Hyderabad based Natco Pharma, which successfully received India’s first compulsory license for Nexavar (cancer drug) is again in news for patent dispute with Bristol-Myers Squibb (BMS).
Dispute relates to generic version of Dasatinib, crucial medicine used in chronic myeloid leukemia. Natco is selling under brand name Sprycel.Natco has gone ahead and launched a generic version of BMS’ patented Sprycel at a whopping 94% discount at Rs 9,000 for 60, 50 mg tablets as against BMS’ price of Rs 1,60,000.Natco has received the marketing license from the Uttarakhand government to sell the drug. Prior to this, the company had approached Drug Controller General of India (DCGI) to sell the drug.
Natco and Hetero Pharma are locked in a patent infringement battle with BMS over the same drug at the Delhi High Court since 2009.According to BMS Sprycel (Dasatinib) is protected by a patent granted by Indian Patent Office, Mumbai (India) in 2000 and indicated that the company will pursue all appropriate legal avenues to protect its intellectual property rights in India. Natco’s launch came at a time when BMS’ injunction suit against Natco is pending hearing at the Delhi High Court.
2000- PCT Application 60/129,510 “A COMPOUND 2-AMINO-THIAZOLE-5-CARBOXAMIDE” filed by BMS
16th November 2006 – Patent Number 203937 granted to BMS
2006 – BMS started selling Dasatinib in India.
2009 – Natco and Hetero Pharma are locked in a patent infringement battle with BMS over the same drug at the Delhi High Court.
2009 – BMS alleged in court that Natco had plans to make and sell generic versions of Dasatinib, an anti cancer drug sold by BMS under the brand name “Sprycel“
2009- BMS had won a patent battle on Sprycel against Hetero Drugs, which was seeking a central regulator nod.
Natco received approval from Uttarakhand government because the Drugs and Cosmetics Act empowers state regulators to approve new drug versions.
June 2012- Natco flooded with the market with Dasanat, prompting BMS to file another application.
22nd June 2012 – Injunction granted and court restrained Natco from manufacturing and selling the product.