Section 3(d) of the Patents Act: A 2026 Survival Guide for Pharma

Section 3(d) of the Patents Act: A 2026 Survival Guide for Pharma

Section 3(d) remains the most formidable barrier for pharmaceutical companies in India, specifically designed to prevent “evergreening.” In 2026, the test for “enhanced efficacy” is strictly interpreted as therapeutic efficacy rather than mere physical improvements like better stability or shelf-life. To succeed, patent applicants must provide comparative clinical data proving that a “new form” of a known substance significantly improves patient treatment outcomes.

Navigating the 2026 “Enhanced Efficacy” Standard

At DURRO IP, we advise our pharma clients that “mere discovery” is not “invention.” The 2013 Novartis precedent remains the gold standard, but 2026 practitioners must also account for:

• The Explanation Clause: Salts, esters, polymorphs, and other derivatives are legally considered the “same substance” unless a major jump in healing power is documented.
• Post-Filing Evidence: The Indian Patent Office increasingly scrutinizes data submitted after the initial application. Your primary filing must be “born healthy” with robust efficacy benchmarks.

Strategic Note for 2026

With India being the “pharmacy of the developing world,” Section 3(d) is your firm’s best tool for ensuring public health access while rewarding genuine, non-trivial medical breakthroughs.