New Treaty Threatens To Set US Innovation Back Decades

The United States holds a singular advantage in turning bold ideas into world-changing inventions: a patent system rooted in legal certainty, entrepreneurial risk-taking, and a commitment to promoting the progress of the useful arts.

Today, that system faces a serious threat. A recently adopted treaty could saddle American inventors with vague, burdensome patent disclosure requirements -- injecting unpredictability into the innovation process and eroding the very foundation of U.S. leadership in science and technology.

U.S. policymakers should refuse to join that treaty, and encourage other nations to do the same. To do otherwise would damage America's innovation ecosystem, and diminish innovation and IP rights globally.

The World Intellectual Property Organization (WIPO) treaty on genetic resources and associated traditional knowledge requires patent applicants to disclose the country of origin of any genetic material used in a claimed invention. While this may sound simple enough, implementation would have serious consequences for innovators, both in the U.S. and abroad.

The problem stems from a lack of clarity. The treaty would require applicants to disclose whether an invention is "based on" genetic resources or traditional knowledge -- but it does not define those terms. In today's complex innovation landscape, discoveries build upon layers of prior research, often using a variety of genetic tools and vast collections of scientific material and data. The origins of those resources may be indeterminate or subject to dispute. For many applicants, especially those in fast-moving fields like biotechnology, this creates a minefield of risk and uncertainty.

Instead of encouraging innovation, the treaty would impose burdens that are, in many cases, impossible to meet and draconian in effect. Unintentional omissions and honest clerical errors will lead to expensive litigation and even invalidation. That's a daunting prospect in a legal environment where even legitimate IP rights are suspect and subject to challenge by anyone with sufficient resources. This treaty would create yet another avenue for such a challenge, but one that is wholly bureaucratic and unrelated to the merits of the invention.

The damage would not be confined to the courtroom. Adding yet another layer of disclosure and review would strain the resources of the U.S. Patent and Trademark Office (USPTO), which acknowledges that its patent backlog is already problematic. In industries like pharmaceuticals, where bringing new therapies and cures to market can take more than a decade and cost more than $2.6 billion, added delay and uncertainty in patent protection will chill investment in high-cost, high-risk research.

The adverse effects will go beyond the pharmaceutical and biotechnology industries. Added legal uncertainty will weaken U.S. global competitiveness in many cutting-edge technologies -- like agriculture, food, and cosmetics industries.

It's not just large companies that stand to lose. For startups and early-stage ventures -- often the source of the most innovative and disruptive ideas -- the treaty's compliance demands would be especially painful. These firms already operate with limited resources and little margin for error. Requiring them to trace genetic materials through complex, international supply chains would add costs they cannot afford and risks they cannot control.

America's success in translating public research into real-world breakthroughs has been built on the strength and predictability of its patent system. The Bayh-Dole Act exemplifies this: by enabling universities to patent and license federally funded inventions, it sparked a surge in public-private partnerships and catalyzed life-saving technologies. That system worked because it reduced bureaucratic burdens and increased the reliability of IP rights. Undermining that legal certainty with vague, extraneous requirements would put decades of progress at risk.

To be clear, respecting the rights of communities that contribute valuable genetic resources is important. But this might better be achieved through voluntary benefit-sharing agreements, not by compromising the integrity of the U.S. patent system. Tailored, enforceable contracts and industry-led transparency initiatives can ensure fair treatment without sowing legal chaos or hampering innovation.

From its earliest days, the U.S. has shown the world that innovation flourishes where inventors' intellectual property rights are reliable, predictable, and enforceable. As our leaders consider whether to sign on to WIPO's disclosure requirements, they should stay true to that principle -- and reject proposals that would do little more than lay a compliance trap for our inventors.

If the U.S. embraces these new mandates, it will no longer be leading on innovation -- it will be following the crowd. We cannot afford to trade our competitive edge in innovation for legal uncertainty and bureaucratic complexity. The costs are too high, and the stakes too great.

Brian O' Shaughnessy is chair of the IP Transactions and Licensing Group of Dinsmore & Shohl, LLP,. He is chair of the Bayh Dole Coalition Board of Directors, and a past president of the Licensing Executives Society (USA & Canada), Inc.