India-based drug maker Ranbaxy Laboratories has won a patent case against Bristol-Myers Squibb (BMS) to sell BMS' generic version of anti-hepatitis B drug Baraclude, Enteca, in India.
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The Delhi High Court (HC) has rejected BMS’ plea for an interim injunction to temporarily stop Ranbaxy from producing and selling the drug in India.
Justice Sunil Gaur said that BMS only had a product-by-process patent and hence vulnerable.
According to Ranbaxy’s lawyers the drug maker used a different process to make Enteca, for which it had already received marketing approval from Drug Controller General of India, and thus did not infringe the US based drug maker’s patent.
The court ruling is expected to help other Indian pharma firms such as Cipla, Cadila and Natco Pharma, which are lining up their generic versions of the drug.
Ranbaxy senior counsel Rajiv Nayar said that the field is now open to produce and market for other generic manufacturers in relation to the patent of entecavir propounded by BMS.
The Delhi HC will now go to a trial stage to verify the validity of BMS’ patent for Baraclude and whether Indian drug maker’s generic version infringes on it.
The Delhi HC has asked Ranbaxy to maintain and file with it quarterly sales accounts of Enteca, to compensate BMS, if the final order goes in the latter’s favour.
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