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안암법학회> 안암법학> 허가-특허 연계제도 법률안의 검토

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허가-특허 연계제도 법률안의 검토

Korea’s Patent Linkage Bill and Its Analysis

이원복 ( Won Bok Lee )
  • : 안암법학회
  • : 안암법학 44권0호
  • : 연속간행물
  • : 2014년 05월
  • : 389-442(54pages)
피인용수 : 45건

(자료제공: 네이버학술정보)

DOI


목차

Ⅰ. 들어가는 글
Ⅱ. 후발 의약품 판매 제한 제도
Ⅲ. 후발 의약품 진입 지연에 대한 책임
Ⅳ. 최초 후발 의약품 우선판매 제도
Ⅴ. 특허 목록 제도
Ⅵ. 허가특허연계심판
Ⅶ. 맺는 글

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The Korea-US Free Trade Agreement stipulates that Korea should adopt patent-registration linkage by March of 2015. The patent listing (Green List), marketing prevention and generic exclusivity mechanisms recently proposed in a bill by the Korean government all have shortcomings. This article explores those shortcomings and possible fixes. The bill also should have established mechanisms through which a pioneer drug company will compensate for undue delay it causes in the marketing of a generic drug. In addition, the special appeals commission envisioned in the bill is not justified based on the nature of the actions to be taken by the Korean drug regulator under the bill. The bill appears to have largely been modeled after the Hatch-Waxman Act. In light of the differences in the legal institutions and health care market between Korea and the U.S., Korea’s patent linkage implementation should look at other examples, such as Canada and Australia, and will eventually have to stand on its own.

ECN

ECN-0102-2015-300-000408039


UCI

I410-ECN-0102-2015-300-000408039

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  • : 사회과학분야  > 법학
  • : KCI 등재
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  • : 1226-6159
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  • : 연속간행물
  • : 1993-2018
  • : 914


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1『안암법학』제44호를 발간하면서

저자 : 김영문

발행기관 : 안암법학회 간행물 : 안암법학 44권 0호 발행 연도 : 2014 페이지 : pp. 1-1 (1 pages)

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2법실증주의와 법률실증주의 - Karl Bergbohm에 대한 오해와 이해 -

저자 : 윤재왕 ( Zai Wang Yoon )

발행기관 : 안암법학회 간행물 : 안암법학 44권 0호 발행 연도 : 2014 페이지 : pp. 1-42 (42 pages)

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“Billigen wir dagegen die realistische Doktrin, so befinden wir uns in der peinlichen Lage, auch das niedertrachtigste Gesetzesrecht, sofern es nur formell korrekt erzeugt ist, als verbindlich anerkennen mussen.” Mit diesem beruhmt-beruchtigen Satz ist Karl Magnus Bergbohm in der Rechtsphilosophie als ein Hauptvertreter des Gestzespositivismus im pejorativen Sinne angesehen. Ofters wird aber dieser Satz in verkurzter Form mit oder ohne Absicht zitiert, und dadurch entsteht ein krasses Mißverstanmdnis daruber, was Bergbohm mit diesem Satz gemeint hat. Vor diesem Hintergrund setzt sich die vorliegende Abhandlung mit der “falschen” Rezeption der Bergbohm``s Rechtsphilosophie bzw. seiner Allgemeinen Rechtslehre auseinander. Zu diesem Zweck versucht sie, sein Hauptwerk “Jurisprudenz und Rechtsphilosophie(1892)” moglichst textnahe und -gerecht zu erortern, wobei auch der Kontext der Entstehung dieses Werkes mit berucksichtigt wird. Im Endeffekt soll sie dazu beitragen, gangige Missverstandnisse uber Bergbohm im Besonderen und auch uber den Rechtspositivismus im Allgemeinen zu beseitigen.

3헌법상 정당조항의 변천

저자 : 양정윤 ( Jeong Yun Yang )

발행기관 : 안암법학회 간행물 : 안암법학 44권 0호 발행 연도 : 2014 페이지 : pp. 43-79 (37 pages)

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Recently, news are filled with issues of political parties. Since Party Clauses were introduced in the 1960 Constitution, opinions are divided into a variety of events, from the problems of Requirements to cancel political parties on the Party Law that increases the barriers to entry of minority parties, to the claims of Dissolution of political parties to request for trial. At this point, it is necessary that we should consider, as a whole, the fact that Party Clauses of Article 8 of the present Constitution is defined for what. The same Article is ruled as follow: on Section 1, the freedom of establishment of political parties and the guarantee of political pluralism; on Section 2, the democracy and the necessary organization of the party; on Section 3, the protection and subsidies of the state for political parties; and on Section 4, the dissolution clause of an anti-democratic political party. By the way, at the first time, when these Party Clauses are prescribed on the 1960 Constitution, it was not defined in the Introduction as the current Constitution but together regulated in Article 13 in the provisions on freedom of expression in Chapter of rights and duties of citizens, and it is principle for political parties to protect of the nation, just placed the exceptional Party Dissolution Clauses. These points present the question of whether there is a difference in the meaning of provisions of the party in the 1960 Constitution and the current Constitution. In addition, it is specified as “the 'free' democratic basic order” in the preamble and Article 4 of the current Constitution, but in the 1960 Constitution, the provisions of “the 'free' democratic basic order” is not seen anywhere, which it is to apply a question of interpretation of the meaning that Article 8, political parties clause of the current Constitution, stipulates in the same way as “the democratic basic order” in political parties clauses of the 1960 Constitution. And, in Party Clauses of the 1960 Constitution, it was defined as unary, there are questions why is defined separately from Section 1 to 4. More and more, Countries after World War II, as a reflection against Nazi Party earlier, Fascist Party, the Communist Party of the Soviet Union, was setting up to provisions of the Constitution on the political parties since the mid-1940 Constitution, there are questions why was not so defined as this Party Clauses at the Constituent Constitution, but was defined the 1960 Constitution. In addition, in the 1960 Constitution, it was not to enforce the political party law, but in the Constitution since 1963, has been establishing a political party law. Although it is overall looked to see Party Clauses due to the recent issue of dissolution of political party, but these points raise the need to study in more detail what is meaning in our constitutional history, and led to study the transition process of Party Clauses on the Constitution of South Korea.

42013년도 주요행정법(主要行政法)(행정(行政))판결(判決)의 분석(分析)과 비판(批判)에 관한 소고(小考)

저자 : 김중권 ( Jung Kwon Kim )

발행기관 : 안암법학회 간행물 : 안암법학 44권 0호 발행 연도 : 2014 페이지 : pp. 81-137 (57 pages)

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Hier werden 17 verwaltungsrechtliche wichtige Falle im Jahre 2013 kritisch analysiert. Die verschiedene Genehemigungsarten im Stadtsanierungsgesetz fuhren zu die schwere dogmatische Verwirrung von Genehmigungen. Bauerlaubnis und Gebrauchseinwilligung werden zu Recht getrennt. Mit Landgewinnung ergibt sich die schwer zu vereinbarende Folgefrage, z.B. die Zurechnungsfrage. Sie wird heftig diskuttiert. Hochtsgerichtshof(HGH) versucht zu Recht die neue Losung aufgrund der anderten Rechtslage(§4) in Gemeideordnung zu finden, obwohl es bedauerlich keine Voraussetzungen fur Zurechnungsentscheidung gibt. Ermessensnichtgebrauch liegt vor, wenn die Behorde von dem ihr zustehenden Ermessen keinen Gebrauch macht. Warnungsverfugung von der Fair Trade Commission bedeutet zu Recht das Verwaltungsakt als Gegensand der Anfechtungsklage. Ermessensnichtgebrauch als Ermessensfehler wird erstmal in Rechtsprechung anerkannt.

5무효심판에서의 일사부재리원칙에 관한 입법론적 고찰 - 일본 개정 특허법 제167조를 중심으로 -

저자 : 강헌 ( Heon Kang )

발행기관 : 안암법학회 간행물 : 안암법학 44권 0호 발행 연도 : 2014 페이지 : pp. 139-163 (25 pages)

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In the case of res judicata, the matter cannot be raised again, either in the same court or in a different court. A court will use res judicata to deny reconsideration of a matter. Art. 163 of the Korea Patent Act prescribes that, after a patent trial is ultimately determined, nobody is allowed to request a new trial with same point and same evidence, based on Res Judicata Doctrine in patent trials. This regulations came from Japanese Patent Act. But Japanese 2011 Revised Patent Act placed new regulations regarding Res Judicata Doctrine in patent trials. Art. 167 of the Japanese 2011 Revised Patent Act prescribes that, after a patent trial is ultimately determined, the parties are not allowed to request a new trial with same point and same evidence in order to protect the right of access to courts of the third parties. So this article focused on a legislative consideration about Res Judicata Doctrine in patent trials. Art. 167 of the Japanese 2011 Revised Patent Act. needs to be considered in Korea Patent Act. I hope that a study on the Res Judicata Doctrine in patent trials goes on in the future.

6공동정범의 구성요건과 본질적 기여에 대한 새로운 검토

저자 : 권영법 ( Young Bub Kweon )

발행기관 : 안암법학회 간행물 : 안암법학 44권 0호 발행 연도 : 2014 페이지 : pp. 165-212 (48 pages)

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Recent Supreme Court ruling is that the elements of decision on crime of co-principal(Mittaterschaft) are subjective requirement of joint aid and abet intention and objective requirement of functional act domination (funktionelle Tatherrschaft). Most of theories also support this ruling. However, though the resolution for joint offense has close relation with the subjective intention of the participant, the resolution itself is the objective form of the subjective intention; therefore, it belongs to objective elements of crime(Tatbestand). Accordingly, this study did a new analysis on the matter by classifying the constituting requirements of co-principal into objective requirement and subjective requirement. At this time, the fulfillment of elements of crime mark, resolution for joint offense, causal contribution of each participant and fulfillment of principal offender qualification by each participant are objective requirement; while the intention and awareness of each participant, which become the basis for the objective requirement mark and co-principal, belong to subjective requirement. The resolution for joint offense is strict elements of crime and the resolution should be on the 'co-principals act'; while the resolution should have been agreed by talk among the participants, in principle. However, the proof of the resolution can be acknowledged either by explicit intention or an act implying such intention. The subjective illegal mark of each participant should be also sufficiently proved as strict elements of crime in addition to the resolution for joint offense. Essential contribution(wesentlicher Tatbeitrag) of each participant in the offense is elements of crime for the co-principal. This study explored the extent of essential contribution as elements of crime for co-principal by classifying them into principal offense mark and causal contribution. The principal offense sign co-principal consequently becomes act domination or act strength. This study did a new analysis on this act strength by examining the studies on the evaluation and measurement of influence, which are discussed in psychology, social psychology and social anthroposophy. Through this analysis, the matters and evaluation elements, which should be considered in the judgment of principal offense mark, were drawn. In order to establish co-principal, a causality(Kausalzusammenhang) should be established. This causality can be seen as 'result-anti-value'; while the principal offense mark above can be seen as 'act-anti-value' in co-principal. Based on this analysis, the limit cases of additional/ alternative co-principals were newly analyzed and the causality issue related to group resolution, which is being discussed in Germany in relation to this matter now, has been reviewed.

7통상임금관련 대법원 전원합의체 판결 검토 - 통상임금 배제합의 무효판단의 위헌성 -

저자 : 이선신 ( Seon Sin Lee )

발행기관 : 안암법학회 간행물 : 안암법학 44권 0호 발행 연도 : 2014 페이지 : pp. 213-281 (69 pages)

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These days, in Korea, there have been big controversies over the Ordinary Wage in the LABOR STANDARDS ACT. In fact, the problems of the Ordinary Wage had been included in the LABOR STANDARDS ACT since the Act was legislated after the model of Japanese LABOR STANDARDS ACT. And, despite of much efforts of the Judiciary and the Government officials and many legal scholars, the problems are not resolved yet and many law-suits have been filed and much legal arguments have developed into serious Labor-Management Disputes. At the end of last year(December 18th, 2013), the Supreme Court(All Judge-attending Court) had passed an important Judgment to resolve the long-time legal arguments on the Ordinary Wage. However, despite of the long and detailed sentences of the Judgment, there have been some controversies around the logic of the Judgment. Among several controversies, I've reviewed the issue of the Unconstitutionality of the Judgment. To clarify the problems, firstly in this thseis, I``ve reviewed the fundamental problems of the Ordinary Wage by way of comparing Ordinary Wage related articles in the Korean LABOR STANDARDS ACT with the corresponding articles in the Japanese LABOR STANDARDS ACT and discovered several critical legal deffects in the korean LABOR STANDARDS ACT. For example, the Korean Act has the article about the definition of Ordinay Wage which was stipulated with several abstact and ambiguous concept-factors like "periodicity", "uniformity", etc. Besides, I``ve found that these concept-factors like "periodicity", "uniformity", etc. have irrational points which are inappropriate to be used for building the definition-article of Ordinay Wage. For reference, the ENFORCEMENT DECREE OF THE LABOR STANDARDS ACT stipulates Article 6 as belows; Article 6 (Ordinary Wages) (1) For the purposes of the Act and this Decree, the term “ordinary wages” means hourly wages, daily wages, weekly wages, monthly wages, or contract wages which are determined to be paid periodically or in lump sum to a worker for his/her prescribed work or whole work. (2) In case of calculating ordinary wages under paragraph(1) at hourly rates, the amount shall be calculated pursuant to the following subparagraphs: 1. - 7. (omitted) (3) In case of calculating ordinary wages under paragraph(1) at daily rates, the ordinary wages shall be calculated by multiplying the number of contractual working hours per day by hourly wage rates prescribed in paragraph (2). The Supreme Court(All Judge-attending Court) had judged that the mutual agreement between Labor and Managemet to exclude some items of the wage from assessing the Ordinary Wage is legally null and void, because of the violation of the Definition-Article of the Ordinary Wage in THE ENFORCEMENT DECREE OF THE LABOR STANDARDS ACT. So to speak, with regard to the interpretation of this article, The Supreme Court(All Judge-attending Court) decided that the term of Ordinary Wage should be judged by the concept-fators(in German, Merkmal) of the peoriodicity, uniformity, stability. So, The Supreme Court(All Judge-attending Court) decided that the agreements excluding the items of wage which meet these conceptfactors( peoriodicity, uniformity, stability) are legally null and void. However, I think that this Judgment is unconstitutional because of the violation of The Labor-Management Autonomy, The Principle of Freedom of Contract, the Right to Pursue Happiness and the Right to use one``s own discretion, market-economy order that are guaranteed by the Constitution. And I``ve proposed that the Ordinary Wage System in the Act should be abrogated and a new alternative Criteria-Wage System should be entrusted with the Labor-Management Autonomy System as the Comprehensive Solution of the Ordinary Wage Problems.

8원자력발전소 주변지역 지원사업의 개선방안

저자 : 손진상 ( Jin Sang Sohn )

발행기관 : 안암법학회 간행물 : 안암법학 44권 0호 발행 연도 : 2014 페이지 : pp. 283-315 (33 pages)

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This paper aims to way to address improvement of the public assistance programs to the neighboring areas of nuclear power plants by analyzing Act on assistance to electronic power plants - neighboring areas. The public assistance programs are guaranteed in the legal system. The purpose of this Act is to promote the development of electric sources, strive for the harmonious operation of electronic power plants and contribute to regional development by efficiently carrying out the assistance programs to the neighboring areas of electronic power business. And the term ``neighboring area`` means the area of Eup/Myeon/Dong which includes the land and island that are located within a five kilometer radius from the location where any facilities of the electronic power are established or are scheduled to be established. Kinds of the assistance programs shall be as follows : basic assistance program, special assistance program, P. R. program, other programs. The assistance programs shall be carried out by the person falling under any executor of assistance program : the head of Si/Gun/Gu having jurisdiction over the neighboring area, operator of the electric generation business, the corporation which has been established for the purpose of publicity of atomic energy. The financial resource required for assistance programs shall be borne by the Electrical Industry Foundation Fund under Article 48 of the Electric Utility Act. This study found the programs have many problems including low trust-level of residents about nuclear power plant, totally moderate resident``s satisfaction-level about assistance programs, etc. Based on these findings, this study suggest that the assistance programs should be improved towards building trust with residents and making cooperative governance among program actors, etc.

9제3자를 위한 계약의 재검토 -새로운 형태의 보증을 중심으로-

저자 : 김명숙 ( Myeong Sook Kim )

발행기관 : 안암법학회 간행물 : 안암법학 44권 0호 발행 연도 : 2014 페이지 : pp. 318-356 (39 pages)

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By contract, as a basic institution of legal thought, the parties may arrange that the third party acquires the right to demand the performance directly. It never vests in the promisee, he only may acquire the right to claim that performance be rendered to the third party. By a contract of suretyship the surety puts himself under a duty to the creditor of a third party to be responsible for discharging that third party's obligation. The contract for the benefit of the third parties has been found on the variety of surrounding pheonomena, especially on the area of suretyship. It is a new type of Surety, but the contract for the benefit of the third parties are of practical importance. In case of insurance such a profit of suretyship ; guaranty insurance policy, insured sum will be paid to the third party on the occurrence of the insured event - non performance of the main debtor. The main function of performance base enrichment is to find a satisfactory solution for multipartite who is performing within contractual relationship involving chain of performance. If any contracts within the chain of performance is imperfect, restitution must occur between adjoining parties in the chain, the rule against leapfrogging is very important. Performance based restitution between three or more parties has become one of the most controversial areas. In case the parties concerned have differing views about has performed toward whom, a contractual approach has a acid test in case of the contract for the benefit of the third parties. The main obstacle is the dogma of privity of contract which creates rights and duties only for and against the parties. The relationships of performance are decisive for the way in which enrichment is returned. On the reasoning, the legal theory of the contract of surety may be applied on the new type of the suretyship. But it is very controversial.

10담배광고 규제에 관한 헌법적 고찰 - 미국에서의 경고도안(graphic warnings) 부착강제에 제기된 헌법적 의문을 중심으로 -

저자 : 박동열 ( Dong Yeol Park )

발행기관 : 안암법학회 간행물 : 안암법학 44권 0호 발행 연도 : 2014 페이지 : pp. 357-388 (32 pages)

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Tobacco-related disputes can generally be classified as litigation for the damages caused by smoking and tobacco regulation. In our current reality, absent comprehensive tobacco control acts, tobacco litigation functions are regarded as the most important social means of tobacco control. The Unites States has enacted and is enforcing the Family Smoking Prevention and Tobacco Control Act (TCA). The essential feature of the  TCA is the granting of powerful supervisory authority over tobacco products to the FDA, which is designated as the main federal regulatory body for the manufacture, marketing and distribution of tobacco products. Meanwhile, based on the TCA, the FDA has enacted regulations making the affixing of graphic warnings, etc., on cigarette packs and tobacco advertisements mandatory, to which tobacco companies filed suit against the TCA and the regulations enacted by the FDA for the violation of their First Amendment rights. The U.S. Court of Appeals for the Sixth Circuit ruled that the TCA provisions providing for the FDA regulation of cigarette packs and tobacco advertisements did not violate the First Amendment rights of the tobacco companies. However, the U.S. Court of Appeals for the District of Columbia Circuit found the regulations enacted by the FDA forcing the affixing of graphic warnings, etc., on cigarette packs, etc., to violate the First Amendment rights of tobacco companies. In our case, discussions regarding comprehensive tobacco control laws have, up to this point, mainly been from the perspective of the recognition of the right to smoke, or the restriction of tobacco companies' freedom of occupation. However, an examination of the discourse in the United States regarding graphic warnings shows that the violation of the freedom of expression also accounts for a very important portion of the discourse surrounding comprehensive tobacco control laws. With the enactment of comprehensive tobacco control laws now a task immediately at hand, discussions in the United States regarding the TCA, and the content thereof, have many implications on us.

12
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