The TRIPS Agreement: A Roaring Lion or Toothless Tiger: An Analysis

Indian law did not recognize product patents under the Patents Act of 1970 with an avowed object of producing food and medicine at comparatively cheaper price. However, process patent continued to be protected thereby creating an opportunity for the Government to regulate production and distribution of patented drugs imported from outside the country. The pharmaceutical industry was thus able to create generic drugs at mass scale albeit under the covert permissible limits provided by the state. This was done in public interest to address the problem of poverty-stricken diseased populace. After the dawn of globalization, liberalization and openness actuated by the establishment of WTO and the multiple agreements thereof, including the TRIPS Agreement 1994, the international trade promised to become barrier free, be it tariff or non –tariff barriers. But the TRIPS Agreement made the protection of product patents along with process patent as mandatory. This resulted into a drastic change in Indian Patent law by bring out Patent (Amendment) Act 2005, after availing of the benefit of 10 years (1995-2005) as allowed the TRIPS Agreement for developing and least developing countries signatories to the Agreement. Given this shift in the Indian patent law, foreign pharmaceutical companies especially MNCs wanted to invest in a big way on the assured protection of product patents that these companies became entitled to under the patent regime now in operation. However, the Indian pharmaceutical industry continued to produce generic drugs on the tacit governmental approval based often on the formulations patented outside India. This has created a precarious situation for MNCs especially the pharmaceutical companies so far product patents of pharma goods are concerned. The Doha Declaration on public health and lifesaving drugs has simply buoyed the Indian pharmaceutical industry to generate more and more generic goods often to the annoyance of MNCs resulting in unabated litigation. It is in this background that the present paper is conceived to analyze TRIPS compliance of India in the contemporary trading world aiming at harmonizing world trade and access to affordable medicine to the people at large.