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PORTSIDE  March 2012, Week 2

PORTSIDE March 2012, Week 2

Subject:

India Orders Bayer to License a Patented Drug (2 items)

From:

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Reply-To:

[log in to unmask]

Date:

Tue, 13 Mar 2012 20:36:43 -0400

Content-Type:

text/plain

Parts/Attachments:

Parts/Attachments

text/plain (129 lines)

India Orders Bayer to License a Patented Drug (2 items)

By VIKAS BAJAJ and ANDREW POLLACK

The New York Times
March13, 2012

http://www.nytimes.com/2012/03/13/business/global/india-overrules-bayer-allowing-generic-drug.html?emc=eta1

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.

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.

To read more, go to 
http://www.nytimes.com/2012/03/13/business/global/india-overrules-bayer-allowing-generic-drug.html?emc=eta1

= = =

India Government Ruling 'Effectively Ends' Bayer's Monopoly
on Cancer Drug
 
Common Dreams staff 
Common Dreams
March 13, 2012

http://www.commondreams.org/headline/2012/03/13-3

The Indian government will allow a local company to
manufacture a generic version of the cancer drug Nexevar,
which is currently patented by Bayer.

The government's ruling is based on a trade law that gives
the government power to allow the manufacturing of generic
versions of otherwise unaffordable drugs. It enables Natco
Pharma to create a version of Nexevar that will cost $176 for
120 tablets. Bayer was charging about $5,600 for the same
amount.

The government action is significant for many reasons, most
notably in that it represents the first time in India a
company has been granted a "compulsory license" to
manufacture and sell a patented drug. Under the agreement,
Bayer will receive 6 percent in royalties from Natco Pharma.

From a BBC report:

A spokesman for Natco Pharma said that the drug, used to
treat kidney and liver cancer, was needed by about 8,800
cancer patients in India.

"This is a victory for Indian patients and for India's
generic manufacturers, which are under attack,'' said
Madineedi Adinarayana, general manager of Natco Pharma.

He said "many more such cases will follow".

Between 2011 and 2012, many drug makers will lose patent
protection on their best-selling products, opening up the
market to cheaper copy-cat drugs made in countries such as
India and China.

They include drugs such as Lipitor, an anti-cholesterol pill
manufactured by the world's largest drug maker, Pfizer.

Bayer, which generates about $40 billion in revenue annually,
opposed the policy. ""We are disappointed about this
decision,'' Bayer spokeswoman Sabina Cusimano told the the
Associated Press. "We will see if we can further defend our
intellectual property rights in India."

Reuters reported on the potential impact the ruling could
have on the affordability of drugs used for HIV and AIDS.

India's move to strip German drugmaker Bayer of its exclusive
rights to a cancer drug has set a precedent that could extend
to other treatments, including modern HIV/AIDS drugs, in a
major blow to global pharmaceutical firms, experts say.

On Monday, the Indian Patent Office effectively ended Bayer's
monopoly for its Nexavar drug and issued its first-ever
compulsory license allowing local generic maker Natco Pharma
to make and sell the drug cheaply in India.

It is only the second time a nation has issued a compulsory
license for a cancer drug after Thailand did so on four drugs
between 2006 and 2008, also on affordability grounds.
Thailand also issued licenses for HIV/AIDS and heart disease
treatments.

"This could well be the first of many compulsory rulings
here," said Gopakumar G. Nair, head of patent law firm
Gopakumar Nair Associates and former president of the Indian
Drug Manufacturers' Association.

___________________________________________

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