Clinical OMICS

JUL-AUG 2019

Healthcare magazine for research scientists, labs, pathologists, hospitals, cancer centers, physicians and biopharma companies providing news articles, expert interviews and videos about molecular diagnostics in precision medicine

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Page 4 of 51 July/August 2019 Clinical OMICs 3 Publisher & CEO MARY ANN LIEBERT President MARIANNE RUSSELL Group Publisher SANDE GIACCONE Editor in Chief CHRIS ANDERSON EVP, Strategic Development KEVIN DAVIES Commercial Director BILL LEVINE Production Editor ROBERT M. REIS Senior Editor JULIANNA LEMIEUX, PH.D. Senior News Editor ALEX PHILIPPIDIS Chief Copy Editor STEVEN HERNACKI Contributing Editors MALORYE ALLISON BRANCA, CAMILLE MOJICA REY, PH.D., EMILY MULLIN Art Director JAMES LAMBO Director, Advertising VICTORIA SHKRELI Online Product Manager SEAN HELMES Associate Director of Brand Marketing JENNIFER GATTI Online Editorial Supervisor KATHERINE VUKSANAJ Design & Layout DIANNE PAULET, BYRON DUQUE Advertising Sales Manager REBECCA SHUMBATA US East ( 617-435-4786) Advertising Sales Manager GREG VALERO US West & Canada ( / 914-740-2271) Advertising Sales Manager GARY KING UK & Europe ( / +44 (0) 203 0020070) List Sales SCOTT PERILLO ( / 914-740-2178) Sales Administrator FALLON MURPHY Advertising Material WANDA SANCHEZ ( Clinical OMICs Advisory Board DANIEL H. FARKAS, PH.D., HCLD Chief Clinical Laboratory Officer, Celmatix JEFFREY GIBBS, J.D. Director, Hyman, Phelps, and McNamara PETER HARRSCH, PH.D. Executive Clinical/Forensic Specialist, Waters Corp. ROGER KLEIN, M.D., J.D. Principal, Roger D. Klein, MD JD Consulting JASON PARK, M.D., PH.D. Assistant Professor, Dept. of Pathology, University of Texas Southwestern Medical Center STEPHEN C. PEIPER, M.D. Professor & Chair, Dept. of Pathology, Anatomy & Cell Biology, Thomas Jefferson University AMIT RASTOGI Senior Vice President, Strategy, Growth, and Innovation, Inova DAVID SMITH, PH.D. Professor of Laboratory Medicine and Pathology, Mayo Clinic KIMBERLY STRONG, PH.D. Director, Program in Genomics and Ethics, Medical College of Wisconsin LARRY WORDEN Principal, IVD Logix The views, opinions, findings, conclusions, and recommendations set forth in any article in Clinical OMICs are solely those of the authors of those articles and do not necessarily reflect the views, policy, or position of Clinical OMICs, its Publisher, or its editorial staff and should not be attributed to any of them. All advertise- ments are subject to review by the Publisher. The acceptance of advertisements does not constitute an endorsement of the product or service advertised. Clinical OMICs (ISSN-2334-1351) is published online bimonthly by GEN Publishing, 140 Huguenot St., 3rd Floor, New Rochelle, NY 10801-5215. For subscription information go to: Copyright © 2018 by GEN Publishing, New Rochelle, NY M uch alarm was raised recently over draft legislation announced in the U.S. Senate that seeks a potential legislative rejiggering of Section 101 of the United States Patent Act (see story page 46). Section 101 is the much-cited portion of U.S. patent law in the 2013 U.S. Supreme Court ruling in The Association for Molecular Pathology v. Myriad Genetics, that famously overturned Myriad's patent claims on the BRCA1 and BRACA2 genes. The issue at hand is determining what constitutes "nonobvi- ous" use of knowledge or methods that are patentable, and those things deter- mined to be "products and laws of nature, abstract ideas, and other general fields of knowledge." To me, it seems obvious that hold- ing a patent on any human gene should not be permitted, as these are naturally occurring laws of nature. But when you begin to move beyond that, to methods for identifying genes or biomarkers and the analytic methods used to make a treatment or diagnostic determination, well, that's when things get a bit murky. Unfortunately, as this came before a Senate subcommittee hearing in June, the battle lines were drawn in typical modern-day D.C. style: either looking for a legislative remedy for Section 101 was uncalled for, flew in the face of 150 years of precedent, and could once again lead to the patenting of human genes; or Supreme Court and lower court rulings over the past 10 years have created such uncertainty and confusion that companies are hampered in efforts to protect their IP—and hence, investment—which is stifling innovation and progress in precision medicine. But poring over the three days of testimony on the issue of those who want to do nothing in section 101 and fall back on Court precedent, versus those who believe legislative action is necessary, it became apparent they weren't address- ing the same issues. And each has a good point. So from the ACLU's perspective—which brought the original action against Myriad—this reexamination could lead again to genes being patented, so let's not open this up again. I agree with this. Human genes should not be patent- able. Researchers should not have to pay money to some entity for doing basic genetic research. On the other hand, however, there are areas that seem to need correction. Peter O'Neill of Cleveland Clinic outlined a patent odyssey for its novel method of detecting a biomarker that can aid in predicting cardiovascular risk that saw its patent overturned twice. And David Spetzler, CSO of Caris Life Sciences, worried in his testimomy about the patentability of the company's algorithms used for determining a broad range of risk factors—a significant issue as poly- genic risk scores are gaining prominence. These areas also need addressing. The courts have seemingly made a mess of differentiating laws of nature from technologies or novel algorithms used to query these natural laws. Novel methods of detection, novel methods of ana- lyzing genetic data, do require protection. FROM THE EDITOR Chris Anderson Editor in Chief A Science—Judicial Disconnect

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