Apotex Pty Ltd v AstraZeneca AB (No 4) [2013] FCA 162

Apotex Pty Ltd v AstraZeneca AB (No 4) [2013] FCA 162

All asserted claims of the three AstraZeneca patents are invalid and liable to be revoked: for the '051' and '165' patents on the grounds of lack of novelty, lack of inventive step, and lack of manner of manufacture; the '842' patent is also not novel and lacks an inventive step, and in each case the invention as claimed was either anticipated in the relevant prior art or was obvious in light of the common general knowledge and certain public disclosures before the asserted priority dates. As a result, there is no sustainable basis for an infringement finding against the generic parties.

Jurisdiction
Australia
Judgment Date
05 March 2013
Procedural Posture
Patent Litigation / Final Judgment on Validity and Infringement
Outcome
All asserted patent claims invalid and revoked; no relief for infringement; interlocutory restraints dissolved; parties to file orders reflecting reasons.
Legal Topics
['patents' 'pharmaceutical Patents' 'patent Validity' 'patent Infringement' 'inventive Step' 'novelty' 'manner of Manufacture' 'entitlement' 'utility']
['intellectual Property Law'] ['patents' 'pharmaceutical Patents' 'patent Validity' 'patent Infringement' 'inventive Step' 'novelty' 'manner of Manufacture' 'entitlement' 'utility']

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Procedural Posture

Patent Litigation / Final Judgment on Validity and Infringement

Legal Issues

  1. 1 ['Whether claims of three AstraZeneca patents regarding rosuvastatin are valid (novel, inventive, manner of manufacture, utility, fair basis, entitlement, clarity, best method)' 'Whether the generic parties (Apotex, Watson, Ascent) infringe these patents by marketing/supplying generic rosuvastatin products in Australia']

Ratio Decidendi

All asserted claims of the three AstraZeneca patents are invalid and liable to be revoked: for the '051' and '165' patents on the grounds of lack of novelty, lack of inventive step, and lack of manner of manufacture; the '842' patent is also not novel and lacks an inventive step, and in each case the invention as claimed was either anticipated in the relevant prior art or was obvious in light of the common general knowledge and certain public disclosures before the asserted priority dates. As a result, there is no sustainable basis for an infringement finding against the generic parties.

Court Disposition

All asserted patent claims invalid and revoked; no relief for infringement; interlocutory restraints dissolved; parties to file orders reflecting reasons.

Orders

  • ['Order 2 of the orders of 14 December 2011 dissolved. Parties to file agreed or competing orders reflecting reasons for judgment within 7 days. Proceedings listed within a further 7 days thereafter in consultation with the parties (for each proceeding: NSD 673/2011, NSD 2342/2011, NSD 208/2012).' 'Generic parties...