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KMID : 1142220140090020079
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Regulatory Research on Food, Drug & Cosmetic
2014 Volume.9 No. 2 p.79 ~ p.93
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A Study on Drug approval - Patent Linkage System in Korea
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Jeong Yong-Ik
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Abstract
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The drug approval-patent linkage system that was introduced by Korea-US FTA is planned to be implemented in earnest in 2015. To promote the understanding of the domestic pharmaceutical companies for new schemes to be implemented and to allow to prepare R&D and market entrance systematically, it is required to review of the key information that is currently being proposed in the revised Pharmaceutical Affairs Law amendment. The revised Pharmaceutical Affairs Law draft that will be implemented in 2015 is innovatively improving the contents related to the drug patent list and the notice of marketing authorisation applications for generic drug which has been inforced since 2012. In the sales restrictions on generic medicines and the primary marketing authorisation granted to the first applicants who are successful patent challenger from generic drugs, it is required more stringent requirements than the United States to promote the market entry of generic drugs while the patent protection is substantially strengthened. In particular, by granting a conditional permittion without stopping approval process, the concerns that are sold-out period may be extended were removed. And in the primary marketing authorisation, by clarifying the winning requirements in patent litigation and considering preferentially the first people taking legal action, it is clarified both that this system is both the reward for patent challenges and the measures to promote generic entry. In addition, there are submission of agreements between pharmaceutical companies for the smooth operation of the system, fees imposed in accordance with the beneficiary pays principle, cooperation system between authorities, and a applications in accordance with a grace period of three years. Although the details in the draft will not be considered sufficient in all respects, it is shown to be well designed by reflecting both the Korean legal system that is possible to take a patent litigation before pharmaceutical marketing authorisation application and the reality of the pharmaceutical industry which generic drug manufacturing companies are a majority in. Just, too complicated procedure due to the nature of the system itself will need to be refined to be more delicate and brief.
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KEYWORD
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Drug approval-patent linkage system, Sales restrictions, primary marketing authorisation, Hatch-Waxman Act, Generic drug, KORUS FTA
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