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PERA overturns Myriad and allows patenting isolated or enriched genes

Jorge L. Contreras, 2023 - James T. Jensen Endowed Professor for Transactional Law and Director of the Program on Intellectual Property and Technology Law, University of Utah S.J. Quinney College of Law. Adjunct Professor, Department of Human Genetics, University of Utah School of Medicine “ PATHOGEN GENOMES AS GLOBAL PUBLIC GOODS (AND WHY THEY SHOULD NOT BE PATENTED)”, 55 N.Y.U. J. Int'l L. & Pol. 533, Nexis Uni, Accessed via University of Michigan //DH

Critics have portrayed the Myriad decision as contributing to the elimination of patents for genetic diagnostic products— a potentially devastating result for the genetic diagnostics industry.54 The emergence of the COVID-19 pandemic led to renewed calls for increased patent protection of biomedical discoveries. As a result, advocates of stronger patent protection have repeatedly sought to overturn the Myriad decision through legislative means.55

In 2022, Senator Thom Tillis (R-NC) introduced the Patent Eligibility Restoration Act - a bill that, if enacted, would explicitly overturn the Supreme Court's ruling in Myriad and other patent eligibility cases.56 The proposed Act would expressly allow patenting of "a human gene or natural material that is isolated, purified, enriched, or otherwise altered by human activity."57 The result would directly negate the Supreme Court's holding in Myriad that "genes and the information they encode are not patent eligible under §101 simply because they have been isolated from the surrounding genetic material."58 Accordingly, the Act attempts to return pathogenic and other non-human genomic sequences, as well as [*547] newly-discovered human genetic variants,59 back to the category of patentable subject matter.60

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