[Ip-health] Andrew Jack in the FT on the Bayer CL

Jamie Love james.love at keionline.org
Mon Mar 12 10:52:52 PDT 2012


March 12, 2012 5:13 pm
India approves generic cancer drug
By Andrew Jack in London and James Fontanella-Khan in New Delhi

India has undermined the patent on a cancer medicine made by Bayer, in
a groundbreaking move praised by patient activists for increasing
access to a costly drug, but which risks setting back the country’s
efforts to attract pharmaceutical industry investment.

Mumbai’s Controller of Patents ruled on Monday that Natco, an Indian
generic drugs company, could sell Nexavar, known generically as
sorafenib tosylate, at just 3 per cent of the price charged by Bayer
of Germany.

The action is a rare example of the use of a “compulsory licence” for
drugs, a procedure to override intellectual property rights to boost
access which is permitted under World Trade Organisation rules but
used infrequently.

It marks a shift away from the focus on antiretroviral medicines for
HIV, as emerging economies struggle to meet the rising costs of
non-communicable and “lifestyle” diseases.

Michelle Childs, director of policy at Médecins sans Frontières’
Access Campaign, said: “This decision serves as a warning that when
drug companies are price-gouging and limiting availability, there is a

Bayer said: “We are currently evaluating our legal options to continue
to defend our intellectual property rights.”

The company argued it was making the drug available to patients on low
incomes, although activists said that its Indian “patient assistance
programme” reached only about 40 of the estimated 8,000 needing
treatment in the country.

There is intensifying pressure on medicine prices in India, with other
generic companies led by Cipla seeking to overturn patents on a range
of drugs, in a challenge that large pharmaceutical groups argue
undermines their ability to generate income for reinvestment in

Bino Pathiparampil, an analyst at India Infoline in Mumbai, said: “The
decision taken by the regulator shows that it is slightly bending in
favour of patients’ interests, so we can expect many other Indian
companies to try and exploit this. [But] big pharma companies will put
a lot of pressure on the government to intervene, they will threaten
to cut investments in India, we’ve seen it before.”

Under the terms of the latest ruling – which could still be the
subject of an appeal – Natco is authorised to sell the drug within
India at $174 a month per patient, compared with $5,500 by Bayer, for
the remainder of the Germany company’s patent until 2020. It must pay
Bayer a 6 per cent royalty.

The action potentially opens the way for Natco to sell the drug into
other developing countries which do not have patents on Nexavar.

The Nexavar decision comes ahead of a landmark Supreme Court hearing
later this month which will pit Novartis against the Indian
government’s patent office, which did not grant the Swiss drugmaker an
exclusive patent for its anti-cancer drug Glivec.

James Love.  Knowledge Ecology International
http://www.keionline.org, +1.202.332.2670, US Mobile: +1.202.361.3040,
Geneva Mobile: +41.76.413.6584, efax: +1.888.245.3140.  Sometimes I am
using my MaxRoam number: +447937390810

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