03 April, 2013

Novartis and the verdict


The major discussion in all the international news channels these two days was the legal battle Novartis led for the patent right for their cancer medicine Glevic  in India. It lost the legal battle which began in the year 2006. But who won the case?

As propagated in the media, the chief beneficiaries of Monday's Supreme Court ruling will be India's Cipla Ltd and Natco Pharma Ltd, which already sell generic Glivec in India at around one-tenth of the price of the branded drug. It is a victory to all the Generic produces as India is the factory of the generic medicine producing 20% of the world’s generic medicine.

The patent rights and the rules in India is different from other countries as the Novartis found it easy to get the patent rights in 40 other countries including US, Russia and China.  Novartis’s patent application was rejected in part because of Section 3(d) of India’s patents act. It is as follows.

Section 3(d) is one of those provisions. It explicitly requires that patents should only be granted on medicines that are truly new and innovative. For new forms and new uses of existing medicines, Section 3(d) requires patent applicants to prove significantly improved efficacy before a patent can be granted. 

Novartis was arguing that a new "beta crystalline" form of Glivec is more effective and hence qualifies as a new invention, and hence should get patent protection. India has refused protection for Glivec on the grounds that it is not a new medicine, but an amended version of a known compound. The Supreme Court, in a 112-page analysis of all the claims and counter- arguments disagreed. It said that the beta crystalline form was nothing new. It has always existed in the original amorphous form.

Whatever it is, the basis on which the verdict is issued is to be considered. For the other developed countries the intellectual property and its rights and the research costs are important but for India, a land which houses millions of poor people, a judgment based on the consideration for the poor and needy was important and it was what mattered.

India has an estimated 3 lakh CML (chronic myeloid leukemia) patients, with 20,000 added every year. Glivec is sold by Novartis for about Rs 1.2 lakh per month. Indian manufacturers sell the same drug at a monthly cost of Rs 8,000. Moreover Novartis has reported a net profit of $9.6 billion in 2012 on sales of $57 billion Glivec sold. In a land where 40% of the population earn less than 1.25$ a day, this judgment is justifiable. This judgment gave a huge sigh of relief from thousands of patients in India and in dozens of developing countries as the fear of an almost 15-fold escalation of drug costs receded.

It was a decision or a justice done for the poor. In a land where a rough 20,000 new patients of leukemia spring up, this decision is justifiable. An objective justice is not suitable here. May be Jesus’s way of knowing the victim and the subjective understanding of the accused before judging them is an example.

I understand this situation better since I know a family which lost their father due to leukemia only after selling their whole property and house to treat him. The whole life’s saving of the family was spend on him but could not save him at the end. As a person who saw the tears in the eyes of their family in losing him and later the wet eyes not having enough to live on still, I welcome the decision of the supreme court with both the hands open and appreciate the concern of the judges for the poor.


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