Commonwealth Consolidated Acts Commonwealth Consolidated Acts(1) The patentee of a standard patent may apply to the Commissioner for an extension of the term of the patent if the requirements set out in subsections (2), (3) and (4) are satisfied.
(2) Either or both of the following conditions must be satisfied:
(a) one or more pharmaceutical substances per se must in substance be disclosed in the complete specification of the patent and in substance fall within the scope of the claim or claims of that specification;
(b) one or more pharmaceutical substances when produced by a process that involves the use of recombinant DNA technology, must in substance be disclosed in the complete specification of the patent and in substance fall within the scope of the claim or claims of that specification.
(3) Both of the following conditions must be satisfied in relation to at least one of those pharmaceutical substances:
(a) goods containing, or consisting of, the substance must be included in the Australian Register of Therapeutic Goods;
(b) the period beginning on the date of the patent and ending on the first regulatory approval date for the substance must be at least 5 years.
Note: Section 65 sets out the date of a patent.
(4) The term of the patent must not have been previously extended under this Part.
Meaning of first regulatory approval date
(5) For the purposes of this section, the first regulatory approval date , in relation to a pharmaceutical substance, is:
(a) if no pre - TGA marketing approval was given in relation to the substance--the date of commencement of the first inclusion in the Australian Register of Therapeutic Goods of goods that contain, or consist of, the substance; or
(b) if pre - TGA marketing approval was given in relation to the substance--the date of the first approval.
(5A) For the purposes of paragraph (5)(a), disregard an inclusion in the Australian Register of Therapeutic Goods of goods that contain, or consist of, a pharmaceutical substance if the inclusion was sought for the sole purpose of exporting the goods from Australia to address a public health problem in an eligible importing country:
(a) in circumstances of national emergency or other circumstances of extreme urgency; or
(b) by the public non - commercial use of the goods.
Note: This subsection also applies in relation to an application for an extension of the term of a standard patent (see paragraph 71(2)(b)).
Meaning of pre - TGA marketing approval
(6) For the purposes of this section, pre - TGA marketing approval , in relation to a pharmaceutical substance, is an approval (however described) by a Minister, or a Secretary of a Department, to:
(a) market the substance, or a product containing the substance, in Australia; or
(b) import into Australia, for general marketing, the substance or a product containing the substance.