US Patent Office Institutes Inter Partes Review Brought by MonoSol Rx Against All Claims in Key BDSI BEMA Patent

Warren, NJ (October 6, 2014) – The United States Patent and Trademark Office (USPTO) has granted MonoSol Rx, LLC’s (MonoSol Rx) petition for inter partes review (IPR) of all claims of US Patent No. 7,579,019 (“the ‘019 patent") and has instituted the IPR. The ‘019 patent, owned by Arius Two, Inc, a wholly-owned subsidiary of BioDelivery Sciences International, Inc. (NASDAQ: BDSI, “BDSI”), is cited by BDSI as a key patent in their BEMA drug delivery technology. Based on information provided by MonoSol Rx in its IPR petition, the USPTO’s decision to institute the post-grant USPTO trial was based on the USPTO’s agreement that MonoSol Rx established a reasonable likelihood that all of the claims in the ‘019 patent are invalid. The trial is now proceeding, with a final decision by the USPTO on whether any claims will survive expected by August 2015. Among the reasons for instituting the IPR are grounds of anticipation. Anticipation grounds are particularly powerful because they indicate that the invention lacks novelty, the very thing that BDSI touts as its strength in the BEMA technology. The USPTO’s institution of the IPR proceeding against all of the claims of the ‘019 patent is also a significant development because the ‘019 Patent is listed in the United States Food and Drug Administration’s “Orange Book” as a patent that specifically covers technology used in BDSI’s BUNAVAIL product.

A. Mark Schobel, Co-President and Chief Executive Officer of MonoSol Rx, commented, “The institution of the inter partes review of the ‘019 patent is a significant and positive development for MonoSol Rx. BDSI continues to attempt to develop and market products without proper consideration of MonoSol Rx’s pioneering patent portfolio relating to film drug delivery. We will not tolerate infringers of our technology, and we will continue to aggressively assert our patent rights against all such infringers.” It is MonoSol Rx’s position that BDSI’s other Orange Book-listed patents for BUNAVAIL are similarly invalid.

About MonoSol Rx
MonoSol Rx is a specialty pharmaceutical company leveraging its proprietary PharmFilm® technology to develop products which address the unmet needs of patients. PharmFilm® is designed to benefit patients by improving the convenience, efficacy, and compliance of new and currently marketed drugs. The Company's leadership in film drug delivery is supported by strong intellectual property, a pipeline of prescription formulations based on PharmFilm® technology, and two FDA approvals - Zuplenz®, the first approved prescription oral soluble film for the prevention of chemotherapy-induced, radiotherapy-induced, and postoperative nausea and vomiting, and Suboxone® sublingual film, the first sublingual film product for the treatment of opioid dependence. For press releases and other company information visit www.monosolrx.com.

* PharmFilm is a registered trademark of MonoSol Rx.

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US Patent Office Institutes Inter Partes Review Brought by MonoSol Rx Against All Claims in Key BDSI BEMA Patent

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