Apotex Pty Ltd v AstraZeneca AB [2011] FCA 1520

Apotex Pty Ltd v AstraZeneca AB [2011] FCA 1520

AstraZeneca established a sufficient prima facie case of patent infringement on the evidence of Dr Nestel and Dr Williams, and the balance of convenience strongly favoured preserving the status quo ante because Apotex's proposed generic launch risked irreversible erosion of AstraZeneca's market position and PBS pricing while Apotex's asserted first mover advantage arose from a new and deliberately surprising market entry. AstraZeneca had not been guilty of unreasonable delay, and because Apotex substantively opposed the application with evidence and submissions, the injunction was properly granted until further order rather than only for a short fixed period.

Jurisdiction
Australia
Judgment Date
14 December 2011
Procedural Posture
Patent Proceedings Concerning Validity and Alleged Infringement, With Application for Interlocutory Injunction / Interlocutory Application
Outcome
Interlocutory injunction granted until further order.
Legal Topics
['interlocutory Injunction' 'pharmaceutical Patents' 'generic Rosuvastatin Product' 'prima Facie Case' 'balance of Convenience' 'delay' 'overarching Purpose' 'ex Parte and Inter Partes Interlocutory Relief']
['patents' 'intellectual Property' 'civil Procedure'] ['interlocutory Injunction' 'pharmaceutical Patents' 'generic Rosuvastatin Product' 'prima Facie Case' 'balance of Convenience' 'delay' 'overarching Purpose' 'ex Parte and Inter Partes Interlocutory Relief']

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Procedural Posture

Patent Proceedings Concerning Validity and Alleged Infringement, With Application for Interlocutory Injunction / Interlocutory Application

Legal Issues

  1. 1 ['Whether AstraZeneca established a sufficient prima facie case of infringement of the 051, 842 and 165 patents.' 'Whether the balance of convenience justified restraining Apotex from selling, supplying, soliciting, taking orders for, advertising or promoting generic rosuvastatin pending further order.' "Whether AstraZeneca's delay in seeking interlocutory relief disentitled it to an injunction." 'Whether the interlocutory injunction should be granted until further order where Apotex opposed the application and led evidence.']

Ratio Decidendi

AstraZeneca established a sufficient prima facie case of patent infringement on the evidence of Dr Nestel and Dr Williams, and the balance of convenience strongly favoured preserving the status quo ante because Apotex's proposed generic launch risked irreversible erosion of AstraZeneca's market position and PBS pricing while Apotex's asserted first mover advantage arose from a new and deliberately surprising market entry. AstraZeneca had not been guilty of unreasonable delay, and because Apotex substantively opposed the application with evidence and submissions, the injunction was properly granted until further order rather than only for a short fixed period.

Court Disposition

Interlocutory injunction granted until further order.

Orders

  • ['AstraZeneca Pty Ltd be joined as the second respondent and second cross-claimant.' 'The applicant/cross-respondent be restrained until further order from, in Australia and without the licence of the respondents/cross-claimants, selling, supplying, offering to sell or supply (including without limitation offering...