Healthy Skepticism Library item: 16383

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Publication type: Media Release

Berne Declaration: Novartis Glivec patent case in India
Berne Declaration 2009 Aug 31

Full text:

Yet another appeal by Novartis in India

A legal stubbornness that threatens the lives of blood cancer patients

For ethical and public health reasons, the Berne Declaration strongly
condemns the appeal filed by Novartis before the Indian Supreme Court
regarding its anticancer drug Glivec. Despite three consecutive defeats in
justice since 2006, the Swiss multinational pharmaceutical company
relentlessly tries to challenge the Indian Law, in particular its section
3(d) – a crucial safeguard against the multiplication of patents around the
same substance. A Glivec monopoly situation would deprive thousands of
blood cancer patients from access to a vital drug, in India and elsewhere.

In May 2006 and June 2009, Novartis already faced two patent rejections in
India for its Glivec (imatinib mesylate), a vital drug against Chronic
Myeloid Leukemia (CML), a form of blood cancer. The Swiss company was also
defeated before the Indian justice in August 2007, when the High Court of
Chennai confirmed the constitutional validity of section 3(d). This unique
provision of the Indian Patent Act states that pharmaceutical derivatives of
already existing drugs must demonstrate increased efficacy before a new
patent can be granted. It aims to prevent “evergreening”, a common practice
in rich countries referring to the multiplication of abusive and worthless
patents on a same substance.

A monopoly situation of Glivec would de facto mean to deprive from access to
a vital drug a majority of the 20’000 new Indian patients suffering each
year from CML. Novartis claims that 99% of all patients in India needing
Glivec receive it for free through its Patient assistance programme, however
in reality less than 30% of all potential CML patients in India is
benefitting.

One of three Indians still lives on less than one dollar a day, and three
out of four on less than two dollars a day. Since a treatment with Glivec
costs around 30’000 US dollars a year, a vast majority of the patients rely
on Indian generic versions of the drug sold up to 15 times cheaper.
Furthermore, many developing countries rely on generic drugs produced in
India, affordable at reasonable costs.

Whilst thousands of lives are at stake, in India and elsewhere, Novartis
refuses to accept passed court decisions and files yet another appeal.
Global world sales of Glivec® have reached 3.8 billion dollars in 2008.
These drugs definitely do not need an additional patent in India to be
financially profitable.