Novartis India, which has been granted the first exclusive marketing right (EMR) by the Indian Patent Controller for their anti-cancer drug imatinib mesylate, would be enforcing this privilege soon. The company would be taking all the necessary steps to ensure that no other brands of this drug is marketed in the country after the Gazette notification is out, according to Ranjit Shahani, chief executive officer, Novartis India.

The Gazette notification on the granting of EMR to Novartis is expected on December 12. Although the EMR is being disputed by the local companies especially by the Hyderabad based Natco Pharma, which is the leading manufacturer of this drug in India, Shahani said that the EMR has been granted by the Patent Controller to Novartis after thorough examination. Hence, the counter arguments on the legality of the same may not stand.

"However, it will be appropriately handled by our lawyers, and I would prefer the legally competent authorities to comment on this at this point of time," Shahani said. But, as far as marketing of Glivec in India is concerned, the company is very serious and it will use its right fully, he said.

"In India, a number of EMR applications have been filed by various companies and some of them are in the examination stage and few have been already rejected as they do not meet the required legal criteria as per the relevant provisions. Thus, the legality in granting the EMR to Novartis cannot be doubted. However, it is not in our hands to stop anyone who wants to challenge the EMR," he added.

Meanwhile, Natco has openly challenged the EMR saying that it is a gross violation of the Indian Patents Act, as it is clearly mentioned in the Act that a drug will be worthy of an EMR only if its original discoverer has patented the product after 1995.

The Natco official said that, "Glivec received its very first patent in 1993 in Switzerland, a convention country and a second patent in US in 1994. As both patents were filed well before 1995, it is unlawful of Indian patent office to grant an EMR to it. The patent information on imatinib mesylate (Glivec) in fda.gov, Orange Book and other patent related websites clearly tells that the original patent was filed in 1993."

The Natco spokesperson Subbarao said that the company has decided to challenge the decision of the patent office. "Our aim is revocation of the EMR. One option we might consider is challenging the EMR grant. Considering the above facts and backing on public sympathy, the argument is very much in favor of us, he said. Otherwise once the product patent sets in post-2005, there is a definite chance of Novartis getting a product patent on the same, which would be bad for the domestic manufacturers and the patients," he added.