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IP Newsletter | Winter 2018/19
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PATENT
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The Supreme Court Affirms that Patent Term Extensions Based on Approvals for Importation Rather Than Manufacturing Are Not Invalid
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Patent term extensions ("PTEs") were first introduced into the Korean Patent Act ("KPA") in 1987. However, while the 1987 KPA and its Presidential Decree (enacting regulations) provided that PTE could be granted based on the approval of a medicinal product for domestic manufacture, it said nothing about whether approval of medicinal products merely for importation was a valid basis for PTE. The KPA Presidential Decree issued in 2000 expressly provided that for patents filed after 2000, importation approvals would be a valid basis for PTE, but it has long been unresolved in Korea whether PTE requests based on approvals for importation for patents filed between 1987 and 2000 are acceptable.
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In 2012, Novartis filed a request for PTE for a patent covering the Exelon® Patch (for treating dementia associated with Alzheimer's disease) on the basis of the approval of the product for importation. However, because the PTE provisions of the 1987 KPA applied to the Novartis patent (which issued in 1988, although it did not expire until 2012 due to the applicable rules at the time of filing), the Korean Intellectual Property Office (KIPO) rejected the PTE request in 2013, primarily on the basis that the 1987 KPA did not allow PTE for importation approvals. This decision was affirmed by the administrative court in 2013, but rejected by the high court in 2014, leading to a Supreme Court appeal.
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The Supreme Court has now resolved this issue, and clarified that importation approval is a proper basis for PTE under the 1987 KPA even for patents filed prior to 2000, in view of the purpose of the PTE system (to compensate for loss of effective patent term due to regulatory approval delays), the WTO/TRIPs Agreements (which provide that patent rights should be enforceable without discrimination as to whether products are imported or locally produced), and the legislative history of revisions to the relevant Korean laws. As a result of the Supreme Court's decision, it is now clear that PTEs granted for importation approvals issued prior to 2000 cannot be invalidated simply because they were granted based on importation rather than manufacturing approval.
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