Trials@uspto.gov
`571.272.7822
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` Paper No. 21
` 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 IPR2019-00329
`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
`Institution of Inter Partes Review
`35 U.S.C. § 314
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`571.272.7822
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` Paper No. 21
` 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 IPR2019-00329
`Patent No. 9,687,454 B2
`
`
`
`
`Before SUSAN L. C. MITCHELL, ZHENYU YANG, and RICHARD J.
`SMITH, Administrative Patent Judges.
`
`SMITH, Administrative Patent Judge.
`
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`
`
`DECISION
`Institution of Inter Partes Review
`35 U.S.C. § 314
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`IPR2019-00329
`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–
`5 and 7–14 (“the challenged claims”) of U.S. Patent No. 9,687,454 B2 (the
`“’454 patent”). Paper 1 (“Pet.”). Petitioners filed a Declaration of Nandita
`Das, Ph.D. with their Petition (“Das Declaration”). Ex. 1003. Indivior UK
`Limited (“Patent Owner”) filed a Preliminary Response to the Petition.
`Paper 12 (“Prelim. Resp.”). Patent Owner filed a Declaration of Dr. Karsten
`Cremer, Ph.D. with its Preliminary Response (“Cremer Declaration”).
`Ex. 2001.
`In its Preliminary Response, Patent Owner argued that Petitioners
`failed to identify LTS Lohmann Therapy Systems, Corp. (“LTS”) as a real
`party in interest (“RPI”). Prelim. Resp. 42–45. Patent Owner also argued in
`its Preliminary Response that the Das Declaration was deficient because it
`failed to include the statement required by 37 C.F.R. § 1.68. Id. at 45–46.
`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 RPI and Das Declaration issues. 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. Patent
`Owner confirmed during the conference call that the Das Declaration issue
`was resolved by Petitioners’ filing of the Corrected Declaration of Nandita
`Das, Ph.D. Ex. 1003.1
`
`
`1 The Corrected Declaration of Nandita Das, Ph.D. (“Corrected Das
`Declaration”) was substituted on March 26, 2019, for the Das Declaration.
`Ex. 1003.
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`2
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`IPR2019-00329
`Patent 9,687,454 B2
`During the conference call, Petitioners were authorized to file a reply
`addressing the RPI issue, and Patent Owner was authorized to file a sur-
`reply to Petitioners’ reply. Paper 17. Petitioners thereafter filed their reply
`(Paper 19, “Reply”) and Patent Owner filed its sur-reply (Paper 20, “Sur-
`reply”). As discussed below, we conclude that the Petition need not be
`dismissed because LTS was not identified as an RPI.
`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). For the reasons set
`forth below, we conclude that Petitioners have established a reasonable
`likelihood that they would prevail in showing the unpatentability of at least
`one of the challenged claims of the ’454 patent. Therefore, we institute an
`inter partes review of the challenged claims of the ’454 patent.
`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.
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`3
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`IPR2019-00329
`Patent 9,687,454 B2
`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. at 47 (Paper 43) (PTAB June 30,
`2015). 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. IPR2019-00328. 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
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`4
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`IPR2019-00329
`Patent 9,687,454 B2
`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
`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.
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`5
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`IPR2019-00329
`Patent 9,687,454 B2
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`C.
`
`Illustrative Claims
`
`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 between
`buprenorphine and naloxone, with a buprenorphine Cmax
`[2]
`from about 0.624 ng/ml to about 5.638 ng/ml and a
`buprenorphine AUC[3] 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.
`
`Claim 13 recites:
`13. A method for treating opioid dependence in a patient in need
`thereof comprising sublingually or buccally administering the
`mucoadhesive film of claim 1 to a sublingual or buccal mucosal
`tissue of the patient to treat the opioid dependence.
`Id. at 25:8–12.
`
`
`2 “[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.
`3 “[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.
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`IPR2019-00329
`Patent 9,687,454 B2
`
`Claims 2–5, 7–12, and 14 depend directly or indirectly on claim 1.
`See id. at 24:47–25:14.
`The Asserted Ground of Unpatentability
`D.
`Petitioners contend that the challenged claims are anticipated by U.S.
`Patent Publication No. US 2011/0033541 A1, filed August 7, 2009, and
`published February 10, 2011 (Ex. 1010, “Myers”), under post-AIA 35
`U.S.C. § 102(a)(1). Pet. 7.
`Petitioners rely on the Corrected Das Declaration to support this
`challenge. Ex. 1003.
`
`
` ANALYSIS
`Real Party-in-Interest
`A.
`The statute governing inter partes review proceedings sets forth
`certain requirements for a petition, including that “the petition identif[y] all
`real parties in interest.” 35 U.S.C. § 312(a)(2); see also 37 C.F.R.
`§ 42.8(b)(1) (requirement to identify real parties-in-interest in mandatory
`notices). Pursuant to 35 U.S.C. § 312(a)(2) and 37 C.F.R. § 42.8(b)(1),
`Petitioners state that “[t]he real parties-in-interest are Dr. Reddy’s
`Laboratories S.A. and Dr. Reddy’s Laboratories, Inc.”4 Pet. 42.
`In its Preliminary Response, Patent Owner argues that LTS also
`qualifies as an RPI, “as evidenced by its exclusive contractual relationship
`with Petitioners and its status as a beneficiary of this proceeding should any
`claims be held unpatentable herein.” Prelim. Resp. 43. Patent Owner relies
`on the decisions of our reviewing court in Applications in Internet Time,
`LLC v. RPX Corp., 897 F.3d 1336 (Fed. Cir. 2018) (“AIT”) and Worlds Inc.
`
`
`4 Petitioners also identify themselves collectively as “DRL.” See Reply 1.
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`IPR2019-00329
`Patent 9,687,454 B2
`v. Bungie, Inc., 903 F.3d 1237 (Fed. Cir. 2018) (“Worlds”). Prelim. Resp.
`43. Patent Owner also cites the Declaration of Joachim Franke, Ph.D.
`(Ex. 2004, “Franke Declaration”) dated June 22, 2018. Id. at 43–44.
`According to the Franke Declaration, the declarant is the CEO of LTS
`and submitted the declaration in support of the opposition of [Petitioners] to
`a motion for a preliminary injunction in Indivior Inc. v. Dr. Reddy’s
`Laboratories S.A., No. 2:17-cv-07111 (D.N.J.) (Consolidated) (“the
`Litigation”). Ex. 2004 ¶¶ 1, 3 & p. 1. Patent Owner cites to several
`paragraphs of the Franke Declaration to support its assertions that (a)
`“Petitioners have a contractual relationship with LTS, wherein LTS serves as
`the exclusive manufacturer of Petitioners’ films, including the proposed
`generic product” (Prelim. Resp. 43 (citing Ex. 2004 ¶ 2)), (b) “Petitioners’
`generic buprenorphine and naloxone film product ‘is one of the biggest and
`most important projects in the history of LTS’ . . . [such that] ‘LTS devoted
`substantial resources to this project,’” (id. at 44 (citing Ex. 2004 ¶¶ 9, 11)),
`and (c) “LTS has explained that the successful launch of Petitioners’ product
`is ‘so important’ to LTS such that, at the beginning of 2018, it was ‘one of
`the company’s three primary goals for the year’” (id. (citing Ex. 2004 ¶ 17)).
`
`Petitioners argue in their Reply that LTS is not a real party-in-interest,
`and rely on the Declaration of Anjum Swaroop (Ex. 1027, “Swaroop
`Declaration”). Reply 1–4. According to the Swaroop Declaration, the
`declarant is the Vice President and Head of Intellectual Property at
`Dr. Reddy’s Laboratories, Inc. Ex. 1027 ¶ 1. Petitioners argue that “LTS is
`an unrelated corporate entity with which DRL has contracted to manufacture
`the DRL product accused in the underlying district court litigation.” Reply 1
`(citing Ex. 1027 ¶ 2). Petitioners further argue that:
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`IPR2019-00329
`Patent 9,687,454 B2
`LTS has had no part in filing (including contributing to the
`financing of) the instant Petition, has no control over DRL’s
`positions in this proceeding, is not represented by counsel for
`DRL in this proceeding, is not a party to any litigation concerning
`the instant patent, and is not bound by any legal agreement
`regarding the outcome of this proceeding or that of the
`underlying district court litigation.
`Id. (citing Ex. 1027 ¶¶ 3–4, 7–10).
`
`Petitioners also argue that there is no evidence that LTS desired
`review of the ’454 patent, that the Petition was filed at the behest of LTS, or
`that LTS exercises (or could exercise) control over DRL’s participation in
`this proceeding. Id. at 3. Furthermore, Petitioners respond to Patent
`Owner’s reliance on the Franke Declaration by quoting counsel for Patent
`Owner in the Litigation: “LTS isn’t a party to this case. Any harm it might
`suffer is irrelevant to the balancing of hardships analysis.” Id. at 4 (quoting
`Ex. 1028, 136:5–15).5
`
`In its Sur-reply, Patent Owner asserts that Petitioners’ Reply fails to
`respond to the Board’s inquiry regarding whether Petitioners could add LTS
`as a real party in interest. Sur-reply 1. Patent Owner also asserts that
`Petitioners’ argument relies on a conclusory declaration that fails to refute
`the testimony by the CEO of LTS “about the importance of its preexisting
`business relationship with DRL.” Id. (citing Prelim. Resp. 42–45,
`Ex. 2004).
`
`Discussion
` On the record before us and for the reasons set forth below, we are
`
`persuaded that Petitioners have satisfied their burden of establishing that
`
`
`5 Exhibit 1028 is identified as “Transcript of Motion for Preliminary
`Injunction” in the Litigation, dated August 22, 2018. Ex. 1028.
`9
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`IPR2019-00329
`Patent 9,687,454 B2
`LTS need not be named as a real party-in-interest under 35 U.S.C.
`§ 312(a)(2).6
`Determining whether a particular entity is a real party-in-interest is a
`“highly fact-dependent question” that is assessed “on a case-by-case basis.”
`Office Patent Trial Practice Guide, 77 Fed. Reg. 48,756, 48,759 (Aug. 14,
`2012) (citing Taylor v. Sturgell, 553 U.S. 880, 893–95 (2008)). Although
`multiple factors may be relevant to the inquiry, “[a] common consideration
`is whether the non-party exercised or could have exercised control over a
`party’s participation in a proceeding.” Id. Our reviewing court has stated
`that the two questions lying at the heart of the RPI inquiry are “whether a
`non-party ‘desires review of the patent’ and whether a petition has been filed
`at a non-party’s ‘behest.’” AIT, 897 F.3d at 1351 (quoting Trial Practice
`Guide, 77 Fed. Reg. 48,759).
`Petitioners have provided persuasive evidence that LTS has not
`exercised, and could not exercise, control over Petitioners’ participation in
`this proceeding. See Ex. 1027. Petitioners persuasively establish that “LTS
`played no role in deciding to file this IPR, and has no control over this
`proceeding. . . . DRL alone directed the preparation of the petition, and DRL
`alone pays the fees and costs for this proceeding.” Reply 4 (citing Ex. 1027
`¶¶ 7–9).
`Patent Owner’s arguments and the Franke Declaration do not
`persuade us otherwise. The Franke Declaration paragraphs cited by Patent
`
`
`6 Unlike AIT or Worlds, the RPI considerations in this case arise under 35
`U.S.C. § 312(a)(2) rather than 35 U.S.C. § 315(b). The Director can allow
`the petitioner to add a real party in interest if a petition fails to identify all
`real parties in interest under § 312(a)(2). Wi-Fi One, LLC v. Broadcom
`Corp., 878 F.3d 1364, 1374 n.9 (Fed. Cir. 2018) (en banc).
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`IPR2019-00329
`Patent 9,687,454 B2
`Owner reflect the normal desire of a manufacturer or supplier of a product;
`namely, that its customer not be prohibited from selling the product. The
`Franke Declaration was submitted in the Litigation several months before
`the Petition was filed and in the context of a motion for a preliminary
`injunction, in which Patent Owner’s counsel addressed the Franke
`Declaration by stating that “[a]ny harm [LTS] might suffer is irrelevant to
`the balancing of hardships analysis.” Ex. 1028, 136:5–11. Notably, the
`Franke Declaration does not state or otherwise show that LTS exercised or
`could have exercised control over Petitioners’ participation in this
`proceeding, that LTS desired review of the ’454 patent, or that the Petition
`was filed at the behest of LTS. See generally Ex. 2004.
`Patent Owner’s reliance on AIT and the asserted “exclusive
`contractual relationship” and “status [of LTS] as a beneficiary of this
`proceeding” is an overly extensive reading of AIT. See Unified Patents, Inc.
`v. Realtime Adaptive Streaming, LLC, IPR2018-00883, slip op. at 14–15
`(Paper 36) (PTAB Nov. 27, 2018) (Public Version) (“We agree with
`Petitioner that Patent Owner is overextending the reasoning of AIT. The RPI
`analysis set out in AIT and the common law require more than simply
`confining the analysis to determining whether a party benefits generally
`from the filing of this Petition and also has a relationship with the
`Petitioner.”).
`Patent Owner’s arguments in its Sur-reply are similarly unpersuasive.
`During the conference call on April 16, 2019, Judge Smith inquired whether
`Petitioners could add LTS as an RPI. Petitioners’ counsel responded that
`they did not represent LTS and could not respond on behalf of LTS. No
`other response was expected by the Board. The argument that the Swaroop
`Declaration does not refute the Franke Declaration is unpersuasive because
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`IPR2019-00329
`Patent 9,687,454 B2
`the Franke Declaration does not persuasively address the pertinent factors
`required for an RPI analysis, whereas the Swaroop Declaration does
`persuasively address those factors.
`Accordingly, based on the record as a whole at this stage of the
`proceeding, we determine that LTS need not be named as a real party-in-
`interest under 35 U.S.C. § 312(a)(2).
`Person of Ordinary Skill in the Art
`B.
`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 possessed 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. 16 (citing Ex. 1003 ¶ 42).
`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. at 16–17.
`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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`Claim Construction
`C.
`In this inter partes review, filed November 13, 2018,7 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.”8 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. 17–18. 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’”)
`
`
`7 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).
`8 Phillips v. AWH Corp., 415 F.3d 1303 (Fed. Cir. 2005).
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`(quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803
`(Fed. Cir. 1999)).
`Priority Date of the Challenged Claims
`D.
`The ’454 patent issued from Application No. 14/989,669, filed
`January 6, 2016 (“the ’669 application”). Ex. 1001, 1; Ex. 1002. The ’669
`application is one of a series of continuation applications that began with
`Application No. 12/537,571, filed on August 7, 2009 (“the ’571
`application”), that published as Myers.9 Ex. 1010, 1; Ex. 1001. The first
`continuation application after the filing of the ’571 application was
`Application No. 13/923,749, filed June 21, 2013 (“the ’749 application”).
`According to Petitioners, the effective filing date of the ’454 patent is
`no earlier than June 21, 2013, the filing date of the ’749 application, because
`the ’571 application does not provide written description support for all
`limitations in the challenged claims. Id. at 18–30. Patent Owner disagrees,
`and argues that the particular limitations argued by Petitioners have written
`description support in the ’571 application, and that the ’454 patent is thus
`entitled to a filing date of August 7, 2009, the filing date of the ’571
`application. Prelim. Resp. 1–3, 5–42. Therefore, according to Patent
`Owner, Myers is not prior art to the ’454 patent. Id. at 1.
`Discussion
`We address the claim limitations that Petitioners contend do not have
`
`written description support in the ’571 application to determine on this
`record at this stage of the proceeding whether Myers qualifies as prior art to
`the challenged claims.
`
`
`9 The ’571 application issued on July 2, 2013, as the ’832 patent. Ex. 1005.
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`IPR2019-00329
`Patent 9,687,454 B2
`As an initial matter, we note that Petitioners and Patent Owner both
`cite a portion of paragraph 65 of the ’571 application in advancing their
`written description arguments:
`The film may contain any desired level of self-supporting film
`forming polymer, such that a self-supporting film composition is
`provided. In one embodiment, the film composition contains a
`film forming polymer in an amount of at least 25% by weight of
`the composition. The film forming polymer may alternatively be
`present in an amount of least 50% by weight of the composition.
`Pet. 21; Prelim. Resp. 6; see Ex. 1011, 1444 ¶ 65.
`
`Petitioners argue that paragraph 65 is the only discussion concerning
`the amount of polymers that should be in the claimed films, and that “[a]s
`this passage makes clear, the ’571 application does not limit the amount of
`polymer to a closed range or express it as a (b):(a) [buprenorphine to
`polymer] ratio, but instead instructs that ‘any desired level of . . . polymer’
`can be used in the films.” Pet. 21 (citing Ex. 1011, 1444 ¶ 65). Patent
`Owner argues that paragraph 65 “explicitly discusses polymer weight
`percentages for the inventive films,” and discloses embodiments “that
`contain a polymer in an amount of at least 25% by weight of the
`composition or at least 50% by weight of the composition.” Prelim. Resp. 6
`(citing Ex. 1011, 1444 ¶ 65).
`Polymer Weight Percentages
`Claim 1 recites that the film comprises “(a) about 40 wt % to about 60
`
`wt % of a water-soluble polymeric matrix.” Ex. 1001, 24:27–28.
`Dependent claims 7 and 12 narrow that range to “about 48.2% to about
`58.6%,” and dependent claim 8 recites “about 48.2%.” Id. at 24:57–61;
`25:3–7.
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`IPR2019-00329
`Patent 9,687,454 B2
`Petitioners’ Arguments
`Petitioners argue that there is nothing in the ’571 application that
`suggests that the bottom end of the range should be 40 wt % or 48.2 wt %,
`nor is there a disclosure of the range top end of 60 wt % or 58.6 wt %. Pet.
`21–22 (citing Ex. 1003 ¶ 61). Petitioners also argue that “the specification
`[of the ’571 application] describes only open-ended ranges, i.e., ‘greater
`than’ and provides no direction that other values or narrower ranges were
`within the scope of the invention.” Id. at 22–23 (citing Ex. 1003 ¶ 61).
`Petitioners further argue that Patent Owner’s reliance on Table 1 of
`the ’571 application is misplaced because it does not demonstrate possession
`of the claimed ranges and ratios. Pet. 26–30 (citing Ex. 1003 ¶¶ 58, 62–63,
`71–80; Ex. 1011, 190–97, 1444, 1463). Although Petitioners acknowledge
`that Table 1 discloses polymer weight percentages of 48.2% and 58.6%,
`Petitioners argue that “Patent Owner appears to contend that written
`description requires only that one can back-calculate seemingly random
`ranges and ratios from one of the many examples in the specification.” Pet.
`26; see also id. n.8.
`Petitioners also argue that “there is no indication in the specification
`that the inventors gave any importance to the amount of polymer in the
`films,” and that a POSA would have understood that “the primary focus of
`the purported invention of the ’571 application was the use of buffering
`agents that would adjust the pH of the films in order to achieve a
`pharmacokinetic profile that was bioequivalent to Suboxone® tablets.” Id.
`at 27–28 (citing Ex. 1003 ¶ 62). Petitioners also argue that Table 5 of the
`’571 application provides conflicting data because two of the three test
`formulations did not produce films that were bioequivalent to Suboxone®
`tablets, yet “they had polymers in amounts that fell within the polymer
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`IPR2019-00329
`Patent 9,687,454 B2
`weight ranges in claims 1, 7, 8, and 12.” Pet. 29 (citing Ex. 1011, 1453–56;
`Ex. 1003 ¶ 77).
`Patent Owner’s Arguments
`Patent Owner argues that, in addition to disclosing embodiments that
`are at least 25% (or 50%) by weight polymer, Table 5 of the ’571 application
`identifies both the weight and percent by weight of the polymers in each of
`three formulations, and Table 1 of the ’571 application identifies the
`polymer weight in each disclosed formulation as well as the total weight.
`Prelim. Resp. 6–7 (citing Ex. 1011, 1444 ¶ 65, 1449–50, 1453, 1459).
`According to Patent Owner, “[t]hese disclosures would reasonably convey to
`a POSA that the inventors were in possession of polymer weight
`percentages.” Id. (citing Ex. 2001 ¶¶ 30–31).
`Patent Owner further argues that in light of these express disclosures
`of polymer weight percentages in the ’571 application, “Petitioners’
`assertion that ‘there is no reason that a POSA would understand the
`applicants placed any significance’ on polymer weight percentages [] strains
`credulity.” Prelim. Resp. 7 (citing Pet. 29); see also Prelim. Resp. 7–8
`(discussing the role and importance of the polymer to claimed films). Patent
`Owner asserts that “[i]t would be clear to a POSA that the inventors were in
`possession . . . [of] the polymer weight percentages.” Id. at 8 (citing
`Ex. 2001 ¶ 34). Patent Owner further asserts that “[b]ecause the inventive
`films have a limited total weight and must include several components, a
`POSA would immediately discern that there is inherently a limit to the
`percentage of the inventive film that the polymer can comprise.” Id. at 9
`(citing Ex. 2001 ¶ 34). Thus, according to Patent Owner, “the ’571
`Application reasonably conveys to a POSA that the inventors were in
`possession of polymer weight percentages.” Id. (citing Ex. 2001 ¶ 35).
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`IPR2019-00329
`Patent 9,687,454 B2
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`Patent Owner also argues that the claimed polymer weight
`percentages (about 40 wt % to about 60 wt %, about 48.2% to about 58.6%,
`and about 48.2%) are all within the disclosed polymer weight percentage of
`“at least 25%.” Prelim. Resp. 10 (citing Ex. 1011, 1444 ¶ 65, 1459 (claim
`5); Ex. 2001 ¶ 36). According to Patent Owner, those percentages and
`ranges are also disclosed by the weight percentages 48.2% and 58.6%
`disclosed in Tables 1 and 5, as well as the disclosure of “at least 25%” by
`weight of the composition. Id. at 10–18 (citing Ex. 2001 ¶¶ 36, 39–44, 46;
`Ex. 1011, 1432 ¶ 22, 1444 ¶ 65, 1449–50, 1453, 1455 (claim 5), 1457
`¶ 101).
`Regarding the limitation “about 40 wt % to about 60 wt %” recited in
`claim 1, Patent Owner argues that 48.2% and 58.6% are within that range,
`that 48.2% is in the middle of that range, and that the range is supported by
`the disclosed ranges of at least 25 % and at least 50%. Id. at 12–13 (citing
`Ex. 1011, 1444 ¶ 65, 1449–50, 1459 (claim 5); Ex. 2001 ¶ 41). Patent
`Owner further argues that the disclosures in Tables 1 and 5 (48.2% and
`58.6%) support the endpoints of “about 40 wt % to about 60 wt %.” Id. at
`13–14. Patent Owner argues that “about 40%” is supported by the disclosed
`polymer weight percentage of “at least 25%” and closer to 48.2% than 25%,
`that “about 60%” is supported by the disclosed polymer weight percentage
`of 58.6%, and that “[b]ecause the interior and both endpoints of the claimed
`polymer weight percentage range of ‘about 40 wt % to about 60 wt %’ are
`supported by the ’571 Application, a POSA would understand that the
`inventors were in possession of this claimed range at the time they filed the
`’571 Application.” Id. (citing Ex. 2001 ¶¶ 42–44; Ex. 1011, 1444 ¶ 65,
`1449–50, 1459 (claim 5)). Patent Owner relies on In re Wertheim, 541 F.2d
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`Patent 9,687,454 B2
`257, 264 (CCPA 1976), as further support for its position. Prelim. Resp. 15–
`16.
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`Based on
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