`571.272.7822
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` Paper No. 23
` Entered: October 4, 2018
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`INDIVIOR INC.,
`Petitioner,
`
`v.
`
`RHODES PHARMACEUTICALS L.P.,
`Patent Owner.
`____________
`
`Case IPR2018-00795
`Patent 9,370,512 B2
`____________
`
`
`
`Before SHERIDAN K. SNEDDEN, TINA E. HULSE, and
`KRISTI L. R. SAWERT, Administrative Patent Judges.
`
`HULSE, Administrative Patent Judge.
`
`
`
`
`
`DECISION
`Denying Institution of Inter Partes Review
`35 U.S.C. § 314(a)
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`IPR2018-00795
`Patent 9,370,512 B2
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`I. INTRODUCTION
`Indivior Inc. (“Petitioner”) filed a Petition requesting an inter partes
`review of claims 1–24 of U.S. Patent No. 9,370,512 B2 (Ex. 1001, “the ’512
`patent”). Paper 1 (“Pet.”). Rhodes Pharmaceuticals L.P. (“Patent Owner”)
`filed a Preliminary Response to the Petition. Paper 17 (“Prelim. Resp.”).
`With our authorization, Petitioner filed a Reply to the Preliminary Response
`(Paper 20), and Patent Owner filed a Surreply (“Surreply,” Paper 22).
`We have authority under 35 U.S.C. § 314, which provides that an
`inter partes review may not be instituted “unless . . . there is a reasonable
`likelihood that the petitioner would prevail with respect to at least 1 of the
`claims challenged in the petition.” 35 U.S.C. § 314(a). Upon considering
`the arguments and evidence, we determine that it is appropriate to exercise
`our discretion to deny institution under 35 U.S.C. § 325(d). Accordingly, we
`decline to institute an inter partes review of the challenged claims of
`the ’512 patent.
`
`Related Proceedings
`A.
`Patent Owner has asserted the ’512 patent against Petitioner in a
`pending lawsuit, Rhodes Pharmaceuticals L.P. v. Indivior Inc., Case No. 1-
`16-cv-01308 (D. Del.). Pet. 3; Paper 4, 2.
`Patent Owner has also identified several patents and applications that
`are related by priority to the ’512 patent, but “does not concede that any of
`the above-identified patents or applications would affect, or be affected by, a
`decision” in this proceeding. Paper 4, 1.
`The ’512 Patent
`B.
`The ’512 patent relates to oral pharmaceutical dosage forms
`comprising buprenorphine that release buprenorphine instantly upon oral
`application of the dosage form. Ex. 1001, 1:4–7. Buprenorphine
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`1
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`IPR2018-00795
`Patent 9,370,512 B2
`preparations are administered in drug substitution programs to treat
`opioid addiction. Id. at 1:61–63. According to the specification,
`buprenorphine is administered in the form of a tablet for sublingual
`administration. Id. Drug addicts, however, sometimes attempt to divert
`the tablets by removing them from the mouth when the supervising
`healthcare professional is not looking. Id. at 2:4–7. The tablets may then
`be sold or the buprenorphine may be extracted to administer it
`parenterally. Id. at 2:7–9.
`The ’512 patent specification notes the drug Suboxone, which is
`approved in the United States, is also aimed at preventing the possibility
`of abuse. Id. at 2:10–12. Suboxone comprises buprenorphine and the
`opioid antagonist naloxone. Id. at 2:13–15. The naloxone is intended to
`prevent parenteral abuse of buprenorphine, as naloxone causes serious
`withdrawal symptoms when co-administered parenterally with
`buprenorphine. Id. at 2:15–18.
`Accordingly, the specification states it is an object of the invention
`to provide an oral dosage form of buprenorphine “that is less prone to
`diversion and/or abuse in drug substitution therapy.” Id. at 2:31–34.
`Thus, in one embodiment, the invention relates to a dosage form that
`releases buprenorphine instantly upon oral, preferably sublingual,
`application of the dosage form. Id. at 2:38–43.
`Illustrative Claim
`C.
`Petitioner challenges claims 1–24 of the ’512 patent, of which claims
`1 and 19 are the only independent claims. Claim 1 is representative and is
`reproduced below:
`1. A method of opioid substitution therapy for
`treating opioid addiction, the method comprising
`contacting the sublingual mucosa of a patient in need
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`2
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`IPR2018-00795
`Patent 9,370,512 B2
`thereof with a sublingual film dosage form
`comprising:
`a) approximately 0.1 mg to approximately 16 mg
`buprenorphine, or an equivalent amount of a
`pharmaceutically acceptable salt thereof;
`b) naloxone or a pharmaceutically acceptable salt
`thereof; and
`c) at least one non-gelatin polymeric film-forming
`material in which the buprenorphine or the
`equivalent amount of the pharmaceutically
`acceptable salt thereof and the naloxone or the
`pharmaceutically acceptable salt thereof, are
`dissolved or homogeneously dispersed;
`the buprenorphine or the equivalent amount of the
`pharmaceutically acceptable salt thereof and the
`naloxone or the pharmaceutically acceptable salt
`thereof being present in the sublingual film dosage
`form in a weight ratio of from 1:1 to 10:1;
`such that within less than 5 minutes after contacting
`the sublingual mucosa of the patient with the
`sublingual film dosage form, the buprenorphine or
`the pharmaceutically acceptable salt thereof and
`approximately substantially all of the naloxone or
`the pharmaceutically acceptable salt thereof
`contact the sublingual mucosa, and wherein said
`contacting achieves:
`(i) an average buprenorphine AUC0-48 from
`approximately 10 to approximately 15
`(hrs*ng)/ml when the sublingual film dosage
`form includes 4 mg buprenorphine or an
`equivalent amount of a pharmaceutically
`acceptable salt thereof;
`(ii) an average buprenorphine AUC0-48 from
`approximately 15 to approximately 25
`(hrs*ng)/ml when the sublingual film dosage
`
`3
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`Claim(s) challenged
`1–5 and 7–24
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`IPR2018-00795
`Patent 9,370,512 B2
`form includes 8 mg buprenorphine or an
`equivalent amount of a pharmaceutically
`acceptable salt thereof, or
`(iii) an average buprenorphine AUC0-48 from
`approximately 25 to approximately 40
`(hrs*ng)/ml when the sublingual film dosage
`form includes 16 mg buprenorphine or an
`equivalent amount of a pharmaceutically
`acceptable salt thereof.
`Ex. 1001, 11:39–12:14.
`The Asserted Grounds of Unpatentability
`D.
`Petitioner challenges the patentability of claims 1–24 of the ’512
`patent on the following grounds:
`References
`Cremer1 and Suboxone PDR2
`in view of Fuisz3 and/or
`Rademacher4
`Cremer, Suboxone PDR, and
`McAleer5 in view of Fuisz
`and/or Rademacher
`
`
`Basis
`§ 103
`
`§ 103
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`6
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`1 Cremer et al., AU 741362, published July 15, 1998 (“Cremer,” Ex. 1004).
`2 Entry for Suboxone in PHYSICIANS’ DESK REFERENCE 2866–69 (58th ed.,
`2004) (“Suboxone PDR,” Ex. 1005).
`3 Fuisz et al., WO 03/030883 A1, published Apr. 17, 2003 (“Fuisz,”
`Ex. 1007).
`4 Rademacher et al., US 2005/0163830 A1, published July 28, 2005
`(“Rademacher,” Ex. 1009).
`5 McAleer et al., Pharmacokinetics of High-Dose Buprenorphine Following
`Single Administration of Sublingual Tablet Formulations in Opioid Naïve
`Healthy Male Volunteers Under a Naltrexone Block, 72 DRUG AND
`ALCOHOL DEPENDENCE 75–83 (2003) (“McAleer,” Ex. 1013).
`4
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`IPR2018-00795
`Patent 9,370,512 B2
`Petitioner also relies on the Declaration of Rodolfo Pinal, Ph.D.
`Ex. 1006.
`
`
`
`II. ANALYSIS
`Institution of inter partes review is discretionary. See Harmonic Inc.
`v. Avid Tech, Inc., 815 F.3d 1356, 1367 (Fed. Cir. 2016) (explaining “the
`PTO is permitted, but never compelled, to institute an IPR proceeding”). In
`particular, § 325(d) states “[i]n determining whether to institute or order a
`proceeding under this chapter . . . [t]he 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.”
`In evaluating whether the same or substantially the same prior art or
`arguments were previously presented to the Office under § 325(d), the Board
`has considered a number of non-exclusive factors, including, for example:
`(a) the similarities and material differences between the asserted
`art and the prior art involved during examination;
`(b) the cumulative nature of the asserted art and the prior art
`evaluated during examination;
`(c) the extent to which the asserted art was evaluated during
`examination, including whether the prior art was the basis
`for rejection;
`(d) the extent of the overlap between the arguments made
`during examination and the manner in which Petitioner
`relies on the prior art or Patent Owner distinguished the
`prior art;
`(e) whether Petitioner has pointed out sufficiently how the
`Examiner erred in its consideration of the asserted prior art;
`and
`(f) the extent to which additional evidence and facts presented
`in the Petition warrant reconsideration of the asserted prior
`art or arguments.
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`IPR2018-00795
`Patent 9,370,512 B2
`Becton, Dickinson & Co. v. B. Braun Melsungen AG, Case IPR2017-01586,
`slip op. 17–18 (PTAB Dec. 15, 2017) (Paper 8) (Informative) (“the Becton
`Dickinson factors”).
`Prosecution History of the ’512 Patent
`A.
`The ’512 patent issued from U.S. Patent Application No. 14/800,270
`(“the ’512 patent application”), which claims priority to U.S. Patent
`Application No. 12/439,410 (“the parent application”), which issued as U.S.
`Patent No. 9,101,625 (“the ’625 patent” or “the parent patent”). Examiner
`Craig D. Ricci was the primary examiner for both applications. Ex. 1002,
`80; Ex. 1003, 1.
`During prosecution of the parent application, the examiner rejected
`the claims as anticipated over the English-translated abstract of
`WO 1998/26780 (“Cremer PCT”). Ex. 1003, 142. The rest of the
`specification of Cremer PCT is published in German. See id. at 146–60. In
`response, the applicants noted that Cremer PCT “issued in Australia as
`Patent No. 741362.” Id. at 127. Australian Patent No. 741362 and Cremer,
`relied upon by Petitioner in this proceeding, are the same reference. Prelim.
`Resp. 7 n.1.
`The examiner maintained the § 102 rejection over Cremer PCT in a
`final office action. Id. at 117. On October 22, 2012, the applicants filed an
`amendment after final that further addressed the examiner’s rejection over
`Cremer PCT. Id. at 90–104. In the remarks, the applicants referred the
`examiner to “Canadian application CA 2 274 910” (“Cremer CA”), which
`was previously cited in an Information Disclosure Statement (“IDS”). Id. at
`98; Ex. 2008, 9. In that same IDS, the applicants also cited Fuisz as “FP19”
`and Rademacher as “US6.” Ex. 2008, 8.
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`Patent 9,370,512 B2
`Relying on the disclosure of Cremer CA, the applicants argued that
`Cremer does not disclose “a pharmaceutical dosage form, which comprises a
`matrix, which is formed from at least one matrix-forming polymer, in which
`buprenorphine is dissolved or homogeneously dispersed.” Ex. 1003, 100.
`The applicants further asserted that the claims would not be obvious over
`Cremer. Id. at 101–03. On December 28, 2012, the examiner issued an
`Advisory Action, stating “THE REPLY FILED 22 October 2012 FAILS TO
`PLACE THIS APPLICATION IN CONDITION FOR ALLOWANCE.” Id.
`at 87. Accordingly, the applicants filed a request for continued examination
`(“RCE”) and a supplemental amendment that stated the examiner’s rejection
`over Cremer PCT was moot in light of the claim amendments. Id. at 75–84.
`The examiner then rejected the claims as anticipated by the Suboxone
`Package Insert. Id. at 68–71. The Suboxone Package Insert is substantively
`identical to Suboxone PDR, asserted by Petitioner in this proceeding.
`Compare Ex. 2003 with Ex. 1005. After the applicants’ response, the
`examiner entered a final rejection, rejecting the claims as obvious over the
`Suboxone Package Insert in view of certain other references. Ex. 1003, 46–
`54. The applicants then filed another RCE, amended the claims, and
`traversed the examiner’s rejections. Id. at 34–44. Following an examiner’s
`amendment, the examiner allowed the claims of the parent patent on June
`18, 2015. Id. at 6–9.
`The applicants filed the ’512 patent application on July 15, 2015. On
`August 19, 2015, the applicants filed an IDS, listing Cremer CA as “FP2”
`(Ex. 1002, 58), Cremer PCT as “FP52” (id. at 64), Fuisz as “FP34” (id. at
`62), and Rademacher as “US80” (id. at 57). The applicants also referred the
`examiner to the prosecution of the parent application and included several of
`the office actions in the IDS. Id. at 123–24. The examiner considered each
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`Patent 9,370,512 B2
`of the references except Cremer PCT, which was not in English. Id. at 189–
`94. The examiner rejected the claims as obvious over Suboxone Package
`Insert and certain other references. Id. at 176–81. The applicants traversed
`the rejection and the examiner issued a notice of allowance on June 24,
`2016. Id. at 223–37, 270.
`Application of Our Discretion Under 35 U.S.C. § 325(d)
`B.
`We address the Becton Dickinson factors to evaluate whether to
`exercise our discretion under § 325(d). Having considered the parties’
`respective arguments and evidence, we determine that exercising our
`discretion is appropriate under the facts and circumstances of this case.
`Factors (a)–(d)
`1.
`Becton Dickinson factors (a)–(d) relate to whether and to what extent
`the prior art asserted in the Petition was considered and relied upon by the
`examiner during prosecution. Petitioner asserts that claims 1–5 and 7–24 of
`the ’512 patent are unpatentable over Cremer in view of Suboxone PDR and
`Fuisz and/or Rademacher. Petitioner also asserts claim 6 is unpatentable
`over Cremer in view of Suboxone PDR, McAleer, and Fuisz and/or
`Rademacher.
`Having considered the prosecution history, we find the examiner was
`aware of each of these references, except McAleer, during prosecution of the
`’512 patent application or the parent application (which was cited during
`prosecution of the ’512 patent application). The applicants noted during
`prosecution of the parent application that Cremer PCT “issued in Australia
`as Patent No. 741362,” which is the same Cremer reference asserted by
`Petitioner in the Petition. Ex. 1003, 127. Moreover, as explained above,
`Suboxone PDR is substantively identical to the Suboxone Package Insert,
`which the examiner relied on during prosecution of both the ’512 patent
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`Patent 9,370,512 B2
`application and the parent application. Compare Ex. 2003 with Ex. 1005.
`Finally, Fuisz and Rademacher were both submitted to the examiner in an
`IDS, and the examiner indicated he considered both references. See
`Ex. 1002, 189, 194. Fuisz is also cited in the ’512 patent specification.
`Ex. 1001, 7:5–7 (“The films are prepared according to standard technology
`and the active agents are displaced thereon and therein as described in WO
`03/030883 [Fuisz].”). Thus, the examiner was aware of each of the
`references asserted by Petitioner, except McAleer, which was not cited
`during prosecution.
`We are persuaded, however, that McAleer is cumulative of prior art
`that the examiner relied on during prosecution. As Patent Owner asserts,
`Petitioner relies on McAleer solely for the T max limitation of claim 6.
`Prelim. Resp. 27 (citing Pet. 66–67). During prosecution, the examiner
`relied on Karch’s6 disclosure that Suboxone sublingual tablets provided a
`“T max from 0.5 to 3 hours.” Ex. 1002, 114. Petitioner relies on McAleer as
`disclosing an average T max of 60 minutes for Suboxone tablets. Pet. 66.
`Thus, we find McAleer’s disclosure is cumulative of Karch, which was
`already considered and relied on by the examiner during prosecution.
`The two main references relied on by Petitioner are Cremer and
`Suboxone PDR.7 It is indisputable that the examiner relied heavily on
`Suboxone PDR (via the Suboxone Package Insert) to reject the claims
`repeatedly during prosecution of both the ’512 patent application and the
`
`
`6 Steven B. Karch, Karch’s Pathology of Drug Abuse (4th ed. 2009)
`(“Karch,” Ex. 2004).
`7 In fact, Cremer and Suboxone PDR may be the only references relied on by
`Petitioner, as Petitioner asserts Fuisz and/or Rademacher in the alternative to
`Cremer. Pet. 49, 51, 64, 65.
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`Patent 9,370,512 B2
`parent application. See supra. Thus, it is clear the examiner was well aware
`of and substantively considered Suboxone PDR.
`Whether the examiner substantively considered Cremer, on the other
`hand, is less clear. After reviewing the prosecution history as a whole,
`however, we are persuaded that the examiner did. For example, the
`examiner expressly relied on the English abstract of Cremer PCT as the
`basis for various anticipation rejections of the parent application’s claims.
`See supra. In response, the applicants pointed the examiner to the
`Australian patent, which is the same Cremer reference that Petitioner relies
`on. Ex. 1003, 127. If the examiner did not consider Cremer at that time, it
`is reasonable to infer that he considered the Canadian counterpart of Cremer,
`which was cited (and considered) in an IDS (Ex. 2008, 9), and which was
`discussed in detail in the applicants’ October 22, 2012, response after final
`office action (Ex. 1003, 98–103). As Patent Owner notes, Cremer CA is
`substantially similar to Cremer. Prelim. Resp. 26 (citing Ex. 2005).
`Petitioner suggests that the examiner did not consider the After Final
`amendment because the amendment was not entered. Reply 2. But we note
`that the Advisory Action entered by the examiner on December 28, 2012,
`states, “THE REPLY FILED 22 October 2012 FAILS TO PLACE THIS
`APPLICATION IN CONDITION FOR ALLOWANCE.” Ex. 1003, 87. In
`light of that statement, we infer that the examiner considered the applicants’
`response, including the extensive discussion of Cremer CA and whether it
`teaches a matrix of buprenorphine that is “dissolved or homogeneously
`dispersed.” Id. at 100. We also agree that it is telling that, after that
`response, the examiner did not rely on Cremer PCT or any other Cremer
`reference to reject the claims of either the parent application or the ’512
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`IPR2018-00795
`Patent 9,370,512 B2
`patent application, despite the fact that the “dissolved or homogeneously
`dispersed” limitation appeared in the claims.
`Thus, we are persuaded that the examiner substantively considered
`and relied upon Cremer and Suboxone PDR—the main references Petitioner
`relies upon in the Petition—during prosecution of the ’512 patent application
`and its parent. We are also persuaded that the examiner was aware of the
`disclosure of McAleer, which was cumulative of Karch, and Fuisz, which is
`cited in the ’512 patent specification (see Ex. 1001, 7:5–7). Accordingly, we
`are persuaded that Becton Dickinson Factors (a) through (d) weigh in favor
`of exercising our discretion under § 325(d).
`Factors (e) and (f)
`2.
` Factors (e) and (f) look to the Petition and whether Petitioner has
`made a case for reconsidering the asserted prior art. We find that Petitioner
`has not.
`Petitioner asserts that the Petition “applies [the references] in a new
`light, through arguments not previously presented to the Patent Office, and
`with support of expert opinion from Dr. Rodolfo Pinal.” Pet. 43. Petitioner
`also claims Cremer PCT “was not presented to the Examiner in English but
`instead was submitted only as a German-language original, without
`translation, and as part of an IDS including over 200 references.” Id.
`Petitioner also asserts that the examiner’s rejections over Cremer PCT “were
`limited to a legal theory different from that presented here” (i.e.,
`anticipation). Pet. 44.
`We are not persuaded. Given the applicants’ disclosure of Cremer
`itself and Cremer CA during prosecution of the parent application, we
`question Petitioner’s argument that the examiner was not aware of the
`English language counterpart of Cremer PCT. Moreover, § 325(d) only
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`IPR2018-00795
`Patent 9,370,512 B2
`requires that the “same or substantially the same prior art or arguments
`previously were presented to the Office.” Thus, that the examiner only
`relied on Cremer PCT for anticipation purposes does not preclude exercising
`our discretion under § 325(d). Regardless, we note the applicants addressed
`the obviousness of the claims over Cremer PCT and Cremer CA, even
`though the examiner did not reject the claims as such. Ex. 1003, 100–03.
`Although Petitioner has offered the testimony of Dr. Pinal, which was
`not considered by the examiner, we are not persuaded that that information
`is sufficient to reconsider substantially the same art that was before the
`examiner during prosecution, particularly in light of the other Becton
`Dickinson factors that weigh in favor of exercising our discretion.
`Thus, under the facts and circumstances of this case, we find that
`substantially the same prior art was previously presented to the Office and
`that exercising our discretion under § 325(d) to deny institution is
`appropriate.
`
`III. CONCLUSION
`For the foregoing reasons, we exercise our discretion under 35 U.S.C.
`§ 325(d) and decline to institute an inter partes review of the ’512 patent
`claims.
`
`IV. ORDER
`In consideration of the foregoing, it is hereby:
`ORDERED that the Petition is denied as to all challenged claims of
`the ’512 patent and no trial is instituted.
`
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`IPR2018-00795
`Patent 9,370,512 B2
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`PETITIONER:
`Carol Pitzel Cruz
`Christie R.W. Matthaei
`William R. Zimmerman
`KNOBBE, MARTENS, OLSON & BEAR, LLP
`2CMP@knobbe.com
`2CRW@knobbe.com
`2WRZ@knobbe.com
`BoxIndivior@knobbe.com
`
`
`PATENT OWNER:
`Eldora L. Ellison
`Neil P. Shull
`Joshua G. McCoy
`Matthew S. Bodenstein
`STERNE, KESSLER, GOLDSTEIN & FOX P.L.L.C.
`eellison-PTAB@sternekessler.com
`nshull-PTAB@sternekessler.com
`jmccoy-PTAB@sternekessler.com
`mbodenstein-PTAB@sternekessler.com
`
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