OPC60570 - A  
 
Intellectual Property Legislation 
Amendment (TRIPS Protocol and Other 
Measures) Regulation  2015  
 
Select Legislative Instrument No. 88, 2015  
I, General the Honourable Sir Peter Cosgrove AK MC (Ret’d), 
Governor -General  of the Commonwealth of Australia, acting with the 
advice of the Federal Executive Council, make the following regulation.  
Dated 17 June 2015  
Peter Cosgrove  
Governor -General  
By His Excellency’s Command  
Ian Macfarlane  
Minister for Industry  
 
   
   
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No. 88, 2015  Intellectual Property Legislation Amendment (TRIPS Protocol and 
Othe r Measures) Regulation  2015  i 
OPC60570 - A Contents  
1 Name  ................................ ................................ ................................ . 1 
2 Commencement  ................................ ................................ .................  1 
3 Authority  ................................ ................................ ...........................  2 
4 Schedules  ................................ ................................ ...........................  2 
Schedule  1—Amendments relating to the TRIPS Protocol 
interim waiver  3 
Patents Regulations  1991  3 
Schedule  2—Further amendments relating to the TRIPS 
Protocol  10 
Patents Regulations  1991  10 
Schedule  3—Amendments relating to document retention  11 
Designs Regulations  2004  11 
Patents Regulations  1991  11 
Trade Marks Regulations  1995  11 
Schedule  4—Amendments relating to amendments made by 
Part  2 of Schedule  5 to the Intellectual Property 
Laws Amendment Act 2015  12 
Patents Regulations  1991  12 
Schedule  5—Other amendments  20 
Designs Regulations  2004  20 
Patents Regulations  1991  21 
Trade Marks Regulations  1995  27 
Schedule  6—Application of amendments  30 
Patents Regulations  1991  30 
 
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No. 88, 2015  Intellectual Property Legislation Amendment (TRIPS Protocol and 
Other Measures) Regulation  2015  1 
OPC60570 - A 1  Name  
  This is the Intellectual Property Legislation Amendment (TRIPS 
Protocol and Other Measures) Regulation 2015 . 
2  Commencement  
 (1) Each provision of this instrument specified in column 1 of the table 
commences, or is taken to have commenced, in accordance with 
column 2 of the table. Any other statement in column 2 has effect 
according to its terms.  
 
Commencement information  
Column 1  Column 2  Column 3  
Provisions  Commencement  Date/Details  
1.  Sections  1 to 4 
and anything in 
this instrument 
not elsewhere 
covered by this 
table  The day after this instrument is registered.   
2.  Schedule  1 At the same time as Schedule  1 to the 
Intellectual Property Laws Amendment Act 
2015  commences.   
3.  Schedule  2 At the same time as Schedule  2 to the 
Intellectual Property Laws Amendment Act 
2015  commences.   
4.  Schedule  3 The day after this instrument is registered.   
5.  Schedule  4 At the same time as items  9 to 17 of 
Schedule  5 to the Intellectual Property Laws 
Amendment Act 2015  commence.   
6.  Schedule s 5 
and 6  The day after this instrument is registered.   
Note:  This table relates only to the provisions of this instrument as originally 
made. It will not be amended to deal with any later amendments of 
this instrument . 
 (2) Any information in column 3 of the table is not part of this 
instrument. Information may be inserted in this column, or 
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2 Intellectual Property Legislation Amendment (TRIPS Protocol and 
Other Measures) Regulation  2015  No. 88, 2015  
OPC60570 - A information in it may be edited, i n any published version of this 
instrument.  
3  Authority  
  This instrument  is made under  the following Acts:  
 (a) the Designs Act 2003 ; 
 (b) the Patents Act 1990 ; 
 (c) the Trade Marks Act 1995 . 
4  Schedule s 
  Each instrument that is specified in a Schedule  to this instrument is 
amended or repealed as set out in the applicable items in the 
Schedule concerned, and any other item in a Schedule to this 
instrument has effect according to its terms.  
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No. 88, 2015  Intellectual Property Legislation Amendment (TRIPS Protocol and 
Other Measures) Regulation  2015  3 
OPC60570 - A Schedule  1—Amendments  relating to the 
TRIPS Protocol interim waiver  
  
Patents Regulations  1991  
1  Subregulation  1.3(1)  
Insert:  
Council for TRIPS  means the Council for Trade -Related Aspects 
of Intellectual Property Rights established under Article IV of the 
WTO Agreement . 
eligible importing country : see regulation  1.4A.  
least developed country means a country included in the list of 
least developed countries maintained by the United Nations, as in 
force from time to time.  
Note:  The list of least developed countries could in 201 5 be viewed on the 
United Nations ’ webs ite (http://www.un.org).  
WTO Agreement  means the Marrakesh Agreement establishing the 
World Trade Organization, done at Marrakesh on 15  April 1994 . 
WTO member  means a country that is a full member of the World 
Trade Organization.  
Note:  The list of members of the World Trade Organization could in 201 5 
be viewed on the World Trade Organization ’s website 
(http://www.wto.org).  
2  After regulation  1.4 
Insert:  
1.4A   Meaning of eligible importing country  
  For the definition of eligible importing country  in Schedu le 1 to 
the Act, the following kinds of  foreign  countries are prescribed:  
 (a) a WTO  member that notifies  the Council for TRIPS , in 
accordance with the WTO General Council decision of 
30 August 2003,  of the member’s intention to use the system 
set out in that decision as an importer ; 
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4 Intellectual Property Legislation Amendment (TRIPS Protocol and 
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OPC60570 - A  (b) a least developed country . 
3  Before regulation  12.1 
Insert:  
Part  1—Compulsory licences (general)  
   
4  Regulation  12.1 (heading)  
Repeal the heading, substitute:  
12.1  Applications for orders for compulsory licences  
5  After regulation  12.2 
Insert:  
Part  2—Patented pharmaceutical invention 
compulsory licences (for manufacture and 
export to eligible importing countries)  
   
12.2A  Applications for PPI orders  
 (1) An applicant for a PPI order  in relation to  the export of a 
pharmaceutical product to an eligible importing country  must 
lodge , with the Registrar of the Federal Cour t, an application that 
includes the following:  
 (a) the name and address of the applicant;  
 (b) the applicant’s  address for service i n relation to the 
application;  
 (c) the name of the eligible importing country;  
 (d) if the pharmaceutical product is to be imported by a person 
on behalf of, and with the authorisation of, the eligible 
importing country —the name and address of that person ; 
 (e) the name of the pharmaceutical product;  
 (f) the proposed use of the pharmaceutical product in the eligible 
importing country;  
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OPC60570 - A  (g) the amount of the pharmaceutical product proposed to be 
manufactured for export ; 
 (h) the proposed duration of the PP I compulsory licence;  
 (i) the identity of the patent;  
 (j) the name of the patentee;  
 (k) if the patent is an innovation patent —the date of certification 
of the innovation patent . 
 (2) For paragraph  (1)(b), the address for service must be an address 
that is mentioned in Rules made by the Federal Court for the 
service of the application, as in force from time to time.  
 (3) The applicant must:  
 (a) serve a copy of the application on the patentee and any other 
person who claims an interest in the patent as soon as 
practicable after lodg ement; and  
 (b) lodge with the Registrar notice of the date when, and the 
place where, he or she complied with paragraph  (a). 
 (4) For subregulation  (3), the applicant must serve the copy in 
accordance with Rules made by the Federal Court for  the service of 
the application , as in force from time to time.  
12.2B  PPI compulsory licences —notification requirements  
 (1) This regulation sets out the notification requirements for 
paragraph  136E(1)(f) of the Act  in relation to the imp ortation of a 
pharmaceutical product into an eligible importing country . 
 (2) Subregulation (3) applies if the  eligible importing country is a 
WTO member . 
 (3) The eligible importing country must have notified the Council for 
TRIPS in accordance with parag raph 2(a) of the WTO General 
Council decision of 30  August 2003.  
 (4) Subregulation (5) appl ies if the eligible importing country is:  
 (a) a least developed country; and  
 (b) not a WTO member.  
 (5) The eligible importing country must have given the Commiss ioner 
a written notice : 
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6 Intellectual Property Legislation Amendment (TRIPS Protocol and 
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OPC60570 - A  (a) stating:  
 (i) the name of the eligible importing country;  and 
 (ii) the name of the pharmaceutical product;  and 
 (iii) the expected quantity of the pharmaceutical product to 
be imported into the eligible importing country ; and  
 (b) confirming that, if the pharmaceutical product is patented in 
the eligible importing country,  it: 
 (i) has granted; or  
 (ii) intends to grant;  
  a compulsory licence that would accord with Article 31 of 
the TRIPS Agreement  and the provisions of the WTO 
General Council decision of 30  August 2003 if the TRIPS 
Agreement and the decision applied to the eligible importing 
country.  
12.2C   PPI compulsory licences —labelling and marking of product  
 (1) For paragraph  136F(1)(c) of th e Act, the pharmaceutical product 
must be labelled or marked in a way that:  
 (a) clearly identifies the product as being exported from 
Australia under the PPI compulsory licence; and  
 (b) distinguishes the product from:  
 (i) the same pharmaceutical product as sold in Australia ; 
and 
 (ii) the same pharmaceutical product as exported  other than 
under the licence . 
 (2) For subregulation  (1), the labelling or marking must:  
 (a) be applied to:  
 (i) the immediate package containing the pharmaceutical 
produc t; and  
 (ii) any other package containing that package (whether or 
not other packages are involved); and  
 (b) remain clear and legible at all times while the product is 
being exported.  
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OPC60570 - A 12.2D   PPI compulsory licences —shipment information  
 (1) For paragraph  136F(1)(d) of the Act, the following shipment 
information is prescribed in relation to  each shipment of a 
pharmaceutical product:  
 (a) the name of the pharmaceutical product;  
 (b) the amount of the product in the shipment;  
 (c) the name of the licensee;  
 (d) the licensee ’s address for service;  
 (e) the name of the eligible importing country;  
 (f) if a person is importing the pharmaceutical product on behalf 
of, and with the authorisation of, the eligible importing 
country —the name and address of the person ; 
 (g) a description of the packaging (including colour, size and 
shape) and the labelling or marking of the pharmaceutical 
product.  
 (2) For paragraph  136F(1)(d) of the Act, the shipment information 
must be made available for at least the duration of the licence.  
12.2E   PPI compulsory licences —giving information to the 
Commissioner  
 (1) This regulation sets out for paragraph  136F(1)(h) of the Act the 
information that a licensee must give to the Commissioner in 
relation to the licence.  
Grant of licence  
 (2) The licensee must give the Commissioner the following 
information in relation to the grant of the PPI compulsory licence:  
 (a) the date of the PPI order ; 
 (b) the place at which the PPI order was made;  
 (c) the name and address of the licensee;  
 (d) the licensee’s address for service;  
 (e) the name of the pharmaceutical product;  
 (f) the quantity of the pharmaceutical product that the Federal 
Court has determined may be manufactured  for export ; 
 (g) the eligible importing country to which the pharmaceutic al 
product is to be exported;  
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8 Intellectual Property Legislation Amendment (TRIPS Protocol and 
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OPC60570 - A  (h) the duration of the licence;  
 (i) the identity of the patent;  
 (j) the address of the website on which the shipment information 
is to be made available . 
 (3) The information mentioned in subregulation  (2) mu st be given to  
the Commissioner:  
 (a) in the approved form; and  
 (b) within 1 month after the Federal Court makes the order 
requiring the grant of the licence.  
Amendment of licence  
 (4) If the licence is amended by order under section  136G of the Act, 
the licensee must give the Commissioner the following information 
in relation to the amendment : 
 (a) the date of the amending order;  
 (b) the place at which the amending order was made;  
 (c) details of the amendment.  
 (5) The information mentioned in subre gulation  (4) must be given to 
the Commissioner:  
 (a) in the approved form; and  
 (b) within 1 month after the Federal Court makes the order 
amending the licence.  
Revocation of licence  
 (6) If the licence is revoked by order under section  136H of the Act, 
the licensee must give the Commissioner the following information 
in relation to the revocation:  
 (a) the date of the revocation order;  
 (b) the place at which the revocation order was made . 
 (7) The information mentioned in subregulation  (6) must be given t o 
the Commissioner : 
 (a) in the approved form; and  
 (b) within 1 month after the Federal Court makes the order 
revoking the licence.  
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OPC60570 - A Agreement or determination of remuneration  
 (8) If an amount of remuneration for the licence is agreed under 
paragraph  136J(3)(a)  of the Act or determined by the Federal Court 
under paragraph  136J(3)(b) of the Act, the licensee must give the 
Commissioner a statement that an amount of remuneration has 
been agreed or determined , as the case may be . 
 (9) The information mentioned in subregulation  (8) must be given to 
the Commissioner:  
 (a) in the approved form; and  
 (b) within 1 month after the agreement is reached or the 
determination is made.  
12.2F   Dealing with information provided  under regulation  12.2E  
 (1) If the Co mmissioner receive s the information mentioned in 
subregulation  12.2E(2) in relation to the grant of a PPI compulsory 
licence, the Commissioner must:  
 (a) if the eligible importing country is a WTO member —give a 
copy of the information to the Council for TR IPS; or  
 (b) in any other case —publish the information on the internet . 
 (2) If the Commissioner receives the information mentioned in 
subregulation  12.2E( 8) in relation to a licence , the Commissioner  
must  give the eligible importing country to which the l icence 
relates a notice stating that the licensee has advised that an amount 
of remuneration in respect of the licenc e has been agreed or 
determined , as the case may be . 
Part  3—Surrender and revocation of patents  
   
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10 Intellectual Property Legislation Amendment (TRIPS Protocol and 
Other Measures) Regulation  2015  No. 88, 2015  
OPC60570 - A Schedule  2—Further a mendments relating to 
the TRIPS Protocol  
   
Patents Regulations  1991  
1  Paragraph 1.4A(a)  
Repeal the paragraph, substitute:  
 (a) a WTO member that notifies the Council for TRIPS, in 
accordance with the Annex to the TRIPS Agreement, of the 
member’s intention to use the system  set out in Article 31bis 
of the TRIPS Agreement and the Annex to that Agreement as 
an importer;  
2  Subregulation  12.2B(3)  
Omit “paragraph  2(a) of the WTO General Council decision of 
30 August 2003”, substitute “paragraph  2(a) of the Annex to the TRIPS 
Agreement”.  
3  Paragraph 12.2B( 5)(b) 
Omit all the words after “would accord with”,  substitute “Articles 31 
and 31bis of the TRIPS Agreement and the Annex to that Agreement  if 
the Agreement and Annex applied to the eligible importing country ”. 
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OPC60570 - A Schedule  3—Amendments relating to 
document retention  
   
Designs Regulations  2004  
1  Subregulation  5.08(1)  
Omit “(1)”.  
2  Subregulation  5.08(2)  
Repeal the subregulation.  
Patents Regulations  1991  
3  Regulation  22.18  
Repeal the regulation.  
Trade Marks Regulations  1995  
4  Subregulation  17A.39(1)  
Omit “, 13.3 and 21.32”, substitute “and 13.3”.  
5  Regulation  21.32  
Repeal the regulation.  
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12 Intellectual Property Legislation Amendment (TRIPS Protocol and 
Other Measures) Regulation  2015  No. 88, 2015  
OPC60570 - A Schedule  4—Amendments relating to 
amendments made by Part  2 of 
Schedule  5 to the Intellectual Property 
Laws Amendment Act 201 5 
   
Patents Regulations  1991  
1  Regulation  3.11 
Omit “subsections  29B(2) and 38(1A)”, substitute “subsection  38(1A)”.  
2  Subregulation  3.12(4)  
Repeal the subregulation, substitute:  
 (4) In this Division , a document, or a set of documents considered 
together,  clearly discloses  an invention if the document, or set of 
documents, discloses the invention in a manner that is clear 
enough, and complete enough, for the invention to be performed by 
a person skilled in the relevant art . 
 (5) For the purposes of subregu lation  (4), a document, or a set of 
documents considered together, is taken to clearly disclose an 
invention as mentioned in that subregulation  so far as such 
disclosure requires a description of a micro -organism, if:  
 (a) the micro -organism is deposited with a prescribed depository 
institution in accordance with such provisions of the 
Budapest Treaty as are applicable; and  
 (b) the prescribed circumstances for paragraph  43(2B)(b) of the 
Act apply.  
3  Subregulation  3.13A(1)  
Repeal the subregulation, substi tute: 
 (1) This regulation applies to a claim if:  
 (a) the circumstance mentioned in subregulation  (2) (a 
prescribed circumstance for paragraph  43(2A)(a) of the Act) 
applies to the invention defined in the claim; and  
 (b) either:  
Federal Register of Legislative Instruments F2015L00852Amendments relating to amendments made by Part 2 of Schedule 5 to the Intellec tual 
Property Laws Amendment Act 2015   Schedule 4  
   
 
 
No. 88, 2015  Intellectual Property Legislation Amendment (TRIPS Protocol and 
Other Measures) Regulation  2015  13 
OPC60570 - A  (i) a document mentioned in subregulation  (4) (a 
prescribed document for paragraph  43(2A)(b) of the 
Act) clearly discloses the invention in the claim; or  
 (ii) 2 or more of those documents (a prescribed set of 
prescribed documents for paragraph  43(2A)(b) of the 
Act), considered to gether, clearly disclose the invention 
in the claim.  
4  Subregulation  3.13A(4)  
Repeal the subregulation  (not including the heading) , substitute:  
 (4) For paragraph  (1)(b), the documents are the documents filed for the 
earlier application at the time the ap plication was made.  
5  At the end of regulation  3.13A  
Add:  
Prescribed circumstances for micro -organisms  
 (6) For paragraph  43(2B)(b) of the Act, the prescribed circumstances 
for a disclosure that requires a description of a micro -organism are 
as follows:  
 (a) the deposit of the micro -organism with a prescribed 
depository institution, in accordance with such provisions of 
the Budapest Treaty as are applicable, occurs on or before the 
date when the documents mentioned in subregulation  (4) are 
filed;  
 (b) either: 
 (i) a document mentioned in subregulation  (4) includes the 
relevant information on the characteristics of the 
micro -organism that is known to the applicant at the 
time the documents are filed; or  
 (ii) 2 or more of those documents, considered together, 
include the relevant information on the characteristics of 
the micro -organism that is known to the applicant at the 
time the documents are filed;  
 (c) the requirements of paragraph  6(c) of the Act are satisfied by 
the complete specification that contains the claim.  
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14 Intellectual Property Legislation Amendment (TRIPS Protocol and 
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OPC60570 - A 6  Subregulations  3.13B(1) and (2)  
Repeal the subregulation s, substitute:  
 (1) This regulation applies to a claim if:  
 (a) the circumstance mentioned in subregulation  (1A) (a 
prescribed circumstance for paragraph  43(2A)(a) of the Act) 
applies to the invention defined in the claim; and  
 (b) either:  
 (i) a document mentioned in subregulation  (2) (a 
prescribed document for paragraph  43(2A)(b) of the 
Act) clearly discloses the invention in the claim; or  
 (ii) 2 or more of those documents (a prescribed set of 
prescribed documents for paragraph  43(2A)(b) of the 
Act), considered together, clearly disclose the invention 
in the claim.  
Circumstance  
 (1A)  For paragraph  (1)(a), the circumstance is that the specification 
containing the claim that defi nes the invention was filed for:  
 (a) a Convention application; or  
 (b) a complete application that has been amended to become a 
Convention application.  
Documents  
 (2) For paragraph  (1)(b), the documents are the documents filed for a 
related basic application at the time when the application was 
made.  
7  At the end of regulation  3.13B  
Add:  
Prescribed circumstances for micro -organisms  
 (5) For paragraph  43(2B)(b) of the Act, the prescribed circumstances 
for a disclosure that requires a description of  a micro -organism are 
as follows:  
 (a) the deposit of the micro -organism with a prescribed 
depository institution, in accordance with such provisions of 
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OPC60570 - A the Budapest Treaty as are applicable, occurs on or before the 
date when the documents mentioned in sub regulation  (2) are 
filed;  
 (b) either:  
 (i) a document mentioned in subregulation  (2) includes the 
relevant information on the characteristics of the 
micro -organism that is known to the applicant at the 
time the documents are filed; or  
 (ii) 2 or more of those documents, considered together, 
include the relevant information on the characteristics of 
the micro -organism that is known to the applicant at the 
time the documents are filed;  
 (c) the requirements of paragraph  6(c) of the Act are satisfied by 
the c omplete specification that contains the claim.  
8  Subregulations  3.13C(1) and (2)  
Repeal the subregulation s, substitute:  
 (1) This regulation applies to a claim if:  
 (a) the circumstance mentioned in subregulation  (1A) (a 
prescribed circumstance for paragraph  43(2A)(a) of the Act) 
applies to the invention defined in the claim; and  
 (b) either:  
 (i) a document mentioned in subregulation  (2) (a 
prescribed document for paragraph  43(2A)(b) of the 
Act) clearly discloses the invention in the claim; or  
 (ii) 2 or more  of those documents (a prescribed set of 
prescribed documents for paragraph  43(2A)(b) of the 
Act), considered together, clearly disclose the invention 
in the claim.  
Circumstance  
 (1A)  For paragraph  (1)(a), the circumstance is that the specificati on 
containing the claim that defines the invention was filed for a 
complete application that is associated with a provisional 
application under section  38 of the Act.  
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OPC60570 - A Documents  
 (2) For paragraph  (1)(b), the documents are the documents filed for the 
provis ional application at the time when the application was made.  
9  At the end of regulation  3.13C  
Add:  
Prescribed circumstances for micro -organisms  
 (4) For paragraph  43(2B)(b) of the Act, the prescribed circumstances 
for a disclosure that requires a descript ion of a micro -organism are 
as follows:  
 (a) the deposit of the micro -organism with a prescribed 
depository institution, in accordance with such provisions of 
the Budapest Treaty as are applicable, occurs on or before the 
date when the documents mentioned in subregulation  (2) are 
filed;  
 (b) either:  
 (i) a document mentioned in subregulation  (2) includes the 
relevant information on the characteristics of the 
micro -organism that is known to the applicant at the 
time the documents are filed; or  
 (ii) 2 or mor e of those documents, considered together, 
include the relevant information on the characteristics of 
the micro -organism that is known to the applicant at the 
time the documents are filed;  
 (c) the requirements of paragraph  6(c) of the Act are satisfied by  
the complete specification that contains the claim.  
10  Paragraph 3.13D(1)(b)  
Repeal the paragraph, substitute:  
 (b) the specification mentioned in subsection  79B(1) of the Act 
(the earlier specification ) clearly discloses the invention in 
the claim.  
11  Subregulation  3.13D(2)  
Repeal the subregulation, substitute:  
 (2) However, this regulation does not apply to a claim if:  
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OPC60570 - A  (a) the deposit requirements must be satisfied in relation to the 
invention to comply with paragraph  40(2)(a) of the Act; and  
 (b) when the divisional application under section  79B of the Act 
is made, the period prescribed in subregulation  1.5(1) has 
ended in relation to the earlier specification; and  
 (c) the requirements of paragraph  6(c) of the Act are not satisfied 
in relation to the earlier specification.  
12  At the end of regulation  3.13D  
Add:  
 (4) For subsection  43(2A) of the Act:  
 (a) the circumstance mentioned in paragraph  (1)(a) is a 
prescribed circumstance; and  
 (b) the document mentioned in paragraph  (1)(b) is a prescribed 
document.  
 (5) For paragraph  43(2B)(b) of the Act, the prescribed circumstances 
for a disclosure that requires a description of a micro -organism are 
as follows:  
 (a) the deposit of the micro -organism with a prescribed 
depository institution, in accordance with such provisions of 
the Budapest Treaty as are applicable, occurs on or before the 
date when the document mentioned in paragraph  (1)(b) is 
filed;  
 (b) the document mentioned in paragraph  (1)(b) includes the 
relevant information on the characteristics o f the 
micro -organism that is known to the applicant at the time the 
documents are filed;  
 (c) the requirements of paragraph  6(c) of the Act are satisfied by 
the complete specification that contains the claim.  
13  At the end of regulation  3.13E  
Add:  
 (3) For subsection  43(2A) of the Act:  
 (a) the circumstance mentioned in paragraph  (1)(a) is a 
prescribed circumstance; and  
 (b) the document mentioned in paragraph  (1)(b) is a prescribed 
document.  
Federal Register of Legislative Instruments F2015L00852Schedu le 4  Amendments relating to amendments made by Part 2 of Schedule 5 to the 
Intellectual Property Laws Amendment Act 2015  
   
 
 
18 Intellectual Property Legislation Amendment (TRIPS Protocol and 
Other Measures) Regulation  2015  No. 88, 2015  
OPC60570 - A  (4) For paragraph  43(2B)(b) of the Act, the prescribed circumst ances 
for a disclosure that requires a description of a micro -organism are 
as follows:  
 (a) the deposit of the micro -organism with a prescribed 
depository institution, in accordance with such provisions of 
the Budapest Treaty as are applicable, occurs on o r before the 
date when the document mentioned in paragraph  (1)(b) is 
filed;  
 (b) the document mentioned in paragraph  (1)(b) includes the 
relevant information on the characteristics of the 
micro -organism that is known to the applicant at the time the 
docume nt is filed;  
 (c) the requirements of paragraph  6(c) of the Act are satisfied by 
the complete specification that contains the claim.  
14  Subregulation  3.15(3)  
Repeal the subregulation.  
15  At the end of Part  2 of Chapter  3 
Add:  
3.32  Provisional specifications —prescribed circumstances  
 (1) For paragraph  41(1A)(b) of the Act, the prescribed circumstances 
are all of the follow ing: 
 (a) the micro -organism was deposited with a prescribed 
depository institution, in accordance with such pr ovisions of 
the Budapest Treaty as are applicable, on or before the date 
the provisional specification was filed;  
 (b) at the time the provisional application to which the 
provisional specification  relates was made, the provisional 
specification clearly di sclose d the invention, other than in 
relation to the description of the micro -organism;  
 (c) at the time the provisional application to which the 
provisional specification relates was made, either:  
 (i) a document filed for the provisional  application  
included the relevant information on the characteristics 
of the micro -organism that was known to the applicant  
at that time; or 
Federal Register of Legislative Instruments F2015L00852Amen dments relating to amendments made by Part 2 of Schedule 5 to the Intellectual 
Property Laws Amendment Act 2015   Schedule 4  
   
 
 
No. 88, 2015  Intellectual Property Legislation Amendment (TRIPS Protocol and 
Other Measures) Regulation  2015  19 
OPC60570 - A  (ii) 2 or more documents filed for the provisional  
application, considered together, included  the relevant 
information on the chara cteristics of the micro -organism 
that was known to the applicant at th at time ; 
 (d) if the circumstances mentioned in subregulation  (2) apply —
the requirements of paragraph  6(c) of the Act are satisfied by 
the complete specification mentioned in paragraph  (2)(a) of 
this regulation . 
 (2) For paragraph  (1)(d), the circumstances are that:  
 (a) a complete specification has been filed for a complete 
application; and  
 (b) the complete application is associated  with the provisional 
application whose specification i s referred to in 
paragraph  (1)(b).  
Note:  A complete application may be associated with a provisional 
application when the complete application is filed, or as a result of a 
subsequent amendment to the complete application.  
16  Subregulation  10.1(1AA)  
Repea l the subregulation.  
Federal Register of Legislative Instruments F2015L00852Schedule 5   Other amendments  
   
 
 
20 Intellectual Property Legislation Amendment (TRIPS Protocol and 
Other Measures) Regulation  2015  No. 88, 2015  
OPC60570 - A Schedule  5—Other a mendments  
   
Designs Regulations  2004  
1  At the end of Chapter  1 
Add:  
1.06  Giving of documents by Registrar  
 (1) For these Regulations, the Registrar may give a document to a 
person by:  
 (a) making the document available to the person in an electronic 
form; and  
 (b) notifying the person that the document is available.  
 (2) If the Registrar gives a document to a person, the document is 
taken to have been given to the person on the day the document is 
dated by the Registrar.  
2  After subregulation  11.13(1)  
Insert:  
 (1A)  Subregulation (1B) applies if:  
 (a) an application for an extension of time for doing a relevant 
act is made under subsection  137(2) of the Act; and  
 (b) the relevant act has not been done; and  
 (c) a notice of opposition to the grant of the application is filed.  
 (1B) If the Registrar grants the application, the Registrar must extend 
the time to include the period from the day on which the notice of 
opposition is filed to the end of:  
 (a) if an appli cation is made to the AAT for a review of a 
decision of the Registrar —the day when the application is 
withdrawn or finally dealt with or determined; or  
 (b) in any other case —21 days after the end of the day on which 
the Registrar  decides the application.  
Federal Register of Legislative Instruments F2015L00852Other amendments   Schedule 5  
   
 
 
No. 88, 2015  Intellectual Property Legislation Amendment (TRIPS Protocol and 
Other Measures) Regulation  2015  21 
OPC60570 - A Patents Regulations  1991  
3  Subregulation  2.1(2)  
Repeal the subregulation, substitute:  
 (2) A person making an application under that section must file with 
the application a notice stating the facts on which the application is 
based.  
4  Regulation  3.2 
Repeal the regulation, substitute:  
3.2  Provisional specifications  
 (1) A provisional specification must:  
 (a) be in the approved form; and  
 (b) be in English.  
 (2) If the Commissioner treats a provisional specification as having 
been filed, t he Commission er may, within 1 month from the date of 
filing of the provisional specification , direct the applicant to do 
anything necessary to ensure that the provisional specification 
complies with the requirements mentioned in subregulation  (1). 
 (3) If an applicant to whom a direction has been given under 
subregulation  (2) does not comply with the direction within 2 
months from the date of the direction, the provisional specification 
is taken not to have been filed.  
5  After paragraph  3.2C(2)(a)  
Insert:  
 (aa) provide  the name of the inventor  of the invention to which 
the application relates; and  
6  Regulation  3.25 
Repeal the regulation, substitute:  
Federal Register of Legislative Instruments F2015L00852Schedule 5   Other amendments  
   
 
 
22 Intellectual Property Legislation Amendment (TRIPS Protocol and 
Other Measures) Regulation  2015  No. 88, 2015  
OPC60570 - A 3.25  Request for Commissioner’s certification authorising release of 
sample of a micro -organism  
 (1) If a micro -organism  is deposited with a prescribed depositary 
institution, a person may request the Commissioner to grant the 
certification referred to in Rule  11.3(a) of the Budapest Treaty in 
respect of the deposit.  
 (2) The request:  
 (a) must be in the approved form; and  
 (b) must relate to  a micro -organism : 
 (i) that is the subject of a patent application or patent; or 
 (ii) the use, modification or cultivation of which is the 
subject of a patent application or patent; and 
 (c) may nominate  another person as a skilled add ressee . 
 (3) Before making a decision under regulation  3.25B (including a 
decision about imposing conditions under regulatio n 3.25G), the 
Commissioner must:  
 (a) give each person mentioned in subregulation  (4) a written 
notice inviting the person to make, within a reasonable time 
specified in the notice, a submission about the matter; and  
 (b) if a person mentioned in subregulation  (4) makes a 
submission within the time specified in the notice —take the 
submission  into account . 
 (4) For subregulation  (3), the persons are as follows:  
 (a) the person who made the request;  
 (b) the applicant or patentee;  
 (c) any other person who apparently has an interest in the 
request.  
3.25A   Request for certification —micro -organis m subject of 
application for standard patent  
 (1) This r egulation applies if : 
 (a) the micro -organism , or the use, modification or cultivation  of 
the micro -organism , is the subject of an ap plication for a 
standard patent; and  
 (b) the complete specification relating to the application is not 
open to public inspection.  
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No. 88, 2015  Intellectual Property Legislation Amendment (TRIPS Protocol and 
Other Measures) Regulation  2015  23 
OPC60570 - A  (2) The applicant may notify the Commissioner that, if:  
 (a)  a request is made under regulation  3.25 in relation to the 
application; and  
 (b) regulation  3.25E does n ot apply to the request;  
a sample of the deposited micro -organism is to be provided during 
the period mentioned in subregulation  (3) only to a person who is a 
skilled addressee without an interest in the invention.  
 (3) For subregulation  (2), the period:  
 (a) begins when the complete specification relating to the 
application is open to public inspection; and  
 (b) ends when : 
 (i) the patent is granted on the application ; or 
 (ii) the application lapses or is withdrawn or refused.  
3.25B   Grant of certificatio n—when Commissioner must grant 
certification  
 (1) Subregulation (2) applies to a request under regulation  3.25 in 
relation to a patent application if:  
 (a) the applicant for the patent has notified the Commissioner as 
mentioned in subregulation  3.25A(2); and 
 (b) the period mentioned in subregulation  3.25A (3) has not 
ended; and  
 (c) regulation  3.25E does not apply  to the request . 
 (2) The Commissioner must grant the certification if:  
 (a) the specification relating to the application is open to public 
inspection; and  
 (b) the Commissioner is reasonably satisfied that the nominated 
person is entitled to rely on the deposit for the purposes of 
the Act; and  
 (c) a person has been nominated as a skilled addressee by the 
person who made the request; and  
 (d) the Commissioner is reasonably satisfied that the nominated 
person:  
 (i) is appropriately skilled; and  
 (ii) does not have an interest in the invention; and  
 (e) regulation  3.25C applies  to the request . 
Federal Register of Legislative Instruments F2015L00852Schedule 5   Other amendments  
   
 
 
24 Intellectual Property Legislation Amendment (TRIPS Protocol and 
Other Measures) Regulation  2015  No. 88, 2015  
OPC60570 - A  (3) Subregulation ( 4) applies to any other request  unde r 
regulation  3.25. 
 (4) The Commissioner must grant the certification if:  
 (a) the specification relating to the application or patent is open 
to public inspection; and  
 (b) the Commissioner is reasonably satisfied that the nominated 
person is entitled to rely on the deposit for the purposes of 
the Act; and  
 (c) one or more of regulations  3.25C, 3.25D, 3.25E and 3.25F 
apply to the request . 
 (5) Despite subregulation s (1) to (4) , the Commissioner must not grant 
the certification if : 
 (a) the request relates to a micro -organism:  
 (i) that is the subject of a PCT application; or  
 (ii) the use, modification or cultivation of which is the 
subject of a PCT application; and  
 (b) the applicant of the PCT application has not complied with 
subsection  29A(5) of the Act. 
3.25C  Grant of certification —limited use undertaking  
 (1) For paragraph s 3.25B (2)(e) and (4)(c), t his regulation  applies to a 
request if: 
 (a) the person making the request or the person nominated as a 
skilled addressee has undertaken to use the micr o-organism, 
during the period mentioned in subregulation  (2), only for 
experimental purposes or in relation to:  
 (i) opposition proceedings under Chapter  5 of the Act in 
relation to the grant of a standard patent on that 
application; or  
 (ii) opposition proceedings under section  101M of the Act 
in relation to an innovation patent; or  
 (iii) relevant proceedings in relation to the patent;  
  and not to make the micro -organism, or a culture derived 
from the micro -organism, available to another person during 
that period; and  
 (b) the Commissioner is reasonably satisfied that the undertaking 
given by the person making the request or the person 
nominated as a skilled addressee is given in good faith.  
Federal Register of Legislative Instruments F2015L00852Other amendments   Schedule 5  
   
 
 
No. 88, 2015  Intellectual Property Legislation Amendment (TRIPS Protocol and 
Other Measures) Regulation  2015  25 
OPC60570 - A  (2) For paragraph  (1)(a), the period is:  
 (a) for a request i n respect of a patent application —the period 
beginning when the request is granted and ending when:  
 (i) the application lapses, or is refused or withdrawn; or  
 (ii) a patent granted on the application expires, ceases or is 
revoked; or  
 (b) for a request i n respect of a patent —the period beginning 
when the request is granted and ending when the patent 
expires, ceases or is revoked.  
3.25D   Grant of certification —order under section  133 of Act  
  For paragraph  3.25B(4)(c), this regulation  applies to a request if: 
 (a) an order has been made, under section  133 of the Act, 
requiring the patentee to grant to the person making the 
request a licence  to work the patented invention ; and  
 (b) the Commissioner is reasonably satisfied that the licence 
provides that the person making the request has a right to 
obtain a sample of the micro -organism.  
3.25E   Grant of certification —exploitation for purposes of 
Commonwealth or a State  
  For paragraph  3.25B(4)(c), this regulation  applies to a request if: 
 (a) the person making the request is authorised by the 
Commonwealth or a State, under subsection  163(1) of the 
Act, to exploit the invention for the purposes of the 
Commonwealth or State; and  
 (b) the C ommissioner is reasonably satisfied that the terms for 
the exploitation of the invention provide that the person 
making the request has a right to obtain a sample of the 
micro -organism.  
3.25F   Grant of certification —expired patent etc . 
  For paragraph  3.25B(4)(c), this regulation  applies to a request if 
the request is in respect of:  
 (a) a patent application that has lapsed  or has been  refused or 
withdrawn; or  
 (b) a patent that is expired, ceased or revoked.  
Federal Register of Legislative Instruments F2015L00852Schedule 5   Other amendments  
   
 
 
26 Intellectual Property Legislation Amendment (TRIPS Protocol and 
Other Measures) Regulation  2015  No. 88, 2015  
OPC60570 - A 3.25G   Imposing conditions  on certification  
  If the Commissioner grants the requested certification  under 
regulation  3.25B , the Commissioner may impose any conditions 
the Commissioner considers reasonable, including a condition that 
the person making the request give security for damages for any 
breach  of the undertaking mentioned in paragraph  3.25C(1)(a) 
given by:  
 (a) the person; or  
 (b) another person who has been nominated by the person as a 
skilled addressee.  
3.25H  Notice of decision  on certification request  
 (1) If the Commissioner makes a decision under regulation  3.25B 
(including a decision about imposing conditions  under 
regulation  3.25G), the Commissioner must inform each person 
mentioned in subregulation  (2) of the decision, and the reasons for 
the decision, by notice in writing given as soon as practicable after 
the date of the decision.  
 (2) For subregulation  (1), the persons are as follows:  
 (a) the person who made the request;  
 (b) the applicant or patentee;  
 (c) any other person who apparently has an inte rest in the 
request.  
7  Paragraph 22.5(a)  
Omit “Special Account established under section  20 of the Financial 
Management and Accountability Act 1997 ”, substitute “special account 
established under section  78 of the Public Governance, Performance 
and Accoun tability Act 2013 ”. 
8  Subregulation  22.15(4) (note)  
Repeal the note, substitute:  
Note:  For a list of these documents, see subregulation  3.14D(1).  
9  Subp aragraph s 22.26(2)(a)(iii) and (iv)  
Repeal the subparagraphs, substitute:  
 (iii) regulation  5.17 or 5.18 (‘dismissal of opposition’);  
Federal Register of Legislative Instruments F2015L00852Other amendments   Schedule 5  
   
 
 
No. 88, 2015  Intellectual Property Legislation Amendment (TRIPS Protocol and 
Other Measures) Regulation  2015  27 
OPC60570 - A  (iv) regulation  5.19 (‘determination of opposition’);  
10  Subparagraph 22.26(2)(a)(vaa)  
Repeal the subparagraph.  
11  Paragraph 22.26(2)(d)  
Omit “AAT”  (wherever occurring) , substitute “Tribunal”.  
12  Subclause  5(2) of Sche dule 3 
Omit “ if a specification is numbered in accordance with 
subclause  6(2),”. 
13  Part 2 of Schedule  7 (table item  239) 
Repeal  the item.  
14   Part 4 of Schedule  7 (paragraph  (a) of table item  403) 
Repeal the paragraph.  
Trade Marks Regulations  1995  
15  Regulation  2.1 
Insert:  
Code of Conduct  means the standard of practice  titled “Code of 
Conduct for Patent and Trade Mark Attorneys” that is established 
by the Board from time to time.  
16  Subregulation  17A.33(3)  
Omit “applicant”, substitute “holder of the  IRDA”.  
17  Subregulations  17A.34B(2) and (5)  
Omit “applicant”, substitute “holder of the IRDA”.  
18  Subregulation  17A.34H(5)  
Omit “opponent”, substitute “holder”.  
19  Subregulation  17A.34H(5)  
Omit “opponent’s”, substitute “holder’s”.  
Federal Register of Legislative Instruments F2015L00852Schedule 5   Other amendments  
   
 
 
28 Intellectual Property Legislation Amendment (TRIPS Protocol and 
Other Measures) Regulation  2015  No. 88, 2015  
OPC60570 - A 20  Subregulation  17A.34M(2)  
Omit “An applicant”, substitute “The holder of an IRDA”.  
21  Paragraph 17A.34M(6)(c)  
Omit “applicant”, substitute “holder of the IRDA”.  
22  Paragraph  17A.36(5) (a) 
Omit “17A.29(3)”, substitute “17A.32(2)”.  
23  Paragraph 20.14(b)  
Omit “the ‘Register’ ”, substitute “the ‘Register of Patent Attorneys’”.  
24  Paragraph 20.14(e)  
Repeal the paragraph.  
25  At the end of regulation  20.15  
Add:  
 ; and (d)  the reference in subparagraph  20.33(2)(b)(i) of the Patents 
Regulations  1991  to ‘regulation  20.6’ were a reference to 
‘regulation  20.6 of the Trade Marks Regulations  1995 ’; and  
 (e) the reference in subparagraph  20.33(2)(b)(ii) of the Patents 
Regulations  1991  to ‘regulation  20.8’ were a reference to 
‘regulation  20.8 of the Trade Marks Regulations  1995 ’. 
26  Regulation  21.14 (note)  
Repeal the note, substitute:  
Note:  Regulation  5.19 deals with directions as to procedure in opposition 
proceedings.  
27  Subregulation  21.21A(2)  
Omit “despite of”, substitute “despite”.  
28  Paragraph 21.28(2)(b)  
Omit “regulation  17.48F”, substitute “regulation  17A.48F”.  
29  Clause  1 of Schedule  7 
Omit “5.5”, substitute “5.18”.  
Federal Register of Legislative Instruments F2015L00852Other amendments   Schedule 5  
   
 
 
No. 88, 2015  Intellectual Property Legislation Amendment (TRIPS Protocol and 
Other Measures) Regulation  2015  29 
OPC60570 - A 30  Schedule  9 (table item  13) 
Repeal the item, substitute:  
13 Filing an application for removal of a trade mark from 
the Register for non -use under section  92 of the Act  $250  
13A Filing an application for cessation of protection for 
non-use under Subdivision D of Division  5 of Part  17A $250  
31  Schedule  9 (table item  18) 
Repeal the item, substitute:  
18 Handling an application for the international 
registration of a trade mark under regulation  17A.7 , if 
the application is filed other than by approved means  $100  
Federal Register of Legislative Instruments F2015L00852Schedule 6   Application of amendments  
   
 
 
 
30 Intellectual Property Legislation Amendment (TRIPS Protocol and 
Other Measures) Regulation  2015  No. 88, 2015  
OPC60570 - A Schedule  6—Application of amendments  
  
Patents Regulations  1991  
1  At the end of Chapter  23 
Add:  
23.37   Amendments made by Intellectual Property Legislation 
Amendment (TRIPS Protocol and Other Measures) 
Regulation  2015  
 (1) The amendments of these Regulations made by Schedule  1 to the 
Intellectual Property Legislation Amendment (TRIPS Protocol and 
Other Measures) Regulation  2015  (the amend ing instrument ) 
apply in relation to patents granted before or after the 
commencement of th at Schedule . 
 (2) The amendments of these Regulations made by items  2 to 13 of 
Schedule  4 to the amending instrument apply in relation to the 
following:  
 (a) patents  for which the complete application is made after th at 
Schedule commences;  
 (b) standard patents for which the appl ication had been made 
before that Schedule commences , if the applicant had not 
asked for an examination of the patent request and 
specificati on for the application under section  44 of the 
Patents Act 1990  before that time;  
 (c) innovation patents granted after that Schedule commences , if 
the complete application to which the patent relates had  been 
made before that time;  
 (d) complete patent applications made after the time th at 
Schedule commences ; 
 (e) complete applications for standard patents made before the 
commencement of that Schedule , if the applicant had not 
asked for an examination of the patent request and 
specification for the appli cation under section  44 of the 
Patents Act 1990  before that time;  
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No. 88, 2015  Intellectual Property Legislation Amendment (TRIPS Protocol and 
Other Measures) Regulation  2015  31 
OPC60570 - A  (f) complete applications for innovation patents made before 
that Schedule commences , if a patent had not been granted in 
relation to the applica tion on or before that time;  
 (g) innovation  patents granted before th at Schedule commences,  
if: 
 (i) the Commissioner had not decided to examine the 
complete specification relating to the patent under 
section  101A of the Patents Act 1990  before that time; 
and 
 (ii) the patentee or any other person had not asked the 
Commissioner to examine the complete specification 
relating to the patent under section  101A of the Patents 
Act 1990  before that time.  
 (3) Regulation  3.25 as repealed and substituted  by Schedule  5 of the 
amending instrument applies in re lation to requests made after the 
commenceme nt of that Schedule, regardless of when the 
micro -organism was deposited with a prescribed depository 
institution.  
 (4) Regulation  3.25A as inserted by Schedule  5 of the amending 
instrument applies in relation to  applications for standard patents 
made:  
 (a) after the commencement of that Schedule; and  
 (b) before the commencement of that Schedule, if the complete 
specification relating to the application is not open to public 
inspection at that commencement.  
Federal Register of Legislative Instruments F2015L00852