Mumbai: The Delhi high court will on Tuesday take up the Roche Scientific Co. (India) Ltd’s petition seeking an injunction against a plan by Indian generic rival Cipla Ltd to market a copycat version of a lung cancer drug patented by Roche, even as at least one other local drug maker and a patient support group are planning to contest the patent.
The drug, known as erlotinib in chemical terms, was granted a patent in India in 2007. It is sold under the brand name Tarceva by Roche at about Rs4,800 a tablet here.
As first reported by Mint on 11 January, Cipla had said it would launch a low-cost version of this drug in India, which it has done at Rs1,600 a tablet. “We are moving a post-grant opposition to Tarceva patent grant in India,” said a senior Cipla executive who did not want to be identified.
High speed: A tablet blister-pack machine at a Cipla plant which can process 7,000 tablets an hour. The company plans to market a copycat version of a lung cancer drug patented by Roche.
At the same time, Hyderabad-based cancer speciality company Natco Pharma Ltd, which unsuccessfully opposed the Tarceva patent application in India, had applied for a compulsory licensing for the drug as it wants to export it to Nepal.
Lawyers Collective, a Mumbai-based, NGO that fights for access to medicines, especially those for HIV/AIDS and cancer, is also likely to oppose the Tarceva patent in India.
Roche India managing director Girish Telang had earlier mentioned that “anyone can oppose the patent as the country’s patent law provides it, but launching a copy version now will infringe our patent and we will be forced to take necessary action immediately.”
At Tuesday’s hearing, attorney Arun Jaitley, a former Union law minister, will represent Cipla.
The Tarceva patent is held by Pfizer Inc. and another US firm, OSI Pharmaceuticals Inc., as they jointly invented the drug. The drug was globally licensed to F Hoffmann-La Roche Ltd, or Roche, which launched it in India in 2006.
While patient groups in India say that the patent granted to any product is to be respected, the high cost of these drugs blocks their access to poor patients. Claiming the ground for a compulsory licensing by the government in such cases, Shamnad Basheer, a patent expert and an associate at the Oxford Intellectual Property Institute, UK, said: “The drug is not reasonably priced. A lung cancer patient could pay close to Rs1.5 lakh a month for treatment.”
Basheer pointed to an important provision in the Indian Patents Act that could give the Tarceva challengers ammunition in the case.
“Local manufacturing is an essential condition for patented drugs though this is a highly controversial ground now in India. However, if this is invoked, I’m sure that at least 80% of all patented drugs by multinational companies, including Tarceva and the highly controversial Glivec, would be subjected to a compulsory licence here,” he said. But the clause can be invoked only three years after the grant of a patent.
Another patent expert said Roche has a strong case for now. “If a generic company launches a product patented by the inventor, it will be considered an infringement,” said Prabudha Ganguly, a patent consultant in Mumbai.
The inventor can secure an injunction as also claim damages from the violator, he added. According to the Indian Council of Medical Research, at least 90,000 men and 79,000 women are diagnosed each year in the country with cancer of the lung. 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.
Clinical trial data shows that Tarceva 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.