Text
1. The part against the plaintiff corresponding to the money ordered to be paid under the judgment of the court of first instance shall be revoked.
2...
Reasons
1. Basic facts
A. The Plaintiff is a juristic person whose purpose is to contribute to the improvement of national health and the promotion of social security by carrying out projects such as the imposition and collection of insurance premiums and the payment of insurance benefit costs pursuant to the National Health Insurance Act. 2) Defendant A Co., Ltd. (hereinafter “Defendant A”) is a company that manufactures and sells medicines, and Defendant B is a person who was the head of the Defendant A’s Bioscience Research Institute.
3) Defendant C, an incorporated association, (hereinafter “Defendant C”).
(2) The biological equivalence test (1) biological equivalence test means a test conducted in order to prove that the main ingredient is identical in terms of the same administration route containing the same major ingredient in terms of the utilization rate of the human body, with respect to a medicine that is incorporated into a biological equivalence test, and whose main ingredient is identical in terms of the same administration route, and whose effect is identical in terms of the utilization rate of the human body, as well as the analysis and research institute of the same center.
The Korea Food and Drug Administration (hereinafter referred to as the "Food and Drug Administration") established a "biological equivalence test criteria" through the notification of the Food and Drug Administration, and established the procedures, methods, etc. necessary for conducting the same-sex test, and made it appropriate for the operation thereof. The same-sex test specifically collects blood from each subject, who has implemented a medicine and a treaty, and compared the statistical process of the area of the blood concentration of active ingredients and the highest blood concentration of active ingredients by converting the blood concentration of active ingredients into the main items for comparison, and then compared them with the statistical process, whether the same-sex test falls within the scope set forth in the "Standards for Biological equivalence Test" above.
2 Where a pharmaceutical company intends to obtain permission for manufacture, etc. of new drugs or medicines for which safety and effectiveness are not verified.