Sanofi-Aventis - [2007] APO 35

ABSTRACT OF DECISIONS
DECISION OF A DELEGATE OF THE COMMISSIONER OF PATENTS
Application : No. 771902 in the name of Sanofi-Aventis (formerly Sanofi-Synthelabo)

Title: Controlled-Release Dosage forms Comprising Zolpidem or a Salt Thereof

Action: Request under s70 of the Patents Act for an extension of term and objections of the Commissioner thereto

Decision: Issued 2 October 2007.
Abstract

The patentee requested an extension of term of the patent on the basis of the inclusion of STILNOX CR^TMon the Australian Register of Therapeutic Goods. The patent relates to modified release formulations of the short acting hypnotic Zolpidem. The dosage units are formulated to result in a bi-phasic profile of dissolution. STILNOX CR^TM is a bi-layered tablet comprising an immediate release layer and a prolonged release layer.
The extension was originally refused as not meeting the provisions of s70(2)(a). It was contended that a bi-layered tablet consists of a controlled spatial configuration and therefore does not meet the requirements of being a mixture of pharmaceutical substances as espoused in LTS Lohmann Therapie-Systeme GmbH & Co KG [2002] APO 12.
It was found that STILNOX CR^TM is not a mixture in the Lohmann sense.
The extension was granted on the basis that STILNOX CR^TM is a compound of pharmaceutical substances and therefore fulfils the requirements of s70(2)(a).
PATENTS ACT 1990
DECISION OF A DELEGATE OF THE COMMISSIONER OF PATENTS
Re:Patent Application No. 771902 by Sanofi-Aventis, a request under s 70 of the Patents Act for an extension of term and objections of the Commissioner thereto.

BACKGROUND

This matter concerns a request by the patentee, Sanofi-Aventis (hereafter referred to as Sanofi), for an extension of term of patent number 771902 under section 70 of the Patents Act 1990. The patent relates to “Controlled-Release Dosage Forms Comprising Zolpidem or a Salt Thereof”. The application was filed on 1 December 1999 and sealed on 12 August 2004. Accordingly its 20 year term will expire on 1 December 2019. The application for extension was lodged on 13 December 2006, and if successful will extend the term of the patent until 6 July 2021.

The basis of the request for the extension of term is the inclusion in the Australian Register of Therapeutic Goods (ARTG) of STILNOX CR^TM (and STILNOXIUM CR^TM), both modified release Zolpidem tartrate tablets comprising either 6.25mg or 12.5mg bi-layered dosage units. ARTG commencement was on 6 July 2006. Following the filing of the application for extension, a delegate of the Commissioner reported that he considered the patent did not include any claim to a pharmaceutical substance per se. He also questioned whether there was any substance in the relevant goods listed in the ARTG that fell within the scope of the claims, and noted that the date of first inclusion of Zolpidem tartrate appeared to be 13 August 1997, precluding the present patent from an extension of term under s70. Despite further submissions and filing of a substitute extension 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: Sanofi-Aventis [2007] APO 35
Case: [2007] APO 35
Decision Date: 2 October 2007

CaseChat Overview and Summary

Sanofi-Aventis sought an extension of the term of their patent relating to controlled-release dosage forms comprising Zolpidem or a salt thereof. The application was filed on 1 December 1999 and sealed on 12 August 2004. The basis for the extension was the inclusion of STILNOX CRTM in the Australian Register of Therapeutic Goods (ARTG) on 6 July 2006. The Commissioner objected to the application, contending that STILNOX CRTM is not a pharmaceutical substance per se as required by s70(2)(a) of the Patents Act 1990. The Commissioner contended that the bi-layered tablet does not meet the requirements of being a mixture of pharmaceutical substances as espoused in LTS Lohmann Therapie-Systeme GmbH & Co KG. The applicant contended that STILNOX CRTM is a compound of pharmaceutical substances and therefore fulfils the requirements of s70(2)(a). The delegate of the Commissioner allowed the application on the basis that STILNOX CRTM is a compound of pharmaceutical substances.

The delegate of the Commissioner held that each layer of the tablet is comprised of a mixture of the active agent Zolpidem tartrate and appropriate excipients which confer the desired pharmacokinetic profile of the individual layer. The combination of the two layers, when taken as a whole defines a pharmaceutical substance or a mixture or compound of pharmaceutical substances. The delegate found that the term compound as used in the Act is to be read in the pharmaceutical sense, not the chemical sense. The delegate found that a bi-layered tablet formed by the combination or union of two layers falls within the meaning of compound. The delegate found that STILNOX CRTM is a compound of pharmaceutical substances within the meaning of the legislation. The delegate found that as a compound of pharmaceutical substances, STILNOX CRTM is a pharmaceutical substance per se. The requirements of section 70(2) have been fulfilled and the request to extend the term of patent 771902 was allowed.

Orders