Leukaemia drug dispute results in lawsuit from US pharma giant

Bristol-Myers Squibb has filed a patent infringement lawsuit against  Xspray Pharma over its plan to produce a generic version of the blockbuster drug  sprycel (dasatinib).

This prescription medicine used to treat adults with newly diagnosed Philadelphia chromosome–positive (Ph+) chronic myeloid leukaemia (CML), as well as leukaemia patients who no longer benefit from, or did not tolerate, other treatment, including imatinib.

The US company filed its  complaint against the Sweden-based company at the  US District Court for the District of New Jersey yesterday, June 29.

According to BMS, Xspray filed a New Drug Application (ANDA) to the US Food and Drug

Administration (FDA) seeking approval to manufacture and sell the generic tablets before the expiration of its patent, US number 7,491,725 and its successor patent, US number 8,680,103.

In February, 2009, the  US Patent and Trademark Office issued the ’725 patent” entitled “Process for preparing 2-aminothiazole-5-aromatic carboxamides as kinase inhibitors” to BMS inventors followed by the 103 patent in 2014 entitled “Process for preparing 2-aminothiazole-5-aromatic carboxamides as kinase inhibitors”.

In May, Xspray sent a letter to BMS, holding that certain claims of the ’725 and ’103 patents are either invalid or will not be infringed by its products.

In its lawsuit, BMS complained that Xspray has not provided any access to samples of the disputed product, violating a rule outlined by the Under the  Hatch-Waxman Act.

“Lack of access to the DMF and samples of the Xspray ANDA Products have hindered

BMS’s ability to consider information that is relevant to its infringement analysis of the ’725 and ’103 patents.

Upon information and belief, the samples of the Xspray NDA Products and DMF, if provided to BMS, would reveal additional information that is relevant to Xspray’s infringement of the ’725 and ’103 patents,” stated BMS.

BMS had previously filed a lawsuit against Xspray in New Jersey arising from Xspray’s submission of its ANDA for Xspray’s 100 mg dasatinib tablets.

According to BMS, Xspray has subsequently amended its ANDA to include five

additional dosage strengths of 15 mg, 36 mg, 50 mg, 57 mg, and 70 mg tablets.

BMS is asking the court to find a ruling of infringement, and/or to award it monetary damages of Xspray proceeds with its plan to market the generic.