FEDERAL COURT OF AUSTRALIA
Pfizer Ireland Pharmaceuticals v Sandoz Pty Ltd [2020] FCA 1648
File number(s): VID 1200 of 2019 Judgment of: BURLEY J Date of judgment: 13 November 2020 Catchwords: PRACTICE AND PROCEDURE – preliminary discovery – where prospective respondent has no current intention to launch pharmaceutical product in Australia – where prospective respondent has undertaken not to launch its pharmaceutical product without first providing the prospective applicants with a substantial notice period – whether prospective applicants hold a reasonable belief that they may be entitled to relief for patent infringement as required by r 7.23(1)(a) of the Federal Court Rules 2011 (Cth) – whether discretion under r 7.23(2) of the Federal Court Rules 2011 (Cth) should be exercised – application dismissed Legislation: Federal Court of Australia Act 1976 (Cth) s 37AF(1)(b)
Patents Act 1990 (Cth) s 119A
Federal Court Rules 2011 (Cth) r 7.23
Cases cited: Luna Park Ltd v the Commonwealth [1923] HCA 49; 32 CLR 596
Pfizer Ireland Pharmaceuticals v Samsung Bioepis AU Pty Ltd [2017] FCAFC 193; 257 FCR 62
Re Barrow [2017] HCA 47; 91 ALJR 1240
Reeve v Aqualast Pty Ltd [2012] FCA 679
St George Bank Ltd v Rabo Australia Ltd [2004] FCA 1360; 211 ALR 147
Warner-Lambert Company LLC v Apotex Pty Limited [2017] FCAFC 58; 249 FCR 17
Division: General Division Registry: New South Wales National Practice Area: Intellectual Property Sub-area: Patents and associated Statutes Number of paragraphs: 36 Date of hearing: 1 July 2020; 6 November 2020 Counsel for the Prospective Applicants: Mr D. Shavin QC with Ms C. Cochrane Solicitor for the Prospective Applicants: DLA Piper Australia Counsel for the Prospective Respondent: Mr C. Burgess Solicitor for the Prospective Respondent: Clayton Utz ORDERS
VID 1200 of 2019 BETWEEN: PFIZER IRELAND PHARMACEUTICALS
First Prospective Applicant
WYETH LLC
Second Prospective Applicant
PFIZER AUSTRALIA PTY LTD
Third Prospective Applicant
AND: SANDOZ PTY LTD
Prospective Respondent
ORDER MADE BY:
BURLEY J
DATE OF ORDER:
13 NOVEMBER 2020
THE COURT ORDERS THAT:
1.The application be dismissed.
2.The Prospective Applicants pay the Prospective Respondent’s costs of the proceedings.
3.Until further order, the text of the reasons for judgment published today is to be published and disclosed only to the parties to these proceedings and their external legal representatives.
4.The parties are to confer and provide to chambers proposed redactions of the reasons published today by 4.00pm on 17 November 2020.
Note: Entry of orders is dealt with in Rule 39.32 of the Federal Court Rules 2011.
REASONS FOR JUDGMENT
BURLEY J:
1. INTRODUCTION
By originating application filed on 1 November 2019, Pfizer Ireland Pharmaceuticals, Wyeth LLC and Pfizer Australia Pty Ltd (collectively Pfizer) seek orders pursuant to r 7.23 of the Federal Court Rules 2011 (Cth) (FCR) for preliminary discovery of documents from the prospective respondent, Sandoz Pty Ltd. The application concerns the production of documents held by or on behalf of Sandoz concerning a pharmaceutical product called ERELZI, in respect of which Sandoz…
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- Case
- [2020] FCA 1648
- Decision Date
CaseChat Overview and Summary
The central legal question was whether Pfizer held a reasonable belief that it might be entitled to relief for patent infringement, as required by rule 7.23(1)(a) of the Federal Court Rules 2011 (Cth). Additionally, the court needed to determine whether the discretion under rule 7.23(2) of the Federal Court Rules 2011 (Cth) should be exercised in Pfizer's favour. The court examined the evidence presented by Pfizer to ascertain whether it had a reasonable belief that Sandoz's potential actions would infringe its patent. It also considered the factors relevant to the exercise of the court's discretion, including the nature of the relief sought and the potential harm to the parties.
The Federal Court held that Pfizer did not hold a reasonable belief that it would be entitled to relief for patent infringement because there was no concrete evidence of Sandoz's intention to launch the generic product in the near future. The court found that Pfizer's concerns were speculative and not supported by sufficient evidence. Furthermore, the court determined that the discretion under rule 7.23(2) should not be exercised in Pfizer's favour, given the lack of a reasonable belief and the absence of urgency. Consequently, the application for preliminary discovery was dismissed. The court also ordered Pfizer to pay Sandoz's costs of the proceedings and imposed restrictions on the publication of the reasons for judgment.
Orders
Orders of the court
1. The application be dismissed.
2. The Prospective Applicants pay the Prospective Respondent’s costs of the proceedings.
3. Until further order, the text of the reasons for judgment published today is to be published and disclosed only to the parties to these proceedings and their external legal representatives.
4. The parties are to confer and provide to chambers proposed redactions of the reasons published today by 4.00pm on 17 November 2020.
Note: Entry of orders is dealt with in Rule 39.32 of the Federal Court Rules 2011.
Background
Background to the litigation
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Evidence
Evidence Before The Court
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Decision
Reasons for decision
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Ratio Decidendi
Legal Principle Established
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