[Ip-health] Reuters: U.S. fears for patents on next-generation drugs in India

Thiru Balasubramaniam thiru at keionline.org
Fri Mar 7 03:54:20 PST 2014


U.S. fears for patents on next-generation drugs in India


NEW DELHI/MUMBAI Thu Mar 6, 2014 4:15pm IST

(Reuters) - The United States on Thursday voiced concern over protection of
patents on safer and more effective next-generation medicines in India amid
fears that authorities are considering allowing more Indian firms to make
new varieties of cheap generic drugs still on patent.

An Indian committee is reviewing up to a dozen patented drugs to see if
so-called compulsory licences, which in effect break exclusivity rights,
can be issued for some of them, two senior government officials said last

"I understand that India has issued one compulsory licence, but there's a
lot of concern about what additional licences are being considered," U.S.
Assistant Secretary of State Nisha Biswal told reporters in the Indian

"There's concern about ... whether next-generation drugs would be
protected, and how do you ensure that investments that are being made to
develop ever-more effective drugs can then be continued."

In 2012, India issued its first-ever compulsory licence to domestic
drugmaker Natco Pharma Ltd
on a kidney and liver cancer drug, Nexavar, patented by Germany's Bayer AG (
BAYGn.DE <http://in.reuters.com/finance/stocks/overview?symbol=BAYGn.DE>).

That and a series of recent decisions on patented drugs in India, as part
of New Delhi's push to increase access to life-saving treatments, is at the
centre of trade friction between Asia's third-largest economy and the
United States.

Like other emerging markets, such as South Africa and China, India is
battling to bring down healthcare costs and boost access to drugs to treat
diseases such as cancer, HIV/AIDS and hepatitis.

Western drugmakers, including Pfizer Inc
Novartis AG (NOVN.VX<http://in.reuters.com/finance/stocks/overview?symbol=NOVN.VX>),
Roche Holding AG
and Sanofi SA (SASY.PA<http://in.reuters.com/finance/stocks/overview?symbol=SASY.PA>),
covet a bigger share of the fast-growing drugs market in India.

But they have been frustrated by a series of decisions on patents and
pricing, as part of New Delhi's push to increase access to treatments in a
country where only 15 percent of the 1.2 billion people have health

"The constant threat of compulsory licences hangs like a Damocles sword
over patent-holders," Ranjit Shahani, vice chairman and managing director
of Novartis' India unit, told Reuters in an interview on Tuesday.

"Over the past two years, the government of India has issued several
intellectual property decisions that disproportionately impact innovative
biopharmaceutical companies," he said. "Not only is this a concern for
business in the Indian market, but also in other emerging markets that may
see India as a model to be emulated."

India is on the U.S. government's Priority Watch List - countries whose
practices on protecting intellectual property Washington believes should be
monitored closely.

U.S. industry trade group Pharmaceutical Research and Manufacturers of
America (PhRMA) believes Washington should take a tougher line by
downgrading it to a Priority Foreign Country, a classification for the
worst offenders, which could trigger possible actions, sources said last

If India is relegated by the U.S. to Priority Foreign Country level, it
would join Ukraine as the second country in that segment. Countries in the
Priority Watch List include China, Indonesia, Pakistan, Russia, Thailand
and Argentina.

(Writing by Sumeet Chatterjee; Editing by Ron Popeski)

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