Analysis of patent scope, effects, and identity standards in Korean pharmaceutical law, emphasizing implications for patent term extensions.
According to the Korean Patent Act Article 97, the scope of protection of a patented invention shall be determined by the descriptions of the claims. During the duration of the patent right, the patentee will enjoy the exclusive right over the entire scope of the claims. However, Article 95 of the Korean Patent Act states that the effects of a patent, the term of which has been extended under Article 90, that is an applications for Registration of Extended Patent Terms by Permission, shall extend only to practicing the patented invention on the things on which permission, etc. for registration of the extension is based (things used for specified purposes, if the purposes of such things are specified in the permission, etc.). This paper examines the trends in pharmaceutical approval, extension of term, and interpretation of scope of effect(Section II), and then examines the types and uses of inventions in the Patent Act, the reason for the introduction and interpretation of the concept of use in Article 95 of the Patent Act, and the relationship between such uses and inventions of administration, dosage, or medical use(Section III). In addition, in determining the scope of effect of pharmaceutical substance patents whose term of effect has been extended under Article 95 of the Patent Act, the scope of substantial identity of use according to the substantial identity standard presented in the Solifenacin decision is discussed as to whether it is limited to efficacy and effect (indication) under the Pharmaceutical Affairs Act, and whether the scope of substantial identity of use includes only the initial approval or also subsequent approvals(Section IV).
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Park et al. (2025) studied this question.
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