Alphapharm Pty Ltd v H Lundbeck A/S - [2011] APO 36

IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Aphapharm Pty Limted & Ors v H.Lundbeck A/S [2011] APO 36

Patent:623144

Title:(+)-enantiomer of citalopram and process for the preparation thereof

Patentee: H.Lundbeck A/S
Opponents:Alphapharm Pty Ltd, Sigma Pharmaceuticals (Australia) Pty Limited, Apotex Pty Ltd and Sandoz Pty Ltd

Delegate:  Karen Ayers
Decision Date:  1 June 2011
Hearing Date:  2 March 2011
Catchwords:  PATENTS – request under section 223 – request for extension of time to file section 70 (extension of term for a pharmaceutical substance) – misunderstanding and uncertainty in the law meant that original extension was for wrong substance – original extension was revoked by court order because of failure to meet timing requirements of section 71 – second extension of term application based on correct substance filed together with a request under section 223 for an extension of time under 223 – Regulation 22.11(4)(b) does not exclude section 70 applications from section 223 provided these are filed within the term of the patent as required by section 71(2) – causative error established to enliven section 223 – opponents would be disadvantaged by the extension but they took the risk of entering the market early despite knowing the patentee’s intention to extend the patent – balance of public interest favours the extension– while there will be a short term increase in the cost of the patented drugs, this is more than offset by the broader public interest of encouraging research and development in the pharmaceutical field– extension therefore granted –costs awarded
Representation:  Representatives for H.Lundbeck A/S: Corrs Chambers Westgarth, Melbourne
Representatives for Alphapharm Pty Ltd: Mallesons Stephen Jaques, Sydney
Representatives for Sigma Pharmaceuticals (Australia) Pty Ltd: Blake Dawson, Sydney
Representatives for Apotex Pty Ltd: Freehills, Melbourne
Representatives for Sandoz Pty Ltd: Griffith Hack, Melbourne

IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Patent:623144

Title:(+)-enantiomer of citalopram and process for the preparation thereof

Patentee: H.Lundbeck A/S
Date of Decision: 1 June 2011
DECISION
I grant an extension of time under section 223 to 12 June 2009 for the patentee to file an application under section 70 for an extension of term for a pharmaceutical substance based on the marketing approval of CIPRAMIL.
Subject to any appeal or review, the Commissioner will proceed to process the section 70 extension of term. If the Commissioner is advised of an appeal or review within 30 days, she will defer consideration of the extension of term until after that action is finally disposed of.
I award costs against the opponents.
REASONS FOR DECISION
Background

Patent number 623144 was filed 13 June 1989 by H. Lundbeck A/S (‘Lundbeck’) as a convention application based on UK application 8814057 filed on 14 June 1988. The Australian application was accepted on 24 February 1992 and sealed on 31 August 1992 without opposition. The original 20 year term of the patent expired on 13 June 2009.

The patent discloses and claims the (+)-enantiomer of citalopram. Citalopram is a compound belonging to the therapeutic category of selective serotonin re-uptake inhibitors (SSRIs) which are used to treat…

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

Case: [2011] APO 36
Decision Date: 1 June 2011

CaseChat Overview and Summary

Alphapharm Pty Ltd and others challenged the validity of an extension of term for a patent held by H Lundbeck A/S (Lundbeck). Lundbeck had initially filed a section 70 extension of term application for the patent based on a pharmaceutical substance which was not the first inclusion on the Australian Register of Therapeutic Goods (ARTG). Lundbeck then filed a second section 70 extension of term application together with an extension of time under section 223. The opponents argued that section 223 was not available to remedy the failure to file an application under section 70. They further argued that there were a number of discretionary issues which weighed heavily against an extension of time being granted under section 223. The court found that the regulation which excluded section 70 applications from section 223 did not exclude all such applications. Rather, it only excluded those filed outside the term of the patent. In the current case, the section 70 application was filed one day before the original term of the patent had expired and therefore section 223 was potentially available as a remedy to extend the time set out in section 71(2)(c) provided the requirements of section 223 were fulfilled. The court accepted that Lundbeck genuinely believed on 26 July 1999 that a section 70 extension of term application could not be based on the racemate, CIPRAMIL. The patentee’s misunderstanding of the law clearly caused them to decide not to file an extension of term application based on CIPRAMIL. The court found that the opponents would be disadvantaged by granting an extension of time under section 223, but this was because of their commercial decisions rather than any delays by the patentee. The court found that the public interest weighed in granting the extension. The court granted the section 223 extension of time to file the extension of term application. Costs were awarded against the opponents.

Orders