News & Analysis as of

CAFC Food and Drug Administration (FDA) Patent Litigation

Knobbe Martens

Life Science Update | August 2025

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The Trump administration is considering changing the U.S. patent maintenance fee structure from the existing three fixed flat fees to an annual, value‑based “tax” model where patent holders would pay 1%–5% of the estimated...more

Hogan Lovells

Reissued patents get Hatch-Waxman PTE based on original patent date, CAFC rules

Hogan Lovells on

The U.S. Court of Appeals for the Federal Circuit (CAFC) recently considered a novel question regarding calculation of the regulatory review period for patent term extension (PTE) under 35 USC § 156 for reissued patents....more

Hogan Lovells

Federal Circuit affirms GSK labeling carve-out ruling in favor of innovator

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Earlier this month, in GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc., a panel of the U.S. Court of Appeals for the Federal Circuit (CAFC) affirmed (2-1) upon rehearing its October 2020 decision that a labeling...more

Troutman Pepper Locke

AIA On-Sale Bar Applies to Publicized Sales, Even When Knowledge of Sale Did Not Disclose the Underlying Invention

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The Court of Appeals for the Federal Circuit (CAFC) recently construed the on-sale bar provision of 35 U.S.C. 102(a) in a way that will make it easier for petitioners to challenge third party patents. While in an inter-partes...more

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