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Navigating Obviousness: Federal Circuit Addresses Patentability of Pharmaceutical Dosing Methods

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On March 6, 2025, the United States Court of Appeals for the Federal Circuit (“Federal Circuit”) issued a precedential decision...

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On March 6, 2025, the United States Court of Appeals for the Federal Circuit (“Federal Circuit”) issued a precedential decision in ImmunoGen, Inc. v. Stewart, in which the court clarified its standards for determining obviousness in the context of a claimed method of treatment involving a specific dosing limitation of a drug, in this case an antibody drug conjugate (ADC).Read the <a href="https://lifesciences.mofo.com/topics/navigating-obviousness-federal-circuit-addresses-patentability-of-pharmaceutical-dosing-methods" target="_blank">full blog post</a>.

Navigating Obviousness: Federal Circuit Addresses Patentability of Pharmaceutical Dosing Methods

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Dr. Jeff Schmidt is a member of the firm’s Patent Group. His practice focuses on patent prosecution in the areas of life sciences, biotechnology, and pharmaceuticals, which includes the preparation and prosecution of patent applications in domestic and international jurisdictions, as well as strategic counseling and global portfolio management.  Jeff also counsels clients on issues including patentability, enforceability, validity, freedom-to-operate, IP due diligence, and IP landscape analysis, and assists with patent litigation in U.S. district court.Jeff has research experience in the fields of genetics, biochemistry, cell and molecular biology, cancer biology, and immunology. He was awarded a Department of Defense predoctoral fellowship to investigate, using cell and animal models, the role that certain cytokine signaling pathways play in the development and progression of breast cancer, and to identify novel strategies for prevention and treatment.Prior to joining Morrison & Foerster, Jeff was a corporate counsel extern for the Whirlpool Corporation, a legal intern for the University of Notre Dame’s Intellectual Property and Entrepreneurship Clinic, and a summer associate with Morrison & Foerster for two summers. He also externed as a patent examiner for the United States Patent and Trademark Office (USPTO), and interned in the technology transfer office at the University of Nebraska Medical Center.Jeff earned his J.D. summa cum laude from the University of Notre Dame Law School, where he was the Executive Articles Editor for the Notre Dame Law Review, and a member of the Moot Court Board. He received his Ph.D. in Cancer Research from the University of Nebraska Medical Center, his M.B.A. from the University of Nebraska at Omaha, and his B.A. in Biology from Saint John’s University.Jeff is admitted to practice before the United States Patent & Trademark Office.

Jeffrey Schmidt

Associate

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

Life Sciences + Healthcare

Patent Strategy + Prosecution