'Linkage' Pharmaceutical Evergreening in Canada and Australia

Austrailia and New Zealand Journal of Health Policy, Vol. 1, No. 4, p. 8, June 2007

11 Pages Posted: 18 May 2009 Last revised: 18 Jul 2014

Date Written: June 1, 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.

Keywords: Evergreening, patent law, linkage evergreening, pharmaceutical regulation, trade agreements, access to medicines

Suggested Citation

Faunce, Thomas Alured and Lexchin, Joel, 'Linkage' Pharmaceutical Evergreening in Canada and Australia (June 1, 2007). Austrailia and New Zealand Journal of Health Policy, Vol. 1, No. 4, p. 8, June 2007 . Available at SSRN: https://ssrn.com/abstract=1405010

Thomas Alured Faunce (Contact Author)

Australian National University ( email )

Canberra, Australian Capital Territory 0200
Australia
61 2 61253563 (Phone)

Joel Lexchin

York University ( email )

4700 Keele Street
Toronto, Ontario M3J 1P3
Canada
+416-736-2100 x 22119 (Phone)
+416-736-5227 (Fax)

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