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US FREE TRADE AGREEMENT IMPLEMENTATION ACT 2004 NO. 120, 2004 - SCHEDULE 7

- Therapeutic goods amendments

Therapeutic Goods Act 1989

1 Subsection 25(3)

Repeal the subsection, substitute:

(3)
If:

(a) the therapeutic goods are therapeutic devices; and
(b) the evaluation of the goods for registration has been completed;

the Secretary must:

(c) notify the applicant in writing of his or her decision on the evaluation within 28 days of the making of the decision and, in the case of a decision not to register the goods, of the reasons for the decision; and
(d) if the decision is to register the goods—include the goods in the Register and give the applicant a certificate of registration.

(4)
If:

(a) the therapeutic goods are not therapeutic devices; and
(b) the evaluation of the goods for registration has been completed;

the Secretary must:

(c) notify the applicant in writing of his or her decision on the evaluation within 28 days of the making of the decision and, in the case of a decision not to register the goods, of the reasons for the decision; and
(d) if the decision is to register the goods:
(i) notify the applicant in writing that the goods will be included in the Register if the applicant gives the Secretary the certificate required under subsection 26B(1); and
(ii) include the goods in the Register and give the applicant a certificate of registration if the applicant gives the Secretary the certificate required under subsection 26B(1).

To avoid doubt, if the applicant gives the Secretary the certificate required under subsection 26B(1), the Secretary must include the goods in the Register under subparagraph (d)(ii) without inquiring into the correctness of the certificate.

(4A)
Civil proceedings do not lie against the Secretary (or a delegate of the Secretary) in respect of loss, damage or injury of any kind suffered by another person as a result of the Secretary (or the delegate) including therapeutic goods in the Register in reliance on a certificate required under subsection 26B(1).

2 After paragraph 26(1)(a)

Insert:

(aa) if goods are not therapeutic devices—the application is accompanied by the certificate required under subsection 26B(1); and

3 After subsection 26(1)

Insert:

(1A)
To avoid doubt, if:

(a) an application is made for the listing of therapeutic goods in relation to a person in accordance with section 23; and
(b) the application is accompanied by the certificate required under subsection 26B(1); and
(c) the other requirements in subsection (1) are met;

the Secretary must list the goods under subsection (1) without inquiring into the correctness of the certificate.

(1B)
Civil proceedings do not lie against the Secretary (or a delegate of the Secretary) in respect of loss, damage or injury of any kind suffered by another person as a result of the Secretary (or the delegate) listing therapeutic goods in relation to a person in reliance on a certificate required under subsection 26B(1).

4 After paragraph 26A(1)(a)

Insert:

(b) the application is accompanied by the certificate required under subsection 26B(1); and

5 After subsection 26A(1)

Insert:

(1A)
To avoid doubt, if:

(a) an application is made for the listing of a medicine in relation to a person in accordance with section 23; and
(b) the application is accompanied by the certificate required under subsection 26B(1); and
(c) the other requirements in subsection (1) are met;

the Secretary must list the medicine under subsection (1) without inquiring into the correctness of the certificate.

(1B)
Civil proceedings do not lie against the Secretary (or a delegate of the Secretary) in respect of loss, damage or injury of any kind suffered by another person as a result of the Secretary (or the delegate) listing a medicine in relation to a person in reliance on a certificate required under subsection 26B(1).

6 After section 26A

Insert:

26B Certificates required in relation to patents
(1)
The certificate required by this subsection is either:

(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
(b) a certificate to the effect that:
(i) a patent has been granted in relation to the therapeutic goods; and
(ii) the applicant proposes to market the therapeutic goods before the end of the term of the patent; and
(iii) the applicant has given the patentee notice of the application for registration or listing of the therapeutic goods under section 23.

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

(2)
A person is guilty of an offence if:

(a) the person gives a certificate required under subsection (1); and
(b) the certificate is false or misleading in a material particular.

Maximum penalty: 1,000 penalty units.

(3)
For the purposes of this section, a patent is taken to have been granted in relation to therapeutic goods if marketing the goods without the authority of the patentee would constitute an infringement of the patent.

(4)
In this section:

"patent" has the same meaning as in the Patents Act 1990 .

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 .

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 .

7 Application of amendments

(1) The amendments made by this Schedule apply to applications for registration or listing under section 23 of the Therapeutic Goods Act 1989 made on or after the day on which this Schedule commences.
(2) The amendments made by item 6 apply to legal proceedings commenced on or after the day on which this Schedule commences.


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