Federal Circuit Confirms Qualification as a "U.S.-Made End Product" under the TAA, Does Not Require Substantial Transformation in the U.S.
Client Alert | 1 min read | 02.10.20
Today, in Acetris Health, LLC v. United States, the Federal Circuit held that a pharmaceutical manufactured in the United States qualified for sale, under the TAA, to the Department of Veterans Affairs even though the active pharmaceutical ingredient (API) came from a non-designated country, India. In reaching this decision, the court questioned, without deciding, the longstanding Customs and Border Enforcement position that the country where the API was manufactured defined the location of “substantial transformation” for any resulting pharmaceutical. In any event, the court held that under the Federal Acquisition Regulation definition, to qualify as a “U.S.-made end product” under the TAA, the product need be either “manufactured” in the U.S. or “substantially transformed” in the U.S. – it need not be both.
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Client Alert | 8 min read | 06.30.25
AI Companies Prevail in Path-Breaking Decisions on Fair Use
Last week, artificial intelligence companies won two significant copyright infringement lawsuits brought by copyright holders, marking an important milestone in the development of the law around AI. These decisions – Bartz v. Anthropic and Kadrey v. Meta (decided on June 23 and 25, 2025, respectively), along with a February 2025 decision in Thomson Reuters v. ROSS Intelligence – suggest that AI companies have plausible defenses to the intellectual property claims that have dogged them since generative AI technologies became widely available several years ago. Whether AI companies can, in all cases, successfully assert that their use of copyrighted content is “fair” will depend on their circumstances and further development of the law by the courts and Congress.
Client Alert | 3 min read | 06.30.25
Client Alert | 3 min read | 06.26.25
FDA Targets Gene Editing Clinical Trials in China and other “Hostile Countries”
Client Alert | 3 min read | 06.26.25