India's patent system faces clinical trial
ANTI-CANCER drug imatinib mesylate is having a positive side-effect on the country's patent system. The disputes following the award of an exclusive marketing right (EMR) for the drug to Novartis India, a subsidiary of the $24-billion, Switzerland-based multinational Novartis AG, are showing up the loopholes in the system.The Patent Controller's Office, which is responsible for granting EMRs (and will be responsible for issuing patents from 2005), gave the one for imatinib mesylate to Novartis. Meanwhile, the Drug Controller General of India (DCGI), which only checks whether a drug is fit to market, allowed a number of generics companies to do so. Neither of the two bodies is required to tell the other what it is doing. Therefore, what they ended up doing was create a situation where the two permissions are in conflict. "The current law is a recipe for litigation," says Rajiv Gulati, chairman and managing director, Eli Lilly India, the Indian subsidiary of the US-based drug company Eli Lilly. Lilly has also applied for an EMR for its anti-impotency drug Tadalafil, but the market has been hijacked by Ajanta Pharma and now Ranbaxy Laboratories with permits from DCGI.Moreover, there is no special court to handle patent disputes. Novartis' EMR has been challenged in the Delhi High Court by Hyderabad-based drug company Natco Pharma India, which has DCGI permission to market imatinib mesylate. But Novartis, on the basis of the EMR, filed a suit in the Chennai High court against six generic drug companies and managed to get a stay against them for the same drug. Now if Natco wins in Delhi, the Chennai High Court's stay will conflict with the Delhi High Court's verdict.Meanwhile, Novartis has also filed a case in the Mumbai High Court against Natco Pharma and two others - Shantha Biotechnics and Camlin - for infringing on its EMR. In its petition in Mumbai, Novartis disclosed to the judge that the EMR was disputed and the matter was under consideration by the Delhi High Court. Four hearings have already been held in Mumbai on 4, 12 and 25 February and 11 March, but the final decision is likely to be taken only after the Delhi High Court gives its verdict in the other case between the two companies.Novartis India chief executive officer Ranjit Shahani says the company will defend the EMR. The CEO of another drug firm says that one knew there were loopholes in the law, but "they would have never come to light if the EMR had not been granted (for imatinib mesylate) and challenged".
Source: BusinessWorld (http://www.businessworldindia.com/mar2904/news17.asp)
No comments:
Post a Comment