Indian Supreme Court to hear Novartis dispute over generic drugs

India’s highest court is set to hear a long-running dispute between Novartis and the country’s government, which has prevented the pharma company from patenting its cancer drug Gleevec.

The case, originally set to start on August 25, will begin on September 11 at the Indian Supreme Court. It strikes to the heart of the debate over patenting drugs and allowing generic companies to sell them more cheaply. Generic companies are allowed to sell the drug in India.

The Swiss-owned company owns patents for Gleevec in around 40 countries. It applied for a patent in India but the national patent office rejected its application in 2006, arguing that the medicine was merely a new form of an old medicine. This meant it could not be patented under Indian law, as laid down in Section 3(d) in India’s Patents Act.

At the time, the drug was sold at $2,600 per patient per month in other countries but generic companies sold the drug in India for less than $200 per patient per month. Novartis subsequently asked a court to declare Section 3(d) unconstitutional. But in 2007, the Madras High Court rejected this challenge. Novartis started a fresh challenge in 2009 at the Indian Supreme Court, where the case will now be heard.

Groups campaigning against Novartis have said Gleevec should be available cheaply to cancer patients in India who cannot afford to pay. “If Novartis won the case, patents would be granted in India as broadly as they are in wealthy countries and on new formulations of known medicines already in use. India would no longer be able to supply much of the developing world with quality affordable medicine,” said Médecins Sans Frontières in a statement on its website.

But Novartis said in a statement that the legal move is “about protecting intellectual property to advance the practice of medicine, not about changing access to medicines”. It argues that the case is about gaining clarity on the application of patent law in India, which “is important to the economic future of the country."