Reconfiguring international pharmaceutical patent protection principles to combat linkage evergreening :|b'de-linking the evergreen' and proposing a solution for developing countries

Recent remarks made by the current South African Minister of Health describing as a plot to ‘genocide’ a leaked document allegedly authored by a group of multinational pharmaceutical companies in response to the country’s Draft IP Policy is evidence of the importance of both pharmaceutical patents and the national intellectual property policies underpinning their legislative landscape. The proliferation of linkage evergreening provisions through multilateral agreements has also recently become a trend globally. Evergreening has been described as the various ways in which pharmaceutical patent owners use the law and related regulatory processes to extend the patent term of their high profit-making pharmaceuticals. The evergreening phenomenon has also been referred to as patent evergreening, which involves the practice of obtaining multiple patents that cover different aspects of the same product. Linkage evergreening however specifically refers to the phenomenon where generics pharmaceutical manufacturers cannot receive regulatory approval or marketing authorization for developing a pharmaceutical product that is still protected by a patent. The evergreening phenomenon is achieved through Free Trade Agreements (FTAs) which require participating nations to incorporate linkage and other intellectual property provisions in their national patent systems in exchange for preferential trade terms. These agreements generally provide for stronger provisions than the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS) and are thus referred to as “TRIPS Plus". Not surprisingly, these “TRIPS Plus” FTAs are negotiated outside the purview of the World Trade Organization (WTO). This thesis examines the role, legality and impact of bilateral free trade agreements which include wide ranging provisions that allow the proliferation of linkage evergreening and thereby frustrate and delay generic medicines’ market entry, prolong and expand patent protections and constrain the exercise of TRIPS flexibilities intended to support access and promote public health. The free trade agreements discussed include the North American Free Trade Agreement (NAFTA), the US - Australia Free Trade Agreement (AUSFTA) and the US - Korea Free Trade Agreement (KORUSFTA). This study also examines the Economic Partnership Agreements (EPAs) in the context of access to medicines and linkage evergreening in developing countries and LDCs in Africa, with a focus on the recently concluded EU – SADC EPA and the EU-EAC EPA still under negotiation. Relevant legislation, policy documents and case law from South Africa, India, the EAC and ARIPO are also explored in this study to gauge their potential to effectively address the challenges of access to medicines and evergreening. This thesis offers a solution to evergreening through the recommendation of guidelines which show law and policy makers how to curtail linkage evergreening. More specifically, it is hoped that the said guidelines as well as the discussion and analyses presented in this thesis will assist in the development of national and regional intellectual property policies, amendment of national and regional legislative instruments as well as the negotiation of regional trade agreements aimed at securing the interests of LDCs and developing countries. It is further hoped that the recommendations made will contribute to ongoing efforts to improve access to affordable medicines in the developing world