GlaxoSmithKline Consumer Healthcare Investments (Ireland) (No. 2) Limited v Apotex Pty Ltd [2016] FCA 608

FEDERAL COURT OF AUSTRALIA

GlaxoSmithKline Consumer Healthcare Investments (Ireland) (No. 2) Limited v Apotex Pty Ltd [2016] FCA 608 File numbers: VID 571 of 2014 VID 638 of 2014

Judge: BEACH J

Date of judgment: 31 May 2016

Catchwords: PATENTS – paracetamol – bilayer tablets – sustained release and immediate release layers – unique in vitro paracetamol dissolution profiles – dissolution testing apparatus – construction of the claims – common general knowledge – meaning of "the USP type III apparatus, reciprocating basket" – whether "reciprocating basket" a mistake or error in the claims and specification – whether claims to be construed as "reciprocating cylinder" – whether effect of construction is to re-write or amend the claims – meaning of "matrix forming polymer" – alleged infringement – whether respondents' products within claimed dissolution profile – whether respondents' products contained matrix forming polymer within the claims – infringement not made out – whether second applicant an exclusive licensee of the patent PATENTS – cross-claims for invalidity – alleged lack of fair basis – paracetamol content range – ratio of immediate release to sustained release – in vitro dissolution ranges – matrix forming polymer – alleged lack of sufficiency – matrix forming polymer – in vitro dissolution profile – apparatus – alleged lack of clarity – alleged failure to define the invention – alleged failure to describe the best method – high viscosity HPMC – granulation end point – alleged lack of inventive step – common general knowledge – impermissible use of hindsight – validity of the patent upheld

Legislation: Evidence Act 1995 (Cth) ss 48, 56, 57, 58, 135, 136, 183 Intellectual Property Laws Amendment (Raising the Bar) Act 2012 (Cth) Patents Act 1990 (Cth) ss 3, 7, 13(2), 18(1)(b)(ii), 40(2)(a), 40(2)(b), 40(3), Sch 1 Patents Amendment Act 2001 (Cth)