Cipla to sell copycat version of Roche drug

Cipla claims it will launch a version of a lung cancer drug at one-third the price that its licence holder, Roche Scientific Co. (India) Ltd, sells it for in India.

Roche has an India patent on the drug, called Tarceva, and says it won’t simply stand by. “If any company launches this product in India, it is an infringement of the patent and we will be forced to take necessary action immediately," said Roche India managing director Girish Telang.

The drug, whose chemical name is erlotinib, was jointly invented by Pfizer Inc. and OSI Pharmaceuticals Inc. It was licensed to F Hoffmann-La Roche Ltd, which launched Tarceva in India in 2006, after securing a product patent here.

“Cipla will launch the product next week in India despite the so-called patent protection granted to Roche here," confirmed a senior executive of Cipla who didn’t want to be named. Cipla has already received marketing approval for this product, which is one of the most important treatment currently available for late-stage lung cancer.

Roche sells Tarceva for about Rs4,800 per tablet, to be taken once a day. It usually means Rs1.4 lakh for a month’s treatment in India.

“We will offer the generic version of the drug at about Rs1,600 in the domestic market. We will also try to export it to other markets at an affordable price," said the Cipla executive.

Cipla, he said, will also challenge the patent, claiming “its original invention date does not justify its claim for patent here" and will file a post-grant opposition. “We are going ahead with the launch and are ready to face the consequence when it comes," the executive said.

Roche got a patent for Tarceva overcoming a pre-grant opposition petition from Hyderabad-based cancer speciality company Natco Pharma Ltd.

“A patent for erlotinib was granted in India after scrutinizing all the relevant data. Since there is no post-grant opposition filed so far in the country for this patent, we understand there is no dispute on the same," Telang said.

According to Prabudha Ganguly, a patent consultant in Mumbai who is not involved in the saga, if a generic company launches a product patented by the inventor, it will be considered an infringement.

“The inventor has the right to file an infringement suit against the generic company and it can secure an injunction. The inventor can also claim damages from the violator," Ganguly said.

Ranga Iyer, president, Organization of Pharmaceutical Producers of India, a body of multinational drug firms operating in India, also noted that “launching a generic version of a patent product is an infringement of the patent and it amounts to violation of the country’s law."

Gopakumar Nair, another patent consultant, had a different view. “Erlotinib is a derivative of another known cancer drug gefitinib, a pre-1995 invention of European drug maker AstraZeneca. Since (the) Delhi patent office had denied a patent for this (the AstraZeneca) drug, a patent for its derivative will not be strong, and the generic company can get the patent revoked through a post-grant opposition," Nair said.

According to a report by the Indian Council of Medical Research, at least 90,000 men and 79,000 women are diagnosed each year in India with cancer of the lungs and bronchitis. Bhopal has the highest incidence of lung cancer at 14.5 per 100,000 men, followed by Mumbai at 14.3 and Delhi at 13.2.

Tarceva’s clinical trial data shows that it has demonstrated a striking survival benefit (42.5%) in advanced non-small cell lung cancer, the most common form of the disease.

The drug was approved in the US in 2004 and a year later in the European Union.

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