Alnylam Pharmaceuticals, Inc. Summary

IP AUSTRALIA

AUSTRALIAN PATENT OFFICE

Alnylam Pharmaceuticals, Inc. [2012] APO 66

Patent Application: 2010201515

Title:Double-stranded RNA structures and constructs, and methods for generating and using the same

Patent Applicant: Alnylam Pharmaceuticals, Inc.

Delegate: E J Knock

Decision Date: 19 June 2012

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

Representation: Patent applicant: Vaughan Barlow, Pizzeys, Canberra

IP AUSTRALIA

AUSTRALIAN PATENT OFFICE

Patent Application: 2010201515

Title:Nucleic acid and corresponding protein entitled 98P4B6 useful in treatment and detection of cancer

Patent Applicant: Alnylam Pharmaceuticals, Inc.

Date of Decision: 19 June 2012

DECISION

I refuse the application.

REASONS FOR DECISION

Patent application 2010201515 was filed by Alnylam Pharmaceuticals, Inc. as a divisional of application 2003284323 on 16 April 2010. An examination report issued on 18 January 2012, raising one objection. In line with the Commissioner's approach to case management of divisionals, the report included the following note:

“Objection 1 of my report are[sic] based on the same grounds objected to in the examination of patent applications 2003284323. 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 18 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

Alnylam Pharmaceuticals, Inc. sought to patent certain double-stranded RNA structures and constructs, along with methods for generating and using the same. The patent application 2010201515 was a divisional application of the earlier application 2003284323. The Commissioner of Patents issued an examination report on 18 January 2012, raising objections to the application. Alnylam Pharmaceuticals, Inc. did not respond to the objections or submit any amendments within the stipulated two-month period. Consequently, the Commissioner issued a hearing notice, allowing one month for written submissions to address the objections. However, Alnylam Pharmaceuticals, Inc. did not provide any submissions, leading to the refusal of the patent application.

The primary legal issue before the court was whether the patent application should be refused due to the applicant's failure to respond to the objections raised by the Commissioner of Patents. The court had to consider the Commissioner's approach to the case management of divisional applications and whether there were reasonable prospects of the applicant overcoming the objections. Given that Alnylam Pharmaceuticals, Inc. did not provide any submissions or amendments to address the objections, the court found that there were no reasonable prospects of the applicant overcoming the objections.

The court, represented by the Delegate E J Knock, reviewed the examiner's report and agreed that the objections were appropriately raised. The applicant's decision not to defend the application, coupled with the absence of submissions and proposed amendments, led the court to conclude that the application should be refused. The court noted that the Commissioner could either refuse the application or direct amendment but, in this case, the applicant's inaction warranted the refusal of the application.

In conclusion, the court upheld the Commissioner's decision to refuse the patent application 2010201515. The court found that the objections raised by the Commissioner were valid and that the applicant's failure to respond or propose amendments led to a lack of reasonable prospects of overcoming the objections. As a result, the patent application was refused.

Alnylam Pharmaceuticals, Inc.

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