WARREN, N.J., Jan. 13, 2017 (GLOBE NEWSWIRE) -- 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 utilizing 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.
Contact MonoSol Rx Jessica Patel jpatel@monosolrx.com The Ruth Group Lee Roth lroth@theruthgroup.com (646) 536-7012