TPP IP Chapter-Leaked Draft- Section E&F: Patents, Undisclosed Data, Traditional Knowledge, & Industrial Design
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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]:
--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 skilled or having ordinary skill in the art having regard to the prior art.
88 Negotiators' Note: JP is considering this provision.
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Article QQ.E.2: {Patentable Subject Matter}
Each Party shall89 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.
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and
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 propose93; 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.]
[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.
94US withdraw Article QQ.E.4 ad referendum pending confirmation from capital.
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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
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 applications98.
--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.
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Article QQ.E.8: [US/AU/PE/VN propose;99 CL/MY/BN/NZ/CA/SG/MX100 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 skilled 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 skilled 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/AU104/CA/SG/PE/CL/NZ/JP propose; MY/BN/VN/MX oppose: For published105 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.
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:
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.]
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[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.
--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
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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.
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 assess additional safety or efficacy implications of marketing a product, such as to assess 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
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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:
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.
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2. Notwithstanding paragraph 2 above, a Party may take measures to protect
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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
--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.
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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.
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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:
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].117Article 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.
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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,
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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:
Article QQ.E.XX.5: {Publication of Regulatory Approval}
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[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 propose118 ; NZ/VN oppose: 1.
--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".
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--FOOTNOTES--
120 Negotiators' Note: JP is considering this provision.
121 Negotiators' Note: JP is considering this provision.
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[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 associated with genetic resources [NZ/CA oppose: and their derivatives] [NZ propose: may] [PE/MY propose: shall]:
--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.]
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[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
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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 associated 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]]]
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[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.]
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About
The Trans-Pacific Partnership is a proposed free trade agreement which grew from an initial 4 countries to include a dozen Pacific Rim nations. Joined by the US in 2008 and Japan in early 2013, the agreement has now grown from a small regional pact to encompass – potentially – nearly 40% of global GDP. The IP Chapter of the Agreement appeared on Wikileaks in early November 2013.
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- 5.TPP IP Chapter-Leaked Draft- Section E&F: Patents, Undisclosed Data, Traditional Knowledge, & Industrial Design