Monosol sues BioDelivery over pain treatment

Monosol Rx, a speciality pharmaceutical company, has filed a  complaint against BioDelivery Sciences International for alleged patent infringement.

The case, which was filed on Friday, January 13, in the US District Court for the District of New Jersey, arose after BioDelivery brought its product Belbuca (buprenorphine), a treatment for severe pain, to market.

Monosol alleged that the product infringes US patent number 8,765,167, and that BioDelivery has had knowledge of the patent since at least October 2014.

The ‘167 patent is titled “Uniform films for rapid-dissolve dosage form incorporating anti-tacking compositions”.

According to the complaint, Monosol claims that it has previously sued BioDelivery for infringing the same patent, however with another product—marketed under the name Bunavail (buprenorphine and naloxone).

Following the complaint, BioDelivery filed four separate petitions for inter partes review of the ‘167 patent with the Patent Trial and Appeal Board (PTAB).

The PTAB declined all of the claims made by BioDelivery in May 2015, finding that it could not “establish ... a reasonable likelihood that it would prevail as to its challenges of claims ... of the ‘167 patent on any of the grounds presented in the petition”.

Keith Kendall, CEO of Monosol, said in a  statement: “Based on the publicly available information in the Belbuca label alone, it is apparent that BDSI infringes all of these claims."

He added: “Because of the one-year bar, BDSI cannot avoid this case by filing another IPR, and we look forward to litigating the merits of this case.”

Monosol has asked the district court for a ruling in its favour, as well as an award of damages.

It has also asked the court for an injunction enjoining BioDelivery from selling Belbuca.