The Indian Drug Manufacturers Association has expressed its grave concern over the grant of exclusive marketing right (EMR) to Novartis (India) in respect of their ‘Glivec’ (imatinib mesylate). The Association, in a media release, stated that the Patent Controller’s decision to clear Novartis’ EMR application has come to the Indian drug industry as a rude shock.

According to IDMA release, imatinib mesylate is a vital life saving drug for treatment of blood cancer. 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, required to be taken for any such 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. The grant of EMR in respect of this vital drug to Novartis can provide leverage to the EMR holders to interfere with the generic production and distribution of this drug, and worse still, with the treatment of patients. The international price of the drug is (about US $ 27,000/- for one year course requirement for one patient), prohibitively costly and only microscopic minority of the suffering patients in India can afford it. The generic price of about US $ 2700/- for the same quantity, though high, makes it possible for a much larger number of patients to get benefit of the treatment.

The IDMA president Yogin Majmudar said “We understand that ‘Novartis’ AG had filed applications for patent in respect of the drug ‘Glivec’ in some of the convention countries in May 1993 or earlier. If this information is correct then it is difficult to understand how the EMR has been granted.” As per Sec. 24B (1) (a) of the Patent Act 1970 (the Act) and EMR would be claimable only in respect of inventions which were subject matter of applications filed on or after 1st January 1995. During debate in Parliament on the 1999 Amendment Bill, it was clarified and confirmed that the pre 1995 inventions would nor qualify for grant of EMR or patents, the IDMA release added.

“In any case it would be inhuman, and in violation of fundamental and human rights of citizens – right to life guaranteed by the Constitution and International Human Right Conventions, to deny to them access to drugs required for their treatment at fair prices. Even if the EMR is taken to be validly granted, it would be necessary in public interests to permit sale and distribution of the drug by the generic manufacturers who have already obtained the required drug licences or have started production and marketing of the drug by grant of compulsory licences in exercise of the powers under Sec. 24D of the Act, Majmudar stated.

Besides this, the companies, which have lawfully introduced the product in the market should not be deprived or prevented from producing and marketing this drug. The investment made by them without any knowledge of the application of the EMR, must be protected. This is particularly so when they were not given any opportunity of pre-grant opposition of the EMR application.

IDMA strongly feels that an opportunity should be given for pre-grant opposition to the affected parties before any such EMRs are granted in future. Also the repercussion on availability of the medicine at affordable prices may be kept in mind while granting EMRs. It is necessary that the prices be kept under check by avoiding monopoly and adequate competition, the IDMA president stated.