Five Years into the Product Patent Regime: India’s Response. UNDP, 2010
(2010; 184 pages)


In 2005, the UN Special Envoys of the UN Secretary General on HIV/AIDS in the Asia Pacific and Africa collaborated for the very first time to write to the Indian government highlighting the importance of generic HIV medicines from India to the achievement of universal access to treatment goals. Along with the UN Special Envoys, the world was watching closely to see how India would balance its obligation to comply with the TRIPS Agreement deadline to amend the Indian Patents Act, 1970 with its role as the leading supplier of safe, effective and affordable generic HIV medicines.

The substance of the original Indian Patents Act, 1970 abolished product patent protection in pharmaceuticals in order to ensure that medicines were available to the public at reasonable prices and was largely based on the recommendations of a report of a commission chaired by the jurist Rajagopala Ayyangar in 1959 which stated that laws “have to be designed, with special reference to the economic conditions of the country, the state of its scientific and technological advance, its future needs and other relevant factors…so as to minimize if not eliminate the abuses to which a system of patent monopoly is capable of being put.”

The resulting Indian law did not provide patent protection for pharmaceutical products and as a result, India’s generic manufacturers were able to offer triple-combination anti-retrovirals (ARV s) at a fraction of the price being offered by patent-holding multinational pharmaceutical companies. The lack of patent barriers also allowed Indian generic companies to manufacture fixed dose combinations of ARV s that have become the weapon of choice in the global scale up of ARV treatment.

But to comply with TRIPS, India amended her patent laws and re-introduced product patent protection in pharmaceuticals from 1 January 2005 leading to global concerns about the continuing ability of Indian generic companies to supply these medicines. These concerns were taken seriously by the Indian Parliament, which aware of its responsibility not only to Indians but to patients across the world adopted the only pragmatic solution available — to utilize flexibilities available under TRIPS in an attempt to secure the availability, affordability and accessibility of medicines. Five years after India changed its Patent regime this Study examines the impact of these safeguards on access to medicines analyzing the impact of TRIPS on the Indian Pharmaceutical Industry as well as the response of the legal system....

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