Federal Circuit Upholds Duty-Free Treatment for Pharmaceutical Ingredient

The Court of Appeals for the Federal Circuit in an April 26 opinion upheld a Court of International Trade ruling that gave duty-free treatment to darunavir ethanolate, the active ingredient in a HIV medication from drugmaker Janssen.

Finding that the ingredient is in fact darunavir by another name, and therefore is included in Table 1 of the Pharmaceutical Appendix, the trade court ruled against the government's arguments that darunavir ethanolate has a different Chemical Abstracts Service (CAS) number, and is not a derivative listed in Table 2.