Indian pharmaceutical majors oppose EMR granted to Novartis

Mumbai: Leading domestic pharmaceuticals companies like Ranbaxy Laboratories, Dr Reddy''s, Nicholas Piramal, Wochkardt and Zydus Cadila have decided to block the exclusive marketing right (EMR) granted to the multinational drug firm Novartis AG by the Indian Patent Office for its anti-blood cancer drug Glivec (bulk drug name: Imatinib Mesylate).

The Indian Pharmaceutical Alliance (IPA), which represents India''s top 13 leading pharmaceutical companies like Ranbaxy, Dr Reddy''s, Nicholas Piramal, Wochkardt,.Cadila and Lupin (they are the strongest lobbying body of the Indian pharmaceutical industry), has written to Dr S N Maity, controller general of patents and designs, Indian Patent Office, that the grant of EMR for Novartis is a gross violation of Section 24(B) and Section 3 of the Indian Patent Act 1970, as the EMR will be granted for what is not an invention.

IPA secretary-general D G Shah says an application for the patent of Imatinib Mesylate by other foreign drug companies was filed in the US patent office on 28 April 1994 and the Canadian patent for the same drug had been filed in 1993.

It is thus obvious that Novartis AG''s EMR application for Glivec dated 27 March 2002 is for an article or substance identical to the product covered by the Canadian and the US applications, which were filed before 1 January 1995. As per the World Trade Organisation provisions, the EMR can be allowed only for drugs invented after 1995.

"It seems that the patent controller has overlooked the facts and wrongly granted or agreed to grant the EMR for Glivec. We, therefore, requested him to rectify the errors and to take appropriate action by holding or cancelling the EMR for the said product," says Shah.

Indian Drug Manufacturers'' Association president Yogin Majmudar says this is a vital life saving drug for treatment of blood cancer. The international price of the drug is about $27,000 for a one-year course for one patient and only a microscopic minority of the suffering patients in India can afford it.

He adds: "Its availability at fair prices and in adequate quantities is a matter of life and death for many victims of this deadly disease. Greatest care is, therefore, to be taken for any such EMR grant. Some of the Indian manufacturers have already developed their own processes for this drug and have been marketing it at about one-tenth of its international price."