Firm Secures Federal Circuit Victory for Client, Affirming Duty-Free Treatment for HIV Drug
On Tuesday, April 14, 2021, the Firm obtained a significant victory for its client when the Federal Circuit affirmed a district court’s decision, following a bench trial, that our client’s blockbuster HIV drug should enter the United States duty-free. The U.S. Customs and Border Protection (“CBP”) had sought to impose duties exceeding $100 million on the drug, darunavir ethanolate, which is the drug substance in HIV medication PREZISTA®.
The appeal focused on whether the imported drug was included on the Pharmaceutical Appendix to the United States’ tariff schedule, an international treaty aimed at eliminating reciprocal tariffs on pharmaceutical products. This was an issue of first impression, as the Federal Circuit had never before interpreted the scope of pharmaceuticals listed in the Pharmaceutical Appendix. In its opinion, the Federal Circuit confirmed that the listing of “darunavir” on the Pharmaceutical Appendix to the Harmonized Tariff Schedule of the United States covers the imported product, darunavir ethanolate. As a result, both retroactively and going forward, this lifesaving pharmaceutical will be imported free of duty.