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Key Takeaways: The U.S. General Services Administration’s (GSA) new AI clause gives the government ownership of fine-tuned model weights and other custom developments built from government data under GSA large…

Key Takeaway: On October 14, 2026, the FDA announced a proposed framework for rare disease drug development that aims to provide greater regulatory flexibility and disease-tailored evaluation. Increased regulatory clarity…

EPIC TECH, LLC V. PEN-TECH ASSOCIATES, INC. Before Moore, Cunningham, and Subramanian (District Judge for U.S. District Court for the Southern District of New York, sitting by designation).  Appeal from…

PARKERVISION, INC. v. QUALCOMM INCORPORATED Before Prost, Chen, and Stark. Appeal from the United States District Court for the Middle District of Florida. Summary: Since infringement of a patent is…

Key Takeaways: Archer Aviation v. Vertical Aerospace highlights the significance of intellectual property in the eVTOL space. The outcome of the litigation could inform the scope of patent protection for…

SATIUS HOLDING, LLC v. SAMSUNG ELECTRONICS CO. LTD. Before Moore, Lourie, and Hughes. Appeal from the United States District Court for the District of Delaware. Summary: The Federal Circuit held that…

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…

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…

Key Takeaway(s): Patent portfolios originally developed for aerospace applications may have relevance to adjacent transportation sectors. Companies developing automotive, rail, maritime, or autonomous vehicle systems should consider relevant aerospace patent…

Key Takeaway(s): First Solar indicated that it will withdraw its Section 337 complaint relating to TOPCon patents in light of a federal action restricting imports of polysilicon and its derivatives,…

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