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Amgen v. Sanofi: The U.S. Supreme Court Reviews Patent Enablement

Published online by Cambridge University Press:  13 December 2023

Gregory Curfman Open the ORCID record for Gregory Curfman [Opens in a new window]  and
Marcia M. Boumil
Gregory Curfman
Affiliation:
JAMA, CHICAGO, IL, USA YALE UNIVERSITY, NEW HAVEN, CT, USA
Marcia M. Boumil
Affiliation:
TUFTS UNIVERSITY, BOSTON, MA, USA.
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Extract

On June 18, 2023, the U.S. Supreme Court in the matter of Amgen, Inc. et al. v. Sanofi, et al.1 unanimously upheld the 2021 decision of the U.S. Court of Appeals for the Federal Circuit,2 striking down as overbroad Amgen’s patent claim to an entire functional genus of monoclonal antibodies. Amgen’s patent claims were not limited to antibody structure or antibody amino acid sequences. This is significant because Amgen’s patent claims did have amino acid sequences, but they were directed to the epitope.

Keywords

Monoclonal AntibodiesPatent EnablementGenus Patent ClaimsPCSK9 InhibitorsLDL Receptors
Type
Columns: Health Policy Portal
Information
Journal of Law, Medicine & Ethics , Volume 51 , Issue 3: Seeking Reproductive Justice in the Next 50 Years , Fall 2023 , pp. 689 - 693
Copyright
© 2023 The Author(s)

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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 [email protected].

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