The Ostensible 'Flexibilities' in Trips: Can Essential Pharmaceuticals Be Excluded from Patentability in Public Health Crises?

The requirement that a country sign up to the complete package of WTO agreements in order to join the organization has been problematic for developing countries, entailing institutional reforms which are arguably ill-suited to their needs; particularly those of the least developed members. The WTO has emphasised that the 'flexibilities' provided by the compulsory licensing provisions in TRIPS allow developing countries to determine their own national health policies and access essential pharmaceuticals. While political attention currently focuses on compulsory licensing under TRIPS, this article examines the art 27(2) of TRIPS, which allows members to exclude inventions from patentability if certain criteria are met. The article argues the approach of future dispute settlement panels and the Appellate Body will be shaped by jurisprudence on both GATT's exception provision and the European Patent Convention. This jurisprudence shows that a very high threshold must be met in order to invoke unilateral trade restrictions or exclude an invention from patentability. This means it is likely that developing countries would have significant difficulty invoking art 27(2) of TRIPS to exclude certain pharmaceuticals from patentability in order to enable affordable access for those affected by diseases such as HIV-AIDS.