News & Analysis as of

Obviousness Appeals Food and Drug Administration (FDA)

Robins Kaplan LLP

Janssen Pharms., Inc. v. Mylan Labs. Ltd.

Robins Kaplan LLP on

Invega Trinza® (paliperidone palmitate) - Case Name: Janssen Pharms., Inc. v. Mylan Labs. Ltd., No. 2023-2042, 2025 WL 946390 (Fed. Cir. Mar. 28, 2025) (Circuit Judges Dyk, Prost, and District Judge Goldberg presiding;...more

Schwabe, Williamson & Wyatt PC

Latest Federal Court Cases: Regeneron Pharmaceuticals, Inc. v. Mylan Pharmaceuticals Inc.

Regeneron Pharmaceuticals, Inc. v. Mylan Pharmaceuticals Inc., Appeal Nos. 2024-1965, -1966, -2082, -2083 (Fed. Cir. Jan. 29, 2025) Our Case of the Week is a 31-page decision that touches on a variety of issues, including...more

Schwabe, Williamson & Wyatt PC

Latest Federal Court Cases - December 2019 #4

PATENT CASE OF THE WEEK - Persion Pharms. LLC v. Alvogen Malta Operations Ltd., Appeal No. 2018-2361 (Fed. Cir. Dec. 27, 2019) - In this week’s Case of the Week, the Federal Circuit affirmed a district court judgment...more

McDermott Will & Schulte

Skepticism Does Not Need to Be Based on Impossibility

Addressing secondary considerations of non-obviousness, the US Court of Appeals for the Federal Circuit affirmed a Patent Trial and Appeal Board (PTAB) obviousness decision, finding that skepticism does not need to be...more

Knobbe Martens

Federal Circuit upholds Millennium’s Patent on Velcade®

Knobbe Martens on

MILLENNIUM PHARMACEUTICALS, INC. v. SANDOZ INC - (Fed. Cir. July 17, 2017) (NEWMAN, Mayer, O’Malley) - This case arose out of an ANDA litigation between Millennium and a number of generic-drug companies who sought FDA...more

Foley & Lardner LLP

Court Rejects Theory Of Derivation Based On FDA Requirement

Foley & Lardner LLP on

The Federal Circuit decision in Cumberland Pharmaceuticals Inc. v. Mylan Institutional LLC may be more interesting for what Mylan argued than for what the Federal Circuit decided. However, it could be an important decision...more

Goodwin

Celltrion and Hospira Have Launched Inflectra® in U.S.

Goodwin on

This past April, the FDA approved Inflectra® (infliximab-dyyb), Celltrion and Hospira’s biosimilar of Janssen’s Remicade®. According to papers filed in the Federal Circuit this week, Celltrion and Hospira (collectively,...more

McDermott Will & Schulte

No Approval for Generic Product for Treatment of Rosacea **WEB ONLY**

Addressing infringement under the doctrine of equivalents and obviousness issues, the US Court of Appeals for the Federal Circuit affirmed the district court’s ruling barring approval of a generic version of Finacea® gel...more

McDermott Will & Emery

Obviousness Only Requires Reasonable Expectation of Success of One Compound Encompassed by Broad Genus Claims

Allergan, Inc. v. Apotex Inc. - Addressing the issue of showing a reasonable expectation of success when making obviousness combinations in the context of broad genus claims, the U.S. Court of Appeals for the Federal...more

McDermott Will & Emery

Combining Two Drugs Is Not Always Obvious

Sanofi-Aventis Deutschland GMBH v. Glenmark Pharmaceuticals Inc. - Addressing the obviousness of combining two known hypertension medications, the U.S. Court of Appeals for the Federal Circuit upheld a ruling of...more

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