A Hearing to Advance the UnETHICal Way of Upending Hatch-Waxman

On June 4, the U.S. House Judiciary Subcommittee on Intellectual Property will hold a hearing titled “Medicines and IP: Balancing Innovation and Access.”

This hearing appears to be pretext for promoting legislation that would dangerously weaken biopharma patent rights: the ETHIC Act. This bill, which Conservatives for Property Rights opposes, prohibits drug innovators from asserting more than one patent in a “patent group” in patent litigation. The ETHIC Act denies enforcing allied patents that all inventors by right should be free to defend.

ETHIC is premised on false narratives cooked up by special interests, invoking made-up, scary-sounding ghost terms such as “evergreening,” “product hopping” and “patent thickets.” Advocates assert that a product protected by several patents must somehow delay generic drug market entry and reduce competition—allegedly by gamesmanship, glomming on duplicative patents, extending a drug’s life with more recent patents.

What this bill’s proponents don’t want people to know is that many products, including complex products in every useful art and field of technology, typically apply more than one patent. Every single one of those inventions must meet the patent law’s standards of novelty, utility and nonobviousness.

Moreover, ETHIC Act backers’ false claims don’t stand up to scrutiny. The average brand drug’s market exclusivity lasts 12-14 years before generic competition begins—well short of the 20 years of a patent term. Also, a 2024 U.S. Patent and Trademark Office report finds that the number of patents on a medicine and its market exclusivity period aren’t connected. Closely related patents must be linked by "terminal disclaimers," which cause those patents to expire simultaneously with the first patent filed.

Supporters of antipatent legislation cite figures from sources like Arnold Ventures-funded researchers and the Initiative for Medicines, Access, & Knowledge. A 2022 Hudson Institute study reports unreliable, unsubstantiated, irreplicable data and conclusions drawn and touted by I-MAK, despite their slim attachment to the facts; further analysis by Hudson confirms I-MAK’s methodological shortcomings and misleading conclusions. Prof. Erika Lietzan of the University of Missouri in a 2025 article finds I-MAK drawing faulty conclusions from the same sorts of questionable practices in its claims about biologic and biosimilar competition.

You might expect the people on the IP Subcommittee to be the most informed about the patent system, the role of patents in incentivizing investment of time, money and effort into invention, how patents secure exclusive rights in the fruits of inventive labor, their role in moving an invention to a commercial product—in short, how patents secure private property rights in one’s creative and inventive efforts and facilitate practical benefits for inventors, investors, customers and society more broadly.

Sadly, many lawmakers, including some on this subcommittee, don’t understand patents and the patent system or how they’re central in fostering human flourishing. America’s property rights-centric patent system, as Abraham Lincoln put it, “secured to the inventor, for a limited time, the exclusive use of his invention; and thereby added the fuel of interest to the fire of genius, in the discovery and production of new and useful things.”

When this hearing convenes, ignorance of patents will probably be on display—combined with ignorance of the drug research and development process, how patents incentivize cutting-edge invention of new therapies, cures and diagnostics, and how the Hatch-Waxman Act solved for balancing pharmaceutical innovation and access 40 years ago—with phenomenal success. Generic medicines now account for more than 90% of U.S. prescriptions filled.

Limiting enforcement to a single patent per "patent group" will diminish incentives for future R&D in a high-risk industry in which it takes multiple patents to cover a product’s full scope. Surely people know that the only way a generic medicine comes about is by copying, in the Hatch-Waxman framework, a brand drug.

Right now, China is investing heavily in biotech and advanced technologies. Only reliable U.S. patents can ensure American leadership in innovative sectors and technologies such as biopharma. Misguided congressional hearings and legislation undermine what America’s innovators—and the United States—need most: the fuel of interest plus the fire of genius.