의약법상 자료독점권에 관한 고찰

다국어 초록 (Multilingual Abstract)

There is a worldwide struggle for existence between manufacturers of original drugs and generic companies in the pharmaceutical industry. Ever-greening and free-riding competition are becoming a frequent issue in the global, pharmaceutical market.
Through the data exclusivity, pioneer drug companies are able to obtain the exclusive right to manufacture and sell the drugs, and, for a fixed period of time, generic drug manufacturers are prevented from developing drugs by relying on the original data.
In Korea, data exclusivity was introduced indirectly through the partial amendment of new drug reexamination regulations in 1995, following the creation of WTO and TRIPs(Agreement on Trade Related Aspects of Intellectual Property Rights) Article 39.3 in 1994. Data exclusivity rights are not private rights, but rights of public law as the standing for administrative litigation, and are negative requisites of pharmaceutical approval.
However, up to now, legal provisions about data exclusivity right were grounded only on the administrative regulations of Korea Food & Drug Administration, not on the act of the National Assembly. These administrative regulations are too short to answer so many legal problems such as contents, objects, and period of data exclusivity right. Besides new chemical entities, data of new therapeutic indications or improved drugs are so strong protected under our present data exclusivity system, and enjoy unfair privilege of monopoly against manufactures of generics too long.
This article contends that our legal system of data exclusivity must be fundamentally amended and be divided out of new drug reexamination system.

목차 (Table of Contents)

• Ⅰ. 우리 의약법상 신약개발자료의 보호
• Ⅱ. 국내법과 TRIPs협정의 내용
• Ⅲ. 미국과 유럽연합의 자료독점권의 보호내용
• Ⅳ. 우리 의약법상 보호되는 권리의 성격
• Ⅴ. 우리 의약법상 자료독점권의 보호대상과 그 내용
• Ⅵ. 결어
• 참고문헌
• 〈Abstract〉

참고문헌 (Reference)

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