The Madras High Court, in its hearing of Ranbaxy Lab's petition seeking vacation of the injunction imposed on generic players manufacturing and marketing the cancer drug imatinib mesylate following grant of EMR to Novartis India, has ruled that since the patent controller's decision to grant market exclusivity for the company's product Glivec in India is found to be ambiguous, there should not be a situation where patients in the country suffer due to this doubtful market exclusivity.

Finding that Novartis' price for the product is 12 times higher than that of the generic players who have been prohibited from the market, the Court has ruled that assuming that majority of the patients in the country cannot afford this price, the company should provide the drug free of charge to all patients falling below an annual income of Rs 35 lakh irrespective of any of its earlier criteria for free supply.

In a very significant judgment, which can have a far reaching effects on the country's Patent Control system, the Madras High Court has also directed the Patent controller to take an appropriate decision on the patent application of Novartis India for this drug in a month from the date of the country passes its Patents (amendments) Bill, to end the validity of the EMR.

Revealing this HC judgment in December 2004, Advocate V Lakshmi Kumaran, who attended the case for Ranbaxy in the Court, said that if Novartis denies free supply of Glivec to any patients in India by any criteria other than the Rs 35 lakh income sealing, it is a violation of the Court order and the company can be sued for contempt of Court.

However, responding to an allegation by the Cancer Patients Aids Association (CPAA), a leading cancer care NGO in Mumbai, about denial of free Glivec under the company's charity programme GIPAP, published by Pharmabiz a month ago, the Company reiterated that its free supply covers only patients who are non-reimbursed and not insured.

According to Novartis India, it has only 3500 patients registered under GIPAP in the country at present. But the CPAA and other health NGOs claim that the country has about 25,000 patients diagnosed with CML currently and another 18,000 are getting added up every year.

So it is believed that despite the Madras HC order in December 2004 to do away with any other criteria than the patients' income cap of Rs 35 lakh per annum, Novartis' GIPAP did not accommodate many deserving low income group patients under the free supply programme as they were found covered by nominal insurance schemes like ESIC etc.