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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 sec 70(2).

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