Merck Sharp & Dohme Corp. v Sandoz Pty Ltd [2022] FCAFC 40

FEDERAL COURT OF AUSTRALIA

Merck Sharp & Dohme Corp. v Sandoz Pty Ltd [2022] FCAFC 40 Appeal from: Merck Sharp & Dohme Corp. v Sandoz Pty Ltd [2021] FCA 947

File number: VID 517 of 2021

Judgment of: ALLSOP CJ, YATES AND BURLEY JJ

Date of judgment: 18 March 2022

Catchwords: INTELLECTUAL PROPERTY – patents – whether extension of term of patent valid – construction of ss 71(2)(b) and 77 of the Patents Act 1990 (Cth) (Patents Act) – consideration of history and purpose of Pt 3 of Ch 6 of the Patents Act - challenge to construction of s 70(5) in Pfizer Corp – appeal dismissed

Legislation: Acts Interpretation Act 1901 (Cth) s 15AA Patents Act 1990 (Cth) ss 2A, 13, 67, 70, 71, 72, 73, 74, 75, 76, 77, 78, 119A(1)(a)(ii), 133(2)(b), 192, 223, Sch 1 Therapeutic Goods Act 1989 (Cth) ss 9A, 17, 19B, 25, 26 Patents Regulations 1991 (Cth) reg 6.8 Therapeutic Goods Regulations 1990 (Cth) reg 10

Cases cited: Alcan (NT) Alumina Pty Ltd v Commissioner of Territory Revenue (Northern Territory) [2009] HCA 41; 239 CLR 27 Alphapharm Pty Ltd v H Lundbeck A/S [2008] FCA 559; 76 IPR 618 Alphapharm Pty Ltd v Lundbeck A/S [2014] HCA 42; 254 CLR 247 Australian Securities Commission v Marlborough Gold Mines Ltd [1993] HCA 15; 177 CLR 485 Commissioner of Patents v Ono Pharmaceutical Co. Ltd [2022] FCAFC 39 Director of Public Prosecutions v Leys [2012] VSCA 304; 44 VR 1 IW v City of Perth [1997] HCA 30; 191 CLR 1 Linkhill Pty Ltd v Director, Office of the Fair Work Building Inspectorate [2015] FCAFC 99; 240 FCR 578 Merck Sharp & Dohme Corp. v Sandoz Pty Ltd [2021] FCA 947; 162 IPR 409 Minister for Immigration, Citizenship, Migrant Services and Multicultural Affairs v FAK19 [2021] FCAFC 153 Ono Pharmaceutical Co, Ltd v Commissioner of Patents [2021] FCA 643 Pfizer Corp v Commissioner of Patents [2006] FCAFC 190; 155 FCR 578 R v A2 [2019] HCA 35; 269 CLR 507 Taylor v The Owners – Strata Plan No 11564 [2014] HCA 9; 253 CLR 531