The United States has 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 month.
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"I understand that India has issued one compulsory
licence, but there's a lot of concern about what additional licences are being
considered," US Assistant Secretary of State Nisha Biswal told reporters
in the Indian capital.
"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.
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,
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Western drugmakers, including Pfizer Inc, Novartis AG, Roche
Holding AG and Sanofi SA, covet a bigger share of the fast-growing drugs market
Only 15 percent have
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% 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.
"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 US government's Priority Watch List –
countries whose practices on protecting intellectual property Washington
believes should be monitored closely.
US 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 month.
If India is relegated by the US 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
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