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...
FDA Announces “RAPID” Pathway for Expedited Access to Breakthrough Devices by Medicare Population
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...
AI Risks With the Patent Office: What Life Science Companies Should Be Asking Now
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...
Proposal for Streamlined U.S. Regulatory Approval for Novel Commercial Space Activities
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...
In Law360 Column, Sean Murray and Jeremiah Helm Explore Limits of Retroactivity in IPR Proceedings
In the latest installment of their monthly Law360 column covering recent noteworthy Federal Circuit decisions, Knobbe Martens partners Sean Murray and Jeremiah Helm discussed the court’s opinion on retroactivity in...
SMEDs Are Working: What the USPTO’s Updated § 101 Patent Eligibility Guidance Means for Innovators
Key Takeaway: The U.S. Patent and Trademark Office’s April 30, 2026 memorandum encourages patent applicants to submit separate declarations supporting “subject matter eligibility” (SMEDs) in response to § 101 rejections....
No Notice, No Fix: Failure to Satisfy § 256(B) Renders Patent Invalid
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:...
A Cure for Written Description and Enablement Headaches: Prior Art
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...
Knobbe Martens Lawyers Analyze Schedule A Litigation Trends in E-Commerce IP Enforcement
In a recent article published in the Association of Business Trial Lawyers Report, Knobbe Martens intellectual property lawyers Jared Bunker, Marko Zoretic, and Oren Rosenberg provide an in-depth analysis of...
