The decision of the Patent Controller to reject the patent application of Novartis for its anti-cancer drug Glivec (imatinib mesylate) has opened the floodgates of generic space for the drug in India. In the absence of the exclusive marketing rights, pharma majors Cipla, Ranbaxy and Sun Pharma can now re-introduce their generic versions of imatinib mesylate.
Natco, the only generic company that was allowed to market its brand 'Veenat' even during the EMR period can also go ahead with the production without any legal trouble. All eyes are now on Novartis to see if the company approaches the High Court with an appeal against the Patent Controller's decision.
"Unless Novartis obtains an injection against the Patent Controller's decision, all the generic players are free to enter the market," sources informed.
At the time of withdrawal, 'Imalec' brand of Sun Pharma, another leading player, was enjoying a sale of about Rs 5 crore.
Interestingly, Glivec was not fetching much money to Novartis as almost every drug prescribed was given free of cost due to a Chennai High Court directive. Since the price ceiling of the drug fixed by the court was so high, almost every Indian patient was able to get it free. What needs to be seen is whether Novartis continues its free distribution programme.
The Supreme Court is also considering the issue of 'Glivec' through two public interest litigations (PILs) filed by consumer organisations. A Special Leave Petition (SLP) moved by the Natco Pharma is also pending before the Apex Court. It is known that it may take another one to two years before the final verdict on the matter can be expected.