1. India’s is fully committed to protecting Intellectual Property. India has a complete eco-system supporting a well-settled, stable and robust intellectual property regime. Its three main pillars are comprehensive laws, detailed rules to back them up, and strong enforcement mechanisms, including for dispute resolution. In India, the IP framework is rooted in law.
2. The full complement of laws on patents, designs, trademarks and geographical indications is in place and is in compliance with the Trade Related Intellectual Property Rights (TRIPS) of WTO. The main acts of Parliament that address the IP regime in India include:
a) The Patents Act, 1970 (amended in 1999, 2002 and 2005);
b) The Designs Act, 2000;
c) The Trade Marks Act, 1999; and
d) The Geographical Indications of Goods (Registration & Protection) Act, 1999;
These are administered through the Office of the Controller General of Patents, Designs and Trade Marks (CGPDTM).
3. Other IP issues are also governed by law:
• Copyright is protected through the Copyright Act, 1957, as amended in 1999;
• Layout of transistors and other circuitry elements is protected through the Semi- conductor Integrated Circuits Layout-Design Act, 2000;
• New varieties of plants are protected through the Protection of Plant Varieties and Farmers’ Rights Act, 2001.
4. The India Patents Act specifically is one of the most comprehensive acts, and it is rigorously enforced. The award of patents is a transparent legal process, with decisions and processes subject to legal scrutiny.
5. Out of all patents granted in India, the highest share, 20-30%, has gone to US Nationals and Corporations.
6. India granted 4064 patents for pharmaceutical inventions during the period from 01 January 2005 to 31 December 2011, and more than 85% were owned by foreign companies in India. This trend shows that the provisions of the Indian Patents Act related to pharmaceutical products are fair and unbiased. The Act does not discriminate between Indian nationals and others.
7. Compulsory Licensing: It is important to understand the legal and public health context of compulsory licensing. The provisions of the compulsory license enshrined in the India Patent Act are in accordance with the provisions of the TRIPs Agreement and the Paris Convention. Furthermore, the Doha declaration on TRIPS and Public Health states:
“-----------TRIPS Agreement does not and should not prevent members from taking measures to protect public health. Accordingly, while reiterating our commitment to the TRIPS Agreement, we affirm that the Agreement can and should be interpreted and implemented in a manner supportive of WTO members' right to protect public health and, in particular, to promote access to medicines for all----”.
8. Through such licensing mechanisms, Governments balance the rights of the patent holder with its obligations to ensure the validity of patents, availability of the products at a reasonable price and protection of public health and nutrition. Compulsory licensing has been an integral part of the patent regime of different countries since its inception. Globally, 15 different countries, developed and developing countries alike, have issued more than 35 compulsory licenses.
9. India has issued only one compulsory license. The provisions for compulsory licensing are not meant to hamper the process of innovation but to ensure a fair balance between the interests of innovators and the urgent need of public health. The provisions are enacted by laws based and in accordance with the India Patent Act and consistent with TRIPS and the Doha Declaration.