SOUTH KOREA Trends and Developments Contributed by: Keum Nang Park, Eileen Jaiyoung Shin, Jeonghoon Hong and Soo Yeon Park, Lee & Ko
Currently, hundreds of scope confirmation action cases against a product patent extended based on the approval of the K-cab® product are pending before the IP High Court. In the first instance, the IPTAB ruled in favour of the paten- tee, and the IP High Court also ruled in support of IPTAB’s decision. Specifically, the IPTAB held that: • although the specific indications asserted by the generics are different from the first- approved indications of the patented drug, all of them are based on the same pharma- cological mechanism, which has been known before the patent at issue; • the PTE scope is limited to practising the invention directed to the approved product, which does not mean practising exactly the same pharmaceutical product as the approved product; and • the asserted indications are deemed substan- tially identical to the first-approved indications in terms of medicinal use and effect. Implications of the PTE Trends in Korea for Pharmaceutical Patent Holders In the important field of PTEs, depending on the interests at stake, there will inevitably be arguments between patentees favouring broad interpretation of rights and generic companies advocating for narrow constructions.
Due to the competing policy aspects of the PTE system, the Korean PTE system is rapidly chang- ing and creating an environment where legal dis- putes are constantly arising in connection with ambiguities in Korea’s interpretation of the law. While the direction of some previous Korean amendments may be favourable to patentees, the recent amendments to the KPA introduce more restrictive requirements for granting PTEs to patentees in Korea. However, further discus- sions regarding amendments to the Korean PTE system are ongoing. These evolving trends in the PTE system signify that the direction of the improvements or revisions is not set in stone and Korea remains open to hearing various views. Therefore, pharmaceutical patent holders and the stakeholders in the pharmaceutical industry are encouraged to examine proactively whether the current and forthcoming amendments to the PTE system are moving in the right direction. In the end, a balanced IP and legal policy approach in Korea should be in line with the purpose and intent of the PTE system.
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