The Differentiation Principle: a Tool for Instrumentalist Application of IP Laws and Policies and Policies

Differentiation is based on the theory that laws and policies cannot be assessed in a vacuum, but must be considered in the context to which they apply.¹⁷² The principle of differentiation states that the law should not be applied to parties that are dissimilar in the same manner, but must be interpreted and applied in a manner that recognises and accommodates such differences.This principle allows for more flexible interpretation of IP regulation, where not just the ordinary meaning, but also the specific context in which the law is applied, are taken into account in implementing its provisions.¹⁷³ This allows for IP regulation to be applied in different ways in order to achieve diverging goals.

170 UN Gen. Ass., ILC Study Group Report, 58^th Session, 13th April, 2006, A/CN.4/L, 682, at 23, para. 34.

171 Shann Kerner et al, “Examples Requirements for Patentability of Inventions in U.S. and Foreign Jurisdictions”

(2009) 3:36 Bloomberg Law Reports-Intellectual Property, at 1.

172 Joyeta Gupta & Nadia Sanchez, “Elaborating the common but differentiated principle in the WTO”, in Marie-Claire Segger & C.G. Weeramantry, eds., Sustainable Development in the Decisions of International Courts and Tribunals: 1992-2012 (New York: Routledge, 2017) 425-441, at 425 [Gupta & Sanchez, Elaborating the common but differentiated principle in the WTO].

173Wei Zhuang, Intellectual Property Rights and Climate Change: Interpreting the TRIPS Agreement for Environmentally Sound Technologies (Cambridge: Cambridge University Press, 2017) 80-81 [Zhuang, IPR and Climate Change].

The WTO TRIPS Agreement provides for differential application of IP regulation in sectors like public health and biodiversity, developing countries and LDCs, and in implementation of the treaty.¹⁷⁴ The goal of differentiation is to promote equity and substantive equality between developing and developed countries, so as to give effect to IPRs objectives, rather than mere formal application of the law.¹⁷⁵

TRIPS Article 27.1 permits differentiation, for food security purposes, where the diffusion of certain plant technologies, such as the sterilization of seeds, may have negative effects on health or the environment. TRIPS Article 27.3(b) contains a specific exception that is linked to biological processes relevant to agricultural production. The provision allows the exclusion from patentability of "essentially biological processes" for the production of plants. In the absence of any definition in TRIPS itself, the exclusion for plant production can be interpreted in broad terms, inclusive of plants as well as plant varieties and species.Countries that opt to implement this exception may exclude plants, whether obtained through conventional breeding processes or through the use of genetic engineering, from IP protection. ¹⁷⁶

Article 27.2 TRIPS provides for the possibility of refusing patents for inventions the commercial exploitation of which is "necessary to protect public order or morality, including to protect human, animal or plant life or health or to avoid serious prejudice to the environment."¹⁷⁷ The Doha Declaration on TRIPS and Public Health affirms that the TRIPS Agreement allows for differential implementation of its provisions in order to promote public health.¹⁷⁸ Though the Declaration is not legally binding, as a subsequent WTO agreement, it confirms the need for

174 TRIPS arts 27, 30, 66, 67.

175 Zhuang, supra note 173.

176 Correa, “TRIPS Flexibility for Patents and Food Security”, supra note 47.

177 [Emphasis added].

178 Doha Declaration, Paras 1-7.

flexible and balanced interpretation of IP regulations and policies so as to advance food security as a component of public health.

Article 27.3(b) TRIPS makes the provision of some form of protection for plant varieties mandatory but does not impose a specific framework by which such protection should be granted.

This allows countries flexibility to adopt sui generis frameworks specifically designed to regulate PVP domestically. This provides developing countries an opportunity to develop IP laws and policies relating to plant varieties that take into account food security interests at the national level and state’s commitments to other international agreements.

Under differentiation, IP norms can be adapted by developing countries to suit their contexts.¹⁷⁹ Such differentiation will not amount to discrimination, for paras 44 and 50 of the Doha Declaration institutes the principle of special and differential treatment for developing and least developed countries as part of the WTO Agreements. A glance at contemporary jurisprudence indicates that countries are becoming more adoptive of such flexibilities. For example, India has adopted this line of reasoning in revoking claims of patent infringement.¹⁸⁰ Similarly, in South Africa the Monsanto case¹⁸¹ considered whether alpha tocopherol acetate, a synthetic Vitamin E, is an “oil” within the meaning of the term as used in the patent regulation. If it was, the respondent was infringing the patent. In its decision the South African Supreme Court held the patent to have been infringed because the substance in dispute fulfilled the same objective as an oil, though it did not fulfill the technical description of the term in the regulation. In effect the court adopted a contextual and purposive approach to statutory interpretation. As South Africa’s Supreme Court

179 Rochelle Dreyfuss & Susy Frankel, “From Incentive to Commodity to Asset: How International Law is Reconceptualizing Intellectual Property” (2015) 36:4 Michigan Journal of International Law 557, at 565-566.

180 See Lynne Taylor, “India Revokes Roche’s Patent on Pegasys”, Pharma Times Digital Magazines (5 November 2012), online: <http://www.pharmatimes.com/news/india_revokes_roches_patent_on_pegasys_976312> (assessed:

28 July2015). [Taylor, India Revokes Roche’s Patent on Pegasys].

181 Monsanto Co v MDB Animal Health (Pty) Ltd (formerly MD Biologics CC), 2001 (2) 887 (SCA).

emphasized in another decision, “A patent specification should be given a purposive construction rather than a purely literal one.”¹⁸²

Adoption of the contextualization principle in international IP regulation is demonstrated by the fact that special forms of legal protection have been recommended in the WTO’s Doha Declaration to protect public health. IP agreements are also interrelated with various other multilateral treaties, whose interests may require different interpretations and contextualisation of IP rules. It is important to remember that there has been a reluctance to utilize TRIPS flexibilities in IP jurisprudence, due to state’s lack of political will and the economic influence of process by multinational corporations, which indicates that making them effective will require more than just regulations.¹⁸³ However, such political and economic challenges are surmountable by countries through adopting strategic IP policies.¹⁸⁴

Previous studies indicate that patents and PBRs only aid development when certain contextual conditions exist. Consequently, the optimal method for applying IP regulation to advance food security will vary based on the socio-economic development levels of each country.¹⁸⁵ In order to integrate different interests, an IP system must provide countries with flexibility as to how they meet their patent obligations. Differentiation necessitates consideration of general international law covering human rights, sustainable development, and biodiversity in

182 See Aktiebolaget Hassle & Astrazeneca Pharmaceuticals Ltd vs. Triomed Ltd (2002) The Supreme Court of Appeal of South Africa, 63/2002, at par. 8.

183 Keith E. Maskus & Jerome H. Reichman, “The Globalization of Private Knowledge Goods and the Privatization of Global Public Goods” (2004) 7:2 Journal of International Economic Law, 279 at 286-287.

184 Jerome H. Reichman, “Compulsory Licensing of Patented Pharmaceutical Inventions: Evaluating the Options”

(2009) 37:2 Journal of Law, Medicine & Ethics, 247 at 249-250 [Reichman, Compulsory Licensing]; Keith E.

Maskus & Jerome H. Reichman, “The Doha Round’s Public Health Legacy: Strategies for the Production and Diffusion of Patented Medicines under the Amended TRIPS Provisions” (2007) 9:1 Journal of International Economic Law, 921.

185 Antony S. Taubman, “TRIPS jurisprudence in the balance: Between the realist defence of policy space and a shared utilitarian ethic” in Christian Lenk et al, eds, Ethics and law of IP: Current problems in politics, science and technology (Burlington, VT: Ashgate, 2007) 89-120.

interpreting IP provisions. The need for a holistic interpretation was emphasised by the report of the UN Special Rapporteur on the right to food, where he proposes agroecology as a solution to global food security challenges.¹⁸⁶

In relation to food security, applying the differentiation principle in drafting frameworks for IP regulation offers the following advantages: Firstly differentiation grants countries the prospect of moving from focusing on the benefits to be obtained from the commercial exploitation of new varieties of plants, to considering important public interest objectives like the attainment of local, national, and regional food security, by adopting measures to increase food production, diversity, and equitable systems for food distribution. Secondly, under differentiated regimes countries can integrate their interests and obligations under other relevant treaties like the CBD, ITPGRFA and ICESCR. Such interests include the promotion of plant varieties adapted to local climate conditions, social contexts, and culinary preferences. Thirdly, differentiated regimes provide an opportunity to go beyond the rights framework provided under TRIPS, to allow consideration and enforcement of rights relevant to food security such as farmers’ rights, the protection of traditional knowledge, and access and benefit sharing schemes.¹⁸⁷

TRIPS also provides for differentiation through exceptions to IP law. For example, Article 30, the general exception clause, may be interpreted in accordance with customary principles of interpretation provided in Article 31 of the Vienna Convention on the Law of Treaties (VCLT), to permit governments to introduce exceptions to IPRs, suitable to accomplish the multiple social,

186 Schutter Report 2010, supra note 12.

187 Philippe Cullet, Food Security and Intellectual Property Rights in Developing Countries (Geneve: RIBios et IUED, 2004), at 56-57.

economic, and environmental objectives of the agreement, including interests connected with human rights like the right to food and food security.¹⁸⁸

TRIPS allows for special and differential treatment of countries based on their classification as developing countries and LDCs. Article 66 grants least developed countries (LDCs) extra time within which to adopt TRIPS obligations and calls for WTO developed countries to provide incentives to companies and institutions in their territories, so as to encourage technology transfer to the LDCs. Also, Article 67 TRIPS obliges the developed member states to provide technical and financial support to developing and least-developed countries, in order to execute the agreement.

Under Article 1.1 of the TRIPS agreement WTO Members may adopt different interpretations, in their national law and practice, of concepts that the TRIPS Agreement simply enunciates but does not define. Examples of such flexibilities include concepts such as novelty and inventiveness; or of situations of extreme urgency for the purposes of compulsory licenses.¹⁸⁹ Articles 7 & 8(1) TRIPS affirm that IPRs are granted to achieve certain public purposes. As the food security objectives of countries differ, these provisions allow for some variation between states in applying IP protection.

The above provisions emphasize the acceptance of differentiation in international IP regulations, and the need not to treat all subjects or objectives of IP law in a similar manner. The first question that will come to mind is whether such an approach can be integrated with the need for consistency and predictability in international law? The first response to this question is that

188 Edson B. Rodrigues Jr, The General Exception Clauses of the TRIPS Agreement: Promoting Sustainable Development (Cambridge: Cambridge University Press, 2012) at 327 [Rodrigues, TRIPS General Exception Clauses].

189 WIPO, “Advice on Flexibilities Under the TRIPS Agreement” online: <http://www.wipo.int/ip-development/en/legislative_assistance/advice_trips.html>.

where differentiations are made to allow the law to function in changing contexts, such variations are not against the consistency requirement. ¹⁹⁰ Secondly, IP regulation requires the recognition and equal consideration of other rights contained in non-IP regimes. Because the relationship between international agreements is constantly changing, this justifies the adoption of dynamic legal frameworks.¹⁹¹ The second question that will come to mind is how can the various soft and hard laws that govern IP and food security related interests be combined in a differentiated approach? The thesis posits that while soft laws are not binding upon states, they can be drawn upon because they reflect the consensus and aspirations of states on issues. Though all laws do not carry equal weights, they are still relevant for consideration in shaping differentiated IP frameworks. The manner in which this may be done is analyzed in sections 2.4 and 3.4 of the thesis.

Considering the unique nature of the factors necessary for food security in West African countries, it is important to allow for differential application of IPRs for food security purposes.

Chapter two examines in detail how much scope is provided for differentiation in the international IPRs regime.