Advances in AI and genomic analysis will allow medical providers to tailor treatment for individual patients at the genome level, but challenges exist for protecting AI-assisted inventions....more
On January 11, 2026, the U.S. Food and Drug Administration announced a clarification to how it applies flexibility to the requirements on the chemistry, manufacturing, and controls (CMC) for cell and gene therapies (CGTs)....more
The USPTO’s December 4, 2025 memorandum on Subject Matter Eligibility Declarations (SMEDs) seeks to raise awareness of the “underutilized path” of submitting Rule 132 declarations, referred to as “SMEDs”, for supporting §101...more
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
9/8/2025
/ Biotechnology ,
CAFC ,
Clinical Trials ,
CRISPR ,
Executive Orders ,
Food and Drug Administration (FDA) ,
Intellectual Property Protection ,
Life Sciences ,
Maintenance Fees ,
National Security ,
Patent Litigation ,
Patent Trial and Appeal Board ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Regulatory Requirements ,
Trump Administration ,
USPTO
On June 18, 2025, the U.S. Food and Drug Administration (FDA) announced that it will review new clinical trials that involve sending biological samples to “hostile countries,” to prevent exploitation of Americans’ sensitive...more
We previously reported a decision by the U.S. Food and Drug Administration (FDA), denying the premarketing authorization of several flavored e-cigarette product. On April 2, 2025, the Supreme Court of the United States...more
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
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
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
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
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
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
8/11/2021
/ Generic Drugs ,
GlaxoSmithKline ,
Induced Infringement ,
Intellectual Property Protection ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Patents ,
Prescription Drugs ,
Product Labels ,
Teva Pharmaceuticals
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
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
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
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
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