Patents Act 1990

A person (the PPI order applicant) may apply to the Federal Court for an order (the PPI order) under section 136E requiring the patentee of a patented pharmaceutical invention to grant the PPI order applicant a licence (a PPI compulsory licence) to exploit the invention to the extent necessary for the purposes of manufacturing a pharmaceutical product in Australia for export to an eligible importing country.

A patented pharmaceutical invention may be a patented product or a patented process: see the definition of patented pharmaceutical invention in Schedule 1.

For remuneration in respect of a licence, see section 136J.

However, a person cannot apply for an order in respect of an innovation patent unless the patent has been certified.

An application must include a copy of a statement made by or on behalf of, and with the authorisation of, the eligible importing country to the effect that it will take reasonable measures within its means, proportionate to its administrative capacities and to the risk of trade diversion, to prevent re‑exportation from its territory of a pharmaceutical product imported into its territory in accordance with a PPI compulsory licence.

If the pharmaceutical product is to be imported on behalf of, and with the authorisation of, the eligible importing country, an application must also include a copy of a statement made by the importer to the effect that it will take reasonable measures within its means to prevent the pharmaceutical product from being used other than in accordance with a PPI compulsory licence.

The following are parties to proceedings on an application under this section:

the PPI order applicant;

the patentee;

any person claiming an interest in the patent as exclusive licensee or otherwise;

at the option of the eligible importing country—that country.