Industry reacts with caution to the grant of a compulsory licence to Natco, but cancer patients welcome it and hope for many more. THE first compulsory licence (CL) issued by the Indian patent office, to the local drug manufacturer Natco Pharma Ltd to sell the generic version of Bayer AG's anti-cancer drug Nexavar, has led to varied reactions. The landmark decision has also raised concerns about the outcome of cases...

India is coming under increasing pressure from the U.S. and the European Union for the strict patentability criteria it applies for medicines. AS was only to be expected, the two landmark decisions made by the Indian patent office in recent times concerning pharmaceutical patent cases have not gone down well with the multinational drug industry. First, there was the rejection in 2006 of the patent application by the Swiss multinational...

The country is clearly shaping its legislation to promote access to medicines by fostering generic production. INDIA'S approach to the revision of its Patents Act in 2005 is a clear example of a country shaping its legislation to promote access to medicines by fostering generic production. Although World Trade Organisation (WTO) rules made it mandatory for India to put in place a patent regime for medicines by 2005, nothing obliges...

NOVARTIS has long been suing the Government of India to eliminate or weaken Section 3(d) of the Patents (Amendment) Act, 2005, which established strict standards of patentability in order to prevent the ever-greening of patent monopolies on medicines. Although Novartis lost in 2007 its initial efforts to have Section 3(d) declared unconstitutional and violative of international norms for national patent regimes, it has persisted in appealing and re-appealing the denial...

That this is the first time a compulsory licence has been granted in India is in itself important. INDIA'S long struggle to ensure access to affordable medicines for its people recently took a positive and interesting turn. In early March, just before he demitted office, Controller General of Patents P.H. Kurian passed an order on an application filed by Natco Pharma, headquartered in Hyderabad, requesting a licence to produce an anti-cancer...