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Patents Amendment Regulations 2005 (No. 1)1 Select Legislative Instrument 2005 No. 51
I, PHILIP MICHAEL JEFFERY, Governor-General of the Commonwealth of Australia, acting with the advice of the Federal Executive Council, make the following Regulations under the Patents Act 1990. Dated 23 March 2005 P. M. JEFFERY Governor-General By His Excellency’s Command IANMACFARLANE Minister for Industry, Tourism and Resources
Contents                         1     Name of Regulations                                                        2                         2     Commencement                                                              2                         3     Amendment of Patents Regulations 1991                           2                         4     Transitional                                                                     2 Schedule 1             Amendments commencing on registration                    4 Schedule 2             Amendments commencing on 1 April 2005                   6 Schedule 3             Amendment commencing on 3 April 2005                   14  
1              Name of Regulations                 These Regulations are the Patents Amendment Regulations 2005 (No. 1). 2              Commencement                 These Regulations commence as follows:                 (a)    on the day after they are registered — regulations 1 to 4 and Schedule 1;                (b)    on 1 April 2005 — Schedule 2;                 (c)    on 3 April 2005 — Schedule 3. 3              Amendment of Patents Regulations 1991                 Schedules 1, 2 and 3 amend the Patents Regulations 1991. 4              Transitional          (1)   The amendments made by Schedule 1 apply to an entry in the Register made:                 (a)    on or after the commencement of these Regulations; and                (b)    before the commencement of these Regulations.          (2)   The amendments made by items [2] to [23] of Schedule 2 apply to an international application if the international filing date of the application is a date on or after 1 April 2005.          (3)   However, the amendments made by items [10] and [18] to [21] of Schedule 2 also apply to an international application that was filed before 1 April 2005 if a demand for international preliminary examination of the application is filed on or after 1 April 2005.
Schedule 1        Amendments commencing on registration (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); Schedule 2        Amendments commencing on 1 April 2005 (regulation 3)    [1]           Subregulation 1.4 (2) omit 1 January 2004 insert 1 April 2005 [2]           Schedule 2A, Adoption and amendment dates, before the Table of Provisions omit October 1, 2002 and on October 1, 2003. insert October 1, 2002, on October 1, 2003 and on October 5, 2004. [3]           Schedule 2A, Table of Provisions omit              13ter.1   Sequence Listing for International Authorities              13ter.2   Sequence Listing for Designated Office insert              13ter.1   Procedure Before the International Searching Authority              13ter.2   Procedure Before the International Preliminary Examining Authority              13ter.3   Sequence Listing for Designated Office [4]           Schedule 2A, Table of Provisions omit              40.1        Invitation to Pay insert              40.1        Invitation to Pay Additional Fees; Time Limit [5]           Schedule 2A, Table of Provisions omit              40.3        Time Limit [6]           Schedule 2A, Table of Provisions omit              76.5        Application of Rules 22.1 (g), 47.1, 49, 49bis and 51bis insert              76.5        Application of Certain Rules to Procedures Before Elected Offices [7]           Schedule 2A, subparagraph 3.3 (a) (ii) omit computer readable insert electronic [8]           Schedule 2A, paragraph 4.6 (a) omit Rule 4.1 (a) (v) or (c) (i) insert Rule 4.1 (a) (iv) or (c) (i) [9]           Schedule 2A, Rule 13ter.1 substitute 13ter.1  Procedure Before the International Searching Authority         (a)   Where the international application contains disclosure of one or more nucleotide and/or amino acid sequences, the International Searching Authority may invite the applicant to furnish to it, for the purposes of the international search, a sequence listing in electronic form complying with the standard provided for in the Administrative Instructions, unless such listing in electronic form is already available to it in a form and manner acceptable to it, and to pay to it, where applicable, the late furnishing fee referred to in paragraph (c), within a time limit fixed in the invitation.        (b)   Where at least part of the international application is filed on paper and the International Searching Authority finds that the description does not comply with Rule 5.2 (a), it may invite the applicant to furnish, for the purposes of the international search, a sequence listing in paper form complying with the standard provided for in the Administrative Instructions, unless such listing in paper form is already available to it in a form and manner acceptable to it, whether or not the furnishing of a sequence listing in electronic form is invited under paragraph (a), and to pay, where applicable, the late furnishing fee referred to in paragraph (c), within a time limit fixed in the invitation.         (c)   The furnishing of a sequence listing in response to an invitation under paragraph (a) or (b) may be subjected by the International Searching Authority to the payment to it, for its own benefit, of a late furnishing fee whose amount shall be determined by the International Searching Authority but shall not exceed 25% of the international filing fee referred to in item 1 of the Schedule of Fees, not taking into account any fee for each sheet of the international application in excess of 30 sheets, provided that a late furnishing fee may be required under either paragraph (a) or (b) but not both.         (d)   If the applicant does not, within the time limit fixed in the invitation under paragraph (a) or (b), furnish the required sequence listing and pay any required late furnishing fee, the International Searching Authority shall only be required to search the international application to the extent that a meaningful search can be carried out without the sequence listing.         (e)   Any sequence listing not contained in the international application as filed, whether furnished in response to an invitation under paragraph (a) or (b) or otherwise, shall not form part of the international application, but this paragraph shall not prevent the applicant from amending the description in relation to a sequence listing pursuant to Article 34 (2) (b).          (f)   Where the International Searching Authority finds that the description does not comply with Rule 5.2 (b), it shall invite the applicant to submit the required correction. Rule 26.4 shall apply mutatis mutandis to any correction offered by the applicant. The International Searching Authority shall transmit the correction to the receiving Office and to the International Bureau. [10]         Schedule 2A, Rule 13ter.2 substitute 13ter.2  Procedure Before the International Preliminary Examining Authority Rule 13ter.1 shall apply mutatis mutandis to the procedure before the International Preliminary Examining Authority. [11]         Schedule 2A, after Rule 13ter.2 insert 13ter.3  Sequence Listing for Designated Office No designated Office shall require the applicant to furnish to it a sequence listing other than a sequence listing complying with the standard provided for in the Administrative Instructions. [12]         Schedule 2A, paragraph 16bis.1 (a) substitute         (a)   Where, by the time they are due under Rules 14.1 (c), 15.4 and 16.1 (f), the receiving Office finds that no fees were paid to it, or that the amount paid to it is insufficient to cover the transmittal fee, the international filing fee and the search fee, the receiving Office shall, subject to paragraph (d), invite the applicant to pay to it the amount required to cover those fees, together with, where applicable, the late payment fee under Rule 16bis.2, within a time limit of one month from the date of the invitation. [13]         Schedule 2A, paragraph 16bis.1 (c) omit paragraph (d): insert paragraph (e): [14]         Schedule 2A, paragraph 23.1 (c) substitute         (c)   Any sequence listing in electronic form which is furnished for the purposes of Rule 13ter but submitted to the receiving Office instead of the International Searching Authority shall be promptly transmitted by that Office to that Authority. [15]         Schedule 2A, Rules 40.1, 40.2 and 40.3 substitute 40.1   Invitation to Pay Additional Fees; Time Limit The invitation to pay additional fees provided for in Article 17 (3) (a) shall:          (i)      specify the reasons for which the international application is not considered as complying with the requirement of unity of invention;          (ii)     invite the applicant to pay the additional fees within one month from the date of the invitation, and indicate the amount of those fees to be paid; and          (iii)    invite the applicant to pay, where applicable, the protest fee referred to in Rule 40.2 (e) within one month from the date of the invitation, and indicate the amount to be paid. 40.2   Additional Fees         (a)   The amount of the additional fees due for searching under Article 17 (3) (a) shall be determined by the competent International Searching Authority.        (b)   The additional fees due for searching under Article 17 (3) (a) shall be payable direct to the International Searching Authority.         (c)   Any applicant may pay the additional fees under protest, that is, accompanied by a reasoned statement to the effect that the international application complies with the requirement of unity of invention or that the amount of the required additional fees is excessive. Such protest shall be examined by a review body constituted in the framework of the International Searching Authority, which, to the extent that it finds the protest justified, shall order the total or partial reimbursement to the applicant of the additional fees. On the request of the applicant, the text of both the protest and the decision thereon shall be notified to the designated Offices together with the international search report. The applicant shall submit any translation thereof with the furnishing of the translation of the international application required under Article 22.         (d)   The membership of the review body referred to in paragraph (c) may include, but shall not be limited to, the person who made the decision which is the subject of the protest.         (e)   The examination of a protest referred to in paragraph (c) may be subjected by the International Searching Authority to the payment to it, for its own benefit, of a protest fee. Where the applicant has not, within the time limit under Rule 40.1 (iii), paid any required protest fee, the protest shall be considered not to have been made and the International Searching Authority shall so declare. The protest fee shall be refunded to the applicant where the review body referred to in paragraph (c) finds that the protest was entirely justified. [16]         Schedule 2A, paragraph 43bis.1 (a) omit report, insert report or the declaration referred to in Article 17 (2) (a), [17]         Schedule 2A, Rule 44.1 substitute 44.1   Copies of Report or Declaration and Written Opinion The International Searching Authority shall, on the same day, transmit one copy of the international search report or of the declaration referred to in Article 17 (2) (a), and one copy of the written opinion established under Rule 43bis.1 to the International Bureau and one copy to the applicant. [18]         Schedule 2A, paragraph 53.9 (b) substitute        (b)   If no amendments under Article 19 have been made and the time limit for filing such amendments has not expired, the statement may indicate that, should the International Preliminary Examining Authority wish to start the international preliminary examination at the same time as the international search in accordance with Rule 69.1 (b), the applicant wishes the start of the international preliminary examination to be postponed in accordance with Rule 69.1 (d). [19]         Schedule 2A, Rules 68.2 and 68.3 substitute 68.2   Invitation to Restrict or Pay Where the International Preliminary Examining Authority finds that the requirement of unity of invention is not complied with and chooses to invite the applicant, at his option, to restrict the claims or to pay additional fees, the invitation shall:          (i)      specify at least one possibility of restriction which, in the opinion of the International Preliminary Examining Authority, would be in compliance with the applicable requirement;          (ii)     specify the reasons for which the international application is not considered as complying with the requirement of unity of invention;          (iii)    invite the applicant to comply with the invitation within one month from the date of the invitation;          (iv)    indicate the amount of the required additional fees to be paid in case the applicant so chooses; and          (v)     invite the applicant to pay, where applicable, the protest fee referred to in Rule 68.3 (e) within one month from the date of the invitation, and indicate the amount to be paid. 68.3   Additional Fees         (a)   The amount of the additional fees due for international preliminary examination under Article 34 (3) (a) shall be determined by the competent International Preliminary Examining Authority.        (b)   The additional fees due for international preliminary examination under Article 34 (3) (a) shall be payable direct to the International Preliminary Examining Authority.         (c)   Any applicant may pay the additional fees under protest, that is, accompanied by a reasoned statement to the effect that the international application complies with the requirement of unity of invention or that the amount of the required additional fees is excessive. Such protest shall be examined by a review body constituted in the framework of the International Preliminary Examining Authority which, to the extent that it finds the protest justified, shall order the total or partial reimbursement to the applicant of the additional fees. On the request of the applicant, the text of both the protest and the decision thereon shall be notified to the elected Offices as an annex to the international preliminary examination report.         (d)   The membership of the review body referred to in paragraph (c) may include, but shall not be limited to, the person who made the decision which is the subject of the protest.         (e)   The examination of a protest referred to in paragraph (c) may be subjected by the International Preliminary Examining Authority to the payment to it, for its own benefit, of a protest fee. Where the applicant has not, within the time limit under Rule 68.2 (v), paid any required protest fee, the protest shall be considered not to have been made and the International Preliminary Examining Authority shall so declare. The protest fee shall be refunded to the applicant where the review body referred to in paragraph (c) finds that the protest was entirely justified. [20]         Schedule 2A, paragraph 69.1 (a) substitute         (a)   Subject to paragraphs (b) to (e), the International Preliminary Examining Authority shall start the international preliminary examination when it is in possession of all of the following:          (i)      the demand;          (ii)     the amount due (in full) for the handling fee and the preliminary examination fee, including, where applicable, the late payment fee under Rule 58bis.2; and          (iii)    either the international search report or the declaration by the International Searching Authority under Article 17 (2) (a) that no international search report will be established, and the written opinion established under Rule 43bis.1; provided that the International Preliminary Examining Authority shall not start the international preliminary examination before the expiration of the applicable time limit under Rule 54bis.1 (a) unless the applicant expressly requests an earlier start. [21]         Schedule 2A, subparagraph 69.1 (d) (iii) omit Rule 54bis.1 (a). insert Rule 46.1. [22]         Schedule 2A, Rule 76.5, heading substitute 76.5   Application of Certain Rules to Procedures Before Elected Offices [23]         Schedule 2A, Rule 76.5 omit Rules 22.1 (g), 47.1, 49, 49bis and 51bis shall apply, provided that: insert Rules 13ter.3, 22.1(g), 47.1, 49, 49bis and 51bis shall apply, provided that: Schedule 3        Amendment commencing on 3 April 2005 (regulation 3)    [1]           Schedule 4 after Colombia insert Comoros Note
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