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Gene Patenting - Why Congress Needs to Get This Right (Guest: Dr. Roger Klein)

July 8, 2019

A U.S. Senate subcommittee panel is considering a proposal to reverse two U.S. Supreme Court rulings that limit patent eligibility for gene sequencing. Dr. Roger Klein explains why this could upend the medical diagnostics industry.

In the last ten years, the U.S. Supreme Court in Association for Molecular Biology v. Myriad Genetics, Inc. and Mayo Collaborative Services v. Prometheus Laboratories Inc. excluded “abstract ideas, laws of nature, and natural phenomena” from patent protection. At issue was whether a party could patent discoveries involving gene sequencing.  The Supreme Court said no, that “abstract ideas, laws of nature, and natural pheneomena” were excluded from patent protection.  Now, under a proposal drafted by Sen. Thom Tills, R – NC and Sen. Chris Coons, D-Del, those exclusions would be limited and could include the identification of a mutation in a gene sequence.

Klein says this would disrupt the advances made in diagnostic testing since the Supreme Court decisions came down.  He discusses the involvement his organization had in the Myriad case, the history of excluding natural phenomenon going back 153 years when Samuel Morse tried to patent electrical transmission when he invented the telegraph.  He talks about the advances in the genetic diagnostic industry that have resulted from the recent Supreme Court cases and what consumers could face if Congress was to broaden patent protection.  “I’m not anti-patent but this proposal goes too far,” said Klein.

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Health Care
AnneMarie Schieber is a research fellow at The Heartland Institute and managing editor of Health Care News, Heartland's monthly newspaper for health care reform. @HCPolicy
Dr. Roger D. Klein, M.D., J.D., is a physician, attorney and health policy expert with specific interests in drug pricing, precision medicine, and healthcare delivery systems. He is also a Policy Advisor to The Heartland Institute. @RogerDKlein