특허권 존속기간 연장산정의 기초가 되는 ‘발명을 실시할 수 없었던 기간’의 의미와 구체적인 산정방법

• 영문명: The meaning and specific calculation of “the period during which the invention could not be utilized” as a basis for calculating patent term extension
• 발행기관: 충북대학교 법학연구소
• 저자명: 신혜은(Hye Eun Shin)
• 간행물 정보: 『과학기술과 법』제15권 제2호, 31~62쪽, 전체 32쪽
• 주제분류: 법학 > 법학
• 파일형태: PDF
• 발행일자: 2024.12.31

국문 초록

Efficacy and safety tests are required for the approval of pharmaceutical products, which often result in a shorter patent term compared to other technologies. To solve this problem, a system was introduced to extend the duration of patent rights for the period during which the invention could not be utilized. This paper examines how to interpret the current law on the extension of patent terms due to regulatory approval in a way that aligns with Korea’s industrial realities and maintains international consistency. As a result, it was concluded that clinical trials conducted in foreign countries are included in the “period during which the invention could not be utilized for approval, etc.” if they are conducted “for domestic approval.” Furthermore, it was clarified that the supplementary period caused by the non-submission of data during the drug approval process cannot be presumed to be due to the patentee's responsibility. Unlike “the period of delay caused by the applicant,” “the period of delay caused by the patent holder” cannot be determined through specific examples alone. Instead, it is necessary to assess whether a given delay constitutes “the period of delay caused by the patent holder” based on the specific facts of each case.

목차

Ⅰ. 들어가며

Ⅱ. 외국사례의 검토

Ⅲ. 발명을 실시할 수 없었던 기간

Ⅳ. 특허권자의 책임 있는 사유로 인해 소요된 기간

Ⅴ. 결론

키워드

제약산업 의약품 허가 유효성 안전성 특허권 존속기간 연장 pharmaceutical industry drug approval efficacy safety patent term extension