Industry Odisha Bureau, Oct 16: Commercial gains like longer shelf life, easier manufacturing or faster absorption will not suffice. Such claims need test data in living models proving better disease treatment.
The draft builds on Section 3(d) of the Patents Act. India added that safeguard in 2005, when it moved from process to product patents. IDMA spokesperson Viranchi Shah said it was designed to bar small tweaks. He welcomed the draft as balancing innovation with affordability and patient access.
India’s pharmaceutical industry is worth about $60 billion. It supplies a fifth of the world’s generic medicines and ranks third by volume. Once a drug’s patent lapses, rivals can launch cheaper copies.
The semaglutide battle shows how high the commercial stakes run. Novo Nordisk’s semaglutide patent expired in India, China and Brazil in March. That opened the door for Cipla, Sun Pharma and Dr Reddy’s Laboratories.
The draft also codifies court rulings from 2013 to 2026. Examiners must apply the Delhi High Court’s seven-pillar novelty test. Claims must be judged alone, without stitching together separate earlier publications. Obviousness tests become flexible guides, applied without hindsight.
Broad Markush claims covering vast chemical families face tighter scrutiny. Filings must show representative compounds, preparation steps and biological test results. Combinations under Section 3(e) need clinical proof of benefit beyond individual ingredients. Treatment methods stay barred under Section 3(i), though diagnostic devices and kits remain eligible.
Health researcher Dr Anant Bhan said standardised examination is key to fairness. He urged close scrutiny so affordable access is not compromised. Entod Pharmaceuticals CEO Nikkhil K Masurkar backed stricter scrutiny. But he urged a Regulatory Data Protection framework to reward original research.
The challenge is rewarding genuine innovation without blocking cheaper generics.
