Dear Chairman Jordan, Ranking Member Raskin, Subcommittee Chairman Issa, and Subcommittee Ranking Member Johnson:
The U.S. Chamber of Commerce appreciates the opportunity to submit this statement for the record regarding proposals addressing the increasingly prevalent but misleading characterization of “patent thickets,” including those associated with H.R. 3269, the Eliminating Thickets to Increase Competition Act(ETHIC Act). We welcome continued engagement with Congress and the U.S. Patent and Trademark Office (USPTO) on policies that will strengthen, not undermine, the United States’ position as the global leader in innovation, discovery, and life sciences advancement.
Patents are not merely policy tools; they are constitutionally grounded property rights that provide innovators with secure and enforceable ownership of their inventions. This property-rights framework is essential to attracting the long-term, high-risk investment necessary to sustain American technological leadership.
For decades, America’s economic strength and global competitiveness have been underpinned by a simple but powerful principle: strong and reliable intellectual property rights drive innovation, create jobs, stimulate investment, and generate breakthrough solutions to the world’s most pressing challenges, including those that save and improve lives. This principle should remain the north star for any patent policy reform.
As an initial matter, the proposals under consideration represent a significant departure from another core and long-standing principle of the U.S. patent system: technology neutrality. Under this approach, the same rules apply to all technologies, allowing the merits of an invention, not technology-specific rules crafted in Washington, to determine what is patentable and commercially viable. It is innovation that determines winners and losers, not politicians.
I. The Patent System Is Foundational to Innovation, Growth, and Public Health
The U.S. patent system reflects a carefully calibrated balance, encouraging innovation by granting time-limited exclusivity while ensuring public disclosure that accelerates knowledge sharing and follow-on invention. This framework has enabled the United States to become the world’s leading innovation economy, delivering advances that improve lives, strengthen public health, and support high-quality jobs across the country.
As the Chamber has long emphasized, intellectual property is not merely a legal construct; it is a foundational driver of the modern, knowledge-based economy and a critical tool for promoting human progress and generating breakthrough solutions to global challenges.
This is particularly true in the life sciences sector. Developing new medicines and therapies demands sustained investment, scientific risk-taking, and years, often decades, of research, testing, and regulatory review. A predictable and enforceable patent system provides the legal certainty necessary for investors, innovators, and research institutions to commit the capital and expertise required to bring these products to patients.
II. Claims of “Patent Thickets” Oversimplify the Innovation Process and Mischaracterize Patent Portfolios
In recent debates, the concept of “patent thickets” has been used to suggest that patents, particularly in the life sciences, are being deployed in ways that hinder competition or restrict access. The term “patent thicket” is not a legally defined concept and is frequently deployed as a rhetorical shortcut that obscures, rather than illuminates, how innovation ecosystems function. Policymaking in this area should be grounded in rigorous, empirical evidence rather than anecdotal or selectively framed data. To date, there is no consensus evidence demonstrating that so-called “patent thickets” systematically impede competition or harm patients.
The existence of multiple patents associated with a single product is not, in itself, evidence of abuse. Rather, it frequently reflects the reality that innovation is cumulative and iterative. Different patents may protect distinct inventions, such as new formulations, improved methods of use, manufacturing advances, or delivery mechanisms, all of which can meaningfully enhance efficacy, safety, adherence, or patient outcomes.
Critically, the USPTO's own Drug Patent and Exclusivity Study confirms that simply quantifying raw numbers of patents and exclusivities is an imprecise way to measure the intellectual property landscape of a drug product, because not every patent or exclusivity has the same scope.[1] For example, one patent could contain different sets of claims directed to: (1) a pharmaceutical product, (2) a method of using the product, and (3) a process for manufacturing the product. The study further found that "counting the number of patents on a product is not a reliable way" to determine exclusivity and the entry of generic products, noting that "patent expiration dates, like the number of patents, may not be predictive of the timing of actual launch of competing products... because not all listed patents may be infringed by a generic product or the patent owner and generic drug applicant agree upon a launch date before patent expiration." This finding directly undermines the premise that the mere existence of multiple patents on a product signals anticompetitive conduct or delays generic entry.
These patented inventions do not represent fragmentation; they represent the iterative nature of R&D and progress. Post-approval innovation is often where the most meaningful patient benefits arise, including improved safety profiles, adherence, manufacturing reliability, and expanded therapeutic uses. Undermining protection for these advances would disproportionately harm precisely the forms of innovation that deliver real-world improvements to patients.
Strong patent protection and robust competition are not mutually exclusive; they are complementary. The U.S. system is designed to enable innovators to take on extraordinary upfront risk, followed by direct competition after patent expiration. Proposals under consideration shift this balance in a way that reduces, rather than enhances, long-term competition by deterring initial investment.
Moreover, longstanding Chamber policy recognizes that intellectual property protections must be robust and enforceable to sustain innovation-led growth and maintain competitive markets. Policymaking that instead begins from the presumption that patenting activity is inherently problematic risks undermining this foundation.
III. Broad Structural Changes to Patent Practice Risk Unintended Consequences Across the Innovation Ecosystem
As a matter of sound policy, changes to long-standing patent tools should not be pursued lightly. The patent system operates as an integrated framework across industries ranging from semiconductors to advanced manufacturing to life sciences. Adjustments intended to address a perceived issue in one area can have far-reaching and unintended consequences elsewhere.
In the life sciences industry, continuation practice, for example, plays an important role in allowing patent applicants to refine and appropriately claim their inventions as scientific understanding evolves. For life science innovators, continuation practice is not a procedural loophole, it is an essential mechanism that ensures patent claims accurately reflect evolving scientific understanding and fully disclose the scope of an invention. Similarly, terminal disclaimers are an established part of the patent system and not an “abuse” or “gaming.” Eliminating or restricting this tool would introduce artificial rigidity into a system that must remain responsive to complex, rapidly advancing technologies.
Rather than weakening established practices, the Chamber has consistently advocated for strengthening the quality and consistency of patent examination as a key to create more robust and enforceable patent rights. This includes ensuring that the USPTO has the resources, expertise, and institutional capacity necessary to provide timely, rigorous, and predictable review. As the Chamber has noted, adequate funding and support for the Patent and Trademark Office are essential to maintaining the integrity and effectiveness of the patent system. Focusing on examination quality is the more constructive and durable policy response.
IV. Life Sciences Innovation Depends on Stability, Predictability, and Long-Term Investment
The stakes in this debate are particularly high for the biopharmaceutical sector, where innovation is characterized by long timelines, high costs, and substantial uncertainty. Companies and research institutions must make investment decisions years in advance, often with no guarantee of success.
A stable and predictable patent system is what makes those investments feasible. It provides the assurance that, if an innovation succeeds, there will be a meaningful opportunity to recoup investment and reinvest in the next generation of research.
The benefits of this system extend far beyond individual firms. Biopharmaceutical innovation strengthens public health, supports a productive workforce, and contributes to broader economic growth. Intellectual property protections enable this ecosystem to function, helping translate scientific discovery into tangible outcomes: new therapies, improved treatments, and better health outcomes for patients.
Policies that weaken patent certainty but are not grounded in claims that are supported by objective evidence, risk reducing the incentive to undertake the most challenging and impactful research. Over time, this would translate into fewer innovations reaching the market and fewer life-saving treatments available to patients.
V. Conclusion
The Chamber stands ready to work with Congress and the USPTO to advance policies that strengthen patent quality, reinforce institutional capacity, and ensure that the U.S. patent system continues to serve as a catalyst for innovation, economic growth, and human progress. At a moment when Members of Congress are raising serious concerns about U.S. biotech investment flight to China, that work has never been more urgent. Preserving a strong and reliable patent system is essential to maintaining American leadership in technology and life sciences, and proposals that undermine it move us in precisely the wrong direction.
Sincerely,
Neil Bradley
Executive Vice President, Chief Policy Officer,
and Head of Strategic Advocacy
U.S. Chamber of Commerce
cc: The Members of the House Judiciary Committee
[1] U.S. Patent & Trademark Office, Drug Patent and Exclusivity Study Report (2024), https://www.uspto.gov/sites/default/files/documents/USPTO_Drug_Patent_and_Exclusivity_Study_Report.pdf.
