The Glivec case

THE astronomical rise in the price of Glivec, the blood cancer drug, which has now become representative of the dangers of a product patents regime, began when the Indian Patent Office granted it exclusive marketing right (EMR) to Novartis A.G., a multinational based in Switzerland. The EMR, which is the first such granted in the country, gave Novartis the right to be the only company that can produce and market the drug in India.

The anti-cancer drug is composed of the beta-crystalline form of the compound imatinib mesylate and is sold under the brand names Glivec, Imanib, Imalek, Temsab, Zoleta, and so on. The drug is used to treat people suffering from chronic myeloid leukaemia (CML), a life-threatening form of cancer. Of the 24,000 people afflicted by CML every year, 18,000 succumb to the disease, mainly because they cannot afford to buy even the generic drugs.

Novartis began enforcing the EMR for Glivec by asking for an injunction against generic manufacturers of the drug in the Madras High Court. In January 2004, the court granted Novartis an injunction, restraining companies such as Cipla, Ranbaxy and Sun from manufacturing, selling, distributing or exporting the drug. The injunction was later made absolute by a single Judge of the High Court. Interestingly, the lawyer representing Novartis A.G. was P. Chidambaram, who is now the Finance Minister.

Once the generic manufacturers stopped producing Glivec, the price of the drug jumped from approximately Rs.10,000 for a month's requirement to around Rs.1,20,000. (The generic version of the drug cost about Rs.90 per 100 mg capsule, and if four capsules are taken a day it would cost Rs.360 a day. After Novartis obtained the injunction, the price of Glivec rose to Rs.1,000 per 100 mg capsule.)Indian drug companies went in appeal, which was heard by a Division Bench of the Madras High Court. They contended that Novartis had obtained a patent in the U.S. and Canada in respect of `pyramadine derivatives and processes for preparation thereof'. They argued that no patent was filed in India for imatinib mesylate. Novartis said that the EMR was conferred for a period of five years, or until an order was passed on the patent claim in India, whichever was earlier. It said that it had instituted a programme called Gipap to supply free Glivec, thus taking care of the element of `public interest'.

The court refused to interfere with the single Judge's order. However, as an interim arrangement, it ordered foreign drug producers to arrange for the free supply of the beta-crystalline form of imatinib mesylate.

The Glivec case is seen widely as an example of what is to come after the product patents regime is put in place. It was cited repeatedly by the Left parties and health activists when the Patents Bill was discussed in and outside Parliament.