The Puzzle of Biologics Manufacturing Platform Patents

Authors

Osmat Azzam Jeferson, Duke University School of Law
W. Nicholson Price II, University of Michigan Law School
S. Sean Tu, West Virginia University College of Law
Saurabh Vishnubhakat, Benjamin N. Cardozo School of LawFollow
Arti K. Rai, Duke University School of Law

Publication Date

3-17-2025

Journal

Nature Biotechnology

Abstract

The predominance of manufacturing process patents asserted in litigation by originator biologics companies against would-be biosimilar entrants has resulted in a number of Congressional and administrative agency proposals that could increase scrutiny and limit enforceability.

Volume

43

First Page

295

Last Page

299

Publisher

Nature

DOI

https://doi.org/10.1038/s41587-025-02579-y

Disciplines

Intellectual Property Law | Law

Recommended Citation

Osmat A. Jeferson, W. N. Price II, S. S. Tu, Saurabh Vishnubhakat & Arti K. Rai, The Puzzle of Biologics Manufacturing Platform Patents, 43 Nature Biotech. 295 (2025).
https://doi.org/10.1038/s41587-025-02579-y