Sigma Pharmaceuticals (Australia) Pty Ltd (ACN 004 118 594) v Wyeth [2009] FCA 595

Sigma Pharmaceuticals (Australia) Pty Ltd (ACN 004 118 594) v Wyeth [2009] FCA 595

Wyeth established a strong prima facie case for patent infringement by Sigma's Evelexa‑XR product, while Sigma raised a triable but not overwhelming case for patent invalidity. Wyeth demonstrated it would likely suffer irreparable harm—including loss of market share and price competition, with additional risks of third-party generic entry and patient confusion—which damages would not adequately compensate. Considering the status quo, Wyeth's established market presence, and the early stage of Sigma's entry into the market, the balance of convenience favoured granting interlocutory injunction restraining Sigma from marketing or supplying Evelexa‑XR pending trial.

Jurisdiction
Australia
Judgment Date
03 June 2009
Procedural Posture
Patent Interlocutory Application / Application for Interlocutory Injunction Pending Final Hearing
Outcome
Interlocutory injunction granted restraining Sigma from marketing and supplying Evelexa‑XR pending determination of the proceeding or further order.
Legal Topics
['interlocutory Injunctions' 'patent Infringement' 'patent Validity' 'inventive Step' 'manner of New Manufacture' 'fair Basis' 'priority Date' 'irreparable Harm' 'balance of Convenience']
['intellectual Property' 'patents'] ['interlocutory Injunctions' 'patent Infringement' 'patent Validity' 'inventive Step' 'manner of New Manufacture' 'fair Basis' 'priority Date' 'irreparable Harm' 'balance of Convenience']

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Procedural Posture

Patent Interlocutory Application / Application for Interlocutory Injunction Pending Final Hearing

Legal Issues

  1. 1 ["Whether Sigma's supply of Evelexa‑XR would infringe Wyeth's patent under s 117 of the Patents Act 1990 (Cth)" "Whether Wyeth's patent claims are invalid for lack of inventive step, lack of manner of new manufacture, or lack of fair basis" 'Whether Wyeth is entitled to interlocutory injunctive relief pending final resolution of the proceeding' 'Whether damages would be adequate remedy or whether Wyeth will suffer irreparable harm' 'How the balance of convenience falls in granting or refusing the interlocutory injunction']

Ratio Decidendi

Wyeth established a strong prima facie case for patent infringement by Sigma's Evelexa‑XR product, while Sigma raised a triable but not overwhelming case for patent invalidity. Wyeth demonstrated it would likely suffer irreparable harm—including loss of market share and price competition, with additional risks of third-party generic entry and patient confusion—which damages would not adequately compensate. Considering the status quo, Wyeth's established market presence, and the early stage of Sigma's entry into the market, the balance of convenience favoured granting interlocutory injunction restraining Sigma from marketing or supplying Evelexa‑XR pending trial.

Court Disposition

Interlocutory injunction granted restraining Sigma from marketing and supplying Evelexa‑XR pending determination of the proceeding or further order.

Orders

  • ['Pending the determination of the proceeding or further order, Sigma (Applicant/Cross‑Respondent), whether by itself, its directors, officers, servants, agents or otherwise, be restrained from marketing, taking orders for, selling, supplying, offering to supply or otherwise exploiting in Australia the products...