D.Pharm, B.Pharm, MBA(Marketing & Finance)
Sohm India Pvt Ltd
The first day of January 2005 marked a dramatic turning point in the history of India. By deliberately excluding pharmaceutical products from patent protection for the previous 34 years, India became a world leader in high-quality generic drug manufacturing. But India’s entry into the global economy at the end of the 20th century, as evidenced by membership in the World Trade Organization (WTO), compelled the nation to once again award patents on drugs. Moreover, India henceforth would have to apply internationally-accepted criteria for granting patents, and the term of its patents would have to extend twenty years beyond filing.
For an emerging superpower still mired in immense domestic poverty and public health crises, these and other fundamental changes to India’s patents regime did not come quickly nor without controversy. Their implementation remains uncertain. It is far too early to empirically establish, for example, whether India’s adoption of stronger patent laws will catalyze a significant shift from generic drug manufacturing to indigenous pharmaceutical innovation. What is clear, however, is that the implications of India’s tumultuous patent system transformation will be felt not only within India but also around the globe. From the perspective of millions suffering worldwide from life threatening diseases, many of whom previously benefited from the low-cost products of India’s thriving generic drug manufacturing sector, the introduction of a pharmaceutical product patents regime in India is viewed as an international healthcare tragedy. That view is the extreme. The true impact of the changes will turn on implementation. Eighteen months into the new patents regime, India is actively exploiting the flexibilities inherent in the WTO’s Agreement on Trade-Related Aspects of Intellectual Property (TRIPS). These flexibilities allow India to balance the need to protect its public from the social costs of stronger patent protection while at the same time provide the necessary incentives for domestic research and development in medicines and healthcare. The transformation of the nation’s patent regime is entirely consistent with a burgeoning domestic pharmaceutical and biotech industry that is beginning to invent rather than merely reverse-engineer. The traditional Indian view of patent protection as a moral wrong antithetical to public health is evolving to a more complex understanding—still in its formative implementation stages, to be sure—that a patent system can be designed and implemented to spur domestic innovation while at the same time maintaining affordable public access to life-saving patented medicines. The first major comparative analysis of India’s newly strengthened patents regime, i.e., the Patents Act, 1970, as last amended in 2005 (hereinafter “India Patents Act, 1970 (2005)”).5 These evaluates the first eighteen months of the new regime’s operation, drawing not only from published literature but also from original fact finding, data gathering, and interviews conducted in India with Indian Patent Office officials, Indian pharmaceutical industry representatives, Indian patent attorneys, and Indian patent law academics.