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U.S. Patent and Trademark Office Upholds the Validity of MonoSol Rx’s US Patent No. 8,765,167 in the Face of Multiple Inter Partes Review Challenges Brought by BioDelivery Sciences International, Inc. (BDSI)

WARREN, N.J., April 7, 2016 – MonoSol Rx, a specialty pharmaceutical company leveraging its PharmFilm® drug delivery technology to improve patient outcomes and to address unmet needs, today announced that the U.S. Patent and Trademark Office (USPTO) has upheld the validity of all challenged claims in U.S. Patent No. 8,765,167 (the ‘167 patent). The challenges to the ‘167 patent were asserted in four Inter Partes Review (IPR) proceedings brought by BioDelivery Sciences International, Inc. (Nasdaq: BDSI, “BDSI”) against MonoSol Rx.

One IPR was denied institution in May 2015, and the rehearing request on that IPR was denied by the USPTO in November of 2015. Even more significantly, the three remaining IPR challenges were decided in final written decisions issued by the USPTO on March 24, 2016, wherein the USPTO upheld the validity of the claims in the ‘167 patent, which is entitled “Uniform films for rapid-dissolve dosage form incorporating anti-tacking compositions.” The ‘167 patent has a priority date as far back as 2001, as well as additional priority in 2005.

“The PTO’s confirmation of the validity of our ‘167 patent is an important victory for MonoSol Rx and for our proprietary, patented PharmFilm technology,” said A. Mark Schobel, Chief Innovation and Technology Officer of MonoSol Rx. “Now that these issues relating to the ‘167 patent have been decided, we will continue to aggressively assert this patent and others against those companies that infringe our intellectual property. At the same time, MonoSol Rx looks forward to quickly and reasonably resolving all outstanding and potential infringement matters related to the claims in the ‘167 and related patents. We remain confident in the strength of our entire portfolio of intellectual property and in the pioneering work we have done in the area of film-based drug delivery.”

About MonoSol Rx
MonoSol Rx is a specialty pharmaceutical company leveraging its proprietary PharmFilm drug delivery technology to develop products that improve patient outcomes and address unmet needs. PharmFilm can benefit patients by improving the efficacy, safety, and convenience of pharmaceutical and over-the counter products. MonoSol Rx’s leadership in film drug delivery is supported by strong IP protection, a robust pipeline of prescription drug formulations, and two FDA-approved products — Suboxone® (buprenorphine and naloxone) sublingual film and Zuplenz® (ondansetron) oral soluble film. For press releases and other company information, visit www.monosolrx.com. More information about PharmFilm can be found at www.pharmfilm.com.

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