IP Newsletter | Winter 2018/19
	PATENT
	Korean Supreme Court Rules that PTE Scope Covers Different Salt Forms of the Approved Product
	On January 17, 2019, the Korean Supreme Court reversed the Patent Court's narrow interpretation of the enforceable scope of the patent term extension ("PTE") for the compound patent covering Astellas' Vesicare® product (main ingredient: solifenacin succinate), holding that the scope of the PTE in that case covers the generic company's product, which utilizes a different salt form (fumarate) of solifenacin. This is the first Supreme Court decision in Korea to interpret the effects of a PTE under Article 95 of the Korean Patent Act ("KPA").
	Facts and Issues
	Astellas filed a patent infringement action against a generic version of the Vesicare® product, which contained a different salt from the original approved product (solifenacin fumarate). The asserted patent covered compounds including solifenacin, the active moiety compound of the Vesicare® product.
	Article 95 of the KPA provides that "the effects of a patent whose term has been extended only reach acts of working the patented invention concerning the product whose approval was the basis for the term extension (and where the approval was obtained for a specific use, for that specific use only)." Thus, the issue in this case was whether, under Article 95 of the KPA, a PTE for a compound patent covers a product containing the same active moiety as the original approved product, but in a different salt form.
	Patent Court's Decision
	The Patent Court had ruled that the scope of a PTE for a compound patent was limited to the product defined by the approval information that was the basis for the PTE, products which would be covered by the same approval since they are considered to be substantially the same product, or products that are substantially the same as the approved product and thus do not need separate approval to be practiced. Under this narrow interpretation, the generic product at issue was considered not to infringe the compound patent during the extended term, under the logic that a different salt product would require a separate approval.
	Supreme Court's Ruling and Implications
	The Supreme Court first noted that the Korean Patent Act defines the scope of a PTE to cover practice of the patented invention as it relates to the approved product which was the basis of the PTE, and does not limit the PTE scope only to acts of practicing the approved product itself. The Court then stated that "the scope of a PTE for a compound patent should be determined by focusing on whether the accused product is the same as the original approved product in terms of the active ingredient which is expected to exhibit a therapeutic effect against a certain disease, the therapeutic effect and the medicinal use." As such, the Supreme Court held that "even if an accused product has a different salt form than the original approved product, it should be considered within the scope of the PTE if it would have been easy for a person skilled in the art to select the salt form used in the accused product, and if the therapeutic effect exhibited by the pharmacological mechanism of the active ingredient in the accused product is the same as the original approved product."
	With respect to the accused product in this case, the Supreme Court held that "while it was different from the approved product in terms of salt form, it was still within the scope of the PTE because a person skilled in the art could easily select the salt of the accused product, and the therapeutic effects were substantially the same as the original approved product."
	Currently a large number of cases with the same issue are pending in the Patent Court and the Intellectual Property Trial and Appeal Board, which will be affected by the Supreme Court's decision. However, different conclusions may be reached in individual cases depending on the specific facts of each case, such as the specific language of the patent claims involved, the nature of the salt form used by the generic company, etc.
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