Expand Document  |  Expand Chapter  |  Full TOC  |  Printable HTML version
Implications of the Doha Declaration on the Trips Agreement and Public Health - Health Economics and Drugs Series No. 012
(2002; 56 pages) [French] [Spanish] View the PDF document
Table of Contents
View the documentForeword
View the documentAcknowledgements
View the documentAbbreviations and acronyms
View the documentExecutive summary
View the documentIntroduction
View the documentScope
View the documentThe role of TRIPS and IPRs
Open this folder and view contentsPublic health measures
Open this folder and view contentsFlexibility in TRIPS
Open this folder and view contentsMembers with insufficient or no manufacturing capacities
View the documentTransfer of technology to LDCs
View the documentExtension of transitional period for LDCs
View the documentSpecial treatment under TRIPS
View the documentLegal status of the Doha Declaration
View the documentIssues not covered in the Declaration
View the documentConclusions
View the documentAnnex 1 - Doha Declaration on the TRIPS Agreement and Public Health
View the documentAnnex 2 - Levels of development of pharmaceutical industry, by country
View the documentReferences
 

Extension of transitional period for LDCs

The Doha Declaration permits LDCs to opt for an extension of the transitional period provided for under Article 66.1 of the TRIPS Agreement. Paragraph 7 establishes the grounds for an extension of the transitional period for LDCs107 in relation to pharmaceutical patents only. It contains a “duly motivated request” - in the terms of Article 66.1 of the TRIPS Agreement108 - on the basis of which the Council for TRIPS must give effect to that extension. LDCs do not need to individually follow the procedure provided for under Article 66.1 to enjoy this period. The Declaration, however, explicitly preserves the right of LDCs to request extensions for other matters (not related to pharmaceutical patents) in accordance with Article 66.1’s procedure109, without diminishing their right to request further extensions for pharmaceutical patents after 2016.

107 Though this paragraph does not amend Article 66.1 of the Agreement, it does innovate with regard to the procedure applicable for the extension of the transitional period for LDCs.

108 TRIPS Article 66.1. “In view of the special needs and requirements of least-developed country Members, their economic, financial and administrative constraints, and their need for flexibility to create a viable technological base, such Members shall not be required to apply the provisions of this Agreement, other than Articles 3, 4 and 5, for a period of 10 years from the date of application as defined under paragraph 1 of Article 65. The Council for TRIPS shall, upon duly motivated request by a least-developed country Member, accord extensions of this period”.

109 In fact, it would have seem more logical to extend the transitional period for all fields of technology since, unless individual extensions are accorded, LDCs would be required anyway to bear the costs of granting patents in other sectors.

This extension applies to “pharmaceutical products”. However, the protection conferred to a patented process encompasses, according to Article 28.1 (b) of the TRIPS Agreement, the protection of the products directly obtained with such process. Hence, the extension of the transitional period should also be deemed to apply to process patents110. Likewise, extension would apply to cases involving a second indication of a pharmaceutical product, since claims are generally drafted in these cases as product claims on the basis of the “Swiss-claims” formulation111.

110 This is also the interpretation of the European Commission, who held that “all least developed Members benefit from the extension of the transition period from 1.1. 2006 to 1.1.2016 (and probably beyond) with regard to product and process patent protection and its enforcement” (European Commission, 2001, p. 4). Also note that the USA delegation, while submitting their proposal for paragraph 7 at the Doha Ministerial Conference did not refer to product patent protection only: “We recommend granting the least-developed countries a 10-year extension to 2016, to come into full compliance with pharmaceutical-related patent obligations under TRIPS” (emphasis added). See also Vandoren, 2002, p. 10.

111 See Correa (2000c).

The extension of the transitional period applies in relation to Sections 5 (patents) and 7 (undisclosed information) of Part II of the TRIPS Agreement, and to the enforcement of such rights.

An important practical aspect is to determine which are the LDCs that can effectively benefit from paragraph 7 of the Doha Declaration. Out of thirty African LDCs, only two112 do not currently grant patents for pharmaceuticals113. These would be, in principle, the only African LDCs that can benefit from this paragraph, unless they amend their legislation.

112 Angola and Eritrea. See Thorpe, 2002 forthcoming.

113 The majority of non-African LDCs also seem to confer patent protection for pharmaceutical products, due to the application of their ex-metropolis’ legislation (personal communication from WIPO).

Twelve out of the 34 African LDCs are members of the Organisation Africaine de la Propriété Intellectuelle (OAPI) and 10 of the African Regional Industrial Property Organization (ARIPO).

Table 3 indicates that 12 out of the 16 members of OAPI are LDCs. Figure 1 illustrates the patents granted by OAPI over a year period from 1984 to 1996. Also indicated is the proportion of these patents relating to pharmaceuticals114. Figure 1 shows the increase of the number of patents granted in such fields since 1991.

114 The data include patents classified under IPC classification mark A61K (preparations for medical, dental, or toilet purposes) or having a corresponding patent filed elsewhere classified under mark A61K. Since medicinal-related inventions can also be classified under other marks, the figures shown should only be taken to represent the bottom end of possible medicinal-related patents.

Table 3

Current membership of OAPI

Benin

Burkina Faso

Cameroon

Central African Republic

Chad

Congo

Côte d’Ivoire

Equatorial Guinea

Gabon

Guinea

Guinea Bissau

Mali

Mauritania

Niger

Senegal

Togo

[Countries in italics are United Nations designated Least Developed Countries (LDCs)]

There are 10 LDCs among ARIPO’s members (see Table 4). Figure 2 illustrates the patents granted by ARIPO from 1985 to 1999115.

115 Also indicated is the proportion of these patents classified under IPC classification mark A61K (preparations for medical, dental, or toilet purposes) or having a corresponding patent filed elsewhere classified under mark A61K.

Table 4

Current Membership of ARIPO

Botswana

Gambia

Ghana

Kenya

Lesotho

Malawi

Mozambique

Sierra Leone

Somalia

Sudan

Swaziland

United Republic of Tanzania

Uganda

Zambia

Zimbabwe

 

[Countries in italics are United Nations designated Least Developed Countries (LDCs)]


Figure 1. Patents Granted by OAPI


Figure 2. Patents Granted by ARIPO

LDCs that already grant pharmaceutical patents could, however, amend their legislation and not grant product patents until 2016116, since they are not constrained by the “freezing clause” of Article 65.5 of the TRIPS Agreement.

116 Such a change, where possible, is likely to raise some complex legal issues under the relevant national laws, including of a constitutional nature. In the case of the LDCs members of OAPI, the use of the additional traditional period would require the amendment of the Libreville Agreement of 1962 (amended in 1977 and 1999). The OAPI establishes a uniform law and a centralized system of examination and registration. In contrast, the African Industrial Property Organization (ARIPO), provides for a centralized system of examination and registration, but it does not establish a common regional law and all designated States are given a chance to refuse an application before granting by the Regional Office. See, e.g., Chirambo, 2002.

Another crucial point is whether LDCs will be obliged to grant exclusive marketing rights (EMRs) under Article 70.9 of the TRIPS Agreement during the extended transitional period117. Paragraph 7 does not explicitly exclude the application of that provision. If LDCs were bound to grant EMRs118, the value of the concession made by the Doha Declaration to LDCs would be very limited, since access to medicines and other products could be effectively blocked for at least five years.

117 TRIPS Article 70.9. “Where a product is the subject of a patent application in a Member in accordance with paragraph 8(a), exclusive marketing rights shall be granted, notwithstanding the provisions of Part VI, for a period of five years after obtaining marketing approval in that Member or until a product patent is granted or rejected in that Member, whichever period is shorter, provided that, subsequent to the entry into force of the WTO Agreement, a patent application has been filed and a patent granted for that product in another Member and marketing approval obtained in such other Member”.

118 Article 70.8 makes it clear that its application (and that of Article 70.9 which provides for EMRs) proceeds “notwithstanding the provisions of Part IV” which includes Article 66.1.

An alternative interpretation for paragraph 7 is possible. Since EMRs do not constitute a category of intellectual property rights (as enumerated in Article 1.2 of the TRIPS Agreement), the granting of such rights only provides one way of enforcing foreign patent rights. As mentioned, paragraph 7 exempts LDCs from the enforcement of rights provided for in accordance with the patents section of the TRIPS Agreement. Under this interpretation, LDCs would be exempted from compliance with Article 70.9.

In addition, in relation to those LDCs that did grant patent protection for pharmaceutical products as of the entry into force of the WTO Agreement119, the chapeau of Article 70.8 of the TRIPS Agreement makes it clear that the mailbox obligation applies to members that did “not make available as of the date of entry into force of the WTO Agreement patent protection for pharmaceutical and agricultural chemical products.” Article 70.8, literally interpreted, means that those LDCs who granted such a protection would not be subject to the obligation to grant exclusive marketing rights.

119 January 1, 1995.

 

to previous section
to next section
 
 
The WHO Essential Medicines and Health Products Information Portal was designed and is maintained by Human Info NGO. Last updated: March 20, 2014