The Senate Health, Education, Labor and Pensions (HELP) Committee recently voted to advance the Medication Affordability and Patent Integrity Act (S. 2658), a bill from Senators Maggie Hassan (D-NH) and Josh Hawley (R-MO) that would impose new disclosure and certification requirements involving information provided to the FDA and USPTO. The bill’s proponents argue it would stop drug companies from “gaming” the patent system to block generic competition. But in reality, the bill rests on a fundamental misunderstanding of how the patent system works.
The FDA and USPTO serve fundamentally different purposes, and much of the information submitted to the FDA has no relevance to patent examination. When FDA information is material to patentability, patent applicants already have a duty to disclose it to the USPTO. S. 2658 would therefore layer new paperwork and certification requirements onto an existing obligation without giving patent examiners information they are not already entitled to receive. It would also put companies at risk of losing patent protection because of paperwork errors — potentially fueling costly litigation, making patent rights less reliable, and weakening America’s biotechnology competitiveness.
Below, we examine three flawed claims underlying the Medication Affordability and Patent Integrity Act:
| Claim: The FDA and USPTO would benefit from greater information sharing. |
| In Reality: The FDA and USPTO are designed to evaluate different questions under different legal standards. The FDA determines whether a medicine is safe and effective, while the USPTO determines whether an invention qualifies for patenting. Information relevant to one agency’s work will generally have little bearing on the other’s. Clinical data provided to the FDA, for example, may be pertinent to some claimed inventions but entirely irrelevant to others. Its significance for patent examination depends on what the patent claims actually cover — not simply on the fact that the information was submitted to the FDA.
When information provided to the FDA is pertinent to questions of patentability, the USPTO already requires inventors to provide it as part of the patent application process. Companies can face severe penalties, including having their patents rendered unenforceable, if they intentionally provide false information in their applications or fail to disclose materially relevant, non-duplicate information. Requiring companies to provide additional FDA-related information to the USPTO, as S. 2658 would do, would not make it any riskier or more difficult for companies to lie. It would only inundate FDA officials and patent examiners with irrelevant documents, slowing patent examination and regulatory review processes to the detriment of both inventors and patients. |
| Claim: The bill would only penalize bad actors that seek to “game” the patent system. |
| In Reality: The bill could put companies at risk of losing otherwise valid patent rights — earned through years of costly research and development — because of a clerical error or inadvertent omission, even when there was no intent to deceive the USPTO. That would be a disproportionate penalty for a paperwork mistake unrelated to whether the underlying invention merits patent protection. By imposing a negligence standard — substantially lower than current law‘s general requirement of specific intent to deceive — the bill would also encourage significantly more patent litigation.
One reason that the Federal Circuit adopted its high standard of intentionality was that previously, lower standards had led to what it called a “plague” of companies accusing their rivals of inequitable conduct in order to get patents invalidated. Companies accused of patent infringement, for example, could use any inconsistency in their opponent’s submissions to the FDA and USPTO to bring a lawsuit to have the relevant patent invalidated. S. 2658 risks reviving that practice. Any apparent discrepancy between submissions to the two agencies could become grounds for a patent lawsuit. As a result, the bill would not only harm companies that lie or seek to exploit loopholes, but would affect virtually every pharmaceutical and biotechnology company by increasing legal expenses, administrative burdens, and weakening the stability of patent rights across the industry. |
| Claim: The bill would benefit patients. |
| In Reality: Patients benefit when innovators can attract the enormous investment required to turn promising discoveries into approved treatments — and that process would become much more difficult under S. 2658. Small companies are responsible for an outsized share of biotech innovation: Research has found that small biopharmaceutical firms developed 55% of the U.S.-originated medicines approved between 2011 and 2020. But small firms are also heavily dependent on reliable patent rights to attract outside investors and commercial partners. By weakening the reliability of biotech patents and leaving small companies more vulnerable to legal attacks from larger, better-resourced competitors, S. 2658 would make it much more difficult for small biotechs to secure investment and take their inventions to market.
The bill could also hurt patients by weakening the strength of the U.S. biotech sector globally. China is working tirelessly to overtake the United States as the world’s chief biotech innovator; it now accounts for nearly a third of the global drug development pipeline. Burdening American innovators with additional litigation and less reliable patent rights would further tilt the competitive landscape in China’s favor. That could increase the chance that the next generation of medical breakthroughs is developed overseas — weakening patient access in the future. |