Trials@uspto.gov
`571.272.7822
`
`
`
`
`
` Paper No. 19
`
` Entered: June 3, 2019
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`
`
`
`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.
`
`
`
`
`Case IPR2019-00328
`Patent No. 9,687,454 B2
`
`
`
`
`Before SUSAN L. C. MITCHELL, ZHENYU YANG, and RICHARD J.
`SMITH, Administrative Patent Judges.
`
`SMITH, Administrative Patent Judge.
`
`
`
`
`
`
`DECISION
`Denying Institution of Inter Partes Review
`35 U.S.C. § 314
`
`
`
`
`
`
`
`
`571.272.7822
`
`
`
`
`
` Paper No. 19
`
` Entered: June 3, 2019
`
`
`
`
`
`
`
`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.
`
`
`
`
`Case IPR2019-00328
`Patent No. 9,687,454 B2
`
`
`
`
`Before SUSAN L. C. MITCHELL, ZHENYU YANG, and RICHARD J.
`SMITH, Administrative Patent Judges.
`
`SMITH, Administrative Patent Judge.
`
`
`
`
`
`
`DECISION
`Denying Institution of Inter Partes Review
`35 U.S.C. § 314
`
`
`
`
`
`
`
`
`
`IPR2019-00328
`Patent 9,687,454 B2
`
`
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`
`
` INTRODUCTION
`Dr. Reddy’s Laboratories S.A. and Dr. Reddy’s Laboratories, Inc.
`(“Petitioners”) filed a Petition to institute an inter partes review of claims 1–
`3 and 5–14 (“the challenged claims”) of U.S. Patent No. 9,687,454 B2 (the
`“’454 patent”). Paper 1 (“Pet.”). Indivior UK Limited (“Patent Owner”)
`filed a Preliminary Response to the Petition. Paper 12 (“Prelim. Resp.”).
`In its Preliminary Response, Patent Owner argued that the Petition
`should not be granted because the same or substantially the same prior art or
`arguments presented in the Petition were previously considered and rejected
`by the Office. Prelim. Resp. 1–29; see 35 U.S.C. § 325(d). Petitioners
`thereafter requested, via e-mail, a telephone conference with the Board to
`seek authorization to file a reply to the Preliminary Response to address the
`§ 325(d) issue and other issues raised in the Preliminary Response.
`A conference call was held between counsel for the parties and Judges
`Zhenyu Yang and Richard J. Smith on April 16, 2019, to discuss Petitioners’
`request. During the conference call, Petitioners were authorized to file a
`reply addressing the issues discussed during the conference call, and Patent
`Owner was authorized to file a sur-reply to Petitioner’s reply. Paper 17.
`Petitioners filed their reply (Paper 19, “Reply”) and Patent Owner filed its
`sur-reply (Paper 20, “Sur-reply”).
`We have authority under 35 U.S.C. § 314 to determine whether to
`institute an inter partes review. To institute an inter partes review, we must
`determine that the information presented in the Petition shows “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
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`IPR2019-00328
`Patent 9,687,454 B2
`decline to institute inter partes review of the challenged claims of the ’454
`patent.
`
`
`
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`
`
`Related Proceedings
`A.
`Petitioners and Patent Owner indicate that the ’454 patent is involved
`in litigation in the District of New Jersey in three separate actions: Indivior
`Inc. v. Dr. Reddy’s Laboratories S.A., No. 2:17-cv-07111 (D.N.J.)
`(Consolidated); Indivior Inc. v. Alvogen Pine Brook, Inc., No. 2:17-cv-07106
`(D.N.J.) (Consolidated); and Indivior Inc. v. Teva Pharmaceuticals USA,
`Inc., 2:17-cv-07115 (D.N.J.) (Consolidated). Paper 3, 2; Paper 4, 1.
`According to the parties, the ’454 patent is also involved in litigation in the
`District of Delaware in Indivior Inc. v. Actavis Laboratories UT, Inc.,
`No. 1:18-cv-00499 (D. Del.). Id.
`Petitioners state that the ’454 patent is commonly owned with, shares
`the same specification as, and is a direct descendant of, U.S. Patent No.
`8,475,832 (“the ’832 patent”). Paper 3, 2. According to Petitioners, claims
`of the ’832 patent were previously found invalid by the District of Delaware
`in Reckitt Benckiser Pharmaceuticals Inc. v. Watson Labs., Inc., No. CV 13-
`1674-RGA, 2016 WL 3186659, at *1 (D. Del. June 3, 2016) (Ex. 1006, “the
`Delaware Opinion”). Id. at 2–3. Petitioners state that aspects of that
`decision that do not involve the ’832 patent are currently on appeal in:
`Indivior Inc. v. Dr. Reddy’s Laboratories, S.A., No. 17-2587 (Fed. Cir.);
`Indivior Inc. v. Actavis Laboratories UT, Inc., No. 18-1405 (Fed. Cir.); and
`Indivior Inc. v. Alvogen Pine Brook LLC, No. 18-1949 (Fed. Cir.). Id. at 3.
`Patent Owner states that the ’454 patent descends from the ’832
`patent, and that claims 15–19 of the ’832 patent were canceled on June 30,
`2015, in Case No. IPR2014-00325. BioDelivery Sciences Int’l Inc. v. RB
`Pharm. Ltd, IPR2014-00325, slip op. 47 (Paper 43) (PTAB June 30, 2015).
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`IPR2019-00328
`Patent 9,687,454 B2
`Paper 4, 1. According to Patent Owner, that decision was affirmed by the
`Federal Circuit. RB Pharm. Ltd. v. BioDelivery Sciences Int’l, Inc., 667 Fed.
`Appx. 997 (Fed. Cir. 2016). Id. Patent Owner also states that the Delaware
`district court separately found that certain asserted claims of the ’832 patent,
`including claims 15–19, were invalid, citing the Delaware Opinion. Id. at 1–
`2; Ex. 1006.
`The parties also identify U.S. Patent Application Serial No.
`15/483,769, filed on April 10, 2017, that claims the benefit of the ’454
`patent, and Petitioners’ filing of a second petition for inter partes review of
`the ’454 patent in Case No. IPR2019-00329. Paper 3, 3; Paper 4, 1.
`The ’454 Patent (Ex. 1001)
`B.
`The ’454 patent “relat[es] to films containing therapeutic actives . . .
`[and] more particularly relates to self-supporting film dosage forms which
`provide a therapeutically effective dosage, essentially matching that of
`currently-marketed tablets containing the same active.” Ex. 1001, 1:20–25.
`The ’454 patent states that “[s]uch compositions are particularly useful for
`treating narcotic dependence while providing sufficient buccal adhesion of
`the dosage form.” Id. at 1:25–27.
`The ’454 patent further states that “the invention relates to the
`treatment of opioid dependence in an individual, while using a formulation
`and delivery that hinders misuse of the narcotic.” Id. at 4:64–67. The ’454
`patent explains that “[c]urrently, treatment of opioid dependence is aided by
`administration of Suboxone®, which is an orally dissolvable tablet. This
`tablet [] provides a combination of buprenorphine (an opioid agonist) and
`naloxone (an opioid antagonist).” Id. at 4:67–5:4. The ’454 patent further
`explains that “the present invention provides a method of treating narcotic
`dependence by providing an orally dissolvable film dosage, which provides
`
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`IPR2019-00328
`Patent 9,687,454 B2
`a bioequivalent effect to Suboxone®. The film dosage preferably provides
`buccal adhesion while it is in the user’s mouth, rendering it difficult to
`remove after placement.” Id. at 5:4–10.
`
`The ’454 patent further states that “[t]he film dosage composition
`preferably includes a polymer carrier matrix. Any desired polymeric carrier
`matrix may be used, provided that it is orally dissolvable.” Id. at 5:11–13.
`According to the ’454 patent, “[t]he film may contain any desired level of
`self-supporting film forming polymer, such that a self-supporting film
`composition is provided.” Id. at 13:1–3.
`
`The ’454 patent describes film compositions that “desirably contain[]
`a buffer so as to control the local pH of the film composition.” Id. at 13:26–
`27. The ’454 patent also describes several examples and states that “[t]he
`data indicates that not only is the local pH of significant importance, but the
`amount of buffer present in the formula is also important.” Id. at 23:54–56.
`Illustrative Claim
`C.
`
`Claims 1 recites:
`1. An oral, self-supporting, A mucoadhesive film comprising:
`(a) about 40 wt % to about 60 wt % of a water-soluble
`polymeric matrix;
`(b) about 2 mg to about 16 mg of buprenorphine or a
`pharmaceutically acceptable salt thereof;
`(c) about 0.5 mg to about 4 mg of naloxone or a pharmaceutically
`acceptable salt thereof; and
`(d) an acidic buffer;
`wherein the film is mucoadhesive to the sublingual mucosa or
`the buccal mucosa;
`wherein the weight ratio of (b):(c) is about 4:1;
`wherein the weight ratio of (d):(b) is from 2:1 to 1:5; and
`wherein application of the film on the sublingual mucosa
`or the buccal mucosa results in differing absorption
`
`5
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`Patent 9,687,454 B2
`a
`naloxone, with
`and
`buprenorphine
`between
`buprenorphine Cmax
` from about 0.624 ng/ml to about
`[1]
`5.638 ng/ml and a buprenorphine AUC[2] from about 5.431
`hr*ng/ml to about 56.238 hr*ng/ml; and a naloxone Cmax
`from about 41.04 pg/ml to about 323.75 pg/ml and a
`naloxone AUC from about 102.88 hr*pg/ml to about
`812.00 hr*pg/ml.
`Ex. 1001, 24:25–46.
`
`Claims 2, 3, 5–12, and 14 depend directly or indirectly on claim 1.
`See id. at 24:47–25:14. Claim 13 recites a method for treating opioid
`dependence comprising administering the film of claim 1. Id. at 25:8–12.
`The Asserted Ground of Unpatentability
`D.
`Petitioners contend that the challenged claims are unpatentable as
`obvious over Euro-Celtique3 and Fuisz4 in view of the Suboxone® PDR,5
`EMEA,6 and the FDA IIG Database.7 Pet. 3.
`
`
`1 “[T]he term Cmax refers to the mean maximum plasma concentration after
`administration of the composition to a human subject.” Ex. 1001, 3:23–25.
`2 “[T]he term AUC refers to the mean area under the plasma concentration-
`time curve value after administration of the compositions formed herein.”
`Ex. 1001, 3:25–28.
`3 Oksche et al., WO 2008/025791 A1, published March 6, 2008 (“Euro-
`Celtique”). Ex. 1007.
`4 Fuisz et al., WO 03/030883 A1, published April 17, 2003 (“Fuisz”).
`Ex. 1008.
`5 Physicians’ Desk Reference, 58th ed., 2866–69 (2004) (“Suboxone®
`PDR”). Ex. 1009.
`6 European Medicines Agency Initial Marketing-Authorization Document for
`Suboxone® Tablet, 1–42 (2006) (“EMEA”). Ex. 1010.
`7 Inactive Ingredient Search for Approved Drug Products (2006) (“FDA
`IIG”), available at
`http://web.archive.org/web/20060206134214/http://www.fda.gov.gov:80/cde
`r/iig/IIGZIP.EXE and
`http://web.archive.org/web/20060206134143/http://www.fda.gov:80/cder/iig
`/IIGZIP.zip. Ex. 1011 (Ex. A).
`
`6
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`IPR2019-00328
`Patent 9,687,454 B2
`Petitioners also rely on the Corrected Declaration of Nandita Das,
`Ph.D. (“Corrected Das Declaration”) to support this challenge. Ex. 1003.
`Person of Ordinary Skill in the Art
`E.
`Petitioners assert that a person of ordinary skill in the art (“POSA”)
`with respect to the technology disclosed in the ’454 patent, “would include a
`person who possesses a Master’s or Ph.D. in pharmaceutical sciences,
`formulation chemistry, or a related field, plus a number of years of relevant
`experience in developing drug formulations.” Pet. 14 (citing Ex. 1003 ¶ 71).
`Petitioners further state that “[a]s part of a collaborative team working to
`develop a new drug product, the POSA would have consulted as needed with
`others possessing the skills that are typically employed in drug development
`and manufacturing.” Id. Patent Owner does not oppose Petitioners’
`proposed POSA or set forth an alternative description of a POSA. See
`generally Prelim. Resp.
`For purposes of this Decision, and based on the current record, we
`apply Petitioners’ assessment because it appears to be consistent with the
`level of ordinary skill in the art at the time of the invention as reflected in the
`prior art in this proceeding. See Okajima v. Bourdeau, 261 F.3d 1350, 1355
`(Fed. Cir. 2001) (explaining that specific findings regarding ordinary skill
`level are not required “where the prior art itself reflects an appropriate level
`and a need for testimony is not shown”) (quoting Litton Indus. Prods., Inc. v.
`Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985)).
`
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`Patent 9,687,454 B2
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`Claim Construction
`F.
`In this inter partes review, filed November 13, 2018,8 we construe the
`claims of the ’454 patent by applying “the standard used in federal courts, in
`other words, the claim construction standard that would be used to construe
`the claim in a civil action under 35 U.S.C. [§] 282(b), which is articulated in
`Phillips.”9 83 Fed. Reg. at 51343. Under that standard, “the words of a
`claim ‘are generally given their ordinary and customary meaning’ . . . the
`ordinary and customary meaning of a claim term is the meaning that the
`term would have to a person of ordinary skill in the art in question at the
`time of the invention, i.e., as of the effective filing date of the patent
`application.” Phillips, 415 F.3d at 1312–13 (citations omitted). Any special
`definitions for claim terms must be set forth with reasonable clarity,
`deliberateness, and precision. See In re Paulsen, 30 F.3d 1475, 1480
`(Fed. Cir. 1994).
`Petitioners advance a proposed construction for the term “acidic
`buffer.” Pet. 24–25. Patent Owner does not challenge that proposed
`construction in its Preliminary Response or advance any other proposed
`constructions. See generally Prelim. Resp. We determine, however, for
`purposes of this Decision, that we need not expressly construe any claim
`terms. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868
`F.3d 1013, 1017 (Fed. Cir. 2017) (“[W]e need only construe terms ‘that are
`in controversy, and only to the extent necessary to resolve the controversy’”)
`
`
`8 Changes to the Claim Construction Standard for Interpreting Claims in
`Trial Proceedings Before the Patent Trial and Appeal Board, 83 Fed. Reg.
`51340 (Oct. 11, 2018) (to be codified at 37 CFR pt. 42).
`9 Phillips v. AWH Corp., 415 F.3d 1303 (Fed. Cir. 2005).
`
`8
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`Patent 9,687,454 B2
`(quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803
`(Fed. Cir. 1999)).
`
`
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`
`
` 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.”
`When evaluating whether to exercise our discretion when the same or
`substantially the same prior art or arguments were previously presented to
`the Office under § 325(d), the Board has weighed several 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 distinguishes the prior art; (e) whether Petitioner has pointed
`out sufficiently how the Examiner erred in its evaluation of the asserted prior
`art; and (f) the extent to which additional evidence and facts presented in the
`Petition warrant reconsideration of the prior art or arguments. Becton,
`Dickinson & Co. v. B. Braun Melsungen AG, Case IPR2017-01586, slip op.
`at 17–18 (PTAB Dec. 15, 2017) (Paper 8) (informative); see also NHK
`Spring Co., Ltd. v. Intri-Plex Techs., Case IPR2018-00752, slip op. at 11–18
`
`9
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`IPR2019-00328
`Patent 9,687,454 B2
`(PTAB Sept. 12, 2018) (Paper 8) (precedential) (analyzing the Becton
`Dickinson factors).
`We analyze these factors in the context of the relevant prosecution
`history and Petition, and find that, on balance, the factors weigh in favor of
`exercising our discretion under 35 U.S.C. § 325(d) to deny institution of an
`inter partes review.
`Relevant Prosecution History of the ’454 Patent
`A.
`The ’454 patent issued from Application No. 14/989,669, filed
`January 6, 2016 (“the ’669 application”). Ex. 1001, 1; Ex. 1002.
`On March 10, 2016, the Examiner rejected all pending claims under
`35 U.S.C. § 103(a) as obvious over Euro-Celtique.10 Ex. 1002, 647–652.
`Patent Owner11 responded to that Office Action on September 9, 2016, by
`cancelling the pending claims and adding a new set of claims similar to the
`issued claims of the ’454 patent. Ex. 1002, 615–22; compare id. at 616–18
`with Ex. 1001, 24:25–25:15. Patent Owner also argued that Euro-Celtique
`provided no teaching or suggestion that the buffer is critical or important to
`optimize absorption of buprenorphine and minimize absorption of naloxone,
`and merely teaches that “a pH modifier is one of nine possible secondary
`components that can be used,” similar to a coloring agent or a flavoring
`agent. Ex. 1002, 620 (citing Euro-Celtique ¶ 72). Patent Owner further
`argued that Euro-Celtique “does not disclose or suggest that the buffer (in a
`
`
`10 The Examiner and Patent Owner refer to Euro-Celtique as Oksche (WO
`2008/025791 A1), and cite to the corresponding Patent Publication No. US
`2010/0087470 (Ex. 3001). See Ex. 1002, 649, 619. References herein to
`paragraphs of Euro-Celtique are to paragraphs of Exhibit 3001.
`11 Patent Owner is identified as the Applicant on the first page of the ’454
`patent. Ex. 1001, 1.
`
`10
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`IPR2019-00328
`Patent 9,687,454 B2
`particular weight ratio of buffer to buprenorphine) optimizes the mucosal
`absorption of buprenorphine and minimizes the mucosal absorption of
`naloxone.” Id. at 621.
`On September 23, 2016, the Examiner entered a Final Office Action
`that rejected all of the pending claims as obvious over Euro-Celtique. Id. at
`173–178. The Examiner also entered an Information Disclosure Statement
`(IDS) indicating that the Examiner considered Euro-Celtique, Fuisz, EMEA,
`and the Suboxone® Sublingual Tablets Package Insert (Ex. 3002,
`“Suboxone® Package Insert”).12 Id. at 181–192.
`The Examiner’s Final Office Action on September 23, 2016,
`specifically identified Euro-Celtique as stating that the Suboxone®
`preparation “comprises buprenorphine hydrochloride and the opioid
`antagonist naloxone hydrochloride dihydrate.” Id. at 177 (citing Euro-
`Celtique ¶ 12). The Examiner stated that Euro-Celtique taught use of a
`citrate (citric acid) buffer, but did not teach buprenorphine and naloxone
`formulations “where the buffer is present in an amount sufficient to inhibit
`the absorption of naloxone.” Id. at 175, 177. The Examiner further stated
`that “it would have been obvious to the ordinary skilled artisan . . . to modify
`[Euro-Celtique] so as to identify the optimal range of pH/dosage/ratio of
`
`
`12 Petitioners state that Suboxone® PDR was listed on an IDS during
`prosecution, but Patent Owner suggests otherwise. See Pet. 59; Prelim.
`Resp. 7. Nevertheless, we find that the Suboxone® Package Insert that was
`cited and considered by the Examiner is substantively identical to the
`Suboxone® PDR. Compare Ex. 3002 with Ex. 1009; see also Indivior, Inc.
`v. Rhodes Pharms. L.P., Case IPR2018-00795, slip op. at 7 (PTAB Oct. 4,
`2018) (Paper 23) (“The Suboxone Package insert is substantively identical to
`Suboxone PDR”).
`
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`11
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`Patent 9,687,454 B2
`naloxone to buprenorphine in an effort to identify formulations that would
`provide optimal absorption of both agonist and antagonist,” and that “since
`the general conditions of the instantly claimed invention are disclosed in the
`prior art, identification of the optimal pH/dosage appears to be a matter of
`routine experimentation.” Id. at 178 (citing MPEP § 2144.05 [R-5]).
`On December 13, 2016, Patent Owner requested continued
`examination (RCE), amended the pending claims, and traversed the
`Examiner’s obviousness rejection based on Euro-Celtique. Id. at 163–171.
`Patent Owner clarified its prior arguments and asserted that Examples 6–8 of
`the ’669 application showed surprising and unexpected results in view of the
`pH partition theory. Id. at 168–170, 684 (see Ex. 1001, 12:6–17). On
`January 3, 2017, the Examiner entered a final rejection of all pending claims
`as obvious over Euro-Celtique. Id. at 77–83. In determining that Patent
`Owner’s arguments were not persuasive, the Examiner stated that it would
`have been obvious “to identify the optimal range of pH/dosage/ratio of
`naloxone to buprenorphine and buffer in an effort to identify formulations
`that would provide optimal absorption of both agonist and antagonist,” and
`that “identification of the optimal pH/dosage appears to be a matter of
`routine optimization.” Id. at 81–82.
`On March 29, 2017, the Examiner and counsel for Patent Owner
`conducted an interview discussing Euro-Celtique and the obviousness
`rejection of the pending claims. Id. at 65. An Examiner’s Amendment was
`agreed to, adding the word “acidic” before “buffer,” and a Notice of
`Allowability was entered. Id. at 62–65.
`Petition
`B.
`Petitioners assert that claims 1–3 and 5–14 of the ’454 patent are
`unpatentable as obvious over Euro-Celtique and Fuisz in view of the
`
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`Suboxone® PDR, EMEA, and FDA IIG. Pet. 3. In applying the art to
`claim 1, Petitioners rely primarily on Euro-Celtique. See Pet. 41–48. With
`respect to the limitations in claim 1 of “an acidic buffer” and “the weight
`ratio of (b):(c) is about 4:1,” Petitioners rely on Euro-Celtique and the
`Suboxone® PDR “individually and in combination.” Id. at 43–45 (citing
`Ex. 1003 ¶¶ 107–108, 110; Ex. 1007, 3, 11, 15; Ex. 1009, 3; Ex. 1014, 23).
`For example, with respect to the “acidic buffer” limitation, Petitioners argue
`that “Euro-Celtique also identifies Suboxone® tablets as a preferred
`pharmaceutical to be formulated into a film dosage form,” that “components
`of the Suboxone® tablet formulation were known years before 2009,” and
`that “[t]he Suboxone® PDR identifies citric acid and sodium citrate as
`components of the Suboxone® tablet formulation.” Id. at 43–44 (citing
`Ex. 1003 ¶ 108; Ex. 1007, 3; Ex. 1009, 3).
`Petitioners rely on Euro-Celtique in combination with FDA IIG, “or
`alternatively routine experimentation,” with respect to the claim limitation
`“the weight ratio of (d):(b) [buffer to buprenorphine] is from 2:1 to 1:5”
`recited in claim 1. Id. at 45–47 (citing Ex. 1003 ¶¶ 54, 111, 114, 124–126,
`129; Ex. 1007, 8, 16; Ex. 1009, 3, 6; Ex. 1010, 12). Petitioners rely on FDA
`IIG as a starting point to show the maximum amount of citric acid (5.92 mg)
`and sodium citrate (2.68 mg) that the FDA had approved for inclusion in
`sublingual tablets. Id. at 46 (citing Ex. 1003 ¶¶ 54, 114; Ex. 1009, 3,
`Ex. 1011, 241, 376; Ex. 1031, 12). Petitioners contend that a POSA would
`have been aware that no more than 8.6 mg (5.92 mg plus 2.68 mg) of buffer
`was in Suboxone® sublingual tablets, and would have started with the
`highest known effective amount of citric acid and sodium citrate to ensure
`that a film had a sufficient buffer capacity to maintain pH when the film was
`placed in the mouth. Id. (citing Ex. 1003 ¶ 124); see also Pet. 27–32.
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`Petitioners thus conclude that the 8 mg Suboxone® tablet has 8.6 mg buffer,
`translating to a (d):(b) ratio of approximately 1:1, which is within the
`claimed (d):(b) range. Id. (citing Ex. 1003 ¶ 124). Petitioners assert that
`only routine experimentation is needed for optimization of the end points of
`the claimed (d):(b) range. Id. at 46–47 (citing Ex. 1003 ¶¶ 124–126, 129;
`Ex. 1010, 12).
`Petitioners rely on Euro-Celtique in combination with EMEA for
`disclosure of Cmax and AUC ranges for both buprenorphine and naloxone
`recited in claim 1. Id. at 47–48 (citing Ex. 1003 ¶¶ 127–129; Ex. 1007, 21;
`Ex. 1010, 12). Petitioners also rely on Euro-Celtique in connection with its
`obviousness challenge of dependent claims 2, 3, and 5–14. Pet. 48–55. As
`to the additional limitations of claims 7–11 and 13, Petitioners rely solely on
`Euro-Celtique. Id. at 51–55.
`In anticipation of Patent Owner’s arguments under § 325(d),
`Petitioners assert that “[w]hile the applicants listed Fuisz, the Suboxone
`PDR, and the EMEA among the over 300 references they disclosed during
`prosecution, the Examiner did not rely upon or cite any of them in any
`Office Action.” Pet. 59; see also Reply 5. Rather, according to Petitioners,
`“[t]he Examiner repeatedly rejected the claims over Euro-Celtique, and the
`applicants repeatedly argued that Euro-Celtique did not disclose the claimed
`‘weight ratio of buffer to buprenorphine’ that they alleged was necessary to
`obtain the claimed pharmacokinetic values.” Pet. 58.
`Petitioners also argue that the Examiner did not have the benefit of the
`Corrected Das Declaration, and that the Examiner’s consideration of the new
`asserted prior art, or acceptance of Patent Owner’s arguments against Euro-
`Celtique, were “insufficient or in error.” Pet. 59. Petitioners argue that the
`Delaware Opinion is at odds with the Examiner’s allowance, and further
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`Patent 9,687,454 B2
`argue that Patent Owner’s arguments against Euro-Celtique have since been
`disavowed in more recent arguments made by Patent Owner to the Board.
`Id. at 59–60.
`
`
`
`C. Discussion
`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 on by the
`Examiner during prosecution, as well as the extent of overlap between
`arguments made during examination and the manner in which Petitioners
`rely on the prior art.
`Euro-Celtique is the primary reference Petitioners rely on in the
`Petition, and the same reference that was considered and substantively
`applied by the Examiner during prosecution, as acknowledged by
`Petitioners. Pet. 58. Fuisz is discussed in Euro-Celtique, and also was
`considered by the Examiner. Ex. 1007, 14; Ex. 1002, 186. Petitioners
`acknowledge that “Euro-Celtique specifically identifies Fuisz as ‘standard
`technology’ for making pharmaceutical thin films containing buprenorphine
`and naloxone,” quoting from Euro-Celtique. Pet. 12.
`The EMEA reference that was considered by the Examiner provides
`information regarding pharmacokinetics (i.e., Cmax and AUC) of Suboxone®
`tablets. Ex. 1010, 12; Ex. 1002, 190. Although Petitioners rely on EMEA
`for disclosing Cmax and AUC values for both buprenorphine and naloxone
`for various strengths of Suboxone® tablets, the ’669 application, from which
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`IPR2019-00328
`Patent 9,687,454 B2
`the ’454 patent issued, also discloses Cmax and AUC values for both
`buprenorphine and naloxone for various strengths of Suboxone® tablets.
`Pet. 47–48; 1002, 25, 190. EMEA is thus cumulative to information
`disclosed in the ’669 application that was previously known. Thus, as relied
`on by Petitioners, EMEA adds no teaching that was not before the Examiner.
`The same or substantially the same art as the Suboxone® PDR (i.e.
`Suboxone® Package Insert) also provides information regarding Suboxone®
`tablets and was also considered by the Examiner. Ex. 1002, 189; Ex. 1009.
`Petitioners rely on the Suboxone® PDR for its disclosure of an acidic buffer,
`the buprenorphine to naloxone ratio of 4:1, and dosage amounts of
`buprenorphine provided by the Suboxone® tablets, but the Examiner cited
`Euro-Celtique for the disclosure of an acidic buffer, the (b):(c) ratio of 4:1,
`and dosages of buprenorphine within the claimed range. See Pet. 43–45;
`Ex. 1002, 80–81, 175–176. Thus, the Suboxone® PDR adds no teaching
`not considered by the Examiner, and is cumulative to Euro-Celtique.
`The only asserted reference that was not before the Examiner is FDA
`IIG. FDA IIG is a database that indicates the total amount of certain inactive
`ingredients, such as the amount of citric acid and the amount of sodium
`citrate, which had been approved by the FDA as of 2006 in certain dosage
`forms, such as sublingual tablets. Pet. 46; Ex. 1003 ¶¶ 62–68. FDA IIG,
`however, does not disclose the actual amount of citric acid, sodium citrate,
`or buffer in Suboxone® tablets, or any ratio of buffer to buprenorphine
`((d):(b)) in Suboxone® tablets or any other sublingual tablet. See generally
`Ex. 1011; see also Prelim. Resp. 18–19. Moreover, as Patent Owner points
`out, FDA IIG “discloses different maximum potency values for the citric
`acid and sodium citrate depending on the dosage form.” Prelim. Resp. 19
`(citing Ex. 1011, 39–40, 174–175) (comparing amounts of citric acid and
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`IPR2019-00328
`Patent 9,687,454 B2
`sodium citrate as between different forms of a tablet). Patent Owner also
`points out that “the [FDA IIG] does not list the use of citric acid or sodium
`citrate in a film, much less an oral, self-supporting mucoadhesive film.” Id.
`at 31. That is significant given that the challenged claims are directed to a
`mucoadhesive film rather than a tablet. Ex. 1001, 24:25–25:15.
`Petitioners rely on FDA IIG as a starting point to back-calculate a
`(d):(b) ratio that falls within the claimed range, notwithstanding that
`FDA IIG does not disclose information about the amount of citric acid or
`sodium citrate in Suboxone® tablets, as discussed above. Pet. 45–46.
`Petitioners posit a scenario wherein a POSA would select the highest
`amounts of citric acid and sodium citrate disclosed by FDA IIG for a
`sublingual tablet (not a film), and then compare that combined amount (8.6
`mg) to the 8 mg Suboxone® tablet to arrive at a ratio of about 1:1. Id.
`Notably, Petitioners do not select the 4 mg Suboxone® tablet for
`comparison because, as the Corrected Das Declaration shows, selection of
`the 4 mg tablet results in a (d):(b) ratio of about 2.2:1 which is outside of the
`claimed range of “2:1 to 1:5.” See Exhibit 1003 ¶ 124. Accordingly, we
`find that an analysis of the disclosure of FDA IIG suggests hindsight
`reconstruction and adds little, if anything, to the obviousness analysis.
`Based on the forgoing, including Petitioners’ reliance on Euro-
`Celtique individually and “alternatively routine experimentation,” an
`iteration of Petitioners’ challenge to claims 1, 7–11, and 13 relies entirely on
`Euro-Celtique and routine experimentation, both of which were addressed
`during examination, with the exception of Petitioners’ reliance on EMEA for
`Cmax and AUC values. Pet. 41–48. But as discussed above, EMEA was not
`only considered by the Examiner, the specification of the ’669 application
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`IPR2019-00328
`Patent 9,687,454 B2
`disclosed Cmax and AUC values for buprenorphine and naloxone for various
`strengths of Suboxone® tablets. Ex. 1002, 25, 190.
`Factors (e) and (f)
`2.
`Factors (e) and (f) look to whether the Petition and Petitioners have
`made a case for reconsidering the application of the asserted prior art in light
`of new evidence. We find that Petitioners have not.
`Petitioners’ reliance on the Delaware Opinion does not persuade us
`that the Examiner erred in evaluating the asserted prior art. Although the
`Delaware Opinion addressed Euro-Celtique, it involved different patents and
`claims, and prior art that is not asserted by Petitioners in their obviousness
`challenge. Ex. 1006; Prelim. Resp. 21–22. The Delaware Opinion was also
`disclosed to and considered by the Examiner during prosecution of the ’454
`patent. Ex. 1002, 612–14, 596–606.
`Petitioners specifically contend that the Examiner “erred to the extent
`she agreed with Patent Owner’s argument that ‘Examples 6-8’ were
`‘unexpected in view of pH partition theory,’” arguing that the Delaware
`Opinion rejected that argument in finding that a POSA would credit actual
`data over theory.13 Pet. 60 (citing Ex. 1002, 169; Ex. 1006, 19–22); see also
`Pet. 27–32. But the Examiner rejected the pending claims over Euro-
`Celtique after Patent Owner advanced that argument indicating that the
`Examiner did not agree with Patent Owner. Ex. 1002, 77–83.
`
`
`13 The Delaware Opinion states that a POSA “would have credit
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