DCGI’s Plan on Patent Linkage Gets HC Booster
January 8, 2009, The Economic Times


The Delhi High Court (HC) has directed the drug controller general of India (DCGI) not to give marketing or manufacturing permission to generic drugmakers for drugs that have already been granted patent in India. The court gave this order last month while preventing Hyderabad-based drug company Hetero Drugs from manufacturing or selling its low-cost version of Bristol- Myers Squibb’s (BMS) patented Leukemia drug, Dasatinib. The order added that Hetero should restrain from manufacturing, selling, distributing, advertising, exporting, offering for sale that would directly or indirectly infringe upon BMS’s drug Dasatinib. The next hearing will be held next month. ET had reported last May that the DCGI was planning to link marketing approval to patents. Indian generic companies had strongly opposed such a policy while patent experts said the DCGI does not have the mandate to do so but the court order could bolster the DCGI’s initiative. Organisation of Pharmaceutical Producers of India (OPPI) director general Tapan Ray said: “OPPI has been trying to impress upon the need of ‘patent linkage’ to the government, since quite sometime. In April last year, the DCGI acceded to our request. Unfortunately, due to some reason, this assurance did not get translated into reality. We are delighted to know about this Delhi HC order, specially at a time when we are still discussing this issue with the government.”