The introduction of the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS) as one of the covered agreements under the WTO brought several uncertainties for India’s generic pharmaceutical industry. This industry had emerged as one of the country’s major sectors after the post-colonial Patents Act was enacted in 1970. The key feature of the 1970 Act that contributed to the growth of this industry was the introduction of a process patent regime, replacing the product patent regime under the Patents and Designs Act of 1911. Alongside this, the period of patent protection for pharmaceutical processes was reduced to seven years from the application date or five years from the grant, whichever was shorter.
Patent Application (Photo used for representational purpose)
India’s acceptance of the TRIPS Agreement as a WTO member meant replacing the process patent regime for pharmaceuticals with a product patent regime and increasing the patent term to 20 years. However, Indian lawmakers developed a TRIPS-compliant patent regime that aimed to protect the domestic pharmaceutical industry’s ability to supply affordable medicines even after the process patent system was discontinued from 1st January 2005. While the TRIPS Agreement strengthened patent rules, it also included flexibilities to protect national interests. Indian legislators incorporated these into domestic law to ensure generic companies could continue to operate effectively and maintain access to affordable medicines.
Two pivotal features defined this post-TRIPS regime: The prohibition of patent evergreening and the introduction of a robust pre-grant opposition mechanism. These provisions were designed to filter out non-innovative patent claims and uphold the integrity of the Indian patent system.
Section 3(d) of the Patents Act is central to India’s strategy against patent evergreening. It restricts patent grants for mere discoveries or minor modifications of known substances unless they demonstrate enhanced therapeutic efficacy. The explanation to this section clarifies that derivatives like salts, esters, polymorphs, and isomers are considered the same substance unless they show significant improvements in efficacy. This ensures that only genuine innovations receive patent protection, enabling timely generic entry and fostering price competition. In essence, a patent cannot be granted on a product unless its enhanced efficacy over an existing product can be proven.
Originator companies often develop minor modifications to proprietary drugs just before the original patent expires, seeking additional patent terms. This strategy aims to block generic entry, keeping medicine prices high. The availability of generics typically leads to a significant reduction in drug prices, enhancing affordability. Section 3(d) is intended to serve as a safeguard against such strategies, keeping access and affordability at the heart of India’s pharmaceutical policy. However, the implementation of this critical provision has left much to be desired. Studies have shown that at least 80% of the pharmaceutical patents granted in India violate the provisions of Section 3(d), in other words, ‘evergreening’ of patents is tending to become an undesirable reality of India’s patent system.
Another TRIPS-compliant safeguard adopted by India is the pre-grant opposition system, which allows stakeholders to challenge patent applications before they are granted. This peer-review mechanism helps prevent unjustified monopolies and contributes to a more robust and transparent IP ecosystem. However, data from the Indian Patent Office between 2008 and 2023 indicates that the mechanism remains underutilised. On average, only five pre-grant oppositions were filed per 1,000 applications each year, suggesting limited stakeholder engagement.
While concerns have been raised about the possible grant of low-quality patents, strengthening the system remains essential. Enhancing the rigour of patent examination and improving the opposition process through stakeholder awareness, expert input, and procedural transparency can raise the quality threshold for granted patents. This will help ensure that the IP framework supports genuine innovation and aligns with public interest.
Despite challenges, India’s patent law remains one of the most balanced globally protecting both innovation and public health. Strengthening the system now requires better implementation, including training for patent examiners, wider awareness of public safeguards like Section 3(d), and increased use of pre-grant opposition. With targeted reforms and greater stakeholder engagement, India can continue to promote innovation while safeguarding affordable access to medicines.
This article is authored by Biswajit Dhar professor (retd), Jawaharlal Nehru University.
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