Reiwa 6 (Gyo-Ko) 10007 [Pharmaceutical composition / registration of patent term extension] <Presiding Judge Nakahira>
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Article type: Case note
Categories: Patents
Issues: —
First published on this website: October 5, 2026
Case information: Reiwa 6 (Gyo-Ko) 10007 [Pharmaceutical composition / registration of patent term extension] <Presiding Judge Nakahira>
Display and classification checked: October 5, 2026
Reiwa 6 (Gyo-Ko) 10007 [Pharmaceutical composition / registration of patent term extension] <Presiding Judge Nakahira>
<Issue> Does a “revision of the package insert” for a pharmaceutical constitute a “disposition” that provides grounds for registration of a patent term extension (Patent Act, Article 67(4); Article 2 of its Enforcement Order)?
⇒ Revision of a package insert does not constitute a “disposition” eligible for extension registration.
(1) Legal nature of revision of a package insert (related to issue 1)
<Distinction from approved matters>
In the marketing approval for the pharmaceutical, the “administration rate” was not applied for as an approved matter (dosage and administration), nor was it subject to examination. The PMDA's instructions concerning the administration rate were merely administrative guidance, not a legally binding disposition.
<Not the lifting of a prohibition>
Even before the package insert was revised, the administration method (administration at a high rate) was not prohibited by law. Accordingly, revision of the package insert did not lift any prohibition (make it possible to work the patented invention).
<Difference from approval of a partial change>
Notification of a revision to a package insert is the performance of an obligation by the marketing authorization holder; it does not itself mean a change in rights or obligations by an administrative authority (a disposition). Its legal nature therefore differs from “approval of a partial change” under the Pharmaceuticals and Medical Devices Act.
(2) Whether the Cabinet Order can be applied by analogy (related to issue 2)
The “dispositions” providing grounds for extension registration specified in Article 2(ii) of the Enforcement Order of the Patent Act are understood to be exhaustively listed.
The Enforcement Order has been amended repeatedly, but even after the introduction of the package-insert revision consultation system, no amendment has been made to include revision of a package insert among the dispositions.
In view of the foundation of the patent system (the public interest), under which anyone can freely use an invention after the patent term expires, “revision of a package insert,” for which there is no express provision, should not be made eligible for extension registration by interpretation by analogy.
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October 5, 2026: First published from the LinkedIn original, with article information, classification, source, language link, and consultation guide.
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