[Ip-health] Economic Times: US protests patent issuance to Natco to sell copied versions of Nexavar

Joanna Keenan-Siciliano joanna.l.keenan at gmail.com
Tue Mar 27 01:54:47 PDT 2012


US protests patent issuance to Natco to sell copied versions of Nexavar
http://economictimes.indiatimes.com/news/news-by-industry/healthcare/biotech/pharmaceuticals/us-protests-patent-issuance-to-natco-to-sell-copied-versions-of-nexaver/articleshow/12421445.cms

NEW DELHI: The US has criticised India's decision to issue its first
compulsory licence to domestic drug company Natco for selling copied
versions of Bayer's anti-cancer
drug<http://economictimes.indiatimes.com/topic/anti-cancer-drug>
Nexaver <http://economictimes.indiatimes.com/topic/Nexaver> arguing that it
would discourage new investments and dilute the international patent
regime, but India said it has not broken any rules.

Visiting US Commerce Secretary John
Bryson<http://economictimes.indiatimes.com/topic/John-Bryson>,
in his meeting with Commerce & Industry Minister Anand Sharma on Monday,
raised concerns about the compulsory licence issued earlier this month to
Natco, a government official told ET.

The compulsory licence would allow the company to make a generic, or
copycat, version of the patented cancer drug bringing down prices by about
30 times. "Bryson said pharmaceuticals was a competitive area and heavy
investments went into R&D every year. Any dilution of the international
patent regime was a cause for deep concern for the US," the official said.

Defending the move, Sharma said the compulsory licence strictly complied
with the flexibility norms provided in the Trips (trade-related
intellectual property rights) Agreement of the WTO since a large number of
cancer patients died in the country every year as they could not afford
treatment. "Sharma said all data was available to show that it (issuing of
compulsory licence to Natco) was a fit case for grant of flexibility under
the Trips agreement," the official added.

The Trips Agreement<http://economictimes.indiatimes.com/topic/Trips-Agreement>allows
governments to issue a compulsory licence allowing someone else to
produce a patented product or process without the consent of the patent
owner to address public health concerns.

The licence, however, can be issued at least three years after a patent has
been granted and the producer needs to pay a royalty to the patent holder
at rates fixed by the government.

The Indian Patent
Office<http://economictimes.indiatimes.com/topic/Indian-Patent-Office>issued
its first compulsory licence to Natco on March 12 to produce the
drug sorafenib tosylate used for treating lever and kidney cancer which has
been patented by German company Bayers.

The patent office ruled that not only was
Bayer<http://economictimes.indiatimes.com/topic/Bayer>not able to
lower prices to a level to make it affordable and accessible,
but was also unable to ensure that it was available in sufficient
quantities within India.

Natco Pharma<http://economictimes.indiatimes.com/natco-pharma-ltd/stocks/companyid-8305.cms>plans
to sell its version of Bayer's Nexavar at Rs 8,880 for a month's dose
as compared to Rs 2.8 lakh by Bayer.

"This decision marks a precedent that offers hope. It shows that new drugs
under patent can also be produced by generic makers at a fraction of the
price, while royalties
<http://economictimes.indiatimes.com/topic/royalties>are paid to the
patent holder.

This compensates patent holders while at the same time ensuring that
competition can bring down prices," said Tido von Schoen-Angerer, director
of the Medecins Sans Frontieres (MSF) Access Campaign.

Global pharmaceutical majors, obviously, see things differently. "If used
arbitrarily, compulsory licenses will serve to undermine the innovative
pharmaceutical industry and will be to the long term detriment of the
patient, " Ranjit Shahani from OPPI, the group representing MNCs, told the
media earlier.

Europe invests more that 27 billion in pharmaceutical R&D every year,
according to a report conducted by the European Federation of
Pharmaceutical Industries and Associations, while the US invests an
estimated $67 billion annually in biopharmaceutical research.



Joanna Keenan
Press Officer
Médecins Sans Frontières - Access Campaign
E: joanna.keenan[at]geneva.msf.org
T: twitter.com/joanna_keenan

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