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Novo Nordisk Seeks to Block Compounded Versions of Diabetes / Weight Loss Drug

On October 22, 2024, Novo Nordisk made a submission to the U.S. Food and Drug Administration (FDA) nominating Novo Nordisk’s semaglutide products (WEGOVY, OZEMPIC and RYBELUS) to be included in the FDA’s lists of drug...more

FDA Approves Colony Stimulating Factor-1 Receptor (Csf-1R) Blocking Antibody for Treatment of Chronic Graft-Versus-Host Disease...

On August 14, 2024, the U.S. Food and Drug Administration (FDA) approved a colony stimulating factor-1 receptor (CSF-1R)-blocking antibody, NIKTIMVO (axatilimab-csfr) developed by Incyte Corporation (and in-licensed from...more

Flavored E-cigarette Manufacturers Face Regulatory Challenges

Manufacturers of e-cigarettes find themselves in a challenging regulatory environment to obtain U.S. Food and Drug Administration (FDA) marketing approval of flavored products.  On October 12, 2023, the FDA denied premarket...more

Famous Trademark Not Abandoned After Original Owner’s Bankruptcy

TIGER LILY VENTURES LTD. v. BARCLAYS CAPITAL INC. Before Lourie, Bryson, and Prost.  Appeal from the United States Patent and Trademark Office, Trademark Trial and Appeal Board. Summary: A trademark associated with a...more

What’s in a Name?: Third Party Use of a Descriptive Term Without Secondary Meaning Can Undermine Assertions of Substantially...

GALPERTI, INC. v. GALPERTI S.R.L. Before: Moore, Prost, Taranto. Appeal from the Trademark Trial and Appeal Board. Summary:  Evidence of use of a term even without a showing of secondary meaning, by any third party,...more

Ineffective Skinny Label Leaves Generic Liable Despite Effort to Carve-Out the Patented Indication

GLAXOSMITHKLINE LLC v. TEVA PHARMACEUTICALS USA, INC. [OPINION] – PRECEDENTIAL - Before Moore, Newman, Prost (dissent). Panel rehearing of an appeal from the U.S. District Court for the District of Delaware - Summary:...more

Copying From a Copyrighted Computer Program May Be Fair Use to the Extent Needed to Promote Adoption of the Use of Accrued Talents...

GOOGLE LLC V. ORACLE AMERICA, INC. Before the United States Supreme Court (Opinion by Justice Breyer) on Writ of Certiorari to the United States Court of Appeals for the Federal Circuit. Summary: Where use of...more

Non-Disclosure Agreement Controls Ownership of Patents Arising From Confidential Information Received Thereunder

SIONYX LLC v. HAMAMATSU PHOTONICS K.K. Before Lourie, Reyna, and Wallach. Appeal from the U.S. District Court for the District of Massachusetts. Summary: A party who discloses confidential information pursuant to a NDA...more

Government’s Pre-Litigation Conduct Cannot Justify a Court of Claims Fee Award

FASTSHIP, LLC v. US - Before Dyk, Wallach, and Chen. Appeal from the United States Court of Federal Claims. Summary: A Court of Claims fee award under 28 U.S.C. § 1498(a), turns on whether the government’s litigation...more

Intrinsic Evidence Establishing the Context of a Claim Term Can Limit Claim Scope

MCRO, INC. v. BANDAI NAMCO GAMES AMERICA - Before Reyna, Mayer and Taranto. Appeal from the United States District Court for the Central District of California. Summary: The scope of a claim term may be limited when...more

En Banc Federal Circuit Denies Rehearing of Holding That Severance of an Unconstitutional Restriction in the America Invents Act...

ARTHREX, INC. v. SMITH & NEPHEW, INC. Before Prost, Newman, Lourie, Dyk, Moore, O’Malley, Reyna, Wallach, Taranto, Chen, Hughes, and Stoll. Petition for rehearing en banc of a panel decision of an appeal from the Patent...more

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