Patents Amendment Regulations 1998 (No. 8) (Cth)

Patents Amendment Regulations 1998 (No. 8)

Statutory Rules 1998No. 319

I, WILLIAM PATRICK DEANE, Governor-General of the Commonwealth of Australia, acting with the advice of the Federal Executive Council, make the following regulations under thePatents Act 1990.

Dated 24 November 1998.

WILLIAM DEANE

Governor-General

By His Excellency’s Command,

nick minchin

Minister for Industry, Science and Resources

Patents Amendment Regulations 1998 (No. 8)1

Statutory Rules 1998No. 3192

made under the

Patents Act 1990

   

Contents

Page

• •
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1Name of regulations

 These regulations are the Patents Amendment Regulations 1998 (No. 8).

2Commencement

These regulations commence on the date of commencement of Schedule 1 to the Intellectual Property Laws Amendment Act 1998.

3Amendment of Patents Regulations 1991

Schedule 1 amends the Patents Regulations 1991.

Schedule 1Amendments of Patents Regulations 1991

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[1]After subparagraph 5.1 (a) (i)

insert

• (ii)

  section 75 (opposition to grant of extension);

[2]After subregulation 5.3 (1)

insert

• (2)

  The Minister or other person who intends to oppose the grant of an extension of the term of a standard patent under section 75 of the Act (opposition to grant of extension) must file a notice of opposition in the approved form within 3 months of publication in the Official Journal of the notice of acceptance under section 74 of the Act (acceptance or refusal of application).

[3]Before regulation 6.1

insert

Part 1Patents generally

[4]After regulation 6.6

insert

Part 2Extension of pharmaceutical patents

6.7Definitions

 In this Part:

pre-TGA marketing approval has the same meaning as in section 70 of the Act.

6.8Information to accompany application

• (1)

  This regulation applies to an application under section 70 of the Act for an extension of the term of a standard patent for a pharmaceutical substance.

• (2)

  For paragraph 71 (1) (c) of the Act, the application must be accompanied by information showing that goods containing, or consisting of, the substance are currently included in the Australian Register of Therapeutic Goods.

• (3)

  The application must also be accompanied by information identifying the substance, as it occurs in those goods, in the same way (as far as possible) as the substance is identified in the complete specification of the patent.

6.9Application without pre-TGA marketing approval

• (1)

  This regulation applies to an application under section 70 of the Act for an extension of the term of a standard patent for a pharmaceutical substance for which pre-TGA marketing approval has not been given.

• (2)

  For paragraphs 71 (1) (b) and (c) of the Act, the application must be accompanied by:

  • (a)

    a certificate under paragraph 25 (3) (b) or subsection 26 (4) or 26A (9) of the Therapeutic Goods Act 1989 stating the date of commencement of the first inclusion in the Australian Register of Therapeutic Goods of goods that contain, or consist of, the substance; or

  • (b)

    if the patentee does not have a certificate mentioned in paragraph (a) — information showing the date of commencement of the first inclusion in the Australian Register of Therapeutic Goods of goods that contain, or consist of, the substance.

Note   For providing a copy of a certificate mentioned in paragraph (2) (a), see the definition of document in subsection 71 (1) of the Act.

6.10Application with pre-TGA marketing approval

• (1)

  This regulation applies to an application under section 70 of the Act for an extension of the term of a standard patent for a pharmaceutical substance for which pre-TGA marketing approval has been given.

• (2)

  For paragraphs 71 (1) (b) and (c) of the Act, the application must be accompanied by:

  • (a)

    a written statement by the person who gave the approval showing:

    • (i)

      that approval has been given; and

    • (ii)

      the date of the first approval; or

  • (b)

    if the patentee does not have a written statement mentioned in paragraph (a) — information showing:

    • (i)

      that approval has been given; and

    • (ii)

      the date of the first approval.

Note   For providing a copy of a written statement mentioned in paragraph (2) (a), see the definition of document in subsection 71 (1) of the Act.

6.11Further information

• (1)

  This regulation applies if the Commissioner needs further information to decide whether he or she is satisfied that the requirements set out in sections 70 and 71 of the Act are satisfied for an application for an extension of the term of a standard patent.

• (2)

  The Commissioner may give the applicant a notice requesting the further information within the period mentioned in the notice.

• (3)

  The period must not be shorter than 2 months or longer than 6 months beginning on the day the notice is issued.

Note The period for giving the further information can be extended — see section 223 of the Act.

• (4)

  If the applicant does not give the further information within that period, the Commissioner must decide whether he or she is satisfied that the requirements set out in sections 70 and 71 of the Act are satisfied.

• (5)

  For subsection 71 (2) of the Act, further information given within the period mentioned in subregulation (2) is taken to have been filed with the application for extension of the term of the standard patent.

[5]After subregulation 13.6 (1)

insert

• (1A)

  However, if an extension of the term of a standard patent is granted under section 76 of the Act, the period in paragraph (1) (b) is taken to be extended until 6 months after the extension is granted for each relevant anniversary happening:

  • (a)

    on or after the twentieth anniversary of the date of the patent; and

  • (b)

    on or before the day the extension is granted.

[6]Subregulation 13.6 (2)

after

 if

insert

 the period mentioned in paragraph (1) (b) is not taken to be extended under subregulation (1A), and

[7]Paragraph 22.11 (3) (c)

substitute

• (c)

  filing, during the term of a standard patent as required by subsection 71 (2) of the Act, an application under subsection 70 (1) of the Act for an extension of the term of the patent.

[8]Schedule 7, Part 2, item 7, after paragraph (q)

insert

(r) If an extension of the term of a standard patent is granted under section 76 of the Act: (i) the twentieth anniversary for the patent; and (ii) each subsequent anniversary for the patent happening during the period of extension $790

[9]Schedule 7, Part 2, after item 31

insert

32 On filing an application under subsection 70 (1) of the Act for the grant of an extension of the term of a standard patent $400

Notes

1. These regulations amend Statutory Rules 1991 No. 71, as amended by 1991 No. 456; 1992 No. 148; 1993 Nos. 113, 227, 340 and 341; 1994 Nos. 182, 317 and 387; 1995 Nos. 16, 20, 82 and 427; 1996 No. 271; 1997 Nos. 192 and 345; 1998 Nos. 45, 56, 141, 241, 257, 264 and 291.

2. Made by the Governor-General on 24 November 1998, and notified in the Commonwealth of Australia Gazette