The bill aims to amend patent infringement laws related to biological products under the "Affordable Prescriptions for Patients Act." It proposes changes in the number and criteria of patents that can be asserted in an infringement action. This includes limitations on the number of patents a reference product sponsor can assert and criteria for including patents on the list. The bill also outlines circumstances under which the court may increase the number of patents that can be asserted and specifies applicability to applications submitted on or after the date of enactment. The bill predominantly focuses on aspects related to patent infringement for biological products and aims to address issues of infringement claims and limitations.
Affordable Prescriptions for Patients Act
This bill limits in certain instances the number of patents that the manufacturer of a biologic drug can assert in a lawsuit against a company seeking to sell a biosimilar version of that drug. (A biologic drug is produced through natural processes or isolated from natural sources. A biosimilar version is substantially similar to the original biologic, which is the reference product, and is often marketed as a less expensive alternative.)
The bill's provisions apply to an existing framework that gives the biosimilar manufacturer an abbreviated path to Food and Drug Administration approval to sell the biosimilar. Specifically, if the biosimilar manufacturer completes certain actions under the framework, such as sharing certain information about its product with the reference product manufacturer, the bill limits the number of certain patents that the reference product manufacturer may assert in a lawsuit, such as patents that were filed more than four years after the reference product received market approval. The limit shall not apply to patents claiming certain methods for using the biologic drug.
The court in which the infringement lawsuit is filed may increase the limit if justice so requires or if there is good cause for the increase.