HQ 450654: Applicability of ITC Limited Exclusion Order (337-TA-293) oncertain Crystalline Cefadroxil Monohydrate

Native CBP ruling rendition. Applicability is fact-specific; modification/revocation relationships and original publisher date are retained. Publisher sentinel year0001 means unknown date, not a historical legal adoption.

                            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
                              Intellectual Property Rights Branch