136EPPI compulsory licences—orders

#### 136E PPI compulsory licences—orders (1) After hearing an application for a PPI order under section 136D, the Federal Court may, subject to this Part, make the order sought if the court is satisfied of all of the following matters: (a) the application is made in good faith; (b) the pharmaceutical product is to be imported: (i) by the eligible importing country; or (ii) by a person (the third party importer) on behalf of, and with the authorisation of, the eligible importing country; (c) the proposed use of the pharmaceutical product is to address a public health problem in the eligible importing country: (i) in circumstances of national emergency or other circumstances of extreme urgency; or (ii) in other circumstances—by the public non‑commercial use of the pharmaceutical product; (d) exploiting the patented pharmaceutical invention is necessary to enable the import and proposed use of the pharmaceutical product as mentioned in paragraphs (b) and (c); (e) if subparagraph (c)(ii) applies: (i) the PPI order applicant has given the patentee a notice in the approved form seeking from the patentee an authorisation to exploit the patented pharmaceutical invention for public non‑commercial use; and (ii) during the 30 days beginning when the notice was given, the PPI order applicant has tried, without success, to obtain such an authorisation from the patentee on reasonable terms and conditions; (f) the notification requirements prescribed by regulation in relation to the importation of the pharmaceutical product into the eligible importing country have been complied with; (g) the PPI order applicant, the eligible importing country and, if there is a third party importer, that importer, will take reasonable measures to prevent a pharmaceutical product that is exported from Australia in accordance with a PPI compulsory licence from being used for a purpose other than the purpose of addressing the public health problem mentioned in paragraph (c). (2) Without limiting the matters that the court may take into account in deciding whether it is satisfied of a matter mentioned in subsection (1), the court must take into account any matters prescribed by regulation. (3) A regulation made for the purposes of paragraph (1)(f) may: (a) without limiting subsection 33(3A) of the Acts Interpretation Act 1901, prescribe different notification requirements for the importation of pharmaceutical products into eligible importing countries of different kinds; and (b) despite subsection 14(2) of the Legislation Act 2003, refer to eligible importing countries (or different kinds of eligible importing countries) by applying, adopting or incorporating, with or without modification, any matter contained in any other instrument or other writing as in force or existing from time to time.