ATR Supports IP Rights, Opposes the Medication Affordability and Patent Integrity Act

This Wednesday, the Senate Health, Education, Labor, and Pensions Committee will mark up S. 2658, the Medication Affordability and Patent Integrity Act, introduced by Senators Maggie Hassan (D-N.H.) and Josh Hawley (R-Mo.). This bill is a solution in search of a problem, and the search will cause considerable damage along the way.

S. 2658 would require drug companies to share with the U.S. Patent and Trademark Office (USPTO) any information material to patentability that they’ve submitted to the Food and Drug Administration (FDA) and certify that what they told each agency is consistent. A company found non-compliant loses the ability to enforce its patent.

In conflating these two distinct agencies, this bill will undermine the work of both. It will worsen backlogs, jeopardize sensitive trade secrets, and undermine intellectual property rights, all while failing to accomplish any of its goals.

The problem this bill purports to solve does not demonstrably exist. It’s already illegal to deliberately withhold material information from the USPTO.

The goal of this legislation, proponents say, is to prevent companies from “gaming the patent system” by keeping information from the USPTO. There is, however, no evidence that pharmaceutical companies are systematically deceiving the USPTO. Existing law already addresses the conduct this bill targets. Deliberately withholding material information from the USPTO with intent to deceive renders a patent unenforceable under the inequitable conduct doctrine. Inter partes review (IPR) proceedings give challengers additional tools to attack weak or improperly obtained patents.

The current system is not without recourse, it simply requires that bad intent be demonstrated.

The FDA and the USPTO exist for fundamentally different purposes. The information each receives reflects that difference.

When a drug company submits a new drug application to the FDA, it provides exhaustive safety and efficacy data, including proprietary formulation data submitted with an expectation of confidentiality. The FDA determines whether the drug is safe and effective.

When a drug company submits an application to the USPTO it lays out the technical claims that distinguish the invention from what already exists – these claims are published publicly within 18 months of filing. The USPTO determines whether the innovation is novel enough to deserve a patent.

S. 2658 wrongly treats these two processes as interchangeable. Conflating them will simply undermine the strength of both systems.

Both the USPTO and the FDA already have their hands full. Flooding them with redundant information and piling on new enforcement mandates, in service of a transparency performance that won’t achieve its stated goal, is counterproductive.

The USPTO in particular is contending with massive backlogs. According to recent testimony from Director John Squires, the agency received approximately 475,233 patent applications in FY 2025, the backlog of unexamined applications stood at 788,229, and average total pendency had grown to 27.9 months. Loading this agency with massive volumes of irrelevant FDA submission data will only deepen those delays.

S. 2658 also puts sensitive trade secrets at risk. The bill requires FDA-facing confidential data to pass through a publication-oriented system at the USPTO. While S. 2658 contains a provision stating that transferred information shall be protected “as if held by the FDA,” the protection is nominal.

The USPTO lacks FDA’s institutional infrastructure for managing confidential submissions, and the bill merely instructs USPTO to “update its applicable regulations or create new procedures.” Telling USPTO to act like the FDA doesn’t make it the FDA. This creates exposure risk for information that, in the wrong hands, could benefit foreign competitors.

Under this bill, the punishment for non-compliance – whether intentional or an honest mistake – is the loss of a constitutionally protected property right. A company that fails to comply loses the ability to enforce its patent. Importantly, not because of the substance of the patent, but because of a procedural filing failure.

This is particularly concerning, as the consequence is identical to that of proven, deliberate fraud. As previously noted in reference to IPR proceedings, under current law, this severe consequence is reserved for cases where bad intent has been established. Under the Hassan-Hawley bill, the same punishment can be triggered by a paperwork error.

Yes, the current system sets a high bar for invalidating a patent. It should! Patents are enumerated, constitutional property rights, not privileges to be revoked on a technicality.

Americans deserve lower drug costs and a patent system with integrity. S. 2658 delivers neither. Instead, it burdens two agencies already stretched thin, exposes trade secrets through a nominal assurance, and strips a constitutional property right as punishment for a procedural failure. ATR urges lawmakers to reject the Medication Affordability and Patent Integrity Act.