This chapter aims to trace the development of patent law regime in India and analyze its evolution in response to globally-influential intellectual property framework, such as TRIPS and pressure from the developed countries US and Europe to open up her markets to permit cash-rich pharmaceutical companies to sell their drugs and receive patent protection in India. An observation of the legislative actions and judicial responses reveal that both the parliament and the supreme echelons of the judiciary have been tediously careful in protecting the healthcare needs of the poor by promoting the generic drug industry through a guarded interpretation of Section 3(d) of Patents Act, 1970. The objective of the chapter is to critically analyze the legislative reforms and judicial interpretations of patent law in light of the socio-economic needs of the country.
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Infectious diseases kill over 10 million people each year, more than 90% of whom are in the developing world (World Health Organisation, The World Health Report 2001). The leading causes of illness and death in Africa, Asia, and South America- regions that account for four-fifths of the world’s population-are HIV/AIDS, respiratory infections, malaria, and tuberculosis (World Health Organisation, The World Health Report 2001). The magnitude of the disease crisis has drawn attention to the fact that millions of people in the developing world do not have access to the medicines that are needed to treat these diseases or alleviate suffering (UNAIDS: Reports on the Global HIV/AIDS Epidemic, 2001).
In India, Hepatitis-B is one of the most common diseases in India. There are over 40 million infected patients, and India is second only to China in the highest number of Hepatitis-B (HBV) infected patients by country (NCBI Report, 2013). Every year, nearly 600,000 patients die from HBV infection in the Indian sub-continent. In addition, around 20,000 people die of typhoid fever in the country (UNAIDS: Reports on the Global HIV/AIDS Epidemic, 2001).
Among vector-borne diseases, malaria is the most common killer in the country, with 40,297 deaths reported per year. In 2006, India reported 1.39 million cases of Chikungunya with no attributable deaths (NCBI Report, 2007). Ahmedabad alone reported around 60,777 cases. Since 1985, India has reported an estimated 25, 000–30, 000 human deaths from rabies annually. The current statistics stand at 20,565 deaths per year (NCBI Report, 2013).
Besides these common infections, India, with 2.1 million patients, has the 3rd highest number of HIV patients in the world, behind only South Africa and Nigeria (Sonowal & Goswami, 2015). On a brighter note, the 2012 UNAIDS Report stated that new HIV cases among adults declined by half in India since 2000, while praising India’s contribution to AIDS response through the manufacture of generic antiretroviral drugs (Sonowal & Goswami, 2015).
The reasons for the lack of access to essential medicines are manifold, however, in many cases, the high prices of drugs are a barrier to needed treatments (Hoen, 2002). Such exorbitant, and thus, prohibitive drug prices are often the result of strong intellectual property protection (Pecoul et al., 1999). Despite the enormous burden of disease, drug discovery and development targeted at infectious and parasitic diseases in emerging countries has ground to a standstill because drug companies in developed and developing nations cannot recoup the cost of R&D for products to treat diseases that abound in developing countries (Pecoul et al., 1999). A number of new medicines vital for the survival of millions are already too costly for the vast majority of the people in emerging countries. Further, the investment in Research and Development (R&D) towards the health needs of people in developing countries has almost come to a standstill. Developing countries, where three-quarters of the world population lives, accounts for less than 10% of the global pharmaceutical market (Hoen, 2002).