Celgene Corporation - [2012] APO 71

IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Celgene Corporation [2012] APO 71

Patent Application: 2011101702

Title:A drug dispensing system

Patent Applicant:  Celgene Corporation
Delegate:  Dr S.D.Barker
Decision Date:  25 June 2012
Hearing Date:  Response to examiner objection received on 23 May 2012
Catchwords:  PATENTS – innovation patent – examiner objections – lack of novelty and innovative step for the same reason as for the parent patent – claims to a system and method of communicating are not a manner of manufacture – patent revoked

Representation: Patentee: Freehills Patent & Trade Mark Attorneys

IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Patent Application: 2011100687

Title:A drug dispensing system

Patent Applicant: Celgene Corporation
Date of Decision: 25 June 2012
DECISION
Claims 1, 2, 3 and 4 lack novelty in the light of the citation. Claims 1 to 5 lack innovative step in the light of the citation. Claims 1 to 5 are not directed to a manner of manufacture.
I revoke the patent.
REASONS FOR DECISION

Innovation patent 2011101702 (the patent) was filed by Celgene Corporation on 23 December 2011. The patent was sealed on 13 January 2012. The patent is a divisional application from innovation patent 2011100687 (the parent patent), which is a divisional application from innovation patent 2010101328 (the grandparent patent), which is itself a divisional application from innovation patent 2010100294 (the great-grandparent patent). Both the grandparent and great-grandparent patents ceased under section 143A due to failure to gain certification within the time prescribed by regulation 9A.4. The parent was the subject of a written decision ([2012] APO 12 dated 17 January 2012, hereafter referred to as my earlier decision) finding that grounds of revocation had been made out, and allowing the patentee an opportunity to amend. That decision has been appealed, and the matter is pending before the Federal Court.
The Commissioner issued an examination report on the patent on 16 April 2012. The patentee provided amendments, and asked that a formal decision be issued if the examiner was not persuaded to certify the patent. The patentee formally waived its right to be heard, and asked that an appealable decision be issued.
The patent
The patent is titled “A drug dispensing system”. The specification states that some pharmaceuticals 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 the patent is a system for carrying out certain checks prior to dispensing the drug. The invention as described is discussed at length in my earlier decision. The system as claimed is understood by considering claim 1 of the patent as proposed to be amended:
A system for dispensing a drug to a patient in need of the drug, so as to minimise or prevent the occurrence of an adverse side effect known or suspected of being caused by the drug, the system comprising:
means for receiving, from a remote pharmacy via a client application, an…

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 [2012] APO 71
Case: [2012] APO 71
Decision Date: 25 June 2012

CaseChat Overview and Summary

Celgene Corporation brought a patent application for a drug dispensing system to the Australian Patent Office, which was a divisional application from a series of patents that had been previously filed. The application was examined and objected to by the Commissioner on the grounds of lack of novelty, lack of innovative step, and failure to be directed to a manner of manufacture. The patentee responded to the objections but ultimately requested a formal and appealable decision. The court was tasked with determining whether the objections were valid and if the patent should be revoked.

The court examined the claims of the patent and found that they were not novel, did not involve an innovative step, and were not directed to a manner of manufacture. The claims were compared to a cited document, which disclosed the same system and method of operation, and it was found that the claims were anticipated by the citation. The court also found that the claims were not directed to a manner of manufacture, as they involved a system for checking risk factors rather than a physical process or product.

Based on the objections and the court's findings, the patent was revoked. The patentee had been given a reasonable opportunity to be heard and to amend the specification, but ultimately the court found that the objections were valid and the patent should be revoked. This decision can be appealed to the Federal Court.

In conclusion, the Australian Patent Office revoked the Celgene Corporation's patent for a drug dispensing system due to lack of novelty, lack of innovative step, and failure to be directed to a manner of manufacture. The decision can be appealed to the Federal Court.

Orders