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PATENTS ACT 1990 - SECT 136F PPI compulsory licences--terms

PATENTS ACT 1990 - SECT 136F

PPI compulsory licences--terms

  (1)   A PPI order must direct that the PPI compulsory licence is granted on the following terms:

  (a)   no more than the quantity of the pharmaceutical product that is determined by the Federal Court to be necessary to meet the needs of the eligible importing country is manufactured;

  (b)   the entirety of the pharmaceutical product manufactured for that purpose is exported to that country;

  (c)   the pharmaceutical product is labelled and marked in accordance with the regulations;

  (d)   before shipment of the pharmaceutical product begins, the shipment information prescribed by regulation is made available on a website by, or on behalf of, the licensee for a minimum period prescribed by regulation;

  (e)   the duration of the licence is only for the period of time determined by the Federal Court to be necessary to address the public health problem concerned;

  (f)   the licence does not give the licensee, or a person authorised by the licensee, the exclusive right to exploit the patented pharmaceutical invention;

  (g)   the licence is to be assignable only in connection with an enterprise or goodwill in connection with which the licence is used;

  (h)   the licensee must give the Commissioner the information prescribed by regulation in relation to the licence in accordance with the regulations.

  (2)   A PPI order may also direct that the licence is to be granted on any other terms specified in the order, including terms covering:

  (a)   other requirements relating to the labelling and marking of the pharmaceutical product; and

  (b)   other information to be made available by the licensee and the way in which it is to be made available.

  (3)   However, a term specified in a PPI order must not be inconsistent with any regulations prescribed for the purposes of paragraph   (1)(c), (d) or (h).