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'Linkage' pharmaceutical evergreening in Canada and Australia

'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, particula...

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Autores principales: Faunce, Thomas A, Lexchin, Joel
Formato: Texto
Lenguaje:English
Publicado: BioMed Central 2007
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1894804/
https://www.ncbi.nlm.nih.gov/pubmed/17543113
http://dx.doi.org/10.1186/1743-8462-4-8
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author Faunce, Thomas A
Lexchin, Joel
author_facet Faunce, Thomas A
Lexchin, Joel
author_sort Faunce, Thomas A
collection PubMed
description '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.
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spelling pubmed-18948042007-06-20 'Linkage' pharmaceutical evergreening in Canada and Australia Faunce, Thomas A Lexchin, Joel Aust New Zealand Health Policy Debate '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. BioMed Central 2007-06-01 /pmc/articles/PMC1894804/ /pubmed/17543113 http://dx.doi.org/10.1186/1743-8462-4-8 Text en Copyright © 2007 Faunce and Lexchin; licensee BioMed Central Ltd. http://creativecommons.org/licenses/by/2.0 This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( (http://creativecommons.org/licenses/by/2.0) ), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Debate
Faunce, Thomas A
Lexchin, Joel
'Linkage' pharmaceutical evergreening in Canada and Australia
title 'Linkage' pharmaceutical evergreening in Canada and Australia
title_full 'Linkage' pharmaceutical evergreening in Canada and Australia
title_fullStr 'Linkage' pharmaceutical evergreening in Canada and Australia
title_full_unstemmed 'Linkage' pharmaceutical evergreening in Canada and Australia
title_short 'Linkage' pharmaceutical evergreening in Canada and Australia
title_sort 'linkage' pharmaceutical evergreening in canada and australia
topic Debate
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1894804/
https://www.ncbi.nlm.nih.gov/pubmed/17543113
http://dx.doi.org/10.1186/1743-8462-4-8
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