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THE PHARMA REVIEW (JULY - AUGUST 2011)

A Perspective on Compulsory Licensing Provisions

Dr. Dhanlakshami Iyer & Dr.P.G.Yeole *

Abstract
Compulsory licenses are the extraordinary legal tool whereby the state allows itself or the third party to have access to produce, use or sell the IP protected product or process without the consent of the IP owner. Thus exploitation of the patent holder’s monopoly rights is prevented by compulsory license, thereby enabling protection and safeguard of public interest such as national emergency, extreme urgency or public non-commercial use. Hence, this paper is an attempt to discuss various attributes of compulsory licensing thoroughly. After reviewing the background pertaining to the emergence of this amazing legal tool, it also discusses the diverse legislations related to the compulsory licensing processes and draws attention towards specific case studies. The article throws light on the global scenario in India, United States and Europe and attempts to significantly pinpoint the importance of compulsory licensing in today’s scenario. Now that India has ushered in a product patent regime with respect to pharmaceuticals, it is expected that the compulsory licensing system will be put to use and will serve the purpose for which it was created.
Introduction
Compulsory licenses1 are the extraordinary legal tool whereby the state allows itself or the third party to have access to produce, use or sell the IP protected product or process without the consent of the IP owner. These involuntary licenses as forced by law may be granted with respect to patents, copy righted works or other exclusive rights. Misuse of the patent holder’s monopoly rights is prevented by these licenses, thereby enabling protection and safeguard of public interest. International agreements such as World intellectual property organization (WIPO) paris convention for the protection of the industrial property, the pertinent provisions of which were incorporated into the World trade organization (WTO)2 agreement on Trade related aspects of intellectual property rights (TRIPS) lead to the enactment of laws pertaining to compulsory patent licensing. The Patent Law has created a robust and comprehensive compulsory licensing system in India. Public health crises (eg, AIDS, tuberculosis and malaria) can be considered circumstances of national emergency and extreme urgency. In addition, the Patent Law permits the granting of compulsory licenses for the manufacture and export of patented pharmaceutical products to countries which have insufficient or no manufacturing capacity, where a specific request is made by such a country. The most pernicious circumstances including anti-competitive practices can be combated by compulsory licensing. Compulsory licensing provisions are envisaged as striking a delicate balance between the needs of technology consumers and producers. In a developing country such as India, compulsory licensing is probably the most effective safeguard against the potential abuse of monopoly by patentees and the grounds for invoking compulsory licensing provisions include: Refusal to enter into the voluntary licensing agreement on reasonable commercial terms.

 

 

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