Introduction
Acting Director of the USPTO, Coke Morgan Stewart, issued a memorandum last week that will change the way petitioners levy challenges to patents via inter partes review (IPR).[1] The change will apply to any petition for IPR
The U.S. Court of Appeals for the Federal Circuit recently issued a non-precedential Rule 36 affirmance of the Patent Trial and Appeal Board (PTAB) in In re Adhami, No. 2024-1218, 2025 WL 1949797 (Fed. Cir. July 16, 2025).[1] This
Introduction
On April 10, 2025, the U.S. Food and Drug Administration (FDA) announced a landmark initiative to phase out animal testing in drug development, signaling a major shift toward human-relevant, science-driven alternatives. This initiative formalizes the agency’s long-building effort to
The Fedtrade® podcast recently interviewed Eugene Laney, President and CEO of the American Association of Exporters and Importers (AAEI). The AAEI represents an international community of trade compliance professionals responsible for complying with and influencing the laws — both domestic
The District Court for the District of Delaware recently rejected Novartis’s effort to block MSN Pharmaceuticals from launching a generic version of Entresto® (sacubitril/valsartan), its top-selling heart failure medication. The decision, issued on July 11, 2025, potentially clears the path
With healthcare costs rising and biologics driving a large portion of drug spend, the next wave of biosimilar launches promises to reshape the U.S. pharmaceutical market in profound ways, including reduced prices for close analogs of existing reference blockbuster branded
The Fedtrade® podcast recently interviewed Andrew Greenfield, Senior Counsel at Fragomen. With more than 6,000 immigration-focused professionals and staff spanning more than 60 offices worldwide, immigration has been Fragomen’s sole focus for 70 years.
Learn more about Fragomen on their
The Fedtrade® podcast recently interviewed Joanne Farquharson, CEO of Foothold America. With a dedicated team of experts, Foothold America provides the tools and resources to make U.S. expansion easy and hassle-free and supports your business journey with turn-key and bespoke
The USPTO’s recent guidance on discretionary denials has shifted patent practitioners back to the Fintiv and Sotera Wireless framework.
The Prior Framework: Fintiv & Sotera Wireless
In Apple Inc. v. Fintiv, Inc., No. IPR2020-00019 (PTAB Mar. 20, 2020), the Patent
In a precedential ruling, the U.S. Court of Appeals for the Federal Circuit in Jazz Pharma. v. Avadel CNS Pharma., 2025 WL 1298920, — F.4th — (Fed. Cir. May 6, 2025), addressed the scope of the 35 U.S.C. § 271(e)(1)
