Section 3(d) and Novartis

In one line

A new form of a known substance is not an invention unless it works better, and Novartis decided what "better" means.

In exam wording: clause (d) of section 3 of the Patents Act 1970 provides that the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance, or the mere discovery of any new property or new use for a known substance, or the mere use of a known process, machine or apparatus, is not an invention, unless such known process results in a new product or employs at least one new reactant; and the Explanation provides that salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes, combinations and other derivatives of a known substance shall be considered to be the same substance unless they differ significantly in properties with regard to efficacy; in Novartis AG v. Union of India (2013) 6 SCC 1 the Supreme Court dismissed the appeal against the refusal of a patent for the beta crystalline form of imatinib mesylate, marketed as Glivec.

The clause, taken apart

Three exclusions in one clause.

One. The mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance.

Two. The mere discovery of any new property or new use for a known substance.

Three. The mere use of a known process, machine or apparatus, unless such known process results in a new product or employs at least one new reactant.

The Explanation. Salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes, combinations and other derivatives of a known substance shall be considered to be the same substance unless they differ significantly in properties with regard to efficacy.

So the test is comparative. The new form is presumed to be the same substance. The applicant displaces that presumption by showing a significant difference in properties with regard to efficacy.

What the case decided

Novartis applied to patent the beta crystalline form of imatinib mesylate, marketed as Glivec. The Controller refused the application. The Supreme Court dismissed the appeal.

The reasoning to carry away. A new form of a known substance is not an invention unless it enhances the known efficacy of that substance, and for a medicine efficacy means therapeutic efficacy. Improvements in physical properties such as flow, stability or hygroscopicity, and improvements in bioavailability standing alone, do not establish enhanced therapeutic efficacy.

Why the clause exists. To prevent the extension of monopoly by successive small modifications of an existing medicine, sometimes called evergreening, and to keep the price of established medicines from being protected indefinitely.