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...

PROFESSOR Shamnad Basheer joined the National University of Juridical Sciences (NUJS), Kolkata, in November 2008 as the first Ministry of Human Resource Development Chaired Professor in Intellectual Property Law. Before this, he was Frank H. Marks Visiting Associate Professor of Intellectual Property Law at the George Washington University law school and a research associate at the Oxford Intellectual Property Research Centre (OIPRC).  He is the founder of several initiatives, including...

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...

Confusion sparked by the setting up of a new committee for drug approvals has led to a slide in the number of new medicines getting cleared even as millions of Indians struggle with diabetes and heart failures remain a major killer. The Drug Controller General of India (DCGI) has shed its role as the sole approver of new drugs in the country after a new committee, set up by the health...