On December 19, 2008 the Delhi High Court issued an ex parte injunction on Hetero Drugs Ltd preventing it from pursuing its application with DCGI for approval of a generic version of Bristol-Meyers Squibb's cancer drug, dasatinib. BMS has been selling this highly expensive drug in the Indian market under patent protection since 2006 with its brand name, Sprycel. According to company's own admission, the BMS brand costs Rs 18 lakh for an year's treatment. The HC injunction says that DCGI should not grant approval to Hetero for the drug as that will be in breach of the patent of BMS. The Court order reads quite clear although no patent infringement of BMS drug has been actually taken place. Last year, two other patent disputes arose between the Indian company, Cipla and two MNCs. In one case, Cipla obtained a marketing approval for the cancer drug, Tarceva, after the Patent Controller issued a product patent to Roche for the drug. Roche moved Delhi High Court against Cipla in March, 2008 but the plea for a stay against Cipla's marketing the generic version got rejected. In the second case, the Delhi High Court had asked DCGI to reject a generic drug application made by Cipla for Bayer AG's cancer drug, Nexavar. Bayer holds an Indian patent for the drug issued in 2007.
Court interventions in patent disputes like these can complicate the whole issue of granting marketing approvals for patented drugs in the country. The Drugs & Cosmetics Act do not say anything specific about the grant of marketing approvals for patented drugs. Therefore, DCGI is supposed to see the safety and efficacy of a new drug before granting marketing approval and his office is not expected to know whether drug has a patent or not. Now, in the case of Hetero, the injunction of the Delhi HC cautions DCGI about granting any marketing approval when the BMS drug is already under patent. It is not normally possible for the office of the DCGI to keep a track of the patent status of a drug while granting a marketing approval as happened in the case of Cipla and Roche. Increasing patent disputes between MNCs and Indian companies in the absence of sufficient clarity in the patent law and drug rules can disrupt the availability cheap generic drugs for deadly diseases in the country in future. It is true that India adopted the new patent law from mid 2005 and patent has to be granted to new molecules after their proper examination. But this exclusive marketing right should not lead to a situation of monopoly pricing of life saving drugs without any consideration of socio economic condition of the country. Already a large number of patented drugs are being sold in the country at exorbitant prices as almost all of them are prescription driven. And the government plan to bring some rationalization on their pricing has not met with any success.