허가-특허 연계제도 법률안의 검토

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.