SOUTH KOREA Trends and Developments Contributed by: Keum Nang Park, Eileen Jaiyoung Shin, Jeonghoon Hong and Soo Yeon Park, Lee & Ko
try of Food and Drug Safety were conducting related activities count toward the PTE period. In practice, the statutory PTE period – defined as “the time period during which the patented invention could not be practiced” will be deter - mined according to the Public Notification on the Administration of the Patent Term Extension (the “Public Notification” ) from KIPO rather than the Supreme Court’s interpretation of the statute. As for PTE scope, in the leading Vesicare® case, the Korean Supreme Court held that the scope of rights should be determined by focusing on the sameness of the active ingredient, the medicinal use, and therapeutic effects. Based on these standards, the court found that the PTE scope of a compound patent covers different salt forms of the approved product. This ruling on the enforceable scope regarding API is similar to the enforceable scope of patent right by PTE/ SPC in the United States and Europe. The Kore- an system differs significantly from its United States and European counterparts, however, in that the majority view takes the position that the PTE right should be limited to the first approved use (indications) as well as the approved API. That is, in the United States and Europe, any medicinal uses approved for the product at issue without any limitations thereon can be protected by the patent extended by PTE/SPC. Recent Trends of Korea’s PTE System PTE eligibility First, according to the amended KPA, the sin- gle-patent selection requirement, whereby only one patent among multiple patents covering an approved product may receive PTE, will be implemented in the second half of 2025. Accord- ing to the new statute, applicants (patentees) should select only one patent to benefit from PTE among the patents that are eligible for PTE since the related marketing approval is granted
after the implementation of the amended KPA. Accordingly, patentees should carefully deter- mine which patents should be extended. Second, regarding PTE eligibility, a recent Supreme Court decision in the Plegridy® case (wherein the API of the approved drug product at issue is a pegylated drug) highlights another key issue. The Supreme Court ruled that a pegylated drug may not be eligible for PTE as long as the active moiety is found to be the same (having the same medicinal use/effect despite different PK profiles, such as long retention time of drug in blood due to pegylation) as the earlier approved drug (a non-pegylated form). Although the “new substance-first approval” requirement is similar to the “first commerciali - sation” requirement in the United States and Europe, the Korean Supreme Court ruling in the Plegridy® case suggests that the PTE eligibil- ity for pegylated drugs will be different from the United States and Europe where a pegylated product is generally considered a new active substance. Under this Korean Supreme Court interpretation, the KIPO is expected to reject PTE applications based on pegylated forms of biologics. In fact, we are already seeing cases in Korea where the KIPO has rejected PTE applications under the Korean Supreme Court’s reasoning. Therefore, patentees who own patents directed to pegylated pharmaceutical products need to show different medicinal uses/effects of their pegylated drugs from the earlier approved unmodified forms if they aim to secure PTE of their patents. Although the above Supreme Court ruling implies that a pegylated drug is not eligible for
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