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…
On April 23, 2026, the Centers for Medicare & Medicaid Services (CMS) and the Food and Drug Administration (FDA) announced “a new pathway designed to expedite access to certain FDA-designated Class II…
Key Takeaway(s): AI tools are reshaping patent preparation and prosecution, but statements made to the USPTO are permanent, and AI-generated inaccuracies don’t come with warning labels. Efficiency gains are real, but…
Key takeaways: The U.S. Office of Space Commerce (“OSC”) has released a proposal for streamlining regulatory approval of novel commercial space activities. The process includes a presumption of approval with…
Fortress Iron, LP, v. Digger Specialties, INC. Before Lourie, Hughes, Circuit Judges, and Kleeh, Chief District Judge. Appeal from the United States District Court for the Northern District of Indiana. Summary:…
TEVA PHARMACEUTICALS INTERNATIONAL GMBH v. ELI LILLY AND COMPANY Before Prost, Cunningham, and Andrews. Appeal from the United States District Court of the District of Massachusetts. Summary: A functionally defined…
In an earlier post, we discussed the high-profile dispute between the estate of the late artist Prince and Patty Apollonia Kotero, over trademark rights derived from the name Apollonia, made…
DEFINITIVE HOLDINGS, LLC v. POWERTEQ LLC Before Moore, Dyk, and Cunningham. Appeal from the United States District Court for the District of Utah. Summary: A third-party sale of a product…
VLSI TECHNOLOGY LLC v. INTEL CORP. Before Moore, Chen, and Kleeh. Appeal from the United States District Court for the Northern District of California. Summary: The Federal Circuit reversed summary…
INTERNATIONAL MEDICAL DEVICES, INC. v. CORNELL Before Dyk, Reyna, and Taranto. Appeal from the United States District Court for the Central District of California Summary: The Federal Circuit held under…
