Patent Infringement Suit Against BDSI

COMPLAINT ALLEGES INFRINGEMENT ON MULTIPLE CLAIMS IN MONOSOL RX’S U.S. PATENT NO. 8,765,167 BY BDSI’S BELBUCA™

WARREN, N.J., January 13, 2017 – MonoSol Rx, a specialty pharmaceutical company utilizing its PharmFilm® drug delivery technology to improve patient outcomes and to address unmet needs, today filed a patent infringement case against BioDelivery Sciences International, Inc. (Nasdaq: BDSI, “BDSI”) for infringement of U.S. Patent No. 8,765,167 (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 complaint was filed in the United States District Court for the District of New Jersey. The complaint asserts that the manufacture, marketing and sale of BDSI’s BELBUCA™ (buprenorphine) buccal film product infringes the ‘167 patent. Specifically, the complaint asserts infringement of claims 13, 33, 39, 45, 52, 66, 73, 83, 89, 95-98, 100-103, 105, 107, 108, 117 and 118 of the ’167 patent (Asserted Claims).

The U.S. Patent and Trademark Office (USPTO) has previously upheld the validity of the ‘167 Patent, after BDSI previously brought challenges to the ‘167 patent in four Inter Partes Review (IPR) proceedings.  One IPR was denied institution in May 2015, and MonoSol Rx has now asserted most of those claims against BDSI in this action.  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. BDSI is currently appealing these decisions to the Federal Circuit.  Because the USPTO already denied BDSI’s IPR, BDSI is barred by statute from challenging any of the Asserted Claims of the ‘167 patent in an IPR, and none of the Asserted Claims are subject to BDSI’s appeal.

“Based on the publicly available information in the BELBUCA™ label alone, it is apparent that BDSI infringes all of these claims,” said Keith Kendall, Chief Executive Officer of MonoSol Rx. “Because of the one-year bar, BDSI cannot avoid this case by filing another IPR, and we look forward to litigating the merits of this case.”

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, convenience, compliance and pharmacoeconomics of pharmaceutical products. MonoSol Rx's leadership in film drug technology 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.

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