evergreening and Section 3(d) of Indian patent Act

NOVARTIS VS GOVERNMENT OF INDIA

Importance of Section 3d of Indian Patent Act

Section 3 of Indian Patent Act defines what is not patentable. Section 3d gives out that the mere discovery of a new form of an old drug does not make it an invention. The section , as it is given in the Act is given below.

NOVARTIS VS GOVERNMENT OF INDIA

Importance of Section 3d of Indian Patent Act

Section 3 of Indian Patent Act defines what is not patentable. Section 3d gives out that the mere discovery of a new form of an old drug does not make it an invention. The section , as it is given in the Act is given below.

Section 3(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 new 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.

            In effect what section 3 of chapter II of the Indian Patent Act 1970 does is to define what is not patentable? Section 3(d) clearly says that a small change in the drug molecule by way of production of a derivative does not become equal to an invention.

The explanation as given in the Act is given above.

Novartis is fighting on two issues; one is that the patent examiner should not have rejected their patent application, another is that Section 3d of the Indian Patent Act is wrong and by putting it in the Act the Indian Government is doing something which is against its international obligations.