Searching over 5,500,000 cases.


searching
Buy This Entire Record For $7.95

Official citation and/or docket number and footnotes (if any) for this case available with purchase.

Learn more about what you receive with purchase of this case.

UNITED STATES v. CIBA GEIGY CORP.

UNITED STATES DISTRICT COURT, DISTRICT OF NEW JERSEY


April 14, 1976

UNITED STATES of America, Plaintiff,
v.
CIBA GEIGY CORPORATION, Defendant

The opinion of the court was delivered by: MEANOR

FINDINGS OF FACT

JURISDICTION

 This is an action instituted on July 9, 1969 by the United States of America under Section 4 of the Sherman Act, 26 Stat. 209 (15 U.S.C. § 4) for injunctive and other appropriate relief to remedy and prevent alleged violations of Section 1 of that Act, 26 Stat. 209 (15 U.S.C. § 1). The court has jurisdiction of the subject matter and the parties.

 DEFENDANT

 CIBA-GEIGY Corporation, a New York corporation has its principal offices in Ardsley, New York, and the principal offices of its pharmaceutical subsidiary in Summit, New Jersey. It was formed in 1970 through the acquisition of CIBA Corporation, a Delaware corporation, by Geigy Pharmaceuticals Corporation ("Geigy"), a New York corporation, following which the name was changed to CIBA-GEIGY Corporation.

 At all times relevant to this proceeding, CIBA was a research-oriented manufacturer and seller of ethical pharmaceutical drugs, principally in specialty form under its own trademarks.

 In 1967, CIBA's total sales were approximately $ 125 million, and CIBA's total assets in that year were about $ 137 million. In 1970, CIBA-GEIGY Corporation was the eighth largest ethical drug firm in the United States.

 CIBA'S LICENSEES AND VENDEES

 MERCK & CO. INC.

 At the time of the complaint, Merck & Co. Inc. ("Merck") was a New Jersey corporation and had its general office in Rahway, New Jersey. In 1969 Merck had total assets exceeding $ 550 million and sales of $ 447 million. In 1970 Merck was the fourth largest ethical drug firm in the United States.

 ABBOTT LABORATORIES

 At the time of the complaint, Abbott Laboratories ("Abbott") was an Illinois corporation and had its general office in North Chicago, Illinois. In 1969 Abbott had total assets of $ 388 million and sales of $ 404 million. In 1970 Abbott was the sixth largest ethical drug firm in the United States.

 WARNER-LAMBERT PHARMACEUTICAL CO.

 At the time of the complaint, Warner-Lambert Pharmaceutical Co. ("Warner") was a Delaware corporation and had its general office in Morris Plains, New Jersey. In 1969 Warner had total assets of $ 572 million and sales of $ 808 million. In 1970 Warner was the 19th largest ethical drug firm in the United States.

 G. D. SEARLE & CO.

 At the time of the complaint, G. D. Searle & Co. ("Searle") was a Delaware corporation and had its general office in Skokie, Illinois. In 1969 Searle had total assets of $ 173 million and sales of $ 164 million. In 1970 Searle was the 16th largest ethical drug firm in the United States.

 SMITH KLINE & FRENCH LABORATORIES

 At the time of the complaint, Smith Kline & French Laboratories ("SKF") was a Pennsylvania corporation and had its general office in Philadelphia, Pennsylvania. In 1969 SKF had total assets of $ 242 million and sales of $ 315 million. In 1970 SKF was the seventh largest ethical drug firm in the United States.

 RICHARDSON-MERRELL INC.

 At the time of the complaint, Richardson-Merrell, Inc. ("RMI") was a Delaware corporation and had its general office in New York, New York. In 1969 RMI had total assets of $ 331 million and sales of $ 381 million. In 1970 RMI was the 21st largest ethical drug firm in the United States.

 McNEIL LABORATORIES, INC.

 At the time of the complaint, McNeil Laboratories Inc. ("McNeil") was a Pennsylvania corporation and a wholly owned subsidiary of Johnson & Johnson, which was a New Jersey corporation with its general office in New Brunswick, New Jersey. In 1969 Johnson & Johnson had total assets of $ 482 million and sales of $ 664 million. In 1970 Johnson & Johnson was the 15th largest ethical drug firm in the United States.

 CARTER PRODUCTS, INC.

 Carter Products, Inc. ("Carter"), originally a Maryland corporation, adopted the title Carter-Wallace Inc. on July 20, 1965 and was incorporated in Delaware by merger into a company of the same name on November 29, 1968. At the time of the complaint, Carter-Wallace Inc. had its general office in New York, New York. In 1969 Carter had total assets of $ 93 million and total sales of $ 125 million.

 LEMMON PHARMACAL CO.

 At the time of the complaint, Lemmon Pharmacal Co. ("Lemmon") was a Pennsylvania corporation and had its general office in Sellersville, Pennsylvania. In 1969 Lemmon had total assets of $ 2.9 million and sales of $ 3.3 million.

 HOFFMAN-LA ROCHE, INC.

 At the time of the complaint, Hoffman-LaRoche Inc. ("Roche") was a New Jersey corporation and had its general office in Nutley, New Jersey. In 1969 Roche had total assets of $ 260 million and sales of $ 290 million. In 1970 Roche was the second largest ethical drug firm in the United States.

 ELI LILLY AND COMPANY

 At the time of the complaint, Eli Lilly and Company ("Lilly") was an Indiana corporation and had its general office in Indianapolis, Indiana. In 1969 Lilly had total assets of $ 538 million and sales of $ 537 million. In 1970 Lilly was the largest ethical drug firm in the United States.

 GENERAL DEFINITIONS

 1. "Package form," "specialty form," and "dosage form" each mean pills, tablets, capsules, solutions, syrups, and other forms of pharmaceutical products packaged for use by or administration to humans or animals.

 2. "Ethical Drug" means a drug sold on the prescription of a physician.

 3. "Bulk form" means the form in which pharmaceutical products are manufactured prior to their being packaged into dosage form.

 4. "Therapeutically active product" and "therapeutically active ingredient" each mean any chemical product possessing pharmacological or therapeutic utility in the treatment of humans or animals.

 5. "Combination product" means any pharmaceutical product containing more than one therapeutically active product.

 6. "Straight formulation" means a dosage form product containing only one therapeutically active product. Hydrochlorothiazide in straight formulation is a tablet or other dosage form that contains hydrochlorothiazide as the only therapeutically active ingredient.

 7. "Combination Form" or "Fixed Combination" mean a specialty form or dosage form drug containing two or more therapeutically active ingredients.

 8. "Free Combination" means the concurrent use of two or more specialty form or dosage form drugs, each of which contains one or more therapeutically active ingredients.

 9. "As such" refers to any chemical product in straight formulation.

 10. "Hydrochlorothiazide products" mean, collectively, bulk form and dosage form products containing hydrochlorothiazide in straight formulation or in combination with another or other therapeutically active ingredients.

 11. "New Drug Application" ("NDA") means that application required to be filed with and approved by the Food and Drug Administration ("FDA") by 21 U.S.C. § 355 and 21 C.F.R. § 314 before a "new drug" (as defined in 21 C.F.R. § 310) may be sold in interstate commerce.

 12. "Anti-bulk sale restriction" means a restriction on or limitation against the resale of hydrochlorothiazide in bulk chemical form.

 13. "Anti-straight formulation restriction" means a restriction on or limitation against the resale of hydrochlorothiazide in straight formulation.

 14. "Approved-combination-only restriction" means a restriction on or limitation against the resale of hydrochlorothiazide other than as a combination product that has been previously approved (in this case, by CIBA).

 15. "Edema" means the condition of an excess of water in the body which occurs when the body does not eliminate a sufficient quantity through the kidneys, thereby resulting in a back pressure through the veins pushing water and fluid through the capillaries out into the tissues causing such conditions as congestive heart failure, chronic lung disease, chronic cirrhosis and kidney failure.

 16. "Diuresis" is the washing of salt and water out of the body by urinary excretion.

 17. "Diuretic" means a chemical substance which produces diuresis.

 18. "Hypertension" means an elevation of the blood pressure within the arterial system of the body which is in excess of the generally accepted level of 140 cystolic or pumping pressure and 90 diastolic or resting pressure. There are different degrees of hypertension generally referred to as mild, moderate, moderate to severe, and severe, depending upon the extent of the elevation of the blood pressure. It is generally believed in the medical profession that, as has been demonstrated by short-term and long-term studies, such elevation of the blood pressure is directly contributory to the early onset of strokes, heart attacks, kidney failure, etc.

 19. "Antihypertensive" means a chemical substance which reduces blood pressure and is used for the treatment of hypertension.

 20. "Saluretic" means a pharmaceutical product which causes increased excretion of salt in the urine.

 TECHNICAL DEFINITIONS

 21. "Benzothiadiazine" means any derivative of a 3,4-dihydros-2-H-(1,2,4)-benzothiadiazinesp-1,1-dioxide.

 22. "Cyclothiazide" means, and is the generic name for, the benzothiadiazine with the chemical name 6-chloro-3,4-dihydro-3-(5-nor-borensp-2-yl)-7-sulfamoyl-1,2,4,- benzothiadiazine-1,1-dioxide.

 23. "Hydrochlorothiazide" (hereinafter referred to as HCT) is the generic name for one benzothiadiazine derivative covered by United States Letters Patent 3,163,645, which issued to CIBA on December 29, 1964 and which will expire on December 29, 1981.

 24. "Chlorothiazide" means, and is the generic name for, the benzothiadiazine with the chemical name 6-chloro-2-H-1,2,4,-benzothiadiazine-7-sulfonamide 1,1-dioxide.

 TECHNICAL BACKGROUND

 Benzothiadiazines are one group of drugs which are used as diuretics, saluretics, and antihypertensives. In such therapy they are administered orally either alone or in conjunction with other drugs. The therapeutic effectiveness of the benzothiadiazines can be increased by administering them together with one or more other drugs. One widely used benzothiadiazine is HCT.

 A commonly employed drug treatment for hypertension is the use of HCT plus reserpine, an antihypertensive and calming agent. The ratio of the HCT to the reserpine that produces the maximum therapeutic effect varies from patient to patient. The various combination products of this type, however, are marketed in the form of a fixed ratio of the two therapeutically active ingredients.

 Hypertension is also treated by the use of combinations of HCT and other drugs, such as deserpidine, syrosingopine, butabarbital, meprobamate, methyldopa, guanethedine sulfate, and hydralazine-hydrochloride. As in the case of reserpine, for any given patient there exists an optimum ratio of the benzothiadiazine to the other therapeutically active product or products. Nevertheless, the various combination products containing HCT and one or more of these therapeutically active ingredients are marketed in a form which contains a fixed ratio of the ingredients.

  Another benzothiadiazine which is used as a diuretic and antihypertensive agent is cyclothiazide. Cyclothiazide is marketed by Lilly in dosage form, in straight formulation and in combination with reserpine and other products for use as a diuretic and antihypertensive agent.

 COMMERCE RELATING TO HYDROCHLOROTHIAZIDE

 At least until the filing of this complaint in 1969, HCT was sold in the United States in dosage form, as such, by only three companies: by CIBA as "Esidrix," by Abbott as "Oretic," and by Merck as "Hydro-DIURIL."

 In 1969, CIBA, Merck and Abbott accounted for over $ 22 million in sales of HCT in dosage form, as such. HCT has also been sold in dosage form in combination with other drugs by the companies and under the trade names listed below: COMPANY TRADE NAME OTHER DRUGS Abbott Oreticyl deserpidine Carter Caplaril mebutamate Miluretic meprobamate CIBA Apresoline-Esidrix hydralazine-HC1 Esidrix-K potassium chloride Esimil guanethedine sulfate Ser-Ap-Es reserpine and hydralazine-HC1 Serpasil-Esidrix reserpine Singoserp-Esideix syrosingopine McNeil Butiserpazide reserpine and butabarbital Butizide butabarbital Merck Aldoril methyldopa Cyclex meprobamate Hydropres reserpine Searle Aldactazide spironolactone Smith, Kline & French Dyazide triamterene Warner Perithiazide pentaerythritol tetranitrate

19760414

© 1992-2004 VersusLaw Inc.



Buy This Entire Record For $7.95

Official citation and/or docket number and footnotes (if any) for this case available with purchase.

Learn more about what you receive with purchase of this case.