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Novartis challenged India's decision not to grant a patent to

Glivec

Glivec is a breakthrough cancer treatment for all phases of Philadelphia-

positive chronic myeloid leukemia (Ph+ CML), as well as for certain

patients with KIT+ gastrointestinal stromal tumors (GIST), and has beengranted patents in 40 countries.

Glivec (imatinib mesylate) is a revolutionary treatment that changed CML and KIT+

GIST diagnoses from a disease with few effective treatments to a manageable

chronic disease. In India, there is a misconception that Glivec was an incremental

improvement or 'evergreening' rather than a novel drug. The confusion is based on

a patent that was granted in 1993 (not in India) for the synthesis of the molecule of

imatinib. This molecule, without further development,could not safely be

administered to patientsand represented only the first step in the process to

develop Glivec as a viable treatment for cancer.

We selected the mesylate salt of imatinib and then developed the beta crystal form

of imatinib mesylate to make it suitable for patients to take in a pill form that would

deliver consistent, safe and effective levels of medicine. This process, which took

years, was more than just an incremental improvement it was a breakthrough

and should not be interpreted as evergreening.

Novartis also disagreed with India's observations that the price of the drug is "too

unaffordable to the poor cancer patients in India" since the cost of a year of

treatment with generic Glivec is three to four times the average annual income. It

is for this reason we voluntarily provide more than 95% of all Glivec patients in

India

currently more than 16,000 patients

their medicine free of charge throughthe Glivec International Patient Assistance Program (GIPAP). Since the program's

launch in 2002, Novartis has provided nearly USD 1.7 billion worth of Glivec to

Indian patients enrolled in (GIPAP).

An Indian Supreme Court ruling rejected Swiss pharmaceutical company Novartiss attempt

to win protection over its major cancer drug, a landmark judgement in a country known as

the developing worlds pharmacy. The ruling has been both criticized by pharmaceutical

companies and lauded by public health activists, highlighting the key struggle of intellectual

property rights and public health interests. Not until 1995 did India offer patent protection forpharmaceuticals, when it was obliged to do so by the World Health Organization. In 2005 the

Supreme Court amended its patent laws, stating that pharmaceutical companies had to prove

significant clinical effectiveness not found in other available pharmaceutical products in

order to obtain a patent. In 2006, Novartis was denied a patent for its cancer drug Gleevec.

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In 2009, the Swiss company filed a case with the Supreme Court, alleging Indias patent law

defines innovation too narrowly. Although Gleevecs main active ingredient, imatinib

mesylate, was already known before the drugs conception, Novartis argued that the form in

which the drug was administered was novel and thus innovative. The April 1st ruling by

the Indian Supreme Court exemplifies a key issue in global health: on the one hand,

patenting of innovative medicines provides motives for pharmaceutical giants such as

Novartis to continue developing life-saving drugs and making them available in nations such

as India; on the other hand, patenting limits the extent to which these drugs may be

administered and therefore limits their life-saving capacity due to lack of access.

Novartis spokespeople noted that the landmark ruling will cause the company to reconsider

whether or not to introduce new drugs into the Indian market in the future. If innovation is

rewarded, there is a clear business case to move forward, said Eric Althoff, a Novartis

spokesman speaking with the Wall Street Journal. If it isnt rewarded and protected, there

isnt.

Public-health groups in developing nations praised the judging on account that it protects

Indian companies that produce low-cost generic forms of drugs such as Gleevec, allowing

them to continue producing and, most importantly, exporting their cheaper product to

developing nations in Asia and Africa.

Currently in India, Gleevec treatments cost $1,900 per month, whereas generic forms of the

drug go for about $175 per month. Novartis contests that 95% of its patients receive the

treatment free of charge.