December, 2014｜News Letter

1. How Should Motivation in Determining Inventive Step of Invention Relating to Drug Regimen be Considered?Novartis AG v. Commissioner of JPO, Case No. 2014 (Gyo-Ke) 10045 (Decision rendered on December 24, 2014)

The Applicant, Novartis, filed a patent application relating to a drug regimen in 2001, but the application was finally rejected on the grounds of lacking inventive step by the Appeal Board of the JPO in 2013. Against the JPO's decision, Novartis filed a cancellation action before the IPHC in 2014.

Claim 1 of the patent application at issue claims as follows:
A treatment agent comprising 2-(imidazol-1yl)-1-hydroxyethane-1,1-diphosphonic acid (zoledronic acid) or a pharmaceutically acceptable salt thereof as an active ingredient, characterized by intravenously administering 4 mg of zoledronic acid over a period of 15 minutes to a patient in need of bisphosphonate treatment.

The main issue in this case lied in how the motivation in examining the inventive step of the invention relating to a drug regimen should be specifically considered. The IPHC answered to the issue as follows:

First, having reviewed prior art references (p.a.r.) 1 and 2, the IPHC found that, according to the phases I and II clinical trials disclosed in p.a.r. 1 and 2, it could be understood (i) that 4 mg of zoledronic acid showed a drug efficacy comparable to that of 90 mg of pamidronic acid, which had been conventionally used, and that (ii) the safety could be ensured by an intravenous administration for 5 minutes.  The IPHC further found that p.a.r. 3 showed that it had been known that rapid administration of first-generation bisphosphonate could have damaged the kidney.
On the basis of the above findings, the IPHC concluded (i) that it was quite difficult to find out the motivation for further extending the time of administration of 5 minutes, since no results posing a question to safety were confirmed in the phases I and II clinical trials, even though there was generally a possibility that contrary results regarding safety to the kidney were found, and that the change of dosage and administration were required in the phase III clinical trial, and (ii) that the knowledge disclosed in p.a.r. 3 was just based on the first-generation bisphosphate, and was not directly applicable to zoledronic acid, which was third-generation bisphosphonate.

Conclusively, the IPHC upheld the Novartis's appeal, and cancelled the JPO's decision.

An appeal to the Supreme Court was NOT filed against this decision, and thus the decision is final and binding.

K&P’s CommentsUnder the Examination Guidelines for Patent and Utility Model in Japan, the inventions directed to a drug regimen have been acknowledged as a patentable subject matter since 2009. This decision provides a specific guideline for determining inventive step of such a new subject matter.

In December 2014, the IPHC handed down 22 decisions including the above case on patent and utility model, and overturned previous decisions in 8 cases.

Additionally, we have now confirmed that the appeal to the Supreme Court against the decision on Case No. 2012 (Ne) 10015 (Sangenic International Ltd. v. Aprica Children's Products Inc.), which we introduced in the K&P's IPHC Decision Report in March 2013 was dismissed on November 18, 2014.

In December 2014, the IPHC handed down No decision on trademark.