Cloned drugs abound as patents wait in mailbox

Indian firms say without a local patent for a drug, they will sell its clones.

Though the country switched to a regime of product patents from January 1, the move has had no impact on the pharmaceutical market as no Indian company has withdrawn any product.

According to India's commitment to the World Trade Organisation (WTO), it will honour all product patents issued after 1995. But Indian companies argue that unless the government issues a patent on any drug, they are free to sell its clones in the country.

"Even if a company gets a patent outside India for a drug, the impact here will be clear only if we can know whether that company has applied for patents in India," Cipla Joint Managing Director Amar Lulla told Business Standard.

A case in point is Eli Lilly's Cialis (tadalifil), which cures erectile dysfunction. The drug continues to be sold by at least 10 companies in India, including Ranbaxy Laboratories. Ranbaxy sources said it would withdraw its tadalifil only after the government granted the patent to Eli Lilly and issued a notification to this effect.

Companies like Eli Lilly have already filed for patents on their products. Their fate will be decided only when the government starts processing the mailbox which has several thousand applications in it.

The number of applications is disputed: while the industry believes that there are not more than 5,000 applications, the ministry of commerce had announced there were 12,000 applications.

Even the number of post-1995 patent filings is unclear. According to the Indian Medical Service health database, India is included in only 25 post-1995 patent filings. But different figures are being quoted in different sections of the industry.

The procedure for processing of the applications, too, is unclear. "Who will decide which application will be published first and who will hear the representation," Lulla said.

He felt that Indian companies would have to get into a litigation overdrive unless the government specified which drugs were off patent. Although the government has announced that 95 per cent drugs are off patent and hence will not be affected, there is no specific list of such drugs.

In fact, most Indian drug manufacturers put a timeframe of one year for patent proceedings to take off in earnest.

"It will take at least a year for the effect to show. Drugs will not be withdrawn unless a company is granted patents in India. Till then generic companies are free to manufacture them," Indian Drug Manufacturer's Association Secretary-General SK Arya said.

Bitter pill

• Indian firms say without a local patent for a drug, they will sell its clones in the country
• So Eli Lilly's Cialis, which cures erectile dysfunction, has at least 10 clones in India
• One of them is Ranbaxy's. Sources say it will withdraw its drug only after the govt grants a patent to Eli Lilly
• Firms like Eli Lilly have filed for patents. Their fate will be decided only when the govt starts processing its mailbox which has several thousand applications