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IP AUSTRALIA

AUSTRALIAN PATENT OFFICE

Novartis AG [2012] APO 57

Patent Application: 2011201286

Title:F,G,H,I and K crystal forms of imatinib mesylate

Patent Applicant: Novartis AG

Delegate: E J Knock

Decision Date: 30 May 2012

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

Representation: Patent applicant: Keith Leslie, Davies Collison Cave, Melbourne

IP AUSTRALIA

AUSTRALIAN PATENT OFFICE

Patent Application: 2011201286

Title:F,G,H,I and K crystal forms of imatinib mesylate

Patent Applicant: Novartis AG

Date of Decision: 30 May 2012

DECISION

I refuse the application.

REASONS FOR DECISION

Patent application 2011201286 was filed by Novartis AG as a divisional of application 2006316823 on 22 March 2011. An examination report issued on 6 January 2012, raising two objections. In line with the Commissioner's approach to case management of divisionals, the report included the following note:

“Objections 1 and 2 of my report are based on the same grounds objected to in the examination of patent application 2006316823. 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 6 January 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

The Australian Patent Office dealt with a case concerning Patent Application 2011201286, filed by Novartis AG, which sought to patent specific crystal forms of imatinib mesylate. This application was a divisional of a previous application, 2006316823. The dispute arose when the Commissioner issued an examination report on 6 January 2012, raising two objections regarding the patentability of the claimed crystal forms. Novartis AG did not respond to the examination report, nor did they provide any submissions or amendments to address the objections raised by the Commissioner.

The key legal issues before the court were whether the objections raised in the examination report were valid and, given the applicant's inaction, whether there were reasonable prospects of overcoming these objections. The Commissioner was required to consider whether the application should be refused under section 49(2) of the Act due to the lack of response and the absence of any proposed amendments.

The Commissioner, E J Knock, reviewed the objections and noted that Novartis AG had not provided any submissions or amendments to address the objections raised in the examination report. Given the lack of response and the absence of any proposed amendments, the Commissioner concluded that there were no reasonable prospects of the applicant overcoming the objections. Consequently, the Commissioner decided to refuse the application, in line with the approach taken in managing divisional applications where no response is provided.

In conclusion, the Commissioner issued a written decision refusing the patent application on 30 May 2012. The Commissioner noted that the objections were appropriately raised and, given the applicant's failure to respond or propose amendments, the application should be refused. The final order was the refusal of Patent Application 2011201286.

Novartis AG

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