iCeutica Pty Ltd - [2018] APO 77

IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
iCeutica Pty Ltd [2018] APO 77

Patent Number: 2013273795

Title:Method for the Preparation of Biologically Active Compounds in Nanoparticle Form

Patentee:  iCeutica Pty Ltd
Hearing Officer:  Dr S.D. Barker – Deputy Commissioner of Patents
Decision Date:  30 October 2018
Hearing Date:  Written submissions filed on 3 September 2018; on 27 September 2018 the patentee advised that they did not wish to be heard in person

Catchwords: PATENTS – application for an extension of term – examiner objection – nanoparticles of diclofenac – pharmaceutical substance per se identified – contained in the goods Zorvolex – nanoparticles of fenofibrate contained in the goods Lipidil – Lipidil is an earlier first inclusion in the ARTG – application not made within 6 months of the date of first inclusion of Lipidil – application for extension of term refused

Representation: Patent attorney for the applicant: Wrays

IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Patent Number: 2013273795

Title:Method for the Preparation of Biologically Active Compounds in Nanoparticle Form

Patentee: iCeutica Pty Ltd
Date of Decision: 30 October 2018
DECISION
I refuse the application for an extension of term.
For the purposes of section 74(4)(a) this decision constitutes notification in writing of the reasons for refusal.
For the purposes of section 224(2) this decision constitutes written notice of the making of a decision and, subject to the Administrative Appeals Tribunal Act 1975, that the patentee or a person whose interests are affected by this decision may make an application to the Administrative Appeals Tribunal for review of this decision.
REASONS FOR DECISION

The present decision relates to one of three applications for an extension of term filed by iCeutica Pty Ltd on 26 April 2017. In each case the extension is based on the goods Zorvolex.
Patent number 2013273795 in the name of iCeutica Pty Ltd was granted on 8 September 2016. On 26 April 2017 the patentee filed an application for an extension of term of the patent based on the goods Zorvolex diclofenac. Several deficiency notices were issued, and on 2 August 2018 a Senior Examiner issued an intention to refuse the extension of term. The patentee requested a hearing, provided written submissions and asked for a decision to be issued based on those submissions.
Background
The patent relates to the substance known as diclofenac, which is used as an anti-inflammatory and an analgesic. The name diclofenac derives from its chemical name: 2-(2,6-dichloroanilino)phenylacetic acid. The structural formula of diclofenac is:
The patent commences with the following statement of the field of the invention:
"The present invention relates to methods for the preparation of biologically active compounds in nanoparticulate form. The invention also relates to biologically active compounds in nanoparticulate form produced by said methods, to compositions comprising such compounds, to medicaments produced using said biologically active compounds in nanoparticulate form and/or compositions, and to methods of treatment of an animal, including man, using a therapeutically effective amount of said biologically active compounds administered…

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: iCeutica Pty Ltd [2018] APO 77
Case: [2018] APO 77
Decision Date: 30 October 2018

CaseChat Overview and Summary

iCeutica Pty Ltd filed an application for an extension of term for patent number 2013273795. The patent relates to a method for the preparation of biologically active compounds in nanoparticle form. The application was refused by the Australian Patent Office. The basis for refusal was that the application for an extension of term was not made within 6 months of the date of the first inclusion in the Australian Register of Therapeutic Goods of goods that contain, or consist of, a pharmaceutical substance. The substance in question was diclofenac. The goods that contain diclofenac, referred to as Zorvolex, were not the first inclusion in the ARTG of goods that contain diclofenac. That distinction belonged to a product referred to as Lipidil. The application for an extension of term was not made within 6 months of the date of the first inclusion in the ARTG of Lipidil. The decision was made pursuant to section 74(3) of the Patents Act 1990. Pursuant to section 74(4)(a), the applicant has been notified in writing of the reasons for the refusal.

Orders