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`571-272-7822
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`Entered: December 19,2014
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`UNITED STATES-PATENT AND TRADEMARK OFFICE
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`BIODELIVERY SCIENCES INTERNATIONAL, INC.,.
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`Petitioner,
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`RB PHARMACEUTICALS LIMITED,
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`Patent Owner.
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`Case IPR2014—00998
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`Patent 8,475,832 B2
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`Before TONI R. SCHEINER, JACQUELINE WRIGHT BONILLA, and
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`ZHENYU YANG, Administrative Patent Judges.
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`YANG, Administrative Patent Judge.
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`DECISION
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`Denying Institution of Inter Partes Review
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`and Dismissing Motion for Joinder
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`37 C.F.R. §§ 42.108, 42.122
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`DRL - EXHIBIT 1002
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`DRL001
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`IPR2014-00998
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`Patent 8,475,832 B2
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`INTRODUCTION
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`BioDelivery Sciences International, Inc. (“Petitioner”) petitioned for
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`an inter partes review of claims 15-19 of U.S. Patent No. 8,475,832 B2
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`(Ex. 1001, “the ’832 patent”). Paper 2 (“Pet.”). Petitioner also sought to
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`join thisproceeding with IPR2014—00325, an inter partes review of the same
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`challenged claims currently pending before the Board. Paper 6. RB
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`Pharmaceuticals Limited (“Patent Owner”) timely filed a Preliminary
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`Response. Paper 9 (“Prelim. Resp.”). In addition, Patent Owner filed an
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`Opposition to Petitioner’s Motion for Joinder. Paper 10. We have
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`jurisdiction under 35 U.S.C. § 314.
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`For the reasons provided below, we exercise our discretion and deny
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`the Petition under 35 U.S.C. § 325(d). Because we do not institute an inter
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`partes review, we dismiss as moot the Motion for Joinder under 35 U.S.C.
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`§ 3 15(c).
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`Related Proceedings
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`Parties state that Patent Owner previously asserted the ’832 patent
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`against Petitioner in Reckitt Benckiser Pharmaceuticals, Inc., v. BioDelivery
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`Sciences International, Inc., No. 5:13-cv-760 (E.D.N.C.). See Pet. 3; Paper
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`5, 3. The case was later dismissed without prejudice as premature on
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`procedural grounds. See Pet. 3; Paper 5, 3.
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`According to Patent Owner, Petitioner filed BioDelivery Sciences
`International, Inc. Reckitt Benckiser Pharmaceuticals, Inc., No. 14—cv-529
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`IPR2014-00998
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`Patent 8,475,832 B2
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`(E.D.N.C.), seeking a declaratory judgment of invalidity of the ’832 patent
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`claims.‘ Prelim. Resp. 1-2.
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`Petitioner previously petitioned for review of, and the Board instituted
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`trial on, the same challenged claims of the ’832 patent in IPR2014-00325
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`(“the ’325 IPR”), currently pending before the Board.
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`The ’832 Patent
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`The ’832 patent relates to compositions and methods for treating
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`narcotic dependence using an orally dissolvable film comprising
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`buprenorphine and naloxone, where the film provides a bioequivalent effect
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`to Suboxone®. Ex. 1001, 4:55-58.
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`Suboxone® is an orally dissolvable tablet of buprenorphine and
`naloxone. Id. at 4:51-55. Buprenorphine provides an effect of satisfying the
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`body’s urge for narcotics, but not the “high” associated with misuse. Id. at
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`1:36-40. Naloxone reduces the effect and, thus, decreases the likelihood of .
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`diversion and abuse of buprenorphine. Id. at 1:46-52. The tablet form,
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`however, still-has the potential for abuse because it can be removed easily
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`from the mouth for later extraction and injection of buprenorphine. Id. at
`1:55-62. The film of the ’832 patent “provides buccal adhesion while it is in
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`the user’s mouth, rendering it difficult to remove after placement.” Id. at
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`4:58-60.
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`1 Patent Owner does not specify when Petitioner filed the declaratory
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`judgment action in the district court. We observe that, despite pointing to
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`the district court case, Patent Owner does not challenge Petitioner’s standing
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`in this proceeding as barred under 35 U.S.C. § 315(a)(1).
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`3
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`IPR2014—00998
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`Patent 8,475,832 B2
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`The ’832. patent teaches controlling the“ local pH to maximize the
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`absorption of the buprenorphine while simultaneously minimizing the
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`absorption of the naloxone. Id. at 11:28-30. According to the ’832 patent,
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`“it has been surprisingly discovered” that, at a local pH level from about
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`to
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`about 4, and most desirably from 3 to 4, the film composition of the
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`invention achieves bioequivalence to the Suboxone® tablet. Id at 11:50-61.
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`The ’832 patent defines bioequivalent as “obtaining 80% to 125% of
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`the Cmax and AUC values for a given active in a different product.” Id at
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`3248--.50. According to the ’832 patent, “Cmax refers to the mean maximum
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`plasma concentration afier administration of the composition to a human
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`subject;” and “AUC refers to the mean area under the plasma concentration-
`time curve value after administration of the compositions .” Id. at 329-14.
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`The ’832 patent discloses:
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`[T]o be considered bioequivalent to the Suboxone® tablet, the
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`Cmax of buprenorphine is between about 0.624 and 5.638, and
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`the AUC ofbuprenorphine is between about 5.431 to about
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`56.238. Similarly,
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`Suboxone® tablet,
`the Cmax of naloxone is between about
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`41.04 to about 323.75, and the AUC of naloxone is between
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`about 102.88 to about 812.00.
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`Id. at 17:41-47.
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`Illustrative Claim
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`Among the challenged claims, claim 15 is the sole independent claim.
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`It reads:
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`comprising
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`15. An
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`buprenorphine and naloxone, wherein said formulation provides
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`an in vivo plasma profile having a Cmax of between about
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`Patent 8,475,832 B2
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`0.624 ng/ml and about 5.638 ng/ml for buprenorphine and an in
`vivo plasma profile having a Cmax of between about 41.04
`pg/ml to about 323.75 pg/ml for naloxone.
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`Asserted Grounds of Unpatentability
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`Petitioner asserts the following grounds, each of which challenges the
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`patentability of claims 15-19:
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`- 103
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`~ 103
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`~ 103
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`~ 103
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`ANALYSIS
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`Under 35 U.S.C. § 325(d),
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`In determining whether to institute or order a proceeding under
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`. chapter 3], the Director may take into account whether, and
`reject the petition or request because, the same or substantially
`the same prior art or arguments previously were presented to
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`Patent Owner asks us to exercise our discretion under 35 U.S.C.
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`§ 325(d) and deny this Petition. Prelim. Resp. 20-33. Patent Owner argues
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`2 Oksche et al., _Int’l Pub. No. WO 2008/025791 Al , published on March 6,
`2008 (Ex. 1018) (“Euro-Celtique”).
`3 European Medicines Agency (EMEA) Study Report on Suboxone®
`Tablets, 2006 (Ex. 1015) (“EMEA Study Report”).
`4 Fuisz et. al., Int’l Pub. No. W0 03/030883 .Al, published on April 17, 2003
`(Ex. 1031) (“the ’883 Application”).
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`5 Yang et al., U.S. Patent No. 7,357,891 B2, issued on April 15, 200
`(Ex. 1016) (“Yang”).
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`Patent 8,475,832 B2
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`that the Petition is redundant “because it substantially repeats the same
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`arguments and relies substantially on the same prior art that the same
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`Petitioner relied upon in its earlier [’325 IPR] Petition regarding the same
`claims of the same patent.” Id. at 1. We agree.
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`In the ’325 IPR, Petitioner challenged claims 15-19 of the ’832 patent
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`on numerous grounds, including, among others, (1) grounds based on
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`Labtec6 as the primary reference (for example, anticipation by Labtec, and
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`‘ obviousness over the combination of Labtec, Birch,7 and Yang); and (2)
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`grounds based on Euro-Celtique as the primary reference (including
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`anticipation by Euro-Celtique, and obviousness over Euro-Celtique, either
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`alone or in combination with Birch, or with Birch and Yang). See the ’325
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`HR, Paper 8 (“the ’325 IPR Pet.”). We instituted a trial to review whether
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`the challenged claims are anticipated by Labtec and/or rendered obvious
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`over the combination of Labtec, Birch, and Yang. See the ’325 IPR, Paper
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`17.
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`In the ’325 IPR, Petitioner did not explain any meaningful advantage
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`of the Euro—Celtique—based grounds over the Labtec-based grounds. To the
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`contrary, according to Petitioner, the Labtec—based grounds are not
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`cumulative to the Euro-Celtique-based grounds “at least because [Labtec]
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`explicitly ‘identifies and understands the criticality of pH’ to modify
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`absorption”—--a teaching that, according to Petitioner, Patent Owner “stated
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`6 Leichs et al., Int’l Pub. No. WO 2008/040534 A2, published on April 10,
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`2008 (Ex. 1017) (“Labtec”).
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`7 Birch et al., U.S. Patent Pub. No. 2005/0085440 A1, published on April 21,
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`2005 (Ex. 1019) (“Birch”).
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`IPR2014-00998.
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`Patent 8,475,832 B2
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`was lacking in Euro-Celtique” during the prosecution of the ’832 patent.
`The ’325 IPR Pet., 39. As a result, we exercised our discretion and declined
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`to institute an inter partes review on all Euro—Celtique—based grounds. See
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`the ’325 IPR, Paper 17, 20.
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`Nearly two months afier Patent Owner filed its Preliminary Response
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`in the ’325 IPR, Petitioner filed this second Petition, challenging claims 15-
`19 of the ’832 patent based on four grounds: obviousness over (1) Euro—
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`Celtique alone, (2) the combination of Euro-Celtique and the EMEA Study
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`. Report, (3) the combination of Euro-Celtique, the EMEA Study Report, and
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`the ’883 Application, or (4) the combination of Euro-Celtique, the EMEA
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`Study Report, and Yang. Pet. 34-54. Petitioner acknowledges:
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`This petition is directed to the same five claims of the same
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`patent as
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`This - petition
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`involves the same parties as the IPR2014-00325 proceedings.
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`The grounds in this petition are substantially based on a subset
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`of the references cited in the IPR2.014—00325 proceedings.
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`"While grounds in this petition cite two references that were not
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`cited in IPR2014-00325, these two references are related to a
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`reference cited in IPR2014-00325.
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`Id. at 2-3.
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`The two references allegedly not cited in the ’325 IPR are the EMEA
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`Study Report and the ’883 Application. Petitioner, however, did present the
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`EMEA Study Report in the ’325 IPR Petition. See the ’325 IPR Pet., iii
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`(showing the EMEA Study Report as Ex. 1015 in the Exhibit list). In
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`addition, Petitioner specifically cited the E1\/[EA Study Report for disclosing
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`the Cmax and AUC values of naloxone. Id. at 28, see also id. at 40-41 '
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`(citing the EMEA Study Report in claim chart for unpatentability grounds
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`IPR2014-00998
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`Patent 8,475,832 B2
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`Study Report in claim chart for
`based on Labtec), 49 (citing the
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`unpatentability grounds based on Euro—Celtique). Noting Petitioner’s
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`argument, we cited the EMEA Study Report in our decision to institute the
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`reliance on page 12 of the El\/[EA Study Report). In the present case,
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`Petitioner cites the same page of the EMEA Study Report (page 12) for the
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`same disclosure, i.e., for disclosing “mean Cmax and AUC values for
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`_ buprenorphine and naloicone following administration of Suboxone tablets
`that fall within the ranges recited in claims 15-17.” Pet. 45.
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`9‘
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`Petitioner did not cite the ’883 Application in the ’325IPR petition.
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`But, according to Petitioner, Euro-Celtique, “a primary reference in both this
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`petition and the IPR2014-—00325 petition .
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`. repeatedly cites” the ’883
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`Application. Id. at 3; see also id. at 49 (stating that Euro-Celtique identifies
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`the ’883 Application as “describing ‘standard technology’ for preparing
`films”). Petitioner explains that the ’883 (Application is part of a family of
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`patent applications that resulted in Yang, a U.S. patent that Petitioner relied
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`on in the ’325 IPR. Id. at 49. In its Motion for Joinder, Petitioner further
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`states that the ’883 Application “is cited for the same relevant disclosure as a
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`related family member cited in the [’325 IPR] Petition (i. e;, Yang)” Paper
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`6, 9.
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`Having considered the papers filed in this proceeding, as well as the
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`papers filed in’ the ’325 IPR, we agree with Patent Owner that Petitioner has
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`recycled previous art and arguments. See Prelim. Resp. 24-32. Petitioner
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`does not provide any persuasive reasoning as to why we should institute
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`DRL008
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`IPR2014-00998
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`Patent 8,475,832 B2
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`another inter partes review of the same challenged claims over “the same or
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`substantially the same prior art or arguments” that were presented in the
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`’325 IPR.8 Based on the totality of the facts before us, we exercise our
`discretion and deny the Petition under 35 U.S.C.
`325(d). We dismiss as
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`moot Petitioner’s Motion for Joinder with the ’325 IPR.
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`Accordingly, it is
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`ORDER
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`ORDERED that Petitioner’s request for an inter partes review of
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`claims 15-19 of the ’832 patent is denied; and
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`FURTHER ORDERED that the Motion for Joinder with Case
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`IPR2013-00325 is dismissed.
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`8 Petitioner contends that “[i]n addition to the recited limitations, Euro-
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`Celtique discloses features that are disclosed in the ‘832 patent but not
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`required by the claims 15-19,” such as a mucoadhesive film and a film that
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`delivers active through the mucosa. Pet. 41. This argument was not
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`presented in the ’325 IPR. Petitioner does not, however, explain why these
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`features matter to our patentability analysis, if they are not required by the
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`IPR2014-00998
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`Patent 8,475,832 B2
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`For PETITIONER:
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`Danielle L. Herritt
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`McCarter & English, LLP .
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`dherri'tt@mccarter.com
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`Kia L. Freeman
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`McCarter & English, LLP
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`kfreeman@mccarter.co,m,
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`For PATENT OWNER:
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`James M. Bollinger
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`Troutman Sanders LLP
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`james.bollinger@troutmansanders.com
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`Daniel A. Ladow
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`Troutman Sanders LLP
`daniel.ladow@troutmansanders.co.m
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`DRL - EXHIBIT 1002
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`Mail Stop 3
`Director of the U.S. Patent and Trademark Olfice
`P.0. Box 1450
`Alexandria. VA 22313-1450
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`REPORT ON THE
`FILING OR DETERMINATION OF AN
`ACTION REGARDING A PATENT OR
`TRADEMARK
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`In Compliance with 35 U.S.C. § 290 andlor 15 U.S.C. § 11l6 you are hereby advised that a court action has been
`filed in the U.S. District Court
`Eastern District of North Carolina
`on the following
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`D Trademarks or
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`IE Patents.
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`( E] the patent action involves 35 U.S.C. § 292.):
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`5:14-cv-529-H
`PLAINTIFF
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`9/20/2014
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`Eastern District of North Carolina
`DEFENDANT
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`BIoDeIivery Sciences lntemational. Inc.
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`Reckitt Bencklser Pharmaceuticals, Inc. et al
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`——
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`—
`——
`——
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`DATE INCLUDED
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`In the above—entitled case, the following patent(s)/ trademark(s) have laeen included:
`INCLUDED BY
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`Tkfiggafkglko
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`%‘;T1§R?,_';';‘:AT/511:]:
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`HOLDER or PATENT OR TRADEMARK
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`E] Amendment
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`I] Answer
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`I] Cross Bill
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`C] Other Pleadin
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`in the above—entitled case, the following decision has been rendered orjudgement issued:
`DECISION/JUDGEMENT
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`CLERK
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`JULIE A. RICHARDS
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`(BY) DEPUTY CLERK
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`Isl Jade Felder
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`mm;
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`9/22/2014
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`Copy l—Upon initiation of action, mail this copy to Director Copy 3—Upon termination of action, mail this copy to Director
`Copy 2—Upon filing document adding patent(s), mail this copy to Director Copy 4-Case file copy
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`5
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`Print
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`Save As... _
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`DRL - EXHIBIT 1002
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`DRL - EXHIBIT 1002
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`Case3:14-cv—O4240—JCS Document? Fi|edO9/19/14 Pagel ofl
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`4% A0 120 Rev. 2/99
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`TO;
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`Mail stop 3
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`P.O. Box 1450
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`Alexandria, VA 22313-1450
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`REPORT ON THE
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`FILING OR DETERMINATION OF AN
`ACTION REGARDING A PATENT OR
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`TRADEMARK
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`In Compliance with 35 § 290 and/or 15 U.S.C. § lll6 you are hereby advised that a court action has been
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`El Patents or
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`on the
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`CV 14-04240 JCS
`PLAINTIFF
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`JACKSON FAMILY WINES, ET AL
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`9/19/14
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`450 Golden Gate Avenue 16”‘ Floor San Francisco CA 94102
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`DEFENDANT
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`CONSTELLATION BRANDS, ET AL
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`PATENT OR
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`DATE OF PATENT
`HOLDER OF PATENT OR TRADEMARK
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`.1, 351 3, 5' T3 _ ***see Attach Complaint***
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`In the above——entitled case, the following patent(s) have been included:
`DATE INCLUDED
`INCLUDED BY
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`[:1 Amendment
`DATE OF PATENT
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`PATENT OR
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`TRADEMARK NO‘
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`[:1 Answer
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`[:1 Other Pleading
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`HOLDER OF PATENT OR TRADEMARK
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`In the above~—entitled case, the following decision has been rendered or judgement issued:
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`DECISION/JUDGEMENT
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`CLERK
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`(BY) DEPUTY CLERK
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`DATE
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`Richard W. Wieking
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`Gina Agustine
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`September 19, 2014
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`Copy 1——Upon initiation of action, mail this copy to Commissioner Copy 3——Upon termination of action, ma“ this Mm" tn Cm"-nissioner
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`Copy 2——Upon filing document adding patent(s), mail this cor" ‘" " “““““““““ M’
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`Trials@uspto.gov
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`571-272-7822
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`Paper 17
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`Entered: July 29, 2014
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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`BIODELIVERY SCIENCES INTERNATIONAL, INC.,
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`Petitioner,
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`V.
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`RB PHARMACEUTICALS LIMITED,
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`Patent Owner.
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`case ]PR2014-00325
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`Patent 8,475,832 B2
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`Before TONI R. SCI-IEINER, JACQUELINE WRIGHT BONILLA, and
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`ZI-IENYU YANG, Administrative Patent Judges.
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`.YANG, Administrative Patent Judge.
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`DECISION
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`Institution of Inter Partes Review
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`37 C.F.R. § 42.108
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`DRL - EXHIBIT 1002
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`DRL - EXHIBIT 1002
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`BioDelivery Sciences International, Inc. (“Petitioner”) petitioned for
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`INTRODUCTION
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`an inter partes review of claims 15-19 of U.S. Patent No. 8,475,832 B2
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`(Ex. 1001, “the ’832 patent”). Paper 8 (“Pet.”). RB Pharmaceuticals
`Limited (“Patent Owner”) timely filed a Preliminary Response. Paper 15
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`(“Prelim. Resp.”). We have jurisdiction under 35 U.S.C. § 314.
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`For the reasons provided below, we determine that Petitioner has
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`satisfied the threshold requirement set forth in 35 U.S.C. § 314(a) and
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`established a reasonable likelihood that it would prevail in showing the
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`unpatentability of the challenged claims. Therefore, we institute an inter
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`partes review of claims 15-19 of the ’832 patent.
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`The ’832 Parent
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`The ’832 patent relates to compositions and methods for treating
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`narcotic dependence using an orally dissolvable film comprising
`buprenorphine and naloxone, where the film provides a bioequivalent effect
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`to Suboxone®. Ex. 1001, 4:55-58.
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`Suboxone® is an orally dissolvable tablet of buprenorphine and
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`naloxone. Id. at 4:51-55. Buprenorphine provides an effect of satisfying the
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`body’s urge for the narcotics, but not the “high” associated with misuse. Id
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`of diversion and abuse of buprenorphine. Id. at 1246-52. The tablet form,
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`however, still has the potential for abuse because it can be removed easily
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`from the mouth for later extraction and injection of buprenorphine. Id. at
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`1:55-62. The film of the ’832 patent “provides buccal adhesion while it is in
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`the user’s mouth, rendering it difficult to remove after placement.” Id. at
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`4:58-60.
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`The ’832 patent teaches controlling the local pH to maximize the
`absorption of the buprenorphine while simultaneously minimizing the
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`absorption of the naloxone. Id. at 11:28-30. According to the ’832 patent,
`“it has been surprisingly discovered” that, at a local pH level from about 2 to
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`about 4, and most desirably from 3 to 4, the film composition of the
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`invention achieves bioequivalence to the Suboxone® tablet. Id. at 11:50-61.
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`The ’832 patent defines bioequivalent as “obtaining 80% to 125% of
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`the Cmax and AUC values for a given active in a different product.” Id. at
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`3:48-50. According to the ’832 patent, “Cmax refers to the mean maximum
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`plasma concentration after administration of the composition to a human
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`subject,” and “AUC refers to the mean area under the plasma concentration-
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`time curve value after administration of the compositions .
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`319-14. The ’832 patent discloses:
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`[T]o be considered bioequivalent to the Suboxone® tablet, the
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`Cmax of buprenorphine is between about 0.624 and 5.638, and
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`the AUC of buprenorphine is between about 5.431 to about
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`56.238. Similarly,
`to be considered bioequivalent
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`Suboxone® tablet,
`the Cmax of naloxone is between about
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`41.04 to about 323.75, and the AUC of naloxone is between
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`about 102.88 to about 812.00.
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`Id. at 17:41-47.
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`Illustrative Claim
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`Among the challenged claims, claim 15 is the sole independent claim.
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`It reads:
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`DRL - EXHIBIT 1002
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`DRL0l5
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`DRL - EXHIBIT 1002
`DRL015
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`comprising
`orally dissolving film fomiulation
`15. An
`buprenorphine and naloxone, wherein said formulation provides
`an in vivo plasma profile having a Cmax of between about
`0.624 ng/ml and about 5.638 ng/ml for buprenorphine and an in
`vivo plasma profile having a Cmax of between about 41.04
`pg/ml to about 323.75 pg/ml for naloxone.
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`Asserted Grounds of Unpatentabilizy
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`Petitioner asserts the following grounds, each of which challenges the
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`patentability of claims 15-19:
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` -v— -*‘.!, 3.. ._,,
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`r’?-.\,..
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`b
`~ 103
`. 103-
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`\ 102 b
`- 103
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`. 103
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`~ 103
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`' Suboxone Tablet Label, Revised September 2006 (Ex. 1013); Yang et al.,
`U.S. Patent No. 7,357,891 B2 (Ex. 1016) (“Yang”); Leichs et al., Int’l Pub.
`No. WO 2008/040534 A2 (Ex. 1017)'(“Labtec”); Oksche et al., Int’l Pub.
`No. W0 2008/025791 A1 (Ex. 1018) (“Euro-Celtique”); Birch et al., U.S.
`Patent Publication No. 2005/0085440 A1 (Ex. 1019) (“Birch”).
`4
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`DRL - EXHIBIT 1002
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`DRL0l6
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`DRL - EXHIBIT 1002
`DRL016
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`ANALYSIS
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`Preliminary Matters
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`Reitman Declaration
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`In support of the Petition, Petitioner submits a declaration by
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`Dr. Maureen Reitman, who testifies that the pH of Suboxone® tablets “was
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`measured to be 3.5.” Ex. 1004 1} 5. Patent Owner asks us to disregard the
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`Reitman Declaration because (1) Suboxone® tablets do not constitute prior
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`art for an inter partes review; and (2) the Reitman Declaration fails to
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`provide sufficient and reliable evidence. Prelim. Resp. 20-22.
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`Patent Owner’s argument is moot because we do not need to rely on
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`Reitman Declaration at this stage of the proceeding. Petitioner, in discussing
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`several assertedigrounds, refers to pH 3-3.5 allegedly emphasized in the ’832
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`patent. See, e. g., Pet. 36 (asserting that “[t]o the extent the pH range of
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`about 3 to about 3.5 is read into the challenged claims, the use of that pH
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`range was already described and obvious in view of Birch”). As Patent
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`Owner points out, however, “pH is not recited in the challenged claims.”
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`Prelim. Resp. 5. Thus, for purposes of this Decision, we do not address
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`Petitioner’s argument or the Reitman Declaration discussing the pH of
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`Suboxone® tablets.
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`Lack of expert testimony on claim construction
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`Patent Owner faults Petitioner for presenting no expert testimonyon
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`how one of ordinary skill in the art would understand the term “film
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`formulation.” Prelim. Resp. 12. As explained below, in this case,
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`disclosures in the Specification provide sufficient guidance for claim
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`5
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`DRL - EXHIBIT 1002
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`DRL017
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`DRL - EXHIBIT 1002
`DRL017
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`construction.‘ Thus, given the record before us, the absence of expert
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`testimony on claim construction is inconsequential. Patent Owner also
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`criticizes Petitioner for only relying on attorney argument. Prelim. Resp. 12.
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`We, however, are satisfied that evidence of record, as supplied by both
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`parties, is sufficient to allow us to construe claim terms for purposes of this
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`Decision.
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`Lack of expert testimony on anticipation and obviousness
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`To support the Petition, Petitioner submits two expert declarations:
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`Reitman Declaration addressing the pH of Suboxone® tablets (Ex. 1004),
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`and a declaration by Dr. Philip T. Lavin discussing certain data in the ’832
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`patent (Ex. 1005). Patent Owner urges us to deny the Petition for the sole
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`reason that neither declaration presents direct analysis on anticipation or
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`obviousness. Prelim. Resp. 4-5; see also id. at 33-37. We decline to do so.
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`Patent Owner is correct that “[t]he Board expects that most petitions
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`and motions will rely upon affidavits of experts.” Prelim. Resp. 4 (quoting
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`Office Patent TrialPractice Guide, 77 Fed. Reg. 48,756, 48,763 (Aug. 14,
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`2012)). Especially in complex cases where obviousness is asserted as a
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`ground of unpatentability, “expert testimony may be critical, for example, to
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`establish the existence of certain features inthe prior art or the existence (or
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`lack thereof) of a motivation to combine references.” Wyers v. Master Lock
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`C0., 616 F.3d 1231, 1240 n.5 (Fed. Cir. 2010) (citations omitted). But
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`expert testimony is not a per se requirement—-—where the technology is
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`simple, where the references are easily understandable without the need for
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`expert explanatory testimony, or where the factual inquiries underlying the
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`DRL - EXHIBIT 1002
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`DRL0l8
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`DRL - EXHIBIT 1002
`DRL018
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`obviousness determination are not in material dispute, expert testimony,
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`though it might be helpful, may not be indispensable. Allergan, Inc. v. Barr
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`Labs., Inc., 501 F-. App’x 965, 972 (Fed. Cir. 2013). In addition, a reason to
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`combine prior art teachings may'exist “in the content of the public prior art,
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`in the nature of the problem addressed by the invention, or even in the
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`knowledge of one of ordinary skill in the art.” Princeton Biochemicals Inc;
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`v. Beckman Coulter Inc., 411 F.3d 1332, 1338-39 (Fed. Cir. 2005). And in
`some cases, “the legal determination of obviousness may include recourse to
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`logic, judgment, and common sense, in lieu of expert testimony.” Wyers,
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`616 F.3d at 1239. Therefore, we reject a bright-line rule requiring expert
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`testimony analyzing unpatentability for all petitions for inter partes review.
`At this stage of the proceedings, Petitioner has provided sufficient
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`evidence and we understand the prior art disclosures and a possible
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`reasoning to modify or combine the references without guidance of an
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`expert.
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`Claim Construction .
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`In an inter partes review, the Board interprets a claim term in an
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`unexpired patent according to its broadest reasonable construction in light of
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`the specification of the paten