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BMS says it defends Sprycel patent in India

Blocks attempts to issue compulsory license for leukaemia drug

Bristol-Myers Squibb (BMS) buildingBristol-Myers Squibb (BMS) has said it has blocked an attempt to issue a compulsory license for its cancer drug Sprycel in India for the second time.

The latest application - by Mumbai-based speciality drugmaker BDR Pharmaceuticals - has been rejected by the Indian Patent office, according to press reports which cite an affidavit filed by BMS in the Delhi High Court. 

However, others suggest that the IPO's ruling on the matter is still pending and accuse BMS of trying to influence the court as it handles the patent dispute with BDR.

Sprycel (dasatinib) is used to treat Philadelphia chromosome-positive chronic myeloid leukaemia (CML), which cleared $1bn in sales for BMS last year and has been growing at a rate of almost 30 per cent per quarter of late.

BMS sells Sprycel for around 100,000 rupees per month (around $1,570), with BDR promising to make its version available at around 8,100 rupees ($128), reports the Economic Times.

BDR had been trying to secure a compulsory license to overturn BMS' 2010 Indian patent on Sprycel on the grounds of public need, a strategy which allowed Natco Pharma to start selling a copy of Bayer's cancer drug Nexavar (sorafenib) last year.

This is not the first time BMS has had to go to court to defend Sprycel, having successfully blocked an application by Natco for a compulsory license in 2011.

In that case, which continues to rumble on, the Indian pharma company went ahead and launched its own Dasanat brand of the drug in June 2012 regardless, forcing BMS to go to the courts again to win an injunction on sales.

Towards the end of last year court documents suggested Natco was no longer selling its product in India.

The compulsory license route is also being used to challenge Roche's patents on breast cancer drug Herceptin (trastuzumab), although the pharma major scored a preliminary success after India's Department of Industrial Policy and Promotion (DIPP) turned down a bid by a consortium of patient groups and non-governmental organisations.

12th September 2013

From: Sales, Regulatory



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