Indian pharma companies, which withdrew the generic brands of Glivec earlier, are now planning reintroduction of their products in the market soon as the new changes in the amended Patents Act has almost sealed the possibility of granting a patent to Novartis for the drug.
With the new amendments in Patent Law, the section 3 (d) explains, "salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes, combinations and other derivatives of known substance shall be considered to be the same substance, unless they differ significantly in properties with regard to efficacy."
The exclusive marketing right (EMR) for Novartis was granted to the beta crystal form of imatinib mesylate, which is learnt to be a pre-1995 invention. The patent experts in the country are of the strong view that considering both these aspects (the molecule as a pre-'95 invention and also as the EMR for the beta crystal form of the molecule), the patentability cannot be claimed to this product in India.
However, the companies are of the view that though the Patent Law is very clear now that the Novartis application for patenting imatinib mesylate does not qualify for grant or any kind of exclusivity right, their hands are tied with the ever lagging judicial procedure with the injunction and the petition challenging the same with the High Courts of Delhi and Chennai.
According to highly placed sources in Cipla which withdrew the generic brand of imatinib myslate after the Novartis' EMR, the company has been trying desperately to utililize the provisions of the amended law to reintroduce their brand Imatib. "But, unless the Court takes some decision on the pending case, we can not re-launch the brand even if the Patent Controller rejects the patent application of Novartis," said the source from Cipla.
While, Sun Pharma, another leading player, which withdrew its brand 'Imalec', said, "We are at present trying all legal options to get the brand re-introduced in the market." Imalec was a product with little less than Rs 5- crore sales for Sun Pharma.
The country's pharma major Ranbaxy also shared the same views even though it was the first company to withdraw the generic brand of this CML drug respecting the Madras High Court decision to grant the injunction to the generic brands after the EMR granted to Novartis.
However, the Hyderabad-based Natco pharma, which was the leader in the generic market for imatinib myslate in India, could continue in the market with its brand 'Veenat' as the company had challenged the Patent controller's decision to grant the EMR to Novartis before Novartis secured the stay against generic players.