• 발명특허
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• v.34 no.6
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• pp.34-36
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• 2009

• 발명특허
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• v.9 no.5 s.99
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• pp.18-19
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• 1984

• 발명특허
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• v.28 no.6 s.324
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• pp.62-64
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• 2003

• 대한임상약리학회:학술대회논문집
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• 2001.06a
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• pp.42-45
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• 2001

• 발명특허
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• v.35 no.5
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• pp.78-82
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• 2010

• The Korean Society of Law and Medicine
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• v.21 no.1
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• pp.223-259
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• 2020

With COVID-19 spreading rapidly around the world, research and development issues on treatments and vaccines for the virus are of high interest. Among them, Remdesivir was the first to show noticeable therapeutic effects and began clinical trials, with each country authorizing the use of the drug through emergency approval. However, Gilead Co., Ltd., the developer of Remdesivir, received a lot of criticism from civic groups for submitting the application for the marketing authorization as an orphan drug. This is because when a new drug got a marketing authorization as an orphan drug could be granted an exclusive status for seven year. The long-term exclusive status of an orphan drug comes from the policy purpose of motivating pharmaceutical companies to develop treatment opportunities for patients suffering from rare diseases, which was not appropriate to apply to infectious disease treatments. This paper provides a review of the problems and improvement directions of the domestic system through comparative legal consideration against the United States, Europe and Japan for the statutes which give exclusive status to medicines. The domestic system has a fundamental problem that it does not have explicit provisions in the statute in the manner of granting exclusive status, and that it uses the review system to give it exclusive status indirectly. In addition, in the case of orphan drugs, the "Rare Diseases Management Act" and the "Regulations on Examination of Items Permission and Reporting of Drugs" provide overlapping review periods, and despite the relatively long monopoly period, there seems to be no check clause to recover exclusive status in the event of a change in circumstances. Given that biopharmaceuticals are difficult to obtain patents, the lack of such provisions is a pity of domestic legislation, although granting exclusive rights may be a great motivation to induce drug development. In the United States, given that the first biosimilar also has a one-year monopoly period, it can be interpreted that domestic legislation is quite strictly limited to granting exclusive status to biopharmaceuticals. The need for improvement of the domestic system will be recognized in that it could undermine local pharmaceutical companies' willingness to develop biopharmaceuticals in the future, and in that it is also necessary to harmonize international regulations. Taking advantage of the emergence of COVID-19 as an opportunity, we look again at the problems of the domestic system that grants exclusive rights to medicines and hope that an overall revision of the relevant legislation will be made to establish a unified legal basis.

• International Commerce and Information Review
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• v.16 no.1
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• pp.117-142
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• 2014

China having largest market in the world, has been criticized by its trading partner countries due to its unfair trade practices, particularly in the field of anti-dumping regulation. The main reasons for such criticism seem to come from the incomplete anti-dumping law as instrument to protect the industry concerned. In 2001, though new anti-dumping law was established to replace the former one by revising it to meet the needs for economic development which should be secured for china to take part in the competition world as the new member of WTO. The provisions concerned have been evaluated not to be sufficient and efficient from the viewpoint of the safeguard mechanism, while are required to be modified to meet the real world of international trade law. I consider that as the biggest partner of chinese trade activity, we will need to maintain a well understanding of the Chinese anti-dumping regulations. So this report conducts the Chinese anti-dumping regulations, compares between the chinese regulations and the WTO agreement, and studies deeply in to the problems and the improvements of the Chinese anti-dumping regulations.

• Korea Trade Review
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• v.42 no.4
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• pp.93-114
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• 2017

Under the FTA agreement, preferential tariffs between FTA members will result in tariff reductions. In order to ensure the stable use of the FTA tariff system, it is necessary for the customs authorities to determine whether the origin goods are clearly applicable. This study analyzed the procedure of appeal according to the origin verification system based on the decision made by Korea Customs Service and Tax Tribunal. From this, we examined whether the rate of re-claiming a case rejected in the 'Review System of the Legality Before Taxation' differs. In addition, we carried out a quantitative analysis using bootstrapping technique in order to overcome the scarcity cases of verification of origin among FTA members. The implications of this paper are summarized as follows: First, we tested the hypothesis that the re-claiming rate of Western countries is higher. Second, some issues represented higher re-claiming rate. Third, there was no significant difference between the verification group and the re-claiming rate. Finally, even if an applicant makes a claim again, there is a possibility of being rejected again.

• The Korean Journal of Archival Studies
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• no.59
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• pp.159-206
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• 2019

This study aims to analyze the details of the executive order of the president of the United States, which have been developed in the country's administrative system to institutionalize the guarantee of the people's right to know the classified records, as well as to protecting national secrets. This study also aims to present any implications for the development of the classified record management system of Korea. To this end, the previously issued EO concerning the classified records management were reviewed in terms of its classification, safeguard, and declassification. The analysis results showed that the EO by the president established and prescribed the special access program for national secrets, the system to exempt and suspend the automatic declassification, and the sanctions for protecting national secrets. The EO also established and prescribed the appointment system for the person with the authority to classify record, automatic declassification program, and Mandatory declassification review system, as well as the procedures for historical researcher and certain former government personal to access the classified records with the purpose of guaranteeing people's right to know. As a result, this study identified implications for the development of Korea's classified record management system, as follows : First, it is necessary to restructure the current classified record management system, by changing the operations that is dependent on the director of the National Intelligence Service to the one that is dependent on the President. Second, it is necessary to legislate a separate special law for the classified record management system. Third, a standing supervisory body should be established for the integrated management and for the consistent and routine supervision of the classified record management. Fourth, it is necessary to establish procedures to further review the classification of classified record to correct the defects of the current classification system, which has been abused and mismanaged by the national agencies and organizations that produce classified record.

• Journal of Korea Technology Innovation Society
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• v.20 no.1
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• pp.127-152
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• 2017

China's utility model as a supplement to the invention patent, has short application duration, fast authorized speed, and has the same exclusive rights with patents, so companies can quickly dominate the market. But the utility model does not need to carry out substantive examination, so has lower stability, high frequency of invalid to accepted, so compare with the invention patent, difficult to be protected. In order to actively encourage the small and medium-sized enterprises to promote their inventions, and protect domestic patents, China established a protection policy of patent evaluation report for the utility model rights, especially the patent evaluation report can be used as evidence in a patent infringement trial, to provide judicial remedies for utility model patentee and the party of patent disputes. Many experts believe that the establishment of patent evaluation report system can improve the stability of the utility model patent right, and when the defendant request for invalidation of the patent right in the defense period, if there is no novelty, creativity lost or no other reason has not led to the stability of patent right given in a patent evaluation report of the utility model patents, the court may not suspend the trial, without having to wait for the Patent Reexamination Board makes the patent invalid declaration decisions, can improve the efficiency of the judicial process, accelerate the patentee's time. However, in practical patent infringement, the patent evaluation report system and invalidation system are in conflict. In this paper, through the analysis of the current China utility model system and compared with the South Korean utility model system, review the role and character of the patent evaluation report system, and through the actual cases of the utility model patent infringement litigation, analysis possible variates from the decision of patent evaluation report, to find out the reason of the patent evaluation report system being in conflict with the invalidation system, and research on the effectiveness for protecting Utility Model with China's Patent Evaluation Report.