Alexion Pharmaceuticals, Inc.

IP AUSTRALIA

AUSTRALIAN PATENT OFFICE

Alexion Pharmaceuticals, Inc. [2011] APO 59

Patent Application: 2009222630

Title:Method of treatment of asthma using antibodies to complement component C5

Patent Applicant: Alexion Pharmaceuticals, Inc.

Delegate: E J Knock

Decision Date: 11 August 2011

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

Representation: Patent applicant: James Cherry, Freehills Patent & TradeMark Attorneys, Melbourne

IP AUSTRALIA

AUSTRALIAN PATENT OFFICE

Patent Application: 2009222630

Title:Method of treatment of asthma using antibodies to complement component C5

Patent Applicant: Alexion Pharmaceuticals, Inc.

Date of Decision: 11 August 2011

DECISION

I refuse the application.

REASONS FOR DECISION

Patent application 2009222630 was filed by Alexion Pharmaceuticals, Inc. as a divisional of application 2003270330 on 08 October 2009. An examination report issued on 29 March 2011, raising eleven objections. In line with the Commissioner's approach to case management of divisionals, the report included the following note:

“Objection(s) 1 – 10 of my report are based on the same grounds objected to in the examination of patent application 2003270330. 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 you intend 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 above."

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

"The examination report of 29 March 2011 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

Alexion Pharmaceuticals, Inc. applied for a patent for a method of treating asthma using antibodies to complement component C5. The application was a divisional of an earlier application, which had been objected to by an examiner. The applicant failed to respond to the objections, leading to the current decision by the Australian Patent Office. The Commissioner of Patents issued a decision refusing the patent application on 11 August 2011.

The primary legal issue before the court was whether the objections raised against the patent application were valid and if there were reasonable prospects of the applicant overcoming them. The applicant had the opportunity to respond to the objections but chose not to do so. The Commissioner of Patents had to decide if the application should be refused or if there were grounds for amendment or further hearing.

The Commissioner found that the objections were appropriately raised and that the applicant had not provided any submissions or proposed amendments to overcome the objections. The Commissioner concluded that there were no reasonable prospects of the applicant overcoming the objections and, therefore, the application should be refused. The Commissioner noted that the applicant had one month to file submissions but did not, leading to the decision to refuse the application.

The final order of the court was that the patent application 2009222630 be refused. The Commissioner emphasised that the decision was based on the applicant's failure to respond to the objections and provide any submissions or proposed amendments. The refusal of the application means that Alexion Pharmaceuticals, Inc. cannot patent the method of treating asthma using antibodies to complement component C5 as described in the application.

CaseChat Overview and Summary

Orders of the court

Background to the litigation

Evidence Before The Court

Reasons for decision

Legal Principle Established