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The Diagnostics Dilemma: Securing and Protecting Diagnostic-Based Claims

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While many life sciences companies are built on platforms involving the development of diagnostic products and methods that underlie personalized medicine allowing treatment that is customized to a patient’s unique biology, the U.S. Supreme Court dealt a blow to the industry with its decision in Mayo Collaborative Services v. Prometheus Laboratories.

We are Morrison Foerster — a global firm of exceptional credentials. Our clients include some of the largest financial institutions, investment banks, and Fortune 100, technology, and life sciences companies. The Financial Times has named us to its list of most innovative law firms in North America every year that it has published its Innovative Lawyers Reports in the region,and Chambers Asia-Pacific has named us the Japan International Firm of the Year for the sixth year in a row. Our lawyers are committed to achieving innovative and business-minded results for our clients, while preserving the differences that make us stronger.Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations. Prior results do not guarantee a similar outcome.

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The Diagnostics Dilemma: Securing and Protecting Diagnostic-Based Claims

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Karen Potter is a partner in Morrison & Foerster’s Life Sciences Patent group. Her practice focuses on patent preparation, prosecution, and strategic counseling for start‑up, emerging, and established life sciences and biotechnology companies. She advises clients in the development and management of comprehensive patent portfolios that match their scientific and business objectives. Karen also helps identify and evaluate patentability, ensure freedom to operate, and perform due diligence review of patent portfolios for clients, including investor-side and target-side due diligence.Building on her technical expertise in cellular and molecular biology and immunology, Karen has experience managing and developing patent portfolios in the areas of immunotherapies and cellular therapies, including T-cell therapies, Natural Killer cell-based therapies, and stem cell therapies; protein therapeutics, including antibody and protein-based therapies; gene-based therapies; virus therapies; companion diagnostics; and diagnostic assays and bioassays.Karen has 18 years of experience in global patent portfolio development and strategy. She works closely with clients to counsel them on all matters of patent strategy and prosecution and is adept at quickly understanding complex technologies to implement patent filing strategies. She manages and mentors a team of scientific analysts, patent agents, and associates in establishing and building life sciences patent portfolios. Representative clients include Alpine Immune Sciences, Applied Biomedical Science Institute, Aspen Neuroscience, Banyan Biomarkers, Bristol Myers Squibb and its subsidiaries Juno Therapeutics and Celgene, Indapta Therapeutics, Inhibrx, Rakuten Medical, Sana Biotechnology, Turnstone Biologics, and Verogen.Before joining Morrison & Foerster, Karen worked as an associate and patent agent in the life sciences patent groups of several prominent law firms. Karen was a postdoctoral fellow at the La Jolla Institute for Allergy and Immunology, Department of Molecular Immunology, in the laboratory of Dr. Carl F. Ware. During her doctorate studies, she worked in the laboratory of the late Dr. Jo Rae Wright who served as an invaluable mentor and supporter. The results of her research have been published in peer-reviewed scientific journals, and she has presented her results at national scientific meetings.She received her J.D. from California Western School of Law, Ph.D. in cellular and molecular biology from Duke University, and B.S. in molecular biology from the University of California, San Diego. Karen was recognized by the San Diego Daily Transcript as an outstanding Young Attorney in 2013 and 2014.

Karen G Potter

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