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Pharmaceutical Patents › Written Descriptions › Clinical Trials

Rothwell, Figg, Ernst & Manbeck, P.C.

One is the Loneliest Number: Can Single-Patient Case Studies Provide an Enabling Basis for Patent Claims?

Rothwell, Figg, Ernst & Manbeck, P.C. on

The U.S. Court of Appeals for the Federal Circuit recently issued a non-precedential Rule 36 affirmance of the Patent Trial and Appeal Board (PTAB) in In re Adhami, No. 2024-1218, 2025 WL 1949797 (Fed. Cir. July 16, 2025)....more

Robins Kaplan LLP

Novartis Pharms. Corp. v. Accord Healthcare, Inc.

Robins Kaplan LLP on

Case Name: Novartis Pharms. Corp. v. Accord Healthcare, Inc., No. 2021-1070, 2022 WL 16759 (Fed. Cir. Jan. 3, 2022) (Circuit Judges Moore, Linn, and O’Malley presiding; Opinion by O’Malley, J.; Dissenting Opinion by Moore,...more

Haug Partners LLP

No Clear Error to Find Lack of Written Description for a Method of Treatment Patent Despite Separate Disclosures of the Drug,...

Haug Partners LLP on

Biogen International GMBH, Biogen MA, Inc., v. Mylan Pharmaceuticals Inc. marks the Federal Circuit’s most recent interpretation of the 35 U.S.C. § 112 written description requirement in the Hatch-Waxman context. No....more

BakerHostetler

Promoting the Progress of Science: Written Description and Enablement

BakerHostetler on

You’ve finished drafting the patent application for a critical, clinical stage invention. The scientific team wrote up the examples and they even included comparative data. You’ve finalized the claims and specification....more

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