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In a boost to domestic drug firm Natco Pharma, Indian patent office has rejected an application by US-based Gilead for hepatitis C drug, sofosbuvir, citing lack of novelty and inventive step.
An order by Deputy Controller of Patents & Designs Hardev Karar said Gilead, which sells the drug under the Sovaldi brand in the US, failed to prove that there were enhancement of therapeutic efficacy in the new discovery.
Gilead's patent application was opposed by Hyderabad-based Natco Pharma and Capital-based NGO Delhi Network of Positive People (DNP+). Another entity Initiative for Medicines, Access & Knowledge {1-MAK), Inc, USA had also opposed it.
When contacted Natco officials declined to comment, while an emailed query sent to Gilead remained unanswered.
Gilead, which sells sofosbuvir under the trade name Sovaldi, had last year entered into licensing agreements with seven India-based firms, including Cipla, Ranbaxy and Cadila for the hepatitis C drugs to make them available in 91 developing countries.
Gilead had said it planned to launch its own branded Sovaldi in India at a price of USD 300 per bottle, while the Indian companies were allowed to fix their own price for the generic product they produce, paying a royalty on sales.
As per reports, Sovaldi was priced USD 84,000 for a 12-week course in the US which has been criticised by advocates of patients.
