Pharmacia LLC v Juno Pharmaceuticals Pty Ltd

Pharmacia LLC initiated proceedings against Juno Pharmaceuticals Pty Ltd, alleging patent infringement concerning a standard patent related to a reconstitutable powder composition containing a cyclooxygenase-2 inhibitor intended for parenteral administration. The crux of the dispute revolved around the interpretation of patent claims, specifically whether they included or excluded residual water from the composition and the meaning of the term “about” as used in the claims. The case also addressed the validity of the patent, particularly whether it lacked an inventive step and if a proposed eight-step development pathway to the claimed invention was non-obvious. The respondents sought to amend their defence during the trial, which the appellants contested. Lastly, the appellants argued that the primary judge should have made specific declarations of infringement and costs orders as requested. The Federal Court of Australia was tasked with resolving these complex issues.

The court was required to decide several legal issues, including the proper construction of the patent claims to determine whether they included or excluded residual water, the interpretation of the term “about” in the claims, and whether the respondents' proposed development pathway demonstrated a lack of inventive step. Additionally, the court had to determine whether the primary judge erred in allowing the respondents to amend their defence during the trial and whether the primary judge should have made specific declarations of infringement and costs orders.

The court found no error in the primary judge's decision to permit the respondents to amend their defence during the trial. The appellants did not object seriously to certain amendments and did not demonstrate prejudice. Regarding the interpretation of the patent claims, the court held that the claims did not exclude residual water from the composition and that the term “about” was consistent with the prior art. The court also concluded that the respondents' proposed development pathway was non-obvious, thereby upholding the patent's validity. Lastly, the court found no error in the primary judge's decision not to make specific declarations of infringement and costs orders, as the parties had reached an agreement on the scope of infringement.

The appeal and cross-appeal were dismissed, with the appellants ordered to pay the respondents' costs of the appeal, and the cross-appellants ordered to pay the cross-respondents' costs of the cross-appeal. The primary judge's findings on patent infringement and validity were upheld, and the parties were directed to agree on the form of short minutes of order to reflect these reasons.