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USPTO Enablement Guidelines After Amgen v. Sanofi

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On January 10, 2024, the USPTO released new Guidelines for Assessing Enablement in Utility Applications and Patents in View of the Supreme Court Decision in Amgen Inc. et al. v. Sanofi et al.

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On January 10, 2024, the USPTO released new <a href="https://www.federalregister.gov/documents/2024/01/10/2024-00259/guidelines-for-assessing-enablement-in-utility-applications-and-patents-in-view-of-the-supreme-court" dir="ltr" target="_blank">Guidelines for Assessing Enablement in Utility Applications and Patents in View of the Supreme Court Decision in Amgen Inc. et al. v. Sanofi et al.</a>The guidelines clarify that the USPTO’s framework for assessing enablement is unchanged after the Supreme Court’s decision in Amgen v. Sanofi. Specifically, the USPTO “will continue to use the In re Wands factors to ascertain whether the amount of experimentation required to enable the full scope of the claimed invention is reasonable.”Read the <a href="https://lifesciences.mofo.com/topics/uspto-enablement-guidelines-after-amgen-v-sanofi" target="_blank">full blog post</a>.

USPTO Enablement Guidelines After Amgen v. Sanofi

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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 cell and gene therapies, including T-cell therapies, Natural Killer cell-based therapies, stem cell therapies and gene-based therapies; protein therapeutics such as immunotherapies, including antibody and protein-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, Bristol Myers Squibb and its subsidiaries Juno Therapeutics and Celgene, Indapta Therapeutics, Inhibrx, Rakuten Medical, Sana Biotechnology, Tune Therapeutics, and Turnstone Biologics.Before entering the patent field, 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 has been recognized for her achievements as a patent attorney including recognition by the Legal 500 US.

Karen Potter

Partner

Dr. Meghan Poon counsels clients on patent preparation and prosecution, portfolio strategy, and IP due diligence in the areas of biotechnology and biologics. She has significant experience in diverse technologies including antibodies, cell therapies, gene therapies, diagnostics, and gene-edited plants. She represents clients ranging from large international pharmaceutical companies to midsized companies, startups, and universities.Meghan has filed numerous Patent Term Extension applications to secure additional term for her clients’ patents, which cover FDA-approved products. In addition, Meghan has extensive experience addressing complex obviousness-double patenting and subject matter eligibility issues impacting her clients’ patent portfolios. Meghan also represents clients in both investor-side and target-side due diligence, in deals from seed funding to initial public offerings.Prior to law school, Meghan attended graduate school at the University of California, Los Angeles, where she received a Ph.D. in biological chemistry based on her work on protein-protein and protein-DNA interactions at a molecular level. Meghan is the author of several scientific publications and has presented her research at international conferences.Meghan received her J.D. from the University of Southern California Law School and spent a year as a visiting student at Santa Clara University, where she focused on intellectual property.

Meghan Poon

Building on her research experience in cellular and molecular biology, Dr. Kelsey Roberts Kingman focuses her work on patent drafting and assisting prosecution, patent analysis, and patent due diligence inquiries, with an emphasis on biotechnology and pharmaceuticals.Before joining Morrison & Foerster, Dr. Roberts Kingman earned her Ph.D. in developmental biology from Stanford University School of Medicine, where she was a National Science Foundation Graduate Research Fellow. As a graduate researcher in the laboratory of Philip Beachy, she investigated the signal transduction mechanism of the Hedgehog signaling pathway.Dr. Roberts Kingman received her B.A. in biology, magna cum laude, from Columbia University, where her research focused on the genetic basis of neuronal fate specification in the developing cerebellum and in the C. elegans nervous system.