In Novartis AG v. Union of India, (2013) 6 SCC 1, the Supreme Court in…

Question

In Novartis AG v. Union of India, (2013) 6 SCC 1, the Supreme Court interpreted 'efficacy' in Section 3(d) Patents Act 1970 to mean:

Accepted Answer

A. THERAPEUTIC EFFICACY — for pharmaceutical substances, this means measurable medical benefit, not merely improved physical properties

1. In Novartis AG v. Union of India (2013), the Supreme Court denied Novartis a patent for the beta crystalline form of Imatinib Mesylate (Glivec).
2. The Court interpreted 'efficacy' in Section 3(d) to mean 'THERAPEUTIC EFFICACY' for pharmaceutical substances — measurable medical benefit (improved bioavailability alone was held NOT sufficient to demonstrate enhanced therapeutic efficacy).
3. The Court emphasised that Section 3(d) aimed to prevent EVERGREENING of patents.
4. The decision strengthened India's generic pharma industry's position.
5. Hence option B is correct.
_Source: Patents Act 1970 / Copyright Act 1957 / Trade Marks Act 1999 (Bare Acts, IPIndia portal + Copyright Office) — Novartis AG v. Union of India, (2013) 6 SCC 1_

Answer

any improvement in the chemical or molecular characteristics of the substance (cf. Novartis AG v. Union of India, (2013) 6 SCC 1)

Answer

any economic advantage or market premium that the new form can command in India (cf. Novartis AG v. Union of India, (2013) 6 SCC 1)

Answer

any change in colour, particle size or melting point of a known pharmaceutical substance (cf. Novartis AG v. Union of India, (2013) 6 SCC 1)