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

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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

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