Commonwealth Numbered Regulations

PATENTS AMENDMENT REGULATIONS 2005 (NO. 1) (SLI NO 51 OF 2005) - SCHEDULE 1

( regulation 3)

1            After subregulation 10.7 (6)

insert

         (7)    If:

                (a)     an extension of the term of a standard patent for a pharmaceutical substance has been granted under section 76 of the Act; and

               (b)     the Commissioner becomes aware that the first regulatory approval date in relation to the pharmaceutical substance is earlier than:

                          ( i )     the date of commencement of the first inclusion in the Australian Register of Therapeutic Goods that was supplied, under subregulation 6.9 (2), with the application for the extension of the term; or

                         (ii)     the date of the first approval that was supplied, under subregulation 6.10 (2), with the application for the extension of the term;

the Commissioner must amend the relevant entry in the Register to insert the correct extension of the term of the patent.

Note 1    Under section 77 of the Act, the term of the extension must be equal to:

(a)    the period beginning on the date of the patent and ending on the earliest first regulatory approval date (as defined by section 70 of the Act) in relation to the pharmaceutical substance;

reduced (but not below zero) by:

(b)    5 years.

The extension of the term of a patent is one of the particulars included in the Register under paragraph 19.1 (1) (c). If the earliest first regulatory approval date is earlier than the date that was used in calculating the term of the extension under section 77 of the Act, then the entry in the Register will be incorrect.

Note 2    Subregulation 6.9 (2) refers to the date of commencement of the first inclusion in the Australian Register of Therapeutic Goods of goods that contain, or consist of, a pharmaceutical substance. The date is supplied with an application for the extension of the term of a patent if pre-TGA marketing approval has not been given.

Subregulation 6.10 (2) refers to the date of the first approval of a pharmaceutical substance. The date is supplied with an application for the extension of the term of a patent if pre-TGA marketing approval has been given.

         (8)    If the Commissioner proposes to amend an entry in the Register under subregulation (7), the Commissioner must:

                (a)     give notice to that effect to the patentee; and

               (b)     act in accordance with regulations 22.22 to 22.24 as if those regulations applied to a decision to amend an entry.

Note    Regulations 22.22 to 22.24 apply to discretionary decisions made by the Commissioner. However, the procedures in those regulations will be used to allow the Commissioner to establish whether the grounds for a decision under subregulation (7) exist.

         (9)    An appeal lies to the Federal Court against a decision of the Commissioner to amend the Register under subregulation (7).

2            Subparagraph 22.26 (2) (a) ( vaa )

omit

subregulation 10.7 (3);

insert

subregulations 10.7 (3), (7) or (8);