DASATINIB: Injunction to continue against BDR

On 29th June, 2015, Justice Manmohan Singh of the Delhi High Court upheld BMS’ patent for anti-cancer drug Dasatinib (marketed as Sprycel).  The order was passed in Bristol-Myers Squibb vs. BDR Pharma case of interim injunction, which is a quia timet action filed by the Plaintiffs.

BMS had filed a suit for a qua timet injunction against BDR back in 2009 when it suspected that BDR was planning on marketing Dasatinib following BDR’s application at the DCGI for approvals. BDR in turn alleged (among several other defenses) that the patent in Dasatinib is invalid.

Justice Manmohan Singh held that the interim injunction would continue during trial proceedings for the various reasons, but primarily because the defendants have failed to establish a prima facie credible defence pertaining to any harm being caused to the them with injunction in force, particulary because BDR has not yet commenced with launch of its products in the market.

The Court was of the opinion that the plaintiffs have got a valid patent and the defences raised by the defendants do not cast doubts on the validity of the patent. They require further substantiation prior to arriving to conclusionary view .

While deciding over the validity of the patent the Court held the patent to be prima facie non-obvious opining that “It is common in the field of the medicines that the chemical compounds are pre-existing and there are further improvements upon treatment and workings on the compounds so as to increase their efficacy by reacting with chemical compounds and the group of the reactants. Therefore, the commonality of the base compound like thaizole derivatives and its characteristics may be one of the attending circumstance which can act as a starting point to consider the plea of the obviousness but it cannot be said that the said commonality is the sole basis which yields to inference of the obviousness to the person skilled in the art. Thus, commonality of few integers would not alter the position unless the cause and effect relation between all the integers are present and indicating towards arriving at the subject invention in the suit patent which is missing in the present case.

 The Judgment also upheld the patent on other grounds of section 3(d), section 8 amongst others.

Thee court did not accept any plea in relation to public interest or the drug being not available to public because the plea of public interest may be invoked once the Court would find that prima-facie the case of credible defence is made out.

This tussle between Bristol-Myers Squibb and BDR Pharma dates back to the first in 2013 when BDR filed for a compulsory license for Dasatinib, citing the price of the drug to be unreasonably high. The application was rejected as the authorities found that BDR had not acted in good faith during the negotiations for a voluntary license preceding the application.

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