The Office of the Controller General of Patents and Trademarks that gives exclusive marketing rights (EMR) to drugs does not have any grievance redressal mechanism attached to it. Neither the government intends to introduce such mechanism before giving EMR as they consider this as a temporary arrangement that would seize to exist once product patent regime ushers in. The complainants have no other option but to approach the court for redressal of their problems, it is learnt.
Informing this to Pharmabiz.com, official sources point out that exclusive marketing right is given to the inventor company only when a generic version of the drug is already marketed in the country. The decision is taken by the Patent Controller and has no connection with the office of Drugs Controller General of India (DCGI). Due to the same reason, there is no need for any DCGI directive for the companies who are possessing marketing approval for the generic brands of such drugs, they say.
The issue can come to the forefront with the recent decision of Patent Controller to grant EMR to Novartis (India) for Glivec (imatinib mesylate), a drug used for the treatment of blood cancer.
Reacting to the decision domestic pharmaceutical companies under the banner of Indian Drug Manufacturers Association (IDMA) had expressed shock over the decision and had demanded an opportunity for pre-grant opposition to the affected parties before any such grants in future.
"Even if the EMR is taken to be validly granted, it would be necessary in public interest 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," IDMA had stated.
The association also said that the companies, who 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," they argue.
Meanwhile the domestic companies who are to be affected by the grant of EMR to Novartis are known to have decided to approach the court on the matter. The outcome of the case is to have a long lasting effect on the future EMRs that are to be granted by the Patent Controller.