BDSI refutes MonoSol's patent infringement claims relating to BEMA Buprenorphine

BioDelivery Sciences International, Inc. (Nasdaq: BDSI) today responded to a process patent infringement lawsuit filed and recently served against the Company and certain co-defendants by MonoSol Rx, LLC. The purpose in responding at this time is for BDSI to strongly refute MonoSol's claims and to assure BDSI stockholders that the Company remains focused on vigorously progressing its pipeline and not allowing this claim to present a distraction.

“Importantly, we have not and will not allow this meritless claim to distract us from driving our promising development pipeline forward including our aggressive pursuit of BEMA Buprenorphine for the treatment of chronic pain and BEMA Buprenorphine/Naloxone for the treatment of opioid dependence.”

"After careful examination, we refute MonoSol's assertion of patent infringement, which relates to our confidential, proprietary manufacturing process for ONSOLIS, as without merit. We intend to defend this case vigorously, and we are very confident that MonoSol's claims will be rejected. Our manufacturing process for ONSOLIS, which MonoSol asserts infringes its process patent, is a trade secret for which no one has any access. MonoSol has failed to disclose any basis for its assertion that our confidential, proprietary manufacturing process infringes its newly-issued patent," stated Dr. Mark A. Sirgo, President and Chief Executive Officer of BDSI. Dr. Sirgo continued, "Importantly, we have not and will not allow this meritless claim to distract us from driving our promising development pipeline forward including our aggressive pursuit of BEMA Buprenorphine for the treatment of chronic pain and BEMA Buprenorphine/Naloxone for the treatment of opioid dependence."

In its claim, originally filed in the Federal District Court of New Jersey on November 2, 2010, and formally served on BDSI on January 19, 2011, MonoSol claims that the manufacturing process for ONSOLIS infringes its patent. Of note, the BEMA technology itself is not at issue in the case, but rather only the manner in which ONSOLIS, which incorporates the BEMA technology, is manufactured.