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Federal Circuit Clarifies Patent Term Extension Calculation for Reissue Patents

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On March 13, 2025, the Federal Circuit issued a decision in Merck Sharp & Dohme B.V. v. Aurobindo Pharma USA, Inc., No. 23-2254...

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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. 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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On March 13, 2025, the Federal Circuit issued a decision in Merck Sharp & Dohme B.V. v. Aurobindo Pharma USA, Inc., No. 23-2254 (Fed. Cir. 2025) that clarifies how patent term extension (PTE) is calculated for reissue patents. PTE was established under the Hatch-Waxman Act as a mechanism by which the term of a patent may be extended for up to five years to compensate for delays in obtaining regulatory approval for certain products such as pharmaceuticals and medical devices. PTE therefore can be an important mechanism for extending exclusivity for valuable products in the life sciences. Notably, the amount of PTE available for any given patent depends upon the issue date of the patent, which is the subject that the Court addressed in this decision.Read the <a href="https://lifesciences.mofo.com/topics/federal-circuit-clarifies-patent-term-extension-calculation-for-reissue-patents" target="_blank">full blog post</a>.

Federal Circuit Clarifies Patent Term Extension Calculation for Reissue Patents

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Dr. Lisa Silverman’s practice focuses on patent portfolio management and strategic patent counseling in the areas of life sciences, pharmaceuticals, and chemistry. She has extensive experience in securing U.S. and global patent protection for pharmaceutical products and a deep understanding of patent lifecycle management and strategies for maximizing patent term and product exclusivity. She co-leads the firm’s Pharmaceutical Patent practice, and she is a member of the firm’s Life Sciences + Healthcare Leadership Team. Lisa works with clients on diverse technologies including small molecule pharmaceuticals, antibody-drug conjugates (ADCs), peptide therapeutics, pharmaceutical formulations and uses, drug-device combinations, cosmetics, digital therapeutics, clean technology, bioassays, and medical devices.As a member of the firm’s <a href="/capabilities/venture-intellectual-property" target="_self">Venture Intellectual Property Group</a>, Lisa routinely represents clients in both investor- and target-side IP due diligence, including patentability and freedom-to-operate assessments, and she provides advice to transactions teams on IP considerations for licensing, financing, and M&A deals. She has a keen interest in the intersection of patent and regulatory considerations for pharmaceutical products and medical devices.  She has prepared numerous applications for patent term extensions for approved drugs and medical devices, and she frequently advises on patent strategies for optimizing Orange Book listings.Lisa represents companies of all sizes, from start-ups to multi-national corporations, as well as venture capital, private equity, and other investment firms, and she provides advice tailored to each client’s unique business needs. She has worked with large companies to ensure robust patent protection for marketed drug products. She has worked closely with mid-size companies to expand patent protection and mitigate potential infringement risks as lead drug candidates have moved through clinical development toward commercialization. She has advised small companies on securing early foundational patents.Lisa received her J.D. from Stanford Law School. Prior to entering the legal field, Lisa obtained her Ph.D. in chemistry from Stanford University, where she was the recipient of a National Science Foundation Graduate Research Fellowship.

Lisa Silverman

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Dr. Emily Roberts is a patent attorney focusing on patent preparation, prosecution, and counseling in the areas of pharmaceuticals, biotechnology, chemistry, and materials. She advises a diverse client base, including individual inventors, startups, emerging companies, and multinational pharmaceutical organizations, on building and protecting high-value patent portfolios.Emily has extensive experience managing U.S. and international patent portfolios. She regularly conducts freedom-to-operate, patentability, and due diligence analyses. Emily is skilled in patent term extension applications and patent term analyses. She also has experience with post-grant procedures, including reissue applications, ex parte reexamination, and inter partes review proceedings.Her patent and research experience spans a wide range of technologies, including small molecule pharmaceuticals, cannabinoids, nutraceuticals, antibody-drug conjugates (ADCs), pharmaceutical formulations, methods of treatment, medical devices, microfluidics, nanoparticles, energy conversion catalysts, biofuels, and renewable energy materials and processes related to carbon capture and conversion.Emily received her J.D. from the University of California, Berkeley, School of Law. While in law school, Emily was a production editor for the Berkeley Technology Law Journal and president of the Patent Law Society. She also earned a Law & Technology Certificate from the Berkeley Center for Law & Technology and was part of a team that received first place in the USPTO National Patent Drafting Competition.Emily holds a Ph.D. in materials chemistry from the University of Southern California, where her research focused on sustainable synthesis of nanoparticle catalysts for renewable energy applications and earned the ACS and NIST Kenneth G. Hancock Memorial Award in Green Chemistry. She has authored multiple first-author publications and presented at major scientific conferences, including the American Chemical Society and the International Materials Research Conference. She received her B.S. in chemistry from the University of California, Santa Cruz, where she conducted organic methodology research.