Life Science Update | March 2026
AI and Genomics: A New Era of Personalized Medicine Robert J. Hilton, Ph.D. & Bailey R. Arenberg Advances in AI and genomic analysis will allow medical providers to tailor treatment for...
IP Considerations Following FDA Announcement on Flexibility for Cell and Gene Therapies
Key Takeaways: Manufacturing processes of cell and gene therapies (CGTs) may remain fluid well into development and even after FDA approval, and therefore sponsors of CGTs may benefit from patent...
Practical Application and Particular Treatment: What the USPTO’s December 4 Memorandum Means for Life Sciences §101 Eligibility
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...
Knobbe Martens Announces Six New Partners in Offices Across the Country
New partner class strengthens Knobbe Martens’ position as a leader in IP Law IRVINE, Calif., January 5, 2026 – Knobbe Martens, a leading intellectual property and technology law firm, is...
Life Science Update | August 2025
Eyeing the Prize of the U.S. Patent System, the Trump Administration Proposes Patent Maintenance Fee Overhaul Jane Dai, Ph.D. & Susan M. Janicki, Ph.D. The Trump administration is considering changing the U.S....
FDA Announces Review of New Clinical Trials That Export Americans’ Biological Samples to Hostile Countries
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...
U.S. Supreme Court Defers to Agency Decision-Making in FDA’s Denial of Premarket Approval of Flavored E-Cigarette Products
We previously reported a decision by the U.S. Food and Drug Administration (FDA), denying the premarketing authorization of several flavored e-cigarette product.[1] On April 2, 2025, the Supreme Court of...
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...
FDA Approves Colony Stimulating Factor-1 Receptor (Csf-1R) Blocking Antibody for Treatment of Chronic Graft-Versus-Host Disease (Cgvhd)
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 Syndax Pharmaceuticals), for treatment of chronic graft-versus-host disease (cGvHD) after failure of at least two prior lines of systemic therapy in adult and pediatric patients weighing at least 40 kg.
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 authorization of flavored e-cigarette products from R.J. Reynolds Vapor Company under its Vuse Alto brand. This follows on the heels of the U.S. Supreme Court’s denial of e-cigarette manufacturer Avail Vapor’s challenge to the FDA’s rejection of premarket authorization of Avail Vapor’s flavored e-cigarette products, which was affirmed earlier by the U.S. Court of Appeals for the 4th Circuit. This is the latest case in a series of legal setbacks for the vaping industry, which has ballooned into an $8.2 billion market in less than a decade.
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 bankrupt company was not abandoned when the trademark continued to be used during bankruptcy and was the subject of active licenses.
What’s in a Name?: Third Party Use of a Descriptive Term Without Secondary Meaning Can Undermine Assertions of Substantially Exclusive Use of the Term
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, is relevant to demonstrate that an assertion of substantially exclusive use was false.
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: Substantial evidence supported the jury verdict of induced infringement when testimony indicated that a generic failed to carve out a potentially infringing use from a label and the generic’s advertisements provided further evidence of an intent to encourage the patented use.
Copying From a Copyrighted Computer Program May Be Fair Use to the Extent Needed to Promote Adoption of the Use of Accrued Talents in Creating a New Software Platform
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 copyrighted computer code is inherently bound together with uncopyrightable ideas and new creative expression, it may be fair use to copy that which is needed to reimplement a user interface for others to make use of their accrued talents.
