AI-Enabled Medical Devices Require an Integrated FDA and IP Strategy
Key Takeaway: Medical device companies should prepare a cohesive patent and premarket submission strategy by considering FDA recommendations when developing AI-enabled features and coordinating statements made to the Patent Office...
FDA Launches Expedited IND Pilot Program to Accelerate Human Trials, Raising IP Considerations for Sponsors
Key Takeaways: The Expedited Investigational New Drug (IND) Pilot Program is intended to evaluate whether leveraging qualified research institutions (QRIs) and a rolling review process can improve the efficiency of...
Transfer of All Substantial Rights Allows a Licensee to Stand in the Patentee’s Shoes
TEXASLDPC INC. v. BROADCOM INC. Before Moore, Chen, and Bissoon (sitting by designation). Appeal from the United States District Court for the District of Delaware. Summary: A license agreement transferring...
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