Monday, 8 April 2013

Humanizing Pharmacy


Supreme Court verdict on Novartis has established the sanctity of Indian Patent Laws and also sent a message across Big Pharma that its laws cannot be exploited. 

As the court struck down ‘evergreening’ of drugs and compulsory licensing already there with the authorities, India has enough power to stop arbitrary pricing of medicines in India by global Pharma giants. Supreme Court verdict on Novartis is the befitting answer to the devious practice of Big Pharmaceuticals who try to constantly extend the life of a drug-patent on frivolous grounds. The decision will benefit the Indian pharmaceuticals companies and also those poor people who by and large depend on the generic form of original drug. This stellar judgment has set a precedent for ongoing and upcoming patent cases which will go a long way to protect the availability of cheap generic drugs for poor patients. It will also drive other developing countries to follow the suit set in by Indian Patent Act.

In 2005 India conformed to the World Trade Organization’s intellectual property standards (1995 TRIPS Agreement), and retroactively accepted applications for product patents from 1995 for scrutiny. It is then that Novartis sought patent for its breakthrough blood cancer drug Glivec but Indian Patent Office, as per the amended Indian Patents Act, section 3(d) rejected its patent plea stating that inventions that are mere "discovery" of a "new form" of a "known substance" and do not result in increased efficacy of that substance are not patentable. Glivec which is a highly effective treatment for leukemia is nothing more than an altered version of beta-crystalline form of the imatinib mesylate compound, thus doesn’t require a patent. Novartis further claimed against this judgment in Madras High Court and also in Intellectual Appellate Board but both the institution dismissed its petition on the same ground, which has now finally been rejected by Indian apex court as well.

Novartis including other multi-national pharmaceuticals are criticizing the ruling stating that Indian patent laws aren’t robust enough to protect intellectual property rights. But the criticism is unfair as drug-companies are known to tweak with the existing molecules to show novelty and thus try to get an extension of drug-patent, a practice popularly known as ‘evergreening’. India rather deserves praise that its patent act is strong enough to keep a check over this unjustified tendency of Big Pharma. They have also threatened India to not invest in Research & Development in the country but the fact that Indian pharmaceuticals market is world’s fourth largest by volume and fourteenth largest by value, hardly any drug industry can afford to treat India as pariah in pharma sector.

Drug patents which are meant for fresh and authentic innovation have only enticed big pharma companies to make super-profits at the expense of social good and well-being. If Novartis were to get its patent on Glivec, it would have forced Indian Pharmaceuticals companies to stop producing generic drugs, thus making the drug non-accessible to a good chunk of poor population in developing world as one tablet of Gleevec, patented in US costs around 1.2 lakh while its generic form, Glivec manufactured by an Indian pharma company Resonance is available at 30/- per tablet.

Supreme Court verdict on Novartis has established the sanctity of Indian Patent Laws and also sent a message across Big Pharma that its laws cannot be exploited. It has marked the beginning of a new era of patent system to regulate the pharma sector.








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