E-DRUG: Novartis files a fresh case (2)
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A response to the call by Dr Debade of Drug Action Forum ? Karnataka for a
product boycott against Novartis issued on e-drug on August 25th.
This is one of many perspectives and opinions voiced on the issues raised
by the Novartis legal action in India, but there are factual inaccuracies
in this piece that we would like to correct.
First, Novartis has not launched a second legal case in India.
The challenge to which Dr Debade now refers is part of our original
Glivec®/Gleevec® patent appeal. In April 2007 this appeal was transferred
to the Intellectual Property Appellate Board (IPAB). The current
technical member of the Appellate Board is the former Controller General
of the Indian Patent office, and was responsible for the original
rejection of the Glivec patent. Novartis is petitioning the High Court
for a new technical member of the IPAB because we believe he cannot act as
an impartial member of the Appellate Board in this case.
Our challenge to Section 3(d) of the Indian patent law was dismissed by
the Chennai High Court earlier in August and our reasoning for taking
forward that case, plus our response to the court's decision have both
been issued on e-drug. I will not reiterate them here, please see our
online India Glivec information center.
Dr Debade's piece, as well as Drug Action Forum ? Karnataka's website, go
on to claim that Glivec is not innovative and that if Novartis were granted a patent in India, 99% of patients requiring therapy with Glivec would not have access to it. Both points are untrue.
Glivec is a tremendous innovation, widely recognized throughout the
scientific community. The original molecule, imatinib, could not be
formulated into a medicine for use in patients. The steps taken to
develop the beta crystal form of imatinib mesylate required significant
investment of time and financial resources. Glivec is a breakthrough,
life-saving cancer drug which has been granted a patent in nearly 40
countries ? including China, Russia and Taiwan ? and the same should be
the case in India.
Novartis has one global price for Glivec. In India we provide the drug
totally free of charge to more than 7,500 patients, 99% of those
prescribed the drug, through the Glivec International Patient Assistance
Program (GIPAP). GIPAP ensures that every patient prescribed Glivec who
does not have access to insurance or the ability to fund the drug will
receive it free from Novartis. GIPAP operates in more than 80 countries
globally and had helped more than 22,000 patients with the cancers.
Even if Novartis received a patent for Glivec, there would still be
generic forms available on the market in India because of a clause in the
Indian patent law that allows generics available before 2005 to stay on
the market.
Pharmaceutical companies like Novartis do contribute to access to
medicines globally. Innovation is the core competency and primary
responsibility of research-based companies in the pharmaceutical industry,
and the research done by these companies is essential to the discovery and
development of new, innovative medicines. Nine of every ten new
prescription drugs are discovered and developed by pharmaceutical
companies. Novartis re-invests about 20% of total sales in research and
also invests considerable resources in our pioneering access-to-medicines
programs. These have reached 34 million patients globally and were valued
at USD 755 million in 2006.
Governments, NGOs and the research-based pharmaceutical industry must
continue to work together to find new models for access to medicines, and
we welcome continued constructive dialogue on this topic.
[Submitted by Dominic Atkins, dominic.atkins@novartis.com; WB]