Granting of Exclusive Marketing Rights (EMR) to Novartis for its molecule, Glivec, by the Controller of General of Patents and Trademarks of India last week has caused a flutter in the domestic pharmaceutical industry. First to react to the decision was Hyderabad-based Natco Pharma, being the leading Indian manufacturer of the drug. Then came a detailed complaint in the form of a press release from IDMA. It is possible that companies like Sun Pharma, Ranbaxy and Cipla may also challenge the Patent Controller's decision soon. Such objections and protests are to be expected as granting of EMR to Novartis should necessarily mean other manufacturers cannot remain in the market now. Natco has said that the first patent for the drug was granted in 1993 in Switzerland and the second patent in the US in 1994. The company, therefore, argues that as both patents were granted prior to 1995, it is unlawful to grant EMR by the Indian Patent Office. Natco has also threatened to challenge the EMR decision along with other domestic manufacturers of India. IDMA stand is fully supportive of Natco. In fact, IDMA president goes a step further and says that even if the granting of EMR is taken as valid, it is necessary in the public interest to permit the sale and distribution of the drug by the existing manufacturers as they have already obtained the required licenses and started production and marketing.
Two issues arise here. Firstly, whether the decision of the Patent Controller to grant EMR to Novartis is right. One should assume that in matters like this, a senior government officer cannot commit such an error considering the fact that the application of Novartis has been with the Patent Controller's office for some time. He should have gone through all the relevant records and documents before coming to a decision like this. Yet, if someone can prove the EMR was wrongly granted, Patent Controller should immediately revoke it. The matter ends there. But the second issue is more controversial. Both Natco and IDMA are of the view that existing manufacturers should be allowed to continue the manufacture and marketing of the drug as it is an expensive life saving drug. That argument is not right. In fact, Novartis can file suits against existing manufacturers of the drug if they continue to market the drug after the grant of EMR. Only after several rounds of deliberations, amendments to the Indian Patent Act including the provision for an EMR were adopted by the government. These amended rules need to be respected and complied with. Otherwise the whole exercise of amending the Patent Act will be nothing but a mockery. Patents and trademarks are intellectual properties and not only MNCs but Indian drug companies also fiercely fight to protect them. And there are even recent cases of such disputes between the Indian drug companies.