Celgene Corporation - [2013] APO 14

IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Celgene Corporation [2013] APO 14

Patent:2012101491

Title:A method to monitor and authorise the distribution of a drug

Patentee:  Celgene Corporation
Delegate:  Dr S.D.Barker
Decision Date:  29 January 2013
Hearing Date:  15 November 2012, in Canberra
Catchwords:  PATENTS – examiner's objections – method of authorising distribution of thalidomide – novelty, innovative step and manner of manufacture considered – claims are novel as approval is generated at a different point in time – claims lack innovative step as the differences do not make a substantial contribution to the working of the invention – claims are not directed to a manner of manufacture – the mere writing of information to a computer file is not an artificial state of affairs – patent revoked

Representation: Patentee: David Shavin QC, assisted by Lisa Taliadoris of Jones Day

IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Patent:2012101491

Title:A method to monitor and authorise the distribution of a drug

Patentee: Celgene Corporation
Date of Decision: 29 January 2013
DECISION
Claims 1 – 5 lack innovative step.
Claims 1 – 5 are not directed to a manner of manufacture.
I revoke innovation patent 2012101491.
REASONS FOR DECISION

Innovation patent 2012101491 was filed by Celgene Corporation on 28 September 2012. The patent claims to be a divisional under the terms of section 79C. The parent is identified as 2011100687 (which was the subject of written decision [2012] APO 12 – hereafter referred to a as my first decision), which is a divisional of 2010101328 (ceased), which is a divisional of 2010100294 (ceased). There is also a related sibling patent 2011101702 (revoked following written decision [2012] APO 71 – hereafter referred to as my second decision).
The patentee appealed my first and second decisions (Federal Court matters VID 102/2012 and VID 501/2012). These matters progressed up to the point where the patentee's evidence was due. The patentee filed the present divisional innovation patent and discontinued the appeals.
The present innovation patent was sealed on 18 October 2012. Given the history of these patents, the Commissioner decided to immediately examine the present patent (pursuant to section 101A). The examination report issued on 22 October 2012, raising two objections: the application is not a manner of manufacture within the meaning of section 18(1A)(a), and the invention defined in all claims is not novel and lacks an innovative step. These grounds of objection have been raised many times in relation to the various parent and sibling patents, so a hearing was set immediately. The hearing was conducted in Canberra on 15 November 2012. The patentee was represented by David Shavin QC, assisted by Lisa Taliadoris of Jones Day.
1 The patent
The patent is titled “A method to monitor and authorise the distribution of a drug”. The specification states that some drugs with useful activity are known to have adverse side effects in some members of the population. Thalidomide is known to cause birth defects, but also has useful activity in the treatment of erythema nodosum leprosum (ENL). The essence of…

Grounds of appeal

[14] The appellant contends that the primary judge erred in finding that the respondent had discharged the onus of establishing the matters required under the relevant provision.

[15] It was submitted that his Honour failed to give adequate weight to the evidence of the second witness, and that the findings of fact were not reasonably open on the material before the Court.

[16] The respondent, for its part, submits that no error is disclosed, and that the conclusions reached were well within the range of outcomes available to the primary judge.

Consideration

[17] It is convenient to deal first with the question of construction, as the resolution of that issue informs the remaining grounds advanced by the appellant.

[18] For the reasons that follow, we are of the view that the appeal should be allowed in part and the matter remitted for further determination.

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Details

AGLC: Celgene Corporation [2013] APO 14
Case: [2013] APO 14
Decision Date: 29 January 2013

CaseChat Overview and Summary

Celgene Corporation, the patentee, sought certification of an innovation patent that claimed a method to monitor and authorise the distribution of a drug. The claims were objected to on the basis that they lacked novelty, innovative step and were not a manner of manufacture. The Delegate of the Commissioner of Patents revoked the patent. The patentee had been given numerous opportunities to amend the claims, but had not done so. The patentee had appealed previous decisions, but had discontinued those appeals when it filed the present patent. The patentee had ample opportunity to draft the claims to avoid the objections, and had not done so. The patent was revoked. The patentee could appeal the decision to the Federal Court. If the claims had encompassed both manual and automated risk assessment, there would have been a lack of fair basis and a lack of full description.

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