솔리페나신 염변경 특허분쟁 판결의 법리적 의미에 대한 고찰

• 영문명: Consideration of Legal Implications of the Patent Dispute Judgement on Solifenacin Salt Change
• 발행기관: 대한약학회
• 저자명: 정미연(Miyeon Jeong) 김광준(Kwang Joon Kim) 이원재(Wonjae Lee)
• 간행물 정보: 『약학회지』제65권 제1호(2021년), 56~63쪽, 전체 8쪽
• 주제분류: 의약학 > 기타의약학
• 파일형태: PDF
• 발행일자: 2021.02.28

영문 초록

This article discusses the solifenacin patent dispute between Astellas and CorepharmBio pharmaceutical companies. Domestic pharmaceutical companies tend to focus on incrementally modified drug (IMD) or generic drugs research rather than on the development of new drugs, which are more likely to fail. Among the various development types for IMDs, pharmaceutical companies are particularly interested in the strategy of changing salts of the original drug products. The key issue regarding the patent dispute between Astellas and CorepharmBio is the scope for validity of the patented invention with extended term for the original drug (solifenacin succinate) of Astellas under Article 95 of the old Patent Act. The first Seoul Central District Court and the second Patent Court recognized the IMD solifenacin fumarate of CorepharmBio as the “major ingredient” for the manufacturing/registration of pharmaceutical products, and the plaintiff Astellas was defeated. However, the Supreme Court investigated the standard for determining whether changing salts of the original drug (solifenacin succinate) may infringe a patent covering the original drug product. Finally, based on the act of implementing the patented invention, the Supreme Court judged and remanded the solifenacin judgement of the second Patent Court. It is expected that this article regarding solifenacin patent dispute will be useful for the research and development of new drugs as well as IMDs or generic drugs by domestic pharmaceutical companies.

목차

서 론(Introduction)

방 법(Methods)

결 과(Results)

고 찰(Discussion)

결 론(Conclusion)

감사의 말씀(Acknowledgment)

Conflict of Interest

References

키워드

Active pharmaceutical ingredient Generic drug Incrementally modified drug Major ingredient Patent dispute Solifenacin