Australia - United States FTA (2004)
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10. Neither Party may require recordal of licences for marks.

11. Each Party shall endeavour to reduce differences in law and practice between the Parties' respective systems for the protection of marks, including differences that affect the cost to users. In addition, cach Party shall endeavour to participate in international trademark harmonisation efforts, including the WIPO fora dealing with reform and development of the international trademark system.

12. (a) Each Party shall provide a system that permits owners to assert rights in marks, and interested parties to challenge rights in marks, through administrative or judicial means, or both.

(b) Consistent with sub-paragraph (a), where a Party provides the means to apply for protection or petition for recognition of geographical indications, through a system for the protection of marks or otherwise, it shall accept such applications and petitions without the requirement for intercession by a Party on behalf of its nationals, and shall:

(i) process applications or petitions, as relevant, for geographical indications with a minimum of formalities;

(ii) make its regulations governing filing of such applications or petitions, as relevant, readily available to the public;

(iii) ensure that applications or petitions, as relevant, for geographical indications are published for opposition, and provide procedures for opposing geographical indications that are the subject of applications or petitions. Each Party shall also provide procedures to cancel any registration resulting from an application or a petition;

(iv) ensure that measures governing the filing of applications or petitions, as relevant, for geographical indications set out clearly the procedures for these actions. These procedures shall include contact information sufficient for applicants or petitioners, as relevant, to obtain specific procedural guidance regarding the processing of those applications or petitions; and

(v) provide that grounds for refusing an application for protection or recognition of a geographical indication include the following:

(A) the geographical indication is likely to cause confusion with a mark that is the subject of a good-faith pending application or registration; and

(B) the geographical indication is likely to cause confusion with a pre-existing mark, the rights to which have been acquired through use in good faith in the territory of the Party.

(17-4) For the purposes of this Article, in respect of the law of Australia, marks means "trademarks".
(17-5) A geographical indication shall be capable of constituting a mark to the extent that the geographical indication consists of any sign, or any combination of signs (such as words, including geographic and personal names, as well as letters, numerals, figurative elements and colours, including single colours), capable of identifying a good as originating in the territory of a Party, or a region or locality in that territory, where a given quality, reputation, or other characteristic of the good is essentially attributable to its geographical origin. For the purposes of this Chapter, originating does not have the meaning ascribed to that term in Article 1.2 (General Definitions).
(17-6) A Party may require an adequate description, which can be represented graphically, of the mark.
(17-7) In determining whether a mark is well known, the reputation of the mark need not extend beyond the sector of the public that normally deals with the relevant goods or services.

Article 17.3. Domain Names on the Internet

1. In order to address trademark cyber-piracy, cach Party shall require that the management of its country-code top-level domain (ccTLD) provide an appropriate procedure for the settlement of disputes, based on the principles established in the Uniform Domain-Name Dispute-Resolution Policy.

2. Each Party shall require that the management of its ccTLD provide online public access to a reliable and accurate database of contact information for domain-name registrants.

Article 17.4. Copyright

1. Each Party shall provide (17-8) that the following have the right to authorise or prohibit (17-9) all reproductions, in any manner or form, permanent or temporary (including temporary storage in material form):

(a) authors, in respect of their works;

(b) performers, in respect of their performances; (17-10) and

(c) producers of phonograms, in respect of their phonograms. (17-11)

2. Each Party shall provide to authors, performers, and producers of phonograms the right to authorise or prohibit the making available to the public of the original and copies(17-12) of their works, performances, and phonograms through sale or other transfer of ownership. (17-13)

3. In order to ensure that no hierarchy is established between rights of authors, on the one hand, and rights of performers and producers of phonograms, on the other hand, each Party shall provide that in cases where authorisation is needed from both the author of a work embodied ina phonogram and a performer or producer owning rights in the phonogram, the need for the authorisation of the author does not cease to exist because the authorisation of the performer or producer is also required. Likewise, each Party shall provide that in cases where authorisation is needed from both the author of a work embodied in a phonogram and a performer or producer owning rights in the phonogram, the need for the authorisation of the performer or producer does not cease to exist because the authorisation of the author is also required.

4. Each Party shall provide that, where the term of protection of a work (including a photographic work), performance, or phonogram is to be calculated:

(a) on the basis of the life of a natural person, the term shall be not less than the life of the author and 70 years after the author's death; and

(b) on a basis other than the life of a natural person, the term shall be:

(i) not less than 70 years from the end of the calendar year of the first authorised publication of the work, performance, or phonogram; or

(ii) failing such authorised publication within 50 years from the creation of the work, performance, or phonogram, not less than 70 years from the end of the calendar year of the creation of the work, performance, or phonogram.

5. Each Party shall apply Article 18 of the Berne Convention and Article 14.6 of the TRIPS Agreement, mutatis mutandis, to the subject matter, rights, and obligations in this Article and Articles 17.5 and 17.6.

6. (a) Each Party shall provide that for copyright, any person acquiring or holding any economic right in a work, performance, or phonogram:

(i) may freely and separately transfer that right by contract; and

(ii) by virtue of a contract, including contracts of employment underlying the creation of works, performances, and phonograms, shall be able to exercise that right in that person's own name and enjoy fully the benefits derived from that right.

(b) Each Party may establish measures to give effect to the measures specified in Article 14¢er of the Berne Convention.

7. (a) In order to provide adequate legal protection and effective legal remedies against the circumvention of effective technological measures that authors, performers, and producers of phonograms use in connection with the exercise of their rights and that restrict unauthorised acts in respect of their works, performances, and phonograms, each Party shall provide that any person who:

(i) knowingly, or having reasonable grounds to know, circumvents without authority any effective technological measure that controls access to a protected work, performance, or phonogram, or other subject matter; or

(ii) manufactures, imports, distributes, offers to the public, provides, or otherwise traffics in devices, products, or components, or offers to the public, or provides services that:

(A) are promoted, advertised, or marketed for the purpose of circumvention of any effective technological measure;

(B) have only a limited commercially significant purpose or use other than to circumvent any effective technological measure; or

(C) are primarily designed, produced, or performed for the purpose of enabling or facilitating the circumvention of any effective technological measure,

shall be liable and subject to the remedies specified in Article 17.11.13. Each Party shall provide for criminal procedures and penalties to be applied where any person is found to have engaged wilfully and for the purposes of commercial advantage or financial gain in any of the above activities. Each Party may provide that such criminal procedures and penalties do not apply to a non-profit library, archive, educational institution, or public non-commercial broadcasting entity.

(b) Effective technological measure means any technology, device, or component that, in the normal course of its operation, controls access to a protected work, performance, phonogram, or other protected subject matter, or protects any copyright.

(c) In implementing sub-paragraph (a), neither Party shall be obligated to require that the design of, or the design and selection of parts and components for, a consumer electronics, telecommunications, or computing product provide for a response to any particular technological measure, so long as the product does not otherwise violate any measures implementing sub-paragraph (a).

(d) Each Party shall provide that a violation of a measure implementing this paragraph is a separate civil or criminal offence and independent of any infringement that might occur under the Party's copyright law.

(e) Each Party shall confine exceptions to any measures implementing sub-paragraph (a) to the following activities, which shall be applied to relevant measures in accordance with sub-paragraph (f):

(i) non-infringing reverse engineering activities with regard to a lawfully obtained copy of a computer program, carried out in good faith with respect to particular elements of that computer program that have not been readily available to the person engaged in those activities, for the sole purpose of achieving interoperability of an independently created computer program with other programs,

(ii) non-infringing good faith activities, carried out by an appropriately qualified researcher who has lawfully obtained a copy, unfixed performance, or display of a work, performance, or phonogram and who has made a good faith effort to obtain authorisation for such activities, to the extent necessary for the sole purpose of identifying and analysing flaws and vulnerabilities of technologies for scrambling and descrambling of information;

(iii) the inclusion of a component or part for the sole purpose of preventing the access of minors to inappropriate online content in a technology, product, service, or device that itself is not prohibited under the measures implementing sub-paragraph (a)(ii);

(iv) non-infringing good faith activities that are authorised by the owner of a computer, computer system, or computer network for the sole purpose of testing, investigating, or correcting the security of that computer, computer system, or computer network;

(v) non-infringing activities for the sole purpose of identifying and disabling a capability to carry out undisclosed collection or dissemination of personally identifying information reflecting the online activities of a natural person in a way that has no other effect on the ability of any person to gain access to any work;

(vi) lawfully authorised activities carried out by government employees, agents, or contractors for law enforcement, intelligence, essential security, or similar governmental purposes;

(vii) access by a non-profit library, archive, or educational institution to a work, performance, or phonogram not otherwise available to it, for the sole purpose of making acquisition decisions; and

(viii) non-infringing uses of a work, performance, or phonogram in a particular class of works, performances, or phonograms, when an actual or likely adverse impact on those non-infringing uses is credibly demonstrated in a legislative or administrative review or proceeding; provided that any such review or proceeding is conducted at least once every four years from the date of conclusion of such review or proceeding.

(f) The exceptions to any measures implementing sub-paragraph (a) for the activities set forth in sub-paragraph (c) may only be applied as follows, and only to the extent that they do not impair the adequacy of legal protection or the effectiveness of legal remedies against the circumvention of effective technological measures:

(i) any measures implementing sub-paragraph (a)(i) may be subject to exceptions with respect to cach activity set forth in sub-paragraph (c);

(ii) any measures implementing sub-paragraph (a)(ii), as they apply to effective technological measures that control access to a work, performance, or phonogram, may be subject to exceptions with respect to activities set forth in sub-paragraph (c)(i), (ii), (aii), (iv), and (vi); and

(iii) any measures implementing sub-paragraph (a)(ii), as they apply to effective technological measures that protect any copyright, may be subject to exceptions with respect to the activities set forth in sub-paragraph (e)(i) and (vi).

8. In order to provide adequate and effective legal remedies to protect rights management information:

(a) each Party shall provide that any person who without authority, and knowing, or, with respect to civil remedies, having reasonable grounds to know, that it would induce, enable, facilitate, or conceal an infringement of any copyright:

(i) knowingly removes or alters any rights management information;

(ii) distributes or imports for distribution rights management information knowing that the rights management information has been removed or altered without authority; or

(iii) distributes to the public, imports for distribution, broadcasts, communicates, or makes available to the public copies of works, performances, or phonograms, knowing that rights management information has been removed or altered without authority,

shall be liable and subject to the remedies specified in Article 17.11.13. Each Party shall provide for criminal procedures and penalties to be applied where any person is found to have engaged wilfully and for purposes of commercial advantage or financial gain in any of the above activities. Each Party may provide that these criminal procedures and penalties do not apply to a non-profit library, archive, educational institution, or public non-commercial broadcasting entity;

(b) each Party shall confine exceptions to measures implementing sub-paragraph (a) to lawfully authorised activities carried out by government employees, agents, or contractors for the purpose of law enforcement, intelligence, essential security, or similar government purposes;

(c) rights management information means:

(i) electronic information that identifies a work, performance, or phonogram; the author of the work; the performer of the performance; the producer of the phonogram; or the owner of any right in the work, performance, or phonogram; or

(ii) electronic information about the terms and conditions of the use of the work, performance, or phonogram; or

(iii) any electronic numbers or codes that represent such information,

when any of these items is attached to a copy of the work, performance, or phonogram or appears in connection with the communication or making available of a work, performance, or phonogram to the public. Nothing in this paragraph shall obligate a Party to require the owner of any right in the work, performance, or phonogram to attach rights management information to copies of the work, performance, or phonogram, or to cause rights management information to appear in connection with a communication of the work, performance, or phonogram to the public.

9. Each Party shall provide appropriate laws, orders, regulations, government issued guidelines, or administrative or executive decrees providing that its central government agencies not use infringing computer software and only use computer software as authorised in the relevant licence. These measures shall provide for the regulation of the acquisition and management of software for such government use and may take the form of procedures such as those under which an agency prepares and maintains inventories of software present on the agency's computers and inventories of software licenses.

10. With respect to Articles 17.4, 17.5, and 17.6:

(a) each Party shall confine limitations or exceptions to exclusive rights to certain special cases that do not conflict with a normal exploitation of the work, performance, or phonogram, and do not unreasonably prejudice the legitimate interests of the right holder;

(b) notwithstanding sub-paragraph (a) and Article 17.6.3(b), neither Party may permit the retransmission of television signals (whether terrestrial, cable, or satellite) on the Internet without the authorisation of the right holder or right holders, if any, of the content of the signal and of the signal;

(c) unless otherwise specifically provided in this Chapter, nothing in this Article shall be construed as reducing or extending the scope of applicability of the limitations and exceptions permitted under the agreements referred to in Articles 17.1.2 and 17.1.4 and the TRIPS Agreement.

(17-8) The Parties reaffirm that it is a matter for each Party's law to prescribe that works and phonograms shall not be protected by copyright unless they have been fixed in some material form.
(17-9) For the purposes of Articles 17.4, 17.5, and 17.6, aright to authorise or prohibit means an exclusive right.
(17-10) For the purposes of Articles 17.4, 175, and 17.6, a performance refers to a performance fixed in a phonogram unless otherwise specified.
(17-11) References in this Chapter to authors, performers and producers of phonograms include any successors in interest.
(17-12) The expressions copies and original and copies subject to the right of distribution in this paragraph refer exclusively to fixed copies that can be put into circulation as tangible objects.
(17-13) Nothing in this Agreement shall affect a Party's right to determine the conditions, if any, under which the exhaustion of this right applies after the first sale or other transfer of ownership of the original or a copy of their works, performances, or phonograms with the authorisation of the right holder.

Article 17.5. Copyright Works

Without prejudice to Articles 11(1)(ii), 11is(1)@) and (ii), 11éer(1)Gi), 14(1)(i), and 145is(1) of the Berne Convention, each Party shall provide to authors the exclusive right to authorise or prohibit the communication to the public of their works, by wire or wireless means, including the making available to the public of their works in such a way that members of the public may access these works from a place and at a time individually chosen by them.

Article 17.6. Performers and Producers of Phonograms

1. Each Party shall accord the rights provided for in this Chapter with respect to performers and producers of phonograms to the performers and producers of phonograms who are nationals of the other Party and to performances first fixed or phonograms first fixed or first published in the territory of the other Party. A performance or phonogram shall be considered first published in the territory of a Party in which it is published within 30 days of its original publication (17-14)

2. Each Party shall provide to performers the right to authorise or prohibit:

(a) the broadcasting and communication to the public of their unfixed performances, except where the performance is already a broadcast performance; and

(b) the fixation of their unfixed performances.

3. (a) Each Party shall provide to performers and producers of phonograms the right to authorise or prohibit the broadcasting or any communication to the public of their performances or phonograms by wire or wireless means, including the making available to the public of those performances and phonograms in such a way that members of the public may access them from a place and at a time individually chosen by them.

(b) Notwithstanding sub-paragraph (a) and Article 17.4.10, the application of this right to traditional free over-the-air (i.e., non-interactive) broadcasting, and exceptions or limitations to this right for such broadcasting activity, shall be a matter of each Party's law.

(c) Each Party may adopt limitations to this right in respect of other non-interactive transmissions in accordance with Article 17.4.10, provided that the limitations do not prejudice the right of the performer or producer of phonograms to obtain equitable remuneration.

4. Neither Party may subject the enjoyment and exercise of the rights of performers and producers of phonograms provided for in this Chapter to any formality.

5. For the purposes of this Article and Article 17.4, the following definitions apply with respect to performers and producers of phonograms:

(a) broadcasting means the transmission to the public by wireless means or satellite of sounds or sounds and images, or representations thereof, including wireless transmission of encrypted signals where the means for decrypting are provided to the public by the broadcasting organisation or with its consent; "broadcasting" does not include transmissions over computer networks or any transmissions where the time and place of reception may be individually chosen by members of the public;

(b) communication to the public of a performance or a phonogram means the transmission to the public by any medium, otherwise than by broadcasting, of sounds of a performance or the sounds or the representations of sounds fixed ina phonogram. For the purposes of paragraph 3, communication to the public includes making the sounds or representations of sounds fixed in a phonogram audible to the public;

(c) fixation means the embodiment of sounds, or of the representations thereof, from which they can be perceived, reproduced, or communicated through a device;

(d) performers means actors, singers, musicians, dancers, and other persons who act, sing, deliver, declaim, play in, interpret, or otherwise perform literary or artistic works or expressions of folklore;

(e) phonogram means the fixation of the sounds of a performance or of other sounds, or of a representation of sounds, other than in the form of a fixation incorporated in a cinematographic or other audiovisual work;

(f) producer of a phonogram means the person who, or the legal entity which, takes the initiative and has the responsibility for the first fixation of the sounds of a performance or other sounds, or the representations of sounds; and

(g) publication of a performance or a phonogram means the offering of copies of the performance or the phonogram to the public, with the consent of the right holder, and provided that copies are offered to the public in reasonable quantity.

(17-14) For the purposes of this Article, fixation includes the finalisation of the master tape or its equivalent.

Article 17.7. Protection of Encrypted Programme-carrying Satellite Signals

1. Each Party shall make it a criminal offence:

(a) to manufacture, assemble, modify, import, export, sell, lease, or otherwise distribute a tangible or intangible device or system, knowing or having reason to know that the device or system is primarily of assistance in decoding an encrypted programme-carrying satellite signal without the authorisation of the lawful distributor of such signal; and

(b) wilfully to receive and make use of, or further distribute, a programme-carrying signal that originated as an encrypted programme-carrying satellite signal knowing that it has been decoded without the authorisation of the lawful distributor of the signal.

2. Each Party shall provide for civil remedies, including compensatory damages, for any person injured by any activity described in paragraph 1, including any person that holds an interest in the encrypted program-carrying signal or its content.

Article 17.8. Designs

1. Each Party shall maintain protection for industrial designs that provides a right of presumptive validity and shall endeavour to simplify and streamline its administrative system for the benefit of users.

2. Each Party shall endeavour to reduce differences in law and practice between the Parties' industrial design systems. In addition, each Party shall endeavour to participate in international activities concerning industrial designs, including those ongoing within WIPO.

Article 17.9. Patents

1. Each Party shall make patents available for any invention, whether a product or process, in all fields of technology, provided that the invention is new, involves an inventive step, and is capable of industrial application. The Parties confirm that patents shall be available for any new uses or methods of using a known product. For the purposes of this Article, a Party may treat the terms "inventive step" and "capable of industrial application" as synonymous with the terms "non-obvious" and "useful", respectively.

2. Each Party may only exclude from patentability:

(a) inventions, the prevention within their territory of the commercial exploitation of which is necessary to protect ordre public or morality, including to protect human, animal, or plant life or health or to avoid serious prejudice to the environment, provided that such exclusion is not made merely because the exploitation is prohibited by law; and

(b) diagnostic, therapeutic, and surgical methods for the treatment of humans and animals.

3. A Party may provide limited exceptions to the exclusive rights conferred by a patent, provided that such exceptions do not unreasonably conflict with a normal exploitation of the patent and do not unreasonably prejudice the legitimate interests of the patent owner, taking account of the legitimate interests of third parties.

4. Each Party shall provide that the exclusive right of the patent owner to prevent importation of a patented product, or a product that results from a patented process, without the consent of the patent owner shall not be limited by the sale or distribution of that product outside its territory, at least where the patentee has placed restrictions on importation by contract or other means.

5. Each Party shall provide that a patent may only be revoked on grounds that would have justified a refusal to grant the patent, or on the basis of fraud, misrepresentation, or inequitable conduct.

6. Consistent with paragraph 3, if a Party permits a third person to use the subject matter of a subsisting patent to generate information necessary to support an application for marketing approval of a pharmaceutical product, that Party shall provide that any product produced under such authority shall not be made, used, or sold in the territory of that Party other than for purposes related to generating information to meet requirements for marketing approval for the product, and if the Party permits exportation, the product shall only be exported outside the territory of that Party for purposes of meeting marketing approval requirements of that Party.

7. A Party shall not permit the use (17-15) of the subject matter of a patent without the authorisation of the right holder except in the following circumstances:

(a) to remedy a practice determined after judicial or administrative process to be anti- competitive under the Party's laws relating to prevention of anti-competitive practices; (17-6) or

(b) in cases of public non-commercial use, or of national emergency, or other circumstances of extreme urgency, provided that:

(i) the Party shall limit such use to use by the government or third persons authorised by the government;

(ii) the Party shall ensure that the patent owner is provided with reasonable compensation for such use; and

(iii) the Party may not require the patent owner to provide undisclosed information or technical know-how related to a patented invention that has been authorised for use in accordance with this paragraph.

8. (a) If there are unreasonable delays in a Party's issuance of patents, that Party shall provide the means to, and at the request of a patent owner, shall, adjust the term of the patent to compensate for such delays. An unreasonable delay shall at least include a delay in the issuance of a patent of more than four years from the date of filing of the application in the Party, or two years after a request for examination of the application has been made, whichever is later. For the purposes of this paragraph, any delays that occur in the issuance of a patent due to periods attributable to actions of the patent applicant or any opposing third person need not be included in the determination of such delay.

(b) With respect to a pharmaceutical product (17-17) that is subject to a patent, each Party shall make available an adjustment of the patent term to compensate the patent owner for unreasonable curtailment of the effective patent term as a result of the marketing approval process.

9. Each Party shall disregard information contained in public disclosures used to determine if an invention is novel or has an inventive step if the public disclosure, (a) was made or authorised by, or derived from, the patent applicant and (b) occurs within 12 months prior to the date of filing of the application in the territory of the Party.

10. Each Party shall provide patent applicants with at least one opportunity to make amendments, corrections, and observations in connection with their applications.

11. Each Party shall provide that a disclosure of a claimed invention shall be considered to be sufficiently clear and complete if it provides information that allows the invention to be made and used by a person skilled in the art, without undue experimentation, as of the filing date.

12. Each Party shall provide that a claimed invention is sufficiently supported by its disclosure if the disclosure reasonably conveys to a person skilled in the art that the applicant was in possession of the claimed invention, as of the filing date.

13. Each Party shall provide that a claimed invention is useful if it has a specific, substantial, and credible utility.

14. Each Party shall endeavour to reduce differences in law and practice between their respective systems, including in respect of differences in determining the rights to an invention, the prior art effect of applications for patents, and the division of an application containing multiple inventions. In addition, each Party shall endeavour to participate in international patent harmonisation efforts, including the WIPO fora addressing reform and development of the international patent system.

15. Each Party shall endeavour to establish a cooperative framework between their respective patent offices as a basis for progress towards the mutual exploitation of search and examination work.

(17-15) "Use" in this paragraph refers to use other than that allowed under paragraph 3 and Article 30 of the TRIPS Agreement.
(17-16) with respect to sub-paragraph (a), the Parties recognize that a patent does not necessarily confer market power.
(17-17) For Australia, the term pharmaceutical substance as used in Section 70 of the Patents Act 1990 on the date of entry into force of this Agreement may be treated as synonymous with the term pharmaceutical product as used in this sub-paragraph.

Article 17.10. Measures Related to Certain Regulated Products

1. (a) If a Party requires, as a condition of approving the marketing of a new pharmaceutical product, the submission of undisclosed test or other data concerning safety or efficacy of the product, the Party shall not permit third persons, without the consent of the person who provided the information, to market the same or a similar product on the basis of that information, or the marketing approval granted to the person who submitted such information, for at least five years from the date of marketing approval by the Party.

(b) If a Party requires, as a condition of approving the marketing of a new agricultural chemical product, including certain new uses of the same product, the submission of undisclosed test or other data concerning safety or efficacy of that product, the Party shall not permit third persons, without the consent of the person who provided the information, to market the same or a similar product on the basis of that information, or the marketing approval granted to the person who submitted such information, for ten years from the date of the marketing approval of the new agricultural chemical product by the Party.

(c) If a Party permits, as a condition of approving the marketing of a new pharmaceutical or agricultural chemical product, third persons to submit evidence concerning the safety or efficacy of a product that was previously approved in another territory, such as evidence of prior marketing approval, the Party shall not permit third persons, without the consent of the person who previously submitted information concerning safety or efficacy, to market the same or a similar product on the basis of evidence of prior marketing approval in another territory, or information concerning safety or efficacy that was previously submitted to obtain marketing approval in another territory, for at least five years, and ten years for agricultural chemical products, from the date of marketing approval by the Party, or the other territory, whichever is late, (17-18)

(d) For the purposes of this Article, a new product is one that does not contain a chemical entity that has been previously approved for marketing in the Party.

(e) If any undisclosed information concerning the safety or efficacy of a product submitted to a government entity, or entity acting on behalf of a government, for the purposes of obtaining marketing approval is disclosed by a government entity, or entity acting on behalf of a government, each Party is required to protect such information from unfair commercial use in the manner set forth in this Article.

2. With respect to pharmaceutical products, if a Party requires the submission of: (a) new clinical information (other than information related to bioequivalency) or (b) evidence of prior approval of the product in another territory that requires such new information, which is essential to the approval of a pharmaceutical product, the Party shall not permit third persons not having the consent of the person providing the information to market the same or a similar pharmaceutical product on the basis of the marketing approval granted to a person submitting the information for a period of at least three years from the date of the marketing approval by the Party or the other territory, whichever is later. (17-19)

3. When a product is subject to a system of marketing approval in accordance with paragraph 1 or 2, as applicable, and is also subject to a patent in the territory of that Party, the Party shall not alter the term of protection that it provides pursuant to paragraph 1 or 2 in the event that the patent protection terminates on a date earlier than the end of the term of protection specified in paragraph 1 or 2, as applicable.

4. Where a Party permits, as a condition of approving the marketing of a pharmaceutical product, persons, other than the person originally submitting the safety or efficacy information, to rely on evidence or information concerning the safety or efficacy of a product that was previously approved, such as evidence of prior marketing approval by the Party or in another territory:

(a) that Party shall provide measures in its marketing approval process to prevent those other persons from:

(i) marketing a product, where that product is claimed in a patent; or

(ii) marketing a product for an approved use, where that approved use is claimed in a patent, during the term of that patent, unless by consent or acquiescence of the patent owner; and

(b) if the Party permits a third person to request marketing approval to enter the market with:

(i) a product during the term of a patent identified as claiming the product; or

  • Chapter   ONE Establishment of a Free Trade Area and Definitions 1
  • Article   1.1 General 1
  • Article   1.2 General Definitions 1
  • ANNEX 1-A  Certain definitions 1
  • Chapter   TWO National Treatment and Market Access for Goods 1
  • Article   2.1 Scope and Coverage 1
  • Section   A National Treatment 1
  • Article   2.2 National Treatment 1
  • Section   B Tariffs 1
  • Article   2.3 Elimination of Customs Duties 1
  • Article   2.4 Customs Value 1
  • Article   2.5 Temporary Admission 1
  • Article   2.6 Goods Re-entered after Repair or Alteration 1
  • Article   2.7 Duty-free Entry of Commercial Samples of Negligible Value and Printed Advertising Materials 1
  • Article   2.8 Waiver of Customs Duties 1
  • Section   C Non-tariff Measures 1
  • Article   2.9 Import and Export Restrictions 1
  • Article   2.10 Administrative Fees and Formalities 1
  • Article   2.11 Export Taxes 1
  • Section   D Other Measures 1
  • Article   2.12 Merchandise Processing Fee 1
  • Section   E Institutional Provisions 1
  • Article   2.13 Committee on Trade In Goods 1
  • Section   F Definitions 1
  • Article   2.13 Definitions 1
  • Chapter   THREE Agriculture 2
  • Article   3.1 Multilateral Cooperation 2
  • Article   3.2 Committee on Agriculture 2
  • Article   3.3 Export Subsidies 2
  • Article   3.4 Agricultural Safeguard Measures 2
  • Article   3.5 Administration of Tariff-rate Quotas 2
  • Article   3.6 Review of Dairy Market Access Commitments 2
  • Article   3.7 Definitions 2
  • Chapter   FOUR Textiles and Apparel 2
  • Article   4.1 Bilateral Emergency Actions 2
  • Article   4.2 Rules of Origin and Related Matters 2
  • Article   4.3 Customs cooperation 2
  • Article   4.4 Definitions 2
  • Chapter   FIVE Rules of origin 2
  • Section   A Rules of origin 2
  • Article   5.1 Originating goods 2
  • Article   5.2 De minimis 2
  • Article   5.3 Accumulation 3
  • Article   5.4 Regional value content 3
  • Article   5.5 Walue of materials 3
  • Article   5.6 Accessories, spare parts, and tools 3
  • Article   5.7 Fungible goods and materials 3
  • Article   5.8 Packaging materials and containers for retail sale 3
  • Article   5.9 Packing materials and containers for shipment 3
  • Article   5.10 Indirect materials 3
  • Article   5.11 Third country transportation 3
  • Section   B Supporting information and verification 3
  • Article   5.12 Claims for preferential treatment 3
  • Article   5.13 Obligations relating to importations 3
  • Article   5.14 Record keeping requirement 3
  • Article   5.15 Verification 3
  • Section   C Consultation and modifications 3
  • Article   5.16 Consultation and modifications 3
  • Section   D Application and interpretation 3
  • Article   5.17 Application and interpretation 3
  • Section   E Definitions 3
  • Article   5.18 Definitions 3
  • Chapter   SIX Customs administration 4
  • Article   6.1 Publication and notification 4
  • Article   6.2 Administration 4
  • Article   6.3 Advance rulings 4
  • Article   6.4 Review and appeal 4
  • Article   6.5 Cooperation 4
  • Article   6.6 Confidentiality 4
  • Article   6.7 Penalties 4
  • Article   6.8 Release and security 4
  • Article   6.9 Risk assessment 4
  • Article   6.10 Express shipments 4
  • Article   6.11 Definition of customs matters 4
  • Chapter   SEVEN Sanitary and phytosanitary measures 4
  • Article   7.1 Objectives 4
  • Article   7.2 Scope and Coverage 4
  • Article   7.3 Affirmation of the Sps Agreement 4
  • Article   7.4 Committee on Sanitary and Phytosanitary Matters 4
  • Article   7.5 Definitions 4
  • Chapter   EIGHT Technical Barriers to Trade Article 4
  • Article   8.1 Scope and Coverage 4
  • Article   8.2 Affirmation of the Tbt Agreement 4
  • Article   8.3 Regional Governments 4
  • Article   8.4 International Standards 4
  • Article   8.5 Technical Regulations 4
  • Article   8.6 Conformity Assessment Procedures 4
  • Article   8.7 Transparency 5
  • Article   8.8 Trade Facilitation 5
  • Article   8.9 Chapter Coordinators 5
  • Article   8.10 Information Exchange 5
  • Article   8.11 Definitions 5
  • Chapter   NINE Safeguards 5
  • Article   9.1 Imposition of a Safeguard Measure 5
  • Article   9.2 Conditions and Limitations 5
  • Article   9.3 Provisional Safeguard Measures 5
  • Article   9.4 Compensation 5
  • Article   9.5 Global Safeguard Measures 5
  • Article   9.6 Definitions 5
  • Chapter   TEN Cross-border Trade In Services 5
  • Article   10.1 Scope and Coverage 5
  • Article   10.2 National Treatment 5
  • Article   10.3 Most-favoured-nation Treatment 5
  • Article   10.4 Market Access 5
  • Article   10.5 Local Presence 5
  • Article   10.6 Non-conforming Measures 5
  • Article   10.7 Domestic Regulation 5
  • Article   10.8 Transparency In Development and Application of Regulations 5
  • Article   10.9 Recognition 5
  • Article   10.10 Transfers and Payments 5
  • Article   10.11 Denial of Benefits 5
  • Article   10.12 Specific Commitments 6
  • Article   10.13 Implementation 6
  • Article   10.14 Definitions 6
  • Chapter   ELEVEN Investment 6
  • Article   11.1 Scope and Coverage 6
  • Article   11.2 Relation to other Chapters 6
  • Article   11.3 National Treatment 6
  • Article   11.4 Most-favoured Nation Treatment 6
  • Article   11.5 Minimum Standard of Treatment (11-1) 6
  • Article   11.6 Treatment In Case of Strife 6
  • Article   11.7 Expropriation and Compensation (11-2) 6
  • Article   11.8 Transfers 6
  • Article   11.9 Performance Requirements 6
  • Article   11.10 Senior Management and Boards of Directors 6
  • Article   11.11 Investment and Environment 6
  • Article   11.12 Denial of Benefits 6
  • Article   11.13 Non-conforming Measures 6
  • Article   11.14 Special Formalities and Information Requirements 6
  • Article   11.15 Implementation 6
  • Article   11.16 Consultations on Investor-state Dispute Settlement 6
  • Article   11.17 Definitions 6
  • Chapter   TWELVE Telecommunications 7
  • Article   12.1 Scope and Coverage 7
  • Section   A Access to and Use of Public Telecommunications Services 7
  • Article   12.2 Access and Use 7
  • Section   B Suppliers of public telecommunications services (12-1) 7
  • Article   12.3 Interconnection 7
  • Article   12.4 Number portability 7
  • Article   12.5 Dialing parity 7
  • Article   12.6 Submarine cable systems 7
  • Section   C Conduct of major suppliers of public telecommunications services (12-2) (12-3) 7
  • Article   12.7 Treatment by major suppliers 7
  • Article   12.8 Competitive safeguards 7
  • Article   12.9 Resale 7
  • Article   12.10 Unbundling of network elements 7
  • Article   12.11 Interconnection 7
  • Article   12.12 Provisioning and pricing of leased circuit services 7
  • Article   12.13 Co-location 7
  • Article   12.14 Access to poles, ducts, conduits, and rights of way 7
  • Section   D Other measures 7
  • Article   12.15 Flexibility in the choice of technology 7
  • Article   12.16 Conditions for the supply of value-added services 7
  • Article   12.17 Independent regulatory bodies and divestment 7
  • Article   12.18 Universal service 7
  • Article   12.19 Regulatory procedures 7
  • Article   12.20 Allocation and use of scarce telecommunications resources 7
  • Article   12.21 Enforcement 7
  • Article   12.22 Resolution of telecommunications disputes and appeal processes 7
  • Article   12.23 Forbearance (12-10) 8
  • Article   12.24 Relationship to other chapters 8
  • Article   12.25 Definitions 8
  • Chapter   THIRTEEN Financial services 8
  • Article   13.1 Scope and coverage 8
  • Article   13.2 National treatment 8
  • Article   13.3 Most-favoured-nation treatment 8
  • Article   13.4 Market access for financial institutions 8
  • Article   13.5 Cross-border trade 8
  • Article   13.6 New financial services 8
  • Article   13.7 Treatment of certain information 8
  • Article   13.8 Senior management and boards of directors 8
  • Article   13.9 Non-conforming measures 8
  • Article   13.10 Exceptions 8
  • Article   13.11 Regulatory transparency 8
  • Article   13.12 Self-regulatory organisations 8
  • Article   13.13 Payment and clearing systems 8
  • Article   13.14 Expedited availability of insurance services 8
  • Article   13.15 Recognition 8
  • Article   13.16 Financial services committee 8
  • Article   13.17 Consultations 8
  • Article   13.18 Dispute settlement 8
  • Article   13.19 Definitions 8
  • Chapter   FOURTEEN Competition-related Matters 9
  • Article   14.1 Objectives 9
  • Article   14.2 Competition Law and Anticompetitive Business Conduct 9
  • Article   14.3 Designated Monopolies 9
  • Article   14.4 State Enterprises and Related Matters 9
  • Article   14.5 Differences In Pricing 9
  • Article   14.6 Cross Border Consumer Protection 9
  • Article   14.7 Recognition and Enforcement of Monetary Judgments 9
  • Article   14.8 Transparency 9
  • Article   14.9 Cooperation 9
  • Article   14.10 Consultations 9
  • Article   14.11 Dispute Settlement 9
  • Article   14.12 Definitions 9
  • Chapter   FIFTEEN Government Procurement 9
  • Article   15.1 Scope and Coverage 9
  • Article   15.2 General principles 9
  • Article   15.3 Publication of procurement information 10
  • Article   15.4 Publication of notice of intended procurement 10
  • Article   15.5 Time limits 10
  • Article   15.6 Information on intended procurements 10
  • Article   15.7 Tendering procedures 10
  • Article   15.8 Limited tendering 10
  • Article   15.9 Treatment of tenders and awarding of contracts 10
  • Article   15.10 Ensuring integrity in procurement practices 11
  • Article   15.11 Domestic review of supplier challenges 11
  • Article   15.12 Exceptions 11
  • Article   15.13 Modifications and rectifications to coverage 11
  • Article   15.14 Cooperation 11
  • Article   15.15 Definitions 11
  • Chapter   SIXTEEN Electronic commerce 11
  • Article   16.1 General 11
  • Article   16.2 Electronic supply of services 11
  • Article   16.3 Customs duties 11
  • Article   16.4 Non-discriminatory treatment of digital products 11
  • Article   16.5 Authentication and digital certificates 11
  • Article   16.6 Online consumer protection 11
  • Article   16.7 Paperless trade administration 11
  • Article   16.8 Definitions 11
  • Chapter   SEVENTEEN Intellectual property rights 11
  • Article   17.1 General provisions 11
  • Article   17.2 Trademarks, including geographical indications 11
  • Article   17.3 Domain names on the internet 12
  • Article   17.4 Copyright 12
  • Article   17.5 Copyright works 12
  • Article   17.6 Performers and producers of phonograms 12
  • Article   17.7 Protection of encrypted programme-carrying satellite signals 12
  • Article   17.8 Designs 12
  • Article   17.9 Patents 12
  • Article   17.10 Measures related to certain regulated products 12
  • Article   17.11 Enforcement of intellectual property rights 13
  • Article   17.12 Transitional provisions 13
  • Chapter   EIGHTEEN Labour 13
  • Article   18.1 Statement of shared commitment 13
  • Article   18.2 Application and enforcement of labour laws 13
  • Article   18.3 Procedural guarantees and public awareness 13
  • Article   18.4 Institutional arrangements 13
  • Article   18.5 Labour cooperation 13
  • Article   18.6 Labour consultations 13
  • Article   18.7 Definitions 13
  • Chapter   NINETEEN Environment 14
  • Article   19.1 Levels of protection 14
  • Article   19.2 Application and enforcement of environmental laws 14
  • Article   19.3 Procedural guarantees and public awareness 14
  • Article   19.4 Voluntary mechanisms to enhance environmental performance 14
  • Article   19.5 Institutional arrangements and public participation 14
  • Article   19.6 Environmental cooperation 14
  • Article   19.7 Environmental consultations 14
  • Article   19.8 Relationship to environmental agreements 14
  • Article   19.9 Definitions 14
  • Chapter   TWENTY Transparency 14
  • Article   20.1 Contact points 14
  • Article   20.2 Publication 14
  • Article   20.3 Notification and provision of information 14
  • Article   20.4 Administrative agency processes (20-1) 14
  • Article   20.5 Review and appeal 14
  • Article   20.6 Definitions 14
  • Chapter   TWENTY-ONE Institutional arrangements and dispute settlement 14
  • Section   A Institutional arrangements and administration 14
  • Article   21.1 Joint committee 14
  • Section   B Dispute settlement proceedings 14
  • Article   21.2 Scope of application 14
  • Article   21.3 Administration of dispute settlement proceedings 14
  • Article   21.4 Choice of forum 14
  • Article   21.5 Consultations 14
  • Article   21.6 Referral of matters to the joint committee 14
  • Article   21.7 Establishment of panel 14
  • Article   21.8 Rules of procedure 14
  • Article   21.9 Panel Report 14
  • Article   21.10 Implementation of the Final Report 15
  • Article   21.11 Non-implementation 15
  • Article   21.12 Non-implementation In Certain Disputes 15
  • Article   21.13 Compliance Review 15
  • Article   21.14 Five-year Review 15
  • Article   21.15 Private Rights 15
  • Chapter   TWENTY-TWO General Provisions and Exceptions 15
  • Article   22.1 General Exceptions 15
  • Article   22.2 Essential Security 15
  • Article   22.3 Taxation 15
  • Article   22.4 Disclosure of Information 15
  • Article   22.5 Anti-corruption 15
  • Chapter   TWENTY-THREE Final Provisions 15
  • Article   23.1 Accession 15
  • Article   23.2 Annexes 15
  • Article   23.3 Amendments 15
  • Article   23.4 Entry Into Force and Termination 15
  • ANNEX I  15
  • ANNEX I  Schedule of australia 15
  • ANNEX I  Schedule of the united states 17
  • ANNEX II  17
  • ANNEX II  Schedule of australia 17
  • ANNEX II  Schedule of united states 18