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.
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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