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KMID : 1170320130190010055
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Korean Journal of Health Economics and Policy
2013 Volume.19 No. 1 p.55 ~ p.76
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A Study on the Generic Exclusivity under the Drug Approval-Patent Linkage
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Kim Dae-Jung
Park Sylvia
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Abstract
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Implemented in 2012, the KORUS FTA includes clauses on intellectual property rights that require linkage between drug approval and patent which, when implemented in detail, are likely to have considerable impact both on the Korean pharmaceutical industry and on people`s access to pharmaceuticals. As the first country ever to have implemented the system of linkage between drug approval and patent in 1984, the US has put in place a policy of granting 180 days of marketing exclusivity to first-to-file generics. The intent was to encourage generic producers to challenge weak brand patents. The number of challenges by generic producers increased, as intended. At the same time, there have been increases in the number of authorized generics and in the cases of reverse payment agreements between generic developers and patent holders. There are some aspects in the policy which make it worthy of consideration and attention. Given, however, that it is much easier to challenge patents in Korea than in the US, and that Korea already has in place price incentives for generic producers, a first generic exclusivity policy is likely to be much less effective in Korea.
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KEYWORD
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Drug approval-Patent linkage, First generic, Generic exclusivity, Authorized generic, Reverse payment agreement, KORUS FTA, Hatch-Waxman Act
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