Otsuka v Sun Pharma [2025] FCAFC 161
This case raises whether a statutory definition may change in meaning when provisions to which it relates are later amended. Otsuka sought extension of its aripiprazole patent on the basis that other ‘pharmaceutical substances’ were disclosed in the patent specification. A ‘pharmaceutical substance’ is defined as a ‘substance … for therapeutic use …’4
It was held that the ‘formulations’ in question fell outside this definition, the meaning of which was unchanged by amendments – extension refused. The interest in this case lies in the principles applied in assessing change of meaning5, and the impact of a protracted failure of parliament to amend the law6.
This principle is from Episode 128 of interpretation NOW!
Footnotes:
4 s 70(2)(a) Patents Act 1990 (Cth); definition found in Schedule 1.
5 [187-190], Elder’s (1936) 57 CLR 610 (625-626), Grain (1946) 73 CLR 70 (86).
6 [207], Probuild [2018] HCA 4 [52], Cunneen [2015] HCA 14 [113].