AI and the Fight Against Antimicrobial Resistance
Antimicrobial resistance has become a major concern in recent years. According to studies, approximately 1.1 million deaths each year are linked to bacterial resistance to antimicrobial drugs.[1] The fear of...
San Diego Business Journal Names Robert Hilton and Daniel Hughes Among “Leaders of Influence in Law”
SAN DIEGO, October 21, 2025 – Knobbe Martens is pleased to share that partners Robert Hilton and Daniel Hughes have been recognized as “Leaders of Influence in Law” by the...
Dozens of Knobbe Martens Lawyers Featured in “Best Lawyers” 2026 Guide
IRVINE, Calif., August 21, 2025 – Knobbe Martens is pleased to share that dozens of the firm’s lawyers, representing a range of practice areas and offices across the country, have...
Johnson & Johnson Study Shows Promise for the Treatment and Potential Cure of Multiple Myeloma
On June 3, 2025, the Journal of Clinical Oncology published a study funded by Johnson & Johnson, which showed that one-third of patients with relapsed/refractory multiple myeloma who were treated...
District Court Finds the FDA Reasonably De-listed Eli Lilly’s Weight Loss Drug From Drug Shortage List
Congress authorized the FDA to determine whether a drug is “in shortage in the United States.” The FDA’s determination of a drug shortage triggers mechanisms designed to alleviate the shortage....
New Tool From EPA, FDA, and USDA Guides Developers of Genetically Modified Microorganisms Through Regulatory Landscape
On October 2, 2024, the U.S. Department of Agriculture (USDA), U.S. Environmental Protection Agency (EPA), and U.S. Food and Drug Administration (FDA) released a new web-based interactive tool on the Unified Website for Biotechnology Regulation for companies that develop microbial biotechnology products. The purpose of the tool is to help developers fulfill the regulatory requirements necessary to work with genetically modified microorganisms. The tool defines "genetic modification" as any technique that uses recombinant, synthesized, or amplified nucleic acids to modify or create a genome. “Microorganisms” include prokaryotes (e.g., bacteria and archaea), protists (e.g., amoebas), fungi (e.g., yeast, mold, mushrooms), green and red algae, and viruses or virus-like particles. Through a series of prompts, the tool provides users with information on regulatory requirements and the approval process across agencies. A built-in feedback function allows stakeholders to submit feedback directly to the agencies, which have expressed a commitment to continuing to improve the tool and expand its utility, scope and user base.
District Court Finds Mylan (Viatris) Infringes Regeneron’s Eylea Patent
On December 27, 2023, Judge Thomas S. Kleeh of the United States District Court for the Northern District of West Virginia issued an order finding that Mylan (Viatris) infringed claims 4, 7, 9, 11, and 14-17 of Regeneron’s U.S. Patent No. 11,084,865 (“the ’865 patent”) after a nine-day bench trial held in June 2023.
Federal Circuit Review | November 2023
November 2023 Federal Circuit Newsletter (Japanese) November 2023 Federal Circuit Newsletter (Chinese) Federal Circuit Orders District Court to Consider Extrinsic Evidence in Claim Construction In Actelion Pharmaceuticals Ltd. v....
Federal Circuit Says Extrinsic Evidence Should Have Been Considered in Claim Construction
In a recent precedential opinion, the Court of Appeals for the Federal Circuit vacated an infringement judgement against Mylan (Actelion Pharmaceuticals Ltd. v. Mylan Pharmaceuticals Inc., No. 2022-1889, Fed. Cir. Nov. 6, 2023). This Abbreviated New Drug Application (ANDA) litigation involved Actelion’s patents related to epoprostenol formulations, which cover Actelion’s brand name product, Veletri®, an injectable drug for treatment of severe pulmonary arterial hypertension.
FDA Approves Qalsody™ for Treatment of ALS
On April 25th, 2023, the U.S. Food and Drug Administration (FDA) approved QalsodyTM (tofersen) for the treatment of amyotrophic lateral sclerosis (ALS) associated with a mutation in the superoxide dismutase 1 (SOD1) gene (SOD1-ALS). The accelerated approval for QalsodyTM was based on a reduction in levels of plasma neurofilament light (NfL), a biomarker associated with neuronal injury and neurodegeneration. QalsodyTM was developed in a partnership between Ionis Pharmaceuticals, Inc. and Biogen Inc.
Knobbe Martens Elevates 10 Attorneys to Partner
Knobbe Martens, one of the leading intellectual property law firms in the United States, is pleased to announce that 10 associates have been promoted to the firm’s partnership ranks, effective...
