On 1 February 2017, Bristol-Myers Squibb (BMS) Company announced that the European Patent Office (EPO) upheld a decision with regard to European Patent No. 1169038 (the '038 patent), the Composition of Matter patent covering dasatinib, the active ingredient in Sprycel. The EPO upheld a decision that found the patent to be invalid.
This decision does not impact the patents outside of the EU.
In their announcement, the company wrote that BMS has a long-standing heritage in oncology. Sprycel will continue to be a significant asset in their broad oncology portfolio and an important treatment option for patients living with chronic myeloid leukaemia (CML). The US Food and Drug Administration (FDA) indications for dasatinib in adults are:
- Newly diagnosed patients with Philadelphia chromosome-positive (Ph+) CML in chronic phase.
- Chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib.
- Philadelphia chromosome-positive acute lymphoblastic leukaemia (Ph+ ALL) with resistance or intolerance to prior therapy.