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
Summary, issues, holding and outcome
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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
Legal Issues
- 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 Whether the applicants established a prima facie case for infringement
- 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.
Full Case Text
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