Novartis AG v Union of India
(2013) 6 SCC 1 · Supreme Court of India · 1 April 2013
- Issue
- Whether the beta crystalline form of imatinib mesylate, a known substance, was patentable under Section 3(d) of the Patents Act, 1970.
- Held
- The Court refused the patent. For medicines, "efficacy" in Section 3(d) means therapeutic efficacy, and improved physical properties such as better flow or stability did not show enhanced therapeutic efficacy.
- Why it matters
- Section 3(d) is a real hurdle for incremental pharmaceutical inventions in India. Applicants should plan the evidence of therapeutic advantage when drafting, not at the objection stage.
