The Hindu Business Line : Novartis patent for cancer drug rejected: Will it open up window of opportunity for generics?

At least not for now, says Mr Y.K. Sapru of the Cancer Patients Aid Association (CPAA), reacting to the Indian Patent Office's decision to refuse Novartis a patent on anti-cancer drug Gleevec (imatinib mesylate).

The association has been supporting cancer patients like Ameeta who were using the generic or chemically-equivalent copy of Gleevec made by a local drug-maker Natco Pharma. And if the patent office had ruled in favour of Novartis, keeping out the generic copies, even that supply would have dried-up, he observes.

But will the Patent Office's decision re-open a window of opportunity for other generic-makers of Gleevec, such as Ranbaxy, Cipla, Sun Pharma, Hetero, Emcure and Intas, who were earlier restrained from making and marketing the drug? Or will Novartis go in for an appeal against this decision at the court? These will be some of the possibilities being evaluated, says a patent attorney following the case, indicating that the last word has not been heard yet on the issue.

A Novartis spokesperson, however, said that they had not got any official communication to the effect. And, hence, did not want to comment on the issue.

As Novartis takes a call on the issue, so are the six generic companies that had been restrained from selling their versions of the cancer drug by a directive from the Madras High Court in early 2004.

This was a follow-through by Novartis, the country's first pharma company to get an exclusive marketing right (EMR) on a drug, Gleevec in this case. A decision that Natco had challenged then at the Delhi High Court, and, hence, kept producing the generic version of the drug, while other companies were restrained.

Cipla said that it would work towards getting the stay order against its version of the drug vacated. Mr Amar Lulla, Cipla's Joint Managing Director, told Business Line that Cipla, at present, markets another form of the drug. But it would be keen on getting the beta-crystalline version of the drug (which Novartis wants to patent) into the market too, depending on how the legal situation plays itself out, Mr Lulla said.

Gleevec has always been an emotive issue in the country. It remained at the centre of the patient versus patent debate, especially since India ushered in the product-patent regime in January 2005.

And price was the crux, with Gleevec costing about Rs 1.20 lakh per month and the clones costing about Rs 10,000 per month to the patient.

But in an effort to make the drug accessible and thwart detractors, Novartis started giving Gleevec free to patients. About Rs 550 crore worth of Gleevec had been given free to patients, a company official had told this correspondent during an earlier discussion on the subject.

But, according to CPAA's Mr Sapru, over 30,000 people in the country suffer from chronic myeloid leukemia, a type of blood cancer. How would the company identify who to give it to, besides for how long will they give it free, he questions.