Harmonization and its Discontents: A Case Study of TRIPS Implementation in India’s Pharmaceutical Sector
Author(s): Amy Kapczynski
Abstract: In 2005, India amended its patent law to provide product patents on medicines, to comply with the WTO’s TRIPS Agreement. In order to mitigate the impact on access to medicines, India at the same time adopted an expansive menu of flexibilities in its patent law. Reviewing these important flexibilities, some of which are entirely novel, this article argues that at a formal level TRIPS leaves developing countries far more policy space than is commonly recognized. But while TRIPS as a formal matter cannot produce deep harmonization, it nonetheless channels a strong harmonizing force, because it inserts countries into a transnational circuit that fills in the gaps in the Agreement and that works against the use of TRIPS flexibilities. Limits on administrative resources, the influence of transnational legal networks, and the threat of unilateral retaliation from high-protection jurisdictions all make it difficult for countries like India to implement an autonomous vision of patent law.
The paper also identifies compensating strategies that may facilitate the effective use of TRIPS flexibilities, responding to the transnationalized pressures that TRIPS implementation sets up. I call these strategies fragmentation, mimicry, and counter-harmonization. As I demonstrate, counter-harmonization shows the most promise for developing countries, because it offers countries safety in numbers, can lower the administrative costs of implementing an alternative patent law, and can generate a transnational legal counterculture.
Lastly, the paper engages with the literature about the implications of the legalization of the global trading regime. The case study offered here suggests that legalization cannot simply be identified, as some prominent trade law scholars have argued, with the substitution of politics for principle, and with the leveling of power differences between states. It also suggests a new perspective on the debate over whether the WTO has a “constitutional” form, and if so, what this means. To date, those who claim a constitutional nature for the WTO have identified that nature with a move beyond politics. The analysis offered here suggests that if the WTO has a constitutional nature, it lies in its capacity to mobilize and channel, rather than to suppress or transcend, political disagreement.
Keywords: intellectual property law, patent law, India, pharmaceuticals, access to medicines, TRIPS, harmonization