2015 <Special News Flash 2>｜News Letter

Supreme Court Affirms Grand Panel’s Decision of IPHC which overturned Current JPO’s Examination Guidelines on Patent Term Extension (PTE)

Commissioner of JPO v. Genentech, Incorporated, Case No. 2014 (Gyo-Hi) 356 (Decision rendered on November 17, 2015)

The Supreme Court affirms a decision of the Grand Panel1) of the Intellectual Property High Court (IPHC) rendered in 2014 which related to the PTE on the basis of two (the prior and the subsequent) regulatory approvals for the same pharmaceutical products except for dosage/administration and overturned the current JPO’s Examination Guidelines2) showing that the working of patented invention shall be interpreted as the production and the distribution of the pharmaceutical product specified by the technical features defined in the claims of the patent.

Specifically, the Supreme Court rules that when two regulatory approvals were obtained, the comparison between the prior approval and the subsequent approval should be made in the examination matters for the approval directly relating to the substantial identity as a pharmaceutical product (not in the technical features defined in the claims of the patent), and if the production and distribution of the pharmaceutical product which is the subject of the prior approval includes that of the pharmaceutical product which is the subject of the subsequent approval, the PTE should not be allowed on the subsequent approval.

On the basis of the above ruling, the Supreme Court decides on this case that the examination matters correspond to ingredients, amount, dosage/administration and indication of the pharmaceutical product, and dosage/administration is different between the prior approval3) and the subsequent approval4), and thus the production and distribution of the pharmaceutical product which is the subject of the prior approval does not include that of the pharmaceutical product which is the subject of the subsequent approval.
Conclusively, the Supreme Court dismisses the JPO’s appeal, and upheld the conclusion of the IPHC decision.
The Supreme Court’s decision is made final and binding.

K&P’s CommentsAccording to the above Supreme Court’s decision, PTEs can be admitted very broadly or rather substantially on the basis of every approval. Therefore, we strongly recommend considering filing an application for PTE with respect to each approval.
Further, following the above Supreme Court’ decision, the current JPO’s Examination Guidelines on PTE will be revised soon.

1) Grand Panel: Grand Panel is convened to hear cases where it is necessary to virtually unify court decisions, or cases involving important issues, which is somewhat similar to en banc in CAFC of the U.S.A. Since the founding of the IPHC in 2005, 9 cases including the above case have been heard.
2) http://www.jpo.go.jp/tetuzuki_e/t_tokkyo_e/Guidelines/6.pdf
3) Prior regulatory approval is for bevacizumab (Avastin), an antibody used as an anti- colon or rectum cancer drug; said approval providing a dosage/administration of 7.5 mg/kg of bevacizumab to an adult in every 3 weeks or more.
4) Subsequent regulatory approval is for bevacizumab (Avastin), an antibody used as an anti- colon or rectum cancer drug; said approval providing a dosage/administration of 5 or 10 mg/kg of bevacizumab to an adult in every 2 weeks or more.