Pfizer Corp v Commissioner of Patents (No 2) [2006] FCA 1176

FEDERAL COURT OF AUSTRALIA

Pfizer Corp v Commissioner of Patents (No 2) [2006] FCA 1176

PATENTS – date for calculation of extension of term of patents relating to pharmaceutical substances – "first inclusion in the Australian Register of Therapeutic Goods" not limited to regulatory approval to market pharmaceutical substance in Australia – correct date if no "pre-TGA marketing approval" granted is first entry in the Australian Register of Therapeutic Goods, including an entry as listed goods for export only STATUTORY CONSTRUCTION – extrinsic materials relevant to context and legislative history – materials equivocal on whether "first inclusion" means registration or listing – legislative objective that patentee should have "effective patent life" to exploit patent WORDS AND PHRASES – "first inclusion in the Australian Register of Therapeutic Goods" – "first regulatory approval date" – "pre-TGA marketing approval"

Patents Act 1990 (Cth) ss 70(1), 70(3), 70(5), 70(6), 77 Patents Regulations 1991 (Cth) reg 10.7(7) Acts Interpretation Act 1901 (Cth) s 15AB Therapeutic Goods Act 1989 (Cth) ss 9A, 19A, 25, 26, 31(2) repealed s 17 Atlantis Corporation Pty Ltd v Schindler [1997] FCA 455 cited Doric Products Pty Ltd v Lockwood Security Products Pty Ltd (2002) 54 IPR 495 cited H Lundbeck A/S v Commissioner of Patents (2006) 150 FCR 269 applied Newcastle City Council v GIO General Limited (1997) 191 CLR 85 applied Pfizer Corp v Commissioner of Patents (2006) 67 IPR 646 cited Re Pfizer Corporation (2005) 67 IPR 201 affirmed Stevens v Kabushiki Kaisha Sony Computer Entertainment (2005) 221 ALR 448 cited Woolworths Limited v BP plc [2006] FCAFC 132 cited Woolworths Limited v BP plc (2006) 150 FCR 134 cited PFIZER CORP, PFIZER LTD, PFIZER INC AND PFIZER RESEARCH & DEVELOPMENT COMPANY N.V/SA v COMMISSIONER OF PATENTS AND SPIRIT PHARMACEUTICALS PTY LIMITED (ACN 109 225 747) NSD 1955 OF 2005