Apotex Pty Ltd v Sanofi-Aventis [2009] FCAFC 134

FEDERAL COURT OF AUSTRALIA

Apotex Pty Ltd v Sanofi-Aventis [2009] FCAFC 134 PATENTS – application for revocation – validity – claim to d-enantiomer (clopidogrel), pharmaceutically acceptable salts and addition salts of d-enantiomer, pharmaceutical compositions containing d-enantiomer and a process for preparation of d-enantiomer – prior art patents describe and claim the racemate and the enantiomers - process for obtaining enantiomers well known and non-inventive - whether disclosure of salts of the racemate discloses salts of the enantiomers - whether d-enantiomer novel - whether pharmaceutically acceptable salts and addition salts of the d-enantiomer novel - whether pharmaceutical compositions containing d-enantiomer novel – selection patents – whether claims obvious and lack inventive step – starting point for applying common general knowledge of skilled addressee - "problem and solution" approach – whether claims valid as a manner of manufacture

Patents Act 1990 (Cth), s 138(3) Patents Act 1952 (Cth), s 40

Advanced Building Systems Pty Limited v Ramset Fasteners (Aust) Pty Limited (1998) 194 CLR 171 cited Aktiebolaget Hässle v Alphapharm Pty Limited (2002) 212 CLR 411 considered Apotex Pty Limited (formerly GenRx Pty Ltd) v Sanofi-Aventis (2008) 78 IPR 485 affirmed in part Re Beecham Group Ltd's (Amoxycillin) Application [1980] 97 RPC 261 cited Biogen Inc v Medeva plc (1996) 36 IPR 438 cited Bristol-Myers Squibb Company v FH Faulding & Co Limited (2000) 97 FCR 524 cited General Tire & Rubber Company v Firestone Tyre and Rubber Company Ltd (1971) 1A IPR 121 cited Hill v Evans (1862) 1A IPR 1 considered H Lundbeck A/S v Alphapharm Pty Ltd (2009) 81 IPR 228 considered Re IG Farbenindustrie AG's Patents (1930) 47 RPC 289 cited Insta Image Pty Ltd v KD Kanopy Australasia Pty Ltd (2008) 78 IPR 20 considered Lockwood Security Products Pty Ltd v Doric Products Pty Ltd (No 2) (2007) 235 CLR 173 considered Merck & Co Inc v Arrow Pharmaceuticals Ltd (2006) 154 FCR 31 cited Minnesota Mining and Manufacturing Company v Beiersdorf (Australia) Limited (1980) 144 CLR 253 cited National Research Development Corporation v Commissioner of Patents (1959) 102 CLR 252 cited Nicaro Holdings Pty Limited v Martin Engineering Co (1990) 91 ALR 513 referred to NV Philips Gloeilampenfabrieken v Mirabella International Pty Limited (1995) 183 CLR 655 cited Olin Corporation v Super Cartridge Co Pty Ltd (1977) 180 CLR 236 cited Ranbaxy Australia Pty Ltd v Warner-Lambert Co LLC (2008) 77 IPR 449 considered Wellcome Foundation Limited v VR Laboratories (Aust) Proprietary Limited (1981) 148 CLR 262 cited