Aug 18 - From Lab to Clinic: What Restoring Patent Eligibility for Genetic Material Means for the Genetics Community and Patient Care OnDemand-Aug 18

Aug 18 - From Lab to Clinic PDF

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This webinar examines whether genetic material should be patent-eligible again under the proposed Patent Eligibility Restoration Act (PERA) 2025, and what that could mean for patient care, research, and the genetics field.<br /><br />The presentation reviews the legal history of gene patenting, including the rise of patents on isolated human genes in the 1980s–2000s and the landmark 2013 Supreme Court decision in Association for Molecular Pathology v. Myriad Genetics, which held that naturally occurring DNA in the body is not patentable, while cDNA may be. Speakers explain that this decision opened genetic testing to competition, lowered BRCA testing costs, increased access, enabled confirmatory testing, expanded data sharing, and improved research into hereditary cancer risk.<br /><br />The webinar argues that PERA 2025 could reverse some of those gains by making purified, isolated, enriched, or otherwise human-altered genetic material patentable again. Concerns include renewed monopolies on gene variants, higher costs, reduced access, licensing barriers for laboratories, limits on research, and possible inequities in clinical care. Historical survey data and case examples suggest patents previously led some labs to stop offering tests or avoid developing new ones.<br /><br />At the same time, the speakers note that PERA would not fully restore the pre-2013 landscape because whole human genome sequences remain prior art, and future disputes would likely shift to issues like novelty, obviousness, enablement, and written description. The presentation concludes that if gene patents are allowed again, additional policy tools such as compulsory licensing, research exemptions, and verification/second-opinion testing exemptions may become important to protect access and patient outcomes.

Keywords

gene patenting

PERA 2025

genetic material

patent eligibility

Myriad Genetics

BRCA testing

patient care

research access

cDNA

compulsory licensing