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28 March 2014Americas

Novartis launches Gleevec action against Dr. Reddy’s

Novartis has sued generic drugmaker Dr. Reddy’s Laboratories for infringing a patent related to its chronic myelogenous leukaemia (CML) drug Gleevec/Glivec (imatinib mesylate).

The case, filed at the US District Court for the District of Delaware on March 26, relates to reissue patent RE43,932, of which Novartis Pharmaceuticals Corporation is the exclusive licensee.

Novartis launched the case after Dr. Reddy’s sent an Abbreviated New Drug Application to the US Food and Drug Administration (FDA) seeking approval from it to make and sell generic 100mg capsules of Gleevec.

In its letter of notice to Novartis, Reddy’s said it believed the RE932 patent is invalid and unenforceable, and that it will not be infringed by the manufacture and sales of its imatinib mesylate capsules.

Novartis asked the court for judgment that the patent is valid and enforceable, that Reddy’s imatinib mesylate capsules infringe the patent, and for a permanent injunction to keep Reddy’s from making the drug.

First approved by the FDA in 2001, Gleevec has been described as a “miracle drug”. According to a study published in Nature Education before the introduction of Gleevec, the survival rate for patients with CML was 30 percent within five years. By contrast, 87 percent of CML patients taking the drug survive over the same period.

According to drugs.com, Gleevec sales totalled more than $1.8 billion in 2013.

In April last year, the Indian Patent Office refused Novartis’s application for an Indian patent covering the drug, deeming the patent too similar to an earlier version.

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