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MonoSol Rx Defeats BDSI’s Reexamination Challenges to MonoSol Rx’s PharmFilm® Patents

New USPTO Patent Claims Strengthens Robust IP Portfolio

Warren, NJ (October 16, 2012) – MonoSol Rx, LLC (“MonoSol Rx”), the developer of PharmFilm® drug delivery technology, announced today that challenges brought by MonoSol Rx competitor, BioDelivery Sciences International, Inc. (NASDAQ: BDSI, “BDSI”), have been soundly defeated.  MonoSol Rx’s PharmFilm® patents (U.S. Patent No. 7,425,292 (“the ‘292 patent”) and U.S. Patent No. 7,357,891 (“the ‘891 patent”), emerged from reexamination at the U.S. Patent and Trademark Office (“PTO”) stronger than they entered, each enhanced with multiple new claims.

A. Mark Schobel, Co-President and Chief Executive Officer of MonoSol Rx, stated, Co-President and Chief Executive Officer of MonoSol Rx, stated, “We are pleased that MonoSol Rx has successfully resolved the two reexaminations originally brought by BDSI in an attempt to delay a pending patent infringement suit brought by MonoSol Rx regarding Onsolis. The bottom line is that BDSI’s attempt to have the PTO invalidate two of MonoSol Rx’s PharmFilm® patents has been unsuccessful. As we move forward as a company, we understand that, as competitors seek to copy our patented technologies, we will face additional validity challenges, especially where our competitors know they are infringing our patents. This is a predictable competitive strategy, and we are confident that we can continue to maintain the advantages provided by our patent portfolio because of the fundamental innovation and soundness of our technology.”

In less than nine months after BDSI filed its requests for reexamination of the PharmFilm® patents, the PTO issued reexamination certificates for both patents. The reexamination certificate on the ‘292 Patent noted 33 new claims and the canceling of no claims, while the reexamination certificate on the ‘891 patent replaced the original nine claims with 19 new claims. The ability of MonoSol Rx and the PTO to rapidly address the reexaminations and to drive each to a successful conclusion with robust claims that broadly cover MonoSol Rx’s innovations in PharmFilm® technology continues to demonstrate the strength of MonoSol Rx’s patent position.

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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