Analysis

Biologics Face Tougher Patent Scrutiny After Amgen Ruling

Law360 (February 18, 2021, 8:07 PM EST) -- A recent Federal Circuit decision clamping down on broad antibody patent claims may have some biologics makers scrambling to save their existing intellectual property and questioning whether to patent future drugs at all.

In Amgen v. Sanofi, the Federal Circuit ruled Feb. 11 that, with rare exceptions, patenting antibodies based on what they bind to doesn't meet enablement requirements under Section 112 of the Patent Act. While the ruling falls in line with past Federal Circuit decisions, it veers from how the scientific community defines antibodies and puts existing patents for top-dollar biologics on the road to invalidation.

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