Natco in patent war with BMS

Source: Times of India

by Rupali Mukherjee

Aug 1, 2012

MUMBAI: Natco, which successfully managed to reduce prices of Bayer’s cancer drug Nexavar by 97% through the country’s first compulsory licence recently, is headed for another major confrontation. This time the tussle is with drug MNC Bristol-Myers Squibb (BMS) over Dasatinib, a crucial medicine used in chronic myeloid leukemia, and is expected to set yet another precedent for the Indian generics industry fighting against patent rights of MNCs. Natco’s version of the drug costs around Rs 9,000 a month as against BMS’ price of nearly Rs 1.5 lakh.

The key patent issue, which will come for hearing on Wednesday in the Delhi high court, will throw open a debate on granting “injunctions” against the generic industry, which in pharma parlance mean—orders to shut down the marketing and supply of low-priced generic medicines. Sources say Natco Pharma is also filing a contempt petition against BMS in the ongoing case over the Dasatinib drug. That’s not all. On Wednesday, Natco Pharma will file a reply on the contempt petition filed by the drug MNC, rubbishing BMS’ claims as “false assertions”.

The case will be keenly watched by the pharma industry and public health experts, and may finally decide the availability of affordable Dasatinib, in the country. What seems to have triggered the current round of battle is Natco’s recent launch of its version of Dasatinib after obtaining approval of the drug regulatory authority from Uttarakhand. BMS then managed to get an order cancelling the company’s licence, which the generic company has now been able to undo, sources told TOI.

While Natco declined to offer comments on the issue, Bristol-Myers Squibb said it does not comment on ongoing litigation. Industry experts said the debate is now on the issue of injunctions and its interpretation. The crux of the dispute seems to be a Delhi HC order passed in June, which is being interpreted in different ways by the two companies. BMS is understood to have interpreted it as an injunction to refrain Natco from selling its drug, as it was “infringing” its patent. On the other hand, Natco is believed to have taken a stand that it is not an injunction as its drug is not infringing the BMS patent, sources say.

In their pursuit of intellectual property (IP) enforcement agenda, MNC drug companies normally want injunctions passed against generic firms. In such cases in the past, courts have considered the impact on access to treatment and balanced IP with health, before ordering an injunction. The June order by the court is part of the ongoing case which BMS filed against Natco in 2009, where it argued Natco had plans to make generic versions of Dasatinib.

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