Federal Court of Australia
FEDERAL COURT OF AUSTRALIA
Generic Health Pty Ltd v Bayer Pharma Aktiengesellschaft [2014] FCAFC 73 Citation: Generic Health Pty Ltd v Bayer Pharma Aktiengesellschaft [2014] FCAFC 73
Appeal from: Bayer Pharma Aktiengesellschaft v Generic Health Pty Ltd [2013] FCA 226; Bayer Pharma Aktiengesellschaft v Generic Health Pty Ltd (No 2) [2013] FCA 279
Parties: GENERIC HEALTH PTY LTD and LUPIN AUSTRALIA PTY LIMITED v BAYER PHARMA AKTIENGESELLSCHAFT and BAYER AUSTRALIA LIMITED APOTEX PTY LTD v BAYER PHARMA AKTIENGESELLSCHAFT and BAYER AUSTRALIA LIMITED GENERIC HEALTH PTY LTD and LUPIN AUSTRALIA PTY LIMITED v BAYER PHARMA AKTIENGESELLSCHAFT and BAYER AUSTRALIA LIMITED APOTEX PTY LTD v BAYER PHARMA AKTIENGESELLSCHAFT and BAYER AUSTRALIA LIMITED
File numbers: NSD 833 of 2013 NSD 921 of 2013 NSD 984 of 2013 NSD 1006 of 2013
Judges: BESANKO, MIDDLETON and NICHOLAS JJ
Date of judgment: 19 June 2014
Catchwords: PATENTS – lack of inventive step – whether the invention would be obvious to the hypothetical skilled addressee of the patent at the priority date – whether the hypothetical skilled addressee of the patent would have undertaken the steps in the patent as a matter of routine to lead, as a matter of course, to the invention – whether expectation of hypothetical skilled addressee of the patent in undertaking the steps in the patent is a necessary element of the test of obviousness – whether hypothetical skilled addressee of the patent must have expectation of successful production of the invention or "some other useful result" – whether the reformulated Cripps question is a test of universal application – lack of fair basis – lack of novelty. PRACTICE AND PROCEDURE – application for leave to appeal against interlocutory decision on admissibility of evidence pursuant to r 34.50 of the Federal Court Rules 2011 (Cth) – whether application made out of time – where application for leave to appeal filed within time to apply for leave to appeal from orders – whether interlocutory decision sufficiently connected with orders such that time began to run on date of orders. EVIDENCE – admissibility of experimental proof of facts – Federal Court Rules 2011 (Cth) r 34.50 – whether manufacture of tablets to be used in dissolution test experiments the subject of directions pursuant to r 34.50 forms part of the experimental proof of fact – whether manufacture of tablets akin to manufacture of standard products used in the course of an experiment. Held: Appeal dismissed.
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