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iCeutica Pty Ltd

iCeutica Pty Ltd

Case [2018] APO 78 30 October 2018

Patent Law

Pharmaceutical Patents

Dissolution Rate

Standard Patent

Extension of Term

Intellectual Property Law

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IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
iCeutica Pty Ltd [2018] APO 78

Patent Number: 2010239080

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 acid of specified particle size and dissolution rate – pharmaceutical substance per se identified – whether the goods Zorvolex have the specified dissolution rate – dissolution rate not established on the balance of probabilities – application for extension of term refused

Representation: Patent attorney for the applicant: Wrays

IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Patent Number: 2010239080

Title:A novel formulation of diclofenac

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 2010239080 in the name of iCeutica Pty Ltd (the patentee) was granted on 11 December 2014. 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] 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…

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 78
Case: [2018] APO 78
Decision Date: 30 October 2018

CaseChat Overview and Summary

The matter involved iCeutica Pty Ltd's application for an extension of term of a patent for a novel formulation of diclofenac. The hearing officer, Dr S.D. Barker, Deputy Commissioner of Patents, issued a written decision on 30 October 2018, refusing the application for an extension of term. The primary issue was whether the requirements of sections 70 and 71 of the Patents Act were met for the goods Zorvolex to be included in the Australian Register of Therapeutic Goods (ARTG) and to satisfy the dissolution rate specified in the patent claims.

The court examined whether the pharmaceutical substance per se was both disclosed and fell within the scope of the claims. It was determined that the pharmaceutical substance, a unit dose containing 18 mg or 35 mg of diclofenac acid, along with lactose monohydrate and sodium lauryl sulfate, met the criteria. However, the court found that the dissolution rate requirement, a critical feature of the claims, was not substantiated on the balance of probabilities. The patentee failed to provide sufficient evidence that Zorvolex had the specified dissolution rate, leaving the court unpersuaded that the requisite dissolution rate was achieved.

Consequently, the court concluded that the application for an extension of term did not meet the requirements of sections 70 and 71 of the Patents Act, leading to the refusal of the application. The decision also constituted notification in writing of the reasons for refusal as per section 74(4)(a) of the Patents Act.

Orders