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JIPR Vol.14(4) [July 2009] >


Title: Evergreening – A Controversial Issue in Pharma Milieu
Authors: Bansal, Inderjit Singh
Sahu, Deeptymaya
Bakshi, Gautam
Singh, Sukhjeet
Keywords: Evergreening
TRIPS Agreement
Hatch-Waxman Act
market exclusivity
patent strategy
generics
paroxetine
Issue Date: Jul-2009
Publisher: CSIR
Abstract: A patent is an exclusive right awarded by the intellectual property (IP) authority of a state to an inventor or his assignee for a limited period of time in lieu of disclosure of an invention for the benefit of mankind. In recent times, it has become a practice by a number of innovator companies to extend the patent term of their innovative molecules to maintain market dominance. The extension of monopoly term ‘Evergreening’ is a predominant aspect of pharmaceutical patenting. ‘Evergreening’ refers to different ways wherein patent owners take undue advantage of the law and associated regulatory processes to extend their IP monopoly particularly over highly lucrative ‘blockbuster’ drugs by filing disguised/artful patents on an already patent-protected invention shortly before expiry of the ‘parent’ patent. These artful patents tend to protect delivery profiles, packaging, derivatives, and isomeric forms, mechanism of action, dosing regimen, and dosing range, and dosing route, different methods of treatment, combinations, screening methods, biological targets and field of use for the same old molecule. This provides the innovator companies sufficient time to recoup their controversially estimated R&D costs. Patent monopolies thus should be designed to function at an optimum level wherein maximum incentive is accorded to investment in research followed by simultaneous accessibility of the protected inventions to the public. The TRIPS compliance has compelled pharma industries of the developing countries to innovate in order to cater to the requirement of current and future drugs. This paper covers different aspects of ‘evergreening’, its impact in the pharma IP domain and identifies means adopted for limiting evergreening.
Page(s): 299-306
ISSN: 0975-1076 (Online); 0971-7544 (Print)
Source:JIPR Vol.14(4) [July 2009]

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