The Patent Controller of India has rejected Swiss multinational Hoffmann La Roche exclusive marketing right (EMR) for its drug Saquinavir. Roche's was the first EMR application registered in India after the country's Patent Law incorporated this provision. Seven more submissions have been made since then.

A top official from the patent head quarters in Calcutta confirmed to Pharmabiz.com that Roche's application was rejected a few days ago, as it did not abide by the conditions for grant of an EMR to a foreign entity. The official, however, refused to specify the exact reasons for the decision.

It may be mentioned that Roche had filed its application on February 24, 2000. Industry sources perceive the beginning of a pattern in the rejection of Roche's application. They believe that most of the other applications that are in process are also non-compliant with the Patent Law provisions.

Among the seven more EMR applications pending with the Controller, most are learnt to be from multinationals, including a couple of applications form Glaxo-SmthKline filed on June 30, 2000, and one by German major BayerAG for moxifloxacin, Ranbaxy's application for its once- a-day delivery system of Ciprofloxacin is the only EMR sought by an Indian company.

Of these, GSK's submission for EMR on the drug Roziglitazone has been most controversial with the domestic drug industry raising objections to the multinational's claim (In fact, the application was filed by SmithKline Beecham before its merger with Glaxo). As per the provisions in Indian Patent Rules, a product for which original patent was granted prior to 1995, is not fit for an EMR in the country. Also, EMR can be granted only for new molecules, not derivatives. Domestic drug companies had complained that most of the EMR submissions filed with the Patent Controller were not for "new molecules" as specified in the law, but for "new derivatives". For instance, the original patent for Rosiglitazone was granted in 1998, and subsequently SKB secured two more patents on its derivatives.

EMR is a prelude to product patent and in India it is to be operational only during 2003-2005. For obtaining the right in India, the applicant is mandated to have filed a corresponding application in another country and obtain beforehand marketing approvals in India and in that country. Further, the EMR seeker must also have secured the original patent during 1995-'96 in a country, which was giving product patent then. Given these conditions, domestic pharma companies are mostly not in position to obtain EMR for any product in India, although the conditions for grant of EMR to domestic applicants are lenient as opposed to those for a foreign applicant.

Given the fact that EMR gives little opportunity for Indian companies, the multinationals' zeal to obtain the right with dubious eligibility is detested by them. The IPA, in this context, seeks a more transparent EMR regime in the country. "Indian companies should be given access to the details of EMR submissions by MNCs and they ought to be able to suo moto verify each application on merit, " D G Shah, secretary general, IPA said.