Federal Register of Legislation - Australian Government

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SLI 2015 No. 88 Regulations as made
This regulation amends the Designs Regulations 2004, the Patents Regulations 1991,and the Trade Marks Regulations 1995 to prescribe matters required under the provisions of the Acts as amended by Schedules 1, 2 and 5 to the Intellectual Property Laws Amendment Act 2015, and delete no-longer-required provisions and correct minor errors.
Administered by: Industry, Innovation and Science
Registered 19 Jun 2015
Tabling HistoryDate
Tabled HR23-Jun-2015
Tabled Senate24-Jun-2015
Date of repeal 24 Jan 2017
Repealed by Division 1 of Part 3 of Chapter 3 of the Legislation Act 2003

EXPLANATORY STATEMENT

Select Legislative Instrument No. 88, 2015

Issued by the Authority of the Minister for Industry and Science

Designs Act 2003

Patents Act 1990

Trade Marks Act 1995

Intellectual Property Legislation Amendment (TRIPS Protocol and Other Measures) Regulation 2015

Legislative Authority

Subsection 149(1) of the Designs Act 2003 (‘Designs Act’), subsection 228(1) of the Patents Act 1990 (‘Patents Act’), and subsection 231(1) of the Trade Marks Act 1995 (‘Trade Marks Act’)—collectively, ‘the Acts’—provide that the Governor-General may make regulations prescribing matters required or permitted by the Acts to be prescribed, or necessary or convenient to be prescribed for carrying out or giving effect to the Acts.

The Acts do not specify any conditions that must be met before the power to make the Regulation may be exercised.

The Regulation

The Intellectual Property Legislation Amendment (TRIPS Protocol and Other Measures) Regulation (‘Regulation’) amends the Designs Regulations 2004 (‘Designs Regulations’), the Patents Regulations 1991 (‘Patents Regulations’) and the Trade Marks Regulations 1995 (‘Trade Marks Regulations’) to:

·         prescribe matters required under the provisions of the Acts as amended by Schedules 1, 2 and 5 to the Intellectual Property Laws Amendment Act 2015 (‘Amendment Act’)

·         delete no-longer-required provisions and correct minor errors in the Designs Regulations, the Patents Regulations and the Trade Marks Regulations.

The Regulation is a legislative instrument for the purposes of the Legislative Instruments Act 2003.

Purposes of the Regulation

The first purpose of the Regulation is to amend the Patents Regulations to complete Australia’s legislative implementation of the ‘WTO Decision’ (the decision of the World Trade Organization (‘WTO’) General Council of 30 August 2003 on the implementation of paragraph 6 of the Doha Declaration on the TRIPS Agreement and public health).[1] These regulation amendments follow from amendments made to the Patents Act by Schedule 1 of the Amendment Act, which inserted new provisions to implement the WTO Decision.

The second purpose of the Regulation is to amend the Patents Regulations to complete Australia’s legislative implementation of the Protocol amending the World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property (‘TRIPS Protocol’), once it comes into effect.[2]

A third purpose of the Regulation is to amend the Designs Regulations, the Patents Regulations and the Trade Marks Regulations to simplify records management at IP Australia, by ensuring that it is governed solely by the Archives Act 1983.

A fourth purpose of the Regulation is to amend the Patents Regulations to correct a number of oversights in amendments made to the Patents Act by the Intellectual Property Laws Amendment (Raising the Bar) Act 2012.

The final purpose of the Regulation is to amend the Designs Regulations, the Patents Regulations and the Trade Marks Regulations to make technical amendments, correct errors, ensure consistency in terminology, and remove obsolete references.

Consultation undertaken on Regulation

The public was consulted on an exposure draft of the Regulation between 3 December 2014 and 15 February 2015. A single query was received from the Institute of Patents and Trade Marks Attorneys of Australia (IPTA), a peak body representing IP professionals. IPTA’s question was addressed by a Deputy Commissioner of Patents, and led to further refinement of the draft Patents Regulations.

No Regulatory Impact Statement required for the Regulation

The Office of Best Practice Regulation (‘OBPR’) did not require a Regulation Impact Statement for any of the measures in the Regulation (OBPR Reference Number 16689).

Matters incorporated by reference

New subsection 228(5) of the Patents Act defines eligible importing country as ‘a foreign country of a kind prescribed by regulation’. The note to that subsection explains that the regulation may incorporate reference to ‘any other instrument or other writing as in force or existing from time to time.’ This enables the Regulation (Schedule 1) to prescribe eligible importing countries by incorporated reference, as follows:

·         by drawing on the United Nations’ (UN) definition of Least Developed Countries, available on the UN website;[3]

·         by drawing on the WTO’s list of full members, available on WTO’s website.[4]

These incorporations by reference are to ensure that the Patents Regulations will not require amendment each time a country becomes a full member of the WTO, or is included or removed from the UN’s list of least developed countries.

Commencement of the Regulation

The Regulation commences as follows:

·         Sections 1 to 4 of the Regulation, and Schedules 3,5 and 6 to the Regulation commences on the day after the instrument is registered in the Federal Register of Legislative Instruments;

·         Schedule 1 to the Regulation commences at the same time as Schedule 1 to the Amendment Act (25 August 2015);

·         Schedule 2 to the Regulation will commence at the same time as Schedule 2 to the Amendment Act. This would be at the later of:

o   immediately after the commencement of Schedule 1 of the Amendment Act;

o   immediately after the TRIPS Protocol comes into force for Australia;

·         Schedule 4 to the Regulation commences at the same time as items 9 to 17 of Schedule 5 to the Amendment Act—a single day to be fixed by Proclamation within the 6 months ending on 24 August 2015. If those items of Schedule 5 to the Amendment Act do not commence within that period, they commence on 25 August 2015.

Details of the Regulation are set out in the Attachment.


ATTACHMENT

 

Details of the Intellectual Property Legislation Amendment (TRIPS Protocol and Other Measures) Regulation 2015

Schedule 1 amends the Patents Regulations to implement the ‘WTO Decision’ (the decision of the WTO General Council of 30 August 2003 on the implementation of paragraph 6 of the Doha Declaration on the TRIPS Agreement and public health). This will help developing countries experiencing public health problems that cannot manufacture their own medicines or purchase them in the normal way, to obtain generic versions from Australia.

Schedule 2 amends the Patents Regulations to complete Australia’s implementation of the TRIPS Protocol, once it comes into effect. The Regulation will do so by correcting subsequently outdated references to the WTO.

Schedule 3 amends the Designs Regulations, the Trade Marks Regulations and the Patents Regulations to remove unnecessary document retention provisions and ensure that retention and disposal of documents is governed solely by the Archives Act 1983 and the relevant disposal authorities issued by the National Archives of Australia.

Schedule 4 amends the Patents Regulations to correct a number of drafting oversights made during the Intellectual Property Laws Amendment (Raising the Bar) Act 2012 (‘Raising the Bar Act’). It will also repeal provisions which were inserted to address these oversights.

Schedule 5 amends the Designs Regulations, the Patents Regulations, and the Trade Marks Regulations to correct errors, ensure consistency in terminology, and remove obsolete references.

Schedule 6 amends the Patent Regulations to specify when the amendments made by Schedule 1, items 2 to 3 of Schedule 4, and item 6 of Schedule 5 will apply.


 

Schedule 1—Amendments relating to the TRIPS Protocol interim waiver

Overview

Schedule 1 amends the Patents Regulations to complete Australia’s legislative implementation of the ‘WTO Decision’ (the decision of the WTO General Council of 30 August 2003 on the implementation of paragraph 6 of the Doha Declaration on the TRIPS Agreement and public health).

The WTO Decision aims to help the many least-developed and developing countries that have difficulty manufacturing or accessing patented pharmaceuticals, and that are therefore unable to respond effectively to public health problems.

Under the amendments to the Patents Act, Australian pharmaceutical companies will be able to apply to the Federal Court for a compulsory licence allowing the pharmaceutical companies to manufacture generic versions of patented medicines, and then export the cheaper medicine to ‘Eligible Importing Countries’ suffering a health crisis. Adequate compensation for patent holders will be as either negotiated by the applying pharmaceutical company and the patent holder or as determined by the Federal Court.  This will ensure that patent holders are not disadvantaged by the arrangements.

The following regulation amendments are necessary to give effect to this arrangement.

Patents Regulations 1991

Items 1 and 2 amend subregulation 1.3(1) and insert new regulation 1.4A to define several new expressions used in new Part 2 of Chapter 12 of the Patents Regulations.

The new expressions in subregulation 1.3(1) include:

·         WTO member—a country that is a full member of the World Trade Organization;

·         least developed countrya country included in the list of least developed countries maintained by the United Nations (‘UN’), as in force from time to time;

·         eligible importing country—to be defined in regulation 1.4A (as explained below).

WTO member and least developed country are defined in a way that avoids having to amend the Patents Regulations each time a country becomes a WTO member, or the UN changes its list of least developed countries.[5]

Patents Regulation 1.4A prescribes eligible importing countries as:

(a)  a WTO member that notifies the Council for TRIPS, in accordance with the WTO Decision of 30 August 2003, of the member’s intention to use the system set out in that decision as an importer;

(b)  a least developed country.

Regulation 1.4A brings the Patents Regulations into accord with the WTO Decision.[6]

Item 3 inserts a new part heading, which will distinguish the existing provisions for general compulsory licences from the new compulsory licensing provisions for patented pharmaceutical inventions (‘PPI’).

Item 4 replaces the heading to regulation 12.1 to make it clear that the regulation is about applications for orders for general compulsory licences, not merely the lodgement of such applications (as the current heading suggests).

Item 5 inserts new Part 2 into Chapter 12 to prescribe several matters which govern proceedings for PPI compulsory licences (new regulations 12.2A to 12.2F). It also inserts a new part heading before the existing provisions for the surrender and revocation of patents, distinguishing them from the new provisions that apply only to PPI compulsory licences.

New regulation 12.2A—applications for PPI orders

New section 136D of the Patents Act allows a person (‘PPI order applicant’) to apply to the Federal Court for an order (‘PPI order’) requiring the patentee of a patented pharmaceutical invention to grant a PPI compulsory licence to the PPI order applicant.

New regulation 12.2A sets out the detailed information required in the application to the court. This includes an address for service complying with the relevant Federal Court Rules for service of the application. The PPI order applicant is required to serve copies of the application on the parties in accordance with those rules. That said, the PPI order applicant is not required to serve a copy of the application on the eligible importing country. The eligible importing country will already be aware of the application due to the requirement for the eligible importing country to provide a statement which will form part of the application under s.136D(3) of the Patents Act.  

New regulation 12.2B—notification requirements

New section 136E of the Patents Act permits the Federal Court to make the PPI order sought under new section 136D, if the court is satisfied of all of the matters listed in new subsection 136E(1). One of these matters is that the notification requirements prescribed by the regulations in relation to the importation of the pharmaceutical product have been complied with.

New regulation 12.2B prescribes the notification requirements. These depend on whether the eligible importing country is a WTO member or is a least developed country that is not a WTO member.

A WTO member is required to have notified the Council for TRIPS in accordance with paragraph 2(a) of the WTO Decision. That paragraph details the notification of use of the system that a WTO member must make to import pharmaceutical products under that system.

A least developed country that is not a WTO member could not be expected to notify the Council for TRIPS under paragraph 2(a) of the WTO Decision, since any such notification could have no legal effect (as they are not a member). Accordingly, that eligible importing country would be required to notify the Commissioner of Patents of the same matters that a least developed country member must notify to the Council for TRIPS. The eligible importing country would be required to confirm that it would meet the same conditions as a WTO member using the system as an importer—as if Article 31 of the TRIPS Agreement and the WTO Decision applied to the country. In particular, if the pharmaceutical product is patented in the country, it would have to confirm that it has granted or intends to grant a compulsory licence for the importation and use of the pharmaceutical product there.

New regulation 12.2C—labelling and marking requirements

New subsection 136F(1) of the Patents Act provides that a PPI order must direct that a PPI compulsory licence be granted on specified terms. One of these terms is that the pharmaceutical product is labelled and marked in accordance with the regulations.

New regulation 12.2C prescribes the labelling and marking requirements in general terms. That is, the pharmaceutical product made under the PPI compulsory licence would be required to be labelled and marked so that it would be:

·         clearly identified as being exported from Australia under the PPI compulsory licence;

·         distinguished from the same pharmaceutical product:

o   sold in Australia (e.g. sold commercially by the Australian patentee);

o   exported from Australia other than under the licence (e.g. exported commercially by the Australian patentee).

These labelling requirements are in addition to any other labelling requirements that must be complied with under Australian law, such as those administered by the Therapeutic Goods Administration.

Two additional requirements are intended to counter diversion of the pharmaceutical product from the eligible importing country. The labelling and marking must:

·         be applied to both the immediate packaging of the pharmaceutical product and any other packaging containing that package. This is to ensure that the marking and labelling can be seen if, for whatever reason, an inner package becomes separated from the outer packaging of the pharmaceutical product;

·         remain clear and legible at all times while the product is being exported.

New subsection 136F(2) of the Patents Act also permits the PPI order to specify other terms in the PPI compulsory licence, including other requirements relating to the labelling and marking of the pharmaceutical product. New subsection 136F(3) requires that a PPI order must be consistent with any regulations prescribed for new subsection 136F(1). This includes the labelling and marking requirements specified in new regulation 12.2C.

Accordingly, during the hearing of an application for a PPI order, the parties could make detailed proposals on distinguishing features to address the requirements in new regulation 12.2C. These distinguishing features could include combinations of labelling, aspects of packaging, marking, colour, size or shape of units of the pharmaceutical product. They could be features of the individual tablet, capsule or vial or container.

It is for the Federal Court to determine whether the distinguishing features meet the requirements in new regulation 12.2C. It is expected that these features should not unduly add to the cost of manufacturing and packaging the pharmaceutical product for export. The Court could be expected to specify the distinguishing labelling and marking  features in the PPI order under new paragraph 136F(2)(a) of the Patents Act.

New regulation 12.2D—shipment information requirements

New paragraph 136F(1)(d) of the Patents Act requires that before shipment of the pharmaceutical product begins, the shipment information prescribed by the regulations be made available on a website by, or on behalf of, the licensee for a minimum period prescribed by the regulations.

New regulation 12.2D prescribes the information that is required in relation to each shipment of a pharmaceutical product. This information must include the name and amount of the pharmaceutical product to be shipped, the name of the importing country, the name of the importer and the distinguishing features of the pharmaceutical product (regulation 12.2C, above).

The shipment information must be made available on the website that the licensee has previously advised the Commissioner of (regulation 12.2E, below). The shipment information must appear on the website before the shipment begins. This is to be understood as meaning that the information must appear on the website before the pharmaceutical product is loaded onto a ship or aircraft leaving Australia. The information must continue to appear on the website for the duration of the licence. This is to ensure that there is transparency in the use of the PPI compulsory licence.

New regulations 12.2E and 12.2F—giving information to the Commissioner and what the Commissioner must do with some of that information

New paragraph 136F(1)(h) of the Patents Act requires that the PPI order must direct the licensee to give the Commissioner information relating to the licence, as required by the regulations.

In turn, new regulation 12.2E prescribes the information the licensee must give the Commissioner in relation to the PPI compulsory licence, and when this information must be given. The licensee must advise the Commissioner:

·         of the grant of the licence, including the details of the PPI order made by the Federal Court;

·         of any amendment of the licence ordered by the Federal Court (new section 136G of the Patents Act);

·         of any revocation of the licence ordered by the Federal Court (new section 136H of the Patents Act);

·         that an amount of remuneration for the licence has either been agreed between the licensee and the patentee, or has been determined by the Federal Court (new section 136J of the Patents Act). It is not necessary for the licensee to disclose the actual amount, as this may be commercially sensitive information.

The information must be provided within one month following the Federal Court making the relevant order, or the agreement on remuneration being reached. The information must be provided to the Commissioner in the form approved by the Commissioner.

Having received that information, the Commissioner would then be required by new subregulation 12.2F(1) to:

·         provide the information to the Council for TRIPS—if the eligible importing country is a WTO member. The WTO Secretariat would then make the information available publicly by means of a dedicated page on the WTO website;[7]

·         publish the information on the internet—if the eligible importing country is not a WTO member. This would ensure that information about the grant of a PPI compulsory licence is publicly available in all cases, not only when the eligible importing country is a WTO member.

In addition, new subregulation 12.2F(2) would require the Commissioner to notify the eligible importing country that the licensee has a remuneration agreement in place. This knowledge would preclude the eligible importing country from inadvertently paying a second licensing fee (which would be inconsistent with the aim of promoting access to affordable medicines).


 

Schedule 2—Further amendments relating to the TRIPS Protocol

Overview

When the amendments to the TRIPS Agreement provided by the TRIPS Protocol come into effect, the Patents Regulations will need to be amended so that they refer to the TRIPS Agreement instead of the WTO Decision that it replaces.

The TRIPS Protocol will only enter into force when two-thirds of WTO members have accepted it. Currently, only one-third of WTO members have done so.

Patents Regulations 1991

Item 1 substitutes paragraph 1.4A(a) of the Patents Regulations, so that a WTO member that is not also a least developed country would be required to notify the Council for TRIPS of its intention to use the system in accordance with the provisions of the amended TRIPS Agreement, rather than the analogous provisions of the WTO Decision it replaces.

Item 2 amends subregulation 12.2B(3) of the Patents Regulations so that it correctly refers to a provision in the amended TRIPS Agreement, rather than to the analogous provision in the WTO Decision it replaces.

Item 3 amends paragraph 12.2B(5)(b) of the Patents Regulations so that it correctly refers to provisions in the amended TRIPS Agreement, rather than to the analogous provisions in the WTO Decision it replaces.


 

Schedule 3—Amendments relating to document retention

Overview

This schedule amends the Designs Regulations, the Patents Regulations and the Trade Marks Regulations to give effect to the amendments made by Part 1 of Schedule 5 to the Amendment Act. Taken together, these amendments would simplify records management at IP Australia, allowing the disposal of documents that are no longer required under the Archives Act 1983 and the relevant disposal authorities issued by the National Archives of Australia.

Designs Regulations 2004

Item 1 amends subregulation 5.08(1) of the Designs Regulations, as a consequence of the repeal of paragraph 69(3)(c) of the Designs Act. Item 2 repeals subregulation 5.08(2) of the Designs Regulations, as a consequence of the repeal of paragraph 69(3)(c) of the Designs Act.

As a result of the repeal, the retention and disposal of documents related to design applications will be governed solely by the Archives Act 1983 (‘Archives Act’).

Before its repeal, paragraph 69(3)(c) of the Designs Act required the Registrar to retain material concerning the newness or distinctiveness of a registered design for the prescribed period. Subregulation 5.08(2) of the Designs Regulations prescribed the period ending six years after the term of registration of the design ceases.

Patents Regulations 1991

Item 3 repeals regulation 22.18 of the Patents Regulations, as a consequence of the repeal of the regulation-making power in paragraph 228(2)(u) of the Patents Act.

As a result of the repeal, the retention and disposal of documents related to patent applications will be governed solely by the Archives Act.

Before its repeal, paragraph 228(2)(u) of the Patents Act permitted the making of regulations for and in relation to the destruction of documents relating to applications for patents filed not less than 25 years before the time of destruction. Regulation 22.18 of the Patents Regulations permitted the Commissioner of Patents to order the destruction of certain documents relating to patents applications that were filed not less than 25 years before the date of the order.

Trade Marks Regulations 1995

In subregulation 17A.39(1) of the Trade Marks Regulations, Item 4 removes a now-redundant reference to regulation 21.32 of the Trade Marks Regulations, which is to be repealed by Item 5 (immediately below).

Item 5 repeals regulation 21.32 of the Trade Marks Regulations, as a consequence of the repeal of paragraph 231(2)(h) of the Trade Marks Act.

As a result of the repeal, the retention and disposal of documents related to trade mark applications will be governed solely by the Archives Act.

Before its repeal, paragraph 231(2)(h) of the Trade Marks Act permitted the making of regulations providing for the destruction of documents relating to a trade mark at least 25 years after the registration of the trade mark has ceased. Regulation 21.32 of the Trade Marks Regulations permitted the Registrar of Trade Marks to order the destruction of documents relating to a trade mark whose registration ceased at least 25 years ago.

Schedule 4—Amendments relating to amendments made by Part 2 of Schedule 5 to the Intellectual Property Laws Amendment Act 2015

Overview

This schedule amends the Patents Regulations to correct a number of drafting issues inserted in the Patents Act by the Intellectual Property Laws Amendment (Raising the Bar) Act 2012 (‘Raising the Bar Act’). It will also repeal provisions which were inserted to address these drafting issues.

Patents Regulations 1991

Item 1 amends regulation 3.11 of the Patents Regulations to delete the now-superseded reference to subsection 29B(2) of the Patents Act.

Item 2 repeals and replaces current subregulation 3.12(4) of the Patents Regulations, which explains the expression clearly discloses used in provisions for determining the priority dates of claims to inventions (in regulations 3.13A to 3.13E of the Patents Regulations). Substitute subregulation 3.12(4) of the Patents Regulations is to put it beyond doubt that a set of documents considered together can clearly disclose an invention. This follows from the Amendment Act’s amendment of paragraph 43(2A)(b) of the Patents Act to make it clear that the priority date of a claim to an invention is not limited to being based on a single document disclosing the invention, but also can be based on sets of documents considered together.

New subregulation 3.12(5) of the Patents Regulations is to put it beyond doubt that a document or set of documents can clearly disclose an invention relating to a micro-organism that is deposited with a prescribed depositary institution in accordance with the Budapest Treaty.[8] This follows from the Amendment Act’s insertion of a new subsection 43(2B) into the Patents Act. That new subsection makes it clear that (in relevant circumstances) a properly deposited sample of a micro-organism can be taken into account when determining whether a claimed invention has been disclosed for determining a priority date of the claim.

Items 3 to 13 amend regulations 3.13A to 3.13E of the Patents Regulations, which are about determining the priority dates of claims to inventions. The amendments are not intended to change the existing policy of regulations 3.13A to 3.13E, but rather to ensure that those regulations clearly match the provisions of amended subsection 43(2A) and new 43(2B) of the Patents Act.

The amendments are to clarify that circumstances and priority documents currently mentioned in regulations 3.13A to 3.13E of the Patents Regulations, are the prescribed circumstances and priority documents for the purposes of paragraphs 43(2A)(a) and (b) of the Patents Act.

The amendments also insert new provisions into regulations 3.13A to 3.13E of the Patents Regulations to prescribe the circumstances for new subsection 43(2B) of the Patents Act to apply. For an applicant to be able to rely on a deposited micro-organism to establish a priority date of a claimed invention, the following requirements must all be met:

·         the micro-organism must have been properly deposited with a prescribed depositary institution on or before the date the priority document is filed;

·         the priority document (or several documents considered together) must include the relevant information on the characteristics of the micro-organism known to the applicant when the priority document or documents are filed;

·         the requirements of paragraph 6(c) of the Patents Act are satisfied by the complete specification that contains the claim.

This continues the existing requirements for relying on a deposited micro-organism, but also makes it clear that the required information about the characteristics of the micro-organism can be in several documents filed at the same time.

The reference to ‘the requirements of paragraph 6(c) of the Patents Act’ means that the complete specification containing the claim must include the name of the prescribed depositary institution and the identifying details the institution has given the deposit. This information must appear in the complete specification at all times after the end of the relevant period prescribed in regulation 1.5 of the Patents Regulations. This is to allow someone who might be affected by a patent being granted for an invention relating to the micro-organism to seek access to a sample of the micro-organism.[9]

Items 14 and 16 repeal subregulations 3.15(3) and 10.1(1AA) of the Patents Regulations, following from the Amendment Act’s inserting new subsection 29A(6) into the Patents Act. New subsection 29A(6) provides that an applicant under the Patent Cooperation Treaty (‘PCT’) cannot require that anything be done under the Patents Act for their PCT application unless it enters national phase in Australia.

For that to happen, the applicant must comply with the requirements in existing subsection 29A(5) of the Patents Act by paying the prescribed fees and filing the prescribed documents. If the PCT application is not in English, new subsection 29A(6) requires the applicant to also file a translation of the application into English.

This makes subregulations 3.15(3) and 10.1(1AA) superfluous.

Item 15 inserts new regulation 3.32 to prescribe the circumstances for a provisional specification disclosing an invention that is a micro-organism, in order to comply with the disclosure requirement in existing subsection 40(1) of the Patents Act. That subsection requires that a provisional specification must disclose the invention so that it can be performed by a person skilled in the relevant art.

New subsection 41(1A) of the Patents Act, inserted by the Amendment Act, makes it clear that a properly deposited micro-organism can be taken into account for meeting the disclosure requirement for provisional specifications in subsection 40(1), just as it can be for complete specifications.

Under new regulation 3.32 of the Patents Regulations, a provisional specification providing a description of a micro-organism complies with subsection 40(1) of the Patents Act if the following conditions apply:

·         the micro-organism is deposited with a prescribed depository institution, in accordance with the applicable rules of the Budapest Treaty, on or before the date the provisional specification is filed;

·         at the time the provisional application was made:

o   the provisional specification clearly discloses the invention, other than in relation to the description of the micro-organism; and

o   a document filed for the provisional application (or several documents considered together) includes the relevant information on the characteristics of the micro-organism known to the applicant at that time;

·         if a complete application is associated under section 38 of the Act with the provisional application for which the provisional specification is filed—the requirements of paragraph 6(c) of the Patents Act are satisfied by the complete specification filed for that complete application.

The latter condition applies only if a complete application is subsequently associated with the provisional application. Not every provisional application has a complete application associated with it. A provisional application is filed for the purpose of establishing an earlier priority date for claims that might appear in an associated complete application. So it is not necessary for a provisional specification to meet the requirements of paragraph 6(c) of the Patents Act: it would suffice that the specification for any associated complete application meets them.


 

Schedule 5—Other Amendments

Overview

Schedule 5 amends the Designs Regulations, the Patents Regulations and the Trade Marks Regulations to make technical amendments, correct errors, ensure consistency in terminology, and remove obsolete references.

Designs Regulations 2004

Item 1 inserts a new regulation 1.06 into the Designs Regulations, modelled directly on existing regulation 2.3 of the Trade Marks Regulations. The new regulation permits the Registrar of Designs to give a document to a person by making it available to the person electronically and then notifying the person that the document is available.

New subregulation 1.06(2) provides that the date a document is taken to have been given to the person is the date it is dated by the Registrar of Designs. This would apply whether access is provided to the document electronically or by another means. This is intended to avoid any uncertainty as to when a document is given to the person.

Item 2 inserts new subregulations 13.13(1A) and (1B) into the Designs Regulations, modelled directly on existing subregulations 22.11(1A) and (1B) of the Patents Regulations. The new subregulations are to ensure that a person applying for an extension of time to do a relevant act under the designs legislation is not unduly affected by the time taken for opposition or review proceedings concerning the application.

Under section 137 of the Designs Act, a person can apply for an extension of time to do a relevant act (e.g. to renew a registered design after the end of the six-month grace period). If the application is for an extension of more than three months, it must be advertised in the Official Journal of Designs. Another person can oppose the application for the extension of time. If the Registrar grants the opposed extension of time, the Registrar must extend the time to include the period from filing of the notice of opposition to 21 days after the Registrar decides the opposed application. If either party seeks Administrative Appeals Tribunal (‘AAT’) review of the Registrar’s decision, then the extension of time continues until the review is withdrawn, finally dealt with or otherwise determined.

This will ensure that the initial applicant is not required to seek further extensions of time in order to allow for opposition proceedings to be heard.

Patents Regulations 1991

Item 3 removes the requirement for a patentee to serve copies of an application on the other patentee(s). With the deletion of the requirement in 2.1(2)(b), it is the Commissioner who provides a copy of an application under section 17 of the Patents Act to the other patentee(s).

This makes matters consistent with the other multi-party proceedings in the patents legislation (e.g. oppositions). In those proceedings, a party files an application or other document with the Commissioner, who then provides it to the other parties.

Item 4 repeals and substitutes a new regulation 3.2 into the Patents Regulations to clarify the formality requirements for provisional specifications. This would align these requirements with the existing requirements for complete specifications in existing regulation 3.2A. In particular, both provisional and complete specifications would have to be in English.

Item 5 inserts a new paragraph 3.2C(2)(aa) into the Patents Regulations, to require an applicant for a PCT application to provide the name(s) of the inventor(s) of the invention in the application. This information is required to ensure that the entitlement of the applicant to be granted a patent is clear.

Just as with the existing requirement for a PCT applicant to provide an address for service in Australia, the name(s) of the inventor(s) would not be required until after the PCT application has entered national phase in Australia.

Item 6 substitutes regulation 3.25 of the Patents Regulations and also inserts new regulations 3.25A to 3.25H. These amendments are not intended to change the existing policy for accessing samples of deposited micro-organisms, but are to make the framework for access clearer and simpler.

A properly deposited sample of a micro-organism can be taken into account when determining whether a claimed invention has been disclosed for determining a priority date of the claim. Under the Budapest Treaty, a sample of the deposited micro-organism supporting the grant of an Australian patent can be obtained from an International Depositary Authority (IDA). To obtain a sample, a person can present the IDA with a certificate from the Commissioner authorising the release of the micro-organism to that person (‘certification’).

One of the existing requirements for obtaining the Commissioner’s certificate is that the recipient gives an enforceable undertaking to use the sample of the deposited micro-organism only for experimental purposes or for legal proceedings concerning the application or patent.[10]

New regulation 3.25C(2) ensures that such limits apply only while the application is pending, or during the life of the granted patent. This protects the legitimate interests of the applicant or patentee in the invention, while also ensuring that samples of the deposited micro-organism would be available for commercial use once:

·         the application lapses, is refused or is withdrawn (that is, no patent is granted);

·         the patent expires, ceases or is revoked.

Once any of those events occurs, no undertaking would be required to obtain a sample, and any undertaking previously given for the sample would cease to bind the person who gave it. This is consistent with the patents legislation, which gives no rights to inventions that are never patented, and which does not prevent the free use of previously-patented inventions once the patent is no longer in force.

New regulation 3.25B(4)(c) ensures that it is also clear that a person authorised to use the invention relating to the micro-organism under the existing compulsory licensing or Crown use provisions (see sections 133 and 163 of the Patents Act) is not required to give an undertaking. Requiring an undertaking in these circumstances would reduce the public benefit of those provisions, since the use of the sample would be limited to experimenting or conducting legal proceedings. The amendments clarify the existing policy intent, ensuring that inventions relating to micro-organisms are treated just like other inventions.

In addition, new regulation 3.25B(5) clarifies how certification will be granted for PCT applications involving micro-organisms. The PCT system enables an applicant to file a single international patent application with the Patent Office in one member state, and then ask for that patent application to be processed as a national application in other member states (‘entering national phase’). Unless a PCT application enters national phase in Australia, it will not go on to be examined in Australia.

New regulation 3.25B(5) provides that certification will be granted only for those PCT applications that have entered national phase in Australia and can therefore  be examined in Australia. This will ensure that only those PCT applications which may result in the grant of a patent in Australia will have the corresponding micro-organism certified for release by the Commissioner.

Item 7 will amend the current reference in paragraph 22.5(a) of the Patents Regulations to a particular section in the former Financial Management and Accountability Act 1997 so that it correctly refers to the relevant section in the Public Governance, Performance and Accountability Act 2013.  

Item 8 repeals and substitutes the note following subregulation 22.15(4) of the Patents Regulations, so that the note correctly refers to the subregulation that lists the documents prescribed for disclosure in a basic application.

Items 9 to 11 amend subregulation 22.26(2) of the Patents Regulations to correct several paragraphs specifying decisions that are reviewable by the Administrative Appeals Tribunal (‘AAT’):

·         Item 9 repeals and substitutes subparagraphs 22.26(2)(a)(iii) and (iv) to ensure that they correctly refer to the provisions governing dismissal and determination of oppositions by the Commissioner;

·         Item 10 repeals subparagraph 22.26(2)(a)(vaa) which provided for the now-superseded AAT review of certain decisions under regulation 10.7 of the Patents Regulations. Those decisions are now made under section 191A of the Patents Act, which provides for them to be appealed to the Federal Court;

·         Item 11 corrects several erroneous references to the ‘Disciplinary AAT’ in paragraph 22.26(2)(d) of the Patents Regulations, so that they correctly refer to the ‘Disciplinary Tribunal’.

Item 12 corrects subclause 5(2) in Schedule 3 to the Patents Regulations by removing an incorrect reference to subclause 6(2). Clause 6 in Schedule 3 had been repealed by the Intellectual Property Legislation Amendment Regulations 2011 (No. 1). The amendment is to make it clear that the sheets of a specification must be numbered in accordance with subclause 5(2), except where the requirement in subclause 5(3) for numbering sheets of drawings applies instead.

Item 13 repeals fee item 239 in Part 2 of Schedule 7 to the Patents Regulations, which imposes the fee for filing an application under subregulation 3.17A(5) for an extension of time to file search results. The fee item has been superfluous since the Raising the Bar Regulation repealed that subregulation.

Item 14 repeals the fee item at item 403(a) in Part 4 of Schedule 7 to the Patents Regulations. This fee item is redundant as the International Bureau of WIPO will no longer be accepting applications in the specified format.

Trade Marks Regulations 1995

Item 15 inserts a new definition of ‘Code of Conduct’ into regulation 2.1 of the Trade Marks Regulations.

Items 16, 17, 20 and 21 amend regulations 17A.33, 17A.34B and 17A.34M of the Trade Marks Regulations to correct erroneous references to ‘applicant’ so that these correctly refer to ‘holder of the IRDA’ or ‘The holder of an IRDA’ as the case requires. The expression ‘applicant’ means an applicant for registration of a trade mark in Australia. In contrast, the owner of an international registration designating Australia (‘IRDA’) is referred to as its holder (see the definitions in regulation 17A.2).

Items 18 and 19 amend subregulation 17A.34H(5) of the Trade Marks Regulations to correct erroneous references to ‘opponent and ‘opponent’s’, so that these correctly refer to ‘holder’ or ‘holder’s’ instead.

Item 22 amends subregulation 17A.36(5) of the Trade Marks Regulations so that it correctly refers to the subregulation requiring the Registrar to notify the International Bureau of the filing of a notice of opposition.

Item 23 corrects a drafting oversight in paragraph 20.14(b) of the Trade Marks Regulations by replacing an occurrence of the expression ‘Register’ with ‘Register of Patent Attorneys’ instead.

Item 24 repeals paragraph 20.14(e) of the Trade Marks Regulations, as it would no longer be necessary with the amendment made by item 21.

Item 25 clarifies the correct application of subparagraphs 20.33(2)(b)(i) and (ii) of the Patents Regulations to individuals who are registered trade marks attorneys. In particular, this is so that the references to regulation 20.6 and 20.8 in those applied subparagraphs are clearly understood to be references to regulations 20.6 and 20.8 of the Trade Marks Regulations.

Item 26 corrects an error in the note following regulation 21.14 of the Trade Marks Regulations, so that it correctly refers to the regulation dealing with directions as to procedure in opposition proceedings.

Item 27 corrects the syntax of subregulation 21.21A(2) of the Trade Marks Regulations.

Item 28 corrects a drafting error in paragraph 21.28(2)(b) of the Trade Marks Regulations, so that an incorrect reference to regulation 17.48F refers to regulation 17A.48F instead.

Item 29 corrects a reference in clause 1 of Schedule 7 of the Trade Marks Regulations so that it correctly refers to regulation 5.18, which deals with the filing of a copy of a foreign application from which an opposed trade mark application claims priority.

Item 30 corrects the description and amount of the prescribed fee to be paid under Item 13 of Schedule 9 of the Trade Marks Regulations.

Item 31 amends Item 18 of Schedule 9 of the Trade Mark Regulations, making clear that the fee for handling an international registration of a trade mark (under regulation 17A.7 of the Trade Marks Regulations) will be payable only if the application is filed by unapproved means. When an application is filed by the approved means, the handling fee will be waived. The approved means is determined by the Registrar of Trade Marks (under regulation 21.21AA of the Trade Marks Regulations) and published on IP Australia’s website and in the Australian Official Journal of Trade Marks.


 

Schedule 6—Application of amendments

 

Schedule 6 specifies when the amendments made by Schedule 1, items 2-13 of Schedule 4, and item 6 of Schedule 5 will apply.

 

Item 1 – application provisions in regulations 23.37

Proposed regulation 23.37(1) provides that the amendments to be made by Schedule 1 will apply in relation to patents granted before or after the commencement of the Schedule. This application provision aligns with the application provision applying to related changes made in the Amendment Act.

Proposed regulation 23.37(2) sets out when the amendments to be made by items 2-13 of Schedule 4 will apply. This application provision aligns with the application provisions applying to related changes made in the Amendment Act.

 

Proposed regulation 23.37(3) relates to regulation 3.25 which, although to be repealed and substituted, is not intended to change existing policy but to make the existing framework for access more clear and simple. As a result, this application provision ensures that requests for certification made under regulation 3.25 will apply to any sample of a micro-organism, even if that sample was deposited before commencement.

 

Proposed regulation 23.37(4)(b) relates to new regulation 3.25A, which is not intended to change existing policy, but to make the existing framework for access more clear and simple. This application provision is included to make clear that the substantive rule in regulation 3.25A(1)(b) does apply in cases where a request for certification is made for a sample micro-organism which was deposited before commencement.

 


 

STATEMENT OF COMPATIBILITY WITH HUMAN RIGHTS

Prepared in accordance with Part 3 of the Human Rights (Parliamentary Scrutiny) Act 2011

Intellectual Property Legislation Amendment (TRIPS Protocol and Other Measures) Regulation 2015

This Legislative Instrument is compatible with the human rights and freedoms recognised or declared in the international instruments listed in section 3 of the Human Rights (Parliamentary Scrutiny) Act 2011.

 

Overview of the Legislative Instrument

 

This Legislative Instrument amends the Designs Regulations 2004, the Patents Regulations 1991, and the Trade Marks Regulations 1995.

 

The amendments are required to implement the Intellectual Property Laws Amendment Act 2015 (‘Amendment Act’), which has amended the Designs Act 2003, the Patents Act 1990 and the Trade Marks Act 1995.

 

The instrument prescribes matters required by the Amendment Act, and amends or deletes regulations required to give effect to the Amendment Act:

  • Schedules 1 and 2 implement the World Trade Organization General Council Decision of 30 August 2003 on the implementation of paragraph 6 of the Doha Declaration on the TRIPS Agreement and public health (‘WTO Decision’) and the Protocol amending the World Trade Organization Agreement on Trade-Related aspects of Intellectual Property (‘TRIPS Protocol’). Implementing the TRIPS Protocol enables Australian generic pharmaceutical producers to apply to the Federal Court for a licence to manufacture and export patented pharmaceuticals to countries experiencing a public health crisis. Australia accepted the TRIPS Protocol in 2007.
  • Schedule 3 amends the Designs Regulations, the Patents Regulations and the Trade Marks Regulations to repeal unnecessary document retention provisions and ensure that IP Australia’s records management obligations are governed solely by the Archives Act 1983.
  • Schedule 4 makes minor amendments to the Patents Regulations to address arising from in the drafting of the Intellectual Property Laws Amendment (Raising the Bar) Act 2012 (‘Raising the Bar Act’).
  • Schedule 5 amends the Designs Regulations, the Patents Regulations and the Trade Marks Regulations to make minor technical changes that will correct errors, ensure consistency in terminology, remove obsolete references and clarify the operation of provisions.
  • Schedule 6 specifies when the amendments made by Schedule 1, items 2-13 of Schedule 4, and item 6 of Schedule 5 will apply.

Human rights implications

This Legislative Instrument has a positive effect on human rights.

The Legislative Instrument engages the following human rights:

  • the right to health (Article 12 of the International Covenant on Economic, Social and Cultural Rights and Article 24 of the Convention on the Rights of the Child);
  • the right to enjoy the benefits of scientific progress and its applications (Article 15(1)(b) of the International Covenant on Economic, Social and Cultural Rights);
  • the right to the protection of interests resulting from one’s scientific production (Article 15(1)(c) of the International Covenant on Economic, Social and Cultural Rights); and
  • the right to privacy (Article 17 of the International Covenant on Civil and Political Rights).

 

Right to health

 

Article 12 of the International Covenant on Economic, Social and Cultural Rights (‘ICESCR’) recognises the right of everyone to enjoy the highest attainable standard of physical and mental health. The ICESCR provides that as part of achieving the full realisation of this right, States Parties shall take necessary steps to prevent, treat and control epidemic, endemic, occupational and other diseases.

 

Article 24 of the Convention on the Rights of the Child (‘CRC’) highlights the right of a child to enjoy the highest attainable standard of health. Article 24(4) of the CRC provides that in achieving this right, countries that are party to the CRC shall undertake the promotion and encouragement of international co-operation having particular consideration for the needs of developing countries.

 

The amendments to the Patents Regulations made by Schedules 1 and 2 of the Legislative Instrument implement the TRIPS Protocol. This will enable the export of generic versions of patented medicines to developing countries that are experiencing serious public health issues and that have no capacity to manufacture the medicines or purchase them in the normal manner. The amendments will advance the human right to health for everyone, including children, in developing countries by assisting with the treatment of serious health problems such as HIV/AIDS, malaria and tuberculosis.

 

Right to enjoy scientific progress and right to protection of interests resulting from scientific production

 

Article 15(1)(b) of the ICESCR recognises the right of everyone to enjoy the benefits of scientific progress and its applications. Article 15(1)(c) of the ICESCR recognises the right of everyone to benefit from the protection of the moral material interests resulting from any scientific, literary, or artistic production of which he is the author.

 

The amendments to the Patents Regulations made by Schedules 1 and 2 of the Legislative Instrument will not compromise the rights of inventors under Articles 15(1)(b) and (c) of the ICESCR. While the amendments will enable manufacturers of generic pharmaceuticals to apply to the Federal Court for a compulsory licence, affected patent owners will be compensated. As a result, there will be no impact on the right of inventors to benefit from their invention, or the rights of others to enjoy the benefits of scientific progress.

 

Right to privacy

 

Article 17 of the International Covenant on Civil and Political Rights (‘ICCPR’) recognises the right to privacy. It prohibits arbitrary or unlawful interference with a person’s privacy, family, home or correspondence. The right to privacy will be engaged when personal information is collected, used, stored and shared.

 

New paragraph 136D of the Patents Act provides that a person may apply to the Federal Court for an order (‘PPI order’) under s.136E requiring the patentee of a patented pharmaceutical invention (‘PPI’) to grant the applicant a licence (‘PPI compulsory licence’) to exploit the invention to the extent necessary for the purposes of manufacturing a pharmaceutical product in Australia for export to an eligible importing country.

 

New paragraph 136F sets out the terms on which the order can be granted, including that the licensee must give the Commissioner of Patents the information prescribed by the regulations.[11]

 

New regulation 12.2E provides that if the PPI order is granted, the licensee must give certain information, including the licensee’s name and address, and an address for service, to the Commissioner of Patents. New regulation 12.2F provides that if the Commissioner receives this information then the Commissioner must:

 

·         give a copy of the information to the Council for TRIPS, if the eligible importing country is a member of the WTO, who will publish it on a WTO website; or

 

·         if the eligible importing country is not a member of the WTO, the Commissioner of Patents must publish the information on a website.

 

Although the right to privacy under Article 17 is engaged by the requirement for applicants to provide personal information, the collection and sharing of the information is not arbitrary or unlawful.

 

The UNHCR has defined ‘unlawful’ to mean that no interference with privacy can take place except in cases envisaged by the law.[12] Applicants for a PPI order will be required to provide prescribed information only as required by the Patents Act and Patents Regulations. Applicants will know before applying that personal information will need to be provided as a condition of obtaining the licence, and that the information will be published. Personal information which is provided to the Commissioner of Patents will be treated in accordance with the principles set out in the Privacy Act 1988 (Cth). Therefore the collection and publication of the information will not be an unlawful interference with privacy under Article 17.

 

In order for an interference with the right to privacy not to be ‘arbitrary’, the interference must be for a reason consistent with the provisions, aims and objectives of the ICCPR and be reasonable in the particular circumstances.[13]

 

In this case, the collection and disclosure of the personal information provided to the Commissioner of Patents is not arbitrary, because it is required in order to achieve a legitimate public health objective – assisting developing countries which cannot manufacture or purchase their own medicines. It is reasonable in the circumstances for the applicant to provide personal information to enable the grant of the PPI order and the export of the pharmaceutical product.

 

Remaining schedules

 

Schedules 3, 4, 5, and 6 do not raise any human rights issues.

 

Conclusion

 

The Legislative Instrument is compatible with human rights because it advances the protection of human rights.

The Hon Ian Macfarlane MP, Minister for Industry and Science



[5] New subsection 228(5) of the Patents Act permits regulations made for the purposes of that new definition to apply, adopt or incorporate, with or without modification, any matter contained in any other instrument or other writing as in force or existing from time to time.

[6] Paragraph 1(b) of the WTO Decision at http://www.wto.org/english/tratop_e/trips_e/implem_para6_e.htm; also, http://www.wto.org/english/tratop_e/trips_e/public_health_notif_import_e.htm

[8] Australia is party to the Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure (http://www.wipo.int/treaties/en/text.jsp?file_id=283784).

[9] Accessing micro-organism samples is discussed in detail in the notes on item 6 in Schedule 5.

[10] Paragraph 3.25C and regulation 3.26 of the Patents Regulations

[11] New paragraph 136F(1)(h) of the Patents Act 1990 (Cth).

[12] Human Rights Committee, General Comment No. 16: The right to respect of privacy, family, home and correspondence, and protection of honour and reputation, Article 17 of the ICCPR, 1988, paragraph 3.

[13] Human Rights Committee, General Comment No. 16: The right to respect of privacy, family, home and correspondence, and protection of honour and reputation, Article 17 of the ICCPR, 1988, paragraph 4.