Dear Friends
The New York Times has news items today that I find read like a fiction (13 03
2012).
1. India Orders Bayer To License a Patent Drug
2. India Starts Letting Students Lab Experiments Online
3. Sears, Once Outfitters of Westward Expansion, Now Stocks Saris
4. Image of The Day: March 12
5. The Great Gatsby Come To India
-bhuban
INDIA ORDERS BAYER TO
LICENSE A PATENT DRUG
MUMBAI, India — India’s government on Monday authorized a drug manufacturer to
make and sell a generic copy of a patented Bayer cancer drug, saying that Bayer
charged a price that was unaffordable to most of the nation.
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Bayer and Onyx Pharmaceuticals
Cipla makes an inexpensive version of Bayer's Nexavar, a drug for liver and
kidney cancer.
The decision by the controller general of patents, designs and trademarks was
the first time a so-called compulsory license of a patented drug had been
granted in India.
Legal specialists and patient advocates said it could open the door to a flood
of other compulsory licenses in India and possibly in other developing
countries, creating a new supply of cheap generic drugs.
According to the decision, Bayer must license the drug Nexavar, or sorafenib,
to Natco Pharma, an Indian company. In exchange, Natco must pay Bayer a 6
percent royalty on its net sales and must sell the drug for 8,800 rupees ($176)
a month, about 3 percent of the 280,000 rupees ($5,600) that Bayer charges for
it in India. Natco’s drug will be for use only in India, the decision said.
Nexavar, which Bayer developed with Onyx Pharmaceuticals, a California
biotechnology company, is used to treat advanced kidney cancer and liver cancer
and has been shown to extend lives by a median of about three months. Fewer
than 200 Indians used the drug, a tablet, in 2011. Advocates for cheaper
generic medicines cheered the decision, which they said could provide a model
for developing countries.
“I think it’s the way forward,” said Shamnad Basheer, a professor at West
Bengal National University of Juridical Sciences, who has written extensively
about the case. “In the entire debate about patents, this is the middle path.”
But Western drug companies are likely to see the decision as another example of
how India does not provide the intellectual property protection necessary to
recoup the cost of developing medicines. India did not grant patents on drugs
at all for 35 years until 2005, helping its manufacturers become the world’s
leading exporters of inexpensive generic pills.
In another closely watched case, India’s Supreme Court is expected late this
month to hear an appeal by Novartis over the denial of a patent for the cancer
drug Gleevec, a patent the company says has been granted by more than 40
countries. That case concerns eligibility for a patent, not the compulsory
licensing of an already granted patent, as in the Bayer case.
Oliver Renner, a spokesman for Bayer at its headquarters in Leverkusen,
Germany, said the company was disappointed by the decision and was “evaluating
our legal options to continue to defend our intellectual property.”
Though multilateral agreements on patents allow compulsory licenses for drugs
for public health reasons, only a handful of countries, including Brazil and
Thailand, have issued such licenses, said Jamie Love, director of Knowledge
Ecology International, a Washington group involved with patents and human
rights. Most were for AIDS drugs, an area where drug companies have been
pressed not to enforce patents.
India is only the second country, after Thailand, to grant a compulsory license
to a cancer drug, Mr. Love said.
“The companies have really tried to draw the line very aggressively against
cancer and other diseases being included,” he said. The United States
government, through trade pressure and trade agreements, has also tried to
limit use of compulsory licensing.
The decision on Monday activates a provision of Indian law that has not been
tested since the country started granting patents for drugs in 2005. The
provision states that a compulsory license may be granted if an invention is
not available to the public at a “reasonably affordable price.”
In his decision, the patent controller, P. H. Kurian, said the paltry use of
Nexavar in India clearly showed that the drug was unaffordable. He said a
compulsory license could be granted because Bayer had not manufactured the drug
in India and was treating only a tiny portion of Indians with liver or kidney
cancer.
Bayer argued that the reasonableness of the price should reflect the
development costs, not only the public’s buying power. It also said a
compulsory license was not necessary because an inexpensive version of Nexavar
was already being sold in India by another generic company that has said it
does not need to recognize Bayer’s patent. Bayer has sued that company, Cipla,
which is based in Mumbai, claiming patent infringement in a separate case that
is pending.
Mr. Kurian rejected that argument, writing that Bayer was engaged in
“two-facedness” by trying to fight Cipla’s drug while using it as a defense
against Natco.
If Mr. Kurian’s ruling survives what is likely to be an appeal to the courts,
other Western drugs might become vulnerable to compulsory licenses, because
they typically cost more than many people in India can afford.
Leena Menghaney, a manager with Doctors Without Borders based in New Delhi,
said a compulsory license could help significantly reduce the $1,800 her
organization spends per patient annually to provide the AIDS drug raltegravir,
which Merck sells under the brand name Isentress, to a group of patients in
Mumbai.
Monday’s decision is likely to have little immediate financial impact on Bayer
and Onyx, because so little Nexavar is being sold in India. Global sales of the
drug in 2011 were 725 million euros, or about $950 million.
Still, with sales growth slowing in the United States and Western Europe, drug
companies have been looking to emerging markets like India as sources of growth.
A version of this article appeared in print on March 13, 2012, on page B2 of
the New York edition with the headline: India Orders Bayer to License a
Patented Drug.
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