Part I: The Legal Framework
2.4 Interpretation of Pharmaceutical Patent Rights under the TRIPS Patent
2.4.2 General Provisions and Basic Principles under Part I TRIPS
2.4.2.3 Articles 7 and 8, and the Preamble: Objectives and Principles
The objectives and principles of TRIPS are established in the agreement’s preamble, as well as in its main provisions in Articles 7 and 8, indicating that the objectives and principles are aimed at creating direct rights and obligations.147 This is of major importance, as it elevates the scope of the principles and objectives from being merely interpretative guidelines148 to being an integral part of the agreement itself.
Generally speaking, by reflecting the intentions of the negotiating parties, the preamble of TRIPS is of particular relevance for identifying the agreement’s teleological purpose. In regard to the relation between the patentability of medical products and the right to health, paragraphs 1, 4, 5, and 6 of the preamble are of particular relevance for the context of this thesis. Paragraph 1 establishes the main purpose of the TRIPS IP regime as the reduction of ‘distortions and impediments to international trade’ by promoting ‘effective and adequate protections’ of IP rights, recognising, however, the possibility that excessive IP protection can become a barrier to legitimate trade itself.149 This acknowledgement reaffirms that the protection of IP rights is not an end in itself. According to the WTO Agreement, the WTO rather aims to promote trade and economic development, and not merely the protection of private interests of rights holders.150 In this regard, paragraph 4 of the preamble of TRIPS defines IP rights as private rights, which can be of importance when these private rights have to be balanced against greater public interests, such as the protection of public health.151 In this consideration, paragraph 5 of the preamble recognises that IP rights are subject to
‘public policy objectives’ of WTO member states, including, inter alia, developmental objectives.152 Paragraph 6 of the preamble then further recognises the special needs of
147 UNCTAD-ICTSD (n 35) 118-119.
148 The preamble of an agreement commonly reflects the nature of negotiations and elaborates the intention of the parties entering such negotiations. In this consideration, a preamble provides interpretative guideline for the implementation of an agreement and the settlement of disputes in cases of ambiguity. This is in accordance with Article 31(2) VCLT which stipulates that the preamble is an integral part for the purpose of interpreting a treaty, as the context shall comprise, inter alia, the text of the treaty, including its preamble and annexes. See thereto: UNCTAD-ICTSD (n 35) 2; VCLT (n 65) Article 31(2).
149 TRIPS Agreement (n 32) Preamble para 1; cf. Gervais DJ, The TRIPS Agreement (n 129) para 2.10.
150 UNCTAD-ICTSD (n 35) 10.
151 TRIPS Agreement (n 32) Preamble para 4; Gervais DJ, The TRIPS Agreement (n 129) para 2.11.
152 TRIPS Agreement (n 32) Preamble para 5.
68 LDCs, and the necessity of maximum flexibility for the domestic implementation of the TRIPS Agreement.153
In essence, the preamble of the TRIPS Agreement thus indicates that IP rights serve a higher purpose than the simple protection of rights holders. By promoting innovation, IP rights should particularly facilitate international trade and economic development, and thereby, in accordance with the core objective of the WTO, improve standards of living.154 In this consideration, the preamble confirms the need to strike a balance between the protection of IP rights and free trade, between the developed world and developing countries, and, not least, between private IP rights and higher public interests.155
The necessity to balance rights and obligations is therefore explicitly integrated in the main text of the TRIPS Agreement, in Article 7. It must be noted, however, that while TRIPS quite clearly defines the rights of IP rights holders, concomitant obligations are commonly not further elaborated by the agreement.156 The general existence of obligations is nevertheless confirmed by Article 7, which outlines the objectives of the agreement, providing:
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 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.157
This provision again reaffirms that IP rights under TRIPS are not an end in themselves, but that they are a means to achieve the objectives set out in Article 7.158 In particular, the promotion of innovation, and the transfer and dissemination of technology should serve wider public policy objectives, including social and economic welfare.159 The use of the term ‘should’ in Article 7, however, indicates that IP rights do not automatically fulfil these objectives.160 In this respect, it is of vital importance that the national implementation of the TRIPS Agreement is conducted in a manner that gives
153 ibid Preamble para 6.
154 cf. UNCTAD-ICTSD (n 35) 13.
155 Gervais DJ, The TRIPS Agreement (n 129) para 2.12.
156 Correa CM, A commentary on the TRIPS Agreement (n 129) 101.
157 TRIPS Agreement (n 32) Article 7.
158 UNCTAD-ICTSD (n 35) 125-126.
159 Correa CM, A commentary on the TRIPS Agreement (n 129) 94.
160 UNCTAD-ICTSD (n 35) 126.
69 effect to an adequate balance of private and public interests.161 This is of particular importance, as IP rights are liable to impact on the enjoyment of human rights. While the UN argues that the WTO is bound by human rights laws, human rights concerns are not directly expressed by the TRIPS Agreement.162 This could be remedied by a balanced implementation of the agreement, which should therefore pay due regard to human rights considerations in domestic IP laws.
While Article 7 indicates the importance of striking a balance, the TRIPS Agreement does not further elaborate on the ways in which an adequate balance can be achieved.163 Consequently, Article 7 must be seen as a guideline providing context for the interpretation of other TRIPS provisions.164 This was confirmed by the WTO panel in the Canada – Patent Protection of Pharmaceutical Products case,165 and further reaffirmed by the Doha Declaration providing in Paragraph 5(a) that ‘each provision of the TRIPS Agreement shall be read in light of the object and purpose of the Agreement as expressed, in particular, in its objectives and principles’, i.e. Articles 7 and 8.166 Therefore, Article 7 is of particular relevance for the interpretation of insufficiently defined obligations and exceptions, and undefined terms,167 as well as for establishing whether the current international patent regime can be regarded as justified in chapter 4.
Article 8 TRIPS establishes the core principles of the agreement. To this end, Article 8(1) explicitly facilitates the adoption of internal measures168 for the protection of public health, further referring to sectors of vital importance to socio economic development, providing:
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.169
161 ibid.
162 Correa CM, A commentary on the TRIPS Agreement (n 129) 99-100.
163 ibid 101.
164 ibid 93.
165 cf. ibid 93-94.
166 Doha Declaration (n 64) Paragraph 5(a); cf. Correa CM, A commentary on the TRIPS Agreement (n 129) 103.
167 Correa CM, A commentary on the TRIPS Agreement (n 129) 94-95.
168 cf. UNCTAD-ICTSD (n 35) 126.
169 TRIPS Agreement (n 32) Article 8(1).
70 Similar to Article 8(1), Article 8(2) TRIPS allows for the adoption of measures to prevent or remedy the abuse of IP rights by rights holders, provided that such measures are consistent with the provisions of the TRIPS Agreement.170
Article 8 is more strongly formulated than Article 7 and, contrary to Article 7, allows members to take specific action.171 WTO member states have considerable leeway in implementing Article 8(1), as TRIPS leaves the scope of the term ‘public interest’
undefined.172 However, any action taken under the provisions of Article 8 has to be necessary to achieve the stated purpose,173 and must be administered in the form of laws or regulations.174 While the adopted measures have to be consistent with the provisions of the TRIPS Agreement, it seems that Article 8 at least allows for the maximum use of the flexibilities and exceptions provided for by TRIPS.175 To assess the legitimacy of a measure taken under Article 8, Article 7 and the preamble have to be taken into consideration, with particular regard to the requirement of striking a balance between rights and obligations, and socio-economic welfare.176 Nothing in the TRIPS Agreement should then prevent members from protecting public health or promoting other vital public policies as defined in Article 8, so long as the measures are adopted in good faith.177
This interpretation was reaffirmed by paragraph 4 of the Doha Declaration, stipulating
‘that the TRIPS Agreement does not and should not prevent Members from taking measures to protect public health’, and ‘that the Agreement can and should be interpreted and implemented in a manner supportive of WTO Members’ right to protect public health and, in particular, to promote access to medicines for all.’178 Thereby, as indicated above in 2.3, the Doha Declaration made public health a stated purpose of the TRIPS Agreement.179 It has been further argued that legitimate measures for the protection of public health and the public interest are not limited to the flexibilities and exceptions provided by the TRIPS Agreement, but may include
170 cf. Correa CM, A commentary on the TRIPS Agreement (n 129) 110; UNCTAD-ICTSD (n 35) 127.
171 Gervais DJ, The TRIPS Agreement (n 129) para 2.123.
172 Correa CM, A commentary on the TRIPS Agreement (n 129) 105.
173 Gervais DJ, The TRIPS Agreement (n 129) para 2.124.
174 Sellin J (n 35) 168.
175 cf. Correa CM, A commentary on the TRIPS Agreement (n 129) 104.
176 ibid.
177 ibid; UNCTAD-ICTSD (n 35) 127.
178 Doha Declaration (n 64) Paragraph 4.
179 Correa CM, A commentary on the TRIPS Agreement (n 129) 109.
71 other measures related to the use of IP rights as well.180 In this regard, the purpose of paragraph 4 of the Doha Declaration indicates that certain derogations from TRIPS provisions seem to be justified if they serve the purpose of Article 8.181 The Doha Declaration, however, does not explicitly provide that TRIPS provisions may be overridden, but rather stipulates that a maximum use of flexibilities and exceptions provided for in TRIPS must be available for the protection of public health, with the agreement’s objectives and principles determining their justification.182 Therefore, Article 8 itself does not justify the creation of new exceptions.183 Article 8 thus rather provides a rationale for the flexibilities and exceptions provided by TRIPS, and, like Article 7, constitutes an interpretative guideline.184
In summary, Articles 7 and 8 stipulate the right of WTO members to implement the