Mr. Herbert J. Lynch
Sullivan & Lynch, P.C.
56 Roland Street, Suite 303
Boston, MA 02129-1223
RE: The tariff classification of Telaprevir (VX-950) (CAS- 402957-28-2), imported in both bulk and dosage forms, from Portugal
Dear Mr. Lynch:
In your letter dated May 17, 2007, on behalf of your client, Vertex Pharmaceuticals Incorporated (Vertex), you requested a tariff classification ruling.
The subject product, Telaprevir, is a protease inhibitor (PI) for the treatment of hepatitis C virus (HCV) infection. You state that Vertex has initiated a Phase 2b clinical trial in the United States to evaluate sustained viral response rates in treatment-naïve patients with genotype-1 HCV. Vertex is also conducting a Phase 2b trial in patients with genotype-1 HCV who have not achieved a sustained viral response with previous interferon-based treatment.
You suggest that Telaprevir in bulk is classifiable in subheading 2924.29. We respectfully disagree. In its structure, Telaprevir contains a pyrazine ring as well as an amide function. Pyrazine is a modified aromatic heterocyclic compound with nitrogen only hetero-atoms, a compound included in heading 2933. Pursuant to Chapter 29 Note 3, the applicable subheading for the Telaprevir in bulk form will be 2933.99.4600, Harmonized Tariff Schedule of the United States (HTSUS), which provides for "Heterocyclic compounds with nitrogen hetero-atom(s) only: Other: Other: Aromatic or modified aromatic: Other: Drugs: Anti-infective agents: Other." The rate of duty will be 6.5 percent ad valorem. At the present time, the subject product is not listed in the Pharmaceutical Appendix to the Tariff Schedule. General Note 13, HTS.
You suggest classification in subheading 3004.90.9190 for Telaprevir when put up in a single dose. We disagree here as well. Since it is an anti-infective medicament, Telaprevir in dosage form is more specifically classifiable in subheading 3004.90.9110, HTSUS, which provides for "Medicaments … consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses … or in forms or packings for retail sale: Other: Other: Other: Anti-infective medicaments: Other." The rate of duty will be free.
Duty rates are provided for your convenience and are subject to change. The text of the most recent HTSUS and the accompanying duty rates are provided on World Wide Web at http://www.usitc.gov/tata/hts/.
This merchandise may be subject to the Federal Food, Drug, and Cosmetic Act and/or The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (The Bioterrorism Act), which are administered by the U.S. Food and Drug Administration (FDA). Information on the Federal Food, Drug, and Cosmetic Act, as well as The Bioterrorism Act, can be obtained by calling the FDA at 1-888-463-6332, or by visiting their website at: www.fda.gov.
This ruling is being issued under the provisions of Part 177 of the Customs Regulations (19 C.F.R. 177).
A copy of the ruling or the control number indicated above should be provided with the entry documents filed at the time this merchandise is imported. If you have any questions regarding the ruling, contact National Import Specialist Harvey Kuperstein at 646-733-3033.
Robert B. Swierupski