FDA Emphasizes Use of Real-World Evidence for Medical Device Makers
The U.S. Food and Drug Administration (FDA) has increasingly emphasized the use of real-world evidence (RWE) to support regulatory decision-making for medical devices. As medical technologies evolve and data sources...
Federal Circuit Confirms Patent Eligibility of Gene Therapy Patent in Regenexbio Inc. v. Sarepta Therapeutics
Key Takeaway: Genetically engineered cultured host cells containing recombinant nucleic acids useful for gene therapy are patent-eligible for being markedly different from anything occurring in nature. In REGENXBIO Inc. v....
Kregg Koch Discusses How Medtech Innovators Can Build a Stronger IP Strategy Through Patent Filing, Portfolio Development, and AI
In an article published by nonprofit educational medtech incubator Fogarty Innovation, Knobbe Martens partner Kregg Koch shared practical strategies for medtech companies and entrepreneurs looking to protect and maximize the...