Commonwealth of Australia v Sanofi (formerly Sanofi-Aventis) (No 5)

• Jurisdiction: Australia Federal only
• Judge: NICHOLAS J
• Judgment Date: 28 April 2020
• Neutral Citation: [2020] FCA 543
• Court: Federal Court
• Date: 28 April 2020

FEDERAL COURT OF AUSTRALIA

Commonwealth of Australia v Sanofi (formerly Sanofi-Aventis)
(No 5) [2020] FCA 543

File number:	NSD 1639 of 2007
Judge:	NICHOLAS J
Date of judgment:	28 April 2020
Catchwords:	PRACTICE AND PROCEDURE – where usual undertaking as to damages given in relation to interlocutory injunction obtained by patentee restraining infringement of pharmaceutical patent – where interlocutory injunction restrained generic supplier from supplying generic medicine – where generic supplier also gave interlocutory undertaking to the Court not to take steps to cause its generic medicine to be listed under the Pharmaceutical Benefits Scheme (“PBS”) – where interlocutory undertaking was not the subject of any cross-undertaking as to damages – where final injunction subsequently granted against generic supplier by trial judge restraining it from supplying its generic medicine – where undertaking as to damages given in relation to final injunction as part of a package of undertakings to operate until determination of generic supplier’s appeal and patentee’s cross-appeal – where Full Court made orders setting aside final injunction and revoking patent – where claim for compensation under undertakings as to damages subsequently brought by generic supplier – where claim by generic supplier discontinued after it entered into settlement agreement with patentee – where Commonwealth claims against patentee for compensation under undertakings as to damages on the basis that it is a person adversely affected by interlocutory injunction and final injunction – where Commonwealth alleges loss and damage reflecting subsidies paid by it under PBS that it would not have paid had generic supplier obtained PBS listing of its generic medicine from 1 April 2008 – whether Commonwealth a person adversely affected by interlocutory injunction and final injunction – whether Commonwealth’s alleged loss and damage would have been suffered but for interlocutory injunction or final injunction – whether generic supplier would have taken steps to list its generic medicine on PBS in absence of interlocutory injunction or final injunction – significance of undertaking given by generic supplier not to take steps to obtain PBS listing of its generic medicine – whether evidence establishes that PBS listing of generic supplier’s medicine would have occurred but for the existence of the interlocutory injunction or final injunction – whether Commonwealth’s alleged loss and damage a direct and reasonably foreseeable result of interlocutory injunction or final injunction – significance of final injunction and undertaking as to damages given in relation to final injunction in relevant counterfactual analysis – whether loss claimed by Commonwealth compensable under undertaking as to damages – whether relief claimed by Commonwealth should be refused in whole or part on discretionary grounds on account of conduct that would have been engaged in under relevant counterfactual scenario involving infringement by generic supplier of patentee’s copyright in product information documents and alleged infringement of Canadian patent by generic supplier’s Canadian parent company and on public interest grounds ; Held: application for compensation dismissed
Legislation:	Copyright Act 1968 (Cth) s 44BA Federal Court of Australia Act 1976 (Cth) s 51A Federal Court Rules 1979 (Cth) O 58, r 14(1)(c) Federal Court Rules 2011 (Cth) r 16.08(b) National Health Act (1953) (Cth) ss 54, 84AD, 84AE, 84AF, 85, 85AB(5), 85AD, 99, 99ACB, 99ACC, 99ACH, 99ACI, 99AD, 99ADB(4)-(6), 99ADD, 99ADE, 99AEB, 99AEC, 99AED, 99AEE, 99AEF, 99AEG, 99AEH, 99AEJ, 100A, 101(3A) National Health Amendment (Pharmaceutical Benefits Scheme) Act 2007 (Cth) s 99ACF, s 99ACIA, Sch 2 National Health (Pharmaceutical Benefits) Regulations 1960 (Cth) reg 37C, reg 37F Therapeutics Good Act 1989 (Cth) s 26C(2) Therapeutic Goods Legislation Amendment (Copyright) Act 2011 (Cth) Therapeutic Goods Regulations 1990 (Cth) reg 9A(2)
Cases cited:	Advanced Building Systems v Ramset Fasteners (Aust) Pty Ltd (1997) 145 ALR 121 Air Express Ltd v Ansett Transport Industries (Operations) Pty Ltd (1981) 146 CLR 249 Barratt Manchester Ltd v Bolton Metropolitan Borough Council [1998] 1 All ER 1 Blatch v Archer (1774) 1 Cowp 63 Brandi v Mingot (1976) 12 ALR 551 British Westinghouse Electric and Manufacturing Company, Limited v Underground Electric Railways Company of London, Limited [1912] AC 673 C T Bowring & Co (Insurance) Ltd v Corsi Partners Ltd [1994] 2 Lloyd’s Rep 567 Commonwealth of Australia v Amann Aviation Pty Ltd (1991) 174 CLR 64 Commonwealth of Australia v Sanofi (formerly Sanofi-Aventis) [2017] FCA 382 Commonwealth v Sanofi (2015) 237 FCR 483 Eastman v The Queen (2008) 166 FCR 579 Elsinora Global Ltd v Deputy Commissioner of Taxation (2006) 155 FCR 413 European Bank Limited v Robb Evans of Robb Evans & Associates (2010) 240 CLR 432 Faulkner v Keffalinos (1970) 45 ALJR 80 Huddart, Parker & Co Pty Ltd v Moorehead (1909) 8 CLR 330 Isaacs v Robertson [1985] 1 AC 97 (PC) Jones v Dunkel (1959) 101 CLR 298 Love v Thwaites (No 4) [2012] VSC 521 Love v Thwaites [2014] VSCA 56 Malec v JC Hutton Pty Ltd (1990) 169 CLR 638 Manly Council v Byrne & Anor [2004] NSWCA 123 March v E & MH Stramare Pty Ltd (1991) 171 CLR 506 Minister for Aboriginal Affairs v Peko-Wallsend Ltd (1986) 162 CLR 24 Minnesota Mining & Manufacturing Company v Johnson & Johnson Limited [1976] FSR 139 Otsuka Pharmaceutical Co Ltd v Generic Health Pty Ltd [2015] FCA 848 Payne v Parker [1976] 1 NSWLR 191 Principal Strategic Options Pty Ltd v Coshott [2003] FCA 736 Red Bull Australia Pty Ltd v Sydneywide Distributors Pty Ltd [2001] FCA 1750 Roche Therapeutics Inc v GenRx Pty Ltd (2007) 71 IPR 546 Schlesinger v Bedford (1893) 9 TLR 370 Sellars v Adelaide Petroleum NL (1994) 179 CLR 332 Servier Laboratories (Australia) Pty Ltd v GenRx Pty Ltd [2006] FCA 1763 Smith v Day (1882) 21 Ch D 421 Specsavers Pty Ltd v The Optical Superstore Pty Ltd (No 3) (2012) 290 ALR 263 Thomson Publications (Australia) Pty Ltd v Trade Practices Commission (1979) 40 FLR 257 Warner-Lambert Company LLC v Apotex Pty Ltd (2017) 249 FCR 17 ; McGregor H, McGregor on Damages (19th ed, Sweet & Maxwell, 2014)
Date of hearing:	28-31 August, 1 September, 4-5 September, 7-8 September, 11 September, 18-20 September, 26-29 September 2017
Registry:	New South Wales
Division:	General Division
National Practice Area:	Intellectual Property
Sub-area:	Patents and associated Statutes
Category:	Catchwords
Number of paragraphs:	698
Counsel for the Applicant:	Mr PJ Brereton SC with Dr BR Kremer and Mr PM Knowles

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