[Ip-health] FT: Bayer loses bid to block cheap version of cancer drug in India

Thiru Balasubramaniam thiru at keionline.org
Fri Dec 12 08:56:46 PST 2014


http://www.ft.com/intl/cms/s/0/36a2d942-8202-11e4-a9bb-00144feabdc0.html


December 12, 2014 4:01 pm
Bayer loses bid to block cheap version of cancer drug in India

Andrew Ward in London and Amy Kazmin in New Delh

Bayer <http://markets.ft.com/tearsheets/performance.asp?s=de:BAYX> has lost
its bid to block a cheap version of the German company’s Nexavar cancer
drug from the Indian market in a landmark ruling that will ensure access to
a life-extending medicine. But the decision will also reinforce industry
concerns over threats to intellectual property in the world’s second-most
populous nation.


The Indian Supreme Court rejected Bayer’s appeal against a decision by the
country’s patent controller in 2012
<http://www.ft.com/cms/s/0/0b00c0cc-0263-11e2-b41f-00144feabdc0.html#axzz3LaOxsVdT>
to
override the company’s monopoly on Nexavar, which treats kidney and liver
cancers.


The case has been closely watched as a test of India’s willingness to challenge
drug patents
<http://www.ft.com/cms/s/0/2cc8d306-6f3b-11e4-8d86-00144feabdc0.html?siteedition=uk#axzz3LaOxsVdT>
and
the associated high prices that keep many medicines out of reach of all but
the wealthiest members of society.


Bayer has been fighting against the issuing of a compulsory licence that
allowed Natco, an Indian generic drugmaker, to sell Nexavar for just $173 a
month compared with the $5,500 a month charged by the German company.


On Friday, Bayer said it was “disappointed” by the Supreme Court decision.
“We are analysing the order and will determine any future course of action
afterwards.”


The Lawyers Collective, an Indian human rights group, described it as a
“momentous decision that would have wide-ranging implications for access to
medicines”. Médecins Sans Frontières, the medical charity, praised “the
independence of the Indian judiciary” in the face of industry lobbying
<http://www.ft.com/cms/s/0/bdaf5880-96de-11e3-a274-00144feab7de.html#axzz3LaOxsVdT>
.


Indian courts have recently rejected patent applications
<http://www.ft.com/cms/s/0/7e7dbd46-9a95-11e2-b982-00144feabdc0.html#axzz3LaOxsVdT>
on
drugs from Novartis
<http://markets.ft.com/tearsheets/performance.asp?s=ch:NOVN> and Roche
<http://markets.ft.com/tearsheets/performance.asp?s=ch:ROG>, fuelling
tensions with the industry as well as with western governments. The US has
kept India on a “watchlist” of intellectual property violators.


However, Nexavar is the only case so far in which India has issued a
compulsory licence under rules that allow the government and companies to
seek permission to overturn drug patents in the interests of public health.


India’s government in New Delhi had no involvement in the application by
Hyderabad-based Natco to apply for a Nexavar licence nor in the patent
controller’s decision to grant it.


Activists complain that few Indian generics producers are willing to pursue
such licences because many have manufacturing, marketing or distribution
tie-ups with the big innovative drug companies.


“There is a huge amount of pressure from multinational companies
discouraging their Indian partners from filing these applications,” said
Leena Menghaney, who works for the MSF campaign on access to affordable
medicines.


Activists had previously appealed to the Indian government to issue
compulsory licences for the breast cancer drug Herceptin, but Roche
subsequently decided to withdraw its patents on the medicine in India. The
drug is now widely available to Indian patients at a fraction of its
previous price.


Nearly 70 per cent of Indian healthcare expenses are paid out of pocket by
patients or their families.


Western drugmakers often accuse India of using public health as a pretext
for boosting the country’s big generic pharmaceuticals industry. They worry
that cheap copies of patent-protected medicines will be exported to other
markets and that India’s approach risks undermining global drug development.


Shamnad Basheer, an intellectual property rights lawyer, and founder of
SpicyIP, a blog focused on intellectual property rights issues, said big
pharma’s biggest fear was that India would set a precedent for other
emerging economies such as Brazil and South Africa. “They think other
countries will pick up the Indian standard.”



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