Roche-Organon, Inc. v. United States

35 C.C.P.A. 99, 1948 CCPA LEXIS 323
CourtCourt of Customs and Patent Appeals
DecidedJanuary 6, 1948
DocketNo. 4578
StatusPublished

This text of 35 C.C.P.A. 99 (Roche-Organon, Inc. v. United States) is published on Counsel Stack Legal Research, covering Court of Customs and Patent Appeals primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Roche-Organon, Inc. v. United States, 35 C.C.P.A. 99, 1948 CCPA LEXIS 323 (ccpa 1948).

Opinion

Garrett, Presiding Judge,

delivered the opinion of the court:

This is an appeal from the judgment of the United States Customs Court, First Division, rendered in conformity with its decision, C. D. 1048, overruling the protest of the importer and sustaining the collector’s classification of a substance invoiced as “Urine Concentrate in form of K Ill-crystals,” entered at the port of New York. The sub[101]*101stance is said, in the brief for the Government, to be known to the medical profession as “the estrogenic hormone.”

The collector classified the merchandise as a medicinal preparation, not specially provided for, under paragraph 5 of the Tariff Act of 1930, duty being assessed at 12½ per centum ad valorem in conformity with the reduced rate provided in the trade agreement with Argentina, T. D. 50504, 77 Treas. Dec. 138, 149.

In its protest appellant made alternative claims, viz: (1) For classification under paragraph 1669 of the 1930 act (with consequent free entry) as a crude drug of animal origin; or (2) for classification under paragraph 34 (with duty assessment at 10 per centum ad valorem) as a drug of animal origin advanced in value or condition; or (3) for classification under paragraph 1558 (with duty assessment at 10 per centum ad valorem) as a nonenumerated unmanufactured article.

The merchandise was manufactured in Holland but imported inte the United States from Curacao in the West Indies. It is agreed that it is the same in all respects as that which was involved in the case of Roche-Organon, Inc. v. United States, 12 Cust. Ct. 164, C. D. 848 Protest 95742-K, decided by the Customs Court April 29, 1944, and not appealed. We hereinafter refer to that case as the first case. The instant case is in effect a retrial of the issues there involved and, upon motions of counsel for the respective parties, the record of that case was incorporated in and made a part of the record in the instant case. It, in fact, constitutes the major part of the record so far as the evidence is concerned.

At the trial of the first case appellant introduced the testimony of two witnesses' — Bernard Joseph Brent, Ph. D. (not an M. D.) and Doctor of Chemical Engineering, who was the scientific director of appellant’s business which is that of preparing hormones for commercial distribution, and Ralph D. Shaner, M. D., who was employed by appellant as its medical director and who was also engaged in the private practice of his profession. Appellant also introduced in evidence a number of documentary and physical exhibits all the originals of which were destroyed by fire in the sample room of the United States Customs Court after the case had been argued before it and before its decision had been rendered. Some of the documentary exhibits could not be replaced. Such of them as could be were replaced by stipulation of counsel together with the physical exhibits. Of those which are missing the Customs Court said “their presence is not regarded as essential for a proper determination of the issue,” and this view obviously was acquiesced in by counsel for the respective parties.

The physical exhibits introduced by appellant are five in number, Exhibit 1 being a sample of the merchandise in its condition as imported, and exhibits 2, 3, 4, and 5 being samples of the commercial [102]*102product prepared by appellant with the use of the imported product after its importation.

At the trial of the second (the instant) case appellant supplemented the testimony of Messrs. Brent and Shaner with that of William Wolf, M. D., apparently an active member of his profession who specializes in endocrinology — the “study of the function and action of the ductless glands” — who has written extensively upon that subject.

The only witness called on behalf of the Government was Ephraim Shorr, M. D., whose professional activity and experience seem to have been quite extensive. He appears to have specialized for many years past in the field of ductless glands “related to the female sex hormones,” and' has written much upon the subject.

We have deemed it unnecessary to recite the training and wort of the several witnesses in great detail. They seem to have been well qualified to give testimony concerning the matters about which they were questioned.

In reality they do not differ in any essential degree as to the nature of the imported substance, Exhibit 1, nor as to the nature of the preparations illustrated by exhibits 2, 3, and 5 made from that exhibit. Their views with respect to Exhibit 4 are hereinafter set forth in detail.

Prior to testifying, Doctor Shorr, with the consent of counsel, was furnished some of the imported substance which he caused to be used in the preparation of tablets which, as we understand it, corresponded to appellant’s Exhibit 5 — Menformon Tablets — and these were introduced in evidence as Illustrative Exhibit A. He described in detail the process by which he directed the tablets to be made. The tablets so made were used by Doctor Shorr in the treatment of patients having deficiencies in the estrogenic hormone, along with •tablets represented by Exhibit 5.

Brent was the only witness who testified respecting the production of the imported substance. After attending and receiving degrees from different institutions in Germany, the last one in 1929, he was employed for about 3 years as scientific director of a company in Hamburg, Germany, engaged in the manufacture of pharmaceutical products, some of them hormones. Thereafter he taught and conducted research work until some time in 1933 when he was employed -as director of certain departments in the plant of Organon, N. V., located at Oss, Holland (the relation between the Holland concern •and appellant, if any, is not shown). His work included research on estrone and the production of hormones. He remained with the Holland company for about 4 years — 'that is until in 1937 when he ■came to the United States and became the scientific director of appellant. ' .

Brent’s testimony respecting the operations by which the imported [103]*103substance was produced in Holland is meager. It is well summarized in the decision of the Customs Court as follows:

* * * The imported commodity consists of equilin, equilenin, hippulin, possibly some estradiol, coloring matter, and “about 90 per cent oestrone,” all of such substances being hormones found naturally in the urine of pregnant mares. The desired product is the estrogenic hormone for its therapeutic properties capable of correcting conditions peculiar to females. It is obtained from urine collected between the sixth and ninth month of pregnancy that.extends over 11 months. The selected period is the time when the hormone excretion is at its highest. Although the witness was thoroughly familiar with the procedure followed to acquire the imported merchandise, having observed it during his 4 years’ experience with the foreign producer in Oss, Holland, and being in possession of “the procedure of manufacture,” he refused to describe what he admitted to be a highly involved and complicated process, stating, “I do not know whether I am at liberty to do so, because the company has a procedure of its own which has not been described in the literature yet, and I don’t think I am at liberty to divulge the process” (referring obviously to what transpires before importation).

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35 C.C.P.A. 99, 1948 CCPA LEXIS 323, Counsel Stack Legal Research, https://law.counselstack.com/opinion/roche-organon-inc-v-united-states-ccpa-1948.