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.
SAN DIEGO, October 31, 2024 – Knobbe Martens is pleased to share that partners Daniel Kamkar and Adam Powell were profiled in San Diego Business Journal’s (SDBJ) 2024 Leaders of…
In the Law360 article “How 2 Proposed Bills Could Transform Patent Law,” partner Philip Nelson writes about the potential impact of two pieces of legislation that could affect patent law:…
In the Managing IP article “USPTO Provides ‘Roadmap’ for AI Patent Eligibility,” partner Mauricio Uribe offered insight on the US Patent and Trademark Office’s recently issued guidance on AI subject…
USPTO Publishes Additional Subject Matter Eligibility Guidance – AI Technology On Tuesday, July 16, 2024, the United States Patent and Trademark Office (USPTO) published the 2024 Guidance Update on Patent…
In the latest installment of their monthly Law360 column on recent noteworthy Federal Circuit decisions, partners Sean Murray and Jeremiah Helm examine the “fundamental shift in intellectual property law” resulting…
Purna is an associate at the firm’s New York office. Her practice focuses on patent litigation and prosecution in the pharmaceutical, biotechnology, consumer products and medical device fields. Prior to…
Sophia Zahn is an associate in our San Diego office. Her practice focuses on patent prosecution and portfolio management, due diligence, IP strategy, transactions/agreements, and opinions/counseling. Sophia currently assists clients…
In the latest installment of Knobbe Martens’ monthly Law360 column focused on recent noteworthy Federal Circuit decisions, partners Jeremiah Helm and Sean Murray discuss the precedential opinion recently issued in…
Joshua Martineau is an associate in our New York Office. His practice includes patent procurement, patent portfolio management, and IP strategy. Josh earned his J.D. at Brigham Young University….