Pharmacia LLC v Juno Pharmaceuticals Pty Ltd [2022] FCA 92

Federal Court of Australia Pharmacia LLC v Juno Pharmaceuticals Pty Ltd [2022] FCA 92 File number: NSD 1370 of 2019

Judgment of: BURLEY J

Date of judgment: 15 February 2022

Catchwords: PATENTS – standard patent claiming reconstitutable powder composition containing a cyclooxygenase-2 inhibitor for parenteral administration – infringement – validity PATENTS – infringement – where respondents manufacture and sell competitor product to applicants – where respondents provided applicants with representative documents relating to six batches of parecoxib sodium product – claim construction – meaning of "about", "therapeutic agent" and "essentially" as used in claims – whether claims include or exclude residual water from the composition – whether omnibus claim infringed – certain batches found to be within scope of asserted claims PATENTS – validity – lack of inventive step – where respondents put forward eight-step development pathway leading to claimed invention – composition of hypothetical skilled team – whether prior art information could be reasonably expected to have been ascertained – where parties accepted that hypothetical team would first attempt to formulate as a "ready to use" composition before moving to consider a lyophilised formulation – whether hypothetical team would persist with "ready to use" formulation – whether hypothetical team would use a bulking agent in lyophilised formulation – lack of inventive step challenge rejected PATENTS – validity – lack of clarity and definition – whether word "essentially" rendered claim unclear – grounds of invalidity not established PATENTS – relief – where patent expires within two months of delivery of judgment – whether injunction restraining exploitation of invention appropriate – injunction appropriate in circumstances