US-Thailand FTA - IPR text proposed by US (2006)

Patents

1. Each Party may only exclude from patentability inventions, the prevention within its territory of the commercial exploitation of which is necessary to protect ordre public or morality, including to protect human, animal, or plant life or health or to avoid serious prejudice to the environment, provided that such exclusion is not made merely because the exploitation is prohibited by law.

2. Each Party shall make patents available for the following inventions:

  • (a) plants and animals, and
  • (b) diagnostic, therapeutic, and surgical procedures for the treatment of humans or animals.

In addition, the Parties confirm that patents shall be available for any new uses or methods of using a known product.

3. 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.

4. Each Party shall provide that a patent may be revoked 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 revoking a patent or holding a patent unenforceable. Where a Party provides proceedings that permit a third party to oppose the grant of a patent, a Party shall not make such proceedings available before the grant of the patent.

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

6. A Party shall not permit the use [4] of the subject matter of a patent without the authorization of the right holder except in the following circumstances:

  • (a) to remedy a practice determined after judicial or administrative process to be anti-competitive under the competition laws of the Party; [5] or
  • (b) in the case of public non-commercial use or in the case of national emergency or other circumstances of extreme urgency, provided that:
    • (i) such use is limited to use by the government or third parties authorized by the government;
    • (ii) the patent owner is provided with reasonable and entire compensation for such use; and
    • (iii) the Party shall not require the patent owner to provide undisclosed information or technical know-how related to a patented invention that has been authorized for use without the consent of the patent owner pursuant to this paragraph.

7. (a) Each Party, at the request of the patent owner, shall adjust the term of a patent to
compensate for unreasonable delays that occur in granting the patent. For purposes of
this paragraph, an unreasonable delay shall at least 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,
whichever is later. Periods attributable to actions of the patent applicant need not be
included in the determination of such delays.

(b) With respect to patents covering pharmaceutical products or methods of using
pharmaceutical products:

  • (i) each Party shall make available, an adjustment of the patent term to compensate the patent owner for unreasonable curtailment of the effective patent term as a result of the marketing approval process related to the first commercial use of a new pharmaceutical product [6] in that Party; and
  • (ii) where a Party approves the marketing of a new pharmaceutical product based on evidence of prior approval in another territory, including information on safety and efficacy submitted in connection with that approval, the Party shall make available an adjustment of the patent term to compensate the patent owner for unreasonable curtailment of the effective patent-term in the Party as a result of the marketing approval process in the other territory and in the Party.

For purposes of this paragraph, effective patent term means the period from the date of approval of the product until the original expiration date of the patent.

8. When a Party provides for the grant of a patent on the basis of a patent granted in another territory, that Party, at the request of the patent owner, shall adjust the term of a patent granted under such procedure by a period equal to the period of the adjustment, if any, provided in respect of the patent granted in the other territory.

9. Each Party shall disregard information contained in public disclosures used to determine if an invention is novel or has an inventive step [7] if the public disclosure:

  • (a) was made, or authorized by, or derived 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.

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

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

12. Each Party shall provide that a claimed invention:

  • (a) is sufficiently supported by its disclosure if the disclosure reasonably conveys to a person skilled in the art that the applicant was in possession of the claimed invention as of the filing date, and
  • (b) is industrially applicable if it has a specific, substantial, and credible utility.

Measures Related to Certain Regulated Products

1. (a) If a Party requires or permits, as a condition of granting marketing approval for a new pharmaceutical or new agricultural chemical product, the submission of information concerning safety or efficacy of the product, the Party shall not, without the consent of a person that previously submitted such safety or efficacy information to obtain marketing approval in the Party, authorize another to market a same or a similar product based on:

  • (i) the safety or efficacy information submitted in support of the marketing approval; or
  • (ii) evidence of the marketing approval; for at least five years for pharmaceutical products and ten years for agricultural chemical products from the date of marketing approval in the territory of the Party.

(b) If a Party requires or permits, in connection with granting marketing approval for a new pharmaceutical or 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 in the other territory, the Party shall not, without the consent of a person that previously submitted the safety or efficacy information to obtain marketing approval in the other territory, authorize another to market a same or a similar product based on:

    • (i) the safety or efficacy information submitted in support of the prior marketing approval in the other territory; or
    • (ii) evidence of prior marketing approval in the other territory; for at least five year for pharmaceutical products and ten years for agricultural chemical products from the date of marketing approval of the new product in the territory of the Party.

(c) For purposes of this Article, a new pharmaceutical product is one that does not contain a chemical entity that has been previously approved in the territory of the Party for use in a pharmaceutical product and a new agricultural chemical product is one that contains a chemical entity that has not been previously approved in the territory of the Party for use in an agricultural chemical product.

2. (a) 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 that previously submitted such new clinical information to obtain marketing approval in the territory of the Party, authorize another to market a same or a similar product based on:

    • (i) the new clinical information submitted in support of the marketing approval; or
    • (ii) evidence of the marketing approval based on the new clinical information, for at least three years from the date of marketing approval in the territory of the Party.

(b) If a Party requires or permits, in connection with granting marketing, approval for a pharmaceutical product of the type specified in subparagraph (a), 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 the new clinical information, the Party shall not, without the consent of the person that previously submitted such new clinical information to obtain marketing approval in the other territory, authorize another to market a same or a similar product based on:

    • (i) the new clinical information submitted in support of the prior marketing approval in the other territory; or
    • (ii) evidence of prior marketing approval based on the new clinical information in the other territory, for at least three years from the dale of marketing approval based on the new clinical information in the territory of the Party.

(c) If a Party requires or permits, as a condition of granting marketing approval, for a new use, for an agricultural chemical product that has been previously approved in the territory of the Party, the submission of safety or efficacy information. the Party shall not, without the consent of a person that previously submitted such safety or efficacy information to obtain marketing approval in the territory of the Party, authorize another to market a same or similar product for that use based on:

    • (i) the submitted safety or efficacy information; or
    • (ii) evidence of the marketing approval for that use, for at least ten years from the date of the original marketing approval of the agricultural chemical product in the territory of the Party.

(d) If a Party requires or permits, in connection with granting marketing approval, for a new use, for an agricultural chemical product that has been previously approved in the territory of the Party, the submission of evidence concerning the safely or efficacy of a product that was previously approved in another territory for that new use, such as evidence of prior marketing approval for that new use, the Party shall not, without the consent of the person that previously submitted the safety or efficacy information to obtain marketing approval in the other territory, authorize another to market a same or a similar product based on:

    • (i) the safety or efficacy information submitted in support of the prior marketing approval for that use in the other territory; or
    • (ii) evidence of the prior marketing approval in another territory for that new use for at least ten years from the date of the original marketing approval granted in the territory of the Party.

3. When a product is subject to a system of marketing approval pursuant to Article 9.1 or 9.2 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 Articles 9.1 and 9.2 in the event that the patent protection terminates on a date earlier than the end of the term of protection specified in Articles 9.1 and 9.2.

4. Where a Party 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 of safety or efficacy information of a product that was previously approved, such as evidence of prior marketing approval in the territory of the Party or in another territory, that Party shall:

  • (a) implement measures in its marketing approval process to prevent such other persons from marketing a product covered by a patent claiming the product or its approved method of use during the term of that patent without the consent or acquiescence of the patent owner; and
  • (b) provide that the patent owner shall be notified of the identity of any such other person that requests marketing approval lo enter the market during the term of a patent notified to the approving authority as claiming that product or any approved method of use.

Footnotes:

A Party may satisfy requirement for publication by making the law, regulation, or procedure available to the public on the Internet

[4 "Use" in this paragraph refers to use other than that allowed under paragraph 3 of this Article and Article 30 of the TRIPS Agreement.

[5With respect to subparagraph (a), the Parties recognize that a patent does not necessarily confer market power.

[6 For greater certainly, the term "new pharmaceutical product" in subparagraphs (i) and (ii) of Article 8.7(b) has the meaning given to that term in Article 9.1 (c).

[7 For purposes of this Article, “inventive step” shall be treated as synonymous with “non-obvious”

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