Warner-Lambert Company LLC v Apotex Pty Ltd [2014] FCA 241

Warner-Lambert Company LLC v Apotex Pty Ltd [2014] FCA 241

The applicants failed to establish a prima facie case that Apotex, by supplying generic pregabalin for seizure indications alone, would have reason to believe its products would be put to infringing use for pain treatment under ss 117(1) and (2)(b) of the Patents Act 1990 (Cth). The narrowing of ARTG registered indications and clear promotional materials excluding pain indications provided strong evidence against such a belief. The balance of convenience also favoured Apotex, as damages would be more straightforward to assess if no injunction were granted and the applicants ultimately succeeded.

Parties
First Applicant: Warner-Lambert Company LLC; Second Applicant: PF PRISM CV; Third Applicant: Pfizer Ireland Pharmaceuticals; Fourth Applicant: Pfizer Asia Pacific Pte Ltd; Fifth Applicant: Pfizer Australia Pty Ltd ACN 008 422 348; Respondent: Apotex Pty Ltd ACN 096 916 148
Jurisdiction
Australia
Judgment Date
18 March 2014
Procedural Posture
Interlocutory Application in Patent Infringement Proceeding / Ruling on Application for Interlocutory Injunction
Outcome
Interlocutory injunction refused in relation to supply of pregabalin for seizure indication; granted (by parties' undertaking) not to market for pain indication.
Legal Topics
Interlocutory Injunctions, Pharmaceutical Patents, S 117 Patents Act 1990 (cth), Patent Infringement, Balance of Convenience

Case Brief

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Parties

Warner-Lambert Company LLC

First Applicant

PF PRISM CV

Second Applicant

Pfizer Ireland Pharmaceuticals

Third Applicant

Pfizer Asia Pacific Pte Ltd

Fourth Applicant

Pfizer Australia Pty Ltd ACN 008 422 348

Fifth Applicant

Apotex Pty Ltd ACN 096 916 148

Respondent

Procedural Posture

Interlocutory Application in Patent Infringement Proceeding / Ruling on Application for Interlocutory Injunction

  1. 1 Whether the supplier of a generic pharmaceutical product (Apotex) should be restrained by interlocutory injunction from supplying products allegedly infringing a pain treatment patent under ss 117(1) and (2)(b) of the Patents Act 1990 (Cth)
  2. 2 Whether the applicants established a prima facie case for infringement
  3. 3 Whether the balance of convenience favours granting injunctive relief

Ratio Decidendi

The applicants failed to establish a prima facie case that Apotex, by supplying generic pregabalin for seizure indications alone, would have reason to believe its products would be put to infringing use for pain treatment under ss 117(1) and (2)(b) of the Patents Act 1990 (Cth). The narrowing of ARTG registered indications and clear promotional materials excluding pain indications provided strong evidence against such a belief. The balance of convenience also favoured Apotex, as damages would be more straightforward to assess if no injunction were granted and the applicants ultimately succeeded.

Court Disposition

Interlocutory injunction refused in relation to supply of pregabalin for seizure indication; granted (by parties' undertaking) not to market for pain indication.

Orders

  • The respondent is restrained, until final hearing or further order, from supplying pregabalin products indicated for the treatment of neuropathic pain in adults (or substantially similar indication).
  • Respondent's costs of and incidental to the interlocutory application are the respondent's costs in the cause.