II. Brazil challenges the established global IPR framework.

• Author: Kogan, Lawrence A.

1. BRAZIL ACTIVELY ENGAGES IN 'REGIME SHIFTING' TO REFORM INTERNATIONAL IP LAW

   The Notion of 'Regime-Shifting'

   Brazil and other developing countries that have become dissatisfied with the WTO TRIPS Agreement and the American capitalist economic model of 'risk and reward' which serves as the basis for the current international intellectual property framework, are now employing, with the assistance of a well funded global civil society (activist NGOs), a strategy known as "regime shifting'. International environmental and human rights activists enamored of the socialist model of sustainable development have already used this strategy successfully in other venues. (119) NGOs, for one, "have proposed to curtail intellectual property rights in one international forum after another, whether or not IP was the main issue: the WTO, WIPO, UNESCO's proposed Convention on Cultural Diversity, the UN's World Summit for the Information Society, the WHO, and others." (120) Brazil et al. have engaged in regime shifting despite the overall mutual and balanced concessions they agreed to and the specific IPR-related bargains they reached previously at the Uruguay Round of trade negotiations leading to the consummation of the WTO Agreements. And they are doing so under the guise of 'harmonizing" international law.

   These protagonists hope to reform WTO law from within and to develop simultaneously new customary international law norms beyond the WTO regime that can eventually swallow up the general principles, norms, and rules that comprise the corpus of WTO IP law. In other words, if the international community of nations permits regime shifting to occur, the temporary and provisional exceptions and derogations (e.g., compulsory licensing) to the general role of strong intellectual property right protection made expressly available in the TRIPS Agreement will ultimately overtake and subsume the general rule. (121 122 123 124) * This would result in the establishment of a new treaty-based presumption against the adoption of strong international IP protections, along with a reversal of the burden of proof to show harm--from the party challenging PP protections to the party defending them. Thus, "higher standards of [IP] protection ... [would] only [be allowed] when it is clearly necessary ... and where the benefits outweigh the costs of protection." (125) Arguably, the ostensible public health and knowledge goals that Brazil and other nations, such as Argentina, assert as being the primary motivation behind such regime shifting, are likely overshadowed by their more ambitious but less transparent economic and trade policy (protectionist) objectives. More importantly, however, opportunistic activities like these further challenge international confidence in the foundations of GATT-WTO law, increase transaction costs, raise international political and economic tensions and only weaken the resolve of nations to pursue international trade, scientific and technological advancement to eradicate poverty and to maintain international peace and security--the original goal of the Bretton-Woods system. (126 127)

   According to one international law export, IPR regime shifting has essentially entailed the

   "shift[ing of] negotiations and hard and soft lawmaking initiatives [from the TRIPS Agreement] to four [other] international legal regimes those governing biodiversity, plant genetic resources, public health and human rights--whose institutions, actors, and subject matter mandates are more closely aligned with these countries' interests. Within these four regimes, developing countries are questioning established legal prescriptions and generating new principles, norms, and rules of intellectual property protection for states and private parties to follow. Intellectual property regime shilling thus heralds the rise of a more complex international environment in which seemingly settled treaty bargains are contested and new dynamics of lawmaking and dispute settlement must be considered." (128)

   He explains, furthermore that, "regimes are broader than specific treaties or organizations ... [and] ... reflect[] the fact that states (and, increasingly, non-state actors) can cooperate without creating formal institutions or legally binding commitments." (129)

   Substantively speaking, regimes consist of principles, norms and rules. In the context of IPRs,

   "The principles ... include recognition of state-created private property in abstract intangible objects that embody human innovation and creativity and the need to protect that property from unauthorized exploitation across national borders. The norms ... include an obligation for states to create legal monopolies (in the form of exclusive rights controlled by private parties) that generate incentives for human innovation and creativity and to allow foreign creators and inventors to market their products in different national jurisdictions on equal footing with local creators and inventors ... [The] ... rules encompass the specific prescriptions and proscriptions by which these principles and norms are given effect, such as the most favored nation and national treatment rules, specific exclusive rights and minimum standards of protection, and coordinated procedural mechanisms or priority rules." (130)

   International regimes also have an institutional component. They "consist of the cooperative arrangements states use to create principles, norms and rules," and can range from highly structured intergovernmental organizations with staffs, facilities and budgets to informal networks of government officials who exchange information and coordinate national policies with each other. (131)

   Regime rules often flow from power politics and reflect the national interests of stronger and more influential states. Yet, power alone does not determine how international regimes subsequently evolve. Intergovernmental organizations and international institutions have played an increasing role in limiting the actions of stronger and more influential states. This has afforded weaker states and non-state actors greater latitude to influence the development of principles, norms and rules. (132) Consequently, the distributions of power among different nations present at the inception of a given regime are not likely to serve as a good predictor of how that regime will later evolve. (133)

   Indeed, relatively weaker states such as Brazil, may lead other less developed countries, together with non-state actors (i.e., nongovernmental organizations (NGOs), activists, etc.) to deliberately alter the status quo ante by moving treaty negotiations, lawmaking initiatives or standard setting activities from one international venue to another through a process known as 'forum shopping'. For example,

   "A powerful state unable to realize its objectives through treaty negotiations may shift to domestic lawmaking and enact rules with extraterritorial effects that have much of the same effect. Similarly, states may operate in multiple domestic and International for a, moving back and forth between venues ... or pursuing parallel lawmaking agendas simultaneously." (134)

   Alternatively, or in addition thereto, weaker states and non-state actors may endeavor to alter the substantives principles, norms and rules of a particular regime by generating "'counter-regime norms' binding treaty rules and non-binding soft law standards that seek to alter the prevailing legal landscape." (135)

   "Disadvantaged actors may articulate counter-regime norms that only incrementally modify existing rules but leave uncontested the broader principles from which these rules emanate. A state or an NGO might, for example, object to treaty obligations that require recognition of specific types of patentable subject matter or that narrow exceptions or limitations to a patentee's exclusive rights without questioning the broader goals that a patent system serves. In other instances, counter-regime norms may be revolutionary rather than evolutionary, posing more fundamental challenges to underlying principles. [States and non-state actors that] question the economic and social benefits of granting intellectual property rights to foreign creators and inventors are asserting norms that fall into this latter category" (emphasis added). (136)

   States and non-state actors may affect change through proposals or amendments within the regime whose principles, norms, and rules they are challenging, or they may decide to shift to a different regime altogether in the event they encounter significant resistance. This decision usually entails a comparative analysis of the participating states and their level of influence, the lawmaking methods, the monitoring and dispute settlement procedures, and the relative roles of intergovernmental institutions and nongovernmental organizations. (137) Since many of the same state and non-state actors may participate in multiple regimes simultaneously, once-distinct regimes have grown interdependent over time, and regimes no longer focus singularly on isolated well-defined issues, regime shifting has become anything but an orderly process. To the contrary, it has become more difficult to ascertain a given regime's boundaries, and thus, to decide whether to shift regimes at all. (138)

   IPR Regime Shifting from TRIPS to UNHRC and WHO

   The WHO, an intergovernmental organization, has been responsible for creating principles, norms, and rules concerning the subject of public health. Its norm building activities have focused during the past thirty years on pharmaceuticals. It introduced the concept of 'essential drugs' and urged its member nations to adopt 'national drug policies'. The WHO first became concerned with intellectual property fights during 1996. This followed the enactment of the WTO TRIPS Agreement, which imposed expanded obligations on states to protect pharmaceutical patents. (139) Since that time, it has produced several...