[Ip-health] Govt cautious on cancer drug patent regimes

Shailly Gupta shailly.gupta at geneva.msf.org
Fri Feb 28 22:28:53 PST 2014



NEW DELHI: Amid heightened scrutiny of the intellectual property regime, the
government has decided to tread with caution on a compulsory licence for a
cancer drug to ensure that its decision is in line with the legal

While compulsory licencing, which entails waiver of patent under extreme
situations, for three
<http://timesofindia.indiatimes.com/topic/cancer-drugs> cancer drugs was
being pushed by the health ministry, the issue is now limited to Dasatinib,
a medicine to treat a type of cancer of the white blood cells, for which
Bristol-Myers Squibb (BMS) holds a patent.

Sources said that the commerce and industry ministry recently wrote to the
health ministry, rejecting the plea that the government should issue a
compulsory licence under section 92 of the Patents Act. Using this
provision, the government can only waive the BMS's patent rights in case of
a national emergency or a circumstance of extreme urgency, which was not the
case at the moment.

There is a third possibility as well, which is to suspend the rights for
public non-commercial use in special circumstances, including public health
crisis. In fact, the Patents Act has listed AIDS, HIV, tuberculosis, malaria
and other epidemics as examples.

Sources said that in case of Dasatinib, this provision may be used but then
the health ministry has to clearly show that it has the budget to procure
the medicine and supply it under a plan for cancer patients. "You can't
expect a manufacturer to sell the medicine below cost," said a source.

Sources said that the commerce & industry ministry has pointed out that
availability of patented drugs at affordable prices, which is being cited by
the health ministry for granting a patent waiver, should not be dealt by the
government. In fact, the health ministry was recently told that section 84
of the Patents Act clearly stipulates that compulsory licence can be issued
if a "patented invention is not available to the public at a reasonably
affordable price".

But the government does not have powers under the law to suspend patent
rights on the grounds of affordability. The law only allows the Patent
Office, which is an independent agency, to issue a compulsory licence. Last
October, the  <http://timesofindia.indiatimes.com/topic/Patent-Office>
Patent Office had rejected an application from BDR Pharma to make a generic
version of BMS's Dasatinib, which is sold under the Sprycel brand. The
proposal was rejected on the grounds that the Indian company did not make
enough efforts to obtain a voluntary licence for the anti-cancer drug.



Shailly Gupta

Advocacy and Communication Officer

MSF Access Campaign

K-30 First Floor, Jangpura Extension

New Delhi -  14

Ph: +91-11-41823783/84

M: +91-9899976108


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