The Hindu Business Line : Date kept, now for the devil in the detail

INDIA seems to have kept its date with the World Trade Organisation, thanks to Sunday's executive order that lays the road for the product patent regime in the country from January.

And while the Government has walked the tightrope of coalition politics and kicked-in the product patent regime, just in time — several issues that were contentious in the draft Patent Third Amendment Bill remain to be sorted out, despite yesterday's Ordinance.

Pharma industry representatives of both hues, with local and multinational companies, lament that they would have rather had the Government bring the Bill into force after a discussion in Parliament. It would have increased the acceptability of the Bill, said a top executive with an MNC.

Now the Patents (Amendment) Ordinance will come up for deliberation in the forthcoming Budget session and if no consensus is arrived at in Parliament, the Ordinance exercise would lapse, said an official with the domestic drug industry.

Respecting product patents would mean that Indian drug companies would no longer be able to make chemically similar versions of new drugs put out by innovator companies in the market. And though the powers that be have sought to allay fears of an increase in medicine prices as a result of product patents — clearly, the devil lies concealed in the detail.

Patentability still remains a grey area and this leaves the industry open to litigation, says Mr D.G. Shah of the Indian Pharmaceutical Alliance. The IPA is a platform of a clutch of domestic drug majors, including Ranbaxy and Dr Reddy's.

Domestic drug companies want only new chemical entities or new drugs to be patentable. But representatives with MNCs want the Government to extend the definition of patentability to new drug delivery systems, for instance.

The stage is also set for interesting interpretations on how the Patent Controller's Office will look at drugs such as Novartis' cancer drug Glivec. The drug had been granted an exclusive marketing right (EMR), or guaranteed sales for a five-year period - however, the EMR has run into litigation, following a case in the Supreme Court.

What happens to GlaxoSmithKline's diabetic drug Rosiglitazone, where the Patent Controller had rejected an EMR? The company had gone in appeal against this decision at the Calcutta High Court and GSK's spokesperson told Business Line that the court had recently redirected the Patent's Office to re-examine the rejection.

Happy that the country has kept its date with the WTO, Mr Ranjit Shahani, President with the Organisation of Pharmaceutical Producers of India, is also concerned on the definition of patentability. He feels that it is in the interest of local drug manufacturers, as well, to extend the definition of patentibility.

And while domestic and MNC drug companies dig out the detail and put it under the scanner, the paying consumer will now have to rely on the large market of drugs that does not come under the product-patent shadow.