Context

  • Indian Patent Office rejected AbbVie’s patent application for cancer drug Venetoclax, utilising Section 3(d) of the Indian Patents Act
  • Section 3(d) prevents “evergreening” — patenting minor modifications without enhanced therapeutic efficacy

The Innovation Gap

  • India built its “pharmacy of the world” reputation on affordable generics (e.g., Cipla’s $1/day HIV therapy in 2001)
  • Global paradigm shifting toward biologics, CRISPR, and AI-driven drug discovery
  • India’s R&D expenditure: below 1% of GDP
  • Lacks integrated biotech-AI ecosystem unlike China (now holds 20% of global drug pipelines)

Way Forward

  • Balance Section 3(d) public health safeguards with heavy state-backed R&D investment (targeting ≥2% of GDP)
  • Bridge academia-industry gap to transition from reverse-engineering to first-in-class breakthrough therapies

UPSC Angle

  • GS3: S&T, industrial policy, IPR
  • GS2: Health policy, right to health

📌 Facts Corner — Knowledgepedia

India Pharma:

  • Section 3(d): prevents evergreening (Indian Patents Act)
  • Venetoclax: AbbVie patent rejected by Indian Patent Office
  • Cipla HIV therapy: $1/day (2001)
  • India R&D spend: <1% of GDP
  • China’s share of global drug pipelines: 20%