[Ip-health] Tony Lopez in the Manila Times: Novartis sues India on patents

[Thiru Balasubramaniam]

http://www.manilatimes.net/national/2007/apr/26/yehey/opinion/
20070426opi5.html

Thursday, April 26, 2007

VIRTUAL REALITY
By Tony Lopez
Novartis sues India on patents

The giant Swiss drug multinational Novartis=92 challenge to India=92s
patent laws could seriously reduce, if not cut the supply of affordable
medicines to treat AIDS and other epidemics in poor countries.

India changed its patent laws in 2005 to comply with a global agreement
on intellectual property. Subsequently, Novar=ADtis applied for a patent.
It is one of the first under the new rules. It is for its leukemia
anticancer drug Glivec.

In January 2006 India=92s patent office rejected the application.
Novartis protested and sued in court. It is also challenging India=92s
patent laws, claiming that they do not comply with the international
agreement.

The trial opened in Madras. The main issue is the question of
innovation. India=92s patent law requires that drugs be =93new and involve
an inventive step=94 in order to win patent protection.

NGOs including Med=E9cins Sans Fronti=E9res (MSF) and Oxfam say that if
Novartis succeeds, pharmaceutical firms will be able to put newer AIDS
treatments based on existing drugs under patent protection in India,
preventing cheap generic versions being exported to Africa and
elsewhere.

India became the =93pharmacy of the world=92s poor=94 in 1970 when it stopp=
ed
issuing drug patents, allowing its many drug producers to create
generic copies of medicines still patent-protected in other
countries=97at a fraction of the price charged by multinational drug
behemoths. In 1994, however, New Delhi became signatory to the
Agreement on Trade Related Aspects of Intellectual Property Rights
(Trips), a deal which required all WTO member countries to grant
patents on technological products, including pharmaceuticals, by 2005.

This prompted drug firms to queue up to patent their brands in India.
Up to 9,000 patents await examination. Glivec was one of the first to
go to court.

Novartis=92 bid was rejected because it was judged to be merely a new
version of an older medicine. The Swiss company argues that India=92s
requirement for drugs to be new and innovative is not in line with the
TRIPS.

  It is not clear whether the Glivec case would set a precedent allowing
other modified drugs to be patented in India. =93There are an estimated
9,000 patent applications waiting to be reviewed, of which some 7,000
are said to be modifications of old drugs,=94 says Richard English,
manager of Oxfam=92s Make Trade Fair campaign. =93If Novartis wins,
countless medicines previously available cheaply to poor people could
then be patented and priced out of reach.=94

While the company sells the drug at a price of Rs 1,200,000, Indian
companies retail it at Rs 8,000. NGOs say the outcome of the case could
have a profound effect on the accessibility to generic medicines in the
developing world.

Glivec is considered a breakthrough therapy for treating Chronic
Myeloid Leukemia.

In challenging the Indian patent law, Novartis in effect is saying any
variation of an existing drug is patentable. Also patentable will be
new uses of existing drugs or even new combinations or delivery systems
of existing drugs might be patentable.

Meanwhile, Med=E9cins Sans Fronti=E9res is said to have collected some
300,000 signatures worldwide to pressure Novartis to drop its case.

MSF says generic manufacturers have helped bring the cost of AIDS
treatment down from $10,000 per patient per year in 2000, to just $130
now.

=93The Glivec case is a litmus test,=94 said US Chamber of Commerce=92s
senior vice president Daniel Christman.

=93If India chooses to protect the intellectual property of Novartis, it
will help open a floodgate of investment into India=92s pharmaceutical
industry, propelling India onto center stage as a destination for
innovation, R & D, and breakthrough medicine,=94 he said.

The Berne Declaration, Ox=ADfarm International and the international
medical humanitarian organization Med=E9cins Sans Fronti=E9res have
emphasized that Novartis is challenging countries=92 rights to have
patent laws that put the interest of people first.

=93The Doha Declaration tries to find a balance between intellectual
property rights and public health,=94 said Ruth Dreifuss, who chaired the
2004-06 WHO Commission on Intellectual Property Rights, Innovation and
Public Health (CIPIH). =93The balance can be achieved only of countries
make use of the flexibilities contained in the TRIPS Agreement, and
this is what the Indian law does. By challenging it, Novartis is
sacrificing public health objectives and weakening the whole system.=94

Many developing countries rely on affordable medicines. Over half the
AIDS drugs used in the developing world are generics. India has been
able to produce affordable versions of medicines patented elsewhere
because until 2005, the country did not grant pharmaceutical patents

---------------------------------
Thiru Balasubramaniam
Geneva Representative
Knowledge Ecology International (KEI)
voice +41.22.791.6727
fax +41.22.723.2988
mobile +41 76 508 0997
thiru@keionline.org