Commonwealth of Australia v Sanofi (formerly Sanofi-Aventis) [2015] FCAFC 172

FEDERAL COURT OF AUSTRALIA

Commonwealth of Australia v Sanofi (formerly Sanofi-Aventis) [2015] FCAFC 172 Citation: Commonwealth of Australia v Sanofi (formerly Sanofi-Aventis) [2015] FCAFC 172

Parties: COMMONWEALTH OF AUSTRALIA v SANOFI (FORMERLY SANOFI-AVENTIS), SANOFI-AVENTIS US LLC and BRISTOL-MYERS SQUIBB INVESTCO LLC

File number: NSD 1639 of 2007

Parties: COMMONWEALTH OF AUSTRALIA v WYETH and WYETH AUSTRALIA PTY LTD

File numbers: VID 195 of 2009 NSD 596 of 2009 NSD 1124 of 2009

Judges: DOWSETT, KENNY AND NICHOLAS JJ

Date of judgment: 7 December 2015

Catchwords: PATENTS – where patentees obtain Australian Register of Therapeutic Goods ("ARTG") registrations for therapeutic goods having particular active components – where such goods are later listed on the Schedule of Pharmaceutical Benefits ("PBS Sch") – where suppliers of generic medicines provide certificates under s 26B(1) of the Therapeutic Goods Act 1989 (Cth) after expiration of data exclusivity period in order to obtain ARTG registrations in respect of their own products with same active components – where patentees obtain interlocutory injunctions restraining suppliers from supplying such products on basis that supply would infringe the patentees' patents – where patentees provide usual undertakings as to damages – where interlocutory injunctions alleged to have prevented suppliers from obtaining listing of their products on PBS Sch – where relevant claims of patents subsequently held invalid – where Commonwealth of Australia seeks to recover from patentees on their undertakings as to damages for losses it claims to have suffered as a result of suppliers being prevented by interlocutory injunctions from obtaining listing of their products on PBS Sch – whether Commonwealth precluded from recovering on the undertakings as to damages by reason of the operation of s 26B, s 26C and s 26D of the Act STATUTORY INTERPRETATION – whether on proper construction of Chapter 3, Part 3-2, Division 2 of the Therapeutic Goods Act 1989 (Cth) the Commonwealth is necessarily precluded from recovering compensation from patentees pursuant to their undertakings as to damages in circumstances where no declaration is or was sought pursuant to s 26D(4) of the Act – whether relevant statutory provisions establish an exhaustive statutory code limiting Commonwealth's rights to recover under undertakings as to damages given to Court by patentees PRACTICE AND PROCEDURE – purpose and scope of usual undertaking as to damages