Mylan Health Pty Ltd v Sun Pharma ANZ Pty Ltd

• Jurisdiction: Australia Federal only
• Court: Federal Court
• Judgment Date: 03 July 2020
• Neutral Citation: [2020] FCAFC 116
• Date: 03 July 2020

FEDERAL COURT OF AUSTRALIA

Mylan Health Pty Ltd v Sun Pharma ANZ Pty Ltd [2020] FCAFC 116

Appeal from:	Mylan Health Pty Ltd (formerly BGP Products Pty Ltd) v Sun Pharma ANZ Pty Ltd (formerly Ranbaxy Australia Pty Ltd) [2019] FCA 28
File number:	NSD 182 of 2019
Judges:	MIDDLETON, JAGOT, YATES, BEACH AND MOSHINSKY JJ
Date of judgment:	3 July 2020
Catchwords:	PATENTS – infringement – Swiss type claims – whether mental element imported into claims – whether it is necessary to establish manufacturer’s intention to prove infringement – discussion of correct approach to determining infringement ; PATENTS – validity – lack of novelty – prior publication of documents – correct test for determining lack of novelty – whether there can be anticipatory disclosure by prior publication of the invention based on a reasoned hypothesis ; PATENTS – validity – lack of inventive step – where case presented on basis of common general knowledge and documentary disclosure – whether primary judge erred in finding lack of inventive step on basis of common general knowledge alone ; PATENTS – validity – whether claims fairly based on the matter described in the specification – proper construction of the specification
Legislation:	Intellectual Property Laws Amendment (Raising the Bar) Act 2012 (Cth) Patents Act 1990 (Cth) ss 7(1)(a), 7(1)(b), 7(2), 7(3), 13(1), 40(3), 117(1), 117(2)(b) Therapeutic Goods Act 1989 (Cth) s 9D(2) Patents Act 1977 (UK) ss 125(1), 125(3) European Patent Convention 2000
Cases cited:	Aktiebolaget Hässle v Alphapharm Pty Ltd [2002] HCA 59; 212 CLR 411 Aldi Foods Pty Ltd v Moroccanoil Israel Ltd [2018] FCAFC 93; 133 IPR 375 Apotex Pty Ltd v Sanofi-Aventis [2008] FCA 1194; 78 IPR 485 Apotex Pty Ltd v Sanofi-Aventis Australia Pty Ltd [2013] HCA 50; 253 CLR 284 Apotex Pty Ltd v Warner-Lambert Company LLC (No 2) [2016] FCA 1238; 122 IPR 17 AstraZeneca AB v Apotex Pty Ltd [2014] FCAFC 99; 226 FCR 324 Branir Pty Ltd v Owston Nominees (No 2) Pty Ltd [2001] FCA 1833; 117 FCR 424 Bristol-Myers Squibb Company v FH Faulding & Company Limited [2000]FCA 316; 97 FCR 524 Bristol-Myers Squibb Co v FH Faulding & Co Ltd (1998) 41 IPR 467 Flour Oxidizing Company Ltd v Carr & Company Ltd (1908) 25 RPC 428 General Tire & Rubber Co Ltd v Firestone Tyre & Rubber Co Ltd [1972] RPC 457 Generic Health Pty Ltd v Bayer Pharma Aktiengesellschaft [2014] FCAFC 73; 222 FCR 336 Generic Health Pty Ltd v Bayer Pharma Aktiengesellschaft [2018] FCAFC 183; 267 FCR 428 Generics (UK) v Warner-Lambert Company LLC [2018] UKSC 56; [2018] RPC 21 Hill v Evans (1862) 31 LJ Ch 456; 4 De GF & J 288; 45 ER 1195 Hospira UK Ltd v Genentech Inc [2014] EWHC 1094 (Pat) Hospira UK Limited v Genentech Inc [2015] EWHC 1796 (Pat); [2016] RPC 1 ICI Chemicals & Polymers Ltd v Lubrizol Corporation Inc [2000] FCA 1349; 106 FCR 214 InterPharma Pty Ltd v Hospira, Inc (No 5) [2019] FCA 960; 149 IPR 182 Lockwood Security Products Pty Limited v Doric Products Pty Ltd (No 1) [2004] HCA 58; 217 CLR 274 Lockwood Security Products Pty Ltd v Doric Products Pty Ltd (No 2) [2007] HCA 21; 235 CLR 173 Merck & Co Inc v Arrow Pharmaceuticals Ltd [2006] FCAFC 91; 154 FCR 31 Meyers Taylor Pty Ltd v Vicarr Industries Ltd (1977) 137 CLR 228 Minnesota Mining and Manufacturing Co v Beiersdorf (Australia) Ltd (1980) 144 CLR 253 Mylan Health Pty Ltd (formerly BGP Products Pty Ltd) v Sun Pharma ANZ Pty Ltd (formerly Ranbaxy Australia Pty Ltd) [2019] FCA 28; 138 IPR 402 Mylan Health Pty Ltd v Sun Pharma ANZ Pty Ltd (No 2) [2019] FCA 505; 141 IPR 26 Nicaro Holdings Pty Ltd v Martin Engineering Co (1990) 91 ALR 513 Optical 88 Ltd v Optical 88 Pty Ltd [2011] FCAFC 130; 197 FCR 67 Otsuka Pharmaceutical Co. Ltd v Generic Health Pty Ltd (No 4) [2015] FCA 634; 113 IPR 191 Raleigh Cycle Co Ltd v H Miller & Co Ltd [No 1] (1946) 63 RPC 113 Regeneron Pharmaceuticals Inc v Genentech Inc [2012] EWHC 657 (Pat) Sigma Pharmaceuticals (Australia) Pty Ltd v Wyeth [2011] FCAFC 132; (2011) 119 IPR 194 Warner-Lambert Company LLC v Apotex Pty Ltd (No 2) [2018] FCAFC 26; 129 IPR 205
Date of hearing:	5-7 February 2020
Date of last submissions:	3 March 2020
Registry:	New South Wales
Division:	General Division
National Practice Area:	Intellectual Property
Sub-area:	Patents and associated Statutes
Category:	Catchwords
Number of paragraphs:	588
Counsel for the Appellants:	Mr B Caine QC with Mr T Cordiner QC and Mr J Cooke
Solicitor for the Appellants:	Minter Ellison
Counsel for the First Respondent:	Mr N Murray SC with Ms C Cunliffe
Solicitor for the First Respondent:	Ashurst Australia
Counsel for the Second Respondent:	The second respondent filed a submitting notice

ORDERS

		NSD 182 of 2019
BETWEEN:	MYLAN HEALTH PTY LTD First Appellant ; BGP PRODUCTS OPERATIONS GMBH Second Appellant
AND:	SUN PHARMA ANZ PTY LTD First Respondent ; ALKERMES PHARMA IRELAND LIMITED Second Respondent

JUDGES:	MIDDLETON, JAGOT, YATES, BEACH AND MOSHINSKY JJ
DATE OF ORDER:	3 JULY 2020

THE COURT ORDERS THAT:

1. The appeal be dismissed.

2. The first respondent’s notice of contention be dismissed.

3. The appellants pay the first respondent’s costs.

Note: Entry of orders is dealt with in Rule 39.32 of the Federal Court Rules 2011.

REASONS FOR JUDGMENT

INTRODUCTION	[1]
Some Medical Conditions	[16]
The 711 patent: Background	[32]
The complete specification	[32]
Relevant claims	[37]
The 711 Patent: Prior art	[44]
The ACCORD Eye Study Protocol	[44]
ETDRS 22	[51]
The 711 patent: Grounds 5 – 7	[59]
The primary judge’s reasons	[59]
The appeal	[66]
Discussion	[73]
The 711 patent: Grounds 10 – 15	[112]
The primary judge’s reasons	[112]
The appeal	[123]
Discussion	[143]
The 711 Patent: Grounds 1 – 4	[175]
The primary judge’s reasons	[175]
The appeal	[185]
Discussion	[193]
The 711 patent: notice of contention	[232]
The 807 patent: background	[237]
Introduction	[237]
The complete specification	[249]
Relevant claims	[302]
The 807 Patent: Section...