Organon, Inc. v. United States

47 Cust. Ct. 205
CourtUnited States Customs Court
DecidedDecember 13, 1961
DocketC.D. 2303
StatusPublished
Cited by1 cases

This text of 47 Cust. Ct. 205 (Organon, Inc. v. United States) is published on Counsel Stack Legal Research, covering United States Customs Court primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Organon, Inc. v. United States, 47 Cust. Ct. 205 (cusc 1961).

Opinion

Wilson, Judge:

The merchandise in the cases at bar, which have been consolidated for trial, invoiced as “Heparin Sodium USP XV,” was classified under paragraph 5 of the Tariff Act of 1930, as modified by the Torquay Protocol to the General Agreement on Tariffs and Trade, T.D. 52739, at the rate of 12% per centum ad valorem, as a medicinal preparation, not specially provided for. Plaintiff claims the merchandise properly free of duty under paragraph 1669 of the said act as a crude drug, or, in the alternative, dutiable under paragraph 34 of the act, as modified by the General Agreement on Tariffs and Trade, T.D. 51802, at the rate of 5 per centum ad valorem as a drug, advanced in condition. It appears that the substance under consideration is used medicinally for the purpose of retarding the clotting of human blood.

The pertinent paragraphs of the tariff act here under consideration are as follows:

Paragraph 5, as modified by T.D. 52739, sufra:

All chemical elements, all chemical salts and compounds, all medicinal preparations, and all combinations and mixtures of any of the foregoing, all the foregoing obtained naturally or artificially and not specially provided for * * *_12%% ad val.
Pak. 1669. Drugs such as barks, beans, berries * * * and all other drugs of vegetable or animal origin; all the foregoing which are natural and uncompounded drugs and not edible, and not specially provided for, and are in a crude state, not advanced in value or condition by shredding, grinding, chipping, crushing, or any other process or treatment whatever beyond that essential to the proper packing of the drugs and the prevention of decay or deterioration pending manufacture: Provided, That no article containing alcohol shall be admitted free of duty under this paragraph.

Paragraph 34, as modified by T.D. 51802, sufra:

Drugs, such as barks, beans, berries, * * * and all other drugs of vegetable or animal origin * * *; any of the foregoing which are natural and uncompounded drugs and not edible, and not specially provided for, but which are advanced in value or condition by shredding, grinding, chipping, crushing, or any other process or treatment whatever beyond that essential to the proper packing of the drugs and the prevention of decay or deterioration pending manufacture, and not containing alcohol_5% ad val.

A sample of the finished product made from the imported material and which is offered on the market to doctors was received in evidence as plaintiff’s exhibit 3 (R. 62). The parties herein stipulated that heparin is usually obtained from the liver or lungs of domestic mammals used for food by man; that heparin contains no alcohol; that it is inedible (R. 11).

[207]*207There was received in evidence a deposition of Berend Drenth, factory chemist employed by the exporter, who supervised the production of the importation here involved. Attached to said deposition is a so-called “Flowsheet” (exhibit A) showing the production of “Heparin USP XV” obtained from the original heparin as contained in certain animal tissues.

The flowsheet, above referred to (exhibit A), describes the manufacturing process for heparin USP as follows:

FLOWSHEET OF THE MANUFACTURING PROCESS FOR HEPARIN (U.S.P.) PART I
Mincing and grinding of frozen beef lung.
Coagulation of ground lung.
Proteollytie digestion of tbe coagulated lung.
Preparation of a precipitate from tbe digested lung, by lowering tbe PH to 2,5-2,6 by means of 3 N. hydrochloric acid.
Filtration and washing of tbe precipitate at a temperature ofl discard 75-80°C. J filtrate
Suspending of the precipitate in 5% (w/y) Na Cl solution, the PH is adjusted to 8,0 by means of 15% sodium hydroxyde.
Boiling of the suspension after adjusting the PH to 6,8 by means of 3 N. hydrochloric acid.
Filtration and washing of the precipitate at a temperature ofl discard 95-100°C. J precipitate
Concentration of the combined filtrates by evaporation in a vacuum still till % of the starting volume.
Boiling of the solution after addition of charcoal and filteraid.
Filtration and washing of the precipitate at a temperature ofl discard 95-100°C. J precipitate
Addition of methanol to the combined filtrates so that the final concentration thereof becomes 40% (v/v).
Filtration and washing of the precipitate after addition of hyflol discard supereell (filteraid) J filtrate
Precipitate is forwarded to Department I

Plaintiff’s witness Drenth testified in the aforesaid deposition substantially as follows: That the merchandise here imported meets the specifications for heparin or heparin sodium as described in the United States Pharmacopoeia (R. 17); that neither the chemical composition nor the structural formula of heparin, from which “Pleparin Sodium USP XV” was derived, was determined by him (R. 16); that he did not personally investigate whether or not heparin sodium XV is formed as such in animal tissue (R. 17). He further testified that the tissue of mammals contains sodium in varying amounts, depending on its source, from dog lung, rabbit lung, or [208]*208human lung (E. 18); and that there is enough sodium in the tissue of beef lung to contain about 13 per centum of sodium (E. 20). This latter conclusion was apparently based upon statements made in the literature which the witness had read upon the subject.

In response to cross-interrogatories, Mr. Drenth stated that “The whole process is a physical one. It is aiming at a concentration of the active principles by removing several inactive impurities” (E. 22). Plaintiff’s witness further testified:

A. As Heparin (Heparin Sodium) is a mixture of sulpbated mucopolysac-charides (see M. Stacey, Advances in Carbohydrate Chemistry 2, 181, 1946) and it is present as such in the basic material, these substances should not be hydrolized nor undergo any other chemical change, otherwise the biological activity can be lost or diminish. (R. 23.)
The answers to the questions propounded to this witness as to the nature of the “basic” material used in the production of the imported product were somewhat ambiguous, as disclosed by the record herein. As to whether the commodity here imported was “that very same Heparin Sodium found in animal tissues, or whether the sodium in that merchandise is obtained from some other source, such as materials which are added during the course of the procedure described” in the “Flowsheet” (exhibit A), plaintiff’s witness responded:
A. I do not know if the Sodium in the Heparin Sodium or Heparin can be exchanged with the Sodium from Sodium compounds used during the isolation of the Heparin Sodium or Heparin from the animal tissue, as I did not undertake experiments with radio-active Sodium to prove this.

Mr.

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Related

Organon, Inc. v. United States
59 Cust. Ct. 363 (U.S. Customs Court, 1967)

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Bluebook (online)
47 Cust. Ct. 205, Counsel Stack Legal Research, https://law.counselstack.com/opinion/organon-inc-v-united-states-cusc-1961.