SOUTH KOREA Trends and Developments Contributed by: Keum Nang Park, Eileen Jaiyoung Shin, Jeonghoon Hong and Soo Yeon Park, Lee & Ko
Introduction Patentees holding patent rights relating to phar- maceutical products often aim to extend their market exclusivity by obtaining Patent Term Extension (PTE) of patents covering their prod- ucts. Conversely, generic companies seeking prompt market entry have a vested interest in opposing PTE. Given these dynamics, the key points of dispute between patentees and generic companies are: (i) which patents are eligible for PTE ( “PTE eligi- bility” ) (ii) how long the term should be extended under PTE ( “PTE period” ) and (iii) what scope of rights should be granted during the extended patent term ( “PTE scope” ). The Korean government has been attempting a statutory harmonisation with global standards while balancing innovation-fostering patent protection rights with the public interest served by lower-priced generic products. The PTE sys- tem, which emerged from these policy consid- erations, represents one of the most dynamic and constantly evolving areas of Korea’s patent policy. For example, the Korean National Assembly recently passed a bill proposing to introduce additional requirements for PTE eligibility and the PTE period, and the Korean Intellectual Property Office (KIPO) is currently reviewing changes to the appellate system for rejected PTE requests. This article examines the current status of Korea’s PTE system and the latest trends that patentees should keep in mind for a global IP strategic framework.
Overall Status of the Korean PTE System Similar to policies in other areas of IP, patent offices worldwide are seeking to harmonise their PTE systems. In Korea, KIPO introduced the so-called new substance-first approval requirement in 2013 as for PTE eligibility. This 2013 requirement is com- parable to the notion of “first commercialisation” in the United States PTE policy and the European SPC systems. Under the amended Korean Pat- ent Act (KPA) that will come into effect later this year, patentees should choose a single patent among multiple patents covering the approved pharmaceutical product, which is similar to the approach used in the United States PTE system. Despite these amendments, however, there are still significant differences between the Korean PTE system and those of the United States and Europe with regard to the PTE period and the scope of the extended rights. As for PTE period, in the leading Betmiga® case, the Korean Supreme Court ruled that the length of the PTE period under Article 89 of the KPA is “the time period during which the patented invention could not be practiced” . The Korean Supreme Court further defined the PTE period as the time period from the initiation of a market- ing approval (MA) process (usually, the start date of clinical trials) or the patent registration date, whichever is later, to the MA date. This PTE peri- od interpretation is akin to the definition under the Japanese PTE system. Despite this techni- cal definitional similarity, however, the average length of PTE periods granted in Korea is much shorter than those in other jurisdictions, includ- ing Japan, because the KIPO takes a restrictive approach in calculating the PTE period. For PTE calculation purposes, only the periods during which clinical trial organisations and the Minis-
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