[Ip-health] Novartis open letter defending it's Glivec legal challenge in India

Wed Feb 7 08:13:14 2007

Dominic Atkins, Head of Business Services / Global Policy for
Novartis International AG, asked us to post this letter to the CPTech
web site.  Jamie

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An open letter from Novartis regarding the Glivec legal challenge in
India:
Why Novartis thinks improving patent law will benefit patients and
society

(for response, please email public.affairs@novartis.com)
February 5, 2007

In the last few weeks we have received concerns regarding our ongoing
legal challenge against the Indian patent law, following the denial
of the patent for our ground-breaking cancer treatment Glivec=AE/
Gleevec=AE. We have heard these concerns and want to clarify our
perspective.

In India, Novartis is faced with a globalization dilemma that
characterizes many emerging economic powers today: two markets within
one country. India has a booming middle class on one hand, and a vast
number of extremely poor people on the other. In order to make
responsible business decisions, we have carefully considered the
following aspects:

*Access to our cancer treatment Glivec in India and globally

*India as an emerging growth market and global competitor

*India=92s current role in supplying medicines to the developing world

As a result, in India, we are pursuing a dual, patient-focused
strategy. We are aware of the many obstacles poor patients face
regarding access to medical care there, and that is why 99% of
patients who receive Glivec in India receive it free from Novartis.
At the same time, we take
affluent India seriously as a formidable power with all the rights
and obligations that such status brings with it. As a consequence, we
seek to establish effective protection for pharmaceutical innovation
in India.

In the following, we outline our approach in more detail:

Novartis has secured access to Glivec both in India and globally

When we launched Glivec, Novartis committed that no patient in need
should be denied this life-saving cancer treatment. We fulfilled this
commitment by establishing the Glivec International Patient
Assistance Program (GIPAP), which is one of the most far-reaching
patient assistance programs ever implemented on a global scale. In
India, Novartis currently provides Glivec at no cost to more than 6
600 diagnosed patients. Glivec treats two rare cancers: chronic
myeloid leukemia (CML) and gastrointestinal stromal tumors (GIST).
The GIPAP covers every person in India who is prescribed Glivec and
cannot afford this life-saving medicine. For more information, please
visit the Max Foundation which administers the program,
www.themaxfoundation.org.

Sustainable access to medicines in developing countries is complex
and requires much more than the availability of generic drugs.
Generics alone do not solve the issue. For example, in India the cost
of a one year treatment with generic imatinib is USD 2 100, or 4.5
times the average annual income. Even our critics recognize that
generic versions of Glivec are not the solution for the poor in
India. Furthermore, generic makers in India have yet to come forward
with an access program for generic imatinib.

Glivec is not an exception. As a matter of business principle,
Novartis is deeply concerned that patients have access to the
medicines they need, as demonstrated by our well-regarded record in
social responsibility.

In 2006, our access-to-medicines program reached 33.6 million
patients. Novartis spent
USD 755 million / EUR 582 million last year alone programs and
research. We seek to move beyond philanthropy to develop new business
models. That is why we engage in many innovative public-private
partnerships with efforts spanning a number of disease areas,
including our partnerships with WHO to combat leprosy, malaria and
tuberculosis. Novartis also established an Institute for Tropical
Diseases in Singapore dedicated entirely to drug discovery for
neglected diseases.

We take India seriously as an emerging growth market and global
competitor

While we are committed to access to Glivec, it is clear that we seek
business opportunities in India=92s growing economy. We also compete
with Indian companies globally in attractive markets, and the export
of copies of our products into richer countries is a major concern to
us.
Protecting innovation is the foundation for massive R&D investments
made by the pharmaceuticals industry that are vital to medical
progress. Companies can continue to bring improvements and
innovations to patients and societies only with effective patent
laws. For a research-based company such as Novartis, patents are not
negotiable.

That Glivec is a tremendous innovation is widely recognized
throughout the scientific community; it has received numerous awards
for innovation. Glivec has been awarded a patent in 36 other
countries, including China. The journey of Glivec through the patent
process in India illustrates the difficulties faced in a country in
transition. The Indian patent law creates new hurdles for
pharmaceutical innovation, unjustifiably and illegally narrowing what
is patentable.

Many of the points we have raised around India=92s patent laws have
been corroborated by the recent Mashelkar Committee report on patent
issues in India. The Government-established Mashelkar Committee
voiced its views in favor of incremental innovation and held that
certain provisions of the Indian Patent Act are not compliant with
international agreements, specifically WTO=92s TRIPS agreement (Trade-
related Aspects of Intellectual Property Rights).

Respect for intellectual property will strengthen, not weaken, the
Indian economy, helping India reach its aspiration of becoming a
pharmaceutical powerhouse. Incremental innovation is exactly the area
where local Indian companies have made first steps into research and
development and registered patents worldwide.
We are seeking clarity. Knowing we can rely on patents in India
benefits government, industry and patients because research-based
organizations will know if investing in the development of better
medicines there is a viable long-term option.

Our actions in India do not hinder the supply of medicines to the poor

We are contesting the provision of Indian Patent Law that has led to
the rejection of the Glivec patent in India. Our case does not
challenge provisions that provide for access under international
trade agreements, specifically the TRIPS and the Doha Declaration.
These flexibilities allow production for export under compulsory
licenses that have been issued for public health reasons. They have
been put in place to allow poor countries to safeguard access to
medicines that do not have sufficient local production capacity. In
fact, political agreement on the Doha flexibilities has been reached
in order to mitigate impact of TRIPS implementation in India.

Novartis supports the TRIPS conditions that promote access for
developing countries. Our patent strategy preempts some of these
flexibilities by not filing patents in the poorest countries.
Furthermore, we believe that in the case of essential and life-saving
medicines, special pricing arrangements in developing countries must,
and can, occur within the context of sufficient intellectual property
and trade-related safeguards.

Denial of patents for better medicines will not improve patient
access to medicines. These restrictions will instead negatively
impact patient access by denying new drugs either through research-
based pharmaceuticals or, at the appropriate time, through the
generic companies.

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. We seek an open dialogue
with all groups, one based on mutual trust and tolerance with the aim
of long-term success =96 not only in access-to-medicines initiatives
but also in day-to-day business activities.

Thank you for reading this perspective. For more information about
this legal challenge and about our extensive corporate responsibility
and patient access programs, please visit www.novartis.com/
corporate_citizenship/en/index.shtml.

Yours sincerely

Head of Public Affairs

Novartis International AG

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James Packard Love
Knowledge Ecology International
http://www.keionline.org
james.love@keionline.org
Washington, DC +1.202.332.2670

"If everyone thinks the same: No one thinks." Bill Walton"