As an innovative pharmaceutical manufacturer, Astellas's patent litigation posture is that of an operating company protecting its products from generic competition. The provided data shows the company exclusively as a plaintiff in three recent suits, all filed in the U.S. District Court for the District of New Jersey, a common venue for pharmaceutical patent litigation. This plaintiff-only record is typical for brand-name drug companies suing generic manufacturers under the Hatch-Waxman Act, which allows for patent infringement suits to be filed in response to a generic drug company's application for regulatory approval.
The tracked cases against Hikma Pharmaceuticals, Haimen Pharma, and Zydus Pharmaceuticals are characteristic of this strategy. These lawsuits typically allege that the generic manufacturers' proposed products, detailed in their Abbreviated New Drug Applications (ANDAs), will infringe upon patents covering Astellas's brand-name drugs. For example, litigation against Zydus and others has involved patents for Myrbetriq®, an overactive bladder treatment, while suits against Haimen Pharma have involved patents for the prostate cancer drug Xtandi®. Such cases are a routine part of the business for research-based pharmaceutical firms seeking to enforce their patent exclusivity.
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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.