Trials@uspto.gov
`571-272-7822
`
`Paper 49
`Entered: June 2, 2020
`
`
`
`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.
`
`
`
`IPR2019-00329
`Patent 9,687,454 B2
`
`
`
`
`
`
`
`
`
`Before SUSAN L. C. MITCHELL, ZHENYU YANG, and RICHARD J.
`SMITH, Administrative Patent Judges.
`SMITH, Administrative Patent Judge.
`
`
`
`JUDGMENT
`Final Written Decision
`Determining Some Challenged Claims Unpatentable
`35 U.S.C. § 318(a)
`
`
`
`
`
`
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`

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`IPR2019-00329
`Patent 9,687,454 B2
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`
`I.
`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.”).
`On June 3, 2019, we entered our Decision on Institution (Paper 21,
`“Inst. Dec.” or “Institution Decision”) instituting inter partes review of all
`challenged claims under the only asserted ground. Inst. Dec. 28. Patent
`Owner filed a Response (Paper 33, “PO Resp.”), Petitioner filed a Reply
`(Paper 42, “Reply”), and Patent Owner filed a Sur-reply (Paper 45, “Sur-
`reply”).1
`Petitioners and Patent Owner requested an oral hearing. Papers 43,
`44. An oral hearing was held on March 3, 2020, and a transcript of that
`hearing has been entered into the record. Paper 48 (“Tr.”).
`We have jurisdiction under 35 U.S.C. § 6(b). This Final Written
`Decision is issued pursuant to 35 U.S.C. § 318(a). Having reviewed the
`arguments of the parties and the supporting evidence, we find that
`Petitioners have demonstrated by a preponderance of the evidence that
`claims 1–5, 7, and 9–14 of the ’454 patent are unpatentable, but have not
`demonstrated by a preponderance of the evidence that claim 8 of the ’454
`patent is unpatentable.
`
`
`1 Petitioners and Patent Owner filed objections to the other party’s evidence,
`but did not file motions to exclude to preserve any objection. Papers 23, 24,
`35; 37 C.F.R. § 42.64(c).
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`A. Real Parties-in-Interest
`Petitioners identify the real parties-in-interest as Dr. Reddy’s
`Laboratories S.A. and Dr. Reddy’s Laboratories, Inc. Pet. 42.
`Patent Owner identifies Indivior UK Limited and Indivior Inc. as the
`real parties-in-interest. Paper 4, 1.
`B. Related Matters
`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.). Paper 3, 2; Paper 4, 1.
`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.
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`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. Patent Owner indicates 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. Id. at 1–2 (citing the Delaware
`Opinion); 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. IPR2019-00328.2 Paper 3, 3; Paper 4, 1.
`C. The ’454 Patent
`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.
`
`
`2 Institution of a trial based on that second petition was denied on June 3,
`2019. See Dr. Reddy’s Labs. S.A. v. Indivior UK Ltd., IPR2019-00328,
`Paper 21 at 21 (PTAB June 3, 2019).
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`
`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.
`However, the ’454 patent states that tablet forms have the potential for abuse
`and, in some instances, “the patient who has been provided the drug may
`store the tablet in his mouth without swallowing the tablet, then later extract
`the agonist from tablet and inject the drug into an individual’s body.” Id. at
`2:1–5.
`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 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
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`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.
`D. Illustrative Claims
`Claim 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
`[3]
`from about 0.624 ng/ml to about 5.638 ng/ml and a
`buprenorphine AUC[4] 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 5 recites:
`5. The film of claim 1, wherein the weight ratio of (b):(a) is from
`about 1:3 to about 1:11.5.
`Id. at 24:53–54.
`Claim 13 recites:
`
`3 “[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.
`4 “[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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`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.
`E. The Asserted Ground of Unpatentability and Declaration Evidence
`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-AIA5 35
`U.S.C. § 102(a)(1) (Pet. 7), as shown in the chart below:
`Claims Challenged
`35 U.S.C. §
`Reference(s)/Basis
`1–5, 7–14
`102(a)(1)
`Myers
`Petitioners rely on the Corrected Declaration of Nandita Das, Ph.D.
`
`Ex. 1003. Patent Owner relies on the Declaration of Karsten Cremer, Ph.D,
`submitted with Patent Owner’s Response. Ex. 2008.
`Patent Owner also filed a Declaration of Dr. Karsten Cremer, Ph.D.
`dated March 7, 2019 (Ex. 2001, “First Cremer Declaration”) with its
`Preliminary Response (Paper 12). Dr. Cremer testified during trial that he
`still held all the opinions expressed in the First Cremer Declaration, and was
`not withdrawing any of those opinions. Ex. 1030, 12:2–7; Reply 5–6 & n.2.
`II. DISCUSSION
`A. Level of Ordinary Skill in the Art
`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,
`
`
`5 Leahy-Smith America Invents Act (“AIA”), Pub. L. No. 112-29, 125 Stat.
`284, 287–88 (2011).
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`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 (citing Ex. 1003 ¶ 42).
`Patent Owner does not oppose Petitioners’ proposed description of a
`POSA or set forth an alternative description of a POSA. See generally PO
`Resp.; Sur-reply.
`We adopt and apply Petitioners’ assessment of a POSA 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))). We also find on this record that Dr. Das and Dr.
`Cremer are persons of at least ordinary skill in the art under this standard.
`See Ex. 1004; Ex. 1003 ¶¶ 3–12; Ex. 2008, Appendix A, ¶¶ 5–15.
`B. Claim Construction
`In this inter partes review, filed November 13, 2018,6 we construe the
`claims of the ’454 patent using the same claim construction standard that
`would be used to construe the claim in a civil action under 35 U.S.C.
`
`
`6 The claim construction standard to be employed in inter partes reviews has
`changed for proceedings in which the petition was filed on or after
`November 13, 2018. 37 C.F.R. § 42.100(b) (2019).
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`§ 282(b), including construing the claim in accordance with the ordinary and
`customary meaning of such claim as understood by one of ordinary skill in
`the art and the prosecution history pertaining to the patent. 37 C.F.R.
`§ 42.100(b) (2019); see also Phillips v. AWH Corp., 415 F.3d 1303 (Fed.
`Cir. 2005).
`We determine 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’”)
`(quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803
`(Fed. Cir. 1999)).
`C. General Principles of Law
`To prevail in their challenge to the patentability of the challenged
`claims, Petitioners must demonstrate by a preponderance of the evidence
`that the challenged claims are unpatentable. 35 U.S.C. § 316(e); 37 C.F.R.
`§ 42.1(d). “In an [inter partes review], the petitioner has the burden from
`the onset to show with particularity why the patent it challenges is
`unpatentable.” Harmonic Inc. v. Avid Tech., Inc., 815 F.3d 1356, 1363 (Fed.
`Cir. 2016) (citing 35 U.S.C. § 312(a)(3) (requiring inter partes review
`petitions to identify “with particularity . . . the evidence that supports the
`grounds for the challenge to each claim”)). This burden of persuasion never
`shifts to Patent Owner. See Dynamic Drinkware, LLC v. Nat’l Graphics,
`Inc., 800 F.3d 1375, 1378 (Fed. Cir. 2015) (discussing the burden of proof in
`inter partes review).
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`D. Priority Date of the Challenged Claims
`The ’454 patent issued on June 27, 2017, from Application No.
`14/989,669, filed January 6, 2016 (“the ’669 application”). Ex. 1001, codes
`(21), (22), (45). The ’669 application is one of a series of continuation
`applications claiming priority to Application No. 12/537,571, filed on
`August 7, 2009 (“the ’571 application”),7 that published as Myers. Ex.
`1010, codes (21), (22); Ex. 1001, code (63). The first continuation
`application after the filing of the ’571 application was Application No.
`13/923,749, filed June 21, 2013 (“the ’749 application”). Ex. 1001, code
`(63).
`
`On September 9, 2016, during prosecution of the ’669 application,
`pending claims 1–10 were cancelled and new claims were added. Ex. 1002,
`615–22. Those new claims included the limitations “about 40 wt % to about
`60 wt % of a water-soluble polymeric matrix” (issued claim 1), “wherein the
`film comprises about 48.2 wt % to about 58.6 wt % of the water soluble
`polymeric matrix” (issued claims 7, 12), “about 48.2 wt % of the water
`soluble polymeric matrix” (issued claim 8), and “wherein the weight ratio of
`(b):(a) is from about 1:3 to about 1:11.5” (issued claims 5, 12). Id. at 16–18.
`At the time the new claims were added, Patent Owner directed the
`Examiner to paragraph 33 of the ’669 application (paragraph 32 of the ’571
`application) as providing written description support for the limitation in
`claim 1 of “about 40 wt % to about 60 wt % of a water-soluble polymeric
`matrix.” Ex. 1002, 619. As Petitioners explain, paragraph 32 of the ’571
`
`
`7 The ’571 application issued on July 2, 2013, as the ’832 patent. Ex. 1005.
`References to “the ’571 application” herein are to its Specification as of its
`filing date of August 7, 2009.
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`application refers to “about 40% to about 60% by weight” of the polymer
`component, which refers to “the total amount of polymer components added
`together, without regard to the other ingredients” (i.e. a different weight
`percentage than claimed in the ’454 patent). Pet. 23 n.6 (citing Ex. 1003
`¶¶ 64, 65; Ex. 1011, 1436 ¶ 32). Patent Owner does not dispute that this
`paragraph 32/33 does not provide written description support for the claimed
`polymer weight percentage limitation of “about 40 wt % to about 60 wt %.”
`Reply 2–3 n.1 (citing Ex. 1030, 87:11–89:15; PO Resp. 29–30). Patent
`Owner now points to other disclosure in the Specification of the ’571
`application, such as exemplary test formulations, as providing such written
`description support. PO Resp. 11–61.
`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 the
`above-referenced limitations that were added during prosecution of the ’669
`application. Pet. 18–30. Patent Owner disagrees, and argues that the
`challenged claims 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. PO Resp. 11–61. Therefore, according to
`Patent Owner, Myers is not prior art to the ’454 patent and, thus, does not
`anticipate the challenged claims. Id. at 1.
`E. Analysis
`Our decision in this case turns on whether any of the challenged
`claims of the ’454 patent can effectively claim priority to the ’571
`application based on satisfaction of the written description requirement of 35
`U.S.C § 112. Specifically, the issue before us is whether the claimed
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`polymer weight percentage and ranges of polymer weight percentages, and
`claimed range of buprenorphine:polymer/(b):(a) ratios, have written
`description support in the ’571 application.
`We first determine whether any of the challenged claims lack written
`description support in the ’571 application. As to any challenged claim for
`which we find no written description support, we then determine whether
`that challenged claim is anticipated by Myers, as asserted by Petitioners.
`1. Written Description
`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%” of the water soluble
`polymeric matrix. Id. at 24:57–61; 25:3–7. Claims 5 and 12 depend directly
`on claim 1, and recite that “the weight ratio of (b):(a) is from about 1:3 to
`about 1:11.5.” Ex. 1001, 24:53–54, 25:4–5.
`a) Petitioners’ Arguments
`Petitioners argue that the ’571 application lacks written description
`support for limitations directed toward the amount of polymer in the claimed
`films. Pet. 20. As Petitioners explain, those limitations take the form of
`(1) expressing the amount of polymer as a percentage of the overall weight
`of the film (claims 1, 7, 8, and 12), and (2) limiting the amount of polymer
`in the film by requiring the film to have a ratio of buprenorphine-to-polymer
`((b):(a)) that falls within a specified range (claims 5 and 12).
`(1) Paragraph 65
`Petitioners argue that “[t]here is nothing in the text of the ’571
`application that demonstrates the inventors believed that the polymer weight
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`percentages and (b):(a) ratios later added to the challenged claims were part
`of their invention.” Pet. 21. Petitioners support this assertion by referring to
`paragraph 65 of the ’571 application that reads as follows:
`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.
`Id. (quoting Ex. 1011, 1444 ¶ 65 (emphasis added by Petitioners)).8
`Petitioners argue that paragraph 65 is the only discussion in the ’571
`application concerning the amount of polymers that should be in the films.
`Pet. 21. According to Petitioners, paragraph 65 makes clear that “the ’571
`application does not limit the amount of polymer to a closed range or
`express it as a (b):(a) ratio, but instead instructs that ‘any desired level of . . .
`polymer’ can be used in the films.” Id. Moreover, according to Petitioners,
`this short description of open-ended ranges does not provide a POSA any
`guidance to, and directs a POSA away from, the polymer weight percentage
`ranges recited in claims 1, 5, 7, 8, and 12. Id. (citing Ex. 1003 ¶ 61).
`Petitioners further argue that “there is nothing in the ’571 application
`that suggests that the bottom end of the range should be ‘40 wt %’ (claim 1)
`or ‘48.2 wt %’ (claims 7 and 12),” and there is no disclosure “of the top-end
`[of the] range, whether it is ‘60 wt %’ (claim 1) or ‘58.6 wt %’ (claims 7 and
`12).” Pet. 21–22 (citing Ex. 1003 ¶ 61). Petitioners argue that “[i]t is well
`established that ‘[t]he disclosure of a broad range of values does not by itself
`
`8 Original claim 5 recites “[t]he composition of claim 1, wherein said
`polymeric carrier matrix comprises at least one polymer in an amount of at
`least 25% by weight of said composition.” Ex. 1011, 1459 (claim 1).
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`provide written description support for a particular value within that range.’”
`Id. at 22 (quoting Gen. Hosp. Corp. v. Sienna Biopharm., Inc., 888 F.3d
`1368, 1372 (Fed. Cir. 2018)). In this case, according to Petitioners, “given
`the complete lack of guidance in the specification, ‘one is left to select[]
`from the myriads of possibilities encompassed by the broad disclosure, with
`no guide indicating or directing that [] this particular selection should be
`made rather than any of the many others which could also be made.’” Id.
`(quoting In re Ruschig, 379 F.2d 990, 995 (CCPA 1967)). Petitioners argue
`further that 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 also argue that “[t]he ’571 application is entirely silent as
`to the claimed (b):(a) ratios,” and does not refer to a (b):(a) ratio at all or any
`(b):(a) ratio ranges claimed in the ’454 patent. Pet. 24 (citing Ex. 1003
`¶ 69). Petitioners further argue that the ’571 application does not provide
`any guidance to a POSA to craft a ratio of buprenorphine-to-polymer,
`although it “lists dozens of ‘optional components’ that may be included in
`the films, and that can be expressed in thousands of different ratios to one-
`another.” Id. (citing Ex. 1003 ¶ 69). According to Petitioners, this lack of
`disclosure “stands in sharp contrast to the other ingredients the inventors
`specifically expressed in the form of a ratio,” such as the (d):(b) ratio and the
`(b):(c) ratio. Id. at 24–25 (citing Ex. 1003 ¶ 70; Ex. 1011, 1445 ¶¶ 66, 67)
`(emphasis added by Petitioner). Petitioners thus argue that, although “the
`’571 application makes clear when the applicants regarded certain ratios to
`be within the scope of the invention,” a POSA would not understand that the
`inventors were in possession of the claimed (b):(a) ratios because no similar
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`discussion appears anywhere in the ’571 application. Id. at 25 (citing
`Ex. 1003 ¶ 67).
`Petitioners argue that there is nothing in the ’571 application that
`directs a POSA to the specific (b):(a) range claimed in the ’454 patent,
`asserting that the ’571 application discloses only that “any desired level” of
`polymer may be used for the “(a)” component of the ratio and that “[a]ny
`desired level of agonist” may be used for the “(b)” component. Pet. 25
`(citing Ex. 1011, 1445 ¶ 66; see also id. ¶ 65). Petitioners thus argue that
`“[t]here is simply no reason a POSA would understand the inventors to have
`been in possession of limitations directed toward specific ratios of two
`ingredients that the application taught could be present in ‘any’ amount.” Id.
`at 25–26 (citing Ex. 1003 ¶¶ 67–70).
`(2) Table 1
`Petitioners assert that, during prosecution of the ’669 application that
`lead to the ’454 patent, Patent Owner claimed that Table 1 of the ’669
`application provided written description support for the claimed polymer
`weight percentage ranges, and 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.”9 Pet. 26 (citing Ex. 1003 ¶ 58; Ex. 1011, 190–97). Table 1
`provides components and amounts thereof for various compositions of film
`dosages, and is set forth below:
`
`
`9 Petitioners note that “[a]s a factual matter, Table 1. . . discloses polymer
`weight percentages of 48.2% and 58.6%.” Pet. 26 n.8.
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`Ex. 1011, 1449–50, ¶ 81.10 Table 1 above is a listing of various
`compositions of film dosages.
`Petitioners argue that the Federal Circuit’s decision in Purdue Pharma
`L.P. v. Faulding Inc., 230 F.3d 1320 (Fed. Cir. 2000), controls in this case,
`and that “the application itself must provide sufficient ‘blaze marks’
`directing POSAs to the specific ranges and ratios claimed,” but that “[h]ere,
`no such blaze marks exist.” Pet. 26 (citing Ex. 1003 ¶¶ 73–80). Petitioners
`argue that the claims at issue in Purdue “were directed to the administration
`of opioid analgesics where the maximum amount of drug in the bloodstream
`
`
`10 The four polymer components identified by the parties in Table 1 are the
`three “Polyethylene Oxide, NF” components (with different molecular
`weights) and hydroxypropylmethyl cellulose (HPMC). Ex. 1011, 1433 ¶ 25;
`Ex. 2008 ¶ 31.
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`(Cmax) is ‘more than twice’ the amount of drug in the bloodstream after 24
`hours (C24).” Id. at 26–27 (citing Purdue Pharma, 230 F.3d at 1322–23).
`Petitioners quote Purdue as stating that “[a]lthough the examples provide the
`data from which one can piece together the Cmax/C24 limitation, neither the
`text accompany[ing] the examples, nor the data, nor anything else in the
`specification in any way emphasizes the Cmax/C24 ratio.” Id. at 27 (quoting
`Purdue Pharma, 230 F.3d at 1326). Petitioners further argue that “[t]he
`Court found that there was nothing in the specification ‘that would suggest
`to one skilled in the art that the Cmax/C24 ratio is an important defining
`quality of the formulation, nor does the disclosure even motivate one to
`calculate the ratio,’” and that “[f]inding no blaze marks, the Federal Circuit
`held the claimed ratios found no written description support.” Id. (quoting
`Purdue Pharma, 230 F.3d at 1326–28).
`
`Petitioners argue that, like Purdue, Patent Owner “crafted claim
`limitations directed toward disparate characteristics of formulas in a single
`table [Table 1] of the ’571 application,” but the ’571 application “does not
`mention those characteristics, even ‘in passing.’” Pet. 27 (quoting Purdue
`Pharma, 230 F.3d at 1327). According to Petitioners, there is no indication
`in the ’571 application that the inventors gave any importance to the amount
`of polymer in the film and, to the contrary, “the ’571 application states that
`‘any’ amount of polymer can be used in the purportedly inventive films.”
`Id. at 27–28 (citing Ex. 1011, 1444 ¶ 65). Petitioners further argue that “[i]t
`is no surprise, therefore, that the ’571 application does not provide direction
`that the claimed polymer weight ranges and (b):(a) ratios impart any
`desirable mucoadhesive, absorption, dissolution, or pharmacokinetic
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`properties in the inventive films.” Id. at 28 (citing Ex. 1003 ¶¶ 62, 63, 71,
`72, 75, 76).
`
`Petitioners argue that “the ’571 application identifies that the principal
`objectives of the inventive films are to (i) provide an active agent for treating
`narcotic dependence and (ii) provide sufficient buccal properties.” Pet. 28
`(citing Ex. 1011, 1463). Petitioners further argue that “[a] POSA reading the
`specification would have understood 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 the prior art Suboxone® tablets.” Id. (citing Ex. 1003
`¶ 62). However, as argued by Petitioners, the ’571 application “contains no
`description that the specific amount of polymers used in the films had any
`impact on these properties of the film,” and does not “communicate to a
`POSA that the amount of polymer in the films impacts the mucoadhesive or
`disintegration properties of the film.” Id. (citing Ex. 1003 ¶¶ 63, 71).
`(3) Table 5
`Petitioners argue that “there is specific data in the specification that
`directs a POSA away from concluding that the polymer weight ranges and
`(b):(a) ratios had any significance to the inventors.” Pet. 29 (citing Ex. 1003
`¶¶ 76–80 (discussing Table 5)) (emphasis added by Petitioner). According
`to Petitioners, the three formulations used to test the bioequivalence of
`certain films to Suboxone® tablets (the principal objective in the ’571
`application) are reported in Table 5 (not Table 1). Id. (citing Ex. 1011,
`1430, ¶ 13, 1453 ¶ 89; Ex. 1003 ¶ 76). Table 5 provides three formulations
`of test films at various pH levels, and is set forth below:
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`Ex. 1011, 1453, ¶ 89.
`
`Table 5 above is a listing of three formulations of test films at various
`pH levels.
`
`Petitioners argue that “Test formulation 1” and “Test formulation 3”
`of Table 5 did not produce films that were bioequivalent to Suboxone®
`tablets, yet they had polymers in amounts “that fell within the polymer
`weight ranges recited in claims 1, 7, 8, and 12.” Pet. 29 (citing Ex. 1011,
`1453–56; Ex. 1003 ¶ 77 (reporting polymer weight percentage of 50.6% for
`Test formulation 1 and 48.2% for Test formulation 3)). Petitioners further
`argue that Test formulation 2 and Test formulation 3 had the same (b):(a)
`ratio, but Test formulation 2 succeeded and Test formulation 3 failed. Id.
`(citing Ex. 1003 ¶ 78 (reporting same (b):(a) ratio of 1:2.8 for Test
`formulations 2 and 3)). Petitioners thus argue that “[i]n view of this
`conflicting data and the explicit instruction that a POSA could use ‘any’
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`amount of polymer, there is no reason that a POSA would understand the
`applicants placed any significance on particular weight ranges for polymers
`or specific (b):(a) values from Table 1.” Id. (citing Ex. 1003 ¶¶ 70–72, 75,
`76, 80). Rather, according to Petitioners, the experiments reflected in Table
`5 would have “indicated to a POSA that variations in the amount of buffer,
`not variations in polymer amounts, were the focus of the purported
`invention.” Id. (citing Ex. 1003 ¶¶ 70–72, 75, 76, 80).
`b) Patent Owner’s Response, Petitioners’ Reply, and Patent
`Owner’s Sur-reply Regarding Polymer Weight Percentages
`Patent Owner argues that “[a] POSA would have understood that the
`inventors possessed the polymer weight percentages recited in challenged
`claims 1, 7, 8, and 12.” PO Resp. 11.
`(1) Polymer Weight Percentage of “about 48.2 wt %”
`Patent Owner argues that t