TAPP Urges Senate HELP Committee to Reject 3 Bills That Would Undermine U.S. Medical Innovation

Today, the Trade Alliance to Promote Prosperity wrote to the U.S. Senate Committee on Health, Education, Labor, & Pensions (HELP) to urge members to reject three bills that would undermine U.S. medical innovation: S. 2658, The Medication Affordability and Patent Integrity Act; S. 1954, The Biosimilar Red Tape Elimination Act; S. 3014, Ensuring Timely Access to Generics Act of 2025.

TAPP wrote the following:

The Trade Alliance to Promote Prosperity (TAPP) respectfully urges the Senate HELP Committee to reject three misguided pieces of legislation that would undermine American medical innovation, weaken intellectual property protections, and ultimately harm patients: S. 2658, the Medication Affordability & Patent Integrity Act; S. 1954, the Biosimilar Red Tape Elimination Act; and S. 3014, the Ensuring Timely Access to Generics Act of 2025. We understand the HELP Committee is slated to mark up these bills this week.

All three of these bills raise significant concerns.

S. 2658 — The Medication Affordability and Patent Integrity Act

  • The bill would significantly increase certification and disclosure requirements, forcing companies to submit additional information to the already-overburdened USPTO. This law would throw extra, unnecessary information at the agency, slowing the patent examination process.

  • Supporters of the bill claim it would help prevent the USPTO from issuing patents for "inherent" aspects of drugs, even though there is no evidence suggesting that companies are systematically deceiving the USPTO and FDA. The law already addresses companies that mean to deceive the USPTO or FDA.

  • The bill would require companies to share highly confidential information and trade secrets with the USPTO when they are already required to do that with the FDA. This would put companies' trade secrets and other confidential information at risk therefore threatening innovation and global competitiveness. Data from American life-science companies would be a gift to our global adversaries like China, Russia, and Iran.

S. 1954 — The Biosimilar Red Tape Elimination Act

  • The bill proposes all biosimilars being interchangeable without the FDA needing to make any additional determination of the risks to patient safety. New data or studies are not currently required for interchangeability because they’re not needed. The FDA has the authority to require them or not based on its judgment to preserve patient safety. Adding additional steps would only slow the process even moreso.

  • Eliminating the need for an interchangeability determination would limit competition and stunt drug research and development as a result.

  • The bill would do nothing to address anticompetitive PBM behaviors which block access to low-cost biosimilars. 

S. 3014 — Ensuring Timely Access to Generics Act of 2025

  • This bill seeks to alter the balance established under the Hatch-Waxman framework by imposing new restrictions and penalties related to patent litigation settlements. For decades, Hatch-Waxman has successfully balanced incentives for pharmaceutical innovation with pathways for generic competition, and thus the United States leads the world in generic utilization.

  • This legislation risks discouraging legitimate patent settlements that frequently allow generic products to enter the market earlier than would otherwise occur through lengthy litigation. Patent settlements often represent efficient resolutions that save judicial resources and provide certainty to all parties involved.

  • By creating additional legal uncertainty around these agreements, the bill could increase litigation costs, prolong disputes, and ultimately delay rather than accelerate patient access to affordable medicines.

At a time when the United States faces growing competition from China and other nations seeking to challenge American leadership in biotechnology and life sciences, Congress should be strengthening our innovation ecosystem, not weakening it.

For these reasons, TAPP respectfully urges the Senate HELP Committee to reject S. 2658, S. 1954, and S. 3014.

Ainsley Shea