Euro-Celtique, S.A. - [2007] APO 13

ABSTRACTS OF DECISIONS

DECISION OF A DELEGATE OF THE COMMISSIONER OF PATENTS

Application : Patent No. 774779 in the name of Euro-Celtique, S.A.

Title:          Method of providing sustained analgesia with buprenorphine
Action  :Request under s 70 of the Patents Act for an extension of term and objections of the Commissioner thereto
Decision:          Issued 26 March 2007.

Abstract

The patent relates to a sustained-release formulation of buprenorphine, a known opioid analgesic used in the relief of moderate to severe pain. The patentee requested an extension of term of the patent based on the inclusion of NORSPAN^TM, a transdermal delivery system comprising buprenorphine, on the Australian Register of Therapeutic Goods.

Claims 22 to 59 are directed towards “A pharmaceutical formulation…in a transdermal delivery system…”. Though the claims did not define an arrangement characterised by features of spatial configuration as in LTS Lohmann Therapie-Systeme GmbH & Co KG [2002] APO 12, a transdermal system, by its very nature, suggests the presence of a backing layer or patch upon which the mixture of chemical entities is applied. It was found that the use of the phrase “transdermal delivery system”, in the context of the patent, does represent a separate physical integer unrelated to the mixture of chemical entities.

It was found that a pharmaceutical substance per se does not in substance fall within the scope of the claim or claims of the specification. As a result, the section 70 application for extension of term of patent 774779 was refused for failing to comply with section 70(2)(a).

PATENTS ACT 1990

DECISION OF A DELEGATE OF THE COMMISSIONER OF PATENTS

Re: Patent No. 774779 in the name of Euro-Celtique, S.A., 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 for an extension of the term of patent no. 774779 in the name of Euro-Celtique, S.A. The patent relates to a "Method of providing sustained analgesia with buprenorphine". The patent is a divisional of 61841/98 (743071) and has a filing date of 24 February 1998. Accordingly its 20-year term will expire on 24 February 2018. An application for extension of term of the patent was lodged on 9 November 2005, and if an extension of the term of the patent is granted, the term would be extended to 9 May 2020.

The basis for the request for an extension of term was the inclusion in the Australian Register of Therapeutic Goods (ARTG) of NORSPAN^TM, a buprenorphine transdermal drug delivery system which was subject to an ARTG registration commencing on 9 May 2005. Following the filing of the request, a delegate of the Commissioner reported that he considered the patent did not include any claim to a pharmaceutical substance per se, and questioned whether there was any substance in the relevant Goods listed on the ARTG that fell within the scope of the claims. Following further information and submissions, the delegate maintained his…

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: Euro-Celtique, S.A. [2007] APO 13
Case: [2007] APO 13
Decision Date: 26 March 2007

CaseChat Overview and Summary

Euro-Celtique, S.A. sought an extension of the term of its patent No. 774779, which pertains to a method of providing sustained analgesia using buprenorphine. The patent, which expires on 24 February 2018, was filed as a divisional of 61841/98 (743071) on 24 February 1998. The request for an extension of the term was based on the inclusion of NORSPANTM, a buprenorphine transdermal drug delivery system, on the Australian Register of Therapeutic Goods (ARTG) as of 9 May 2005. The Commissioner of Patents objected to the extension on the grounds that the patent did not claim a pharmaceutical substance per se as required by s 70(2)(a) of the Patents Act 1990.

The legal issue before the court was whether the claims in the patent for a pharmaceutical formulation of buprenorphine in a transdermal delivery system constituted a claim to a pharmaceutical substance per se, as required by s 70(2)(a) of the Patents Act. The court had to determine if the claims met the criteria set forth in the statute, which mandates that at least one pharmaceutical substance per se must be disclosed in the complete specification of the patent and fall within the scope of the claims of the patent.

In its reasoning, the court found that the claims did not meet the requirements of s 70(2)(a) of the Patents Act. The court distinguished the claims in this case from those in LTS Lohmann Therapie-Systeme GmbH & Co KG, where the claims were characterized by features of spatial configuration. The court held that the reference to a "transdermal delivery system" in the claims of this patent represented a separate physical integer, and therefore, the claims were not to a pharmaceutical substance per se. The court further noted that the claims included limitations on commercial packaging aspects, which were not typical of a claim to a pharmaceutical substance per se. Additionally, the court found that NORSPANTM, the subject of the ARTG listing, was not disclosed as a pharmaceutical substance per se in the complete specification of the patent.

Based on the findings, the court refused the request to extend the term of patent 774779. The court concluded that the specification did not include any claim where a pharmaceutical substance per se was in substance within the scope of the claim or claims of the specification. Therefore, the requirements of s 70(2)(a) of the Patents Act could not be met.

This decision underscores the importance of ensuring that the claims in a patent specification align with the statutory requirements for an extension of term under the Patents Act. The court's analysis highlighted the need for claims to clearly define a pharmaceutical substance per se, free from additional limitations that might detract from the core inventive concept.

Orders