Japanese Patent Term Extensions I

While not a staple territory around these parts, we thought that some recent developments on Japanese case law concerning pharmaceutical patent term extensions may be of general interest to our readers.

The following case summary is derived from the May 2011 Newsletter of Anderson Mori & Tomotsune, which was passed to us by Hugh Goodfellow of Carpmaels and Ransford.

Based upon the summary, it appears that it is possible in Japan to obtain a patent term extension for a new form of a previously approved medicine if the pre-approved form is not covered by the patent in question (e.g. the patent to be extended covers a tablet and not the pre-approved injectable form of the drug).

"Under the JPO practice of granting patent term extensions, an application for a patent term extension based on the later approval of a medical product ("later product") with an active ingredient and an effect, which are the same as those specified in a precedent approval of another medical product "precedent product"), is rejected since it is not acknowledged that "obtaining the approval as designated by the Cabinet Order was necessary for the working of the patented invention" as prescribed in Article. 67ter (1)(i) of the Patent Act.

In the subject case, the patentee of a patent directed to the "release control composition" (the "Patent") filed an application for a patent term extension (the "Application") based on a governmental approval (the "Approval")of the medical product "PACIF CUPSULES 30mg" (the "Medical Product") under Article 14(1) of the Pharmaceutical Affairs Act. The Examiner rejected the Application on the ground that there was a previous approval (the "Preceding Approval ") of another medical product which had the same active ingredient and effect as the Medical Product. The Board of Appeals of the JPO decided to uphold this rejection. However, the decision by the JPO was revoked on appeal before the IP High Court. The JPO filed an appeal against the IP High Court's decision before the Supreme Court. 

 The Supreme Court made a notable judgment in which it found that even where there exists a previous approval as aforementioned, if the precedent product does not fall within the scope of a patent to be extended based on a later approval, it cannot be said that obtaining the later approval was unnecessary for the working of the patented invention on the ground that there is a previous approval. Then, for the subject case, since the other medical product does not fall within the scope of any of the claims of the Patent, the Supreme Court applied the above standard, and affirmed the IP High Court decision which revoked the decision of the JPO.

 This Supreme Court's decision has clearly denied the current JPO practice of granting patent term extensions, and where, for instance, there exists a first approval for a drug in the form of an injection, a patent directed to a drug in a form of tablet may be extended based on a second approval for the tablet despite it having the same active ingredient and effect as those of the first approved injection drug."