Alphapharm Pty Ltd v H Lundbeck A/S - [2014] APO 41

IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Alphapharm Pty Ltd v H Lundbeck A/S
Apotex Pty Ltd v H Lundbeck A/S
Aspen Pharma Pty Ltd v H Lundbeck A/S
Sandoz Pty Ltd v H Lundbeck A/S
[2014] APO 41
Patent:623144

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

Patentee:  H Lundbeck A/S
Opponents:  (1) Alphapharm Pty Ltd
  (2) Apotex Pty Ltd
  (3) Aspen Pharma Pty Ltd
  (4) Sandoz Pty Ltd
Delegate:  Dr S.D. Barker
Decision Date:  25 June 2014
Hearing Date:  7 May 2014, in Canberra
Catchwords:  PATENTS – oppositions to an extension of term of a pharmaceutical patent – previous extension of term removed from the Register – application for extension based on the goods CIPRAMIL – oppositions fail – extension of term granted

Representation: Patentee: Katrina Howard SC and Richard Niall SC, and Matthew Swinn of Corrs Chambers Westgarth
Opponents:David Catterns QC, Christian Dimitriadis of counsel, and Kim O’Connell and James Ellsmore of King & Wood Mallesons

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: 25 June 2014
DECISION
The oppositions fail on all grounds.
I grant an extension of the term of patent 623144. According to section 77, the term of the patent is extended to 9 December 2012. I direct that notice of the grant be published in the Official Journal.
I direct that the Register is not updated to reflect the extended term until 28 days from the date of this decision or, in the event that the Commissioner is served in that period with a copy of a notice of appeal and an application for a stay, until the stay application is determined by the court.
I award costs according to Schedule 8 against each of the opponents: Alphapharm Pty Ltd, Apotex Pty Ltd, Aspen Pharma Pty Ltd and Sandoz Pty Ltd.
REASONS FOR DECISION

Patent application number 623144 (the patent) was filed on 13 June 1989, and granted on 31 August 1992. The patentee is H Lundbeck A/S (Lundbeck). Lundbeck has sought an extension of the term of the patent. Oppositions to the extension of term were filed by four different opponents: Alphapharm Pty Ltd (Alphapharm), Apotex Pty Ltd (Apotex), Aspen Pharma Pty Ltd (Aspen) and Sandoz Pty Ltd (Sandoz) (together, the Opponents). The four oppositions are identical, and were run as a single action on behalf of the Opponents jointly. A hearing was held on 7 May 2014 in Canberra to decide the oppositions. Lundbeck was represented by Katrina Howard SC and Richard Niall SC, and Matthew Swinn of Corrs Chambers Westgarth. The Opponents were represented by David Catterns QC, Christian Dimitriadis of counsel and Kim O’Connell and James Ellsmore of King & Wood Mallesons.
The history of the present matter
Citalopram is a compound belonging to the therapeutic category of selective serotonin re-uptake inhibitors. Citalopram is a racemate, meaning that the molecule exists as…

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: [2014] APO 41
Decision Date: 25 June 2014

CaseChat Overview and Summary

The case of Alphapharm Pty Ltd v H Lundbeck A/S and related proceedings involved an opposition to an extension of the term of a pharmaceutical patent. The patent in question, numbered 623144, held by H Lundbeck A/S, related to the (+)-enantiomer of citalopram, also known as escitalopram, a compound within the therapeutic category of selective serotonin re-uptake inhibitors. The original patent term expired on 13 June 2009, but Lundbeck applied for an extension based on the registration of the goods CIPRAMIL on the Australian Register of Therapeutic Goods (ARTG). This application was opposed by four entities: Alphapharm Pty Ltd, Apotex Pty Ltd, Aspen Pharma Pty Ltd, and Sandoz Pty Ltd. The hearing took place on 7 May 2014, with legal representation from both sides.

The legal issues centred around whether the extension of the patent term complied with the requirements of the Patents Act. Specifically, the opponents argued that the application failed to meet the criteria under sections 70(2)(a), 70(3)(a), 70(4), and 71(1) of the Act. These sections pertain to the substance claimed being a pharmaceutical substance per se, the inclusion of the substance in the goods on the ARTG, the non-previous extension of the patent term, and the proper form and information accompanying the application, respectively. Additionally, the opponents raised concerns about the procedural history, arguing that the Commissioner should not grant the extension due to previous litigation and the estoppel principle.

The court, Dr. S.D. Barker, examined each ground of opposition meticulously. It found that claim 1 of the patent was indeed directed to a pharmaceutical substance per se, as it explicitly claimed escitalopram in pure form. The court also determined that the goods CIPRAMIL contained escitalopram, despite being a mixture of the (+) and (-) enantiomers. Furthermore, the court held that the term of the patent had not been previously extended as the earlier extension based on LEXAPRO was invalid and removed from the Register before Lundbeck filed the current application. Lastly, the court concluded that the application complied with section 71(1) and the relevant regulations. Therefore, all grounds of opposition were dismissed.

Consequently, the court granted the extension of the term of the patent, effective from the date of the decision. The term was extended to 9 December 2012. The court also ordered that the Register would not be updated to reflect the extended term until 28 days from the date of the decision, or until a stay application was determined by the court if one was filed. Costs were awarded to Lundbeck against the opponents.

Orders