E-DRUG: MSF Statement on Novartis Court Ruling in India (3)
Could I please post the following as response to that (above) from MSF
sent on Monday August 6th.
Head of Corporate Public Affairs
Novartis International AG
Global Public Affairs
Phone: +41 61 3244327
Email : email@example.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.