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Access to Medicine in the Global EconomyInternational Agreements on Patents and Related Rights$

Cynthia Ho

Print publication date: 2011

Print ISBN-13: 9780195390124

Published to Oxford Scholarship Online: May 2011

DOI: 10.1093/acprof:oso/9780195390124.001.0001

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(p.375) Appendix A: Selected TRIPS Provisions

(p.375) Appendix A: Selected TRIPS Provisions

Source:
Access to Medicine in the Global Economy
Publisher:
Oxford University Press

Note:

The TRIPS Agreement is authored and copyrighted by the WTO. The full text may be found online at www.wto.org. Footnote numbers replicate the numbering online www.wto.org.

This abbreviated version is provided to aid the discussion of TRIPS provisions. Specific terms given discussion in the book are noted through the use of bold text. Similarly, small annotations to clarify references or omission of material are noted in italics, surrounded by square brackets. These annotations are not part of the original text, but provided for ease of reference.

Article 1

nature and scope of obligations

1. Members shall give effect to the provisions of this Agreement. Members may, but shall not be obliged to, implement in their law more extensive protection than is required by this Agreement, provided that such protection does not contravene the provisions of this Agreement. Members shall be free to determine the appropriate method of implementing the provisions of this Agreement within their own legal system and practice.

2-3. Omitted

(p.376) Article 2

intellectual property conventions

1. In respect of Parts II, III and IV of this Agreement [standards, enforcement, and acquisition of rights], Members shall comply with Articles 1 through 12 [including Art. 5 regarding compulsory licenses for “failure to work” a patented invention], and Article 19, of the Paris Convention (1967).

Article 3

national treatment

1. Each Member shall accord to the nationals of other Members treatment no less favourable than that it accords to its own nationals with regard to the protection3of intellectual property,….

Article 4

most-favoured-nation treatment

With regard to the protection of intellectual property, any advantage, favour, privilege or immunity granted by a Member to the nationals of any other country shall be accorded immediately and unconditionally to the nationals of all other Members. [Exemptions omitted]

Article 6

exhaustion

For the purposes of dispute settlement under this Agreement, subject to the provisions of Articles 3 and 4 nothing in this Agreement shall be used to address the issue of exhaustion of intellectual property rights.

Article 7

objectives

The protection and enforcement of intellectual property rights should contribute to the promotion of technological innovation and to the transfer and dissemination of technology, to the (p.377) mutual advantage of producers and users of technological knowledge and in a manner conducive to social and economic welfare, and to a balance of rights and obligations.

Article 8

principles

1. Members may, in formulating or amending their laws and regulations, adopt measures necessary to protect public health and nutrition, and to promote the public interest in sectors of vital importance to their socio-economic and technological development, provided that such measures are consistent with the provisions of this Agreement.

2. [Omitted]

Article 27

patentable subject matter

1. Subject to the provisions of paragraphs 2 and 3, patents shall be available for any inventions, whether products or processes, in all fields of technology, provided that they are new, involve an inventive step and are capable of industrial application.5 Subject to paragraph 4 of Article 65 [permissible delay of product patents for some developing countries], paragraph 8 of Article 70 [transitional requirements, such as “mailbox provision” for countries that do not immediately provide product patents], and paragraph 3 of this Article patents shall be available and patent rights enjoyable without discrimination as to the place of invention, the field of technology and whether products are imported or locally produced.

2. [Omitted]

3. [Omitted]

Article 28

rights conferred

1. A patent shall confer on its owner the following exclusive rights:

  1. (a) where the subject matter of a patent is a product, to prevent third parties not having the owner’s consent from the acts of: making, using, offering for sale, selling, or importing6 for these purposes that product;

  2. (p.378)
  3. (b) [Omitted – Process Patent Rights]

2. [Omitted]

Article 30

exceptions to rights conferred

Members 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 31

other use without authorization of the right holder

[Compulsory Licenses]

Where the law of a Member allows for other use7 of the subject matter of a patent without the authorization of the right holder, including use by the government or third parties authorized by the government, the following provisions shall be respected:

  1. a. authorization of such use shall be considered on its individual merits;

  2. b. such use may only be permitted if, prior to such use, the proposed user has made efforts to obtain authorization from the right holder on reasonable commercial terms and conditions and that such efforts have not been successful within a reasonable period of time. This requirement may be waived by a Member in the case of a national emergency or other circumstances of extreme urgency or in cases of public non-commercial use. [additional requirements concerning public non-commercial use excluded ];

  3. c. the scope and duration of such use shall be limited to the purpose for which it was authorized,…;

  4. d. such use shall be non-exclusive;

  5. e. such use shall be non-assignable,…;

  6. f. any such use shall be authorized predominantly for the supply of the domestic market of the Member authorizing such use [subject to 2003 Waiver, and Article 31bis amendment];

  7. g. authorization for such use shall be liable,…to be terminated if and when the circumstances which led to it cease to exist and are unlikely to recur. The competent authority shall have the authority to review, upon motivated request, the continued existence of these circumstances;

  8. (p.379)
  9. h. the right holder shall be paid adequate remuneration in the circumstances of each case, taking into account the economic value of the authorization;

  10. i. the legal validity of any decision relating to the authorization of such use shall be subject to judicial review or other independent review…;

  11. j. any decision relating to the remuneration provided in respect of such use shall be subject to judicial review or other independent review…;

  12. k. [more limited obligations when compulsory license as a remedy for anti-competitive use] Members are not obliged to apply the conditions set forth in sub-paragraphs (b) and (f) where such use is permitted to remedy a practice determined after judicial or administrative process to be anticompetitive. The need to correct anti-competitive practices may be taken into account in determining the amount of remuneration in such cases. Competent authorities shall have the authority to refuse termination of authorization if and when the conditions which led to such authorization are likely to recur;

  13. l. [additional conditions for “blocking patents”] where such use is authorized to permit the exploitation of a patent (“the second patent”) which cannot be exploited without infringing another patent (“the first patent”), the following additional conditions shall apply:

    1. i. the invention claimed in the second patent shall involve an important technical advance of considerable economic significance in relation to the invention claimed in the first patent;

    2. ii. the owner of the first patent shall be entitled to a cross-license on reasonable terms to use the invention claimed in the second patent; and

    3. iii. the use authorized in respect of the first patent shall be nonassignable except with the assignment of the second patent.

Article 33

Term of Protection

Term of ProtectionThe term of protection available shall not end before the expiration of a period of twenty years counted from the filing date. [footnote omitted]

Article 39

1-2 [Omitted]

3. Members, when requiring, as a condition of approving the marketing of pharmaceutical or of agricultural chemical products which utilize new chemical entities, the submission of undisclosed test or other data, the origination of which involves a considerable effort, shall protect such data against unfair commercial use. In addition, Members shall protect such data 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.

(p.380) Article 41

  1. 1. Members shall ensure that enforcement procedures as specified in this Part are available under their law so as to permit effective action against any act of infringement of intellectual property rights covered by this Agreement, including expeditious remedies to prevent infringements and remedies which constitute a deterrent to further infringements. These procedures shall be applied in such a manner as to avoid the creation of barriers to legitimate trade and to provide for safeguards against their abuse.

  2. 2. Procedures concerning the enforcement of intellectual property rights shall be fair and equitable. They shall not be unnecessarily complicated or costly, or entail unreasonable time-limits or unwarranted delays.

3-5 [Omitted]

Article 51

suspension of release by customs authorities

Members shall, in conformity with the provisions set out below, adopt procedures 13 to enable a right holder, who has valid grounds for suspecting that the importation of counterfeit trademark or pirated copyright goods14 may take place, to lodge an application in writing with competent authorities, administrative or judicial, for the suspension by the customs authorities of the release into free circulation of such goods. Members may enable such an application to be made in respect of goods which involve other infringements of intellectual property rights, provided that the requirements of this Section are met. Members may also provide for corresponding procedures concerning the suspension by the customs authorities of the release of infringing goods destined for exportation from their territories

(p.381) Article 52

application

Any right holder initiating the procedures under Article 51 shall be required to provide adequate evidence to satisfy the competent authorities that, under the laws of the country of importation, there is prima facie an infringement of the right holder’s intellectual property right and to supply a sufficiently detailed description of the goods to make them readily recognizable by the customs authorities. The competent authorities shall inform the applicant within a reasonable period whether they have accepted the application and, where determined by the competent authorities, the period for which the customs authorities will take action.

Notes:

(3) For the purposes of Articles 3 & 4, “protection” shall include matters affecting the availability, acquisition, scope, maintenance and enforcement of intellectual property rights, as well as those matters affecting the use of intellectual property rights specifically addressed in this Agreement.

(5) For the Purposes of this Article, the terms “inventive step” and “capable of industrial application” may be deemed by a Member to be synonymous with the terms “non-obvious” and “useful” respectively.

(6) This right, like all other rights conferred under this Agreement in respect of the use, sale, importation or other distribution of goods, is subject to the provisions of Article 6.

(7) “Other use” refers to use other than that allowed under Art. 30.

(13) It is understood that there shall be no obligation to apply such procedures to imports of goods put on the market in another country by or with the consent of the right holder, or to goods in transit.

(14) For the purposes of this Agreement: (a) “counterfeit trademark goods” shall mean any goods, including packaging, bearing without authorization a trademark which is identical to the trademark validly registered in respect of such goods, or which cannot be distinguished in its essential aspects from such a trademark, and which thereby infringes the rights of the owner of the trademark in question under the law of the country of importation; (b) “pirated copyright goods” shall mean any goods which are copies made without the consent of the right holder or person duly authorized by the right holder in the country of production and which are made directly or indirectly from an article where the making of that copy would have constituted an infringement of a copyright or a related right under the law of the country of importation.