Though largely absent from mainstream news, proposed reforms to patent law are poised to affect everything from biotech startups to major pharmaceutical R&D programs.Specifically, there are four ongoingbipartisaneffortsto modernize the U.S. intellectual property (IP) systemthatcould reshape the future of biomedical innovation in the United States. Legislators from both sides of the aisle are working collaboratively.These updates could profoundly impact the life sciences industry, where strong patent protections are critical for translating research into lifesaving therapies and diagnostics.
Reinstating Effective Remedies for IP Theft in the Biotech Sector
The RESTORE Patent Rights Act, introduced February 25 of this year, seeks to reverse the consequences of the Supreme Court's 2006 eBay v.MercExchangedecision, which significantly limited the ability of patent holders to obtain injunctions against infringers.
In the life sciences, where product development can span a decade and cost billions, an inability to enforce patent exclusivity can be devastating. The current system allows competitorsto exploit patented discoveries and erode market share before a final legal resolution is reached. Although only one sentence long, the RESTORE Act would reenable courts to grant injunctions more readily, helping life sciencesinnovators protect the integrity and commercial viability of their discoveries.
Restoring Patent Eligibility for Biotechnology and Diagnostics
The Patent Eligibility Restoration Act (PERA), introduced May 1, addresses a major concern in the life sciences community: legal uncertainty around what innovations are considered patentable. This uncertainty stems from a series of U.S. Supreme Court decisions,including Mayo, Myriad,and Alice,which have led to the exclusion of key biotechnologies, medical diagnostics, and even some AI-driven tools from patent protection.
This has created a chilling effect on investment. Without confidence in patent eligibility, investors hesitate to fund risky but potentially transformative science. The proposedPERA would restore clarity, establishing consistent and inclusive standards for what constitutespatent-eligible subject matter, which would bea crucial step toward reinvigorating innovation in genomics, precision medicine, and digital health technologies.
Reducing Litigation Pressure on Life Sciences Startups
The PREVAIL Act, also introduced May 1, tackles the burden of redundant legalchallenges to patent validity, which has become a growing concern for smallerlife sciences companies. Under the current system, a patent can be attacked in both federal courts and the Patent Trial and Appeal Board (PTAB). This can lead toduplicative litigation, costing companies time and capital.
PREVAILcouldstreamline these proceedings and reduce legal costs, freeing up resources for clinical trials, regulatory submissions, and R&D, which areall essential for advancing medical innovation and bringing new therapies to patients.
Limiting Enforceability of Disclaimed Life Sciences Patent
Unfortunately, not all of the proposed reforms may be favorable for the life sciences sector.The Eliminating Thickets to Increase Competition (ETHIC) Act, introduced May 8, seeks to limit the number of patents that can be asserted in a single infringement action against a generic or biosimilar drug manufacturer to one patent per "Patent Group."A "Patent Group," as defined by the act, refers to two or more commonly owned patents or patent applications that are connected via a terminal disclaimer.Importantly, the effect would be to link terminally disclaimed patents together such that the validity of the entire patent family would rise or fall based on a single family member.It is worth noting that this is precisely what the USPTO attempted to do in 2024 with its proposed rule on terminal disclaimers, which was later withdrawn after significant public backlash.
Proponents assert that the ETHIC Act would "reward innovation" and "reduce patent complexity and potential anticompetitive practices."It is unclear, however, how a reform that discourages continuation practice and thereby increases patent prosecution costs and complexity could be viewed as rewarding to life sciences innovators.
Conclusion
For the life sciences sector,where IP is often a company's mostvaluable asset,many of these reforms could provide the legal certainty and enforcement power necessary to support innovation. By restoring robust patent rights, simplifying litigation, deterring foreign interference, and modernizing laws to reflect technological change, Congress has a chance to reignite U.S. leadership inlife sciences.
Reforms such as the ETHIC Act may promote very different goals.In practice, the ETHIC Act would create many of the same issues that led to the withdrawal of the USPTO's proposed rule regarding terminal disclaimers; namely, creating legal uncertainty and decreasing confidence in the patent system.
If alternative reforms such as the RESTORE Act, PERA, and the PREVAIL Act are successful, this new framework will ensure that researchers, clinicians, and inventors can continue turning scientific insights into real-world solutionswithout fear of losing their competitive edge before reaching the market. However, with Senator Thom Tillis, one of the driving forces behind the PERA and PREVAIL Acts, recently announcing that he will not run for reelection, the future of these efforts remains uncertain.
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