THE INDIAN PHARMACEUTICAL PATENT REGIME: PROTECTION OF INNOVATION VIS-À-VIS ACCESS TO MEDICINES

Abstract: The Indian pharmaceutical industry is a prime example of an industry that is being forced to revisit its long-term strategies and business models as India opens its markets to global trade. Factors such as protection of intellectual property are increasing in significance due to the growing recognition of the need to ensure protection of valuable investments in research and development (R&D). Efforts are being made to curb problems of weak enforceability of existing intellectual property legislations, and the Indian government is moving towards establishing a patent regime that is conducive to technological advances and is in keeping with its global commitments including the Trade-Related Aspects of Intellectual Property Rights (TRIPS). Patents on medicines have been one of the most hotly-debated topics since the adoption of the TRIPS Agreement because patents grant exclusivity for the duration of the patent term and result in patent holders having control over the production, supply, distribution and, by virtue of exclusivity, price which creates monopoly and eliminates competition in the pharmaceutical market. The introduction of product patent thus reduces accessibility and affordability of drugs effectively putting them out of the reach of the majority. Thereby adversely affecting industrially developing and least developed countries, hampering their ability to formulate appropriate public health policies that would enable their ailing citizen to access medicines. Also, Indian companies have some challenges ahead in product patent regime, as multinational Pharmaceutical giants launch products in India from their portfolio of global products, which may have higher prices. The paper seeks to discuss these issues and challenges in the light of the flexibilities like Compulsory Licensing, Parallel Imports, and Bolar Exemption that can be used judiciously by Indian government to make drugs affordable to masses.