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US Free Trade Agreement Implementation Bill 2004

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2002-2003-2004

 

 

THE PARLIAMENT OF THE COMMONWEALTH OF AUSTRALIA

 

 

THE SENATE

 

 

US Free Trade Agreement Implementation Bill 2004

 

 

Schedule of the amendments made by the Senate

 

 

 

 

 

(1)     Govt (1) [Sheet QS266]

          Clause 2, page 4 (at the end of the table), add:

21. Schedule 10

The day on which this Act receives the Royal Assent.

 

(2)     Opp (1) [Sheet 4371]

          Schedule 7, item 6, page 82 (lines 19 to 22), omit paragraph 26B(1)(a), substitute:

                     (a)  a certificate to the effect that the applicant, acting in good faith, believes on reasonable grounds that it is not marketing, and does not propose to market, the therapeutic goods in a manner, or in circumstances, that would infringe a valid claim of a patent that has been granted in relation to the therapeutic goods; or

(3)     Opp (2) [Sheet 4371]

          Schedule 7, item 6, page 83 (after line 8), after section 26B, insert:

26C  Certificates required in relation to patent infringement proceedings

             (1)  This section applies if:

                     (a)  a person gives a certificate required under subsection 26B(1) in relation to therapeutic goods; and

                     (b)  another person (the second person ) intends to commence proceedings under the Patents Act 1990 against the person referred to in paragraph (1)(a) for infringement of a patent that has been granted in relation to the therapeutic goods (the proceedings ).

             (2)  The second person, before the date upon which the proceedings are commenced, must give to the Secretary and to the person referred to in paragraph (1)(a) the certificate required by subsection (3).

             (3)  The certificate required by this subsection is a certificate to the effect that the proceedings:

                     (a)  are to be commenced in good faith; and

                     (b)  have reasonable prospects of success; and

                     (c)  will be conducted without unreasonable delay.

The certificate must be signed by, or on behalf of, the second person and must be in a form approved by the Secretary.

             (4)  For the purpose of paragraph (3)(b), proceedings have reasonable prospects of success if:

                     (a)  the second person had reasonable grounds in all the circumstances known to the second person, or which ought reasonably to have been known to the second person (in addition to the fact of grant of the patent), for believing that he or she would be entitled to be granted final relief by the court against the person referred to in paragraph (1)(a) for infringement by that person of the patent; and

                     (b)  the second person had reasonable grounds in all the circumstances known to the second person, or which ought reasonably to have been known to the second person (in addition to the fact of grant of the patent), for believing that each of the claims, in respect of which infringement is alleged, is valid; and

                     (c)  the proceedings are not otherwise vexatious or unreasonably pursued.

             (5)  The person referred to in paragraph (1)(a), with leave of the court, or the Attorney-General, may apply to a prescribed court for an order that the second person pay to the Commonwealth a pecuniary penalty if the second person gives a certificate required under subsection (3) and:

                     (a)  the certificate is false or misleading in a material particular; or

                     (b)  the second person breaches an undertaking given in the certificate.

Maximum penalty: $10,000,000.

             (6)  When determining the extent of a pecuniary penalty to be ordered pursuant to subsection (5), the court must take into account:

                     (a)  any profit obtained by the second person; and

                     (b)  any loss or damage suffered by any person;

by reason of the second person exploiting the patent during the proceedings.

             (7)  For the avoidance of doubt, subsection (6) does not limit the matters the court may take into account when determining a pecuniary penalty ordered pursuant to subsection (5).

             (8)  If:

                     (a)  the second person has sought and obtained in the proceedings an interlocutory injunction restraining the person referred to in paragraph (1)(a) from infringing a patent; and

                     (b)  section 26D does not apply; and

                     (c)  a prescribed court declares that the second person has given a certificate required under subsection (3); and

                     (d)  a prescribed court declares that:

                              (i)  the certificate is false or misleading in a material particular; or

                             (ii)  the second person has breached an undertaking given in the certificate;

the prescribed court may, pursuant to this section, order that the second person pay to the Commonwealth, a State or a Territory compensation for any damages sustained or costs incurred by the Commonwealth, a State or a Territory as a result of the grant of the interlocutory injunction.

             (9)  In this section:

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



(4)     Opp (3) [Sheet 4371]

          Schedule 7, item 6, page 83 (after line 8), after section 26B, insert:

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 .

(5)     Opp (4) [Sheet 4371]

          Schedule 7, item 7, page 83 (after line 12), at the end of the item, add:

(2)               The amendments made by item 6 apply to legal proceedings commenced on or after the day on which this Schedule commences.

(6)     Govt (2) [Sheet QS266]

          Page 163 (after line 27), at the end of the bill, add:

Schedule 10 Broadcasting amendments

   

Broadcasting Services Act 1992

1  At the end of section 122

Add:

             (5)  The ABA must ensure that, at all times after the commencement of this subsection, there is in force under subsection (1) a standard that is, or has the same effect as, the standard in section 9 of the Broadcasting Services (Australian Content) Standard 1999 as in force on 4 August 2004.

Note:          Section 9 of the Broadcasting Services (Australian Content) Standard 1999 deals with quotas for Australian television programs.

             (6)  The ABA must ensure that, at all times after the commencement of this subsection, there is in force under subsection (1) a standard that is, or has the same effect as, the standard in section 5 of Television Program Standard 23—Australian Content in Advertising as in force on 4 August 2004.

Note:          Section 5 of Television Program Standard 23—Australian Content in Advertising deals with quotas for Australian television advertisements.

 

 

 

 

 

HARRY EVANS

Clerk of the Senate

 

The Senate

13 August 2004