Senate Bill Seeks to Link FDA and USPTO Disclosures, Raising Concerns Over Patent Integrity and Innovation
Key Insights
The Medication Affordability and Patent Integrity Act (search) (S. 2658) would require drug companies to certify consistency between FDA and USPTO (search) submissions, with non-compliance resulting in patent unenforceability.
Critics argue the bill targets a problem that does not demonstrably exist, as current law already penalizes deliberate withholding of material information from the USPTO (search) under the inequitable conduct doctrine.
The legislation risks worsening USPTO (search) backlogs—already at 788,229 unexamined applications—and exposing sensitive trade secrets by routing confidential FDA data through a publication-oriented patent system.
The Senate Health, Education, Labor, and Pensions (HELP) Committee is set to mark up S. 2658, the Medication Affordability and Patent Integrity Act (search), this week—a bill that would fundamentally alter the relationship between the U.S. Food and Drug Administration (FDA) and the U.S. Patent and Trademark Office (USPTO (search)). Introduced by Senators Maggie Hassan (D-N.H.) and Josh Hawley (R-Mo.), the legislation would require pharmaceutical companies to share with the USPTO any information material to patentability that they have submitted to the FDA, and to certify that representations made to each agency are consistent.
Under the proposed law, a company found non-compliant with these new disclosure requirements would lose the ability to enforce its patent—a penalty currently reserved for cases of proven, deliberate fraud under the inequitable conduct doctrine.
A Solution in Search of a Problem
Proponents of S. 2658 argue that drug companies are "gaming the patent system" by withholding information from the USPTO (search) that they disclose to FDA regulators, thereby securing patents they do not warrant and delaying generic market entry. However, critics contend there is no evidence that pharmaceutical companies are systematically deceiving the USPTO.
"It's already illegal to deliberately withhold material information from the USPTO (search)," notes an analysis from Americans for Tax Reform (ATR). Under existing law, deliberately withholding material information from the USPTO with intent to deceive renders a patent unenforceable. Additionally, inter partes review (IPR) proceedings provide challengers with tools to attack weak or improperly obtained patents. "The current system is not without recourse, it simply requires that bad intent be demonstrated."
The argument that the United States lacks robust generic competition also faces scrutiny. Approximately 90% of prescriptions dispensed in America are already generic medicines, according to Forbes.
Two Agencies, Fundamentally Different Missions
The FDA and USPTO (search) serve distinct purposes, and 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.
In contrast, USPTO (search) submissions lay out technical claims distinguishing the invention from existing art, and these claims are published publicly within 18 months of filing. The USPTO determines whether an innovation is novel enough to merit a patent.
"S. 2658 wrongly treats these two processes as interchangeable," ATR states. "Conflating them will simply undermine the strength of both systems."
Deepening USPTO (search) Backlogs
The USPTO (search) is already contending with significant operational strain. According to recent testimony from Director John Squires, the agency received approximately 475,233 patent applications in fiscal year 2025, with a backlog of unexamined applications standing at 788,229 and average total pendency growing to 27.9 months. Loading the agency with massive volumes of FDA submission data, critics argue, will only deepen those delays.
Trade Secret Exposure and Security Risks
S. 2658 would require FDA-facing confidential data to pass through a publication-oriented system at the USPTO (search). While the bill contains a provision stating that transferred information shall be protected "as if held by the FDA," critics describe this protection as nominal. The USPTO lacks the FDA's institutional infrastructure for managing confidential submissions, and the bill merely instructs the USPTO to "update its applicable regulations or create new procedures."
"Telling USPTO (search) to act like the FDA doesn't make it the FDA," ATR notes. "This creates exposure risk for information that, in the wrong hands, could benefit foreign competitors."
Forbes highlights that China has been "working furiously to unseat the United States as the world's leading source of medical breakthroughs" and has proven adept at stealing American intellectual property. By one estimate, IP theft by China costs America's economy between $225 billion and $600 billion annually. Forcing drug firms to disclose sensitive data to yet another government agency, the publication argues, increases the chances that this information will fall into the wrong hands.
Constitutional Property Rights at Stake
Perhaps the most significant concern raised by opponents is the penalty structure. Under S. 2658, non-compliance—whether intentional or an honest mistake—results in the loss of a constitutionally protected property right: the ability to enforce a patent. This consequence is triggered not by the substance of the patent but by a procedural filing failure.
"Under the Hassan-Hawley bill, the same punishment can be triggered by a paperwork error," ATR warns. "Patents are enumerated, constitutional property rights, not privileges to be revoked on a technicality."
The bill would also create an entirely new avenue for challenging pharmaceutical patents in court, handing competitors a mechanism to attack patents unrelated to whether an invention is actually novel. Any firm accused of infringing on an innovator's intellectual property could argue that the patent holder failed to satisfy the legislation's disclosure requirements, resulting in costly litigation over paperwork and disclosure procedures.
Impact on Innovation Investment
The pharmaceutical R&D ecosystem depends heavily on predictable intellectual property protections. It takes an average of $2.7 billion over the course of a decade or more to bring a drug from the laboratory to patients, and only about one in ten drugs that enter clinical testing ultimately wins FDA approval. The promise of an exclusive period of sales offered by a patent is among the primary incentives for companies and investors to take such outsized risks.
By calling the enforceability of these basic intellectual property protections into doubt, critics argue, the Medication Affordability and Patent Integrity Act (search)'s most likely effects would be a less reliable IP system, an easier path for patent violators, and a drop-off in research investment that ultimately deprives patients of future therapeutic breakthroughs.