Faunce Thomas A, Lexchin Joel
College of Law and Medical School, Australian National University, Canberra, Australia.
Aust New Zealand Health Policy. 2007 Jun 1;4:8. doi: 10.1186/1743-8462-4-8.
'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.
“专利常青化”并非专利法的正式概念。最好将其理解为一种社会理念，用于指代制药专利所有者利用法律及相关监管程序来延长其高盈利的知识垄断特权的种种方式，尤其是针对那些利润丰厚（无论是总销量还是单价）的“重磅炸弹”药物。因此，虽然法院是制药品牌制造商常用的延长专利使用费的工具，但在专利保护案件中，法官很少明确提及“专利常青化”。该术语通常指品牌制造商对竞争对手就其对制药专利的策略性使用（包括过度使用、给药系统甚至包装）所构成的威胁，而非指对活性产品成分的任何特定专利的延长。本文特别关注与美国的贸易协定中的特定条款对加拿大和澳大利亚仿制药监管（安全、质量和疗效）审批系统所施加的所谓“关联”条款的“专利常青化”潜力。这些“关联”条款最近也出现在《韩美自由贸易协定》（KORUSFTA）中。它们要求此类药品监管机构促进对仿制药制造商任何潜在专利侵权行为进行通报，甚至加以阻止。本文探讨从加拿大和澳大利亚在尽量减少此类“关联专利常青化”条款对药品成本进而可能对公民获取平价基本药物的潜在不利影响方面所积累的共同经验中可以吸取的监管教训。
