Paper No. 9
`Filed: October 1, 2014
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`____________________
`
`BIODELIVERY SCIENCES INTERNATIONAL, INC.
`Petitioner
`
`v.
`
`RB PHARMACEUTICALS LIMITED
`Patent Owner.
`
`____________________
`
`Case IPR2014-00998
`Patent 8,475,832
`____________________
`
`PATENT OWNER PRELIMINARY RESPONSE
`PURSUANT TO 37 C.F.R. § 42.107
`
`
`Filed: October 1, 2014
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`____________________
`
`BIODELIVERY SCIENCES INTERNATIONAL, INC.
`Petitioner
`
`v.
`
`RB PHARMACEUTICALS LIMITED
`Patent Owner.
`
`____________________
`
`Case IPR2014-00998
`Patent 8,475,832
`____________________
`
`PATENT OWNER PRELIMINARY RESPONSE
`PURSUANT TO 37 C.F.R. § 42.107
`
`
`
`TABLE OF CONTENTS
`
`Page
`
`INTRODUCTION AND BACKGROUND...................................................2
`I.
`THE ʼ832 PATENT ........................................................................................ 7
`II.
`III. CLAIM CONSTRUCTION .........................................................................10
`IV.
`THE PETITION SHOULD BE REJECTED AS REDUNDANT
`OVER THE ʼ325 IPR AND BECAUSE PETITIONER HAS NOT
`DEMONSTRATED A REASONABLE LIKELIHOOD OF
`PREVAILING ON ANY OF THE PROPOSED GROUNDS FOR
`UNPATENTABILITY .................................................................................20
`A.
`The Board Should Decline to Institute a Second Trial Because
`the Petitioner Already Presented the Same Art and Arguments
`in the ’325 IPR ...................................................................................20
`1.
`The Board Has Routinely Denied Duplicative
`Proceedings ..............................................................................21
`Petitioner Admits That It Has Recycled Previous Art and
`Arguments................................................................................24
`a.
`Ground 1, obviousness over Euro-Celtique,
`mirrors Ground 10 in the ’325 IPR................................25
`Grounds 2-4 rely on the EMEA Study Report,
`which was previously presented to the Board and
`relied upon by Petitioner and the Board in the ’325
`IPR .................................................................................27
`Petitioner’s reliance on WO 03/030883 in Ground
`3 uses substantially the same art and arguments as
`in the ’325 IPR...............................................................29
`Petitioner’s reliance on Yang in Ground 4 uses the
`same art and arguments as in the ’325 IPR ...................31
`Instituting Trial on These Duplicative Grounds Would
`Not Be in the Interests of Justice .............................................32
`Euro-Celtique Fails to Teach or Suggest a Specific
`Embodiment Within the Scope of Claim 15 ......................................34
`
`2.
`
`3.
`
`B.
`
`b.
`
`c.
`
`d.
`
`-i-
`
`
`
`TABLE OF CONTENTS
`(continued)
`
`Page
`
`C.
`
`V.
`
`Petitioner Fails to Set Forth Any Evidence Explaining How the
`Prior Art Could Be Used to Obtain the Specific Claimed Film
`Formulations.......................................................................................38
`1.
`Euro-Celtique fails to teach or suggest how to produce a
`film providing the claimed Cmax and AUC ranges ................40
`Each of the secondary references proposed by Petitioner
`fail to teach or suggest how to produce a film providing
`the claimed Cmax and AUC ranges.........................................44
`Dr. Çelik fails to explain how to produce a film providing
`the claimed Cmax and AUC ranges.........................................47
`CONCLUSION.............................................................................................50
`
`2.
`
`3.
`
`-ii-
`
`
`
`TABLE OF AUTHORITIES
`
`Page(s)
`
`CASES
`3D-Matrix Ltd. v. Menicon Co., Ltd., IPR2014-00398......................................40, 44
`
`Ariad Pharms., Inc. v. Eli Lilly & Co.,
`598 F.3d 1336 (Fed. Cir. 2010) (en banc) ..........................................................37
`
`Butamax Advanced Biofuels LLC v. Gevo, Inc., IPR2013-00539 ...........................47
`
`Ex Parte Cima Labs Inc.,
`No. 2009-3071, 2009 ..........................................................................................18
`
`Ferring B.V. v. Watson Labs., Inc.,
`No. 3:11cv481, 2013 U.S. Dist. LEXIS 17536 (D. Nev. Feb. 6, 2013).......17, 18
`
`Garmin Int’l, Inc. v. Cuozzo Speed Tech., LLC, IPR2012-00001 ...........................15
`
`In re O’Farrell,
`853 F.2d 894 (Fed. Cir. 1988) ..........................................................39, 43, 46, 48
`
`In re Rosuvastatin Calcium Patent Lititigation,
`703 F.3d (Fed. Cir. 2012) ...................................................................................39
`
`Intelligent Bio-Systems, Inc. v. Illumina Cambridge Ltd.,
`IPR2013-00324...................................................................................................21
`
`Medichem, S.A. v. Rolabo, S.L.,
`437 F.3d 1157 (Fed. Cir. 2006) ....................................................................43, 48
`
`Medtronic, Inc. v. Nuvasive, Inc.,
`IPR2014-00487...................................................................................................23
`
`Phillips v. AWH Corp.,
`415 F.3d 1303 (Fed. Cir. 2005) (en banc)..........................................................14
`
`Prism Pharma Co., Ltd. v. Choongwae Pharma Corp.
`IPR2014-00315 (8 July 2014) ............................................................................23
`
`Sanofi-Aventis Deutschland GmbH v. Glenmark Pharms., Inc.,
`748 F.3d 1354 (Fed. Cir. 2014) ....................................................................39, 46
`
`-iii-
`
`
`
`TABLE OF AUTHORITIES
`(continued)
`
`Page(s)
`
`SAS Institute, Inc. v. ComplementSoft, LLC,
`IPR2013-00581............................................................................................passim
`
`Unilever, Inc. v. Procter & Gamble Co.
`IPR2014-00506 (7 July 2014) ......................................................................23, 26
`
`Vitronics Corp. v. Conceptronic, Inc.,
`90 F.3d 1576 (Fed. Cir. 1996) ............................................................................15
`
`STATUTES
`
`35 U.S.C. § 313..........................................................................................................1
`
`35 U.S.C. § 314(a) ...................................................................................................21
`
`35 U.S.C §§ 314(a) ............................................................................................20, 50
`
`35 U.S.C. § 316(b) .............................................................................................21, 33
`
`35 U.S.C. § 325(d) ............................................................................................passim
`
`OTHER AUTHORITIES
`
`37 C.F.R. § 42.1(b). .................................................................................................33
`
`37 C.F.R. § 42.100(b) ..............................................................................................14
`
`37 C.F.R. § 42.107 .....................................................................................................1
`
`37 C.F.R. § 42.108(a)...............................................................................................27
`
`37 C.F.R. § 42.108(b) .............................................................................................20
`
`-iv-
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`
`
`Case IPR2014-00998
`Patent No. 8,475,832
`Patent Owner RB Pharmaceuticals Limited respectfully submits this
`
`Preliminary Response to the Petition (Paper 2) (“Pet.”) seeking inter partes review
`
`(IPR) of claims 15-19 of U.S. Patent 8,475,832 (“the ʼ832 patent”). This
`
`Preliminary Response is timely under 35 U.S.C. § 313 and 37 C.F.R. § 42.107
`
`because it is filed within three months of the July 1, 2014 Notice of Filing Date.
`
`Paper 3, 1.
`
`As further discussed below, Patent Owner respectfully submits that the
`
`Board should exercise its discretion under 35 U.S.C. § 325(d) and decline to
`
`institute an IPR based on any of the Grounds proposed by Petitioner. Among other
`
`things, the Board should reject the present redundant Petition in its entirety because
`
`it substantially repeats the same arguments and relies substantially on the same
`
`prior art that the same Petitioner relied upon in its earlier (January 15, 2014)
`
`Petition regarding the same claims of the same patent. The Board determined to
`
`institute an IPR on certain Grounds in that first petition but not on a number of
`
`others, including because several of the others, which overlap with Grounds
`
`reasserted in the present Petition, were viewed as redundant of the Grounds
`
`instituted upon. That IPR proceeding is case number IPR2014-00325 (“the ’325
`
`IPR”) and is captioned Biodelivery Sciences Int’l, Inc. v. RB Pharmaceuticals
`
`Limited.
`
`(The earlier Petition is Paper 8 in the ’325 IPR.) Further multiplying the
`
`proceedings, in addition to its duplicate Petitions, BDSI has also filed a declaratory
`
`-1-
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`Case IPR2014-00998
`Patent No. 8,475,832
`judgment suit attacking the validity of the ’832 patent. BioDelivery Sciences
`
`International, Inc. v. Reckitt Benckiser Pharmaceuticals, Inc. et al., E.D.N.C. Civil
`
`Action No. 14-cv-529-H.
`
`I.
`
`INTRODUCTION AND BACKGROUND
`
`Patent Owner shares the same parent company as real party-in-interest
`
`Reckitt Benckiser Pharmaceuticals Inc. (“RBP”), which is the exclusive licensee of
`
`the ʼ832 patent. RBP has been the pioneer in developing pharmaceutical
`
`formulations to treat opioid addiction. The ʼ832 patent is listed in the Food and
`
`Drug Administration’s (FDA) Orange Book as covering RBP’s commercial
`
`product Suboxone® sublingual film, which was launched in 2010 and is the
`
`leading opioid addiction treatment in the U.S. The predecessor product to
`
`Suboxone® film was Suboxone® tablets, which were approved by FDA in 2002.
`
`The active ingredients in both Suboxone® film and Suboxone® tablets are
`
`buprenorphine (a partial opioid agonist that is used to effect the addiction
`
`dependence treatment) and naloxone (an opioid antagonist that is included to deter
`
`abuse). As explained in the ʼ832 patent, when used for these purposes in these
`
`products, the objective is to obtain the desired level of absorption of the
`
`buprenorphine through the oral mucosa upon dissolution while inhibiting the
`
`absorption of naloxone (so that the patient is not put into withdrawal).
`
`The manufacture, use and sale of self-supporting pharmaceutical films,
`
`-2-
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`Case IPR2014-00998
`Patent No. 8,475,832
`where the film is not a coating on a drug carrying vehicle (such as a film on the
`
`exterior of a tablet formulation), but rather itself carries the drug to be delivered,
`
`such that the film itself is the drug delivery vehicle, is a relatively new area of
`
`pharmaceutical formulation that has only emerged over the last decade or so and
`
`has only seen the introduction of FDA approved products in the last several years.
`
`The generally well-established technology used to produce compressed
`
`pharmaceutical tablets is very different from and involves very different challenges
`
`and types and ratios of excipients as compared to the newly emerging area of
`
`orally dissolvable, mucoadhesive pharmaceutical films. The pioneering company
`
`in this technology space has been MonoSol Rx LLC (“MonoSol”).
`
`The first two lingual and sublingual pharmaceutical films approved by FDA
`
`(in 2010) were developed by MonoSol, one of which was Suboxone® film, of
`
`which MonoSol is the exclusive manufacturer for RBP. The named inventors on
`
`the ʼ832 patent were, at the time, employees of MonoSol. When RBP sought to
`
`replace Suboxone® tablets with a more advantageous product and one that would
`
`be safer and less subject to potential abuse, RBP turned to MonoSol to develop
`
`what became Suboxone® film, which is the subject matter of the ʼ832 patent. The
`
`filing of the ʼ832 patent in August 2009 marked the first disclosure of an actual
`
`embodiment of, and the first specific teaching how to make an orally dissolvable,
`
`mucoadhesive pharmaceutical film containing buprenorphine and naloxone that is
`
`-3-
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`Case IPR2014-00998
`Patent No. 8,475,832
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`bioequivalent to Suboxone® tablets.1
`
`The current Petition is the second petition for inter partes review of Claims
`
`15-19 in the ʼ832 patent filed by Petitioner. Petitioner originally filed a petition for
`
`inter partes review of the ’832 patent on January 15th, 2014 – assigned case
`
`number IPR2014-00325 (“the ’325 IPR”). Biodelivery Sciences Int’l, Inc. v. RB
`
`Pharmaceuticals Limited, IPR2014-00325, Paper 8. Patent Owner filed its
`
`preliminary response in that proceeding on April 30, 2014. IPR2014-00325, Paper
`
`15. On July 29, 2014, the Board issued a Decision that: (1) instituted trial on
`
`Claims 15-19 with respect to two Grounds proposed by Petitioner (anticipation by
`
`Labtec and obviousness over the combination of Labtec, Birch, and Yang); (2)
`
`refused to institute trial on other Grounds because the Petitioner failed to establish
`
`a reasonable likelihood of success; and (3) refused to institute trial on other
`
`Grounds as redundant to Grounds on which trial was already instituted.2 See
`
`1 As explained in the ʼ832 patent, the Cmax ranges recited in the sole challenged
`
`independent claim, Claim 15, are based on the Cmax ranges of Suboxone® tablets.
`
`See, e.g., Ex. 1001, 17:18-48, including Table 3.
`
`2 As discussed below in Section III, the Decision to institute in the ‘325 IPR also
`
`adopted Patent Owner’s proposed construction of the disputed claim terms, which
`
`are the same terms disputed in this proceeding, and found Petitioner’s proposed
`
`-4-
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`
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`Case IPR2014-00998
`Patent No. 8,475,832
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`generally IPR2014-00325, Paper 17.
`
`After Patent Owner’s Preliminary Response but prior to the Board’s
`
`Decision to institute trial in the ’325 IPR, Petitioner filed the Petition in this
`
`proceeding, relying on substantially the same prior art and arguments that it had
`
`already presented to the Board over 5 months earlier in the ’325 IPR. Patent Owner
`
`submits that the Board should exercise its discretion and refuse to institute inter
`
`partes review of this second, redundant Petition because Petitioner has failed to
`
`demonstrate that it has a reasonable likelihood of prevailing with respect to any of
`
`the challenged claims of the ʼ832 patent. Specifically, the Petition should be
`
`rejected for at least two fundamental reasons.
`
`First, the Grounds of rejection requested in this proceeding are redundant of
`
`the Grounds on which Petitioner previously requested inter partes review and on
`
`which, in part, the Board instituted trial in the ’325 IPR. See IPR2014-00325,
`
`Paper 17, 21 (instituting trial on Grounds that the ʼ832 patent is anticipated by
`
`Labtec and obvious over the combination of Labtec, Birch, and Yang, but denying
`
`institution based on the Euro-Celtique reference and others as redundant). Indeed,
`
`as explained below, the Grounds proposed by Petitioner in this proceeding rely on
`
`constructions, which are the same constructions proposed in this proceeding, to be
`
`unreasonable. IPR2014-00325, Paper 17, 7-12.
`
`-5-
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`Case IPR2014-00998
`Patent No. 8,475,832
`substantially the same art and arguments as the Petitioner presented over 5 months
`
`ago to the Board in the ’325 IPR. As the Board has cautioned: “The practice of a
`
`particular petitioner filing serial petitions challenging claims already involved in an
`
`instituted proceeding and asserting arguments and prior art previously considered
`
`by the Board is contrary to the goals set forth in our statutory mandate and
`
`implementing rules.” SAS Institute, Inc. v. ComplementSoft, LLC, IPR2013-00581,
`
`Paper 15, 22–23 (Dec. 30, 2013) (denying the petition as to four grounds based on
`
`substantially the same prior art and arguments as an earlier petition). Accordingly,
`
`Patent Owner respectfully requests the Board exercise its discretion and deny
`
`Petitioner’s second request to institute trial on each of the Grounds proposed in the
`
`present, redundant Petition.
`
`Second, Petitioner fails to carry its burden of establishing a reasonable
`
`likelihood of showing that any of the references, either alone or in combination,
`
`would enable a person skilled in the art to make the film formulations recited in
`
`Claims 15-19. Rather, Petitioner asserts that merely because there was a desire for
`
`film formulations that would be bioequivalent to Patent Owner’s Suboxone tablets,
`
`it would have been obvious to a person skilled in the art to use conventional film
`
`compositions and processing techniques to achieve such film formulations.
`
`Petitioner, however, has failed to establish how these conventional film
`
`manufacturing techniques could have been used to obtain the claimed invention
`
`-6-
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`Case IPR2014-00998
`Patent No. 8,475,832
`without undue experimentation. For example, Petitioner provides no evidence that
`
`a person skilled in the art would have any reasonable expectation of successfully
`
`obtaining the claimed film formulations simply by employing one of the
`
`conventional processes indicated by Petitioner.
`
`For at least these reasons, Patent Owner respectfully requests the Board to
`
`issue a decision denying institution with respect to each Ground set forth in the
`
`Petition.
`
`II.
`
`THE ʼ832 PATENT
`
`As indicated on its face, the ʼ832 patent was filed on August 7, 2009 and
`
`issued on July 2, 2013. The patent was originally assigned to MonoSol and is now
`
`assigned to Patent Owner.3
`
`As indicated by its heading, “Sublingual and Buccal Film Compositions,”
`
`the ʼ832 patent concerns certain specific pharmaceutical film dosages or
`
`formulations. As set forth in the “Field of the Invention” section at the outset of the
`
`3 This section regarding the subject matter of the ’832 patent, as well as the
`
`following section regarding claim construction issues raised by the present
`
`Petition, essentially repeats the parallel sections in Patent Owner’s Preliminary
`
`Response (Paper 15) to the first Petition in the ’325 IPR since the present Petition
`
`raises substantially the same issues about the same claims of the same patent as did
`
`that earlier Petition.
`
`-7-
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`Case IPR2014-00998
`Patent No. 8,475,832
`
`patent:
`
`to compositions, methods of
`invention relates
`The present
`manufacture, products and methods of use relating to films containing
`therapeutic actives. The invention 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, 1:6-11 (emphasis added). Noting that “[o]ral administration of two
`
`therapeutic actives in a single dosage form can be complex if the intention is to
`
`have one active absorbed in the body and the other active remain substantially
`
`unabsorbed” ( id. at 1:20-24), the specification references Suboxone® tablets (see,
`
`e.g., id. at 1:53-54) and goes on to describe the need the invention of the patent is
`
`meant to satisfy: “There is currently a need for an orally dissolvable film dosage
`
`form that provides the desired absorption levels of the agonist and antagonist,
`
`while providing an adhesive effect in the mouth, rendering it difficult to remove
`
`once placed in the mouth, thereby making abuse of the agonist difficult” (id. at
`
`1:65 to 2:2). More specifically, the “Detailed Description of the Preferred
`
`Embodiments” section of the patent states 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®” tablets. Id. at 4:55-
`
`58.
`
`-8-
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`Case IPR2014-00998
`Patent No. 8,475,832
`The ʼ832 patent repeatedly refers throughout to “films,” “film
`
`compositions,” “film dosage compositions,” “film formulations,” “film dosages,”
`
`“film products,” and “film strips,” using all of these terms interchangeably and
`
`synonymously. See, e.g., id. at 2:7,15, 23-24, 43-44, 55-56, 64; 3:57-66; 4:57, 61;
`
`5:4; 6:60; 13:11, 45; 15:29, 63-65; 17:51, 56; 18:30-50; 23:8, 50. Such “film
`
`formulation[s]” stand in contrast to “tablet formulation[s]” (see, e.g., id. at 23:49-
`
`55).
`
`The specification discloses nothing about preparing tablet formulations, but
`
`is, instead, directed throughout to the preparation of a self-supporting film
`
`formulation, specifically one that is orally dissolvable, is mucoadhesive, and has
`
`the same active ingredients as and is bioequivalent to Suboxone® tablets. Thus, the
`
`“Summary of the Invention” section describes the “present invention” as a “film
`
`dosage composition” or “film formulation.” Id. at 2:6 to 3:2. The “Definitions”
`
`subsection of the section headed “Detailed Description of the Preferred
`
`Embodiments” makes clear that the term “film” includes “thin films and sheets” in
`
`any desired shape or size and contains no suggestion that a film formulation as that
`
`term is used in the patent somehow embraces a tablet formulation.
`
`Similarly, the specification makes clear that the subject dosage form
`
`constitutes a self-supporting film composition: “The film may contain any desired
`
`level of self-supporting film forming polymer, such that a self-supporting film
`
`-9-
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`Case IPR2014-00998
`Patent No. 8,475,832
`composition is provided.” Id. at 12:37-39. Not surprisingly, all of the “how to”
`
`sections of the patent are directed to making a self-supporting film and then, more
`
`specifically, how to make one that is orally dissolvable, mucoadhesive and
`
`bioequivalent to Suboxone® tablets. See, e.g., cols. 5 to 15, as well as Table 1 (at
`
`col. 16) setting forth the specific components of the film formulations tested, as
`
`further described in the Examples at cols. 15 to 23.
`
`This disclosure in Table 1 (at col. 16) is the first disclosure in the art of an
`
`actual embodiment, including the specific ingredients, their amounts and ratios, of
`
`a film dosage or formulation containing buprenorphine and naloxone, and more
`
`specifically, of one that is orally dissolvable, mucoadhesive, and bioequivalent to
`
`Suboxone® tablets. And, the entirety of the specification, including but not limited
`
`to the specific ingredients, their amounts and ratios as disclosed in Table 1 and the
`
`inventors’ discovery that the oral mucosal absorption of buprenorphine (and
`
`naloxone) is bioequivalent to Suboxone® tablets when the local pH provided by
`
`the film (as it dissolves in the mouth, see, e.g., 3:35-38) is lowered to about 3.0 to
`
`3.5 (see, e.g., 23:1-7 and 11:50-61), constitutes the first teaching in the art how to
`
`make such a film formulation. Id. at 11:44-61.
`
`III. CLAIM CONSTRUCTION
`
`Just like the Petition in the ‘325 IPR, the present Petition is directed to
`
`claims 15-19 of the ‘832 patent and raises the same claim construction issues as
`
`-10-
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`Case IPR2014-00998
`Patent No. 8,475,832
`were raised by the Petition in the ‘325 IPR. Claim 15 is the sole challenged
`
`independent claim and the remaining claims depend from it. Claim 15 recites:
`
`An orally dissolving film formulation comprising buprenorphine and
`naloxone, wherein said formulation provides an in vivo plasma profile
`having a Cmax of between about 0.624 ng/ml and about 5.638 ng/ml
`for buprenorphine and an in vivo plasma profile having a Cmax of
`between about 41.04 pg/ml to about 323.75 pg/ml for naloxone.4
`
`Claim construction here is entirely straightforward. “Orally dissolving,” as
`
`the term is used in the claim and throughout the specification, means dissolving in
`
`the mouth. See, e.g., id. at 4:1-24. The term “film formulation,” as explained
`
`above, is, as demonstrated throughout the specification, synonymous with a film
`
`product, film composition, or film dosage, i.e., a self-supporting pharmaceutical
`
`film. The term “Cmax” is defined in the specification as “the mean maximum
`
`plasma concentration after administration of the composition to a human subject.”
`
`4 The Cmax values that appear in this claim concern Suboxone® tablets, ranging in
`
`buprenorphine/naloxone dosages from 2 mg/0.5 mg to 16 mg/4 mg, and were taken
`
`from Table 3 (at col. 17) and were, in turn, as the text explains, based on the
`
`extrapolated absorption data set forth in Table 2A (see, generally, 16:35 to 17:48).
`
`-11-
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`
`
`Id. at 3:9-11.5
`
`The parties’ proposed claim constructions for purposes of this proceeding
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`Case IPR2014-00998
`Patent No. 8,475,832
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`are as follows:
`
`Term
`
`film formulation
`
`provides an in vivo
`plasma profile
`
`Patent Owner’s
`Construction
`film composition, film
`dosage, or film
`
`No construction needed
`
`Petitioner’s Construction
`
`combination of components
`capable of being used to
`prepare a single film
`results in an in vivo plasma
`profile after a resulting film is
`administered to a human
`subject
`
`In the ’325 IPR, these same claim terms were disputed, and the parties
`
`proposed the same constructions as in this proceeding. There, in its decision to
`
`institute trial, the Board rejected Petitioner’s construction of “film formulation” as
`
`“unreasonably broad in view of the specification.” IPR2014-00325, Paper 17, 11.
`
`5 Two of the dependent claims in issue, claims 16 and 17, also use the term AUC,
`
`which is defined in the specification as meaning “the mean area under the plasma
`
`concentration-time curve value after administration of the compositions formed
`
`herein.” Id. at 3:11-14. (In Patent Owner’s view, all of these constructions are the
`
`same whether one uses the broadest reasonable interpretation standard applied by
`
`the Board in IPRs or the standard set forth in governing Federal Circuit case law
`
`with respect to actions in district court.)
`
`-12-
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`Case IPR2014-00998
`Patent No. 8,475,832
`The Board also agreed with Patent Owner that the term “provides an in vivo
`
`plasma profile” has a “plain an unambiguous meaning on its face” such that the
`
`Board “s[aw] no need to construe the term . . . beyond its ordinary meaning.” Id. at
`
`12. For the same reasons adopted by the Board in the ’325 IPR and for the reasons
`
`stated below, Patent Owner respectfully requests the Board reject Petitioner’s
`
`claim constructions and adopt those proposed by Patent Owner.
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`To begin with, it should be pointed out that the sole reason that Petitioner is
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`again making the contrived assertion the claim term “film formulation” means
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`something other than a film dosage or composition is that Petitioner needs to
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`effectively read “film” out of that claim term and have that term mean components
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`that are merely “capable of being used to prepare” a film (among other dosage
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`forms) in order to be able to assert several of its arguments proposed in the ’325
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`IPR and in this proceeding. For example, Petitioner’s arguments for Ground 1 in
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`the ’325 IPR, which has since been rejected by the Board, is that the conventional
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`Suboxone® tablets, which disclose the ingredients in the tablet label, somehow
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`anticipate Claims 15 (and its dependent claims) on the basis that Claim 15 is not
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`limited to film dosage forms and that the individual ingredients shown on the label
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`for Suboxone® tablets are included in the ʼ832 patent’s general disclosure of
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`components that may be used in making a pharmaceutical film. IPR2014-00325,
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`Paper 8, 27. Similarly, in its Ground 1 argument in this proceeding, Petitioner
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`-13-
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`Case IPR2014-00998
`Patent No. 8,475,832
`again asserts that Euro-Celtique need not disclose an actual film or process for
`
`making a film. Pet. 42-43. Thus, Petitioner’s claim construction rests on the
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`unsupported assertion that: “the specification distinguishes a film formulation from
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`a resulting film product.” Id. at 23. And the purpose of this assertion is for
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`Petitioner to advance the remarkable contention that: “claims 15-19 recite no
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`limitation that distinguished the claimed formulations from admitted prior art
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`formulations” – Suboxone tablets. Id. at 30. There are, however, numerous reasons
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`why that position is clearly wrong.
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`First, nowhere in the claims, the specification or the file history is there any
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`statement to the effect, or which even suggests, that the Applicant meant to draw a
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`distinction between its use of the term film formulation and its use of the terms
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`film dosage, film product, film composition, film strip, and film.
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`Second, as discussed above, in fact all of those terms have a plain and
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`unambiguous meaning and are used synonymously and interchangeably throughout
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`the specification.6 See, e.g., Ex. 1001 at 2:7,15, 23-24, 43-44, 55-56, 64; 3:57-66;
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`6 When construing claims in inter partes review, the Board gives each claim “its
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`broadest reasonable construction in light of the specification of the patent in which
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`it appears.” 37 C.F.R. § 42.100(b). The specification “is always highly relevant to
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`the claim construction analysis. Usually, it is dispositive; it is the single best guide
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`to the meaning of a disputed term.” Phillips v. AWH Corp., 415 F.3d 1303, 1315
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`-14-
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`Case IPR2014-00998
`Patent No. 8,475,832
`4:57, 61; 5:4; 6:60; 13:11, 45; 15:29, 63-65; 17:51, 56; 18:30-50; 23:8, 50. To take
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`a few illustrative examples:
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`Still other embodiments of the present invention provide an orally
`dissolving film formulation including buprenorphine and naloxone,
`where the formulation provides an in-vivo plasma profile having a
`Cmax of between about 0.624 ng/ml and about 5.638 ng/ml for
`buprenorphine and an in-vivo plasma profile having a Cmax of
`between about 41.04 pg/ml to about 323.75 pg/ml for naloxone. [Id. at
`2:63 to 3:2, emphasis added]
`
`***
`Film dosages were prepared for use in an in vivo study to determine
`the bioavailability of buprenorphine/naloxone tablets and film
`formulations.
`the films were tested to determine
`Specifically,
`whether the film provides a bioequivalent effect to that of a tablet
`formulation. [Id. at 18:30-34, emphasis added]
`The first excerpt above from the specification corresponds to the subject
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`matter claimed in claim 15. The syntax of the passage makes it unmistakably clear
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`(Fed. Cir. 2005) (en banc) (internal citations and quotations omitted). “The
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`specification acts as a dictionary when it expressly defines terms used in the claims
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`or when it defines terms by implication.” Vitronics Corp. v. Conceptronic, Inc., 90
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`F.3d 1576, 1582 (Fed. Cir. 1996) (citation omitted). See also Garmin Int’l, Inc. v.
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`Cuozzo Speed Tech., LLC, IPR2012-00001, Paper 15, 4 (Jan. 9, 2013).
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`-15-
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`Case IPR2014-00998
`Patent No. 8,475,832
`that the “orally dissolvable film formulation” is “the formulation” (meaning the
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`film product, dosage or composition) that provides a certain in-vivo plasma profile.
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`In claim 15 itself, the wording is slightly different (“wherein said formulation” as
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`opposed to “where the formulation” as in the passage quoted above), but clearly
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`has the same meaning: “said formulation” is the film dosage or composition. The
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`second excerpt shows the explicit, interchangeable use of the terms “film dosages,”
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`“film formulations,” and “films.” Furthermore, each of the dependent claims in
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`issue (claims 16-19) begin by reciting “The formulation of claim 15, wherein said
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`formulation provides . . . .” Thus, the structure of the dependent claims also shows
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`that the term “film formulation” in claim 15 refers to a film dosage, composition or
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`product. Therefore, the broadest reasonable construction (indeed, the only
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`reasonable construction) of the term “film formulation” in claim 15 is film dosage
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`or composition.
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`That this is the correct construction is further brought home by Petitioner’s
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`apparent recognition that one needs to have, in Petitioner’s phrase, a “resulting
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`film dosage” in order to achieve the in-vivo plasma profile recited in claim 15. Pet.
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`28. However, what Petitioner does to make sure there is in fact a film dosage in
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`the claim is, bizarrely enough, to read the term “resulting film” into the otherwise
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`perfectly unambiguous claim term “provides an in-vivo plasma profile,” which
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`Patent Owner does not believe needs any construction. Thus, Petitioner’s proposed
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`-16-
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`Case IPR2014-00998
`Patent No. 8,475,832
`construction reads film dosage or composition out of the unambiguous term “film
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`formulation,” but (since there must be a film dosage to provide the plasma profile)
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`then reads “resulting film” into an unambiguous claim term (“provides an in-vivo
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`plasma profile”) that does not even have the term “film” in it. This tortured
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`construction has no support in the intrinsic record, is contrary to the plain meaning
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`of the claim terms and the syntax of the claim, to the overall thrust of the
`
`specification, and to the governing principles of claim construction, and should,
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`therefore, be rejected.7
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`At least one court has construed a similar claim term in which “tablet,” a
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`word indicative of the final drug product, modified the word “formulation.”
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`Ferring B.V. v. Watson Labs., Inc., No. 3:11cv481, 2013 U.S. Dist. LEXIS 17536,
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`7 Petitioner cites two patents that were incorporated by reference in the ʼ832 patent
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`as discussing “the effect of different ingredient formulations and processing
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`techniques on the resultant film products.” Pet. 23. Though this captures language
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`from both patents, Petitioner fails to explain how the cited language leads to its
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`unsupp
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