Catchwords: PATENTS - section 223 – request for extension of time of 10 years and 4 months to file an application under section 70 (extension of term for a pharmaceutical substance) – error or omission – error identified immediately but decision not to apply for an extension of time for commercial reasons – extension application reflects changed commercial interests – discretionary factors considered –extension inconsistent with the purpose of section 223 and the intended operation of the extension of term scheme – extension refused.

Representation: Patentee: S Irani, patent attorney,
Spruson & Ferguson, Sydney

IP AUSTRALIA

AUSTRALIAN PATENT OFFICE

Patent No.:670300

Title:Benzoxazinones as inhibitors of HIV reverse transcriptase

Patentee: Merck Sharp & Dohme Corp.

Date of Decision: 21 February 2012

DECISION

I refuse the application for an extension of time under subsection 223(2)(a).

REASONS FOR DECISION

This matter concerns an application for an extension of time under subsection 223(2)(a). It is for the purpose of extending the period for filing an application for an extension of term provided for in subsection 71(2) and the period of extension sought is 10 years and 4 months. The question to be answered is whether, pursuant to subsection 223(6A), I should refuse the application. If I decide that is not appropriate, the consequence is that the application will be advertised pursuant to subsection 223(4) and any subsequent decision to refuse or allow the extension will be made in light of any opposition filed under subsection 223(6).

Background

Patent application 44496/93 was filed on 6 August 1993. It claims certain compounds said to be useful for the inhibition of HIV reverse transcription to treat or prevent HIV infection or AIDS. The application was accepted and the present patent subsequently granted by the Commissioner on 29 October 1996. It is in force and, subject to payments of renewal fees, will expire on 6 August 2013.

A compound disclosed in the patent specification and within the scope of the claims is 6-chloro-4-cyclopropylethynyl-4-trifluoromethyl-1,4-dihydro-2H-3,1-benzoxazin-2-one also known as Efavirenz. Efavirenz is the active ingredient in a pharmaceutical product known as Stocrin. This product in various forms is included in the Australian Register of Therapeutic Goods (ARTG) including both as a Registered Medicine and export listings. The earliest inclusions for the product have the ARTG commencement date of 9 April 1999.

Part 3 of Chapter 6 of the Patents Act 1990 provides for an extension of term for certain patents that disclose and claim one or more pharmaceutical substances per se and for which exploitation of the patent is delayed because of the requirements for regulatory approval. The term of the available term extension is provided by section 77 and is determined based on the “earliest first regulatory approval date”.…

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 Merck Sharp & Dohme Corp.

Details

AGLC: Merck Sharp & Dohme Corp. [2012] APO 25
Case: [2012] APO 25
Decision Date: 21 February 2012

CaseChat Overview and Summary

The case concerns an application by Merck Sharp & Dohme Corp. (Merck) for an extension of time to file an application for an extension of term for Australian Patent No. 670300, titled "Benzoxazinones as inhibitors of HIV reverse transcriptase." The patent is due to expire on 6 August 2013 but could be extended by 8 months 3 days if an application for an extension of term is made within the specified timeframe. The original deadline for filing such an application had passed on 9 October 1999, but Merck applied for an extension of time under section 223 of the Patents Act 1990 on 29 June 2010. The delegate of the Commissioner, P M Spann, refused the application and Merck sought a review of that decision.

The primary legal issue was whether the Commissioner should refuse Merck's application for an extension of time under section 223(2)(a) of the Patents Act 1990. The court considered whether an error or omission had occurred that prevented the original application for an extension of term being filed and whether, in the exercise of discretion, the application should be refused. The court also considered the implications of granting the extension on the interests of Merck, third parties, and the public.

The court found that there was indeed an error or omission that prevented the original application for an extension of term being filed by the due date. However, it was clear that Merck had made a conscious decision not to proceed with the application shortly after the due date and was now seeking to change its position over 10 years later. The court concluded that granting the extension of time would exempt Merck from the timeframes contained in the extension of term scheme, contrary to strong opposing interests. The court found that granting the extension would be inconsistent with the purpose of section 223 and the intended operation of the extension of term scheme. Accordingly, the Commissioner's discretion should not be exercised in favour of Merck, and the application for an extension of time was refused.

The final orders of the court were that the application for an extension of time under subsection 223(2)(a) of the Patents Act 1990 be refused.

Orders