Section 3(d) of the Indian Patent Act

Swiss pharma major Novartis lost a seven-year long legal battle for getting its blood cancer drug Glivec patented in India and to restrain Indian companies from manufacturing generic drugs, with the Supreme Court rejecting the multinational company’s plea.

A Supreme Court dismissed the claim of the Swiss firm for getting exclusive rights for manufacturing the cancer drug on the ground that a new substance has been used in the medicine.

Basel-headquartered Novartis had contested the rejection of its patent application for anti-cancer drug Glivec by the Indian patent office and subsequently by the Intellectual Property Appellate Board  (IPAB) and had challenged IPAB’s interpretation of section 3 (d) of Indian Patent Act.

The IPAB had upheld the contention of the Indian Patent Office that the drug, Glivec, is simply a new form of imatinib and hence not patentable as per Section 3 (d) of Indian Patent Act

This section states that inventions that are mere “discovery” of a “new form” of a “known substance” and do not result in increased efficacy of that substance are not patentable. This implied that India did not support patents for inventions which were minor modifications and prevented undue monopoly during the extended period of patent protection by the company.

Chapter II of the The Patents Act, 1970 on ‘Inventions not patentable’ reads as:

3. What are not inventions.—The following are not inventions within the meaning of this Act,—

(a) an invention which is frivolous or which claims anything obviously contrary to well established natural laws;
(b) an invention the primary or intended use or commercial exploitation of which could be contrary public order or morality or which causes serious prejudice to human, animal or plant life or health or to the environment;
(c)the mere discovery of a scientific principle or the formulation of an abstract theory or discovery of any living thing or non-living substance occurring in nature;
(d) 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 of 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.

Explanation.—For the purposes of this clause, salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes, combinations and other derivatives of known substance shall be considered to be the same substance, unless they differ significantly in properties with regard to efficacy;

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