Publication Date

8-12-2025

Journal

Nature Biotechnology

Abstract

Notwithstanding Amgen’s strenuous objections, the core premise of our article should be uncontroversial to most policy analysts: biosimilar firms that simply want to manufacture an originator biologic in the manner it was manufactured at the time of US Food and Drug Administration (FDA) approval should be able to enter the market expeditiously once valid manufacturing (and other valid patents) that legitimately cover the ‘at approval’ biologic have expired. Our core premise relies on the widely accepted values of patent validity and notice. Instead of expensive litigation discovery fights over such ‘at approval’ issues, of the sort Amgen itself has spearheaded (as we discuss below), our article proposes that expert examiners be allowed to improve validity and notice more cheaply and impartially ex ante.

Volume

43

First Page

1229

Last Page

1230

Publisher

Nature

DOI

https://doi.org/10.1038/s41587-025-02765-y

Disciplines

Intellectual Property Law | Law

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