한미 FTA 저지 지적재산권 분야 대책위원회

IPR text proposed by US to Thailand (2006)

US proposal on ‘patents’ and on ‘measures related to certain regulated products’ for negotiation with Thailand under the IPR chapter of the current US-Thailand FTA talks.

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.
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.
[5] With 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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More IPR text proposed by US to Thailand (2006)

General provisions, trademarks (including GIs) and domain names

CHAPTER 14 : INTELLECTUAL PROPERTY RIGHTS

ARTICLE 14 : GENERAL PROVISIONS

1. Each Party shall, at a minimum, give effect to this Chapter.
2. Each Party shall make best efforts to ratify or accede to the following agreements:
a) the Patent Law Treaty (2000); and
b) the Hague Agreement Concerning the International Registration of Industrial Designs (1999)
3. Each Party shall ratify or accede to the following agreements:
(a) the Patent Cooperation Treaty (1970), as amended in 1979;
(b) the Convention Relating to the Distribution of Programme-Carrying Signals Transmitted by Satellite (1974);
(c) the Protocol Relating to the Madrid Agreement Concerning the International Registration of Marks (1989);
(d) the Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure (1977), as amended in 1980;
(e) the International Convention for the Protection of New Varieties of Plants (1991) (UPOV Convention);
(f) the Trademark Law Treaty (1994);
(g) the WIPO Copyright Treaty (1996); and
(h) the WIPO Performances and Phonograms Treaty (1996)

More Extensive Protection and Enforcement
4. A Party may implement in its domestic law more extensive protection and enforcement of intellectual property rights tan required under this Chapter, provided that such protection and enforcement does not contravene this Chapter.
National Treatment
5. In respect of all categories of intellectual property covered in this Chapter, each Party shall accord to nationals [1] of the other Party treatment no less favorable than it accords to its own nationals with regard to the protection [2] and enjoyment of such intellectual property rights and any benefits derived from such rights.
6. A Party may derogate from paragraph 5 in relation to its judicial and administrative procedures, including any procedure requiring a national of the other Party to designate in its territory, provided that such derogation:
◦ a) is necessary to secure compliance with laws and regulations that are not inconsistent with this Chapter; and
◦ b) is not applied in a manner that would constitute and disguised restriction on trade,
7. Paragraph 5 does not apply to procedures provide in multilateral agreements concluded under the auspices of the World Intellectual Property Organization in relation to the acquisition or maintenance of intellectual property rights.
8. Except as otherwise provided in this Chapter, including Article 14.4.6, this Chapter gives rise to obligations in respect of all subject matter existing at the date of entry into force of this Agreement that is protected on that date in the Party where protection is claimed, or that meets or comes subsequently to meet the criteria for protection under the terms of this Chapter.
9. Except as otherwise provided in this Chapter, including Article 14.4.6, a Party shall not be required to restore protection to subject matter, that on the date of entry into force of this Agreement has fallen into the public domain in the Party.
10. This Chapter does not give rise to obligations in respect of acts that occurred before the date of entry into force of Agreement.
11. Further to Article ... (Publication), each Party shall ensure that all laws, regulations, and procedures concerning the protection or enforcement of intellectual property rights are writing and are published, [3] or where such publication is not practicable, made publicly available, in national language in such a manner as to enable governments and right holders to become acquainted with them, with the object of making the protection and enforcement of intellectual property rights transparent.

ARTICLE 14.2 : TRADEMARKS, INCLUDING GEOGRAPHICAL INDICATIONS
1. Neither Party may require, as a condition of registration, that signs be visually perceptible and neither Party may deny registration of a trademark solely on grounds that the sign of which it is composed is a sound or that the sign includes a scent.
2. Each Party shall provide that trademarks shall include certification marks. Each Party shall also provide that signs that may serve, in the course of trade, as geographical indications are eligible for protection as trademarks. [4]
3. Each Party shall ensure that its measures mandating the use of term customary in common language as the common name for a good or service (“common name”) including, inter alia, requirements concerning the relative size, placement or style of use or effectiveness of trademarks used in relation to such good or service.
4. Each Party may provide limited exceptions to rights conferred by a trademark, such as fair use of descriptive terms, provided that such exceptions take account of legitimate interest of owner of the trademarks and third parties.
5. Each Party shall provide that the owner of a registered trademark shall have the exclusive right to prevent all third parties not having the owner’s consent from using in the course of trade identical or similar signs, including geographical indications, for goods or services that are related to those goods or services in respect of which the owner’s trademark is registered, where such use would result in a likelihood of confusion.
6. Article 6bis of the Paris Convention for the Protection of Industrial Property (1976) shall apply, mutatis mutandis, to goods or services that are not identical or similar to those identified by a well-known trademark, [5] whether registered or not, provided that use of that trademark in relation to those goods or services would indicate a connection between those goods or services and the owner of the trademark, and provided that the interests of the owner of the trademark are likely to be damaged by such use.
7. Each Party shall provide a system for the registration of trademarks, which shall include:
◦ (a) providing to the applicant a communication in writing, which may be electronic, of the reasons for a refusal to register a trademark;
◦ (b) providing an opportunity for the applicant to respond to communications from the trademark authorities, to contest an initial refusal, and to appeal judicially a final refusal to register;
◦ (c) providing an opportunity for interested parties to petition to oppose a trademark application or to seek cancellation of a trademark after it has been registered; and
◦ (d) a requirement that decisions in opposition or cancellation proceedings be reasoned and in writing.

8. Each Party shall provide:
◦ (a) a system for the electronic application, processing, registration, and maintenance of trademarks, and
◦ (b) a publicly available electronic database — including an on-line database — of trademark applications and registrations,

9. Each Party shall provide that:
(a) each registration or publication that concerns a trademark application or registration and that indicates goods or services shall indicate the goods or services by their names, grouped according to the classes of the classification established by the Nice Agreement Concerning the International Classification of Goods and Services for the Purposes of the Registration of Marks (1979) (“Nice Classification”).
◦ (b) goods or services may not be considered as being similar to each other solely on the ground that, in any registration or publication, they appear in the same class of the Nice Classification. Conversely, each Party shall provide that goods or services may not be considered as being dissimilar from each other solely on the ground that, in any registration or publication, they appear in different classes of the Nice Classification.
10. Neither Party may require recordation of trademark licenses to establish the validity of the license, to assert any rights in a trademark, or for other purposes
11. Each Party shall provide that initial registration and each renewal of registration of a trademark shall be for a term of no less than 10 years.
12. If a Party shall provide the means to apply for protection or petition for recognition of geographical indications, through a system of protection of trademarks or otherwise, it shall accept those applications and petitions without the requirement for intercession by a Party on behalf of its nationals and shall:
◦ (a) process applications or petitions, as relevant with a minimum of formulations.
◦ (b) make its regulations governing filling of such applications or petition, as the case may be, readily available to the public.
◦ (c) provide that applications or petitions, as the case may be, for geographical indications are published for opposition, and shall provide procedures for opposing geographical indications that are the subject of applications or petitions. Each Party shall also provide procedures to cancel a registration resulting from an application or a petition.
◦ (d) provide that measures governing the filling of applications or petitions for geographical indications set out clearly the procedures for these actions. Such procedures shall include contact information sufficient for applicants and/or petitioners to obtain specific procedural guidance regarding the processing
13. Each Party shall provide that grounds for refusing protection or recognition of a geographical indication include the following:
◦ (a) the geographical indication is likely to cause confusion with a trademark that is the subject of a good-faith pending application or registration; and
◦ (b) the geographical indication is likely to cause confusion with a preexisting trademark, the rights to which have been acquired through use in good faith in that Party.
◦
◦ ARTICLE 14.3: DOMAIN NAMES ON THE INTERNET

1. Each Party shall require that the management of its country-code top top-level domain (ccTLD) provide an appropriate procedure for the settlement of disputes, based on the principles established in the Uniform Domain-Name Dispute-Resolution Policy (UDRP), in order to address the problem of trademark cyberpiracy.
2. Each Party shall require that management of its ccTLD provide online public access to a reliable and accurate database of contact information for domain name registrants.
[1] For purpose of Articles 14.1.5, 14.1.6, 14.3.2 and 14.7.1 a national of Party shall also mean, in respect of the relevant right, an entity located in such Party that would meet the criteria for eligibility for protection provided for in the agreements listed in Article 14.1.2 and the TRIPS Agreement.
[2] For purposes of this paragraph, “protection” shall include matters affecting the availability, acquisition, scope, maintenance and enforcement of intellectual property rights as well as matters affecting the use of intellectual property rights specifically covered by this Chapter. Further for this paragraph, “protection” shall also include the prohibition on circumvention of effective technological measures pursuant to article 14.4.7 and the provisions concerning right management information pursuant to article 14.4.8
[3] For greater certainty, a Party may satisfy the requirement for publication by making it available to the public on the internet.
[4] Geographical indications means indications that identify a good as originating in the territory of a Party, or a region or locality in that territory, where a given quality, reputation, or other characteristic of the good is essentially attributable to its geographic origin. Any sign or combination of signs (such as words - including geographical and personal names, as well as letters, numerals, figurative elements and including single colors), in any from whatever, shall be eligible to be a geographical indication.
[5] In determining whether a trademark is well known, the reputation of the trademark need not extend beyond the sector of the public that deals with relevant goods or services.