Granting of Exclusive Marketing Rights (EMR) to Novartis' Glivec by controller general of Patents and Trademarks of India is a gross violation of 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, according to senior officials in Natco Pharma.

"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," said a highly placed official in Natco Pharma.

Considering the above points, Natco 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, said the official," said the Natco official. 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.

Natco is one of the copycat manufacturers of Novartis' Imatinib Mesylate (Glivec), used in the treatment of myeloid leukemia. Natco Pharma along with Ranbaxy, Sun Pharma, Cipla, Intas and Camlin are the other manufacturers making copycat versions of Glivec. However, Natco controls 80 per cent among the domestic manufacturers, said the Natco official.

Novartis' Glivec therapy costs $ 27,000 annually, which comes to about Rs. 1.10 lakh per patient per month in India. Compared to this treatment from Indian manufacturers comes at one-tenth of Novartis' price.

Ranjit Shahani, CEO, Novartis Pharma said that four conditions were required for an EMR grant. These are filing an application by the inventor for an EMR in India, product patent approval on the applied product from a convention country, marketing approval from a convention country and marketing approval from India. All these conditions have to be met with post 1995. "Novartis had applied for EMR in July 1998, received product patent from Australia in February 2002, received Australian marketing approval in August 2001 and received marketing approval in India in December 2001. Therefore there is no chance of any violation of law," said Shahani.

Supportively, Dr. SN Maiti, controller general of patents confirmed that it was only after fully scrutinizing the matter that the EMR was granted to Novartis. "We clearly verified that Novartis had filed an EMR application in 1998 and patent was granted to the product in 2002. With the EMR grant, the ball was clearly in Novartis court to initiate any action against the domestic manufacturers," said Maiti.

"We have not decided on any action against any one. We have full faith on Indian legal institutions. The confusion is on account of being the first EMR case. We are hopeful the situation to improve in coming months when guidelines will evolve and become stronger favoring the requirements of the product patent regime post 2005," explained Shahani.