Novartis India has approached Chennai High Court against the orders of the Patent Controller invalidating the patent claim on Novartis' block buster anti-cancer drug Glivec (Imatinib Mesvlate). The company has questioned the constitutional validity of Section 3(d) of the Patents Act 1970 itself and has pleaded that any decision considered under Section 3 (d) should be considered legally non-tenable. The HC has issued notices to all respondents and has called for a hearing on August 23.

The Glivec was the only drug that had received exclusive marketing rights (EMR) during the mail box period. Further examination of the patent application showed that the patent specification of Novartis AG does not bring out any improvement in the efficacy of the beta-crystal form over the known substances.

As per Section 3(d) of the Patents Act, any salt, polymorph or derivative of known substance is not patentable unless such salt, polymorph or other substance shows enhanced efficacy of the substance.

Giving its ruling in January 2006, Patent Office had stated that Glivec is only a new form of a known substance. Further, stating that Novartis AG failed to prove enhanced efficacy of the beta-isomer over the known substance, the patent office had concluded that, the subject matter of this (patent) application (filed by Novartis AG) is not patentable under Section 3(d) of the Patents Act 1970 as amended by the Patents (Amendment) Act, 2005.

It is against this ruling Novartis has now approached the High Court.

Interestingly, the Chennai HC had, in an earlier ruling, asked Novartis to give Glivec free of cost to all patients who are suffering from CML and are earning from less than Rs.3,36,000 per month. This was the time when Novartis was having EMR on the drug. Natco was the only generic company that had obtained permission to market the generic version of the drug at a fraction of Glivec's cost in the country. After the expiry of the EMR period, Chennai HC had allowed all generic manufacturers to enter the fray. All generic manufacturers who are into the manufacture and sale of the generic versions of Glivec are party to the new case.