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(영문) 서울고등법원 2012.02.22 2011나76718

손해배상(기)

Text

1. Of the judgment of the first instance court, the part against Defendant A, E, and F, and the part against Defendant C and D, respectively, are 308,271.

Reasons

1. The following facts:

(a)bee;

(h) Each fact described is without dispute between the parties, or recognized by Gap evidence Nos. 1, 2, 7, 9, 10, 12, 14 through 18 (including paper numbers), Eul evidence Nos. 1, 6 (including paper numbers), Eul evidence Nos. 5, 6, and 8 and the purport of the whole argument.

A. The Plaintiff is a corporation established with the purpose of contributing to the improvement of public health and the promotion of social security by carrying out businesses such as the imposition and collection of insurance premiums and the payment of insurance benefit costs under the National Health Insurance Act.

(2) Defendant Sejong District Co., Ltd. (hereinafter referred to as “Defendant Sejong”) and Defendant Korea Tyd Co., Ltd. (hereinafter referred to as “Defendant Korea Tyd Co., Ltd.”) are companies engaged in manufacturing, selling, etc. of drugs.

(3) Defendant A Co., Ltd. (hereinafter “Defendant A”) is a company engaging in pharmaceutical analysis business. Defendant C was a technical adviser of the foregoing company, Defendant D was a business director, Defendant E, and Defendant F was an analysis researcher.

(b) Biological equivalence test (1) Biological equivalence test (hereinafter referred to as “biological equivalence test”) means a test conducted for the purpose of proving that, as a part of a biological equivalence test, the two preparations in the same administration route containing the same major ingredient are statistical equivalent in terms of the utilization rate of the human body with respect to a medicine in which the major ingredient is absorbed into the clibal blood, and indicating efficacy.

The Korean Food and Drug Administration (hereinafter referred to as the "Food and Drug Administration") has established the "biological equivalence test standards" by the notification of the Food and Drug Administration, and has set the procedures, methods, etc. necessary for conducting the same-sex test and are appropriate for the operation thereof.

The results of the same-sex test are as follows: (a) collecting blood from the subjects who specifically implemented the test medicine and the large treaty; and (b) converting the area under the blood concentration of active ingredients and the highest blood concentration into the main comparison items.