On February 10, 2020, the Federal Circuit issued a decision in Acetris Health, LLC v. United States, a case of first impression with huge implications for drug manufacturers that source API from non-designated countries. The court held that the finished drug product not the API was the product being acquired by the government, and it was not a product of India because it was not substantially transformed in India, and thus was not prohibited under the Trade Agreement Act. Further, the court held that the procuring agency, not CBP, must decide if the product complies with FAR and that CBP lacked jurisdiction to decide whether a product complied with the FAR. Finally, the court determined the product was U.S.-made because it was manufactured in the U.S., and therefore it was not necessary to determine whether the product was also substantially transformed in the U.S..
Hear from Stephen Ruscus and Donna Lee Yesner of Morgan, Lewis and Bockius, who successfully protested the VA’s decision to exclude the company’s products in the Court of Federal Claims, defended the decision on appeal and have 11 current cases before the Court of International Trade challenging CBP’s country of origin determinations on behalf of Acetris.
The webinar will discuss the decision and its implications for finished drug products that are not manufactured in the U.S. and for non-drug products manufactured in the U.S. More broadly, the decision is important for bid protests challenging agency interpretations of statutes and regulations, because, like mootness, it expands the concept of interested party beyond the particular solicitation or contract award when the government’s interpretation will persist and the plaintiff is likely to bid in the future and be affected by the interpretation.
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