On Monday, in the much-anticipated decision in Acetris Health, LLC v. U.S. 18-2399, the Court of Appeals for the Federal Circuit (the “Federal Circuit”) ruled that U.S. manufacture of a drug is sufficient to confer U.S. origin under the Trade Agreements Act (“TAA”) – regardless of the origin of its main component, the Active Pharmaceutical Ingredient (“API”).

The decision affirmed a lower court ruling by the U.S. Court of Federal Claims (“CoFC”) that had found that Acetris product manufactured in the U.S. with API from India was considered a “U.S.-made end product.”  While this case addresses the country of origin (“COO”) analysis for drug products, it has the potential to be applied more broadly to other manufactured items procured by the Federal government.