National Health Insurance Corporation (Attorney Kim Han-soo et al., Counsel for the plaintiff-appellant)

United Nations District Court Decision 201Na11448 delivered on May 2, 201

Hab-F Co., Ltd. and three others (Law Firm Flag et al., Counsel for the plaintiff-appellant)

March 28, 2012 (Defendant 8)

February 29, 2012 (Suss Defendants)

Seoul Western District Court Decision 2009Kahap17332 Decided July 21, 201

1. Of the judgment of the court of first instance, the part of the judgment against the defendant rap-free, defendant 8, 9, and 10 shall be revoked, and the plaintiff's claim corresponding to the revoked part shall be dismissed in its entirety.

2. The plaintiff's appeal against the defendant Uimeral medicine Co., Ltd., Daeigue Co., Ltd., Ansan medicine Co., Ltd., Co., Ltd., Copial medicine Co., Ltd., Ltd., Dlimpama and Hanmi medicine Co., Ltd.

3. The costs of appeal arising between the Plaintiff and the Defendant Uimeral medicine Co., Ltd., Mawd Co., Ltd., Mawd Co., Ltd., Mawd Co., Ltd., Mawd Co., Ltd., Co., Ltd., Co., Ltd., Co., Ltd., Mawd Co., Ltd., Ltd., Mawd Co.,

1. Purport of claim

A. Claim of the claim against Defendant Woo Co., Ltd. and Defendant 8,9, and 10

Defendant Haps Co., Ltd., Ltd., 8, 9, and 10 shall pay to each of the Plaintiff 1,370,712,270 won and each of the amounts listed in the separate sheet column for interest in arrears of the same list, 5% per annum from each of the corresponding dates to the service date of a copy of the complaint of this case, and 20% per annum from the next day to the day of full payment.

B. Purport of the claim against the Defendant UND Pharmaceutical Co., Ltd.

Main Claim: Defendant U.S. Co., Ltd. shall pay 5% per annum from the corresponding date to the delivery date of a copy of the complaint of this case, and 20% per annum from the next day to the date of full payment with respect to each of the amounts stated in Section A., the amount stated in Section 8, 9, 10, and each of the amounts listed in the separate sheet to the Plaintiff.

Preliminary Claim: Defendant U.S. Co., Ltd. pays 166,730,838 won among the amount set forth in paragraph (1) to Defendant U.S. Co., Ltd., Defendant U.S., and each of the Plaintiff, 166,730,838 won per annum, and the amount set forth in the attached list No. 1 amount per annum from the corresponding date to the date of delivery of the duplicate of the complaint of this case, and 20% per annum from the next day to the date of full payment.

C. Claim against the defendant Troopian Co., Ltd., Ansan Medicine Co., Ltd., Co., Ltd., Co., Ltd., droppyma Co., Ltd., and Hanmi medicine Co., Ltd

Of the funds set forth in Section A. 1 to the Plaintiff, Defendant 8, 9, 10 and each of the Plaintiff, Co., Ltd.:

(1) From the corresponding date in the column for commencing interest in arrears No. 2 of the Schedule No. 369,866,850 won and the corresponding amount No. 2 of the Schedule No. 369,86,850 won and among them:

(2) As to each money listed in the column of No. 35,781,506 won and the column of No. 3 of the attached list among them, the Defendant Ansan Pharmaceutical Co., Ltd. from the corresponding date in the column of the initial date of counting interest in arrears No. 3 of the same list;

(3) As to each of the amounts stated in the column of No. 81,204,512 and the column of No. 4 of the attached list among the Defendant Copia Copia Copia Co., Ltd., Ltd., from the corresponding date in the column of the base date of interest in arrears No. 4

(4) From the corresponding date in the column for commencing the start-up of the interest in arrears of Defendant Dlima Co., Ltd., 70,663,530 won and the amount stated in [Attachment 5,6] No. 5,60 won per annum in [Attachment 5,6] 5,60 won per annum;

(5) As to each money listed in the column of 646,465,034 won and No. 7 of the Schedule of Schedule of Schedule of Korea Co., Ltd, from the corresponding date of the initial date of calculation of interest in arrears No. 7 of the same Schedule;

Until the delivery date of a duplicate of each complaint of this case, 5% per annum and 20% per annum from the next day to the day of complete payment shall be paid.

2. Purport of appeal

A. The plaintiff

Of the judgment of the court of first instance, the part against the plaintiff, equivalent to the following amount of money ordered to be paid, shall be revoked among the part against the defendant Uimere Co., Ltd., defendant Uimere Co., Ltd., defendant 2, safe medicine Co., Ltd., Co., Ltd., Co., Ltd., Co.

(1) As to the Defendant U2D Co., Ltd.

(A) Main Claim: from each of the corresponding dates, the Defendant U.S. Bank Co., Ltd. stated in the [Attachment No. 964,139,099] and the [Attachment No. 1 to 7] co-payment column in the [Attachment No. 964,139,09] and the respective amounts stated in the [Attachment No. 1 to 7];

(B) Preliminary Claim: from each of the corresponding dates, the Defendant U.S. Co., Ltd. entered the amount stated in No. 117,203,046 won and the column of each Corporation’s charges No. 1 of the annexed Schedule No. 1 of the same Schedule with respect to the amount stated in the column of charges of each Corporation;

Until the delivery date of a duplicate of each complaint of this case, 5% per annum and 20% per annum from the next day to the day of complete payment shall be paid.

(2) Of the funds listed in paragraph (1)(a) above, the Plaintiff:

(A) From the corresponding date in the column for the initial date of interest in arrears No. 2 of the Schedule No. 259,509,724 won and the amount indicated in the column for the share of Corporation No. 2 of the attached Table among the Defendant Corporation:

(B) As to each money indicated in the column for the share of Corporation No. 25,298,281 and the column for the share of Corporation No. 3 of the attached list among them, the Defendant Ansan Pharmaceutical Co., Ltd. from the corresponding date in the column for the initial date of the share of arrears No. 3

(C) From the corresponding date in the column for the initial date of interest in arrears No. 4 of the Schedule No. 57,297,870 won and the amount stated in the Schedule No. 4 of the Schedule No. 57,297,870 for Defendant Culula Co., Ltd.:

(D) from each of the corresponding dates on which the Defendant Dlima Co., Ltd. stated the amount of KRW 49,602,503 and the amount stated in the [Attachment List 5,6 Corporation] No. 5,603 and the [Attachment List] No. 5,6 Corporation's charges;

(E) As to each money listed in the [Attachment 7 Corporation] No. 455,227,653 won and the [Attachment 7] Corporation’s charges, the Defendant Han Han-dong Co., Ltd., from each of the corresponding dates on which the initial date of calculation of the interest in arrears was stated in the

Until the delivery date of a duplicate of each complaint of this case, 5% per annum and 20% per annum from the next day to the day of complete payment shall be paid.

(b) Defendant Woo-Woo, Defendant 8, 9, and 10

The part against the above Defendants in the judgment of the court of first instance shall be revoked and the plaintiff's claim corresponding to that part shall be dismissed.

1. Basic facts

The following facts are not disputed between the parties, or acknowledged in accordance with Gap evidence Nos. 1, 2, 7, 9, 10, 12, 14 through 18 (including paper numbers), Eul evidence Nos. 1, 6 (including paper numbers), and Eul evidence Nos. 5, 6, and 8, and the purport of the whole pleadings.

A. Status of the parties

(1) The purpose of the Plaintiff is to contribute to the improvement of national health and the promotion of social security by carrying out businesses such as imposition and collection of insurance premiums and payment of insurance benefit costs under the National Health Insurance Act.

(2) Defendant Uimers Bank Co., Ltd. (former title; hereinafter referred to as “Nimers Bank”), Daee Co., Ltd. (hereinafter referred to as “Nimers Bank”), Abrospyspys Ltd. (hereinafter referred to as “Nanspyspyspyspyspys”), Co., Ltd. (hereinafter referred to as “Cospyspyspyspyspyspyspys”), Drpima Co., Ltd. (hereinafter referred to as “Dlime”), and Korea-U.S. Pharmaceutical Co., Ltd. (hereinafter referred to as “Korea-U.P.”) are companies engaged in the manufacture, sales, etc. of drugs.

(3) The Defendant rap-ray Co., Ltd. (hereinafter referred to as “rap-ray”) is a company operating pharmaceutical analysis business, etc. In the above company, the Nonparty served as the representative director, Defendant 8 as the Nonparty’s technical adviser, Defendant 9 as the test manager, and Defendant 10 as the Analysis and Research Institute.

(b) Biological equivalence test;

(1) The biological equivalence test (hereinafter “biological equivalence test”) means a test conducted in order to prove that the two preparations (Preparations) of the same administration route containing the same major ingredient are identical in terms of the utilization rate of the body of a person with respect to a medicine that has been incorporated into a generally circularly circulating blood, as a part of a living body test, and whose main ingredient is identical to that of the same medicine. The Korea Food and Drug Administration (hereinafter “Food and Drug Administration”) shall set the “standards for Biological equivalence test” as the notification of the Food and Drug Administration, and set the procedures, methods, etc. necessary to conduct the same-sex test, and make it appropriate for the operation thereof. Specifically, the same-sex test shall determine whether the area and maximum blood concentration of the active ingredients after collecting the blood of each subject under the administration of the medicine and the related treaty were converted into the main comparison item, and then compared it with the statistical process, and then determine whether the same-sex test falls under the scope set forth in the “biological equivalence test standards.”

(2) If a pharmaceutical company intends to obtain permission to manufacture, etc. a drug whose new medicine or safety and effectiveness are not verified, it shall submit to the Administrator of the Food and Drug Administration data proving that the drug in question is safe and effective to the human body. On the other hand, the term “duplicative drug” means a drug that has the same efficacy, content, and dosage as that of original drugs, and whose efficacy, effect, usage, dosage, etc. are identical to that of original drugs. In ordinary cases, comparative clinical trials for many patients (at least 200 persons) should be conducted in order to establish the same effect as that of original drugs. As such, a large number of time and expenses are required in this case, so that the quantity of blood concentration following the administration after the administration reflects treatment effects, and thus permission to manufacture and sell a drug in cases where it is proved that the same sex with original drugs is identical with that of original drugs.

(3) According to Article 26(1) and (6) of the former Pharmaceutical Affairs Act (wholly amended by Act No. 8365 of Apr. 11, 2007) and Article 23(1)1(c) of the former Enforcement Rule of the Pharmaceutical Affairs Act (wholly amended by Ordinance of the Ministry of Health and Welfare No. 401 of May 4, 2007), a person who intends to engage in the manufacture of a drug must obtain marketing approval from the Administrator of the Food and Drug Administration and obtain marketing approval and modify the permitted matters, as prescribed by Ordinance of the Ministry of Health and Welfare. In addition, where an item he/she intends to obtain marketing approval after January 1, 1989 is identical with an original drug which has obtained marketing approval and a reproduction of a drug whose ingredients are the same, the person who intends to engage in the manufacture of a drug must submit an application for marketing approval along with data relating to a biological mobility test plan, data related to genetic mobility test plan, comparative clinical trial or clinical trial report prescribed by the Administrator of the Food and Drug Administration.

(4) A pharmaceutical company shall request an independent testing agency recognized by the Food and Drug Administration to conduct a same-sex test. A testing agency shall prepare a test plan and conduct a test in accordance with the procedure and method established in the “biological equivalence test standards” with approval from the Review Committee. A pharmaceutical company shall prepare a report and deliver the report to the Food and Drug Administration, and the pharmaceutical company shall submit the report to the Food and Drug Administration. The Administrator of the Food and Drug Administration shall determine whether the same-sex test is appropriate after examining the results of the test conducted for a level of time between 2 and 3 months. On the other hand, the Administrator of the Food and Drug Administration may have relevant public officials and experts conduct a fact-finding survey on the testing agency if necessary to verify

(c) A research service contract for same-sex testing;

On January 19, 2004, in order to obtain marketing approval for the manufacture of the ○○○○○○ (the ○○○○○○ (the dedicated-type medical treatment product) which is a reproduction drug, the Defendant U.S. entered into a research service contract with the content of requesting the examination of whether the reproduction and the above reproduction are equal to the biologically as the original drug.

(d) Handling data on same-sex test;

(1) Defendant 10, who is the representative director of Defendant Woo-Woo, Defendant 8, Defendant 9, who is a technician, Defendant 9, and Defendant 10, an analysis researcher, submitted a test report prepared on the basis of the aforementioned research service agreement in a case where test data occurs or test data deviates from the part of the same-sex trust while conducting a same-sex test for reproduced drugs in accordance with the said research service agreement. Based on this, Defendant 10 decided to manipulate test data in a case where test data occurs or test data deviates from the part of the same-sex trust. Based on this, Defendant 10 decided to avoid being requested for the same-sex test for reproduced drugs by a pharmaceutical company that did not receive the permission for the change of items manufactured by the Administrator of the Food and Drug Administration or the notification for the same-sex trust service cost from the pharmaceutical company that did

(2) Accordingly, the Nonparty and Defendant 8 received a report on the result of the test that Defendant 9 and Defendant 10, a person in charge of the same-sex test on the ○○○○○○○○ of Defendant U.S. drugs, who was the ○○○○○ Laboratory, did not recognize the same-sex treatment of the relevant reproduced drug, and instructed Defendant 9 and 10 to prepare a test report recognizing the same-sex treatment by manipulating the test data on the relevant reproduced drug.

(3) Upon receipt of such instructions, Defendant 10 did not use the data analyzing ○○○○○○○, used other sampling data, etc., and fabricated the test data so that it does not deviate from the part of the same sex, and Defendant 9 prepared a test report on the fact that the same sex is recognized based on the aforementioned fabricated test data on the ○○○○○○○○○○○○○○○○○○○○, and submitted it to the Defendant U.S. Drug.

(e) Product approval for manufacturing of drugs, publication of recognition of mobility, and registration of medical care benefit targets;

(1) On December 22, 2004, Defendant Uimeral medicine submitted the examination report to the Food and Drug Administration, and received permission from the Food and Drug Administration for modification of the product items of medicine to ○○○○○○○○○○○, and notification for recognition of the same-sex relationship. The Minister of Health and Welfare registered ○○○○○○ as medical care benefits.

(2) 피고 대웅제약, 안국약품, 코오롱제약, 드림파마, 한미약품 및 한국메디텍제약 주식회사는 피고 유니메드제약과 생동성이 인정되어 제조품목허가를 받은 ○○○○○○에 관한 위탁제조계약을 체결한 후 식약청으로부터 품목명을 달리하여 각 아래 일자에 품목허가를 받았고, 보건복지부장관은 위와 같이 품목허가를 받은 피고 대웅제약의 ‘△△△△△ 5㎎’(이하 ‘△△△△△’이라 한다, 2005. 1. 28. 품목허가), 피고 안국약품의 ‘□□□□□(2005. 5. 19. 품목허가)’, 피고 코오롱제약의 ‘◇◇◇◇◇(2005. 5. 19. 품목허가)’, 피고 드림파마의 ‘☆☆☆☆☆(2004. 9. 3. 품목허가)’, 한국메디텍제약 주식회사의 ‘▽▽▽▽▽(2005. 5. 19. 품목허가)’, 피고 한미약품의 ‘◎◎◎◎◎(2004. 3. 29. 푸목허가)’을 요양급여대상으로 각 등재하였다(이하 위 의약품들을 통칭할 경우 ‘이 사건 각 의약품’이라 한다).

(f) Revocation of marketing approval and the number of items eligible for medical care benefits;

On January 9, 2007, the Food and Drug Administration revoked marketing approval as of January 18, 2007, and ordered the recovery and destruction of the above drugs on the grounds that Defendant UAD drug submitted the data on the same-sex test that was operated at the time of application for marketing approval for manufacture. Accordingly, the Minister of Health and Welfare revised and announced “the pharmaceutical benefit list and the equivalent amount table of the pharmaceutical benefit” to delete the above drugs from the pharmaceutical benefit list.

(g) related criminal cases;

The Nonparty and Defendant 8, 9, and 10 conspired to prepare a report on the result of the same-sex test with the test data operated as mentioned in the above paragraph (d) and ordered the head of the Food and Drug Administration to change the items manufactured by drugs and thereby interfere with the performance of official duties by the Administrator of the Food and Drug Administration, and they were prosecuted for committing the crime of obstructing the performance of official duties of the Administrator of the Food and Drug Administration. The judgment became final and conclusive on July 9, 2009.

(h) Medical care benefit costs and individual co-payment;

(1) Medical institutions, pharmacies, and other medical care institutions provide medical care benefits for prescribing and preparing each of the instant drugs listed in the health care benefit table as above, depending on symptoms to the patient, the health insurance policyholder, who is an outpatient or an outpatient patient, and his/her dependents (hereinafter “health insurance policyholder”), and receive each of the medical care benefit costs and the co-payment from the Plaintiff, who is the insurer, respectively.

(2) As above, the Plaintiff and the health insurance policyholder’s amount of health care benefit, co-payment, and its aggregate are as listed in the separate sheet.

2. Determination as to the claim against Defendant Wps, Defendant 8, 9, and 10 (determination as to the claim for damages related to the medical care benefit cost)

A. Defendants 8, 9, and 10’s illegal acts

The Nonparty and the Defendants’ act of falsely preparing a report on the result of the same-sex test by manipulating the test data as seen earlier, thereby allowing the Food and Drug Administration to grant permission for manufacturing each of the drugs of this case and publish the approval for the same-sex test (hereinafter “instant illegal act”).

B. The plaintiff's losses

Property damage caused by an illegal act refers to the difference between the property damage caused by the illegal harmful act and the current property damage caused by the illegal act (see Supreme Court Decision 2010Da21276, Jul. 8, 2010).

However, according to the relevant provisions such as the former Pharmaceutical Affairs Act and the former Enforcement Rule of the Pharmaceutical Affairs Act, only the reproduction and sale of medicines of which the same sex is recognized are permitted. Therefore, if the same-sex test data concerning each of the drugs of this case, which are reproduction and drug, were not fabricated and sold, each of the drugs of this case would not have been manufactured and sold. Moreover, the Plaintiff did not pay the medical care benefit cost for each of the drugs of this case to the medical care institution.

Examining these circumstances in light of the aforementioned legal principles, the Plaintiff’s financial status of the Plaintiff, which had existed without the instant illegal act, was not listed as medical care benefits items, and thus, the Plaintiff ought to be deemed to have failed to pay medical care benefits costs at the expense of the medicine for each of the instant medicines.

Therefore, according to the registration of each of the instant medical care benefit items, which cannot be registered as medical care benefit items due to the instant illegal act, the Plaintiff spent medical care benefit items that would not have been paid if each of the instant medical care benefits items were not registered as medical care benefits items, to medical care institutions that prescribed and prepared the instant medical care benefits items, thereby causing damage to the amount equivalent to the medical care benefits amount

C. Sub-decision

Therefore, pursuant to Article 756 of the Civil Act, Defendant 8, 9, and 10 are obligated to pay each Plaintiff the medical care benefit cost of each of the drugs of this case (the aggregate of the medical care benefit cost in the separate list) and its delay damages pursuant to Articles 760 and 750 of the Civil Act, barring special circumstances.

D. Determination as to the defendants' defense of offsetting profits and losses

(1) The Defendants asserted that even without the instant illegal act, medical care institutions prescribed and prepared alternative drugs identical to each of the instant medicines, and received more than the same medical care benefit cost from the Plaintiff, and thus, they did not recognize the Plaintiff’s damage caused by the instant illegal act (the assertion argues that the Plaintiff’s payment of medical care benefit cost with respect to each of the instant medicines itself was not recognized as the Plaintiff’s damage, even if the Plaintiff’s payment of medical care benefit cost with respect to the instant medicines is considered as the Plaintiff’s damage caused by the instant illegal act, and thus, the Plaintiff’s damage liability against the said Defendants is not recognized).

The plaintiff is an insurer of the national health insurance under Article 12 of the National Health Insurance Act. In the event that an insured event, such as diagnosis, examination, provision of medicine and materials for medical treatment, treatment, surgery, other treatment, prevention and rehabilitation, hospitalization, nursing, transfer, etc., occurs with respect to the disease, injury, childbirth, etc. of the health insurance policyholder, the plaintiff shall pay the medical care benefit cost to the medical care institution pursuant to Article 43 (1) and (2) and (3) of the same Act if the health care institution provides medical care benefit and the Health Insurance Review and Assessment Service notifies the health care institution of the review of the medical care benefit cost. Therefore, the medical care institution’s prescription and preparation of each of the instant medical care benefit cost constitutes an insured accident in the health insurance, and the plaintiff shall pay the medical care benefit cost if the medical care institution claims for each of the instant medicines except each of the instant medical care institutions under Article 12 (1) and (3) of the same Act. However, since it is possible to prepare alternative medicines, the plaintiff should not pay the medical care benefit cost to the insured.

Therefore, it is reasonable to view that the Plaintiff exempted the health insurance subscriber to each of the above symptoms from the obligation to pay the cost of health care benefit for alternative drugs of the same ingredients that were prescribed and prepared by the health insurance subscriber.

그런데 제1심 법원의 건강보험심사평가원에 대한 사실조회 결과 및 변론 전체의 취지에 의하면, 2005.경 6.경부터 2006. 9경까지 사이에 보험급여 대상으로 등재된 의약품 중 이 사건 의약품과 동일한 성분을 가진 의약품은 약 24종이 있었던 사실, ○○○○○○과 ◎◎◎◎◎의 상한금액은 각 1,095원이었고, 나머지는 각 797원(△△△△△은 984원)이었던 사실, 2005. 3/4분기와 4/4분기에는 ♡♡♡제약의 ◁◁◁◁◁, ▒▒제약이 ▷▷▷, ■■제약의 ♤♤♤♤♤이 시장의 대부분을 차지하고 있었는데, ◁◁◁◁◁이 1,092원, ▷▷▷이 1,089원, ♤♤♤♤♤이 1,092원이어서 이 사건 각 의약품의 상한금액 평균을 초과하는 사실, 다만 2006. 2/4분기에 ◎◎◎◎◎의 청구금액이 196,993,000원으로(2006. 2/4분기 이 사건 각 의약품의 청구량 합계 326,000개), 2006. 3/4분기에 254,008,000원(2006. 3/4분기 이 사건 각 의약품의 청구량 합계 377,000개)으로 증가하였으나 나머지 의약품은 여전히 점유율이 미미하였고, 반면 2006. 2/4분기 ◁◁◁◁◁이 126,238,000원, ▷▷▷이 158,413,000원, ♤♤♤♤♤이 138,231,000원(같은 기간 3개 의약품의 청구량 합계 341,000개), 2006. 3/4분기에는 각 129,306,000원, 184,716,000원, 142,015,000원(청구량 합계 367,000개 다만 이 기간 동안 ●●약품의 ◈◈◈◈◈◈◈◈과 ▲▲제약의 ◐◐◐◐◐의 청구량이 급증하여 각 179,000개, 176,000개로 되었다)이었던 사실, 결국 2005.경 6.경부터 2006. 9경까지 전체기간 동안의 앞서 본 3가지 약품의 청구금액 만으로도 이 사건 각 의약품의 청구금액이나 청구량을 초과하는 사실 등을 인정할 수 있다.

According to the above facts, by registering each of the instant medicines as medical care benefit items and paying the medical care benefit costs for each of the instant medicines to the medical care institution, the Plaintiff obtained more benefit from the obligation to pay alternative medicines.

(2) On this issue, the Plaintiff asserts that the Plaintiff cannot avoid the obligation to pay the cost of health care benefit for alternative medicine due to the payment of the cost of health care benefit for each of the instant pharmaceutical products, since each of the instant pharmaceutical products is not recognized as safe and effective.

However, in full view of the purport of the oral argument as a whole, it is recognized that the same-sex assessment of 232 items among the items subject to re-examination has been completed as of April 2009, and that there was no case on the ground of the safety and effectiveness of 230 items and the side effects of each item of this case. In light of these circumstances, the Plaintiff appears to be exempted from the obligation to pay the medical care benefit costs for alternative drugs. Therefore, the Plaintiff’s above assertion is without merit.

(3) Therefore, the aforementioned defendants' defense of offsetting profits and losses is justified.

E. Determination as to the statute of limitations defenses by Defendant 1, Defendant 8, and Defendant 9

(1) Article 766(1) of the Civil Act, which serves as the starting point for calculating the short-term extinctive prescription of a claim for damages due to a tort, means the time when the facts constituting a tort have been practically and specifically recognized, such as the occurrence of damages, the existence of an illegal harmful act, and the causal link between the harmful act and the damage (see, e.g., Supreme Court Decision 2010Da7577, May 27, 2010).

(2) However, according to the statements in Eul evidence Nos. 12 and Eul evidence Nos. 19, comprehensively considering the overall purport of the pleadings, the following facts are acknowledged: ① on July 6, 2006, the head of the Food and Drug Administration planned to cancel permission for the original computerized data submitted by a same-sex testing institution and the 30 test data submitted to the Food and Drug Administration; and the Ministry of Health and Welfare announced that the relevant item should be deleted from the medicine benefit list and the Plaintiff would be required to file a lawsuit claiming damages against the relevant same-sex testing institution and pharmaceutical company. ② On September 28, 2006, the head of the Food and Drug Administration announced that "the result of the final investigation into the same-sex testing institution" was "the result of the second investigation into the same-sex testing institution" and "the head of the Food and Drug Administration notified the Plaintiff as to whether the difference between the original data submitted during the examination process and the test data submitted to the Food and Drug Administration."

According to the above facts, around September 29, 2006, the plaintiff filed the lawsuit of this case on December 30, 2009, where the drugs of this case were listed in the medical care benefits coverage through the operation of data for the same-sex test, thereby causing damage to the plaintiff, and the perpetrator appears to have actually and specifically recognized the fact that the defendant was a testing institution for the same-sex test, such as the Republic of Korea, and it cannot be viewed that this fact was known only due to the confirmation of administrative litigation. Nevertheless, the plaintiff filed the lawsuit of this case on December 30, 2009, which was three years after the expiration of the statute of limitations. The plaintiff'

(3) Therefore, the aforementioned Defendants’ defense of extinctive prescription is with merit.

3. Determination as to the plaintiff's claim against the defendant U2d's U2k's medication

A. Judgment on the main claim

(1) The plaintiff's assertion

In light of the research services agreement with Defendant YFFF and the standards for biological equivalence test (Notice No. 2002-60 of the Food and Drug Administration Notice No. 2002, Nov. 22, 2002; hereinafter “Standards for Management of Clinical Test of Drugs”) and the “Standards for Management of Clinical Test of Drugs” (Notice No. 1999-67 of the Food and Drug Administration Notice No. 1990, Jan. 4, 200), the above Defendant did not take measures, such as requesting the Plaintiff to submit or supplement the data for the operation of the same-sex test of ○○○○○○, even though he/she had a duty to manage and supervise the same-sex test of drugs of this case. Accordingly, even if he/she had a duty to request the Plaintiff to pay the amount equivalent to the medical care benefit cost of each of the drugs of this case. Accordingly, the Plaintiff has a duty to pay the Plaintiff damages equivalent to the medical care benefit cost of each of the instant drugs of this case.

(2) Determination

(A) As alleged by the Plaintiff, ① there was an economic need to keep the same-sex test to Defendant U2P drug, ② Defendant U2P drug was in a superior position to pay research service costs to Defendant U2P drug, a testing institution for Defendant U2PP, so it was able to exercise its influence on Defendant U2P, and ③ Defendant U2PP drug with expertise and human resources was found to have discovered the fact that the test report on each of the drugs of this case was fabricated, as in the Food and Drug Administration when he paid little attention, even if such circumstance alone is insufficient to acknowledge that Defendant U2P drug was directly involved in the operation of the same-sex test data, and there is no other evidence to acknowledge this.

(B) Article 26(1) and (6) of the former Pharmaceutical Affairs Act provides that "a person who intends to obtain marketing approval for a drug shall submit a test report on safety and effectiveness, related documents, and other necessary data, as prescribed by Ordinance of the Ministry of Health and Welfare, in cases where the item intended to obtain marketing approval is a new drug or a drug designated by the Administrator of the Food and Drug Administration." Article 23(1)1 Item (c) of the former Enforcement Decree of the Pharmaceutical Affairs Act provides that "a person who intends to obtain marketing approval for a drug that falls under a new drug after January 1, 1989 shall submit a plan for the same-sex test, test data on the same-sex test, etc." However, this provision alone does not necessarily mean that the legal duty of care in the content that the Plaintiff claims.

In addition, according to the research services contract 1 note, it can be recognized that the research services contract note "the defendant's Med's Med's Med's Med's Med's Med's Med's Med's Med's Med's Med's Med's Med's Med's Med's Med's Med's Med's Med's Med's Med's Med's Med's Med's Med's Med's Med's Med's Me

However, even if there are the relevant provisions under the Pharmaceutical Affairs Act and the above contract provisions, there is no evidence to acknowledge that only this point is the duty to manage and supervise the same sex test of each of the drugs of this case, and that there is no evidence to prove that the test report was prepared based on the test data in which the nimeral medicine of this case was fabricated.

(C) Meanwhile, Article 23(1) of the Criteria for Single-sex Testing provides that “In the event that a fact that a person has failed to observe the same provision during the performance of a test is discovered, the requester shall correct such fact and take appropriate measures to prevent recurrence. Where significant and continuous non-compliance is verified, the requester shall suspend the test and report it to the Administrator of the Food and Drug Administration.” Article 24(1) provides that “The matters not provided for in the standards for same-sex Testing shall be governed by the standards for clinical trials.

However, in the standards for same-sex testing, ① a testing institution is entitled to conduct a same-sex test (Articles 4 and 6), and the head of the testing institution is required to appoint a test manager (Article 8), ② the test manager is required to prepare a test report and submit it to the Commissioner of the Food and Drug Administration (Article 20), ④ the test manager is not separately required to manage and supervise the test manager’s testing institution. On the other hand, “standards for the management of clinical trials of drugs” provides that ① the test requester is required to select a test manager (Article 30(1)), ② the test requester is required to prepare a report on the results of the clinical test and submit it to the Administrator of the Food and Drug Administration (Article 45), ③ the test requester’s duty of request for the clinical test (Article 45), ③ the test manager’s duty of request for the clinical test is separately prepared. In light of this, the examination standards cannot be applied in the case of the same-sex test, and there is no other duty to request the test manager to submit the test report.

(D) Therefore, the Plaintiff’s above assertion is without merit.

(A) Even if liability for family damages is recognized, the above defendant's ground for offsetting profits and losses, such as the above defendant's statement on February 2, 201, is with merit. Therefore, the plaintiff's above ground for appeal is without merit.

B. Determination as to the Plaintiff’s primary claim on Defendant U.S. drugs, Defendant U.S.P.’s primary claim on Defendant U.S. drugs, A.P.P. medicine, E.P.P. medicine, C.O.P. medicine, D.P. medicine, and K.P.

(1) The plaintiff's assertion

Medical care institutions are pharmaceutical companies that gain substantial profits from the payment of medical care benefit costs, etc., because they do not gain any profits from the sale of drugs by claiming the medical care benefit costs and co-payment to the Plaintiff and health insurance subscribers in the same manner as the pharmaceutical prices purchased from the pharmaceutical companies. However, the effect of revocation of manufacture approval and deletion of the list of medicines, etc. of each of the instant medicines is retroactively null and void, or the notice of determination of the amount on the list of medicines, etc. and the amount on the benefits of each of the instant medicines is retroactively null and void, the payment of medical care benefit costs, etc. of each of the instant medicines was deprived of legal causes. Accordingly, the said Defendants are obligated to return to the Plaintiff the

(2) Determination

However, since the above Defendants paid medical care benefit costs for each of the drugs of this case to medical care institutions rather than the above Defendants, even if the medical care benefit costs paid as above did not have any legal ground, the Plaintiff can only claim the return of unjust enrichment against the medical care institution. Moreover, the medical care benefit amount paid to the above Defendants was paid according to the sales contract among them, and there is no evidence suggesting that the above sales contract was null and void or cancelled. Therefore, it cannot be deemed that the above Defendants obtained profit from the Plaintiff’s property without any legal ground and thereby caused damage to the Plaintiff. Accordingly, the Plaintiff’s above assertion is

C. Determination as to the second preliminary claim on the Defendant U.S. drugs, the second preliminary claim on the Defendant U.S. drugs, the Defendant U.S.P.P. drug, the internal medicine, the copinsal medicine, and the first claim on the U.S. drugs

(1) The plaintiff's assertion

As the revocation of the license for each of the drugs of this case and the elimination of the list of medicines of this case retroactively take effect, the plaintiff has the right to claim the return of unjust enrichment equivalent to the amount of the medical care benefit cost for each of the drugs of this case against the medical care institution (the

On the other hand, the fact that each of the drugs of this case is a drug that can not be distributed in the city after obtaining marketing approval on the basis of false reports on ○○○○○○ ○○○, even though it was a drug that could not have been distributed in the city, the medical care institution has purchased the drug by deceiving or mistake that it had obtained marketing approval, or the sales contract for each of the drugs of this case between the medical care

Therefore, in order to preserve the above right to claim restitution of unjust enrichment against the medical care institution, the Plaintiff filed a claim for unjust enrichment equivalent to the medical care benefit cost on the ground that the sales contract for each of the instant medicines was revoked by fraud or mistake through the delivery of a copy of the complaint of this case, or invalidated in violation of social order. ② As to the Defendant UND medicine, the Plaintiff claims damages equivalent to the medical care benefit cost due to the nonperformance of obligation due to the Plaintiff’s intentional act or negligence by the performance assistant (Article 391 of the Civil Act).

(2) Determination

However, in order for the plaintiff to exercise creditor's subrogation right as above, it is recognized that there is no financial resources of the medical care institution, but there is no evidence to acknowledge it.

Therefore, this part of the Plaintiff’s claim is unlawful without examining the remainder of the claim, as the need for preservation is not recognized.

As to this, the Plaintiff asserts again as follows: “The Plaintiff’s claim for return of unjust enrichment against the Plaintiff’s medical care institution, and the medical care institution’s claim for return of unjust enrichment against the said Defendants, which is the right of subrogation, arising from the same unlawful act; and thus closely related thereto; the amount of the medical care benefit cost paid to the said Defendants is small amount; thus, it is difficult for the medical care institution to take individual recovery procedures because the amount of the claim for return of unjust enrichment or damage claim against the said Defendants is small amount; and when the Plaintiff claims return of unjust enrichment against the said Defendants, the medical care institution must again claim return of unjust enrichment to the said Defendants.” In light of the Plaintiff’s subrogation

However, solely on the above circumstances, the exercise of the rights by subrogation of the medical care institution is difficult to obtain complete satisfaction of the Plaintiff’s claims unless the Plaintiff exercises the rights by subrogation of the medical care institution. It is difficult to deem it necessary to ensure that the actual performance of the Plaintiff’s claims is valid and appropriate. In addition, the exercise of the right to return unjust enrichment or the right to claim damages by subrogation of the medical care institution with a financial care institution is an unjust interference with the act of free management of the medical care institution.

4. Conclusion

Therefore, the part of the plaintiff's conjunctive claim as to the defendant U2ow's subrogation, the part of the plaintiff's conjunctive claim as to the plaintiff's conjunctive claim as to the plaintiff's U2ow's main claim as to the defendant's U2ow's subrogation, the part of the plaintiff's conjunctive claim as to the defendant's U2ow's main claim as to the defendant's U2ow's main claim and the remainder of the conjunctive claim as to the defendant's U2Bio's main claim as to the defendant's U2ow's main claim as to the defendant's U2ow's main claim, the relation to the defendant's hrap, the defendant's 8,9, and the defendant's claim as to the defendant's hrap

However, in the judgment of the court of first instance, the part concerning the conjunctive claim based on subrogation of the creditor among the lawsuit against the defendant's U2ot medication, the part concerning the defendant's U2ot medication, the part concerning the safe claim against the defendant's U2ot medication, the safe-of-the-counter medication, the safe-of-counter medication, and the part concerning the safe-of-the-counter medication is justified. Thus, the plaintiff's appeal against the above defendants is dismissed as it is without merit, and the part concerning the defendant's YF, the defendant's 8,9, and 10 as to the plaintiff's claim against the above defendants is unfair in conclusion. Thus, the part against the plaintiff's claim against the defendant's above defendants is revoked, and the part against the plaintiff's loss is revoked, and it is so decided as per Disposition.

[Attachment List omitted]

Judges Park Jong-dae (Presiding Judge)

1) Reference materials (record 1214 pages)

2) The Plaintiff asserts the retroactive effect by comprehensively taking account of the following: (a) the purpose of the Pharmaceutical Affairs Act is to contribute to the improvement of national health; (b) the purpose of the Act is to obtain marketing approval for each of the instant drugs by fraudulent means; (c) the social risks that may arise in the event that drugs are distributed in society; (d) the public interest that may arise in the event that the revocation of marketing approval is recognized retroactively; (e) the public interest that may arise in the event that the revocation of marketing approval is recognized retroactively, is greater than the private interest that the pharmaceutical company, etc. loses; and (e) the Pharmaceutical Affairs Act prohibits sales and display of non-pharmaceuticals.