Alphapharm Pty Ltd v H Lundbeck A/S - [2006] APO 18

ABSTRACTS OF DECISIONS
DECISION OF A DELEGATE OF THE COMMISSIONER OF PATENTS
Application : No. 623144 in the name of H.Lundbeck A/S

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

Action: Request to amend the Register under reg 10.7(1) by Alphapharm Pty Ltd; and an amendment of the Register under reg 10.7(7)

Decision: Issued 19 May 2006.
Abstract

Regulation 10.7(7): The Merck decision has taken a broad construction of what it means for goods to “contain” a substance. It is not necessary for the substance contained in the goods to be the substance that gives the goods their pharmaceutical activity. It follows that escitalopram is contained in citalopram, and the Commissioner must amend the Register under reg 10.7(7) to insert the correct extension of the term of the patent, i.e. 9 December 2012.
Merck & Co Inc v Arrow Pharmaceuticals Ltd [2003] FCA 1344; 59 IPR 226 followed.
Regulation 10.7(1): It is possible to invoke reg 10.7(1) to correct mistakes that appear on the Register as a direct result of an obvious mistake elsewhere.
Behringwerke Aktiengesellschaft’s Application (1986) 7 IPR 59 applied.
In the present case it is necessary to consider the specification, and the entries in the ARTG, in the light of the Act and decisions of the Federal Court, in order to appreciate that an error exists. The depth of consideration that is necessary is antithetical to the notion of the mistake being obvious. Obvious mistake was not established.
PATENTS ACT 1990
DECISION OF A DELEGATE OF THE COMMISSIONER OF PATENTS
Re:Patent Application No. 623144 by H.Lundbeck A/S and a request to amend the Register under reg 10.7(1) by Alphapharm Pty Ltd, and an amendment of the Register under reg 10.7(7)

BACKGROUND

Patent number 623144 (‘the patent’) is recorded in the name of H.Lundbeck A/S (‘Lundbeck’). The term of the patent has been extended under s 76 of the Patents Act 1990 (Cth) (‘the Act’), and the Register of Patents (‘the Register’) records that the term has been extended until 13 June 2014.
The Commissioner has been advised by Alphapharm Pty Ltd (‘Alphapharm’) of facts that would lead to the extension of term being recalculated to 9 December 2012. If these facts are established, then the Commissioner must amend the Register under reg 10.7(7) of the Patents Regulations 1991 (Cth) (‘the Regulations’). On the basis of the same facts, Alphapharm have requested that the Commissioner amend the Register under reg 10.7(1) (to correct an obvious mistake).
A hearing was held in Canberra on 13 April 2006 in relation to both matters. Lundbeck was represented by Ms Katrina Howard of counsel and Mr Matthew Swinn of Corrs Chambers Westgarth. Alphapharm was represented by Mr Stephen Burley of counsel and Ms Lynne Peach of Mallesons Stephen Jaques. Mr Barry Spencer of Alphapharm attended.
FACTS
The relevant facts in this case are straight forward. Citalopram is a compound belonging to the therapeutic category of selective serotonin re-uptake inhibitors. Citalopram is a racemate, meaning that its…

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: [2006] APO 18
Decision Date: 19 May 2006

CaseChat Overview and Summary

In the case of Alphapharm Pty Ltd v H Lundbeck A/S, the primary focus was on the patent held by H Lundbeck A/S regarding the (+)-enantiomer of citalopram, commonly known as escitalopram. Alphapharm sought amendments to the Register of Patents to correct what it argued were errors in the patent's term extension. The dispute centred on whether the patent term should be extended to 9 December 2012 rather than the currently recorded date of 13 June 2014.

The legal issues before the court involved the interpretation of sections 70 and 77 of the Patents Act 1990 and regulations 10.7(1) and 10.7(7) of the Patents Regulations 1991. Specifically, the court had to determine whether escitalopram was contained in citalopram and, consequently, if the goods known as Cipramil contained escitalopram. Another issue was whether an obvious mistake had been made in the request for the patent term extension, warranting a correction under regulation 10.7(1).

The court's reasoning hinged on the interpretation of the term "contain" within the context of the Act and relevant case law. The court followed the decision in Merck & Co Inc v Arrow Pharmaceuticals Ltd, which held that for the purposes of the Act, if goods contained a substance to any extent, the requisite link was established. The court determined that since citalopram, marketed as Cipramil, contained escitalopram, the Commissioner must amend the Register under regulation 10.7(7) to reflect the correct patent term extension of 9 December 2012. However, the court found that the mistake alleged by Alphapharm was not obvious, as it required a detailed analysis of the patent specification, the ARTG entries, and the Act's provisions. Therefore, the court refused to advertise the amendment under regulation 10.7(1).

The final outcome of the case mandated that the Register be amended to reflect the correct patent term extension date of 9 December 2012. Given the nature of the proceedings, the court deemed it inappropriate to award costs to either party.

Orders