Federal Court of Australia
FEDERAL COURT OF AUSTRALIA
Sandoz AG v Bayer Intellectual Property GmbH [2023] FCA 1321 File number(s): VID 683 of 2021
Judgment of: ROFE J
Date of judgment: 2 November 2023
Catchwords: PATENTS – infringement – where invention claimed is an oral tablet comprising the compound rivaroxaban "in hydrophilized form" and the use of that drug for the prophylaxis and/or treatment of a thromboembolic disease – construction of patent – meaning of "in hydrophilized form" and "hydrophilization" – whether pieces of prior art referred to in the specification are incorporated by reference PATENTS – validity – challenge to best method – incorrect PCT reference – principles regarding rectification of mistakes in patent specifications PATENTS – validity – lack of inventive step – consideration of s 7(3) of the Patents Act 1990 (Cth) – whether two pieces of prior art are s 7(3) documents – consideration of common general knowledge – whether invention was obvious in light of prior art – whether person skilled in the art could engage in pre-clinical testing and Phase I, II and III clinical trials without the identity or structure of the relevant compound – drug development journey for the compound was "voyage of discovery" not the undertaking of "routine steps PATENTS – validity – clarity – whether "plasma concentration half life" is sufficiently clear PATENTS – application to amend – typographical error – whether unreasonable delay – application granted under s 105 of the Act
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