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

Video Transcription

Video Summary

This webinar, part of ACMG’s Translating Genes into Health series, examined the proposed 2025 Patent Eligibility Restoration Act (PARA) and its potential impact on genetic material patents and patient care.

George Contreras reviewed the legal history of gene patenting. He explained that patents give inventors exclusive rights for 20 years, but natural products cannot be patented. The key turning point was the 2013 Supreme Court decision in <em>Association for Molecular Pathology v. Myriad Genetics</em>, which held that naturally occurring human DNA is not patentable, while synthetic cDNA can be. This ruling ended gene patents on isolated human DNA and contributed to lower prices and broader access to genetic testing.

Lisa Schaliger offered the patient perspective, speaking as a BRCA1 mutation carrier and advocate. She described how gene patents once created testing monopolies, raised costs, limited confirmatory testing, restricted research, and slowed development of multi-gene panels. After the Myriad decision, testing became cheaper, more competitive, and more accessible, with major gains in research, data sharing, and clinical options. She argued that restoring patent eligibility for genetic material could reverse these benefits and harm patients.

Bob Cook-Deegan added broader policy context, noting that the debate reflects a tension between innovation policy and health access. He explained that PARA would likely not simply restore old gene patents, but could open the door to patents on newly discovered variants or altered genetic material, leading to new legal challenges and possibly renewed patent logjams. He also discussed possible responses such as patent pools, compulsory licensing, and research exemptions.

Overall, the speakers agreed that PARA could have significant consequences for research, innovation, access, and equity, though it has not yet passed.

Keywords

ACMG

Translating Genes into Health

Patent Eligibility Restoration Act

PARA

gene patents

Myriad Genetics

BRCA1

genetic testing access

patent eligibility

patient care