Novartis patent case: Section 3(d) of Indian Patent Act explained

The Supreme Court has just rejected a patent claim by Swiss Pharma giant Novartis filed against Indian companies over its cancer drug Glivec (Known as Gleevec in Europe).

In its verdict, the Supreme Court said that the drug showed no new innovation or invention and therefore did not satisfy the criteria under section 3(d) of the Indian patent act.

But what is section 3(d)?

This section states that inventions that are a mere "discovery" of a "new form" of a "known substance" and do not result in increased efficacy of that substance are not patentable. This effectively means that if there is an old molecule in a new substance you cannot patent it by making a minor modification, and passing it off as a completely new invention.

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The act reads as follows:

"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".

Pratiba Singh, who represented Cipla in the Supreme Court, told Times Now that the law was designed to prevent pharma companies from trying to make minor modifications to drugs and passing them off as completely new medicines just to get a further 20 year patent period on its drugs.

According to the Economic Times, "The nub of the dispute is this interpretation of Section 3 (d) which would determine what is patentable and what is not". Patent advocates have warned that this could lead to the perception that India offers very weakprotectionfor Intellectual Property. However it has been welcomed by health advocates who say that this will provide better drugs for patients who would not ordinarily be able to afford them.

Novartis for its part claimed that India's Patents Act did not meet rules set down by the World Trade Organization and was in violation of the Indian constitution. Both claims were initially rejected by the Madras High Court.