iCeutica Pty Ltd - [2018] APO 76

IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
iCeutica Pty Ltd [2018] APO 76

Patent Number: 2014208310

Title:A novel formulation of diclofenac

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 – a unit dose of diclofenac having a specified particle size – pharmaceutical substance per se identified – contained in the goods Zorvolex – application for extension of term accepted

Representation: Patent attorney for the applicant: Wrays

IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Patent Number: 2014208310

Title:A novel formulation of diclofenac

Patentee: iCeutica Pty Ltd
Date of Decision: 30 October 2018
DECISION
I accept the application for an extension of term.
For the purposes of section 74(2)(a) this decision constitutes notification in writing of the acceptance.
The acceptance will now be advertised in the Official Journal.
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 2014208310 in the name of iCeutica Pty Ltd was granted on 3 November 2016. On 26 April 2017 the patentee filed an application for an extension of term of the patent based on the goods Zorvolex. 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 of producing particles of diclofenac using dry milling processes as well as compositions comprising diclofenac, medicaments produced using diclofenac in particulate form and/or compositions, and to methods of treatment of an animal, including man, using a therapeutically effective amount of diclofenac administered by way of said medicaments."[1]
[1] The specification at page 1.
The specification describes a method of producing particles of a wide range of active substances. The particles are stated to be of a particle size equal to or less than 2000 nanometres. A nanometre (nm) is 10^-9metre. The specification asserts generally that small particles should be more soluble, and thus be more useful as pharmaceutical agents.
"It is known that the rate of dissolution of a particulate drug will increase with increasing surface area. One way of increasing surface area is decreasing particle size. Consequently, methods of making finely divided or sized drugs…

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 76
Case: [2018] APO 76
Decision Date: 30 October 2018

CaseChat Overview and Summary

iCeutica Pty Ltd applied for an extension of the term of Patent 2014208310, granted to it on 3 November 2016. The patent relates to a formulation of diclofenac, a pharmaceutical substance used as an anti-inflammatory and an analgesic. The application was objected to by an examiner on the basis that the pharmaceutical substance per se did not in substance fall within the scope of the claims. The hearing officer, Dr Barker, found in favour of the applicant and accepted the application for extension of term. The decision notes that the claims are directed to a specific amount of diclofenac, and a specific particle size. The hearing officer found that the pharmaceutical substance per se is in substance within the scope of the claims and that the goods Zorvolex contain or consist of the pharmaceutical substance. The Commissioner is required to accept an application for extension of term if she is satisfied that the requirements of sections 70 and 71 are satisfied in relation to the application. The Commissioner is satisfied on the balance of probabilities that the requirements of sections 70 and 71 have been met. The Commissioner must notify the applicant in writing of the acceptance. This decision constitutes notification of those reasons. A notice of acceptance will be published in the Official Journal.

Orders