Affordable Prescriptions for Patients Act

The "Affordable Prescriptions for Patients Act" proposes significant amendments to patent law concerning biological products, aiming to clarify and streamline infringement proceedings. It expands the definition of patent infringement under title 35, United States Code, to explicitly cover patents claiming the biological product itself, its methods of use, or any method or product integral to its manufacture. A central provision introduces a limit on the number of patents a reference product sponsor can assert against an applicant for a biosimilar product, capping it at 20 patents in an infringement action. This limit is contingent upon the biosimilar applicant fulfilling all required information exchange obligations under the Public Health Service Act. While courts may increase this limit for good cause, such as a biosimilar applicant's failure to provide necessary information, patents claiming methods of use for therapy or diagnosis are specifically exempt from this numerical restriction. These changes are designed to influence the landscape of biosimilar patent litigation.