Sun Pharma ANZ Pty Ltd v Otsuka Pharmaceutical Co Ltd [2025] FCA 44

FEDERAL COURT OF AUSTRALIA Sun Pharma ANZ Pty Ltd v Otsuka Pharmaceutical Co Ltd [2025] FCA 44 File number(s):

Judgment of: DOWNES J

Date of judgment: 5 February 2025

Catchwords: PATENTS – patent for controlled release aripiprazole formulations and methods for preparing and using such formulations – validity of extension of term of patent – validity of claims – whether pharmaceutical substance per se – whether pharmaceutical substance can include formulations – whether formulations can only include substances which have therapeutic use – whether pharmaceutical substances fall within scope of claims within meaning of s 70(2) Patents Act 1990 (Cth) – whether goods on the Australian Register of Therapeutic Goods take all of the features of the pharmaceutical substance as required by s 70(3) Patents Act 1990 (Cth) PATENTS – whether claims limited by result – validity of claims – whether claims should be revoked for lack of clarity and lack of definition – s 40(2)(b) Patents Act 1990 (Cth) – s 40(3) Patents Act 1990 (Cth)

Legislation: Competition and Consumer Act 2010 (Cth) Sch 2 (Australian Consumer Law) s 18 Patents Act 1990 (Cth) ss 40(2)(b), 40(3), 70, 70(2), 70(3), 78, 192

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