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Overlapping Method of Use Patents to Prevent Generic Entry

Published online by Cambridge University Press:  16 September 2025

Jin Park
Affiliation:
https://ror.org/03vek6s52 Harvard Medical School , Boston, MA
Aaron S. Kesselheim
Affiliation:
Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, https://ror.org/04b6nzv94 Brigham and Women’s Hospital and Harvard Medical School , Boston, MA
S. Sean Tu*
Affiliation:
Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, https://ror.org/04b6nzv94 Brigham and Women’s Hospital and Harvard Medical School , Boston, MA https://ror.org/051fvmk98 University of Alabama School of Law , Tuscaloosa, AL
*
Corresponding author: S. Sean Tu; Email: shinetu@gmail.com

Abstract

Brand-name pharmaceutical firms increasingly use method of use patents and associated Orange Book “use codes” to delay generic entry, complicating the skinny labeling pathway that permits low-cost generics to omit patented indications from their labels and market their products for unpatented uses. Recent litigation, however, shows how overlapping use codes — targeting patient subgroups or biomarker thresholds rather than distinct conditions — can obstruct the skinny labeling pathway. Case studies of icosapent ethyl (Vascepa) and sacubitril-valsartan (Entresto) illustrate how overlapping use codes delay generic entry, inflate costs, and limit patient access. Reforms are needed to improve FDA and USPTO oversight of use code assignments and clarify legal standards for induced infringement, which would preserve the balance between rewarding innovation and ensuring timely access to affordable medicines.

Information

Type
Columns: Health Policy Portal
Copyright
© The Author(s), 2025. Published by Cambridge University Press on behalf of American Society of Law, Medicine & Ethics

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Footnotes

About This Column: Aaron Kesselheim serves as the editor for Health Policy Portal. Dr. Kesselheim is the JLME editor-in-chief and director of the Program On Regulation, Therapeutics, And Law at Brigham and Women’s Hospital/Harvard Medical School. This column features timely analyses and perspectives on issues at the intersection of medicine, law, and health policy that are directly relevant to patient care. If you would like to submit to this section of JLME, please contact Dr. Kesselheim at akesselheim@bwh.harvard.edu.

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