IPA patent 7.12.1.4-meaning-of--mixture-or-compound-of-substances- — IP Australia Patent Manual of Practice and Procedure – 7.12.1.4 Meaning of "mixture or compound of substances"

Also in this Chapter: 7.12.1.1 Pharmaceutical Substance per se 7.12.1.2 Meaning of Pharmaceutical Substance 7.12.1.3 Meaning of “when produced by a process that involves the use of recombinant DNA technology” 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 The definition of a “pharmaceutical substance” provided in schedule 1 refers to: "a substance (including a mixture or compound of substances) for therapeutic use …”. Other than the passing remarks made by Burchett J that the expression “a mixture or compound of substances” was unusual in a scientific context ( Virbac (Australia) Pty Limited and Ancare Distributors Limited v Merck Patent GmbH [1994] FCA 1255), this phrase has not been the subject of judicial consideration. A pharmaceutical substance was defined as the pharmaceutical active ingredient in Otsuka Pharmaceutical Co Ltd v Sun Pharma ANZ Pty Ltd [2025] FCAFC 161. Consequently, a mixture or compound of substances would be a mixture or compound of pharmaceutical active ingredients. The term does not include formulations or compositions of pharmaceutical active ingredients with excipients and/or carriers. Where the claim is directed to a mixture or compound of substances, the same must also be found in the relevant ARTG goods.