The Delhi High Court will take up for hearing the petition filed by Natco Pharma challenging the decision of patent controller to grant exclusive marketing right to Novartis for imatinib myslate in the last week of January. The court, which admitted the petition on December 23, has reported to send notices to the Patent Controller as well as the other parties concerned to be present on the date.

According to industry sources, the Natco petition has questioned the Patent Controller's decision to grant the EMR on a drug, which 'do not qualify for the same as per the existing law in the country'. The petition is learnt to have questioned that since the Novartis' drug does not fit the criterion that is required by the Indian EMR provisions, how was it considered by the controller for an exclusive right. The current EMR law in the country specifies that the drug should have been a post 1995 invention and it should possess novelty.

The Natco plea has also reportedly mentioned that the substance, beta crystal form of imatinib, on which the EMR is granted, now, does not meet the requisite conditions to qualify for EMR in India.

However, the EMR holder, Novartis, has categorically denied all these allegations by saying that the Patent Control office in India has examined the application for two years and the controller must have verified all these factors before granting EMR.

But, the patent experts are of the view that since the Product Patent Law is yet to be enforced in the country, the Patent Control office may not have necessarily looked into the technicalities of the original patent and the patent history of the drug. "They must have gone through only the details furnished by the applicant, which is only required in the country," they added.

Though the local manufacturers and the Indian Industry associations have technically objected to the granting of EMR to this drug, Novartis has announced that it will enforce the EMR rigorously.