Questions and answers on Novartis and the Glivec patent case in India

By Oxfam

Share this story:

What is the case all about?

In 2005, cancer patient groups in India used Indian intellectual property law to stop a patent application by Swiss company Novartis for its anti-cancer drug, Glivec. This allowed Indian companies to continue making generic versions at about $2,700 a year, as opposed to Novartis having a monopoly priced version for sale at about $27,000 a year.

Novartis recently appealed the decision in a direct challenge to India's right to use safeguards contained in trade rules agreed by the WTO in 2001 in the interests of public health.

What is Glivec?

Glivec (Gleevec in the US) is an important drug that means the difference between life and death for cancer patients suffering from leukemia (CML), stomach tumors, and other conditions. Glivec is a significant improvement over other forms of treatment and should be as widely available as possible, at affordable prices.

Why is Novartis enforcing its patent on Glivec in India and in other in developing countries?

Glivec is a key drug for Novartis worldwide. It's the company's second best selling drug with sales reaching $2.8 billion in 2005 and accounts for 9.6 per cent of Novartis's estimated share value. Research indicates that there are multiple diseases that respond to the drug. In only five years, Glivec is now approved in the US for seven different diseases. There is a danger that the company could apply for a new patent based on these "new uses" elsewhere, which would extend its monopoly and delay availability of affordable generic versions of Glivec for people who need it.

Novartis says that there is virtually no commercial market for Glivec in India and that it is taking the case in part to "align Indian IP laws with TRIPS", The World Trade Organization's agreement on intellectual property. This action is one that will affect India's right to produce not only generic versions of Glivec but also for other new medicines in the future.

What would happen if Novartis were successful in its appeal?

Not only would it increase the price of the drug it would also jeopardize India's generic export industry. India is the world's leading supplier of inexpensive generic medicines to developing countries with approximately 67 percent of its exports going to developing countries. As a result people needing cheaper versions of medicines in many developing countries would lose out.

Oxfam believes that generic competition reduces the price of many patented medicines and makes them much more affordable to poor people in developing countries. Lower prices via generic competition could ensure free or subsidized medicines for millions of poor people through increased public sector funding for health, through health insurance and because many poor people are willing to pay out of pocket for medicines because the health and well being of themselves and their family a top priority.