MonoSol Rx Files Patent Infringement Suit against BioDelivery Sciences International (BDSI)
January 13 2017 - 3:39PM
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
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