Intellectual Property Laws Amendment Act 2015 (Cth)

Intellectual Property Laws Amendment Act 2015 No. 8, 2015 An Act to amend legislation relating to intellectual property, and for related purposes Contents 1 Short title 2 Commencement 3 Schedule(s) Schedule 1—TRIPS Protocol interim waiver Part 1—Amendments Patents Act 1990 Part 2—Application Schedule 2—TRIPS Protocol: later commencing amendments Patents Act 1990 Schedule 3—Plant Breeder's Rights Act 1994: Federal Circuit Court Plant Breeder's Rights Act 1994 Schedule 4—Australia New Zealand Single Economic Market Part 1—Amendments Designs Act 2003 Patents Act 1990 Plant Breeder's Rights Act 1994 Trade Marks Act 1995 Part 2—Transitional provisions Schedule 5—Other amendments Part 1—Document retention Division 1—Amendments Designs Act 2003 Patents Act 1990 Trade Marks Act 1995 Division 2—Application of amendments Part 2—Technical amendments Division 1—Amendments Patents Act 1990 Division 2—Application of amendments Intellectual Property Laws Amendment Act 2015 No. 8, 2015 An Act to amend legislation relating to intellectual property, and for related purposes [Assented to 25 February 2015] The Parliament of Australia enacts: 1 Short title This Act may be cited as the Intellectual Property Laws Amendment Act 2015. 2 Commencement (1) Each provision of this Act 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 Provision(s) Commencement Date/Details 1. Sections 1 to 3 and anything in this Act not elsewhere covered by this table The day this Act receives the Royal Assent. 25 February 2015 2. Schedule 1 The start of the day after the end of the period of 6 months beginning on the day this Act receives the Royal Assent. 25 August 2015 3. Schedule 2 The later of: 23 January 2017 (a) immediately after the start of the day after the end of the period of 6 months beginning on the day this Act receives the Royal Assent; and (F2017N00010) (b) immediately after Article 31bis of the Agreement on Trade‑Related Aspects of Intellectual Property Rights set out in Annex 1C to the Marrakesh Agreement Establishing the World Trade Organization, done at Marrakesh on 15 April 1994, comes into force for Australia. (paragraph (b) applies) However, the provision(s) do not commence at all if the event mentioned in paragraph (b) does not occur. The Minister administering the Patents Act 1990 must announce by notice in the Gazette the day the event mentioned in paragraph (b) occurs. 4. Schedule 3 The day after the end of the period of 6 months beginning on the day this Act receives the Royal Assent. 25 August 2015 5. Schedule 4 A single day to be fixed by Proclamation. 24 February 2017 However, if the provision(s) do not commence within the period of 24 months beginning on the day this Act receives the Royal Assent, the provision(s) are repealed on the day after the end of that period. (F2016N00044) 6. Schedule 5, Part 1 The day after this Act receives the Royal Assent. 26 February 2015 7. Schedule 5, item 8 Immediately after the commencement of item 32 of Schedule 6 to the Intellectual Property Laws Amendment (Raising the Bar) Act 2012. 15 April 2013 8. Schedule 5, items 9 to 17 A single day to be fixed by Proclamation. 25 August 2015 However, if the provision(s) do not commence within the period of 6 months beginning on the day this Act receives the Royal Assent, they commence on the day after the end of that period. 9. Schedule 5, item 18 Immediately after the commencement of item 32 of Schedule 6 to the Intellectual Property Laws Amendment (Raising the Bar) Act 2012. 15 April 2013 10. Schedule 5, items 19 to 21 A single day to be fixed by Proclamation. 25 August 2015 However, if the provision(s) do not commence within the period of 6 months beginning on the day this Act receives the Royal Assent, they commence on the day after the end of that period. 11. Schedule 5, item 22 The day this Act receives the Royal Assent. 25 February 2015 Note: This table relates only to the provisions of this Act as originally enacted. It will not be amended to deal with any later amendments of this Act. (2) Any information in column 3 of the table is not part of this Act. Information may be inserted in this column, or information in it may be edited, in any published version of this Act. 3 Schedule(s) Each Act that is specified in a Schedule to this Act is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this Act has effect according to its terms. Schedule 1—TRIPS Protocol interim waiver Part 1—Amendments Patents Act 1990 1 Section 3 (list of definitions) Omit "compulsory licence". 2 Section 3 (list of definitions) Insert "eligible importing country". 3 Section 3 (list of definitions) Insert "patented pharmaceutical invention". 4 Section 3 (list of definitions) Insert "pharmaceutical product". 5 Section 3 (list of definitions) Insert "PPI". 6 Section 3 (list of definitions) Insert "PPI compulsory licence". 7 Section 3 (list of definitions) Insert "PPI order". 8 Section 3 (list of definitions) Insert "PPI order applicant". 9 Section 3 (list of definitions) Insert "TRIPS Agreement". 10 Section 3 (list of definitions) Insert "WTO General Council decision of 30 August 2003". 11 Before subsection 70(5) Insert: Meaning of first regulatory approval date 12 After subsection 70(5) Insert: (5A) For the purposes of paragraph (5)(a), disregard an inclusion in the Australian Register of Therapeutic Goods of goods that contain, or consist of, a pharmaceutical substance if the inclusion was sought for the sole purpose of exporting the goods from Australia to address a public health problem in an eligible importing country: (a) in circumstances of national emergency or other circumstances of extreme urgency; or (b) by the public non‑commercial use of the goods. Note: This subsection also applies in relation to an application for an extension of the term of a standard patent (see paragraph 71(2)(b)). Meaning of pre‑TGA marketing approval 13 At the end of paragraph 71(2)(b) Add ", as worked out under subsection 70(5A) (if applicable)". 14 Before section 133 Insert: Part 1—Introduction 132A Simplified outline of this Chapter This Chapter provides for court orders requiring the grant of compulsory licences in respect of patented inventions. Special provision is made for compulsory licences to exploit patented pharmaceutical inventions. This is to enable the manufacture of a pharmaceutical product in Australia for export to an eligible importing country, to address public health problems in that country. This Chapter also provides generally for the surrender of patents, and for court orders revoking patents. Part 2—Compulsory licences (general) 132B Simplified outline of this Part The Federal Court may make an order under this Part requiring the grant of a compulsory licence to work a patented invention. The court may order a compulsory licence to be granted if the reasonable requirements of the public are not being met with respect to a patented invention. The reasonable requirements of the public relate, broadly speaking, to whether Australian trade or industry is unreasonably affected by the actions of the patentee in relation to the manufacture or licensing of the invention (or the carrying on of a patented process). The court may also order a compulsory licence to be granted if the patentee has engaged in restrictive trade practices in connection with the patent under the Competition and Consumer Act 2010 or under an application law (within the meaning of that Act). The court may order a patent to be revoked after an order for a compulsory licence has been made (on the same grounds that apply to an order for a compulsory licence). The patentee must be paid an agreed amount of remuneration, or an amount of remuneration determined by the court. 15 Section 133 (heading) Repeal the heading, substitute: 133 Compulsory licences—general 16 At the end of subsection 133(1) Add: Note: For compulsory licences for the manufacture and export of patented pharmaceutical inventions to eligible importing countries, see Part 3. However, Part 3 does not prevent a compulsory licence from being ordered under this Part in relation to such an invention (see section 136C). 17 Section 134 (heading) Repeal the heading, substitute: 134 Revocation of patent after grant of compulsory licence under section 133 18 Subsection 134(1) After "compulsory licence", insert "ordered under section 133". 19 After section 136A Insert: Part 3—Patented pharmaceutical invention compulsory licences (for manufacture and export to eligible importing countries) Division 1—Introduction 136B Simplified outline of this Part The Federal Court may make an order under this Part requiring the grant of a compulsory licence to exploit a patented pharmaceutical invention for manufacture and export to an eligible importing country. The court may order a compulsory licence to be granted if the proposed use of the pharmaceutical product is to address a public health issue in the eligible importing country: (a) in a national emergency (or other extremely urgent circumstances); or (b) by the public non‑commercial use of the product. The order may be amended or revoked by another order of the court. The patentee must be paid an agreed amount of remuneration, or an amount of remuneration determined by the court. 136C Relationship between Parts 2 and 3 This Part does not prevent a compulsory licence from being ordered under Part 2 in relation to a patented pharmaceutical invention. Division 2—Patented pharmaceutical invention compulsory licences 136D PPI compulsory licences—applications for orders Application for order (1) A person (the PPI order applicant) may apply to the Federal Court for an order (the PPI order) under section 136E requiring the patentee of a patented pharmaceutical invention to grant the PPI order applicant a licence (a 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. Note 1: A patented pharmaceutical invention may be a patented product or a patented process: see the definition of patented pharmaceutical invention in Schedule 1. Note 2: For remuneration in respect of a licence, see section 136J. (2) However, a person cannot apply for an order in respect of an innovation patent unless the patent has been certified. Statement—eligible importing country (3) An application must include a copy of a statement made by or on behalf of, and with the authorisation of, the eligible importing country to the effect that it will take reasonable measures within its means, proportionate to its administrative capacities and to the risk of trade diversion, to prevent re‑exportation from its territory of a pharmaceutical product imported into its territory in accordance with a PPI compulsory licence. Statement—importer (4) If the pharmaceutical product is to be imported on behalf of, and with the authorisation of, the eligible importing country, an application must also include a copy of a statement made by the importer to the effect that it will take reasonable measures within its means to prevent the pharmaceutical product from being used other than in accordance with a PPI compulsory licence. Parties (5) The following are parties to proceedings on an application under this section: (a) the PPI order applicant; (b) the patentee; (c) any person claiming an interest in the patent as exclusive licensee or otherwise; (d) at the option of the eligible importing country—that country. 136E PPI compulsory licences—orders (1) After hearing an application for a PPI order under section 136D, the Federal Court may, subject to this Part, make the order sought if the court is satisfied of all of the following matters: (a) the application is made in good faith; (b) the pharmaceutical product is to be imported: (i) by the eligible importing country; or (ii) by a person (the third party importer) on behalf of, and with the authorisation of, the eligible importing country; (c) the proposed use of the pharmaceutical product is to address a public health problem in the eligible importing country: (i) in circumstances of national emergency or other circumstances of extreme urgency; or (ii) in other circumstances—by the public non‑commercial use of the pharmaceutical product; (d) exploiting the patented pharmaceutical invention is necessary to enable the import and proposed use of the pharmaceutical product as mentioned in paragraphs (b) and (c); (e) if subparagraph (c)(ii) applies: (i) the PPI order applicant has given the patentee a notice in the approved form seeking from the patentee an authorisation to exploit the patented pharmaceutical invention for public non‑commercial use; and (ii) during the 30 days beginning when the notice was given, the PPI order applicant has tried, without success, to obtain such an authorisation from the patentee on reasonable terms and conditions; (f) the notification requirements prescribed by regulation in relation to the importation of the pharmaceutical product into the eligible importing country have been complied with; (g) the PPI order applicant, the eligible importing country and, if there is a third party importer, that importer, will take reasonable measures to prevent a pharmaceutical product that is exported from Australia in accordance with a PPI compulsory licence from being used for a purpose other than the purpose of addressing the public health problem mentioned in paragraph (c). (2) Without limiting the matters that the court may take into account in deciding whether it is satisfied of a matter mentioned in subsection (1), the court must take into account any matters prescribed by regulation. (3) A regulation made for the purposes of paragraph (1)(f) may: (a) without limiting subsection 33(3A) of the Acts Interpretation Act 1901, prescribe different notification requirements for the importation of pharmaceutical products into eligible importing countries of different kinds; and (b) despite subsection 14(2) of the Legislative Instruments Act 2003, refer to eligible importing countries (or different kinds of eligible importing countries) by applying, adopting or incorporating, with or without modification, any matter contained in any other instrument or other writing as in force or existing from time to time. 136F PPI compulsory licences—terms (1) A PPI order must direct that the PPI compulsory licence is granted on the following terms: (a) no more than the quantity of the pharmaceutical product that is determined by the Federal Court to be necessary to meet the needs of the eligible importing country is manufactured; (b) the entirety of the pharmaceutical product manufactured for that purpose is exported to that country; (c) the pharmaceutical product is labelled and marked in accordance with the regulations; (d) before shipment of the pharmaceutical product begins, the shipment information prescribed by regulation is made available on a website by, or on behalf of, the licensee for a minimum period prescribed by regulation; (e) the duration of the licence is only for the period of time determined by the Federal Court to be necessary to address the public health problem concerned; (f) the licence does not give the licensee, or a person authorised by the licensee, the exclusive right to exploit the patented pharmaceutical invention; (g) the licence is to be assignable only in connection with an enterprise or goodwill in connection with which the licence is used; (h) the licensee must give the Commissioner the information prescribed by regulation in relation to the licence in accordance with the regulations. (2) A PPI order may also direct that the licence is to be granted on any other terms specified in the order, including terms covering: (a) other requirements relating to the labelling and marking of the pharmaceutical product; and (b) other information to be made available by the licensee and the way in which it is to be made available. (3) However, a term specified in a PPI order must not be inconsistent with any regulations prescribed for the purposes of paragraph (1)(c), (d) or (h). 136G PPI compulsory licences—amendment Application for order (1) A person may apply to the Federal Court for an order amending any of the following terms of a PPI compulsory licence: (a) the quantity of the pharmaceutical product concerned; (b) how the pharmaceutical product is labelled and marked; (c) the duration of the licence; (d) the information that is to be made available by the licensee and the way it is to be made available. Note: For remuneration in respect of the licence as amended, see section 136J. Order (2) The court may make the order sought in relation to a term if it is satisfied that: (a) it is just to do so in all the circumstances; and (b) the legitimate interests of the following are not likely to be adversely affected by the amendment of the term: (i) the patentee; (ii) any person claiming an interest in the patent as exclusive licensee or otherwise; (iii) the licensee; (iv) the eligible importing country. (3) However, an amended term must not be inconsistent with any regulations prescribed for the purposes of paragraph 136F(1)(c), (d) or (h). Parties (4) The following are parties to any proceedings under this section: (a) the applicant under subsection (1); (b) the patentee; (c) any person claiming an interest in the patent as exclusive licensee or otherwise; (d) the licensee; (e) at the option of the eligible importing country—that country. 136H PPI compulsory licences—revocation Application (1) A person may apply to the Federal Court for an order revoking a PPI compulsory licence. Note: For remuneration in respect of the use of a PPI compulsory licence while it is in force, see section 136J. Federal Court may revoke licence (2) The Federal Court may make the order sought if the court is satisfied that: (a) one or more of the following applies: (i) the substantive circumstances that justified the grant of the licence have ceased to exist and are unlikely to recur; (ii) the licensee has not complied with the terms of the licence; (iii) if an amount of remuneration has been agreed or determined under section 136J—the amount has not been paid within the time agreed or determined; and (b) the legitimate interests of the licensee or the eligible importing country are not likely to be adversely affected by the revocation. Parties (3) The following are parties to any proceedings under this section: (a) the applicant for revocation; (b) the licensee; (c) at the option of the eligible importing country—that country. Division 3—Remuneration 136J PPI compulsory licences—remuneration Working out amount of remuneration (1) The patentee is to be paid an amount agreed or determined under subsection (3) in respect of the use of a patented pharmaceutical invention authorised by a PPI compulsory licence. (2) For the purposes of subsection (1), the use of a patented pharmaceutical invention authorised by the PPI compulsory licence is: (a) while it is in force—the use authorised by the licence as granted and as amended (from time to time) under section 136G; or (b) if it has ceased to be in force (whether because it was revoked or otherwise)—the actual use of the patented pharmaceutical invention under the licence while it was in force. (3) For the purposes of subsection (1), the amount is: (a) an amount agreed between the patentee and the PPI order applicant, licensee or former licensee (as the case requires); or (b) if paragraph (a) does not apply—an amount determined by the Federal Court to be adequate remuneration taking into account the economic value to the eligible importing country of the use of the patented pharmaceutical invention authorised by the PPI compulsory licence. Application to make or amend a determination (4) A person may apply to the Federal Court: (a) to make a determination under paragraph (3)(b); or (b) to amend a determination made under that paragraph. Note: Grounds for an application under paragraph (b) may include the fact that the terms of the PPI compulsory licence have been amended, or the licence has been revoked. Parties (5) The following are parties to any proceedings under this section: (a) the applicant for the determination or the amendment of the determination; (b) the PPI order applicant; (c) the licensee; (d) the patentee of the patented pharmaceutical invention; (e) any person claiming an interest in the patent as exclusive licensee or otherwise. Can PPI be exploited if remuneration is not agreed or determined? (6) To avoid doubt, if the proposed use of the pharmaceutical product is to address a public health problem in the eligible importing country in circumstances of national emergency or other circumstances of extreme urgency, the licensee may exploit a patented pharmaceutical invention under a PPI compulsory licence, as granted or amended (as the case may be), whether or not an amount has been agreed or determined under this section. (7) However, if the proposed use of the pharmaceutical product is to address a public health problem in the eligible importing country in other circumstances, by the public non‑commercial use of the pharmaceutical product, the licensee must not exploit a patented pharmaceutical invention under a PPI compulsory licence unless an amount has been agreed or determined under this section. Can PPI compulsory licence be revoked if remuneration is not agreed or determined? (8) To avoid doubt, a PPI compulsory licence may be revoked whether or not an amount has been agreed or determined under this section. Division 4—General 136K PPI compulsory licences—nature of orders Without prejudice to any other method of enforcement, a PPI order operates as if it were embodied in a deed granting or amending a licence and executed by the patentee and all other necessary parties. 136L PPI compulsory licences—consistency of orders with international agreements A PPI order must not be made that is inconsistent with a treaty between the Commonwealth and a foreign country. 136M PPI compulsory licences—applications heard together Nothing in this Part prevents the Federal Court from dealing with the following applications together: (a) applications for different PPI orders, or for the amendment or revocation of such orders; (b) applications for determinations under paragraph 136J(3)(b) for remuneration in relation to different PPI compulsory licences, or for the amendment of such determinations. Part 4—Surrender and revocation of patents 136N Simplified outline of this Part A patentee may offer to surrender a patent by giving the Commissioner written notice. The Commissioner may accept the offer of surrender, and revoke the patent, after hearing all interested parties. If court proceedings are pending in relation to the patent, leave of the court, or the consent of the parties, is required. The Commissioner must not accept the offer if a compulsory licence ordered under Part 2 is in force in relation to the patent. In addition, a court may revoke a patent on the following grounds: (a) the patentee is not entitled to the patent; (b) the invention is not a patentable invention; (c) the patent was (broadly speaking) improperly obtained; (d) the patent was (broadly speaking) obtained on the basis of a non‑compliant specification. 20 Subsection 137(5) Omit "compulsory licence", substitute "licence ordered under Part 2". 21 After section 138 Insert: Part 5—Other matters 138A Simplified outline of this Part This Part deals with the parties to proceedings under this Chapter (other than proceedings under Part 3). This Part also enables the Commissioner to appear and be heard in all proceedings under this Chapter. 22 At the end of subsection 139(1) Add: Note: See Part 3 for details of parties to proceedings under that Part. 23 Subsection 139(2) Omit "section 133, 134 or 138", substitute "this Chapter". 24 At the end of subsection 228(1) Add: ; and (f) for the purpose of carrying out or giving effect to the WTO General Council decision of 30 August 2003. 25 After subsection 228(4) Insert: (5) Despite subsection 14(2) of the Legislative Instruments Act 2003, regulations made for the purposes of the definition of eligible importing country in Schedule 1 may make provision in relation to a matter by applying, adopting or incorporating, with or without modification, any matter contained in any other instrument or other writing as in force or existing from time to time. 26 Schedule 1 (definition of compulsory licence) Repeal the definition. 27 Schedule 1 Insert: eligible importing country means a foreign country of a kind prescribed by regulation. Note: A regulation made for the purposes of this definition may make provision in relation to a matter by applying, adopting or incorporating, with or without modification, any matter contained in any other instrument or other writing as in force or existing from time to time (see subsection 228(5)). 28 Schedule 1 Insert: patented pharmaceutical invention, in relation to a pharmaceutical product, means: (a) if the product is a patented product—the patented product; or (b) if the product results from the use of a patented process—the patented process. 29 Schedule 1 Insert: pharmaceutical product means any patented product, or product manufactured through a patented process, of the pharmaceutical sector. Example: Examples of a pharmaceutical product include: (a) active ingredients necessary for manufacturing such a product; and (b) diagnostic kits needed for using such a product. 30 Schedule 1 Insert: PPI is short for patented pharmaceutical invention. 31 Schedule 1 Insert: PPI compulsory licence has the meaning given by section 136D. 32 Schedule 1 Insert: PPI order has the meaning given by section 136D. 33 Schedule 1 Insert: PPI order applicant has the meaning given by section 136D. 34 Schedule 1 Insert: TRIPS Agreement means the Agreement on Trade‑Related Aspects of Intellectual Property Rights set out in Annex 1C to the Marrakesh Agreement establishing the World Trade Organization, done at Marrakesh on 15 April 1994, as Annex 1C is in force for Australia from time to time. Note: The WTO Agreement is in Australian Treaty Series 1995 No. 8 ([1995] ATS 8) and could in 2015 be viewed in the Australian Treaties Library on the AustLII website (http://www.austlii.edu.au). 35 Schedule 1 Insert: WTO General Council decision of 30 August 2003 means the decision of the World Trade Organization General Council of 30 August 2003 (including the Annex to the decision) on the implementation of paragraph 6 of the Doha Declaration on the TRIPS Agreement and public health. Note: The decision could in 2015 be viewed on the World Trade Organization website (http://www.wto.org). Part 2—Application 36 Application of amendments (1) The amendments of the Patents Act 1990 made by this Schedule apply in relation to patents granted before, on and after the commencement of this Schedule. (2) The amendments of sections 70 and 71 of the Patents Act 1990 made by this Schedule apply in relation to an application that is made on or after the commencement of this Schedule to include a pharmaceutical substance in the Australian Register of Therapeutic Goods. Schedule 2—TRIPS Protocol: later commencing amendments Patents Act 1990 1 Section 3 (list of definitions) Omit "WTO General Council decision of 30 August 2003". 2 Paragraph 228(1)(f) Omit "WTO General Council decision of 30 August 2003", substitute "TRIPS Agreement". 3 Schedule 1 (definition of WTO General Council decision of 30 August 2003) Repeal the definition. Schedule 3—Plant Breeder's Rights Act 1994: Federal Circuit Court Plant Breeder's Rights Act 1994 1 Subsection 3(1) (definition of Court) Repeal