TransPacific Partnership (TPP) Negotiating Parties - TPP IP Chapter-Leaked Draft- Section E&F: Patents, Undisclosed Data, Traditional Knowledge, & Industrial Design lyrics

{PATENTS/ UNDISCLOSED TEST OR OTHER DATA/ TRADITIONAL KNOWLEDGE} {Section E: Patents / Undisclosed Test or Other Data / Traditional Knowledge} Article QQ.E.1: {Patents / Patentable Subject matter} 1. Subject to the provisions of paragraph 2 and 3, 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. 87 [US/AU propose; 88 CL/MY/PE/SG/VN/BN/NZ/CA/MX oppose: The Parties confirm that: (a) [patents shall be available for any new uses or methods of using a known product], US/JP propose; CL/MY/PE/SG/VN/BN/AU/NZ/CA/MX oppose: (b) a Party may not deny a patent solely on the basis that the product did not result in enhanced efficacy of the known product when the applicant has set forth distinguishing features establishing that the invention is new, involves an inventive step, and is capable of industrial application.] 2. Each Party may exclude from patentability 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 nature or the environment, provided that such exclusion is not made merely because the exploitation is prohibited by their law. 3. [US: Consistent with paragraph 1] [each Party US propose; AU/NZ/VN/BN/CL/PE/MY/SG/CA/MX oppose: shall make patents available for inventions for the following] [NZ/CL/PE/MY/AU/VN/BN/SG/CA/MX propose: may also exclude from patentability]: (a) plants and animals, [NZ/CL/PE/MY/AU/VN/BN/SG/CA/MX propose: other than microorganisms]; --FOOTNOTES-- 87 For purposes of this [Section] Article, a Party may deem the terms "inventive step" and "capable of industrial application" to be synonymous with the terms "non-obvious" and "useful", respectively. In determinations regarding inventive step (or non-obviousness), each Party shall consider whether the claimed invention would have been obvious to a person sk**ed or having ordinary sk** in the art having regard to the prior art. 88 Negotiators' Note: JP is considering this provision. 28---PAGE BREAK--- [JP oppose: (b) diagnostic, therapeutic, and surgical methods for the treatment of humans or animals [US propose; AU/SG/MY/NZ/CL/PE/VN/BN/CA/MX oppose: if they cover a method of using a machine, manufacture, or composition of matter]; [NZ/CL/PE/MY/AU/VN/BN/SG/CA/MX propose:] and (c) essentially biological processes for the production of plants or animals, other than non-biological and microbiological processes for such production.] [MX propose: (d) and the diagrams, plans, rules and methods for carrying out mental processes, playing games or doing business, and mathematical methods as such; software as such; methods to present information as such; and aesthetic creations and artistic or literary works.][NZ/CA/SG/CL/MY propose: ALT 3. Each Party may also exclude from patentability: (a) diagnostic, therapeutic and surgical methods for the treatment of humans or animals; and (b) plants and animals other than microorganisms, and essentially biological processes for the production of plants or animals other than non- biological and microbiological processes. However, Parties shall provide for the protection of plant varieties either by patents or by an effective sui generis system or by any combination thereof.] Article QQ.E.2: {Patentable Subject Matter} Each Party shall 89 disregard at least information contained in public disclosures used to determine if an invention is novel or has an inventive step if the public disclosure[ 90] [ 91] 92: --FOOTNOTES-- 89 Negotiator's Note: NZ/VN accept ad referendum pending confirmation on scope of publication and duration of grace period. 90 [CA/SG/JP propose: A Party shall not be required to disregard information contained in [gazettes related to intellectual properties or] patent applications made available to the public by a patent office unless erroneously published or unless the application was filed without the consent of the inventor or their successor in title by a third party who obtained the information directly or indirectly from the inventor.] 91 For greater certainty, a Party may limit application of this provision to disclosures made by or obtained directly or indirectly from the inventor or joint inventor. [PE/US/MY/SG/AU propose: For greater certainty, a Party may provide that, for purposes of this article information obtained directly or indirectly from the patent applicant may be information contained in the public disclosure that was authorized by, or derived from, the patent applicant.] 92 Negotiators' Note: Parties will continue to work to resolve the drafting of footnotes 61 & 62 (2nd sentence) intersessionally. 29---PAGE BREAK--- (a) was made by the patent applicant or by a person who obtained the information directly or indirectly from the patent applicant, and (b) occurred within 12 months prior to the date of filing of the application in the territory of the Party. Article QQ.E.3: [US: Without prejudice to Article 5A (3) of the Paris Convention,] Each Party shall provide that a patent may be cancelled, revoked or nullified only on grounds that would have justified a refusal to grant the patent. A Party may also provide that fraud, misrepresentation, or inequitable conduct may be the basis for cancelling, revoking, or nullifying a patent or holding a patent unenforceable. [AU/CL/MY/NZ/BN/CA/MX/VN propose 93; US/JP oppose: A Party may also provide that a patent may be cancelled, revoked or nullified on the basis that the patent is used in a manner determined to be anti-competitive in a judicial [VZ/CA/MX propose: or administrative] proceeding] [AU/CL/CA/MX propose: US oppose; consistent with Article 5A(3) of the Paris Convention.] Article QQ.E.4: 94 Article QQ.E.4: {Opposition to Grant of Patent} [NZ/CA/SG/CL/MY propose: Each Party shall provide a procedure for third persons to oppose the grant of a patent, either before or after the grant of a patent, or both.] Article QQ.E.5: {Exceptions} Each 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 into account the legitimate interests of third parties. Article QQ.E.5bis: {Regulatory Review Exception} [NZ/CA/SG/CL/MY propose: Consistent with [Article QQ.E.5 (Exceptions)], each Party may provide that a third person may do an act that would otherwise infringe a patent if the act is done for purposes connected with the collection and submission of data in order to comply with the regulatory requirements of that Party or another --FOOTNOTES-- 93 Negotiator's Note: PE and SG are flexible with both options. 94 US withdraw Article QQ.E.4 ad referendum pending confirmation from capital. 30---PAGE BREAK--- country, including for purposes connected with marketing or sanitary approval.] Article QQ.E.5ter: {Experimental Use of a Patent} [NZ/CA/SG/CL/MY propose: 1. Consistent with [Article QQ.E.5 (Exceptions)], each Party may provide that a third person may do an act that would otherwise infringe a patent if the act is done for experimental purposes relating to the subject matter of a patented invention. 2. For the purposes of this Article, experimental purposes may include, but need not be limited to, determining how the invention works, determining the scope of the invention, determining the validity of the claims, or seeking an improvement of the invention (for example, determining new properties, or new uses, of the invention).] Article QQ.E.5quater: {Other Use Without Authorisation of the Right Holder} [NZ/CA/SG/CL/MY propose: Nothing in this Chapter shall limit a Party's rights and obligations under Article 31 of the TRIPS Agreement or any amendment thereto.] Article QQ.E.6: {Patent filing} 1 Each Party shall provide that where an invention is made independently by more than one inventor, and separate applications claiming that invention are filed with or for the relevant authority of the Party, any patent granted for the claimed invention shall be granted on the application [US/VN/MX propose; AU/NZ/CL/MY/CA/PE oppose: which has been found to be patentable and] which has the earliest filing or, if applicable, priority date [AU/NZ/PE/BN/CL/CA 95 propose; 96 US/VN/MY/MX/SG oppose: and which is published].[US: 97] Article QQ.E.7: Each Party shall provide patent applicants with at least one opportunity to make amendments, corrections, and observations in connection with their applications 98. --FOOTNOTES-- 95 Negotiator's note: CA reserves its position on Articles QQ.E.6,QQ.E.11 and QQ.E.12 pending clarification of the definition of publish/published. 96 Negotiators' Note: JP is considering this provision. 97 [US: A Party may limit application of this provision to patent applications in which there is at least one claim to new subject matter filed after the entry into force of this Agreement.] Negotiators' Note: JP is considering this provision. 98 Each Party may provide that such amendments do not go beyond the scope of the disclosure of the invention as of the filing date. 31---PAGE BREAK--- Article QQ.E.8: [US/AU/PE/VN propose; 99 CL/MY/BN/NZ/CA/SG/MX 100 oppose: 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 sk**ed in the art, without undue experimentation, as of the filing date.] Article QQ.E.9: [US/PE/AU propose; 101 CL/VN/MY/BN/NZ/CA/SG/MX oppose: Each Party shall provide that a claimed invention [AU oppose: is] [AU propose: shall be] sufficiently supported by its disclosure [AU oppose: if the disclosure reasonably conveys to a person sk**ed in the art that the applicant was in possession of the claimed invention] as of the filing date.] Article QQ.E.10: [US/AU/MX propose; 102 SG/CL/MY/VN/PE/BN/NZ/CA oppose: Each Party shall provide that a claimed invention is [US/AU propose: useful] [MX propose: industrially applicable] if it has a specific [MX propose: and], substantial, [MX oppose: and credible] utility.] Article QQ.E.11: {Publication of Patent Applications} [AU/PE/NZ/MY/CL/VN/US/CA/MX/JP: 1. Each Party shall publish [US/MX oppose: or make available for public inspection] any patent application promptly after the expiry of 18 months from its filing date or, if priority is claimed, from its priority date, unless the application has been published earlier or has been withdrawn, abandoned or refused [CA propose: , without leaving any rights outstanding].] 103 [AU/PE/NZ/CL/VN/CA/MX propose; MY oppose: 2. Each Party shall provide that an applicant may request the early publication of an application prior to the expiry of the period mentioned above.] Article QQ.E.12: [US/AU 104/CA/SG/PE/CL/NZ/JP propose; MY/BN/VN/MX oppose: For published 105 patent applications and issued patents, each Party shall make available to the public [US/PE/CA propose: at least] the following information: submitted [US/SG/PE propose: to that Party's competent authorities] in accordance --FOOTNOTES-- 99 Negotiators' Note: JP is considering this provision. 100 Negotiator's Note: MX/SG are willing to accept the article provided that the sentence "without undue experimentation" is deleted. 101 Negotiators' Note: JP is considering this provision. 102 Negotiators' Note: JP is considering this provision. 103 Negotiator's note: SG/BN/US/MY is not fundamentally opposed, but considering how their concerns over exceptions will be addressed. US support for this provision is contingent upon resolution of exceptions under U.S. law. JP is considering the issue of exceptions. 104 Negotiator's Note: AU is considering the issue of "in the possession of the competent authority". 105 Negotiator's Note CA: Publish includes making available for public inspection. 32---PAGE BREAK--- with [US/SG/PE propose: their] requirements [US/SG/PE oppose: of the Party's competent authorities] [AU/CA/CL propose: in their possession] [US/SG/PE propose: and] in connection with the prosecution of such patent applications andpatents: (a) search and examination results, [JP oppose: including any relevant prior art search histories]; (b) [SG/PE/CL/US/NZ/AU/JP propose: non confidential]106 communications from applicants; and c) patent and non-patent related literature citations submitted by applicants, and relevant third parties.] Article QQ.E.X: {Exhaustion of Rights} [CL propose: The Parties are encouraged to establish international exhaustion of patent rights. For this purpose, the registration of a patent shall not entitle its holder to prevent third parties from making, using, offering for sale, selling or importing a product protected by that patent, which has been put in the market in any country by the patent holder or with his consent.] [ Article QQ.E.XX US propose; CA/NZ/JP oppose: Each Party, at the request of the patent owner, shall adjust the term of a patent to compensate for unreasonable delays that occur in the granting of the patent. For purposes of this subparagraph, anunreasonable delay at least shall include a delay in the issuance of the patent of more than four years from the date of filing of the application in the territory of the Party, or two years after a request for examination of the application has been made, whichever is later. Periods attributable to actions of the patent applicant need not be included in the determination of such delays. Any patent term adjustment under this article shall confer all of the exclusive rights of a patent subject to the same limitations and exceptions that would otherwise apply to the patent absent any adjustment of the patent term.] Article QQ.E.13107108: {Exceptions / Regulatory Review Exception} --FOOTNOTES-- 106 Negotiator's Note: AU is still considering whether this would include personal information. 107 Negotiator's Note: CA/MX/AU is still considering the options in this provision. 108 [MX propose: For greater clarity, the duration of the regulatory review exception will be subject to each Party's national legislation.] 33---PAGE BREAK--- [US/NZ/PE/CA/MX/JP propose: Consistent with paragraph [QQ.E.5] (patent exceptions and limitations), each Party shall permit] [CL/SG/MY/AU/VN/BN propose: Where a Party permits] a third person to use the subject matter of a subsisting patent to [US/NZ/PE/AU/MX/VN/BN/JP] propose: generate information necessary to] support an application for [AU/CA/MX/VN/BN propose: regulatory or] marketing approval [CL/NZ/PE/SG/MY/AU/CA/MX/VN/BN propose: or sanitary permit] of a [AU/CA/VN/BN oppose: pharmaceutical] product [PE propose: or agricultural chemical product], [US/NZ/PE/SG/MY/MX/JP propose: and shall further] [CL/AU/CA/VN/BN propose: that Party may also] provide that any product produced under such authority [CL/AU/CA/VN/BN propose: may be] [US/NZ/PE/SG/MY/MX/JP propose: shall not be] made, [CA propose: constructed,] [CL/PE/VN/BN propose: offered for sale], [PE/VN/BN propose: imported,] used, or sold in its territory [US/NZ/PE/SG/MY/MX/JP propose: other than] for purposes related to [US/NZ/PE/AU/MX/VN/BN/JP propose: generating such information to support an application for] meeting [AU/CA/MX/VN/BN propose: regulatory or] marketing approval [CL/NZ/PE/SG/MY/AU/CA/MX/VN/BN propose: or sanitary permit] requirements of that Party [NZ/SG/MY/AU/CA/MX/CL/VN/BN propose: or another country]. [US/SG/MY/PE/MX/CL propose; 109 NZ/AU/CA/VN/BN oppose: If the Party permits exportation of such a product, the Party shall provide that the product shall only]] [NZ/CA/BN propose: Each Party shall permit a product to] [AU/VN propose: Each Party may permit such a product to] be exported outside its territory [US/NZ/PE/AU/MX/VN/BN propose: for purposes of generating information] to support an application for meeting [AU/CA/MX/VN/BN propose: regulatory or] marketing approval [CL/NZ/SG/MY/PE/AU/CA/MX/VN/BN propose: or sanitary approval] requirements of that Party [CL/NZ/SG/MY/AU/CA/MX/VN/BN propose: or another country]. [ Article QQ.E.14: US propose; 110 AU/NZ/CL/PE/MY/SG/BN/VN/CA/MX oppose: 6. (a) Each Party shall make best efforts to process patent applications and marketing approval applications expeditiously with a view to avoiding unreasonable or unnecessary delays. (c) Each Party, at the request of the patent owner, shall make available an adjustment of the patent term of a patent which covers a new pharmaceutical product111 or a patent that covers a method of making or --FOOTNOTES-- 109 Negotiators' Note: JP is considering this provision. 110 Negotiators' Note: JP is considering this provision. 111 [US: For greater certainty, new pharmaceutical product in subparagraphs 6 (c)-(e) means a product that at 34---PAGE BREAK--- using a pharmaceutical product, to compensate the patent owner of unreasonable curtailment of the effective patent term as a result of the marketing approval process. (d) In implementing subparagraph 6(c), a Party may: (i) limit the applicability of subparagraph 6(c) to a single patent term adjustment for each new pharmaceutical product that is being reviewed for marketing approval; (ii) require the basis for the adjustment to be the first marketing approval granted to the pharmaceutical product in that Party; and (iii) limit the period of the adjustment to no more than 5 years. (e) In implementing subparagraph 6(c), and as a condition for providing the adjustment set forth in subparagraph 6(c) for a new pharmaceutical product approved consistent with Article 9.2(b) or Article 9.2(d), a Party may require an applicant that has submitted an application for marketing approval consistent with Article 9.2(b) or Article 9.2(d) to commence the process of obtaining marketing approval for that new pharmaceutical product in the Party within [X] years of the date of the first marketing approval of the same pharmaceutical product in another Party.112 (f) Any adjustment under subparagraph 6(c) shall confer all of the exclusive rights, subject to the same limitations and exceptions, of the patent claims of the product, its method of use, or its method of manufacture in the originally issued patent as applicable to the product and the approved method of use of the product.]] ] Article QQ.E.16: 113 [ US: Pharmaceutical Products least contains a new chemical entity that has not been previously approved as a pharmaceutical product [JP propose: for human use] in the territory of the Party.] --FOOTNOTES-- 112 [US: Negotiator's Note: For purposes of paragraph 6(e) of Article 8 and paragraphs 4 and 6 of Article 9, the length of the [X]-year period should: enhance certainty regarding access to innovative and generic pharmaceutical products for all; provide incentives for innovation; provide incentives for the diffusion of pharmaceutical products within the TPP region; respect commercial considerations; and account for special challenges in developing and commercializing such products throughout the region (e.g., challenges faced by smaller or less experienced applicants, or the time that an applicant may need to a**ess additional safety or efficacy implications of marketing a product, such as to a**ess such implications in jurisdictions where risks may differ from those faced in markets where the product has previously been approved).] 113 Negotiators' Note: CA reserves its position and seeks to develop its understanding of these provisions further 35---PAGE BREAK--- Submission of Information or Evidence Concerning the Safety or Efficacy of a New Pharmaceutical Product [US propose; AU/PE/VN/NZ/CL/MY/SG/BN oppose: 1. (a) If a Party requires or permits, as a condition for granting marketing approval for a new pharmaceutical product, the submission of information concerning the safety or efficacy of the product, the origination of which involves a considerable effort, the Party shall not, without the consent of a person previously submitting such safety or efficacy information to obtain marketing approval in the territory of the Party, authorize a third person to market a same or a similar product based on: (i) the safety or efficacy information previously submitted in support of the marketing approval; or (ii) evidence of the existence of the marketing approval, for at least five years from the date of marketing approval of the new pharmaceutical product in the territory of the Party. (b) If a Party requires or permits, in connection with granting marketing approval for a new pharmaceutical product, the submission of evidence concerning the safety or efficacy of a product that was previously approved in another territory, such as evidence of prior marketing approval in the other territory, the Party shall not, without the consent of a person previously submitting the safety or efficacy information to obtain marketing approval in the other territory, authorize a third person to market a same or a similar product based on: (i) the safety or efficacy information submitted in support of a prior marketing approval in the other territory; or (ii) evidence of the existence of a prior marketing approval in the other territory, for at least five years from the date of marketing approval of the new pharmaceutical product in the territory of the Party. Submission of New Clinical Information or Evidence relating to a Pharmaceutical Product that Includes a Chemical Entity that has been Previously Approved for Marketing in Another Pharmaceutical Product --FOOTNOTES-- to the discussion in Singapore. JP is still considering its position on Article QQ.E.16. to E.22. 36---PAGE BREAK--- (c) If a Party requires or permits, as a condition of granting marketing approval for a pharmaceutical product that includes a chemical entity that has been previously approved for marketing in another pharmaceutical product, the submission of new clinical information that is essential to the approval of the pharmaceutical product containing the previously approved chemical entity, other than information related to bioequivalency, the Party shall not, without the consent of a person previously submitting such new clinical information to obtain marketing approval in the territory of the Party, authorize a third person to market a same or a similar product based on: (i) the new clinical information previously submitted in support of the marketing approval; or (ii) evidence of the existence of the marketing approval that was based on the new clinical information, for at least three years from the date of marketing approval based on the new clinical information in the territory of the Party. (d) If a Party requires or permits, in connection with granting marketing approval for a pharmaceutical product of the type specified in subparagraph (c), the submission of evidence concerning new clinical information for a product that was previously approved based on that new clinical information in another territory, other than evidence of information related to bioequivalency, such as evidence of prior marketing approval based on new clinical information, the Party shall not, without the consent of a person previously submitting such new clinical information to obtain marketing approval in the other territory, authorize a third person to market a same or a similar product based on: (i) the new clinical information submitted in support of a prior marketing approval in the other territory; or (ii) evidence of the existence of a prior marketing approval that was based on the new clinical information in the other territory for at least three years from the date of marketing approval based on the new clinical information in the territory of the Party.] [US: Additional Provisions relating to Pharmaceutical Products 2. Notwithstanding paragraph 2 above, a Party may take measures to protect 37---PAGE BREAK--- public health in accordance with: (a) the Declaration on the TRIPS Agreement and Public Health (WT/MIN(01)/DEC/2) (the "Declaration"); (b) any waiver of any provision of the TRIPS Agreement granted by WTO Members in accordance with the WTO Agreement to implement the Declaration and in force between the Parties; an (c) any amendment of the TRIPS Agreement to implement the Declaration that enters into force with respect to the Parties. 3. A Party that requires or permits an applicant to obtain approval for marketing a new pharmaceutical product in its territory by relying, in whole or in part, on the prior approval of the pharmaceutical product by the regulatory authority in another territory may, as a condition for providing the period of data protection specified in subparagraph 2(b) or 2(d), require an applicant that has submitted an application for marketing approval consistent with said subparagraphs to commence the process of obtaining marketing approval for that pharmaceutical product within [X] years of the date of first marketing approval of the same pharmaceutical product in another Party. Article QQ.E.17: 1. Where a Party requires or permits, as a condition of approving the marketing of a pharmaceutical product, persons, other than the person originally submitting safety or efficacy information, to rely on that information or on evidence concerning safety or efficacy information for a product that was previously approved, such as evidence of prior marketing approval in another territory, each Party shall: 114 (a) provide a transparent and effective system to: (i) identify a patent or patents covering an approved pharmaceutical product or its approved method of use; and (ii) provide notice to a patent holder of the identity of another person who intends to market, during the term of the identified patent or patents, a product that is the same as, or similar to, the approved pharmaceutical product referenced in subparagraph 5(a)(i). --FOOTNOTES-- 114 For greater certainty, the Parties recognize that this paragraph does not imply that the marketing approval authority should make patent validity or infringement determinations. 38---PAGE BREAK--- (b) unless such other person agrees to defer the marketing of the product until after the expiration of an identified patent, ensure that a patent holder may seek, prior to granting of marketing approval to an allegedly infringing product, available remedies by providing: (i) an automatic delay of the grant of marketing approval that remains in place for a period of time designed to ensure sufficient opportunity to adjudicate115 disputes concerning the validity or infringement of allegedly infringed patents; and (ii) judicial or administrative procedures, including effective provisional measures, to allow for the timely adjudication of disputes concerning the validity or infringement of an allegedly infringed patent. (c) If such other person's product has been found to infringe a valid patent identified pursuant to subparagraph (a), provide measures that operate to prohibit the unauthorized marketing of that product prior to the expiration of the patent. (d) when a Party delays the grant of marketing approval consistent with subparagraph 5(b)(i), provide an effective reward, consistent with the provisions of this Agreement, for the successful challenge of the validity or applicability of the patent.116 2. In implementing subparagraph 5(b)(i), and as a condition for providing the automatic delay of the grant of marketing approval specified in subparagraph 5(b)(i) for a new pharmaceutical product approved consistent with subparagraph 2(b) or 2(d), a Party may require that an applicant that has submitted an application for marketing approval consistent with subparagraph 2(b) or 2(d) to commence the process of obtaining marketing approval for that new pharmaceutical in the Party within [X] years of the date of first marketing approval of the pharmaceutical product in another Party. Article QQ.E.18: Where a Party provides for a period of data protection for a pharmaceutical product of more than [5+Y] years pursuant to subparagraph 2(a) or 2(b) of this Article, that Party is not required to implement for that pharmaceutical product --FOOTNOTES-- 115 [Negotiator's Note: As used in Article 9.5(b)(i), "adjudicate" does not mean final adjudication.] 116 A Party may comply with paragraph 5(d) by providing a period of marketing exclusivity in appropriate circumstances to the first such other person or persons to challenge a patent. 39---PAGE BREAK--- subparagraphs 2(c), 2(d) ( 3-year data protection in connection with submission of new clinical information), 5(b)(i) ( automatic delay of marketing approval) or 5(d) of this Article ( reward for the successful challenge of the validity or applicability of a patent). Article QQ.E.19: Where a Party chooses to apply subparagraph 6(e) of Article 8 and paragraphs 4 and 6 of this Article, the following provisions shall apply: (a) a Party shall permit an applicant to commence the process of obtaining marketing approval by providing the regulatory authority of the Party information supporting approval of the new pharmaceutical product in the Party that is available to the person at the time the request is made, such as evidence of the prior approval of the product in another Party. It is understood that, while a Party may impose reasonable additional requirements or deadlines as a condition of authorizing the person to market the pharmaceutical product in its territory, satisfaction of those additional requirements or deadlines or the granting of approval shall be recognized by the Party as necessarily occurring after the commencement of the marketing approval process within the meaning of subparagraph 6(e) of Article 8 and paragraphs 4 and 6 of this Article; and (b) a Party may not refuse to grant approval of a new pharmaceutical product on the basis of a failure of an applicant for marketing approval to satisfy the requirements of subparagraph 6(e) of Article 8 or paragraphs 4 and 6 of this Article. Article QQ.E.20: [Placeholder for specific provision applying to biologics].] [ US: General Provisions relating to Pharmaceutical Products and Agricultural Chemical Products Article QQ.E.21: For purposes of this Article, a new pharmaceutical product means a product that does not contain a chemical entity that has been previously approved in the territory of the Party for use in a pharmaceutical product [JP propose: for human use]. 117 Article QQ.E.22: Subject to paragraph 3 ( protection of public health), when a product is subject to a system of marketing approval in the territory of a Party pursuant to paragaph 1 or 2 and is also covered by 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 --FOOTNOTES-- 117 For greater certainty, the Parties understand that the term " pharmaceutical product" as used in this Chapter includes biologic products. 40---PAGE BREAK--- 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.]] Article QQ.E.XX.1: {Measures to Encourage Timely Entry of Pharmaceutical Products} [NZ/CA/SG/CL/MY/VN propose: Each Party may adopt or maintain measures to encourage the timely entry of pharmaceutical products to its market.] Article QQ.E.XX.2: {Patent Quality and Efficiency} [NZ/CA/SG/CL/MY/VN propose: 1. Each Party shall endeavour to improve quality and efficiency in its patent system. 2. Each Party shall endeavour to enhance its patent registration system by maintaining examination procedures, cancellation procedures and, where provided, opposition procedures that consistently provide high quality rights for granted patents, and endeavour to simplify and streamline its administration system for the benefit of all users of the system and the public as a whole.] Article QQ.E.XX.3: {Processing Efficiency} [NZ/CA/SG/CL/MY/VN propose: 1. Each Party shall endeavour to process applications for patents, and applications for marketing, regulatory or sanitary approval of pharmaceutical products, in an efficient and timely manner. 2. Each Party may provide a procedure for patent applicants to apply to expedite the examination of their patent application. 3. If there are unreasonable delays in a Party's processing of applications for patents, or processing of applications for marketing, regulatory or sanitary approval of pharmaceutical products, the Party shall endeavour to address those delays.] Article QQ.E.XX.4: {Protection of Undisclosed Data} [NZ/CA/SG/CL/MY/VN propose: 1. Where a Party requires, as a condition of marketing, regulatory or sanitary approval for pharmaceutical products which utilize new chemical entities, the submission of undisclosed test or other data, the origination of which involves a considerable effort, that Party shall protect such data against unfair commercial use. In addition, each Party shall protect such data against disclosure, 41---PAGE BREAK--- except where necessary to protect the public or unless steps are taken to ensure that the data is protected against unfair commercial use. 2. Each Party may provide that the protection of data under paragraph 1, inter alia: (a) is limited to undisclosed test or other data, the origination of which involves a considerable effort; (b) is limited to pharmaceutical products that do not contain a new chemical entity that has been previously approved for marketing in the Party; (c) is limited to pharmaceutical products which utilize a new chemical entity; (d) is available only once per pharmaceutical product; (e) is not available for new uses or indications, new dosage forms or methods of making a pharmaceutical product; (f) is limited to a period of time as determined by the Party; or (g) may be waived to facilitate the marketing, regulatory or sanitary approval of a pharmaceutical product that is the subject of a voluntary or compulsory license, or a licence otherwise issued pursuant to the TRIPS Agreement.3. Each Party may take measures to protect public health in accordance with: (a) the Declaration on the TRIPS Agreement and Public Health (WT/MIN(01)/DEC/2) (the "Declaration"); (b) any waiver of any provision of the TRIPS Agreement granted by WTO Members in accordance with the WTO Agreement to implement the Declaration and in force between the Parties; and (c) any amendment of the TRIPS Agreement to implement the Declaration that enters into force with respect to the Parties.] Article QQ.E.XX.5: {Publication of Regulatory Approval} 42---PAGE BREAK--- [NZ/CA/SG/CL/MY/VN propose: Each Party shall endeavour to promptly make public the granting of marketing, regulatory or sanitary approval of pharmaceutical products.] Article QQ.E.XXX {Agricultural Chemical Products} [US/SG/PE/MX/JP propose 118 ; NZ/VN oppose: 1. (a) If a Party requires [AU/CL/MX oppose: or permits], as a condition of granting marketing approval [CL/MX propose: or sanitary permit] for a new agricultural chemical product [CL/MX propose; JP oppose: which utilize new chemical entity], the submission of [CL/MX propose: undisclosed] [AU oppose: information] [AU propose; JP oppose: undisclosed test or other data] concerning safety or efficacy of the [CL/MX oppose: product] [CL/MX propose; JP oppose: new chemical entity], the Party shall not, without the consent of [AU oppose: a person that previously submitted such] [AU propose: the person who provided the] [CL/MX oppose: safety or efficacy] information [AU oppose: to obtain marketing approval in the Party, authorize another] [AU propose: , permit third persons] to [CL/MX oppose: market] a [CL/MX oppose: same or a similar] product based on: [SG oppose: (i) [CL/MX propose; JP oppose: undisclosed information concerning][AU oppose: the safety or efficacy information submitted in support of the marketing approval] [CL/MX propose: or sanitary permit][AU propose; JP oppose: that undisclosed test or other data]; or] [CL/MX oppose: (ii) [AU oppose: evidence of the existence of] the marketing approval,] [MX oppose: for [AU oppose: at least] ten years from the date of marketing approval [AU oppose: in the territory of] [AU propose: by] the Party.] [MX propose: Where origination of such data involve considerable efforts,119 ] [CL/MX propose; JP oppose: Each Party shall protect such information against disclosure except where necessary to protect the public, or unless steps are taken to ensure that the data are protected against unfair commercial use] --FOOTNOTES-- 118 Negotiators' Note: AU/CA/MY/CL/BN can support the inclusion of provisions on agriculture chemical but still considering the scope and drafting of the protection. CA is also considering the duration of the protection. 119 Negotiator's Note: MX: Placeholder for definition for "considerable efforts". 43---PAGE BREAK--- [CL/MX oppose: (b) If a Party [AU oppose: requires or permits, in connection with] [AU propose: permits, as a condition of ] granting marketing approval for a new agricultural chemical product, the submission of evidence concerning the safety or efficacy of a product that was previously approved in another territory, such as evidence of prior marketing approval [AU oppose: in the other terrritory ]; the Party shall not, without the consent of [AU oppose: a person that] [AU propose: the person who] previously submitted [AU oppose: the safety or efficacy] information [AU propose: concerning safety or efficacy] to obtain marketing approval in another territory, [AU oppose: authorize another] [AU propose: permit third persons] to market a same or a similar product based on: [SG oppose: (i) [AU oppose: the safety or efficacy] information [AU propose: concerning safety or efficacy] submitted [AU oppose: in support of] [AU propose: to obtain] the prior marketing approval in the other territory; or] (ii) evidence of [AU oppose: the existence of a] prior marketing approval in the other territory, for [AU oppose: at least] ten years from the date of marketing approval [AU oppose: of the new product in the territory of the Party].] [PE propose120: In order to receive protection under subparagraph (b), a Party may require that the person providing the information in the other territory seek approval in the territory of the Party within five years after obtaining marketing approval in the other territory.] [MX propose121: Where a Party relies on a marketing approval granted by another Party, the reasonable period of exclusive use of the data submitted in connection with obtaining the approval relied on shall begin with the date of the first marketing approval relied on.] [CL/MX oppose: 2. For purposes of this Article, a new agricultural chemical product is one that [AU oppose: contains] [AU propose: does not contain] a chemical entity that has [AU oppose: not] been previously approved [AU propose: for marketing] in the [AU oppose: territory of the] Party [AU oppose: for use in an agricultural chemical product].]] --FOOTNOTES-- 120 Negotiators' Note: JP is considering this provision. 121 Negotiators' Note: JP is considering this provision. 44---PAGE BREAK--- [NOTE: ARTICLES ORIGINALLY LABELED AS QQ.E.23-24 HAVE BEEN MOVED TO QQ.A.4-5] Article QQ.E.23 122: [PE/NZ/MX/SG: Proposed joint text for the Intellectual Property Chapter on Traditional Knowledge, Traditional Cultural Expressions and Genetic Resources [PE/NZ/VN/BN/MX/SG/CL/MY propose: 1. The Parties recognise the importance and contribution of traditional knowledge, traditional cultural expressions, and biological diversity to cultural, economic and social development.] [PE/MY/MX/BN propose; NZ/AU/SG/CL oppose: 2. Each Party exercises sovereignty over their biological [MY/BN oppose: diversity] [MY/BN propose: resources] and shall determine the access conditions to their genetic resources and their derivatives in accordance to their domestic legislation.] [PE/NZ/BN/MY/MX/VN propose; AU/SG/CL oppose: 3. Where national legislation [MY/BN propose: or policies] establishes such requirements, the Parties recognise that users of genetic resources [NZ/CA oppose: and their derivatives] [ 123 ] or traditional knowledge a**ociated with genetic resources [NZ/CA oppose: and their derivatives] [NZ propose: may] [PE/MY propose: shall]: (a) obtain prior informed consent to access genetic resources [NZ/CA oppose: and their derivatives]; (b) access traditional knowledge a**ociated with genetic resources [NZ/CA oppose: and their derivatives] with the prior informed consent or approval and involvement of the indigenous or local community holding such knowledge; and (c) [BN/MY propose: fairly and] equitably share the benefits arising from the use of genetic resources [NZ/CA oppose: and its derivatives] and traditional knowledge a**ociated with genetic resources [NZ/CA oppose: and their derivatives] on mutually agreed terms.][PE/NZ/MX/CL/VN propose; SG oppose: 4. The parties recognize that: --FOOTNOTES-- 122 Negotiators' Note: CA/US position is that QQ.E.23 provisions should be addressed in the Environment Chapter. The US/JP opposes the inclusion of this proposal in this Chapter. 123 [MX propose; CL oppose: For greater certainty "derivative" means a naturally occurring biochemical compound resulting from the genetic expression or metabolism of biological or genetic resources, without human manipulation, even if does not contain functional units of heredity.] 45---PAGE BREAK--- (a) information about genetic resources [NZ/CL/AU/CA oppose: and their derivatives] and traditional knowledge [CL oppose: a**ociated with genetic resources [NZ/AU/CA oppose: and their derivatives]] can be useful in a**essing patent applications against existing eligibility criteria; and (b) the intellectual property system is one possible means to protect the traditional knowledge [CL oppose: a**ociated with genetic resources [NZ/AU/CA oppose: and their derivatives]] and traditional cultural expressions of indigenous and local communities.][PE/NZ/MX/CL propose; SG oppose: 5. The Parties affirm that they will promote quality patent examination of applications concerning genetic resources and traditional knowledge [CL oppose: a**ociated with genetic resources [NZ/AU/CA oppose: and their derivatives]] to ensure that the eligibility criteria for patentability are satisfied. This may include: (a) in determining prior art, ensuring that readily available documented information related to genetic resources [NZ/CL/AU/CA oppose: and their derivatives] or traditional knowledge [CL oppose: a**ociated with genetic resources [NZ/AU/CA oppose: and their derivatives]] is taken into account; (b) an opportunity to cite, in writing, to the appropriate examining authority prior art that may have a bearing on patentability; (c) where applicable and appropriate, the use of databases or digital libraries containing traditional knowledge [CL oppose: a**ociated genetic resources [NZ/AU/CA oppose: and their derivatives]]; and (d) cooperation in the training of patent examiners in the examination of patent applications related to genetic resources [NZ/CL/AU/CA oppose: and their derivatives] and traditional knowledge [CL oppose: a**ociated with genetic resources [NZ/AU/CA oppose: and their derivatives]].] [PE/NZ/AU/MX/MY/BN/VN/CL propose; SG oppose: 6. Subject to each Party's international obligations [AU/MY/BN/VN/CL oppose: the Parties affirm that they will endeavour to][AU/MY/BN/VN/CL propose: each Party may] establish appropriate measures to protect traditional knowledge and [MY oppose: traditional cultural expressions].] [PE/MX propose; NZ/AU/SG/CL oppose: 7. Each Party will take appropriate, effective and proportionate measures to address situations of non-compliance with 46---PAGE BREAK--- provisions established in paragraph 3.] [PE/NZ/MX/SG/MY/BN/VN propose: 8. The Parties shall, through their respective agencies responsible for intellectual property, cooperate to enhance understanding of how the intellectual property system can deal with issues a**ociated with traditional knowledge, traditional cultural expressions and genetic resources. [ This text is a place holder, to be reconsidered depending on the outcome of the cooperation section of the IP chapter]]] 47---PAGE BREAK--- [JP propose: {INDUSTRIAL DESIGNS} {Section F: Industrial Designs} Article QQ.F.1: {Partial Design} Each Party shall ensure that adequate and effective protection is provided to industrial designs, including to designs of a part of an article, regardless of whether or not the part can be separated from the article.] 48---PAGE BREAK---