Subject: Economy

The 2005 Amendment to Section 3(d) of Indian Patent Law marked a significant milestone in India's pharmaceutical patent regime, balancing innovation protection with public health accessibility.

Historical Context and Amendment

• The TRIPS compliance deadline of 2005 necessitated India to introduce product patents in pharmaceuticals, leading to the amendment of Section 3(d).
• The amendment aimed to prevent "evergreening" - a practice where pharmaceutical companies extend patent protection through minor modifications without significant therapeutic benefits.
• Section 3(d) mandates that new forms of known substances must demonstrate enhanced efficacy to qualify for patent protection.

Supreme Court's Interpretation in Novartis Case

• In the landmark 2013 Novartis vs Union of India case, the Supreme Court rejected the patent application for Glivec (imatinib mesylate).
• The court established that:
  • Mere discovery of new forms of known substances without improved efficacy is not patentable.
  • Bioavailability enhancement alone doesn't constitute improved efficacy.
  • The new form must demonstrate significant improvement in therapeutic efficacy.

Advantages of the Decision

• Access to Affordable Healthcare: Enabled production of generic versions at significantly lower prices (Rs. 8,000 vs Rs. 1,20,000 per month).
• Prevention of Evergreening: Set a precedent against frivolous patent extensions.
• Strengthened Generic Industry: Boosted India's position as the "pharmacy of the developing world".
• Promoted genuine pharmaceutical innovation focused on therapeutic improvements.

Challenges and Concerns

• International Criticism: Faced opposition from multinational pharmaceutical companies.
• Investment Concerns: Potential deterrent to R&D investments in India.
• Trade Relations: Strained relationships with developed nations viewing it as weak IP protection.
• Innovation Impact: Possible discouragement of incremental innovation in drug development.

The Supreme Court's interpretation of Section 3(d) exemplifies India's balanced approach to patent law, prioritizing public health accessibility while encouraging meaningful innovation. The decision continues to influence global pharmaceutical patent policies, positioning India as a leader in equitable healthcare access through robust generic medicine production.