Pfizer Ireland Pharmaceuticals v Sandoz Pty Ltd [2020] FCA 1648

Pfizer Ireland Pharmaceuticals v Sandoz Pty Ltd [2020] FCA 1648

Pfizer did not satisfy r 7.23(1)(a) because its asserted belief that it may have a right to relief depended on Sandoz later changing its current position and deciding to launch ERELZI in Australia. Sandoz had made no decision to launch, might never launch, and had undertaken to give substantial notice before exploiting the product or proceeding with PBS listing. The Court should not make preliminary discovery orders based on hypothetical future circumstances; in any event, the discretion under r 7.23(2) would not be exercised because the scope and confidentiality terms of any discovery could not prudently be determined in advance and there was no imminent threat of launch.

Jurisdiction
Australia
Judgment Date
13 November 2020
Procedural Posture
Application for Preliminary Discovery Under R 7.23 of the Federal Court Rules 2011 (cth) Concerning Potential Patent Infringement by a Pharmaceutical Product / Originating Application Heard; Application Dismissed
Outcome
Application dismissed; prospective applicants ordered to pay the prospective respondent's costs; publication of reasons restricted pending proposed redactions.
Legal Topics
['preliminary Discovery' 'prospective Respondent' 'pharmaceutical Patents' 'biosimilar Pharmaceutical Product' 'threatened Patent Infringement' 'artg Registration' 'pbs Listing' 'confidentiality and Suppression Orders']
['practice and Procedure' 'intellectual Property' 'patents'] ['preliminary Discovery' 'prospective Respondent' 'pharmaceutical Patents' 'biosimilar Pharmaceutical Product' 'threatened Patent Infringement' 'artg Registration' 'pbs Listing' 'confidentiality and Suppression Orders']

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Procedural Posture

Application for Preliminary Discovery Under R 7.23 of the Federal Court Rules 2011 (cth) Concerning Potential Patent Infringement by a Pharmaceutical Product / Originating Application Heard; Application Dismissed

Legal Issues

  1. 1 ['Whether Pfizer reasonably believed that it may have the right to obtain relief from Sandoz as required by r 7.23(1)(a) of the Federal Court Rules 2011 (Cth).' 'Whether the Court should exercise its discretion under r 7.23(2) of the Federal Court Rules 2011 (Cth) to order preliminary discovery.' 'Whether orders should be made in anticipation of a future notice by Sandoz of an intention to launch ERELZI in Australia.']

Ratio Decidendi

Pfizer did not satisfy r 7.23(1)(a) because its asserted belief that it may have a right to relief depended on Sandoz later changing its current position and deciding to launch ERELZI in Australia. Sandoz had made no decision to launch, might never launch, and had undertaken to give substantial notice before exploiting the product or proceeding with PBS listing. The Court should not make preliminary discovery orders based on hypothetical future circumstances; in any event, the discretion under r 7.23(2) would not be exercised because the scope and confidentiality terms of any discovery could not prudently be determined in advance and there was no imminent threat of launch.

Court Disposition

Application dismissed; prospective applicants ordered to pay the prospective respondent's costs; publication of reasons restricted pending proposed redactions.

Orders

  • ['The application be dismissed.' "The Prospective Applicants pay the Prospective Respondent's costs of the proceedings." '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.' 'The...