This year, the Senate Judiciary Committee advanced several such troubling bills, including the Affordable Prescriptions for Patients Act and the Drug Competition Enhancement Act.
The reason these bills would have such negative effects -- despite their good intentions -- is that they are based on misunderstandings of the patent system and its invaluable role in supporting biopharmaceutical research and development.
The lawmakers behind the Affordable Prescriptions for Patients Act, for instance, believe biotech companies file patents on the same biologic drug over and over again to keep biosimilar drugs from reaching the market.
This gets the patent system all wrong, however. The law already prohibits an inventor from getting more than one patent on the same invention. But complex therapies like biologics require companies to address multiple challenges, and overcoming these challenges often involves inventing new solutions. Each of these solutions represents a legitimate -- and vital -- scientific advance deserving of patent protection.
More generally, despite the overheated rhetoric, more patents don’t mean less competition or increased prices. A 2024 U.S. Patent and Trademark Office (USPTO) study -- as well as my own research -- found no evidence that the number of drug patents has anything to do with when a generic version of the drug enters the market.
The Drug Competition Enhancement Act is equally misguided. Biopharmaceutical companies often work hard to improve their products to make them more effective, easier to take, or less likely to cause side effects. The Act nonetheless would wrongly treat such innovations as anti-competitive and potential antitrust violations based on the cleverly named but misleading concept of “product hopping” -- the allegation that companies create and patent new versions of their drugs merely to undercut any market share generic manufacturers might have.
Beneficial improvements to drugs should be encouraged, not punished.
Unfortunately, lawmakers are advancing these bills alongside a slate of other troubling proposals.
The Preserve Access to Affordable Generics and Biosimilars Act proposal, for example, would unnecessarily regulate settlements of patent lawsuits between innovator and generic drug manufacturers, ironically leading to the possibility that generic drugs will enter the market later than they would under reasonable settlement terms. Meanwhile, the proposed Interagency Patent Coordination and Improvement Act of 2025 would saddle the FDA and USPTO with red tape, potentially delaying both patent examination and regulatory approval of new medical treatments.
Ohio is home to nearly 4,900 life sciences businesses that depend on patents to attract investment and bring cutting-edge advances to patients. By needlessly complicating the industry’s ability to rely on the patent system, the proposed bills would endanger investment in tomorrow’s breakthrough therapies.
Emily Michiko Morris is the David L. Brennan Endowed Chair and Associate Faculty Director of the Intellectual Property Policy Institute at the University of Akron School of Law.
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