JAPAN Trends and Developments Contributed by: Kenji Tosaki and Takahiro Hatori, Nagashima Ohno & Tsunematsu
specified by the “ingredients, quantity, dosage, administration, indication, and usage” stipulated in the marketing authorisation, but also those consid ‑ ered substantially identical as pharmaceuticals in light of the technical significance of the patented invention and the contents of the marketing authorisation. Furthermore, the IPHC pointed out that the technical feature of the Invention lies in the fact that the Inven ‑ tion is a medicinal use invention which uses a sub ‑ stance known at the time of the filing of the Patent as an active ingredient having an effect as an antipruritic agent, and stated that: “[i]n the case where the technical features and effects of [Toray’s Drug] and [the Defendants’ Drugs] are iden ‑ tical in that they are both antipruritic agents whose active ingredient is nalfurafine, and their specific dos ‑ age form as a pharmaceutical is identical, if some inactive ingredients are added or modified using techniques that were well-known and conventional at the time of the marketing authorisation application, or if the differences between the inactive ingredients of [Toray’s Drug] and those of [the Defendants’ Drugs] do not affect the ‘indications and usage’ of the drug and such differences are regarded as minor or insig ‑ nificant as a whole, [the Defendants’ Drugs] should be deemed to be substantially identical to [Toray’s Drug] as pharmaceuticals.” The court then noted that the Invention is a medicinal use invention whose technical feature lies in that it provides a new medicinal application as an antipru ‑ ritic agent based on the “κ receptor agonist activity of compounds represented by general formula (I)”, which was the unknown property, and does not specify any excipients to be contained in the antipruritic agent. The IPHC went on to indicate that: • both Toray’s Drug and the Defendants’ Drugs are antipruritic agents whose active ingredient is nalfurafine, a κ receptor agonist represented by general formula (I), and are drugs for which bio ‑
equivalence with Remitch® Capsule 2.5 μg has been confirmed; • both Toray’s Drug and the Defendants’ Drugs were developed as orally administered drugs to be OD tablets having no difference in efficacy and safety from Remitch® Capsule 2.5 μg; • it can be understood that the use of the Defend ‑ ants’ Drugs is aligned with that of Toray’s Drug; and • Toray’s Drug and the Defendants’ Drugs are identi ‑ cal in their “active ingredient and quantity” and “dosage, administration, indications and usage,” and they differ only in their excipients. Furthermore, the IPHC noted that excipients are gen ‑ erally substances that do not exhibit pharmacological effects at the dosage of the drug, that are harmless, and that are added as substances not impairing the therapeutic effects of the active ingredient, and that, in light of the description in the specification and the development history of the Defendants’ Drugs, the excipients used in Toray’s Drug and the Defendants’ Drugs do not have any other technical significance. Based on the above, the IPHC determined that, because the technical features and effects of Toray’s Drug and the Defendants’ Drugs are identical as they are both antipruritic agents with the active ingredient nalfurafine, and because their specific dosage form as a pharmaceutical is also identical, then, in light of the significance of excipients, the differences in excipi ‑ ents between both are generally regarded as minor or insignificant as a whole, and the Defendants’ Drugs are substantially identical to Toray’s Drug as pharma ‑ ceuticals. Comments These judgments are noteworthy because they addressed the issue as to whether or not the drugs at issue fall under the scope of a patent during the extended term. It was reported that Sawai and Fuso have filed a final appeal and a petition for acceptance of final appeal against this judgment, but the Supreme Court has not issued any decision/judgment.
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