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[e-drug] MSF Statement on Novartis Court Ruling in India (3)

E-DRUG: MSF Statement on Novartis Court Ruling in India (3)

Dear E-druggers,

Could I please post the following as response to that (above) from MSF 
sent on Monday August 6th.

Many thanks

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


Novartis response to Chennai High Court ruling on Glivec legal action

As a response to the statement by MSF regarding the ruling on the Novartis 
legal challenge to Section 3(d) of the Indian Patent Law, we are sending 
you this communication to update and give you our perspective on the 

On August 6, the High Court in Chennai issued a decision that will have 
long-term consequences for research and development into better medicines 
for patients in India and abroad. The Court dismissed the writ petition 
challenging the constitutionality of a provision of the Indian patent law, 
and deferred to the World Trade Organization (WTO) to resolve the question 
of TRIPS compliance. Novartis will likely not appeal the decision.

The case in India had two parts: the Glivec patent appeal and the Section 
3(d) challenge. Glivec, our innovative cancer drug, was denied a patent in 
India under a unique clause in the Indian patent law. Novartis appealed 
the patent rejection and asked the court to examine this clause, Section 
3(d), against India?s international obligations and its constitution. This 
decision was related to the Section 3(d) challenge; our Glivec patent 
appeal is ongoing.

Section 3(d) introduces a new ?improved efficacy? hurdle for patentability 
and excludes important pharmaceutical developments in the form of 
incremental innovation. Because medical progress occurs through 
incremental innovation, Section 3(d) significantly limits medical 

There has been speculation that changing India?s patent law will impact 
access to medicines. Eliminating Section 3(d) will not hinder the supply 
of medicines from India to poor countries given the safeguards already in 
place in international agreements and also in the Indian law. This case 
has always been about gaining clarity on how innovation is valued and 
protected in India, and Novartis brought this case forward because we 
firmly believe it was the right thing to do for patients. 

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. 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 world power with all the international rights and obligations 
that such status brings with it, and we seek effective protection for 
genuine pharmaceutical innovation in India.

The dialogue on the deficiencies of the Indian patent law will continue 
among all stakeholders, ensuring incentives are in place to bring 
innovative medicines to patients. We have advanced this essential debate 
in India, and will continue to participate in this important discussion.

There is much that can and should be done to improve healthcare provision 
in the world?s least developed and developing countries.  Novartis 
recognizes the responsibility of the pharmaceutical industry to be part of 
a solution along with governments, NGOs and others.  History has 
demonstrated intellectual property rights are the best way to stimulate 
investment in innovation that leads to new discoveries that help patients 
and benefit societies. We firmly believe safeguarding this system is the 
right thing to do and stand by our original decision to pursue the case.

On August 8 Novartis accepted a petition initiated by MSF during their 
campaign.  We have willingly engaged in all open debate on the issues 
which have been raised by our action and now call on MSF to issue our 
response to their petitioners and members.

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