This article is part of a series on The Global Pharmaceutical Market and Generic Drugs: Policy Challenges for Australia, edited by Simon Barraclough (deputy editor) and Dr Hans Lofgren, from the School of International and Political Studies, Deakin University Victoria.

Debate

'Linkage' pharmaceutical evergreening in Canada and Australia

Thomas A Faunce¹ and Joel Lexchin²

¹  College of Law and Medical School, Australian National University, Canberra, Australia

²  School of Health Policy and Management, York University, Toronto, Canada

Australia and New Zealand Health Policy 2007, 4:8doi:10.1186/1743-8462-4-8

Published:	1 June 2007

Abstract

'Evergreening' is not a formal concept of patent law. It is best understood as a social idea used to refer to the myriad ways in which pharmaceutical patent owners utilise the law and related regulatory processes to extend their high rent-earning intellectual monopoly privileges, particularly over highly profitable (either in total sales volume or price per unit) 'blockbuster' drugs. Thus, while the courts are an instrument frequently used by pharmaceutical brand name manufacturers to prolong their patent royalties, 'evergreening' is rarely mentioned explicitly by judges in patent protection cases. The term usually refers to threats made to competitors about a brand-name manufacturer's tactical use of pharmaceutical patents (including over uses, delivery systems and even packaging), not to extension of any particular patent over an active product ingredient. This article focuses in particular on the 'evergreening' potential of so-called 'linkage' provisions, imposed on the regulatory (safety, quality and efficacy) approval systems for generic pharmaceuticals of Canada and Australia, by specific articles in trade agreements with the US. These 'linkage' provisions have also recently appeared in the Korea-US Free Trade Agreement (KORUSFTA). They require such drug regulators to facilitate notification of, or even prevent, any potential patent infringement by a generic pharmaceutical manufacturer. This article explores the regulatory lessons to be learnt from Canada's and Australia's shared experience in terms of minimizing potential adverse impacts of such 'linkage evergreening' provisions on drug costs and thereby potentially on citizen's access to affordable, essential medicines.