`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`________________________
`
`DR. REDDY’S LABORATORIES S.A. AND
`DR. REDDY’S LABORATORIES, INC.
`Petitioners
`
`
`v.
`
`
`INDIVIOR UK LIMITED.
`Patent Owner
`
`________________________
`
`
`U.S. PATENT NO. 9,687,454
`
`SUBLINGUAL AND BUCCAL FILM COMPOSITIONS
`
`Case No. IPR2019-00329
`________________________
`
`PETITIONERS’ UPDATED EXHIBIT LIST
`
`
`
`TITLE:
`
`Mail Stop PATENT BOARD
`Patent Trial and Appeal Board
`United States Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`
`
`
`List of Exhibits for U.S. Patent No. 9,687,454 Petition for Inter Partes Review
`Ex. No.
`Description
`1001
`U.S. Patent No. 9,687,454
`
`1002
`
`1003
`
`1004
`
`1005
`
`1006
`
`1007
`
`1008
`
`1009
`
`1010
`
`1011
`
`1012
`
`1013
`
`1014
`
`1015
`
`1016
`
`File History of U.S. Patent Application No. 14/989,669
`
`Expert Declaration of Nandita Das, Ph.D.
`
`Curriculum Vitae of Nandita Das, Ph.D.
`
`U.S. Patent No. 8,475,832
`
`PCT Application No. WO 2008/02579 (“Euro-Celtique”)
`
`2004 Physician’s Desk Reference (“Suboxone PDR”)
`
`European Medicines Agency Initial Marketing-Authorisation
`Document for Suboxone® Tablet (“EMEA”) (2006)
`
`Affidavit of Christopher Butler
`
`U.S. Patent Pub. No. 2011/0033541 (“Myers”)
`
`File History of U.S. Patent Application No. 12/537,571
`
`Aulton, et al., Pharmaceutics The Science of Dosage Form
`Design, Second Edition (2002) (“Aulton”)
`
`Dawson, et al., pH, buffers, and physiological media, Data for
`Biochemical Research, 428 (1986) (“Dawson”)
`
`U.S. Patent Application Publication No.: US 2005/0085440
`A1 (“Birch”)
`
`Cassidy, et al., Controlled buccal delivery of buprenorphine,
`Journal of Controlled Release, 21-29 Volume 25 (1993)
`(“Cassidy”)
`
`Campbell, et al., The history of the development of
`buprenorphine as an addiction therapeutic, Ann. N.Y. Acad.
`Sci. 124–139 (2012) (“Campbell”)
`
`
`
`
`2
`
`
`
`1017
`
`1018
`
`1019
`
`1020
`
`1021
`
`1022
`
`1023
`
`1024
`
`1025
`
`Chiang, et al., Pharmacokinetics of the combination tablet of
`buprenorphine and naloxone, Drug and Alcohol Dependence
`S39 - S47 Volume 70 (2003) (“Chiang”)
`
`Bullingham, et al., Sublingual Buprenorphine Used
`Postoperatively: Clinical Observations and Preliminary
`Pharmacokinetic Analysis, British Journal of Clinical
`Pharmacology, 117-122 Volume 12 (1981) (“Bullingham”)
`
`European Patent Application No. 82303582.9 (“Todd”)
`
`U.S. Patent No. 5,288,497 (“Stanley”)
`
`Suboxone, European Medicines Agency,
`https://www.ema.europa.eu/medicines/human/EPAR/suboxone
`(Last visited Oct. 26, 2018) (“EMEA Web”)
`
`Ciraulo, et al., Pharmacokinetics and Pharmacodynamics of
`Multiple Sublingual Buprenorphine Tablets in Dose-
`Escalation Trials, The Journal of Clinical Pharmacology, 179-
`192 Volume 46 (2006) (“Ciraulo”)
`
`Reckitt Benckiser Pharma, Inc. v. Watson Labs., Inc., 13-cv-
`1674-RGA (D. Del. June 26, 2015)
`
`Suboxone® Tablet Label (2002)
`
`Batheja, P. et al., Basic Biopharmaceutics of Buccal and
`Sublingual Absorption in Enhancement in Drug Delivery (Elke
`Touitou and Brian W. Barry, eds., 2007) (“Batheja”)
`
`1026
`
`Corrected Declaration of Robert Frederickson III in Support of
`Petitioners’ Renewed Motion for Pro Hac Vice Admission
`
`1027 Declaration of Anjum Swaroop
`
`1028
`
`1029
`
`Transcript of June 28, 2018 Hearing of Motion for a
`Preliminary Injunction
`
`Declaration of Alexandra D. Valenti In Support of Petitioners’
`Motion for Pro Hac Vice Admission
`
`
`
`
`
`3
`
`
`
`CERTIFICATE OF SERVICE
`
`
`
`Pursuant to 37 C.F.R. §§ 42.6(e) and 42.105(a), the undersigned certifies
`
`that on November 12, 2019, a copy of the foregoing Updated Exhibit List was
`
`served electronically via e-mail on the following:
`
`dgarr@cov.com
`
`pchen@cov.com
`
`IndiviorSBX@cov.com
`
`
`
`
`
`
`
`Date: November 12, 2019
`
`
`
`
`
`
`
`
`
`
`By: /Ira J. Levy/
`Registration No. 35,587
`Goodwin Procter LLP
`The New York Times Building
`620 Eighth Avenue
`New York, NY 10018-1405
`T: 212-459-7459
`F: 646-558-4143
`ILevy@goodwinlaw.com
`
`4
`
`
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