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Natco challenges Novartis' patent on anti-cancer drug

Our Bureau

Hyderabad , June 20

NATCO Pharma Ltd (NPL) has filed an opposition to the patent claim made by Novartis India Ltd for an anti-cancer drug (Imatinib Mesylate) with the Controller of Patents.

The Hyderabad-based Natco said the move was to curb a widely prevailing practice called the `Evergreening' strategies, which essentially involves a manufacturer obtaining patent rights beyond the basic molecule.

The Indian Patents Act was amended in April 2005, excluding grant of patents to salts, esters, ethers, polymorphs and similar forms, combinations of known substance unless they differ significantly in properties with regard to efficacy.

Natco's pre-grant patent opposition application challenges the validity of the patent application (No. 1602/Mas/1998) regarding the crystalline modification of Imatinib Mesylate.

The basic ground of opposition is that Novartis claim squarely falls within the concept of `Evergreening' as the polymorph claimed is the same as that of the 1993 molecule.

Stating this there was no merit for the grant of a patent, Natco also claimed `lack of novelty and inventive step' (both key elements in patents), in the Patent application by Novartis.

According to a press release from Natco, the invention of the drug in question was made in 1993 and the Indian patent application merely claims a crystal form (beta) version of the same substance, and hence would not deserve consideration.

Several licences have been granted by the Drug Controller General of India for various crystal forms of Imatinib Mesylate to other manufacturers, including Cipla, Sun Pharmaceutical Industries etc, the release said.

Interestingly, Novartis had obtained exclusive marketing rights (EMRs) for Imatinib Mesylate (a drug useful in the treatment of certain forms of Chronic Myeloid Leukemia) in November 2003.

Natco had challenged the grant of EMRs for the drug to Novartis, and the case is presently before the Supreme Court of India.

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