Cancer patients group to contest patent for Roche’s Herceptin

Cancer patients group to contest patent for Roche’s Herceptin

An Indian patient group plans to oppose a patent granted by the country’s patent authorities to a cancer drug from Swiss drug maker F. Hoffman-La Roche Ltd’s stable on grounds that it denies large sections of women fighting breast cancer access to cheap variants of the medicine.

Delhi-based Cancer Patient Aid Association, or CPAA, has had discussions with Lawyers Collective, a group of advocates that takes up public health and women’s issues, to file a post-grant opposition on Roche’s breast cancer drug ‘trastuzumab’, Y.K. Sapru, president of CPAA, said.

Sold under the brand Herceptin, the drug generated worldwide sales of $3.48 billion for the drug maker in 2006 (Rs16,151 crore then). Roche has received a patent in India for the drug and this will prevent Indian makers of generic, or copycat, drugs from making it and provide Indian patients affordable medication to combat breast cancer.

CPAA had also challenged another Swiss drug company, Novartis AG’s application for securing a patent on its cancer medicine Glivec in 2005. The litigation between the health activists and Novartis in time snowballed into a heated public debate on innovation versus issues of mass access to medicines. Earlier this year, the Madras high court dismissed Novartis’ challenge of an Indian patent law that disallows incremental innovations while the appeal on the Glivec patent rejection is still before the Intellectual Property Appellate Board.

Some 400,000 women in India are currently living with breast cancer and about 120,000-150,000 are being added every year. Herceptin (trastuzumab) treats a particularly aggressive form of tumour that accounts for 20–30% of all breast cancers by blocking the multiplication of tumour cells. The drug is being sold in India in very small quantities.

A year’s regimen of the intravenous drug, estimates Ajay Dewan, cancer surgeon at Delhi’s Rajiv Gandhi Cancer Institute and Research Centre (RGCIRC), will cost between Rs16 lakh and Rs18 lakh and has no low-cost, non-patented or generics copies available. “It is a new drug and very effective as it fights the cancer cells through body’s own immune system. But it is so expensive that it is beyond the reach of most people looking to pay out of their pocket."

Girish Telang, managing director of Roche Scientific Co. (India) Pvt. Ltd, Roche’s Indian arm, said he would comment only when he receives a formal notice of the Herceptin patent challenge.

Sapru declined to reveal the grounds on which the patient group will challenge the Herceptin patent but said that post-grant opposition was a tougher ground to fight on. “The patent protection is already there with the company and it will continue until we are able to revoke it," he said, unlike a pre-grant opposition when the process gets stalled.

Project director of Lawyers Collective, Anand Grover, said the body was in the process of obtaining the Herceptin patent application to look into it and the final picture will emerge in a day or two.

Roche has a very successful stint with receiving patents in India. In recent years, it has obtained patents for Pegasys, a drug for Hepatitis C that is now being opposed by Wockhardt Ltd; lung cancer drug Tarceva; anti-HIV drug Valcyte and Mircera that treats renal anaemia.