H Lundbeck A/S v Alphapharm Pty Ltd - [2016] APO 45

IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
H Lundbeck A/S v Alphapharm Pty Ltd and Ors [2016] APO 45
Patent:623144

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

Applicants for
Licences:  (1) Alphapharm Pty Ltd
  (2) Apotex Pty Ltd
  (3) Aspen Pharma Pty Ltd
  (4) Sandoz Pty Ltd
Patentee and
Opponent:  H Lundbeck A/S
Hearing Officer:  P M Spann, Deputy Commissioner of Patents
Decision Date:  8 July 2016
Hearing Date:  14 May 2016 by written submissions
Catchwords:  PATENTS – Applications for licences to exploit – opposition to applications – request for stay – request for determination of threshold issues – requests refused – directions for filing of evidence for determination of all issues.

Representation: Licence Applicants: C Dimitriadis SC and N R Murray Counsel instructed by King & Wood Mallesons
Patentee:S Stern, Corrs Chambers Westgarth

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: 8 July 2016
DECISION
Request for stay refused
Request for determination of threshold issues refused
I direct that (subject to any application for review of this decision):
i.The Licence Applicants file evidence in support of their applications within 3 months from the date of this decision; and
ii.The patentee file any evidence in answer within 3 months of the day the Commissioner gives it a copy of the evidence in support of the applications and notifies it that all the evidence has been filed; and
iii.The Licence Applicants file any evidence in reply within 2 months of the day the Commissioner gives them a copy of the evidence in answer and notifies them that all the evidence has been filed.

REASONS FOR DECISION

Patent application number 623144 (the patent) was filed on 13 June 1989, and granted on 31 August 1992 to H Lundbeck A/S (Lundbeck). It has had an exceptionally complex litigation history which I will summarise below. The present matter however concerns directions under r. 5.12 which the Commissioner may make for the practice and procedure to be followed in the oppositions by Lundbeck to applications under r. 22.21 for licences to exploit the patent. These were filed by each of Alphapharm Pty Ltd (Alphapharm), Apotex Pty Ltd (Apotex), Aspen Pharma Pty Ltd (Aspen) and Sandoz Pty Ltd (Sandoz) (together, the Licence Applicants). The requests for licences and oppositions thereto have been joined in a single proceeding.
In making directions for the further conduct of the proceedings I will more specifically consider:
a)a request made by the Licence Applicants for the proceedings to be stayed pending final determination of the infringement proceedings brought by Lundbeck against them; and
b) a request by Lundbeck that the Commissioner proceed to decide a number of threshold questions which in its view will result in the applications for licences being dismissed.
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 two mirror-image forms in equal…

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: [2016] APO 45
Decision Date: 8 July 2016

CaseChat Overview and Summary

The case before the Australian Patent Office (APO) involved patent application 623144, held by H Lundbeck A/S, and applications for licences to exploit the patent by Alphapharm Pty Ltd, Apotex Pty Ltd, Aspen Pharma Pty Ltd, and Sandoz Pty Ltd (the Licence Applicants). The dispute centred on the terms under which the Commissioner of Patents should determine the licence applications, specifically whether the proceedings should be stayed pending the outcome of infringement proceedings and whether certain threshold issues should be resolved first. The Hearing Officer, P M Spann, Deputy Commissioner of Patents, delivered the decision on 8 July 2016.

The central legal issues in the case were whether the proceedings should be stayed pending the outcome of the infringement proceedings and whether certain threshold issues should be resolved before proceeding with the determination of the licence applications. The Licence Applicants argued that a stay was necessary to avoid prejudice and to align with the infringement proceedings. Conversely, Lundbeck argued that a stay would unnecessarily delay the resolution of the licence applications and was not justified by the circumstances.

The Hearing Officer considered the principles applicable to determining the conduct of opposition proceedings under the Patents Act 1990 and the Patents Regulations 1991. The Commissioner has broad discretion in determining the practice and procedure of the proceedings. The Hearing Officer found that the Licence Applicants' request for a stay was not justified, as it would lead to an indeterminate and prolonged suspension of the proceedings, contrary to the public interest in the prompt and orderly administration of the legislation. Furthermore, the Hearing Officer determined that the proposed partial determination of threshold issues would lead to lengthy delays and inefficiencies, and was not in line with the Commissioner's usual practice of hearing and determining all issues at one time.

In conclusion, the Hearing Officer refused both the Licence Applicants' request for a stay and Lundbeck's request for a partial determination of threshold issues. Instead, the Hearing Officer made directions for the filing of evidence toward the determination of all issues, allowing the Licence Applicants to proceed with their applications while addressing the uncertainty and difficulties they faced. The Hearing Officer also declined to make any award of costs under Schedule 8 Part 1 of the Patents Act 1990.

Orders