[Ip-health] Novartis on the Gleevec case in India Taken from the e-drug list...
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In response to the piece "Novartis in India: Patents for profit" written
by Dr Gopal Dabade of Drug Action Forum, Karnataka

The legal case about which Dr Dabade writes was brought following the
denial of a patent for our ground-breaking cancer treatment
GlivecR/GleevecR.  This case has always been about gaining clarity on
how innovation is valued and protected in India.  We brought the case
forward because we firmly believe it was the right thing to do for
patients.  It is clear that there are inadequacies in Indian patent law
that will have long-term consequences.

Access to Glivec in India is not threatened by this case

Firstly Dr Dabade states that "there is no explanation as to why
Novartis is not offering different prices (for Glivec) depending on the
circumstances in a country like India".  Later in the same piece he
makes reference to our Glivec International Patient Assistance Program
(GIPAP).

GIPAP is in fact one of the largest and most far-reaching patient
assistance programs ever created.  Recognizing the cost of such
medication and the truly life saving nature of Glivec, Novartis has
committed to make it available to any patient who cannot afford the
treatment.  This is why in India over 7,000 patients suffering from the
rare cancers CML and GIST receive Glivec free of charge from Novartis
through GIPAP for as long as they need it.  This represents 99% of the
patients in India who are prescribed the drug.  Worldwide we provide
free Glivec to over 20,000 patients in more than 80 countries.  There is
no way to say how many CML patients in India go undiagnosed, but it is
clear that given India's healthcare spending and infrastructure nowhere
near all the patients suffering with CML can be diagnosed and treated.
That is why GIPAP goes even further than drug donation, and helps to
train and support physicians to increase diagnosis and treatment of
these rare diseases.

There are generic versions of Glivec on the market in India currently
and they will stay on the market regardless of the outcome of this case.
This is because of a clause in the Indian Patent Law (the "Grandfather
clause") which allows generics on the market prior to 2005 to stay
there.  Novartis is not challenging this clause.  However, can these
generics really solve the problem of access to medicines in India when
they are still priced at over 4 times the average annual salary?

Why a patent for Glivec?

The piece states that the Novartis claim for a patent for the beta
crystalline form of imatinib mesylate is objectionable.  The original
molecule imatinib was invented by Novartis in 1993, prior to India
adopting the patent laws in place today.  Imatinib can not be formulated
as an oral medication and therefore we developed the beta crystalline
form of its mesylate salt.  This type of incremental innovation is what
is at question here and exactly why we have pursued this case.  Without
it the many of thousands of patients who have benefited from Glivec
would have been denied this medicine.  In fact many Indian companies
have made gains from exactly this type of work, patenting incremental
innovation, and they support this cause.  The beta crystalline form of
imatinib mesylate has been awarded a patent in nearly 40 other
countries, including China and Russia, and the same should be true in
India.  It is the only form of Glivec that has ever been marketed by
Novartis.

Section 3(d) and what it means

Novartis as a company can not enter into the special international
dispute redressal mechanism under WTO.  This can only be taken forward
by the member countries of WTO.  As is our right as a company operating
in India, we are asking a legal question through the proper mechanism,
the Indian legal system.

We are not challenging any of the flexibilities under TRIPS,
specifically the Doha Declaration, allowing production of medicines for
export under compulsory licenses that have been issued for public health
reasons. They have been put in place to allow poor countries that do not
have sufficient local production capacity to safeguard access to medicines.

Acknowledging innovation by granting a patent is unrelated to the access
to medicines issue. Improving access to medicines is a matter of making
medicines available. Medicines can be made available through access
safeguards in international agreements and, in the case of essential and
life-saving medicines, special pricing arrangements in developing
countries can, and must, be made.

Access to medicines in the developing world is a complex problem in
which medicine prices and intellectual property rights are but two
pieces of the puzzle.  A range of underlying or related issues such as
appropriate infrastructure and distribution networks must be addressed
in parallel.  This can only be achieved through the collaboration of all
involved stakeholders working together to ensure that patients in need
receive proper care.

For more information on this case, including patient testimonials and
other views, please see
http://www.novartis.com/newsroom/india-glivec-patent-case/index.shtml

For more information on The MAX Foundation, the organization which runs
GIPAP please see https://www.maxaid.org/Default.aspx?trgt=home

Dominic Atkins
Head of Corporate Public Affairs
Novartis International AG
Global Public Affairs
Forum 1
CH-4002 Basel
Switzerland
Phone: +41 61 3244327
Cell: +41798203710
Email : dominic.atkins@novartis.com

--
Mike Palmedo
Research Coordinator
Program on Information Justice and Intellectual Property
American University, Washington College of Law
4910 Massachutsetts Ave., NW Washington, DC 20016
T - 202-274-4442 | F 202-274-0659
mpalmedo@wcl.american.edu


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