Teva moves US court against Aurobindo Pharma on cancer drug Bendeka

Teva Pharmaceuticals, along with Cephalon Inc and Eagle Pharmaceuticals, has filed a petition in a US court against Aurobindo Pharma alleging that the Indian pharma company is planning to come out with a generic version of Bendeka, a cancer medicine, before the expiration of its patents.

Bendeka (bendamustine hydrochloride) is indicated for chronic lymphocytic leukaemia and indolent B-cell non-Hodgkin lymphoma. Eagle, the patent-holder, has provided a licence to Cephalon the right to sue for infringement of the drug and in 2015, Cephalon assigned its rights to Teva Pharmaceuticals.

Teva has filed a probable patent infringement petition on May 11 against Aurobindo in the US district court for the District of Delaware on 28 counts. Reportedly, on April 6, Aurobindo Pharma had sent a letter to Teva saying that it had submitted US FDA an Abbreviated New Drug Application (ANDA) with paragraph IV certifications to make copycat version before expatriation of the patents of Bendeka Injection, 100 mg/4 mL (25 mg/mL), the petition said.

Teva sought the court a permanent injunction pursuant to, among other things, enjoining Aurobindo, its officers, agents, servants, employees and attorneys, and all persons acting in concert with them, from making, using, selling, offering for sale, marketing, distributing, or importing Aurobindo’s ANDA product which allegedly infringes the patents-in-suit. Various patents of bendamustine expire through 2033.

Under Paragraph IV Patent Certifications, a company can seek FDA approval to market a generic drug before the expiration of patents related to the branded medicine that the generic seeks to copy.