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NY J80522




February 21, 2003

CLA-2-29:RR:NC:2:238 J80522

CATEGORY: CLASSIFICATION

TARIFF NO.: 3003.90.0000; 3004.90.9145

Herbert J. Lynch, Esq.
Sullivan & Lynch, P.C.
156 State Street
Boston, MA 02109-2508

RE: The tariff classification of Amevive® (alefacept), Alefacept (CAS-222535-22-0), imported in bulk form and single-dose vials, from Germany

Dear Mr. Lynch:

In your letter dated January 31, 2003, on behalf of your client, Biogen, Inc., you requested a tariff classification ruling.

The subject product, Amevive® (alefacept), is a formulated drug product containing Alefacept (CAS-222535-22-0), an antipsoriatic drug, as the active ingredient. You state that your client will import Amevive® (alefacept) in bulk form and put up in single-dose vials.

Alefacept is a fusion protein (human) consisting of the portion of the LFA-3

Leukocyte function-associated antigen 3 - a cell-surface glycoprotein (“marker”) expressed on a wide variety of cells. It is referred to as an “antigen,” since it can be identified by specific monoclonal antibodies. molecule that binds to CD-2 antigen CD-2 antigen - a specific cell-surface marker, found on T lymphocytes, whose major function is to interact with LFA-3. Like LFA-3, it is referred to as an “antigen,” since it can be identified by specific monoclonal antibodies., linked to the Fc portion of human immunoglobulin G1 It is produced by recombinant DNA techniques, and is represented by the following empirical chemical formula: C3264H5002N840O988S20. Alefacept belongs to the class of drugs known as immunomodulators, and is indicated for the treatment of adult patients with moderate to severe chronic plaque psoriasis. An article found on the FDA’s website, dated January 30, 2003, indicates that your client’s biologics license application for Alefacept has been approved (by the FDA), which, in effect, allows Biogen to bring the formulated drug product, i.e., Amevive® (alefacept), to market. It is your belief that Amevive® (alefacept) constitutes a modified immunological product which (imported in bulk or dosage form) is properly classifiable under subheading 3002.10.0190, HTS. However, although we agree that Amevive® (alefacept) does, in fact, constitute a modified immunological product obtained by biotechnological processes, it is our determination, nonetheless, that it is precluded from classification as such - for tariff purposes - by Note 2 to Chapter 30, HTS, and the Explanatory Notes to heading 3002, HTS.

Note 2 to Chapter 30, HTS, states that “For the purposes of heading 3002, the expression ‘modified immunological products’ applies only to monoclonal antibodies (MABs), antibody fragments, antibody conjugates and antibody fragment conjugates.” Monoclonal antibodies (MABs) are defined in the Explanatory Notes to heading 3002, HTS (see E.N. 30.02(C)(2)(a)), as “[s]pecific immunoglobulins from selected and cloned hybridoma cells cultured in a culture medium or ascites.” Antibody fragments are defined in the Explanatory Notes to heading 3002, HTS (see E.N. 30.02(C)(2)(b)), as “[p]arts of an antibody protein obtained by means of specific enzymatic splitting.” Finally, the Explanatory Notes to heading 3002, HTS (see E.N. 30.02(C)(2)(c)), indicate that antibody conjugates and antibody fragment conjugates consist of enzymes (e.g., alkaline phosphatase, peroxidase or betagalactosidase) or dyes (fluorescin) covalently bound to an antibody or antibody fragment (“the protein structure”), and “[a]re used for straightforward detection reactions.” Accordingly - based upon its actual composition, and by application of the definitions cited above - it is our determination that Alefacept does not meet the tariff definition of a modified immunological product.

The applicable subheading for Amevive® (alefacept), imported in bulk form, will be 3003.90.0000, Harmonized Tariff Schedule of the United States (HTS), which provides for “Medicaments consisting of two or more constituents which have been mixed together for therapeutic or prophylactic uses, not put up in measured doses or in forms or packings for retail sale: Other.” The rate of duty will be free.

The applicable subheading for Amevive® (alefacept), imported put up in single-dose vials, will be 3004.90.9145, HTS, 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: Dermatological agents and local anesthetics.” The rate of duty will be free.

This merchandise may be subject to the requirements of the Federal Food, Drug, and Cosmetic Act, which is administered by the U.S. Food and Drug Administration. You may contact them at 5600 Fishers Lane, Rockville, Maryland 20857, telephone number 301-443-1544.

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.

Sincerely,

Robert B. Swierupski

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