Trials@uspto.gov
`571-272-7822
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` Paper No. 12
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` Entered: December 19, 2014
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`BIODELIVERY SCIENCES INTERNATIONAL, INC.,
`Petitioner,
`
`v.
`
`RB PHARMACEUTICALS LIMITED,
`Patent Owner.
`____________
`
`Case IPR2014-00998
`Patent 8,475,832 B2
`____________
`
`
`Before TONI R. SCHEINER, JACQUELINE WRIGHT BONILLA, and
`ZHENYU YANG, Administrative Patent Judges.
`
`YANG, Administrative Patent Judge.
`
`
`
`
`DECISION
`Denying Institution of Inter Partes Review
`and Dismissing Motion for Joinder
`37 C.F.R. §§ 42.108, 42.122
`
`
`
`
`
`
`
`
`
`571-272-7822
`
`
`
`
`
`
`
` Paper No. 12
`
`
` Entered: December 19, 2014
`
`
`
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`BIODELIVERY SCIENCES INTERNATIONAL, INC.,
`Petitioner,
`
`v.
`
`RB PHARMACEUTICALS LIMITED,
`Patent Owner.
`____________
`
`Case IPR2014-00998
`Patent 8,475,832 B2
`____________
`
`
`Before TONI R. SCHEINER, JACQUELINE WRIGHT BONILLA, and
`ZHENYU YANG, Administrative Patent Judges.
`
`YANG, Administrative Patent Judge.
`
`
`
`
`DECISION
`Denying Institution of Inter Partes Review
`and Dismissing Motion for Joinder
`37 C.F.R. §§ 42.108, 42.122
`
`
`
`
`
`
`
`
`
`
`IPR2014-00998
`Patent 8,475,832 B2
`
`
`INTRODUCTION
`BioDelivery Sciences International, Inc. (“Petitioner”) petitioned for
`an inter partes review of claims 15–19 of U.S. Patent No. 8,475,832 B2
`(Ex. 1001, “the ’832 patent”). Paper 2 (“Pet.”). Petitioner also sought to
`join this proceeding with IPR2014-00325, an inter partes review of the same
`challenged claims currently pending before the Board. Paper 6. RB
`Pharmaceuticals Limited (“Patent Owner”) timely filed a Preliminary
`Response. Paper 9 (“Prelim. Resp.”). In addition, Patent Owner filed an
`Opposition to Petitioner’s Motion for Joinder. Paper 10. We have
`jurisdiction under 35 U.S.C. § 314.
`For the reasons provided below, we exercise our discretion and deny
`the Petition under 35 U.S.C. § 325(d). Because we do not institute an inter
`partes review, we dismiss as moot the Motion for Joinder under 35 U.S.C.
`§ 315(c).
`
`Related Proceedings
`Parties state that Patent Owner previously asserted the ’832 patent
`against Petitioner in Reckitt Benckiser Pharmaceuticals, Inc., v. BioDelivery
`Sciences International, Inc., No. 5:13-cv-760 (E.D.N.C.). See Pet. 3; Paper
`5, 3. The case was later dismissed without prejudice as premature on
`procedural grounds. See Pet. 3; Paper 5, 3.
`According to Patent Owner, Petitioner filed BioDelivery Sciences
`International, Inc. v. Reckitt Benckiser Pharmaceuticals, Inc., No. 14-cv-529
`
`2
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`IPR2014-00998
`Patent 8,475,832 B2
`
`(E.D.N.C.), seeking a declaratory judgment of invalidity of the ’832 patent
`claims.1 Prelim. Resp. 1–2.
`Petitioner previously petitioned for review of, and the Board instituted
`trial on, the same challenged claims of the ’832 patent in IPR2014-00325
`(“the ’325 IPR”), currently pending before the Board.
`The ’832 Patent
`The ’832 patent relates to compositions and methods for treating
`narcotic dependence using an orally dissolvable film comprising
`buprenorphine and naloxone, where the film provides a bioequivalent effect
`to Suboxone®. Ex. 1001, 4:55–58.
`Suboxone® is an orally dissolvable tablet of buprenorphine and
`naloxone. Id. at 4:51–55. Buprenorphine provides an effect of satisfying the
`body’s urge for narcotics, but not the “high” associated with misuse. Id. at
`1:36–40. Naloxone reduces the effect and, thus, decreases the likelihood of
`diversion and abuse of buprenorphine. Id. at 1:46–52. The tablet form,
`however, still has the potential for abuse because it can be removed easily
`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
`the user’s mouth, rendering it difficult to remove after placement.” Id. at
`4:58–60.
`
`
`1 Patent Owner does not specify when Petitioner filed the declaratory
`judgment action in the district court. We observe that, despite pointing to
`the district court case, Patent Owner does not challenge Petitioner’s standing
`in this proceeding as barred under 35 U.S.C. § 315(a)(1).
`3
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`IPR2014-00998
`Patent 8,475,832 B2
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`The ’832 patent teaches controlling the local pH to maximize the
`absorption of the buprenorphine while simultaneously minimizing the
`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
`about 4, and most desirably from 3 to 4, the film composition of the
`invention achieves bioequivalence to the Suboxone® tablet. Id. at 11:50–61.
`The ’832 patent defines bioequivalent as “obtaining 80% to 125% of
`the Cmax and AUC values for a given active in a different product.” Id. at
`3:48–50. According to the ’832 patent, “Cmax refers to the mean maximum
`plasma concentration after administration of the composition to a human
`subject;” and “AUC refers to the mean area under the plasma concentration-
`time curve value after administration of the compositions .” Id. at 3:9–14.
`The ’832 patent discloses:
`[T]o be considered bioequivalent to the Suboxone® tablet, the
`Cmax of buprenorphine is between about 0.624 and 5.638, and
`the AUC of buprenorphine is between about 5.431 to about
`56.238. Similarly, to be considered bioequivalent to the
`Suboxone® tablet, the Cmax of naloxone is between about
`41.04 to about 323.75, and the AUC of naloxone is between
`about 102.88 to about 812.00.
`Id. at 17:41–47.
`
`Illustrative Claim
`Among the challenged claims, claim 15 is the sole independent claim.
`It reads:
`formulation comprising
`film
`15. An orally dissolving
`buprenorphine and naloxone, wherein said formulation provides
`an in vivo plasma profile having a Cmax of between about
`
`4
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`IPR2014-00998
`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.
`Asserted Grounds of Unpatentability
`Petitioner asserts the following grounds, each of which challenges the
`patentability of claims 15–19:
`
`Basis
`§ 103
`§ 103
`§ 103
`§ 103
`
`
`Reference(s)
`Euro-Celtique2
`Euro-Celtique and EMEA Study Report3
`Euro-Celtique, EMEA Study Report, and the ’883 Application4
`Euro-Celtique, EMEA Study Report, and Yang5
`
`ANALYSIS
`Under 35 U.S.C. § 325(d),
`In determining whether to institute or order a proceeding under
`. . . chapter 31, 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
`the Office.
`Patent Owner asks us to exercise our discretion under 35 U.S.C.
`§ 325(d) and deny this Petition. Prelim. Resp. 20–33. Patent Owner argues
`
`
`2 Oksche et al., Int’l Pub. No. WO 2008/025791 A1, 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. WO 03/030883 A1, published on April 17, 2003
`(Ex. 1031) (“the ’883 Application”).
`5 Yang et al., U.S. Patent No. 7,357,891 B2, issued on April 15, 2008
`(Ex. 1016) (“Yang”).
`
`5
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`IPR2014-00998
`Patent 8,475,832 B2
`
`that the Petition is redundant “because it substantially repeats the same
`arguments and relies substantially on the same prior art that the same
`Petitioner relied upon in its earlier [’325 IPR] Petition regarding the same
`claims of the same patent.” Id. at 1. We agree.
`In the ’325 IPR, Petitioner challenged claims 15–19 of the ’832 patent
`on numerous grounds, including, among others, (1) grounds based on
`Labtec6 as the primary reference (for example, anticipation by Labtec, and
`obviousness over the combination of Labtec, Birch,7 and Yang); and (2)
`grounds based on Euro-Celtique as the primary reference (including
`anticipation by Euro-Celtique, and obviousness over Euro-Celtique, either
`alone or in combination with Birch, or with Birch and Yang). See the ’325
`IPR, Paper 8 (“the ’325 IPR Pet.”). We instituted a trial to review whether
`the challenged claims are anticipated by Labtec and/or rendered obvious
`over the combination of Labtec, Birch, and Yang. See the ’325 IPR, Paper
`17.
`
`In the ’325 IPR, Petitioner did not explain any meaningful advantage
`of the Euro-Celtique-based grounds over the Labtec-based grounds. To the
`contrary, according to Petitioner, the Labtec-based grounds are not
`cumulative to the Euro-Celtique-based grounds “at least because [Labtec]
`explicitly ‘identifies and understands the criticality of pH’ to modify
`absorption”—a teaching that, according to Petitioner, Patent Owner “stated
`
`6 Leichs et al., Int’l Pub. No. WO 2008/040534 A2, published on April 10,
`2008 (Ex. 1017) (“Labtec”).
`7 Birch et al., U.S. Patent Pub. No. 2005/0085440 A1, published on April 21,
`2005 (Ex. 1019) (“Birch”).
`
`6
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`IPR2014-00998
`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
`to institute an inter partes review on all Euro-Celtique-based grounds. See
`the ’325 IPR, Paper 17, 20.
`Nearly two months after Patent Owner filed its Preliminary Response
`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-
`Celtique alone, (2) the combination of Euro-Celtique and the EMEA Study
`Report, (3) the combination of Euro-Celtique, the EMEA Study Report, and
`the ’883 Application, or (4) the combination of Euro-Celtique, the EMEA
`Study Report, and Yang. Pet. 34–54. Petitioner acknowledges:
`This petition is directed to the same five claims of the same
`patent as the IPR2014-00325 proceedings. This petition
`involves the same parties as the IPR2014-00325 proceedings.
`The grounds in this petition are substantially based on a subset
`of the references cited in the IPR2014-00325 proceedings.
`While grounds in this petition cite two references that were not
`cited in IPR2014-00325, these two references are related to a
`reference cited in IPR2014-00325.
`Id. at 2–3.
`The two references allegedly not cited in the ’325 IPR are the EMEA
`Study Report and the ’883 Application. Petitioner, however, did present the
`EMEA Study Report in the ’325 IPR Petition. See the ’325 IPR Pet., iii
`(showing the EMEA Study Report as Ex. 1015 in the Exhibit list). In
`addition, Petitioner specifically cited the EMEA Study Report for disclosing
`the Cmax and AUC values of naloxone. Id. at 28, see also id. at 40–41
`(citing the EMEA Study Report in claim chart for unpatentability grounds
`7
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`IPR2014-00998
`Patent 8,475,832 B2
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`based on Labtec), 49 (citing the EMEA Study Report in claim chart for
`unpatentability grounds based on Euro-Celtique). Noting Petitioner’s
`argument, we cited the EMEA Study Report in our decision to institute the
`’325 IPR. See the ’325 IPR, Paper 17, 14 (acknowledging Petitioner’s
`reliance on page 12 of the EMEA Study Report). In the present case,
`Petitioner cites the same page of the EMEA Study Report (page 12) for the
`same disclosure, i.e., for disclosing “mean Cmax and AUC values for
`buprenorphine and naloxone following administration of Suboxone tablets
`that fall within the ranges recited in claims 15-17.” Pet. 45.
`Petitioner did not cite the ’883 Application in the ’325 IPR petition.
`But, according to Petitioner, Euro-Celtique, “a primary reference in both this
`petition and the IPR2014-00325 petition . . . repeatedly cites” the ’883
`Application. Id. at 3; see also id. at 49 (stating that Euro-Celtique identifies
`the ’883 Application as “describing ‘standard technology’ for preparing
`films”). Petitioner explains that the ’883 Application is part of a family of
`patent applications that resulted in Yang, a U.S. patent that Petitioner relied
`on in the ’325 IPR. Id. at 49. In its Motion for Joinder, Petitioner further
`states that the ’883 Application “is cited for the same relevant disclosure as a
`related family member cited in the [’325 IPR] Petition (i.e., Yang).” Paper
`6, 9.
`
`Having considered the papers filed in this proceeding, as well as the
`papers filed in the ’325 IPR, we agree with Patent Owner that Petitioner has
`recycled previous art and arguments. See Prelim. Resp. 24–32. Petitioner
`does not provide any persuasive reasoning as to why we should institute
`
`8
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`IPR2014-00998
`Patent 8,475,832 B2
`
`another inter partes review of the same challenged claims over “the same or
`substantially the same prior art or arguments” that were presented in the
`’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
`moot Petitioner’s Motion for Joinder with the ’325 IPR.
`
`
`ORDER
`
`Accordingly, it is
`ORDERED that Petitioner’s request for an inter partes review of
`claims 15–19 of the ’832 patent is denied; and
`FURTHER ORDERED that the Motion for Joinder with Case
`IPR2013-00325 is dismissed.
`
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`8 Petitioner contends that “[i]n addition to the recited limitations, Euro-
`Celtique discloses features that are disclosed in the ‘832 patent but not
`required by the claims 15-19,” such as a mucoadhesive film and a film that
`delivers active through the mucosa. Pet. 41. This argument was not
`presented in the ’325 IPR. Petitioner does not, however, explain why these
`features matter to our patentability analysis, if they are not required by the
`challenged claims.
`
`9
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`IPR2014-00998
`Patent 8,475,832 B2
`
`
`
`For PETITIONER:
`
`Danielle L. Herritt
`McCarter & English, LLP
`dherritt@mccarter.com
`
`Kia L. Freeman
`McCarter & English, LLP
`kfreeman@mccarter.com
`
`
`For PATENT OWNER:
`
`James M. Bollinger
`Troutman Sanders LLP
`james.bollinger@troutmansanders.com
`
`Daniel A. Ladow
`Troutman Sanders LLP
`daniel.ladow@troutmansanders.com
`
`10
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