Last week, the House Judiciary Committee held a hearing on “Medicines and IP: Balancing Innovation and Access.” The conversation had major implications for patients, inventors, and the future of medical research.
The Alliance for U.S. Startups and Inventors for Jobs (USIJ) supports policies that expand access to medicines and encourage healthy competition. But proposals currently under consideration, including the Eliminating Thickets to Increase Competition (ETHIC) Act, risk undermining the very innovation ecosystem that makes new medicines possible in the first place.
Most breakthrough medicines do not come from large, established companies. They originate in startups, small biotech firms, university spinouts, and research-driven ventures that take enormous scientific and financial risks. These innovators often spend years — and raise billions in investment capital — to bring new treatments to patients.
And underpinning this entire ecosystem is strong, reliable patent rights.
Supporters of the ETHIC Act argue that pharmaceutical companies accumulate too many patents around individual products, creating so-called “patent thickets” that delay competition. But the issue is far more complex than simple patent counts suggest.
Modern medicines are often protected by multiple patents because they embody multiple inventions. A single therapy may involve innovations in formulation, manufacturing, delivery mechanisms, dosing methods, or new therapeutic applications. Each of these advances can require years of research and can provide meaningful benefits to patients.
Importantly, the patent system already contains safeguards against improper extensions of exclusivity. U.S. patent law does not allow companies to endlessly extend patent terms through additional filings. Existing mechanisms, including terminal disclaimers, are specifically designed to prevent that outcome.
There is also no clear empirical evidence on whether so-called patent thickets represent a widespread problem. As the U.S. Patent and Trademark Office has noted, counting patents alone does not provide a clear picture of competition or innovation. The scope and substance of patent claims matter far more than the raw number of patents associated with a product.
The ETHIC Act, rather than evaluating patents on their merits, would limit the number of patents innovators can defend in lawsuits. That would dramatically weaken the ability of inventors and research-driven companies to protect legitimate technological advances.
If the protections surrounding a successful invention erode, then investors are less likely to fund high-risk research. Over time, reduced investment means fewer discoveries, fewer new treatments, and ultimately fewer opportunities for future competition as those innovations enter the marketplace.
America leads the world in biomedical innovation because it has built a system that rewards invention, encourages investment, and supports risk-taking. As policymakers consider reforms to the pharmaceutical landscape, they should be careful not to weaken the foundation that has enabled generations of medical breakthroughs.
Read our full letter urging lawmakers to reject the ETHIC Act here.