HQ 0450654 - Applicability of ITC Limited Exclusion Order (337-TA-293) on certain Crystalline Cefadroxil Monohydrate - United States International Trade Commision Rulings

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HQ 450654

May 8, 1991

TRA CO:I:TI:I 450654 TPT

CATEGORY: PATENTS

Raymond F. Sullivan, Jr., Esq.
Soller, Singer & Horn
Suite 280
1850 M Street, N.W.
Washington, D.C. 20036

RE: Applicability of ITC Limited Exclusion Order (337-TA-293) on certain Crystalline Cefadroxil Monohydrate

Dear Mr. Sullivan:

This is in reference to your letter dated December 6, 1990, wherein you asked Customs to issue a ruling pursuant to section 177.1 of the Customs Regulations (19 C.F.R. 177.1(a)) concerning the admissibility of certain crystalline cefadroxil monohydrate known as "cefadroxil DC" for future importations.

FACTS:

The ITC Limited Exclusion Order referenced above prohibits the entry of crystalline cefadroxil monohydrate capsules and bulk powder manufactured by Gema, S.A. of Spain. The requester has identified Gema, S.A. of Spain, as the manufacturer of the product intended to be imported (cefadroxil CD). The Food and Drug Administration approved the sale of cefadroxil CD within the United States on October 31, 1990.

The sample submitted for analysis was taken from a trial importation of cefadroxil CD. A laboratory report based upon the sample was issued on February 12, 1991.

ISSUE:

Whether the cefadroxil DC manufactured by Gema falls within the scope of the ITC order?

LAW & ANALYSIS:

The instant matter is being considered under Part 177 of the Customs Regulations (19 C.F.R. 177.1(a)(1)), which relates to a prospective transaction (importation) concerning articles identical to the submitted sample. A ruling issued in response 2
to a request for a ruling under Part 177 of the Customs Regulations reflects Customs' official position as to the specific question presented regarding the prospective transaction and is binding on all Customs personnel. 19 C.F.R. 177.9. Therefore, this ruling is qualified in that it applies to importations of articles which are identical to the submitted sample.

The above referenced exclusion order was issued based upon an ITC finding that Gema manufactured crystalline cefadroxil monohydrate in capsule and bulk powder forms which are covered by claim 1 of the Letters Patent 4,504,657 (cefadroxil monohydrate). The unique properties of the patented product as found in claim 1 are reflected in the x-ray diffraction of the crystalline cefadroxil monohydrate.

Using the sample provided to Customs, Customs performed x- ray diffraction and infrared spectrographic analysis on the sample. Based upon the analysis, it is our conclusion that, although the cefadroxil CD is chemically similar to the patented product, the cefadroxil CD has a crystalline structure which differs from the patented product to an extent that the cefadroxil CD is not covered by the exclusion order.

HOLDING:

Customs finds that the cefadroxil CD manufactured by Gema, S.A., of Spain and to be imported by Zenith Laboratories, Inc., does not come within the scope of the ITC Limited Exclusion Order (337-TA-293) and, therefore, may be imported.

Sincerely,

John F. Atwood, Acting Chief

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