Warner-Lambert Company LLC v Apotex Pty Ltd [2014] FCAFC 59

Warner-Lambert Company LLC v Apotex Pty Ltd [2014] FCAFC 59

The primary judge erred in concluding that no prima facie case, or only a weak case, had been established because the appellants' evidence supported, at least prima facie, that the pregabalin seizure market was extremely small, that pregabalin was widely used for pain states, and that there was an unresolved expert conflict about whether pharmacists would be deterred by Apotex's materials from substituting Apotex-Pregabalin for Lyrica. Those errors affected the balance of convenience. Reassessing the matter, the Court held that the appellants had a non-weak prima facie case under s 117(1) and s 117(2)(b), and that the balance of convenience favoured preserving Pfizer Australia's...

Jurisdiction
Australia
Judgment Date
19 May 2014
Procedural Posture
Appeal From Refusal of Interlocutory Injunction in Patent Infringement Proceeding / Appeal Against Interlocutory Decision; Quia Timet Interlocutory Relief
Outcome
Appeal allowed; orders 2 and 3 made by the primary judge set aside; additional interlocutory injunction granted restraining Apotex from supplying or offering to supply specified pregabalin products in Australia until determination of proceeding NSD 763 of 2013 or further order.
Legal Topics
['interlocutory Injunction' 'threatened Patent Infringement' 'supply of Non Staple Commercial Product' 'patents Act 1990 (cth) S 117(1) and S 117(2)(b)' 'pregabalin' 'method of Medical Treatment Patent' 'balance of Convenience' 'prima Facie Case']
['patents' 'intellectual Property' 'civil Procedure' 'therapeutic Goods'] ['interlocutory Injunction' 'threatened Patent Infringement' 'supply of Non Staple Commercial Product' 'patents Act 1990 (cth) S 117(1) and S 117(2)(b)' 'pregabalin' 'method of Medical Treatment Patent' 'balance of Convenience' 'prima Facie Case']

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Procedural Posture

Appeal From Refusal of Interlocutory Injunction in Patent Infringement Proceeding / Appeal Against Interlocutory Decision; Quia Timet Interlocutory Relief

Legal Issues

  1. 1 ['Whether the appellants established a prima facie case that Apotex had reason to believe, for the purposes of Patents Act 1990 (Cth) s 117(2)(b), that Apotex-Pregabalin would be supplied by pharmacists to patients for treatment of pain.' 'Whether the primary judge erred by rejecting or giving no weight to evidence concerning the very small seizure market and possible pharmacist substitution of Apotex-Pregabalin for Lyrica.' 'Whether the conflict between expert evidence from pharmacists could be resolved on an interlocutory application.' 'Whether the balance of convenience favoured granting an additional interlocutory injunction restraining supply or offer to supply of Apotex-Pregabalin.']

Ratio Decidendi

The primary judge erred in concluding that no prima facie case, or only a weak case, had been established because the appellants' evidence supported, at least prima facie, that the pregabalin seizure market was extremely small, that pregabalin was widely used for pain states, and that there was an unresolved expert conflict about whether pharmacists would be deterred by Apotex's materials from substituting Apotex-Pregabalin for Lyrica. Those errors affected the balance of convenience. Reassessing the matter, the Court held that the appellants had a non-weak prima facie case under s 117(1) and s 117(2)(b), and that the balance of convenience favoured preserving Pfizer Australia's...

Court Disposition

Appeal allowed; orders 2 and 3 made by the primary judge set aside; additional interlocutory injunction granted restraining Apotex from supplying or offering to supply specified pregabalin products in Australia until determination of proceeding NSD 763 of 2013 or further order.

Orders

  • ['The appeal be allowed.' 'Orders 2 and 3 made by the primary judge on 14 March 2014 be set aside.' 'Until the determination of proceeding number NSD 763 of 2013 between the appellants and the respondent (the proceeding) or further order of a Judge of the Court, the respondent, whether by it servants, agents or...