FDA Issues Recommendations for the Development of Individualized Therapies for Patients With Ultra-Rare Diseases
Key Takeaway: The FDA is developing a “plausible mechanism framework” to facilitate approval of individualized therapies for the treatment of rare genetic diseases that currently face approval challenges. As discussed previously...
USPTO’s Supplemental Guidance on Design Patents for Computer-Generated Interfaces and Icons
Key Takeaway: The USPTO has revised its design patent guidance to better reflect evolving digital interface technologies, including projections and augmented or virtual reality environments. The updated guidance provides design...
Is Your IP Ready? Navigating IP Challenges for Commercial-Stage Technologies in Due Diligence and M&A
Presenting as part of an LSI ’26 panel, Knobbe Martens partners Kregg Koch and Sabing Lee joined fellow panelists to explore the complexities of intellectual property management for commercial-stage technologies in the medtech industry, and the...