Oral argument in Acetris TAA case

Earlier this week, the U.S. Court of Appeals for the Federal Circuit (the Federal Circuit) heard oral argument in Acetris Health LLC v. U.S. 18-2399 (Fed. Cir, argued 1 Oct. 2019), an appeal of a decision that focuses on whether products manufactured in the United States with an active pharmaceutical ingredient (API) from Trade Agreements Act (TAA) "nondesignated countries" (such as India or China) can be considered of U.S. origin for federal procurement even if the manufacture is found not to effect a "substantial transformation" per the TAA.

The U.S. Court of Federal Claims (CoFC) had ruled in favor of Acetris, concluding that the U.S. manufacture of the Acetris Entecavir tablets was sufficient to confer U.S. origin per the governing Federal Acquisition Regulation (FAR) clause, accepting Acetris' argument that the clause required application of the less-stringent Buy American Act (BAA) "manufacture" standard for assessing origin, rather than the TAA's substantial transformation test.

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