Bringing out the circumstances in 2005 which forced amendment to the section 3(d) in Indian Patent Law, 1970, discuss how it has been utilized by the Supreme Court in its judgement in rejecting Novartis’ patent application for ‘Glivec’. Discuss briefly the pros and cons of the decision.

Circumstances behind Section 3(d)

Under the TRIPS Agreement India had to shift from a process-only patent regime (Patents Act, 1970) to granting product patents in pharmaceuticals by 2005. Fearing that broad product patents would enable 'evergreening' — extending monopolies through trivial modifications — and threaten access to affordable generics, Parliament inserted Section 3(d) through the Patents (Amendment) Act, 2005.

The provision and the Novartis judgement

• Section 3(d) bars patents on a mere new form of a known substance unless it shows enhanced therapeutic efficacy.
• In Novartis AG v. Union of India (2013), the Supreme Court upheld rejection of a patent for the beta-crystalline form of imatinib mesylate (Glivec), holding it failed to demonstrate improved therapeutic efficacy over the known molecule.

Pros of the decision

• Protected access to low-cost generic cancer drugs and public health, reinforcing the right to health under Article 21.
• Curbed evergreening and strengthened India's role as the 'pharmacy of the developing world'.

Cons

• Innovator firms argued it discourages incremental innovation and dampens R&D investment and the IP climate.

Conclusion

The judgement balanced innovation incentives against public health, using TRIPS flexibilities and the spirit of the Doha Declaration to keep essential medicines affordable.