특허 대상성 회복법과 생명과학 혁신

The biotechnology and life science sectors underpin breakthroughs in health care, agriculture, and environmental sustainability by leveraging living systems to create next-generation medicines, diagnostics, and bio-based products. Innovations like gene therapies, therapeutic proteins, and precision diagnostics enhance disease detection and treatment, drive personalized medicine, and bolster global food security through advanced crop protection and yield optimization.[1]

The life sciences sector has witnessed significant advancements, despite facing tighter research funding. In 2024, for instance, the U.S. Food and Drug Administration (FDA) approved 32 new chemical entities and 18 new biological entities. These first-in-class therapies addressed various areas such as oncology, rare genetic disorders, metabolic diseases, and autoimmune conditions, highlighting the industry’s resilience and inventive capacity.[2] With respect to diagnostics, FDA approved several new in vitro diagnostic (IVD) tests and imaging agents such as: expanded oncology panels for liquid biopsies and tumor profiling, next generation sequencing, novel contrast agents, and point of care tests for rapid pathogen detection.[3] These diagnostics strengthen early detection, enable real-time treatment decisions, and support outbreak preparedness.

However, there is concern that the reduction in federally-supported biomedical research will impact America’s health care infrastructure and innovation, which in turn could impact the pace of biomedical treatments for long-felt needs like cancer and autoimmune disorders.[4] With diminished federal grants, support from venture capital and private investment can help fill that gap. A strong patent system can help encourage and protect these investments. 

The Patent Eligibility Restoration Act of 2025[5] or “PERA” can further strengthen our patent system and provide needed additional support for life science and biotech investments.

Retired federal appeals judges Paul Michel and Kathleen O’Malley recently argued that Congress should pass PERA to reverse the harm done to U.S. innovation by misguided U.S. Supreme Court rulings. PERA seeks to overturn U.S. Supreme Court rulings (Mayo v. Prometheus, Alice v. CLS Bank) that have significantly narrowed patent eligibility in diagnostics, biotech, and software. Post-Mayo, investment in diagnostics plunged by an estimated US$9 billion over four years, with many startups exiting the field.[6] Innovation would be supported by explicitly restoring patentability for certain diagnostic methods and biotech inventions previously deemed ineligible. However, isolated human genes and mere computer implementation of processes remain ineligible for patenting.[7]

The urgency of passing PERA is underscored by the current global landscape, where China is leading the U.S. in 57 out of 64 critical technology sectors.[8] By restoring patent eligibility for categories of inventions that courts have wrongly declared ineligible—and establishing clear guidelines to prevent future uncertainty — PERA could give U.S. inventors and companies confidence to invest in technologies that will define our future. 

Indeed, when my colleague Courtenay Brinckerhoff testified before the Subcommittee on Intellectual Property of the Senate Judiciary Committee considering an earlier version of PERA, concerns were raised about potential erosion of the U.S. position in the global marketplace, including due to competition with China and uncertainty surrounding patent eligibility of important technologies in diagnostic, biotechnology, and quantum computing fields. 

[1] See https://www.techtarget.com/pharmalifesciences/feature/The-Impact-of-Biotechnology-Breakthroughs-in-Healthcare.

[2] See https://pubmed.ncbi.nlm.nih.gov/39788065/.

[3] See https://www.fda.gov/medical-devices/in-vitro-diagnostics/list-cleared-or-approved-companion-diagnostic-devices-in-vitro-and-imaging-tools.

[4] See https://www.latimes.com/science/story/2025-07-06/nih-budget-cuts-threaten-the-future-of-medical-research-and-young-scientists; https://yaledailynews.com/blog/2025/02/12/analysis-nih-funding-cuts-threaten-biotech-innovation-and-economy/; https://www.pharmasalmanac.com/articles/nih-funding-cuts-put-innovation-health-equity-and-lives-at-risk.

[5] See https://www.congress.gov/bill/119th-congress/senate-bill/1546.

[6] See https://www.pharmasalmanac.com/articles/nih-funding-cuts-put-innovation-health-equity-and-lives-at-risk.

[7] Id.

[8] 위의 자료.

By restoring patent eligibility for categories of inventions that courts have wrongly declared ineligible—and establishing clear guidelines to prevent future uncertainty—PERA would once again give US inventors and companies confidence to invest in technologies that will define our future. After over a decade of ongoing harm, it is time for Congress to fix the Supreme Court’s mistakes.

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