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MonoSol Rx, LLC Remains Confident in its Patent Portfolio

Prepares to Defend U.S. Patent Against BioDelivery Sciences International

Warren, NJ (November 29, 2011) – MonoSol Rx, LLC (“MonoSol Rx”), the developer of PharmFilm® drug delivery technology, is preparing to defend its U.S. Patent No. 7,824,588 (“the ‘588 patent”) at the U.S. Patent and Trademark Office (“PTO”) from a reexamination challenge brought by MonoSol Rx’s competitor, BioDelivery Sciences International, Inc. (NASDAQ:  BDSI, “BDSI”).

On September 12, 2011, BDSI filed a request at the PTO for an inter partes reexamination, challenging the validity of the ‘588 patent.  BDSI’s request was seen by MonoSol Rx as a litigation tactic to slow down the lawsuit MonoSol had previously filed against BDSI and its development partners MEDA Pharmaceuticals Inc. (“MEDA”), and Aveva Drug Delivery Systems, Inc. (“Aveva”) for patent infringement in federal court in Trenton, New Jersey.  Moreover, BDSI’s request was filed shortly before Congress modified the law on inter partes reexamination requests, tightening the standard for such requests made in the future.

On November 10, 2011, the PTO granted BDSI’s request and issued an Office Action, as procedurally required, allowing MonoSol Rx 60 days within which to file its initial response to the challenges to the validity of the ‘588 patent.  As the reexamination process continues, the claims of the ‘588 patent remain valid and in force until a final decision is made by the PTO.

A. Mark Schobel, President and Chief Executive Officer of MonoSol Rx, stated, “We are in the process of drafting our response to BDSI’s challenge to our ‘588 patent at the PTO and are confident that, at the end of the process, the PTO will confirm the patentability of our claims.  To be clear, there has been no ruling on our ‘588 patent challenge and the patent and claims remain valid and enforceable until the USPTO rules otherwise on the case. The ‘588 patent is only a small part of MonoSol Rx’s broad and robust patent portfolio that places MonoSol Rx as the industry leader in the development of drug-containing film products.”

As announced by MonoSol Rx last month, MonoSol Rx’s lawsuit against BDSI, MEDA and Aveva now includes U.S. Patent Nos. 7,357,891 and 7,425,292 in addition to the ‘588 patent, all of which cover specific methods of preparing drug containing films infringed by the three defendants in the case.  BDSI, MEDA and Aveva must all respond to MonoSol Rx’s claims for patent infringement of all relevant MonoSol Rx patents.

About MonoSol Rx 
MonoSol Rx is a specialty pharmaceutical company leveraging its proprietary PharmFilm® technology to deliver drugs in films. 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 portfolio of commercialized prescription and over-the-counter (OTC) drug products, a pipeline of prescription formulations based on PharmFilm® technology, and two recent 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.

MonoSol Rx’s commercialization strategy for all PharmFilm® products is to partner with the innovator or other specialty pharma companies that can sell-in and manage product sales and marketing.  PharmFilm® is also a tool to help sales and marketing partners differentiate in competitive markets while offering unique advantages over drugs dosed by traditional tablets, capsules and orally disintegrating tablets (ODTs).For existing and future partners, PharmFilm® formulations can also represent revenue-life cycle extensions for products with patent lives that have expired or are approaching expiration.

For press releases and other company information visit www.monosolrx.com.

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