Dasatinib - EU

On Feb 1, 2017, the EPO’s Technical Board of Appeal announced that it rejected BMS’s appeal and revoked the EP1169038 patent.

European Patent EP'038 (set to expire in April 2020, with SPC until November 2021) covers dasatinib as a compound per se. Actavis, Apotex, Mylan, and an anonymous party initiated opposition proceedings in the European Patent Office (EPO) seeking the revocation of the ’038 patent. In January 2016, the EPO’s Opposition Division issued a decision revoking the ’038 patent.

Bristol-Myers Squibb (BMS) appealed. BMS asserted that the Opposition Division misapplied the legal requirements to prove insufficiency of disclosure and lack of inventive step. BMS also asserted that the Opposition Division erred by failing to consider evidence of dasatinib’s benefits published after the filing of the BMS’s patent application.After deliberation, the Technical Board of Appeal announced that it dismissed BMS’s appeal and revoked the ’038 patent due to lack of inventive step.

Dasatinib was granted approval by EMA in Nov. 2006 for the treatment of:

1. Newly diagnosed Philadelphia-chromosome-positive (Ph+) chronic myelogenous leukaemia (CML) in the chronic phase

2. Chronic, accelerated or blast phase CML with resistance or intolerance to prior therapy including imatinib mesilate;

3. Ph+ acute lymphoblastic leukaemia (ALL) and lymphoid blast CML with resistance or intolerance to prior therapy.

Market exclusivity & orphan drug exclusivity expired in Nov. 2016. BMS has submitted to the European Medicines Agency on 17 January 2013 an application for modification of the agreed paediatric investigation plan (PIP) with a deferral and a waiver for CML & ALL indications. The Paediatric Committee has agreed to changes to the paediatric investigation plan. This may result in extension of orphan drug exclusivity till Nov. 2018 (additional 2 years because of PIP). 

BMS owns another patent  EP1610780 (set to expire on March 23, 2024) that covers method of using dasatinib for various cancer including CML. In October 2012, the Opposition Division decided to revoke the ’780 patent due to insufficiency of disclosure. BMS appealed the ’780 patent’s revocation. The Board of Appeal has scheduled a hearing to decide the appeal for Friday, February 3, 2017.

There is another patent EP1711481 (set to expire on February 4, 2025) covers a monohydrate polymorph of dasatinib. The ’481 patent as amended, withstood opposition proceedings initiated by Apotex and an anonymous party.