The effects of a patent, the term of which has been extended – focusing on the substantially same therapeutic effect and use –

Abstract

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.). Despite the fact that a considerable period of time has passed since the registration system for the extension of the duration of patent rights was introduced in Korea, it was unclear to what extent the scope of the extended patent rights could be recognized. However, in the first Supreme Court ruling on the scope of the validity of the patent right with an extended duration (Supreme Court Decree of Jan. 17, 2019, 2017Da245798; hereinafter referred to as Solifenacin ruling ), reasonable criterion was presented and it is expected that the confusion can be cleared up to some extent. In this paper, focusing on the criteria suggested by the Solifenacin ruling, I investigated in which direction it would be desirable to interpret the scope of validity of patent rights with extended duration. As a result, I came to the following conclusion. First, considering the purpose of the Pharmaceutical Affairs Law and the Patent Law, and the text of the relevant law, it is desirable to determine the effects of a patent, the term of which has been extended in accordance with the purpose of the patent law. Second, to determine the effects of a patent, the term of which has been extended, it is important to explore what the essence of the patented invention is. In conclusion, even if there is a difference in salt, etc., it should be regarded as belonging to the scope of validity of the extended patent right if it can be easily selected by a person with ordinary skill in the art. In addition, if the patentee who developed the new substance obtains the drug product license and then obtains the registration for an extension of the duration of the patent right based on this, the scope of the validity of the extended patent right will be extends to the range that can be regarded as substantially the same as the therapeutic effect of the diseases, for example, such as high blood pressure and diabetes, etc..