CLA–2 OT:RR:CTF:TCM H110419 AMM
Mr. Herbert J. Lynch, Esq. Sullivan & Lynch, P.C. 56 Roland Street, Suite 303
Boston, MA 02129-1223
RE: Revocation of New York Ruling Letter K86861; classification of monoclonal antibody medicaments
Dear Mr. Lynch,
This is in regard to New York Ruling Letter (NY) K86861, dated June 18, 2004, regarding the classification under the Harmonized Tariff Schedule of the United States (HTSUS) of certain monoclonal antibody drug products. In NY K86861, Customs and Border Protection (CBP) classified the drug product Antegren® (natalizumab) under headings 3003 and 3004, HTSUS. We have reconsidered this ruling and have determined that these monoclonal antibody drug products are provided for in heading 3002, HTSUS.
Pursuant to section 625(c)(1), Tariff Act of 1930 (19 U.S.C. §1625(c)(1)), as amended by section 623 of Title VI, notice proposing to revoke NY K86861 was published on May 11, 2011, in Volume 45, Number 20, of the Customs Bulletin. CBP received no comments in response to this notice.
FACTS:
NY K86861 described the Antegren® product as follows:
The subject products consist of Antegren® (natalizumab) mixed with excipients and imported in bulk form, and Antegren® (natalizumab) mixed with excipients and imported put up in single-dose vials. Antegren® is the registered trade name for an investigational drug having the nonproprietary (generic) name: natalizumab, a humanized monoclonal antibody designed to inhibit the migration of immune cells into chronically inflamed tissue where these cells may cause or maintain inflammation. You indicate in your letter that, on May 25, 2004, your client submitted a Biologics License Application (BLA) to the FDA, based on data obtained and analyzed from the first year of FDA-regulated Phase lll clinical trials, for the approval of Antegren® (natalizumab) for the treatment of multiple sclerosis (MS). You further indicate that Antegren® (natalizumab) is currently in FDA-regulated Phase lll clinical trials to evaluate its efficacy for use in the treatment of Crohn’s disease, and in FDA-regulated Phase ll clinical trials to evaluate its efficacy for use in the treatment of rheumatoid arthritis.
NY K86861 classified Antegren® mixed with excipients and imported in bulk form under subheading 3003.90.00, HTSUS, 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”, and Antegren® mixed with excipients and imported put up in single dose vials under subheading 3004.90.91, HTSUS, which provides for: “Medicaments … consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses (including those in the form of transdermal administration systems) or in forms or packings for retail sale: Other: Other”.
ISSUE:
What is the proper classification of the subject monoclonal antibody medicaments?
LAW AND ANALYSIS:
Classification of goods under the HTSUS is governed by the General Rules of Interpretation (GRI). GRI 1 provides that classification shall be determined according to the terms of the headings of the tariff schedule and any relative section or chapter notes. In the event that the goods cannot be classified solely on the basis of GRI 1, and if the headings and legal notes do not otherwise require, the remaining GRI may then be applied.
The HTSUS provisions at issue are as follows:
3002 Human blood; animal blood prepared for therapeutic, prophylactic or diagnostic uses; antisera and other blood fractions and modified immunological products, whether or not obtained by means of biotechnological processes; vaccines, toxins, cultures of micro-organisms (excluding yeasts) and similar products:
3002.10.01 Antisera and other blood fractions and modified immunological products, whether or not obtained by means of biotechnological processes:
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3003 Medicaments (excluding goods of heading 3002, 3005 or 3006) 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:
3003.90.00 Other
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3004 Medicaments (excluding goods of heading 3002, 3005 or 3006) consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses (including those in the form of transdermal administration systems) or in forms or packings for retail sale:
3004.90 Other:
3004.90.91 Other:
Note 2 of Chapter 30, HTSUS, states: “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.”
The Harmonized Commodity Description and Coding System Explanatory Notes (EN), constitute the official interpretation of the Harmonized System at the international level. While neither legally binding nor dispositive, the EN provide a commentary on the scope of each heading of the HTSUS and are generally indicative of the proper interpretation of the headings. It is CBP’s practice to consult, whenever possible, the terms of the ENs when interpreting the HTSUS. See T.D. 89–80, 54 Fed. Reg. 35127, 35128 (August 23, 1989).
The EN to Heading 30.02 states, in pertinent part:
This heading covers:
* * *
(C) Antisera and other blood fractions and modified immunological products, whether or not obtained by means of biotechnological processes. These products include:
* * *
(2) Modified immunological products, whether or not obtained by means of biotechnological processes.
Products used for diagnostic or therapeutic purposes and for immunological tests are to be regarded as falling within this product group. They can be defined as follows:
(a) Monoclonal antibodies (MABs) - specific immunoglobulins from selected and cloned hybridoma cells cultured in a culture medium or ascites.
* * *
The products of this heading remain classified here whether or not in measured doses or put up for retail sale and whether in bulk or in small packings.
Ruling K83806 classified Antegren® under headings 3003 and 3004, HTSUS, depending on whether it was imported in bulk form or put up in single-dose vials. However, both headings specifically exclude goods which can be classified under heading 3002, HTSUS. Therefore, if the above-identified product can be properly classified under heading 3002 HTSUS, it is precluded from classification under headings 3003 or 3004, HTSUS.
Antegren® contains monoclonal antibodies as its active ingredient. Monoclonal antibodies (MAbs) are included within the definition of “modified immunological products”. See Note 2 to Chapter 30, HTSUS; EN 30.02(C)(2)(a). MAbs are used therapeutically to stimulate the immune system. Here, the MAbs are put up in measured doses for retail sale, but remain classified in heading 3002, HTSUS. See EN 30.02. Therefore, the above identified drug product is properly classified under heading 3002, HTSUS, and is excluded from classification under headings 3003 and 3004, HTSUS. The product is specifically provided for under subheading 3002.10.01, HTSUS, which provides for: “Human blood; animal blood prepared for therapeutic, prophylactic or diagnostic uses; antisera and other blood fractions and modified immunological products, whether or not obtained by means of biotechnological processes; vaccines, toxins, cultures of micro-organisms (excluding yeasts) and similar products: Antisera and other blood fractions and modified immunological products, whether or not obtained by means of biotechnological processes”
HOLDING:
By application of GRI 1, the drug product Antegren® is classified in subheading 3002.10.01, HTSUS, which provides for “… modified immunological products, whether or not obtained by means of biotechnological processes …: Antisera and other blood fractions and modified immunological products, whether or not obtained by means of biotechnological processes”. The rate of duty is free. Duty rates are provided for your convenience and are subject to change.
EFFECT ON OTHER RULINGS:
New York Ruling Letter K86861, dated June 18, 2004, is hereby REVOKED.
In accordance with 19 U.S.C. §1625(c), this ruling will become effective 60 days after publication in the Customs Bulletin.
Sincerely,
Myles B. Harmon, Director
Commercial and Trade Facilitation Division