What a yes vote endorsed
Affordable Prescriptions for Patients Act
What this does
The bill amends the federal patent law that governs lawsuits over biosimilar drugs. It limits a brand-name biologic's sponsor to asserting no more than 20 patents in an infringement action against a company seeking approval of a biosimilar, and no more than 10 of those may be patents that issued after a set statutory date. It also expands what counts as infringement in a biosimilar filing to reach any patent claiming the product, a method of using it, or a method or product used to make it. Courts may raise the 20 patent cap for good cause, and patents claiming a method of using the product in therapy, diagnosis, or prophylaxis are exempt from the cap. The cap applies only when the biosimilar applicant completes the disclosure steps required under the patent exchange process.
Passed the Senate by unanimous consent
How we know · 8 sourced claims
- The bill amends the federal patent law that governs infringement actions over biosimilar drugs.Source: Sec. 2(a)
- It limits a reference product sponsor to asserting no more than 20 patents in an infringement action against a biosimilar applicant.Source: Sec. 2, new para (7)(A)
- No more than 10 of the asserted patents may be patents that issued after the date specified in section 351(l)(7)(A).Source: Sec. 2, new para (7)(A)
- It extends the act of infringement in a biosimilar filing to any patent claiming the biological product, a method of using it, or a method or product used to manufacture it.Source: Sec. 2(a)(1)
- A court may increase the patent cap for good cause or when the interest of justice requires, if the request is made without undue delay.Source: Sec. 2, new para (7)(C)
- Patents claiming a method of using the product in therapy, diagnosis, or prophylaxis are exempt from the cap.Source: Sec. 2, new para (7)(E)(ii)
- The cap applies only when the biosimilar applicant completes the disclosure and exchange steps required under section 351(l) of the Public Health Service Act.Source: Sec. 2, new para (7)(E)(i)
- The measure changes a single subject by amending section 271(e) of title 35, United States Code.Source: Sec. 2