7.12.1.5 Meaning of "in substance disclosed"

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＂
• 7.12.1.4 Meaning of ＂mixture or compound of substances＂
• ​​​​​​​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:

• s70 Applications for extension of patent  

The pharmaceutical substance on which an application for an extension of term is based must in substance be disclosed in the complete specification. The established criteria for determining whether a substance is "in substance disclosed" in the specification apply.  Thus, a substance that has been exemplified in the specification will prima facie have been in substance disclosed.  

However, the absence of any explicit examples does not necessarily mean that a substance is not in substance disclosed. The principles of Hoffman-La Roche & Co. AG v Commissioner of Patents (1971) CLR 529 should be applied. In this case, Gibbs J had to determine whether a specific compound was in substance disclosed in a basic application that contained a broad description of a class of compounds, but did not specifically exemplify the particular compound claimed. Gibbs J applied the Mond Nickel Rules from Re Mond Nickel Co. Ltd's Application [1956] RPC 189 and concluded that there was a clear disclosure of the compound in the basic application.

The issue of selection patents in the context of a request for an extension of term was considered in Pfizer Inc v Commissioner of Patents [2005] FCA 137. In this case, the ‘parent patent’ contained a generic disclosure of a compound that was the subject of a ‘selection patent’. It was held that the existence of the selection patent was irrelevant for the purpose of determining whether the parent patent satisfied the disclosure requirements of section 70(2).