`Filed: January 26, 2015
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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`____________________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`____________________
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`BIODELIVERY SCIENCES INTERNATIONAL, INC.
`Petitioner
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`v.
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`RB PHARMACEUTICALS LIMITED
`Patent Owner.
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`____________________
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`Case IPR2014-00325
`Patent 8,475,832
`____________________
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`PATENT OWNER THIRD AMENDED MANDATORY NOTICE
`INFORMATION UNDER 37 C.F.R. § 42.8(a)(2)
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`Active 24623697v1 021898.000010
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`Case No. IPR2014-00325
`Patent No. 8,475,832
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`I. REAL PARTY-IN-INTEREST
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`The real parties-in-interest are RB Pharmaceuticals Limited (Patent Owner),
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`the sole owner of U.S. Patent No. 8,475,832 (ʼ832 patent), and Reckitt Benckiser
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`Pharmaceuticals Inc. (RBP), the exclusive licensee of the ʼ832 patent in the U.S.
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`Both companies are ultimately subsidiaries of and wholly owned by Indivior PLC.
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`RBP US Holdings Inc. and RBP Global Holdings Ltd. are intermediate
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`subsidiaries. Patent Owner’s address is 103-105 Bath Road, Slough, UK. RBP’s
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`address is 10710 Midlothian Turnpike, Suite 430, Richmond, Virginia.
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`Pursuant to a written agreement with RBP, MonoSol Rx, LLC (MonoSol)
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`has exclusive manufacturing rights under the ʼ832 patent and therefore is an
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`implied, exclusive licensee thereunder. MonoSol is also the original assignee of
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`the patent, and the named inventors were, and in some cases remain, MonoSol
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`employees. To the extent these facts are sufficient to render MonoSol a real party-
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`in-interest, Patent Owner also identifies MonoSol under 37 CFR § 42.8(b)(1).
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`MonoSol’s address is 30 Technology Drive, Warren, New Jersey.
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`II. RELATED MATTERS
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`The ʼ832 patent was previously asserted against Petitioner in Reckitt
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`Benckiser Pharmaceuticals, Inc., RB Pharmaceuticals Limited, and MonoSol Rx,
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`LLC. v. BioDelivery Sciences International, Inc., E.D.N.C. Civil Action No. 5:13-
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`cv-760-BO. That action was subsequently dismissed without prejudice as
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`premature on procedural grounds. The ʼ832 patent has also been asserted against
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`Petitioner in Reckitt Benckiser Pharmaceuticals, Inc., RB Pharmaceuticals
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`Limited, and MonoSol Rx, LLC. v. BioDelivery Sciences International, Inc., D.N.J.
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`Civil Action No. 3:14-cv-5892-MAS-TJB. Petitioner has filed a declaratory
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`judgment action involving the ’832 patent styled Biodelivery Sciences
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`International, Inc. v. Reckitt Benckiser Pharmaceuticals Inc., RB Pharmaceuticals
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`Limited and MonoSol Rx, Ltd., E.D.N.C. Civil Action No. 5:14-cv-529-H.
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`The ʼ832 patent has also been asserted in Reckitt Benckiser
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`Pharmaceuticals, Inc., RB Pharmaceuticals Limited, and MonoSol Rx, LLC. v. Par
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`Pharmaceutical, Inc., and IntelGenx Technologies, Corp., D. Del. Civil Action No.
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`13-1461-RGA; Reckitt Benckiser Pharmaceuticals, Inc., RB Pharmaceuticals
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`Limited, and MonoSol Rx, LLC. v. Watson Laboratories, Inc., D. Del. Civil Action
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`No. 13-1674-RGA; Reckitt Benckiser Pharmaceuticals, Inc., RB Pharmaceuticals
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`Limited, and MonoSol Rx, LLC. v. Alvogen Pine Brook, Inc., D. Del. Civil Action
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`No. 13-2003-RGA; Reckitt Benckiser Pharmaceuticals, Inc., RB Pharmaceuticals
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`Limited, and MonoSol Rx, LLC. v. Par Pharmaceutical, Inc., and IntelGenx
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`Technologies, Corp., D. Del. Civil Action No. 14-422-RGA; and Reckitt Benckiser
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`Pharmaceuticals, Inc., RB Pharmaceuticals Limited, and MonoSol Rx, LLC. v.
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`Case No. IPR2014-00325
`Patent No. 8,475,832
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`Teva Pharmaceuticals USA, Inc., D. Del. Civil Action No. 14-1451-RGA. The 13-
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`1674 (Watson), 14-422 (Par), and 14-1451 (Teva) Actions remain pending. (The
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`13-1461 (Par) and 13-2003 (Alvogen) Actions were dismissed without prejudice in
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`light of Par and Alvogen having prematurely triggered the Hatch-Waxman ANDA
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`litigation process in regard to those Actions.)
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`U.S. Application No. 14/478,786, which is a continuation of U.S.
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`Application No. 13/964,975 (now abandoned), which was a continuation of U.S.
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`Application No. 13/923,749 (now abandoned), which was a continuation of U.S.
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`Application No. 12/537,571 (ʼ571 application, now the ʼ832 patent), is pending.
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`U.S. Application No. 12/537,580, which was filed at the same time as, and shares a
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`portion of the specification of, the ʼ571 application is pending and may also
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`potentially be affected by a decision in the proceeding herein.
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`III. LEAD AND BACKUP COUNSEL AND SERVICE INFORMATION
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` Lead Counsel:
`James M. Bollinger, Esq.
`Troutman Sanders LLP
`The Chrysler Building
`405 Lexington Avenue
`New York, NY 10174
`Tel: (212) 704-6113
`Fax: (212) 704-5954
`Email: james.bollinger@troutmansanders.com
`Registration No. 32,555
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`Case No. IPR2014-00325
`Patent No. 8,475,832
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`Backup Counsel:
`Daniel A. Ladow, Esq.
`Troutman Sanders LLP
`The Chrysler Building
`405 Lexington Avenue
`New York, NY 10174
`Tel: (212) 704-6218
`Fax: (212) 704-5929
`Email: daniel.ladow@troutmansanders.com
`Pro hac vice
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`Counsel consent to electronic service at their email addresses.
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`IV. PATENT OWNER PRELIMINARY RESPONSE
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`Patent Owner filed a preliminary response on April 30, 2014 and a Response
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`on November 7, 2014.
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`Dated: January 26, 2015
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` ___/James M. Bollinger/
`James M. Bollinger
`Reg. No. 32,555
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`CERTIFICATE OF SERVICE
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`The undersigned hereby certifies that a copy of the foregoing Patent Owner
`Third Amended Mandatory Notice Information Under 37 C.F.R. § 42.8(a)(2) was
`served electronically via email on January 26, 2015, on attorneys for Petitioner:
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`Danielle L. Herritt
`Kia L. Freeman
`McCARTER & ENGLISH, LLP
`265 Franklin Street
`Boston, MA 02110
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`dherritt@mccarter.com
`IPR832@mccarter.com
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`Dated: January 26, 2015
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` ___/James M. Bollinger/
`James M. Bollinger
`Reg. No. 32,555
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