Merck Serono SA v. TWI Pharmaceuticals Inc.
judgment- Docket:
- 25-1464
- Filed:
- 2025-02-19
- Terminated:
- 2025-10-30
The Federal Circuit affirmed a lower tribunal's ruling of unpatentability for US8377903B2, rendering the patent invalid and unenforceable.
Defendant
1 case as defendant.
TWI Pharmaceuticals Inc. is a specialty pharmaceutical company headquartered in Taipei, Taiwan. Established in April 2010 as a spin-off from Anchen Inc., the company focuses on the development, manufacturing, and commercialization of high-barrier generic prescription products and new drug products. As of September 2022, TWi Pharmaceutical Co. Ltd. was acquired by Bora Pharmaceuticals, a contract development and manufacturing organization (CDMO), though TWi Pharmaceuticals USA operations remain a separate entity. PitchBook reports TWi Pharmaceuticals as privately held, with 215 employees, while Prospeo estimates 51-100 employees and an annual revenue of $11.1 million for its Paramus, New Jersey (US) operations.
The company's operations include research and development, contract manufacturing, and contract research, with a focus on drug delivery systems and products offering Paragraph IV first-to-file or first-to-market opportunities in the United States. TWI Pharmaceuticals manufactures and commercializes generic drugs such as dexlansoprazole delayed release, guanfacine hydrochloride, mycophenolic acid delayed release, and sevelamer carbonate. They also develop new drugs, including targeted therapies and vaccines.
TWI Pharmaceuticals Inc. primarily operates as an operating company that defends against patent infringement suits. The company has been involved in 1 tracked patent litigation case, appearing solely as a defendant. This posture is consistent with a pharmaceutical manufacturer and developer of generic drugs.
The notable case involving TWI Pharmaceuticals Inc. is Merck Serono SA v. TWI Pharmaceuticals Inc., where the company is listed as a defendant in a case before the United States Court of Appeals for the Federal Circuit (CAFC), with activity recorded as of February 19, 2025. This case highlights the challenges operating pharmaceutical companies face in navigating patent landscapes.
The Federal Circuit affirmed a lower tribunal's ruling of unpatentability for US8377903B2, rendering the patent invalid and unenforceable.