Document ID: chunk:federal_register_of_legislation:F2024C00944:reg:6:p1
Version: federal_register_of_legislation:F2024C00944
Segment Type: reg
Provision Reference: reg 6 (pt 1/73)
Character Range: 156263–159067

6              a basic application made more than 12 months before the international filing date of the PCT application, being the first application made in a Convention country for the invention  the Commissioner has granted an extension of time under section 223 of the Act that has the effect of restoring a right of priority

Part 2—Extension of pharmaceutical patents

6.7  Definitions
  In this Part:
pre‑TGA marketing approval has the same meaning as in section 70 of the Act.

6.8  Information 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.

6.9  Application 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.

6.10  Application 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