SOUTH KOREA Trends and Developments Contributed by: Keum Nang Park, Eileen Jaiyoung Shin, Jeonghoon Hong and Soo Yeon Park, Lee & Ko
can be extended and the length of the possible extension period, when pursuing a PTE applica- tion. PTE Scope (enforceable scope of patent right during extended patent term) The scope of rights during the extended patent term by PTE is stipulated by Article 95 of the KPA. It provides that the PTE scope is limited to only practising the approved product for its approved medicinal uses. In this regard, the Korean Supreme Court clari- fied in the Vesicare® case that the PTE scope should be determined by focusing on the active ingredient, its medicinal use and therapeutic effect of the approved product. The Korean Supreme Court then found that any salt-modi- fied forms can be covered by the compound pat- ent extended based on the MA of the approved product at issue and where the API is a different salt. Although the Supreme Court provided some clarity about how to assess the sameness of the active ingredients, uncertainties remain regard- ing how to interpret “the approved use” . These uncertainties are currently stirring controversy in Korea. The following key points are worth pondering regarding “the approved use” : (i) whether the use should be the first approved uses; and (ii) whether the use means the specific approved indications or general concept of the medicinal use. As at the time of writing, the latter is being dis- puted and tested in many cases, but patentees need to raise the former issue before moving to the latter one.
With respect to the former issue (referred to as “Issue 1” ), although the majority view in Korea is that the PTE right should be limited by the first approved uses as well as the first approved API, the language of Article 95 of the KPA does not clearly limit the use to be that approved first for the product. The statute merely states that the scope of patent right is limited to practising the approved product for its approved uses. Histori- cally, the PTE system was first established in the United States, and the relevant provision in 35 USC §156 (b)(1) also states that the scope of rights is limited to any approved use. The limitation to approved medicinal uses was introduced in line with the original purpose of the PTE, which was to extend patent rights directed to a pharmaceutical product. No matter how broad the scope of the patent, the scope of rights during the patent term extended by the PTE was limited to the approved API, and there was no rational reason to further narrow this limited scope based on the first approved medicinal use. Accordingly, patentees may need to raise ques- tions regarding Issue 1 and the proper interpre- tation and purpose of Article 95 of the KPA in terms of PTE history. Regarding the latter issue (referred to as “Issue 2” ), one common strategy taken by generic companies had been to change the API of the patented product, such as changing the salt, to claim non-infringement of the PTE scope. With the Supreme Court decision in the Betmiga® case blocking this strategy, local generics in Korea are turning to another strategy by claim- ing differences in approved medicinal use.
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