Q15.The circumstances in 2005 forced an amendment to section 3(d) in the Indian Patent Law, 1970. Discuss how it has been utilized by the Supreme Court in its judgment rejecting Novarti's patent application for “Glivec“. Discuss briefly the pros and cons of the decision.

Section 3(d) of the Indian Patent Law, 1970, prevents "evergreening" by disallowing patents for new forms of known substances unless they demonstrate significantly enhanced therapeutic efficacy.

Circumstances and 2005 Amendment

The 2005 amendment clarified this provision, ensuring trivial modifications could not extend patent life, promoting access to affordable medicines.

Supreme Court's Glivec Judgment

The Supreme Court applied Section 3(d) to reject Novartis's patent for Glivec (Imatinib Mesylate). It ruled Glivec, a beta-crystalline form of a known drug, did not show significantly enhanced therapeutic efficacy, failing the 3(d) test.

Pros of the Decision

• Ensured affordability and accessibility of life-saving drugs.
• Boosted the domestic generic drug industry.
• Upheld public health interests over corporate profits.

Cons of the Decision

• Raised concerns among multinational pharmaceutical companies regarding India's IPR regime.
• Potentially discouraged R&D investment in India.
• Perceived by some as a barrier to innovation.

The judgment balanced innovation incentives with public health, reinforcing India's commitment to affordable healthcare.