Novo Nordisk A/S Summary

IP AUSTRALIA

AUSTRALIAN PATENT OFFICE

Novo Nordisk A/S [2012] APO 111

Patent Application: 2011232797

Title:Heteroaryl-ureas and their use as glucokinase activators

Patent Applicant: Novo Nordisk A/S

Delegate: E J Knock

Decision Date: 4 October 2012

Catchwords: PATENTS – examiner objection – case management of divisional applications – no response by applicant – application refused

Representation: Patent applicant: Grant Shoebridge, Shelson IP, Sydney

IP AUSTRALIA

AUSTRALIAN PATENT OFFICE

Patent Application: 2011232797

Title:Heteroaryl-ureas and their use as glucokinase activators

Patent Applicant: Novo Nordisk A/S

Date of Decision: 4 October 2012

DECISION

I refuse the application.

REASONS FOR DECISION

Patent application 2011232797 was filed by Novo Nordisk A/S as a divisional of application 2005203930 on 8 October 2011. An examination report issued on 17 May 2012, raising two objections. In line with the Commissioner's approach to case management of divisionals, the report included the following objection:

“Objection 2 of my report is based on the same grounds objected to in the examination of patent application 2005230930. Please note that if a response overcoming this objection is not filed within two months of the date of this report the Commissioner will consider whether to direct amendment of the application under section 107 or proceed to refuse the application under section 49(2) of the Act. If intending to proceed under either of these provisions the Commissioner will notify you in writing and indicate the time and place you may be heard on the matter. In deciding the matter the Commissioner will consider all possible grounds of objection to the application not only those identified below.

As no reply was received, the Commissioner issued a hearing notice in the following terms:

"The examination report of 17 May 2012 raised an objection(s) equivalent to that in the parent application. In line with our approach to case management of divisionals, you were given two months to respond to that report. As no response has been received, the matter will now be set for hearing.
I believe that it is possible to hear this matter on the basis of written submissions, so I allow you one (1) month from the date of this letter to file any submissions you wish. Your submissions should address the ground(s) of objection identified in the examination report. Once your submissions have been received, or alternatively if no submissions are received, the matter will be passed to a hearing officer to issue a written decision. Please note that it is possible for the Commissioner to refuse the application or direct amendment.
Alternatively, if you file amendments overcoming the objection(s) within this period, the Commissioner will not proceed with the hearing. However, if the amendments do not fully overcome the objection(s), you will be advised of this fact and the hearing may continue as above."

The applicant has not provided any submissions.

The objection

I have reviewed the examiner's report, and I agree that there are appropriately raised objections. The applicant has chosen not to defend the application. They have provided no submissions disputing the objections, and have not proposed any amendment to attempt to overcome the objections. In these circumstances there are no reasonable prospects of the applicant overcoming the objections. The application should be refused.

E J Knock
Delegate of the Commissioner of Patents

Novo Nordisk A/S filed a patent application for a pharmaceutical product, "Heteroaryl-ureas and their use as glucokinase activators," as a divisional application of an earlier application. An examination report raised objections to the patent application, and after the applicant failed to respond within the required two months, a hearing notice was issued. The applicant did not provide any submissions or proposed amendments to overcome the objections. The Delegate of the Commissioner of Patents considered the objections and concluded that there were no reasonable prospects of the applicant overcoming them.

The primary legal issue before the Delegate was whether the patent application should be refused due to the applicant's failure to respond to the objections raised in the examination report and the hearing notice. The Delegate examined the examiner's report and agreed with the raised objections, noting that the applicant did not dispute the objections and did not propose any amendments. The Delegate concluded that, in these circumstances, there were no reasonable prospects of the applicant overcoming the objections.

In deciding to refuse the patent application, the Delegate considered the Commissioner's approach to case management of divisional applications, which allows for the application to be refused or directed for amendment if no response is received within the required timeframe. The Delegate also noted the applicant's failure to provide any submissions or proposed amendments to overcome the objections. The Delegate concluded that, given the applicant's lack of response and proposed amendments, there were no reasonable prospects of the applicant overcoming the objections.

The final order of the Delegate was to refuse the patent application. The applicant was given the opportunity to provide submissions or proposed amendments within the specified timeframe, but failed to do so. As a result, the application was refused, and there were no reasonable prospects of the applicant overcoming the objections raised in the examination report and hearing notice.

Novo Nordisk A/S

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