Date:21/12/2004 URL: http://www.thehindubusinessline.com/2004/12/21/stories/2004122101370200.htm

Back Novartis' Glivec story: A sign of things to come?

P.T. Jyothi Datta

Mumbai , Dec. 20

A LITTLE more than a year ago, a significant step towards establishing a product patent regime was taken in India.

Novartis was granted the country's first exclusive marketing right (EMR) for its blood cancer drug Glivec.

But today the Glivec story evokes emotion-filled reactions from several quarters. It stands mired in litigation and pharma industry representatives say in `I-told-you-so' tones that seeking the refuge of the law was bound to happen when it concerned access to life-saving drugs.

The concern stems from the fact that an EMR gives Novartis the right to be the only company in the country legitimately marketing the drug for a period of time. And local companies making the me-too version of the same drug would have to stop producing it with immediate effect.

Bottomline, feared non-government agency representatives, cancer patients would find the drug too expensive. A year's course of Glivec internationally costs about $27,000, while local copies from India sell at $2,700.

Novartis, meanwhile, initiated legal steps to keep other Indian companies such as Cipla, Ranbaxy and Sun from making similar versions of Glivec.

It also began to give Glivec for free to patients. At last count, about 3,000 cancer patients benefited.

The Glivec story gives us a key-hole view into what is in store when India goes in for product patents in January. Product patents will give companies 20-year monopolies on their innovative products. And concerns abound over whether medicines would see a shortage or a price increase as a result of this.

But for multinational companies looking into India, is the Glivec experience off-putting? Or does the slow trot towards product patents instil confidence to invest in India?

"The Government is likely to bring product patent protection through an Ordinance. But there is still no clarity on what is patentable, whether pre-grant opposition before patents are granted and the triggers for compulsory licencing," said Mr Kewal Handa, Executive Director (Finance) with Pfizer.

Foreign direct investment is connected to patent protection in a knowledge-based industry and one will bring in the other, he adds.

On the "human side", he clarifies: "Companies are donating drugs, others are looking at differential pricing. Bring in patent protection with checks and balances in the interest of consumers."

Mr Rajiv Gulati, Chairman and Managing Director with Eli Lilly in India, says: "Lilly will more than double investment in clinical research, if patents are protected."

It currently invests about Rs 10 crore in research in India. Other MNCs too, such as Merck and GlaxoSmithKline, are waiting in the wings, he adds.

Waiting and watching how the patent regime will be implemented on the ground, as indicated by the Novartis Chairman and Chief Executive Officer, Dr Daniel Vasella, during his recent visit to India. The Glivec experience in India, notwithstanding.