Australia's Patents Act provides an extension of term to account for the lengthy delays that can occur when seeking regulatory approval for a new pharmaceutical substance. The extension can last for up to five years beyond the normal 20-year term of a patent and is available in circumstances where:

• One or more pharmaceutical substances per se (or one or more pharmaceutical substances when produced by a process that involves the use of recombinant DNA technology) is in substance disclosed in the patent specification and in substance falls within the scope of the claims;
• Goods containing, or consisting of, the substance are included in the Australian Register of Therapeutic Goods (ARTG); and
• The period beginning on the effective filing date of the patent application and ending on the first regulatory approval date for the substance is at least five years.

Pharma Mar S.A. [2020] APO 8 concerns an application for an extension of term for a patent claiming:

A pharmaceutical composition of a didemnin compound, comprising firstly a lyophilised didemnin preparation including water-soluble material and secondly a reconstitution solution of mixed solvents.

The patentee's request was based on the ARTG registration of APLIDIN; a two-part mixture of plitidepsin powder and reconstitution solvent.

The Delegate of the Commissioner of Patents first construed claim 1, finding that it did not define a 'composition' in the sense of an admixture of components. Rather, claim 1 was construed as encompassing a two-part mixture including, firstly, a lyophilised didemnin preparation and a water-soluble material and, secondly, a reconstitution solution of mixed solvents. APLIDIN was therefore considered to in substance fall within the scope of the claim.

All that remained, then, was to determine whether the admixture defined by claim 1 is a pharmaceutical substance per se within the meaning of the Patents Act. The Delegate acknowledged that new formulations of known actives in the form of tablets or solutions can be considered pharmaceutical substances per se and can provide the basis for a patent term extension. But claim 1 was not considered to define an integrated dosage form. Claim 1 was considered to define a 'deconstructed' combination intended for later reconstitution. In other words, claim 1 defines the 'antecedent' to the pharmaceutical substance and not the pharmaceutical substance itself. The patentee's application for an extension of term was therefore refused.