India’s journey with the TRIPS Agreement under the WTO has had a huge impact on its patent system, especially in the pharmaceutical sector. The Doha Declaration (2001) reaffirmed that countries should have the flexibility to protect public health by ensuring access to essential medicines. India has taken advantage of these provisions, using compulsory licensing and strict patent laws to prevent the monopolization of life-saving drugs. However, balancing intellectual property rights (IPR) with affordable healthcare remains a challenge. While India has met TRIPS obligations, it continues to face pressure from global pharmaceutical giants over its policies.
Before TRIPS, India’s patent laws focused on process patents rather than product patents, allowing its generic drug industry to thrive. But after joining the WTO, India had to amend its Patent Act (1970) in 2005 to allow product patents for pharmaceuticals and biotechnology. However, India introduced key safeguards, like Section 3(d), which prevents companies from evergreening patents (i.e., making minor tweaks to extend monopoly rights on a drug).
India’s strict patent laws have played a critical role in making medicines more affordable, thanks to compulsory licensing provisions. A famous example is Natco Pharma’s compulsory license for Bayer’s cancer drug Nexavar (2012), which slashed the drug’s price by 97%. However, India faces ongoing international pressure, with developed nations and big pharma lobbying for stricter patent enforcement.
India must continue to protect its public health safeguards, support its generic pharmaceutical industry, and push back against excessive patent restrictions. The challenge will be to maintain affordable medicine access while fostering innovation and investment in the pharmaceutical sector.
Keywords: TRIPS Agreement, Patent System, Doha Declaration, Intellectual Property Rights (IPR), Compulsory Licensing, Pharmaceutical Patents, Access to Medicines, WTO Regulations, Patent Protection, India’s Patent Law
Trips Patent System and Doha Declaration-Implementation Process by India
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