Q13. 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.
Model Answer:
Introduction
In 2005, India amended its Patent Law, 1970 by introducing Section 3(d) to address specific challenges in the pharmaceutical sector.
Body
Circumstances Leading to Amendment
- Access to Medicines: Rising drug prices limited accessibility for the population.
- Patent Evergreening: Prevented minor modifications of existing drugs from obtaining new patents.
- Promoting Innovation: Encouraged genuine pharmaceutical advancements over superficial changes.
- Global Pressure: Aligning with international standards while safeguarding public health interests.
Supreme Court’s Utilization in Novartis Case
- Case Overview: Novartis sought patent protection for “Glivec” (imatinib), a cancer drug.
- Application of Section 3(d): The Court assessed if Glivec was a significant innovation or merely a modified version of an existing drug.
- Decision: Rejected the patent, stating it did not demonstrate enhanced efficacy over prior formulations, thus falling under Section 3(d).
Pros of the Decision
- Public Health Protection: Ensures essential medicines remain affordable and accessible.
- Prevents Monopolies: Stops companies from extending patent life through minor tweaks.
- Encourages True Innovation: Promotes investment in genuine research and development.
Cons of the Decision
- Reduced Incentive for Pharma: May deter companies from investing in new drug development in India.
- Global Competitiveness: Potentially affects India’s position in the global pharmaceutical market.
- Legal Uncertainties: Creates ambiguities in patent eligibility criteria.
Conclusion
The amendment of Section 3(d) and its application in the Novartis case underscore India's commitment to balancing innovation with public health. While it safeguards accessibility and curtails patent misuse, it also poses challenges for pharmaceutical innovation and investment.
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