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(Question 13: Page 114, paragraph 250)

According to the Secretariat report, "Section 3(d) of the Patent Act refers to the scope of patentability of pharmaceutical and other chemicals and calls for proof of the efficacy of the substance." Japan would like to know how ''efficacy'' is measured.

(1) According to the explanation of Section 3(d) in India's "MANUAL OF PATENT OFFICE PRACTICE AND PROCEDURE" published in last March which says that "In a recent case in relation to a pharmaceutical substance, the Madras High Court held that efficacy means therapeutic efficacy". With regard to pharmaceutical substance related inventions, please indicate whether "efficacy" means only therapeutic efficacy, or not.

(2) Please indicate whether there are any differences between the definition of efficacy for pharmaceutical substance related inventions and that for other chemical substance related inventions.

Reply: According to Section 3(d) of the Indian Patents Act, 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 is not an invention and hence not patentable. The explanation given under Section 3(d) of the Indian Patents Act further elaborates on application of efficacy criteria to salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes, combinations and other derivatives of known substance. The explanation to Section 3(d) further clarifies that these substances may be considered as patentable only if they differ significantly in properties with regard to efficacy.

The Examiner on a case to case basis applies the test as to what constitutes such salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes, combinations and other derivatives to differ significantly in properties with regard to efficacy from the known substance. The complete specification may bring out clearly and categorically in the description, as to how the subject matter differs significantly in properties with regard to efficacy from the known substance thereof.

In a recent case (Novartis AG Vs. Union of India, W.P. No. 24760/06), the Madras High Court held that in relation to a pharmaceutical substance, the efficacy means therapeutic efficacy. It was held that:

"… what the patent applicant is expected to show is, how effective the new discovery made would be in healing a disease and having a good effect on the body? In other words, the patent applicant is definitely aware as to what is the "therapeutic effect" of the drug for which he had already got a patent and what is the difference between the therapeutic effect of the patented drug and the drug in respect of which patent is asked for."