IPA patent 7.12.1.2-meaning-of-pharmaceutical-substance — IP Australia Patent Manual of Practice and Procedure – 7.12.1.2 Meaning of Pharmaceutical Substance

Also in this Chapter: ​​​​​​​​​​​​​ 7.12.1.1 Pharmaceutical Substance per se ​​​​​​​ 7.12.1.3 Meaning of ＂when produced by a process that involves the use of recombinant DNA technology＂ 7.12.1.4 Meaning of ＂mixture or compound of substances＂ 7.12.1.5 Meaning of ＂in substance disclosed＂ 7.12.1.6 Meaning of ＂in substance fall within the scope of the claim＂ 7.12.1.7 Included in the Goods 7.12.1.8 First Regulatory Approval Date Key Legislation: Patents Act: Schedule 1 Dictionary Schedule 1 defines a pharmaceutical substance as follows: "pharmaceutical substance means a substance (including a mixture or compound of substances) for therapeutic use whose application (or one of whose applications) involves: (a) a chemical interaction, or physico-chemical interaction, with a human physiological system; or (b) action on an infectious agent, or on a toxin or other poison, in a human body; but does not include a substance that is solely for use in in vitro diagnosis or in vitro testing”. From this definition, the substance must have at least one therapeutic use, which is defined in schedule 1 as follows: "therapeutic use means use for the purpose of: (a) preventing, diagnosing, curing or alleviating a disease, ailment, defect or injury in persons; or (b) influencing, inhibiting or modifying a physiological process in persons; or (c) testing the susceptibility of persons to a disease or ailment”. If a substance is listed in the ARTG, there is a prima facie assumption that the substance is a pharmaceutical substance, and therefore the Commissioner is unlikely to query whether a substance is a pharmaceutical substance within the meaning of the Act without good reason.