Hyderabad based Natco Pharma Ltd has decided to challenge the exclusive marketing rights granted by controller general of Patents and Trademarks of India to Novartis India for its drug Glivec (imatinib mesylate).

Natco had started marketing Veenat (imatinib mesylate) for the treatment of chronic myeloid leukemia in January 2003 at 1/10th of the cost of Novartis’ Glivec. Natco’s therapy costs $2,700 per annum as against Novartis therapy of $27,000 per annum.

Natco at the time of the launch of its product had also undertaken a drug donation programme under which it is helping more than 250 patients suffering from CML with free supply of Veenat, according to company press release on Wednesday.

Reacting to this, Novartis India Ltd vice chairman and managing director Ranjit Shahani said, “We have met all the criteria for the grant of EMR. However, we are in an uncharted territory and we are evaluating all our options carefully. We hope that the Indian government will ensure the enforcement of the rights of all research-based companies vigorously."

As per the provisions of the Indian Patent Rules, exclusive marketing rights can be granted only in respect of patents/applications filed in a convention country after January 1, 1995.

Natco feels that granting of EMR to Novartis is not correct and it has a strong case for asking for its revocation as the applications for patents with respect to imatinib mesylate were filed prior to 1995.Natco said that it is examining various other legal options available to it. The company feels that in respect of life-saving drugs such as imatinibi mesylate, the concerned authorities should look beyond commercial and legal considerations.

A breakthrough product in the treatment of cancer, Glivec is one of the first oncology drugs that validate rational drug design based on an understanding of how some cancer cells work.