The patent Act 1970 does not explain what inventions are; rather, it outlines what are not inventions. Section 3 of the Act provides for various situations where the invention cannot be patentable. It provides for about 15 kinds of inventions that cannot be patentable. One such is ‘mere discovery of a new form of known substance envisaged under clause (d) of section 3. It says that mere discovery of a new form of a known substance that does not result in enhancement of known efficacy of that substance cannot be patentable. However, there was no clarity to the term’s ‘efficacy’, ‘enhancement’ and ‘known-substance.
Novartis AG v. Union of India is a landmark case of Supreme Court concerning section 3(d) of Patents Act, 1970. It is a case where the beta-crystalline form of the known substance ‘Imatinib Mesylate’ was in question as to whether it constitutes a new invention and can be patentable. It played a significant role in analysing section 3(d) and discussed the meaning of the term’s ‘efficacy’ and what constitutes ‘enhancement of efficacy’ of a known substance. Through the analysis of this case, we can under the rationale taken by the supreme court behind rejecting the patent.