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TPP Confidential – Intellectual property rights/Intellectual property (5)
10/11/2015
  1. {Section E: Patents / Undisclosed Test or Other Data}

{Subsection A: General Patents}

Article QQ.E.1: {Patentable Subject matter}

1. Subject to paragraphs 3 and 4, 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 application33.

2. Subject to paragraphs 3 and 4 and consistent with paragraph 1, each Party confirms that patents are available for inventions claimed as at least one of the following: new uses of a known product, new methods of using a known product, or new processes of using a known product. A Party may limit such processes to those that do not claim the use of the product as such34.

3. 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. Each Party may also exclude from patentability: diagnostic, therapeutic, and surgical methods for the treatment of humans or animals; animals other than microorganisms; and essentially biological processes for the production of plants or animals, other than non-biological and microbiological processes.

4. Each Party may also exclude from patentability plants other than microorganisms. However, consistent with paragraph 1 and subject to paragraph 3, each Party confirms that patents are available at least for inventions that are derived from plants35.

Article QQ.E.2: {Grace Period}

Each Party shall disregard at least information contained in public disclosures used to determine if an invention is novel or has an inventive step if the public disclosure36,37:

  1. (a)  was made by the patent applicant or by a person who obtained the information directly or indirectly from the patent applicant; and
  2. (b)  occurred within 12 months prior to the date of filing of the application in the territory of the Party.

Article QQ.E.3: {Patent Revocation}

TPP Negotiations IP Group Intellectual Property [Rights] Chapter 05 Oct 2015

1. 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.

2. Notwithstanding Paragraph 1, a Party may provide that a patent may be revoked, provided it is done in a manner consistent with Article 5A of the Paris Convention and the TRIPS Agreement.

Article QQ.E.4: {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 account of the legitimate interests of third parties.

Article QQ.E.5: {Other use without authorization of the right holder}

The Parties understand that nothing in this Chapter limits a Party’s rights and obligations under Article 31 of the TRIPS Agreement, or waivers or amendments to that Article that the Parties accept38.

Article QQ.E.6: {Patent filing}

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, that Party shall grant the patent on the application that is patentable and that has the earliest filing, or if applicable, priority date39, unless that application has, prior to publication40, been withdrawn, abandoned or refused.

Article QQ.E.7: {Amendments, corrections and observations}

Each Party shall provide patent applicants with at least one opportunity to make amendments, corrections, and observations in connection with their applications41.

Article QQ.E.11: {Publication of Patent Applications}

1. Recognizing the benefits of transparency in the patent system, each Party shall endeavor to publish unpublished pending patent applications promptly after the expiry of 18 months from the filing date or, if priority is claimed, from the priority date.

2. Where a pending application is not published promptly under paragraph 1, Parties shall publish such application or the corresponding patent as soon as practicable.

3. Each Party shall provide that an applicant may request the early publication of an application prior to the expiry of the period mentioned in paragraph 1.

Article QQ.E.11bis: {Information relating to published patent applications and issued patents}

For published patent applications and issued patents, and in accordance with the Party’s requirements for prosecution of such applications and patents, each Party shall make available to the public at least the following information, to the extent that such information is in the possession of the competent authorities and is generated on or after the date of entry into force of the Agreement for that Party:

  1. (a)  search and examination results, including details of, or information related to, relevant prior art searches;
  2. (b)  non confidential communications from applicants, where appropriate; and
  3. (c)  patent and non-patent related literature citations submitted by applicants,

    and relevant third parties.

Article QQ.E.12: {Patent Term Adjustment for Patent Office Delays}

1. Each Party shall make best efforts to process patent applications in an efficient and timely manner, with a view to avoiding unreasonable or unnecessary delays.

2. Each Party may provide procedures for patent applicants to request to expedite the examination of their patent application.

3. If there are unreasonable delays in a Party’s issuance of patents, that Party shall provide the means to, and at the request of the patent owner, shall, adjust the term of the patent to compensate for such delays.

4. For purposes of this Article, an unreasonable delay at least shall include a delay in the issuance of a patent of more than five years from the date of filing of the application in the territory of the Party, or three years after a request for examination of the application has been made, whichever is later. A Party may exclude, from the determination of such delays, periods of time that do not occur during the processing42 of, or the examination of, the patent application by the granting authority; periods of time that are not directly attributable43 to the granting authority; as well as periods of time that are attributable to the patent applicant44.

{Subsection B: Data Protection for Agricultural Chemical Products}

Article QQ.E.13: {Agricultural Chemical Products}

1. If a Party requires, as a condition for granting marketing approval45 for a new agricultural chemical product, the submission of undisclosed test or other data concerning the safety and efficacy of the product46, the Party shall not permit third persons, without the consent of the person who previously submitted such information, to market the same or a similar47 product on the basis of that information or the marketing approval granted to the person who submitted such test or other data for at least ten years48 from the date of marketing approval of the new agricultural chemical product in the territory of the Party.

2. If a Party permits, as a condition of granting marketing approval for a new agricultural chemical product, the submission of evidence of a prior marketing approval of the product in another territory, that Party shall not permit third persons, without the consent of the person who previously submitted undisclosed test or other data concerning the safety and efficacy of the product in support of that prior marketing approval, to market the same or a similar product based on that undisclosed test or other data, or other evidence of the prior marketing approval in the other territory, for at least ten years from the date of marketing approval of the new agricultural chemical product in the territory of the Party.

3. For the purposes of this Article, a new agricultural chemical product is one that contains49 a chemical entity that has not been previously approved in the territory of the Party for use in an agricultural chemical product.

{Subsection C: Measures Relating to Pharmaceutical / Regulated Products}

Article QQ.E.14: {Patent Term Adjustment for Unreasonable Curtailment}

1. Each Party shall make best efforts to process applications for marketing approval of pharmaceutical products in an efficient and timely manner, with a view to avoiding unreasonable or unnecessary delays.

2. With respect to a pharmaceutical product50 that is subject to a patent, each Party shall make available an adjustment51 of the patent term to compensate the patent owner for unreasonable curtailment of the effective patent term as a result of the marketing approval process52.

3. For greater certainty, in implementing the obligations of this Article, each Party may provide for conditions and limitations provided that the Party continues to give effect to this Article.

4. With the objective of avoiding unreasonable curtailment of the effective patent term, a Party may adopt or maintain procedures that expedite the examination of marketing approval applications.

Article QQ.E.15: {Regulatory Review Exception}

TPP Negotiations IP Group Intellectual Property [Rights] Chapter 05 Oct 2015

Without prejudice to the scope of, and consistent with, QQ.E.4, each Party shall adopt or maintain a regulatory review exception53for pharmaceutical products.

Article QQ.E.16: {Pharmaceutical Data Protection/Protection of Undisclosed Test or Other Data}

1. (a)

If a Party requires, as a condition for granting marketing approval for a new pharmaceutical product, the submission of undisclosed test or other data concerning the safety and efficacy of the product54, the Party shall not permit third persons, without the consent of the person who previously submitted such information, to market the same or a similar55 product on the basis of:

  1. (i)  that information; or
  2. (ii)  the marketing approval granted to the person who submitted such information

for at least five years56 from the date of marketing approval of the new pharmaceutical product in the territory of the Party.

(b) If a Party permits, as a condition of granting marketing approval for a new pharmaceutical product, the submission of evidence of prior marketing approval of the product in another territory, the Party shall not permit third persons, without the consent of a person who previously submitted such information concerning the safety and efficacy of the product, to market a same or a similar product based on evidence relating to 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.

  1. Each Party shall57:
    1. (a)  apply Article QQ.E.16.1 mutatis mutandis for a period of at least three years with respect to new clinical information submitted as required in support of a marketing approval of a previously approved pharmaceutical product covering a new indication, new formulation or new method of administration; or alternatively,
    2. (b)  apply Article QQ.E.16.1 mutatis mutandis for a period of at least five years to new pharmaceutical products that contain a chemical entity that has not been previously approved in the Party58.
  2. Notwithstanding paragraphs 1 and 2 above and Article QQ.E.20, a Party may take

measures to protect public health in accordance with:

  1. (a)  the Declaration on the TRIPS Agreement and Public Health (WT/MIN(01)/DEC/2) (the “Declaration”);
  2. (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
  3. (c)  any amendment of the TRIPS Agreement to implement the Declaration that enters into force with respect to the Parties.

Article QQ.E.17: {}

1. If a Party permits, as a condition of approving the marketing of a pharmaceutical product, persons, other than the person originally submitting the safety and efficacy information, to rely on evidence or information concerning the safety and efficacy of a product that was previously approved, such as evidence of prior marketing approval by the Party or in another territory, that Party shall provide59:

(a) a system to provide notice to a patent holder60 or to allow for a patent holder to be notified prior to the marketing of such a pharmaceutical product, that such other person is seeking to market that product during the term of an

applicable patent claiming the approved product or its approved method of use;

  1. (b)  adequate time and opportunity for such a patent holder to seek, prior to the marketing61 of an allegedly infringing product, available remedies in subparagraph (c); and
  2. (c)  procedures, such as judicial or administrative proceedings, and expeditious remedies, such as preliminary injunctions or equivalent effective provisional measures, for the timely resolution of disputes concerning the validity or infringement of an applicable patent claiming an approved pharmaceutical product or its approved method of use.

2. As an alternative to paragraph 1, a Party shall instead adopt or maintain an extra- judicial system which precludes, based upon patent-related information submitted to the marketing approval authority by a patent holder or the applicant for a marketing approval, or based on direct coordination between the marketing approval authority and the patent office, the issuance of marketing approval to any third party seeking to market a pharmaceutical product subject to a patent claiming that product, unless by consent or acquiescence of the patent holder.

Article QQ.E.20: {Biologics}

1. With regard to protecting new biologics, a Party shall either:

  1. (a)  with respect to the first marketing approval in a Party of a new pharmaceutical product that is or contains a biologic62,63, provide effective market protection through the implementation of Article QQ.E.16.1 and Article QQ.E.16.3 mutatis mutandis for a period of at least 8 years from the date of first marketing approval of that product in that Party; or alternatively
  2. (b)  with respect to the first marketing approval in a Party of a new pharmaceutical product that is or contains a biologic, provide effective market protection:
    1. (i)  through the implementation of Articles QQ.E.16.1 and QQ.E.16.3 mutatis mutandis for a period of at least 5 years from the date of first marketing approval of that product in that Party;
    2. (ii)  through other measures; and
    3. (iii)  recognizing that market circumstances also contribute to effective

      market protection

    to deliver a comparable outcome in the market.

    2. For the purposes of this Section, each Party shall apply this provision to, at a minimum, a product that is, or alternatively, contains, a protein produced using biotechnology processes64, for use in human beings for the prevention, treatment, or cure of a disease or condition.

    3. Recognizing that international and domestic regulation of new pharmaceutical products that are or contain a biologic is in a formative stage and that market circumstances may evolve over time, the Parties shall consult after 10 years, or as otherwise decided by the TPP Commission, to review the period of exclusivity provided in paragraph 1 and the scope of application provided in paragraph 2, with a view to providing effective incentives for the development of new pharmaceutical products that are or contain a biologic, as well as with a view to facilitating the timely availability of follow-on biosimilars, and to ensuring that the scope of application remains consistent with international developments regarding approval of additional categories of new pharmaceutical products that are or contain a biologic.

    PLACEMENT TBD: To implement {and comply with} QQ.E.20.1(a) and (b), only the following TPP Parties have determined that they require change to their law, and thus require transition periods:
    (i) For (**), a transition of (x) years

    (ii) For (***), a transition of (y) years.

    Article QQ.E.21: {Definition of New Pharmaceutical Product}65

    For the purposes of Article QQ.E.16.1, a new pharmaceutical product means a pharmaceutical product that does not contain66 a chemical entity that has been previously approved in the Party.

  1. (i)  through the implementation of Articles QQ.E.16.1 and QQ.E.16.3 mutatis mutandis for a period of at least 5 years from the date of first marketing approval of that product in that Party;
  2. (ii)  through other measures; and
  3. (iii)  recognizing that market circumstances also contribute to effective

    market protection

to deliver a comparable outcome in the market.

2. For the purposes of this Section, each Party shall apply this provision to, at a minimum, a product that is, or alternatively, contains, a protein produced using biotechnology processes64, for use in human beings for the prevention, treatment, or cure of a disease or condition.

3. Recognizing that international and domestic regulation of new pharmaceutical products that are or contain a biologic is in a formative stage and that market circumstances may evolve over time, the Parties shall consult after 10 years, or as otherwise decided by the TPP Commission, to review the period of exclusivity provided in paragraph 1 and the scope of application provided in paragraph 2, with a view to providing effective incentives for the development of new pharmaceutical products that are or contain a biologic, as well as with a view to facilitating the timely availability of follow-on biosimilars, and to ensuring that the scope of application remains consistent with international developments regarding approval of additional categories of new pharmaceutical products that are or contain a biologic.

PLACEMENT TBD: To implement {and comply with} QQ.E.20.1(a) and (b), only the following TPP Parties have determined that they require change to their law, and thus require transition periods:
(i) For (**), a transition of (x) years

(ii) For (***), a transition of (y) years.

Article QQ.E.21: {Definition of New Pharmaceutical Product}65

For the purposes of Article QQ.E.16.1, a new pharmaceutical product means a pharmaceutical product that does not contain66 a chemical entity that has been previously approved in the Party.

Article QQ.E.22: {}

Subject to Article QQ.E.16.3 (protection of public health), when a product is subject to a system of marketing approval in the territory of a Party pursuant to Articles QQ.E.16, QQ.E.20, or QQ.E.13 (agricultural chemical products) 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 Articles QQ.E.16, QQ.E.20, or QQ.E.13 (agricultural chemical products) in the event that the patent protection terminates on a date earlier than the end of the term of protection specified in Articles QQ.E.16, QQ.E.20, or QQ.E.13 (agricultural chemical products).

 

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