[Ip-health] LiveMint: India’s patent protection regime will be a key issue in next month’s strategic dialogue with the US, NATCO CL to be issue

Jamie Love james.love at keionline.org
Wed May 9 12:12:04 PDT 2012


* A senior official in the health ministry characterized the flap over
the Nexavar case as a "trade war" between Indian drug companies and
multinational pharmaceutical firms.
* Mira Shiva is quoted.

http://www.livemint.com/2012/05/07221037/India8217s-patent-protectio.html

Mon, May 7 2012. 10:10 PM IST
India’s patent protection regime to be key issue in talks with US

Next month’s dialogue takes place ahead of a hearing in SC on an
appeal by Novartis seeking an extension of its patent on Glivec

Vidya Krishnan

New Delhi: India’s patent protection regime will be a key issue in
next month’s strategic dialogue with the US, against the backdrop of a
landmark ruling by the Indian patent office allowing Natco Pharma Ltd
to make and sell a copy of German drug maker Bayer AG’s patented
cancer treatment Nexavar.

This month, the US Trade Representative (USTR) put India on a priority
watch list for allegedly providing insufficient protection and
enforcement of intellectual property rights. The USTR report urged
India "to continue to work to streamline its patent opposition
proceedings".

It added, "the United States will closely monitor developments
concerning compulsory licensing of patents in India following the
broad interpretation of Indian law in a recent decision by the
Controller General of Patents, while also bearing in mind the Doha
Declaration on TRIPS and Public Health."

TRIPS is short for trade-related intellectual property rights.

In March, India’s Controller General of Patents passed an order
allowing Hyderabad-based Natco Pharma to manufacture and market a
generic version of Nexavar—the first time an Indian firm was granted a
so-called compulsory licence, which permits a generic drug producer to
make and sell its version of a patented drug without the consent of
the patent holder.

The drug, patented by Bayer in India in 2008, is used in the treatment
of liver and kidney cancer, and costs Rs 2.8 lakh for a month’s
dosage. The patent office stipulated that Natco price the drug at Rs
8,880 for a pack of 120 tablets (a month’s dosage) and pay 6% of net
sales as royalty to Bayer.

Soon after the verdict, US commerce secretary John Bryson, who was
visiting India in March, told commerce and industry minister Anand
Sharma that the US was "deeply concerned" over the issue, which he
said may weaken the global patent regime under TRIPS. Bayer has
appealed against the patent office’s ruling.

A senior official in the health ministry characterized the flap over
the Nexavar case as a "trade war" between Indian drug companies and
multinational pharmaceutical firms.

"The Indian government has put its weight behind Indian drug companies
so far and will continue to resist pressure to agree to TRIPS plus,"
said this person who did not want to be identified. "There is a
sustained campaign to call India generic drugs substandard. If any
trading partner feels that India has violated the trade agreement, the
right platform to bring up the issue is the World Trade Organization
(WTO) instead of arm-twisting in bilateral meets."

TRIPS plus is a reference to provisions that are in addition to the
patent requirements of WTO.

Next month’s dialogue in the US takes place ahead of the July hearing
in the Supreme Court on an appeal by Swiss drug maker Novartis AG
seeking an extension of its patent on the cancer drug Glivec. Novartis
has argued that its patent on the drug should be extended as it has
increased its efficacy by 30%.

The compulsory licence granted to Natco Pharma was welcomed by some
developing countries and healthcare groups as a step towards making
costly cancer therapies accessible to the poor. International drug
makers said the move would kill the incentive for drug research and
didn’t respect intellectual property rights.

Pressures on the trade front have only grown in the years since the
creation of WTO in 1995, said public health activist and coordinator
of the All India Drug Action Network (AIDAN) Mira Shiva.

"Multinational drug companies are going to insist on stronger and
stronger IPR because the Indian generic industry is a threat to them,"
Shiva said. "The report (by USTR) is part of that continued pressure
tactic."

vidya.krishnan at livemint.com

-- 
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
twitter.com/jamie_love




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