Despite strong opposition from civil society, in 1994 India signed the General Agreement on Trade and Tariffs (GATT) and became in 1995 party to the nascent WTO TRIPS Agreement. By way of TRIPS, India acquired new, far-reaching international obligations on the protection of all types of intellectual property rights that would require modifications to its patent regime by 2005.6 For example, the TRIPS agreement requires countries to extend patent protection for any invention whether products or patents in all fields of technology, for a 20 year term, subject to patentability criteria. Accordingly, in the process of implementing the TRIPS Agreement, India had to revise several of the main aspects of its patent regime. This process was undertaken progressively through several amendments to the Patents Act, 1970. The Patents (Amendment) Act, 1999 introduced exclusive marketing rights (ERMs)and established mailbox applications for patents for pharmaceuticals and agrochemicals from 1 January 1995.
The Patents Act, 1970 was amended for a second time in 1999, and again in 2002 and 2005. The Patent (Third Amendment) Act, 2005, extended product patents to products from all industry sectors, including pharmaceuticals. It also set the term of patent protection to 20 years to meet the TRIPS deadline for January 1, 2005. This closed the option of reverse engineering that largely contributed to the growth of the Indian pharmaceutical industry. It will not be possible to produce the patented product by adopting a different process. Some safeguard measures and flexibilities contained in the TRIPS Agreement were introduced in the patent system to protect public health, such as the provision for compulsory licensing to support access to sources of generic medicines, restricting pharmaceutical patents to new chemical and medical entities, and the introduction of pre-grant opposition to patent applications.