• Journal of Pharmaceutical Investigation
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• v.38 no.3
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• pp.207-215
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• 2008

Drug approval-patent linkage is the practice of linking drug marketing approval to the patent status of the originator's product and not allowing the grant of marketing approval to any third party prior to the expiration of the patent term unless by consent of the patent owner. Article 18.9.5 of Korea-US Free Trade Agreement requires that Korea introduce the linkage system in drug marketing approval. However, Korea is unfamiliar with the linkage system. In addition, there have been lots of arguments over the impacts of this system on Korean pharmaceutical industry and pharmaceutical market in the future. This report investigated the linkage systems of the US and Canada. The US and Canada have implemented drug approval-patent linkage system since 1984 and 1993, respectively. Both countries have patent lists for drug approvalpatent linkage on which originators are required to list patents on substance, product, and use of their drugs. Generic or follow-on drug applicants must contain a certification regarding each patent listed that relates to the referenced drug. If the patent holder files suit for patent infringement within 45 days of notice of application, drug approval is not allowed for several months - 30 months in the US and 24 months in Canada. Both countries have amended their systems after having experienced unexpected results such as listing improper and additional patents, multiple patent litigations and delayed generic entries. After reviewing the US and Canada's experiences, we suggested three principles needed in implementing the system: protecting patent holder's right; promoting generic drug development and marketing; monitoring the process and the effect of the system.

• The Korean Society of Law and Medicine
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• v.20 no.1
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• pp.25-43
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• 2019

This study analyzed the problem of the time difference of medicine price cut in Korea according to the administrative and judicial process and sought to present the amendment in the related law to achieve substantial fairness. We considered unfairness of medicine price cut caused by the administrative and judicial process in three situations, the approval-patent linkage system, realistic differences in the practice of administration and suspension of price cut execution. Based on it, we reasoned out the solution to get substantial fairness in the administrative and judicial process of medicine price cut in Korea. Although each step of the administrative and judicial process is lawful and reasonable, the time difference of medicine price cut according to the administrative and judicial process can result in damages or windfall to both of pharmaceutical company and National Health Insurance Service. In the present legal system of Korea, it is unable to be correct. Thus, we present the amendment to correct the damages and windfall when it happens.