Infringement exemptions: acts for obtaining regulatory approval of pharmaceuticals
119A Infringement exemptions: acts for obtaining regulatory approval of pharmaceuticals
The rights of a patentee of a pharmaceutical patent are not infringed by a person exploiting an invention claimed in the patent if the exploitation is solely for:
purposes connected with obtaining the inclusion in the Australian Register of Therapeutic Goods of goods that:
are intended for therapeutic use; and
are not medical devices as defined in the Therapeutic Goods Act 1989; or
purposes connected with obtaining similar regulatory approval under a law of a foreign country or of a part of a foreign country.
Subsection (1) does not apply to the export from Australia of goods for purposes described in paragraph (1)(b) unless the term of the patent has been extended under Part 3 of Chapter 6 and the goods consist of or contain:
a pharmaceutical substance per se that is in substance disclosed in the complete specification of the patent and in substance falls within the scope of the claim or claims of that specification; or
a pharmaceutical substance when produced by a process that involves the use of recombinant DNA technology, that is in substance disclosed in the complete specification of the patent and in substance falls within the scope of the claim or claims of that specification.
Part 3 of Chapter 6 provides for the extension of the term of standard patents claiming pharmaceutical substances.
In this section:
pharmaceutical patent means a patent claiming:
a pharmaceutical substance; or
a method, use or product relating to a pharmaceutical substance, including any of the following:
a method for producing a raw material needed to produce the substance;
a product that is a raw material needed to produce the substance;
a product that is a pro‑drug, metabolite or derivative of the substance.
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