The Novartis Case : A Summary- By Pravar Veer Misra

The Novartis case polarized opinions across the globe. The Supreme Court of India in this case was faced with the difficult question of the rights of innovators vis a vis the benefit of the public at large. While some believed the supreme court took a very narrow view to deny Novartis a patent , others hailed it as a progressive judgement both from the point of view of law as well as the benefit to the public . Was the court right in deciding how it did ? Decide for yourself. Consider the facts .

India Joined the Trade Related Intellectual Property Rights (TRIPS) patent regime after becoming a part of World Trade Organization in 1995 . After this, India had to make changes to its Patent laws to conform to TRIPS. Novartis had patented a salt called imantib in the USA. From this salt it developed a Beta Crystalline version of the salt. This new development is what it called Glivec and it is a drug for treating cancer. Novartis filed for a patent for Glivec in India which was rejected at the first instance and by the appellate body. Thus, the case came before the Supreme Court.

The whole case hinged on the issue of the interpretation of Section 3(d) of the act , which reads as follows.

“S 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 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”

The case was decided on the underlined portions of the section. While Novartis did show change in chemical properties of Glivec vis a vis imantib , the court held it was not enough. The court reasoned that firstly imantib is a known substance. Thus , looking at the underlined portion of the explanation to the section , Glivec which was a derivate of Imantib would only be an invention if it differed significantly I properties with regard to efficacy. Thus mere difference in properties wasn’t enough , the difference had to be with regard to efficacy. Novartis was not able to demonstrate this and thus were denied a patent

This case was very important as it allowed generic manufacturers in India to manufacture a drug for cancer patients at a much cheaper price compared to Novartis. Needless to say, this has greatly benefited Cancer patients in India. Additionally, the message sent by the court was that corporations could not undertake evergreening of patents in India by merely making cursory changes to known inventions.

Pravar Veer Misra – 4th Year Student , The West Bengal National university of Juridical Sciences , Kolkata