Re: G.D.Searle LLC - [2008] APO 31

ABSTRACTS OF DECISIONS
DECISION OF A DELEGATE OF THE COMMISSIONER OF PATENTS
Application : No. 680635 in the name of G.D.Searle LLC

Title: Hydroxyethylamino sulfonamides useful as retroviral protease inhibitors

Action: Request for an extension of term under section 70

Decision: Issued 05 December 2008
Abstract

The patentee applied for an extension of term based on the substance darunavir. Another substance (known as amprenavir) within the scope of the claims had an earlier inclusion in the Australian Register of Therapeutic Goods (ARTG).

An application for extension of term must be made within six months of “the date of commencement of the first inclusion in the Australian Register of Therapeutic Goods of goods that contain, or consist or, any of the pharmaceutical substances referred to in subsection 70(3)”. This provision was found to mean that an application for extension of term is to be made within six months of the earliest first inclusion in the ARTG.
The patentee is not obligated to search the ARTG for all possible pharmaceutical substances covered by their patent, and all possible first regulatory approvals. Patentees can rely on the regulatory approvals that they are aware of. However, once they become aware that there is an earlier first regulatory approval, they have no option but to amend their application, and if necessary make a request under section 223.
Equally, the Commissioner is not required to carry out a search, and will record the extension on the basis of the information provided to her. However, the Commissioner is not prevented from undertaking her own investigation, and if she becomes aware of an earlier inclusion she has no option but to bring that to the patentee’s attention so that the application for extension of term is correctly made.
Since the application was not made within six months of the date of the earliest first inclusion in the ARTG, the application is refused.
It was noted that regulation 10.7(7) operates when the full facts were not known to the patentee at the time of granting the extension of term.
PATENTS ACT 1990
DECISION OF A DELEGATE OF THE COMMISSIONER OF PATENTS
Re:Patent Application No. 680635 by G.D.Searle LLC and a request for an extension of term under section 70

BACKGROUND

Patent number 680635 in the name of G.D.Searle LLC was sealed on 27 November 1997. The normal 20 year term of the patent will expire on 24 August 2013. On 29 August 2007, the patentee filed an application for an extension of term of the patent under section 70 of the Patents Act 1990. The extension is based on the substance darunavir. During examination of the application, a Senior Examiner reported that there was another substance (known as amprenavir) within the scope of the claims that had an earlier inclusion in the Australian Register of Therapeutic Goods (ARTG), and as a consequence the application for an extension of term was not made within six months of the commencement of the first inclusion in the ARTG…

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.

Continue reading Re: G.D.Searle LLC

Details

AGLC: Re: G.D.Searle LLC [2008] APO 31
Case: [2008] APO 31
Decision Date: 5 December 2008

CaseChat Overview and Summary

The case involves G.D. Searle LLC, which sought an extension of term for its patent number 680635 under section 70 of the Patents Act 1990, based on the substance darunavir. The dispute revolves around the timing of the application for the extension of term in relation to the inclusion of relevant pharmaceutical substances in the Australian Register of Therapeutic Goods (ARTG). The primary legal issue was determining the correct interpretation of subsection 71(2) of the Patents Act, specifically whether an application for an extension of term should be made within six months of the first inclusion in the ARTG of any relevant pharmaceutical substance or within six months of the earliest inclusion.

The court examined the statutory language, extrinsic materials, and the purpose of the extension of term provisions to resolve the ambiguity. It concluded that the intention of the Act was for an application to be made within six months of the earliest first inclusion in the ARTG. The court emphasized the importance of the earliest first regulatory approval date and the limited window provided for making an application. It also noted that the patentee is not obligated to search the ARTG for all possible pharmaceutical substances but must amend the application if aware of an earlier inclusion. The Commissioner, while relying on the information provided, can independently investigate and must correct any inaccuracies.

Based on this reasoning, the court found that the application for extension of term was not made within the required six months of the earliest first inclusion in the ARTG. Therefore, the application was refused. The decision allows the patentee to make a new application based on the earlier inclusion, accompanied by an application for an extension of time under section 223.

Orders