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〔Latest〕 Supreme Court Upheld IP High Court Grand Panel Decisions on Patent Term Extension

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The Supreme Court of Japan (SCJ) rendered a decision (SCJ decision No. 2014 (Gyo-Hi) 356) on November 17, 2015, to dismiss the final appeal by the Japan Patent Office (JPO) against the decisions held by the Intellectual Property High Court of Japan (IPHC) for registration of patent term extension (PTE).

Meaning of the SCJ’s decision:
According to the JPO’s current examination guidelines, when a patentee files an application for PTE registration based on marketing approval of a new drug which shares the same Active Pharmaceutical Ingredient (API) and has the same efficacy/effect as a previously-approved drug, depending on given conditions, the application for PTE registration can be rejected. Decisions by the IPHC Grand Panel (IPHC Decisions Nos. 2013 (Gyo-Ke) 10195 to 10198) had denied the propriety of the JPO’s examination guidelines, by ruling that even if an application for PTE registration is based on a newly-approved drug which shares the same API and has the same efficacy/effect as a previously-approved drug, the PTE registration should be allowed, as long as the newly-approved drug differs from the previously-approved drug in any remaining element such as dose or regimen. The present SCJ decision has upheld such a ruling by the IPHC Grand Panel.

JPO’s response:
In response to the present SCJ decision, the JPO announced on November 18, 2015, that it would suspend examination of applications for PTE registration for the present, and begin to work on revising its examination guidelines. Publication of the revised guidelines is scheduled for the spring of 2016.
The JPO had its examination guidelines regarding applications for PTE registration previously denied in terms of propriety by the IPHC and the SCJ (IPHC Decisions Nos. 2008 (Gyo-Ke) 10458 to 10460; SCJ decisions Nos. 2011 (Gyo-Hi) 324 to 326), requiring the JPO to revise its examination guidelines in December 28, 2011. Accordingly, this is the second time the propriety of the JPO’s examination guidelines have been denied and required to be revised within only five years, which is a most unusual situation.

Scope of the extended patent right:
The IPHC Grand Panel also remarked in its original decisions, merely as an obiter dictum, that the scope of a patent right extended by PTE registration should be defined by the “ingredients (not limited to API)”, “efficacy/effect”, and “dose/regimen” of the drug on which the PTE registration is based. However, this remark was considered controversial, since it might possibly lead to an extremely narrow interpretation of the scope of a patent right. The present SCJ decision made no reference at all to this remark by the IPHC, leaving this matter undetermined. Since there has as yet been no court decision issued in Japan ruling on the scope of an extended patent right in an infringement case, we will have to wait for future court decisions on this matter.

 

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