Mumbai / New Delhi: US drug maker Bristol-Myers Squibb Co. has secured an ex-parte injunction from the Delhi high court preventing India’s drug regulator from approving an off-patent version of its cancer medicine dasatinib. The drug, currently patented by Bristol-Myers in India, is sold under the brand name Sprycel and prescribed for chronic myeloid leukemia.
In a 19 December order, the Delhi high court stayed Hetero Drugs Ltd, which had sought approval for marketing dasatinib, from making, selling ,distributing or exporting the medicine.
Working hard:A researcher at Bristol-Myers Squibb’s Genomic Technologies Pharmaceutical Research Institute in New Jersey. Emile Wamsteker / Bloomberg
The court also stopped the Drug Controller General of India (DCGI) from proceeding with Hetero Drugs’ application for approval of its generic version of the medicine.
Brian Henry, a top executive handling corporate and financial communications at Bristol Myer’s Squibb, responded to a Mint email query last week that he can address the queries only after looking at the specific information related to the development.
Hetero’s chairman and managing director B. Parthasarathy Reddy was not available for comment as he was travelling. Another executive said the company has received the order and is evaluating its options.
“Since it was an ex-parte order, and the company was not heard by the court, there is an adjourned hearing in March,” he added. The executive didn’t want to be identified because he is not authorized to talk to the media.
A.B. Ramtake, deputy drug controller at DCGI’s office said, “We haven’t received any copy from the high court or the company yet. However, we are aware of this injunction...if the high court has passed this order then we would have to follow it.”
The court’s order will effectively establish a link between the country’s patent and drug regulatory laws, according to some patent law experts and members of patient groups.
Such a linkage was discussed earlier in India after the new product patent regime came into effect in 2005, but was pulled out on criticism that it would burden the drug regulator.
“Linking patent status and the registration of medicines means that the drug regulatory authority is required to withhold marketing approval to a generic version of a patented drug regardless of whether the patent granted is valid or not,” said Leena Menghaney, project manager in India for Campaign for Access to Essential Medicines, Medecins Sans Frontieres.
“From a policy perspective too, any such linkage is hugely problematic,” Shamnad Basheer, a patent law expert and a professor in intellectual property law at the National University of Juridical Sciences, Kolkata, wrote in his patent blog SpicyIP on Wednesday.
“Apart from issues of institutional competence, such linkage contravenes the very essence of the Bolar provision, a patent defence that permits generic companies to safely generate regulatory data while the patent is in force and pursue their drug regulatory application process, so that no time is lost between the expiry of a patent and the entry of a generic product in the market.” Basheer wrote.