Generation Patient applauds Senate HELP vote to advance S. 2658
Luis Gil Abinader
Policy Director
luis@generationpatient.org
Members of the Senate Committee on Health, Education, Labor and Pensions (HELP) voted on June 17, 2026, to advance the Medication Affordability and Patent Integrity Act (S. 2658), a bipartisan bill introduced by Senators Maggie Hassan (D-NH) and Josh Hawley (R-MO). Generation Patient applauds this Senate HELP vote to advance S. 2658.
Two amendments aimed at weakening the bill’s enforcement mechanism failed. One would have stripped the defense available to generic companies.
Drug companies bringing new products to market typically submit information to two distinct federal agencies. They submit clinical and manufacturing data to the Food and Drug Administration (FDA) to show that a drug is safe and effective. They also disclose information to the U.S. Patent and Trademark Office (USPTO) to obtain patents on that drug. While the information that drug companies submit to both agencies often overlaps, the FDA and the USPTO do not systematically compare the disclosures that applicants submit. Drug companies can exploit this gap by characterizing their product one way to secure FDA approval and provide inconsistent information to obtain patent protection.
Belcher v. Hospira (2021) illustrates how drug companies have exploited this gap to obtain patents that can be asserted to delay competition. In Belcher, the brand company told the FDA that a pH change in its injectable formulation was “a very minor change not requiring additional stability studies.” Belcher then told USPTO that the same change was “unexpected,” “nonobvious,” and had “never been accomplished before.”
Patent applicants already owe a duty of candor and good faith to the USPTO under 37 C.F.R. § 1.56. Inconsistency with statements made to another federal agency about the same product may violate 37 C.F.R. § 1.56, and a patent issued thereon can be held unenforceable if an alleged infringer brings an inequitable conduct defense. However, inequitable conduct is available only in litigation and often several years after the patent has issued. The defense requires clear and convincing evidence of specific intent to deceive, depending on a competitor with sufficient resources to bring the challenge.
Senators Patrick Leahy and Thom Tillis wrote a letter to the USPTO in September 2021 asking to “take steps to reduce patent applicants' making inappropriate conflicting statements in submissions to the PTO and other federal agencies.” USPTO then published a Federal Register notice in 2022 clarifying that providing material information to FDA “while simultaneously withholding the same information from the USPTO” violates existing disclosure obligations under § 1.56. S. 2658 carries this bipartisan effort forward by establishing a certification and disclosure mechanism that makes compliance with the duty of candor verifiable during the examination stage, before a patent issues.
Generation Patient has supported S. 2658 since its introduction. S. 2658 requires drug sponsors to certify to the FDA that information submitted in support of their application is, to the best of their knowledge, consistent with information they provided to the USPTO. Sponsors must also submit to the USPTO any information material to patentability that they provided to the FDA. Scope of this obligation is limited to information “material to patentability, as defined in regulations promulgated” by the USPTO. Trade secret and confidential information protections are expressly preserved in the current version of the bill. S. 2658 creates no new federal agency, tribunal, or adjudicative process.
Competition remains one of the most reliable mechanisms to reduce high drug prices. Patents secured on inconsistent statements can delay that competition and increase costs for young adult patients. S. 2658 is now expected to move to coordination with the Judiciary Committee, which has jurisdiction over patent litigation provisions in the bill. Generation Patient urges the Judiciary Committee and full Senate to act swiftly.
Please see Generation Patient’s live comments at the USPTO-FDA Listening Session in 2023 and our written submitted feedback.