Patents Act 1990

The patentee is to be paid an amount agreed or determined under subsection (3) in respect of the use of a patented pharmaceutical invention authorised by a PPI compulsory licence.

For the purposes of subsection (1), the use of a patented pharmaceutical invention authorised by the PPI compulsory licence is:

while it is in force—the use authorised by the licence as granted and as amended (from time to time) under section 136G; or

if it has ceased to be in force (whether because it was revoked or otherwise)—the actual use of the patented pharmaceutical invention under the licence while it was in force.

For the purposes of subsection (1), the amount is:

an amount agreed between the patentee and the PPI order applicant, licensee or former licensee (as the case requires); or

if paragraph (a) does not apply—an amount determined by the Federal Court to be adequate remuneration taking into account the economic value to the eligible importing country of the use of the patented pharmaceutical invention authorised by the PPI compulsory licence.

A person may apply to the Federal Court:

to make a determination under paragraph (3)(b); or

to amend a determination made under that paragraph.

Grounds for an application under paragraph (b) may include the fact that the terms of the PPI compulsory licence have been amended, or the licence has been revoked.

The following are parties to any proceedings under this section:

the applicant for the determination or the amendment of the determination;

the PPI order applicant;

the licensee;

the patentee of the patented pharmaceutical invention;

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

To avoid doubt, if the proposed use of the pharmaceutical product is to address a public health problem in the eligible importing country in circumstances of national emergency or other circumstances of extreme urgency, the licensee may exploit a patented pharmaceutical invention under a PPI compulsory licence, as granted or amended (as the case may be), whether or not an amount has been agreed or determined under this section.

However, if the proposed use of the pharmaceutical product is to address a public health problem in the eligible importing country in other circumstances, by the public non‑commercial use of the pharmaceutical product, the licensee must not exploit a patented pharmaceutical invention under a PPI compulsory licence unless an amount has been agreed or determined under this section.

To avoid doubt, a PPI compulsory licence may be revoked whether or not an amount has been agreed or determined under this section.