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NY N016203

August 28, 2007



TARIFF NO.: 9817.85.01

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 bulk form, from Portugal and the United Kingdom, as a prototype under subheading 9817.85.01 HTSUS

Dear Mr. Lynch:

In your letter dated August 22, 2007, on behalf of your client, Vertex Pharmaceuticals Incorporated (Vertex), you requested a tariff classification ruling on the applicability of subheading 9817.85.01 (“Prototypes to be used exclusively for development, testing, product evaluation, or quality control purposes”) for bulk Telaprevir, a protease inhibitor (PI) drug for the treatment of hepatitis C virus (HCV) infection. Previously, in New York Ruling N011563, dated May 24, 2007, this office provided classifications for both bulk and dosage forms of Telaprevir,

Following the suggestions found in HQ 563056 and HQ 563139, you have submitted extensive documentation in support of the prototype claim.

You state that Vertex had 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. Phase 3 clinical studies are scheduled to begin in the fourth quarter of 2007. There will be two Phase 3 studies, each enrolling approximately 1000 patients at a dose of 2.25 grams per patient per day. This will result in the total consumption of 300 kilograms of active drug substance. A total of approximately 1450 kilograms of Telaprevir will be manufactured to support all the Phase 2 and 3 clinical studies in the United States, Canada and Europe. This includes a fifty per cent overage to ensure sufficient product for all the trials. None of the drug product imported into the United States will be sold or be made otherwise commercially available.

The importation of Telaprevir is solely for the purpose of Phase 2 and 3 clinical trials for the treatment of hepatitis C virus infection (HCV). By definition, clinical trials are conducted for "testing" and "product evaluation" where the effectiveness and safety of a drug is tested in a controlled environment. Additionally, the amounts imported will be in limited noncommercial quantities only for use in the clinical trials. None of the drug product will be sold or incorporated into products that will be sold. Finally, the imported product is not subject to antidumping or countervailing duty orders. Therefore, it is the opinion of this office that the importation of Telaprevir satisfies all the conditions delineated in U.S. Note 7, Chapter 98, Subchapter XVII, Harmonized Tariff Schedule of the United States (HTSUS).

Pursuant to Section XXII, Subchapter XVII, U.S. Note 7(a), (b) and (c), the applicable subheading for the subject merchandise will be 9817.85.01, HTSUS, which provides for "Prototypes to be used exclusively for development, testing, product evaluation, or quality control purposes." 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

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