솔리페나신 염변경 특허분쟁 판결의 법리적 의미에 대한 고찰

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