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THERAPEUTIC GOODS ACT 1989 - SECT 26D

Requirements for interlocutory injunction

  (1)   This section applies where:

  (a)   an applicant gives notice to a patentee in accordance with subparagraph   26B(1)(b)(iii); and

  (b)   the patentee and/or its exclusive licensee (in this section the party or parties is or are referred to as the patentee ) applies to a prescribed court for an interlocutory injunction to restrain the applicant from marketing the therapeutic goods the subject of the application on the ground that such conduct will constitute an infringement of its patent.

  (2)   An application for interlocutory relief in accordance with subsection   (1) may not be instituted unless the patentee has first notified the Attorney - General of the Commonwealth, or of a State or of a Territory, in writing of the application.

  (3)   The Attorney - General of the Commonwealth shall be deemed to be a party to any proceedings commenced in accordance with subsection   (1) unless the Attorney - General gives written notice to the prescribed court that he or she does not desire to be a party.

  (4)   If an interlocutory injunction is granted pursuant to an application made as described in subsection   (1) and:

  (a)   the patentee subsequently discontinues the principal proceedings without the consent of the other parties thereto; or

  (b)   the principal proceedings are dismissed; and

  (c)   in either case, the prescribed court declares that:

  (i)   the patentee did not have reasonable grounds, in all the circumstances known to the patentee or which ought reasonably have been known to the patentee:

  (A)   to believe that it would be granted final relief by the prescribed court against the applicant referred to in paragraph   (1)(a) for infringement by that person of the patent; or

  (B)   (in addition to the fact of grant of the patent), for believing that each of the claims, in respect of which infringement is alleged in the proceedings, would have a reasonable prospect of being held to be valid if challenged by the applicant referred to in paragraph   (1)(a); or

  (ii)   the application for the interlocutory injunction was otherwise vexatious or not reasonably made or pursued;

the prescribed court may, in addition to any other relief which it believes should be granted to any person, make any of the orders described in subsection   (5).

  (5)   If the prescribed court makes a declaration pursuant to paragraph   (4)(c), the prescribed court may, pursuant to the usual undertaking as to damages given by the patentee to the prescribed court to obtain the interlocutory injunction:

  (a)   assess and award compensation to the applicant referred to in paragraph   (1)(a) against whom the interlocutory injunction was made :

  (i)   on the basis of an account of the gross profits of the patentee arising from the sale by it in Australia of the therapeutic goods the subject of the interlocutory injunction, during the period of the interlocutory injunction, without requiring the said applicant to establish or quantify its actual loss; or

  (ii)   on such other basis as the court determines to be appropriate; and

  (b)   award to the Commonwealth compensation for any damages sustained, or costs incurred, by it as a result of the grant of the interlocutory injunction; and

  (c)   award to a State or a Territory compensation for any damages sustained, or costs incurred, by it as a result of the grant of the interlocutory injunction.

  (6)   In this section:

"prescribed court" has the same meaning as in the Patents Act 1990 .



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