The Delhi High Court today allowed domestic drug major Cipla to sell its generic version of lung cancer drug, Erlotinib, vacating an earlier interim order restraining it from selling the drug. The earlier order was based on an appeal by Swiss multinational Hoffman Laa Roche.
A division bench headed by Chief Justice AP Shah today dismissed the plea of the Swiss company saying that Cipla should be restrained from manufacturing and selling the generic drug till the issue of patent rights was decided through litigation.
“We are yet to get a copy of the order. We will soon decide whether to appeal the decision in the Supreme Court”, said Girish Telang, managing director of Roche India Scientific Company, the Indian arm of Roche.
Meanwhile, Amar Lulla, joint managing director of Cipla, said the court decision would help numerous lung cancer patients access the drug. “This is a victory for the cause of patients, than our business interests,” he said.
Roche was awarded a product patent for the drug, which it has been selling as Tarceva in India since 2006. Cipla launched its generic version, Erlocip, in India in January last year, challenging the monopoly rights of Roche. Separately, Hyderabad-based company Natco Pharma approached the patent office in New Delhi a few months ago to allow it to export its generic version of Tarceva to Nepal.
Roche filed an infringement lawsuit at the Delhi High Court immediately after Cipla launched its generic version. In March, the high court allowed Cipla to sell its version of the Roche drug. However, Roche challenged the decision with the Division Bench of the same court and obtained a decision restraining Cipla from selling the drug.
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The case is being keenly watched by patent experts, global and Indian drug firms and consumer interest groups, as it is one among the first test cases of India’s product patent regime since January 2005.
Nearly 1,60,000 people in the country are estimated to be suffering from the disease, which has a high fatality rate, according to sources with patient groups.
Both Amar Lulla and Girish Telang declined to reveal the size of their business from Erlocip in India. Sources said Cipla’s generic version costs about Rs 1,600 a tablet, one-third the price of Roche, which charges over Rs 4,500 a tablet.