Paper No.
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`
`
`Filed: March 15, 2016
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`_______________
`
`TEVA PHARMACEUTICALS USA, INC.,
`Petitioner
`
`v.
`
`MONOSOL RX, LLC,
`Patent Owner
`_______________
`
`Case IPR2016-00282
`
`Patent 8,017,150 B2
`_______________
`
`PATENT OWNER’S PRELIMINARY RESPONSE
`PURSUANT TO 35 U.S.C. § 313 & 37 C.F.R. § 42.107
`
`
`
`
`
`
`
`
`Filed: March 15, 2016
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`_______________
`
`TEVA PHARMACEUTICALS USA, INC.,
`Petitioner
`
`v.
`
`MONOSOL RX, LLC,
`Patent Owner
`_______________
`
`Case IPR2016-00282
`
`Patent 8,017,150 B2
`_______________
`
`PATENT OWNER’S PRELIMINARY RESPONSE
`PURSUANT TO 35 U.S.C. § 313 & 37 C.F.R. § 42.107
`
`
`
`
`
`
`
`
`
`
`
`
`TABLE OF CONTENTS
`
`INTRODUCTION ........................................................................................... 1
`I.
`THE PETITION IS TIME-BARRED UNDER § 315(b) ................................ 3
`II.
`III. CLAIM CONSTRUCTION ............................................................................ 6
`IV. PRIORITY DATE ......................................................................................... 12
`V.
`PETITIONER HAS NOT SHOWN A REASONABLE LIKELIHOOD
`THAT THE CHALLENGED CLAIMS OF THE ’150 PATENT ARE
`UNPATENTABLE ........................................................................................ 15
`A.
`The Challenged Claims Would Not Have Been Obvious Over
`Schiraldi In View of Verma ................................................................ 15
`1.
`U.S. Patent No. 4,713,243 (“Schiraldi”) (Ex. 1004) ................. 16
`2.
`U.S. Patent No. 6,322,811 (“Verma”) (Ex. 1005) .................... 17
`The Challenged Claims Would Not Have Been Obvious Over
`Schiraldi In View of Verma And Khan ............................................... 18
`The Challenged Claims Would Not Have Been Obvious Over Yang 19
`C.
`VI. CONCLUSION .............................................................................................. 19
`
`
`B.
`
`i
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`
`
`TABLE OF AUTHORITIES
`
`
`
`Page(s)
`
`
`CASES
`Ariad Pharms., Inc. v. Eli Lilly & Co.,
`598 F.3d 1336 (Fed. Cir. 2010) (en banc) .......................................................... 13
`Arness v. Franks,
`138 F.2d 213 (C.C.P.A. 1943) .............................................................................. 9
`In re Cuozzo Speed Techs., LLC,
`793 F.3d 1268 (Fed. Cir. 2015), reh’g en banc denied, 793 F.3d 1297
`(Fed. Cir. 2015), cert. granted, 2016 WL 205946 (U.S. Jan. 15, 2016) .............. 6
`In re Mochel,
` 470 F.2d 638 (C.C.P.A. 1972) ............................................................................. 9
`In re Suitco Surface, Inc.,
`603 F.3d 1255 (Fed. Cir. 2010) ........................................................................ 6, 7
`Lannett Holdings, Inc. v. Astrazeneca AB,
`IPR 2015-01629, Paper 14 (PTAB, Jan 27, 2016) ............................................ 4,5
`Microsoft Corp. v. Proxyconn, Inc.,
`IPR2012-00026, Paper 17 (P.T.A.B. December 21, 2012) ................................ 11
`Terremark N. Am. LLC v. Joao Control & Monitoring Sys.,
`LLC, IPR2015-01482, Paper 10 (PTAB, December 28, 2015) ............................ 4
`United States v. Locke,
`471 U.S. 84 (1985) ................................................................................................ 5
`STATUTES
`35 U.S.C. § 315(b) ......................................................................................... 1, 3, 4, 6
`
`
`
`ii
`
`
`
`
`
`
`
`CODE OF FEDERAL REGULATIONS
`
`
`CODE OF FEDERAL REGULATIONS
`37 C.F.R. § 42.100(b) ................................................................................................ 6
`37 C.F.R. § 42.100(b) .............................................................................................. ..6
`37 C.F.R. § 42.101 ..................................................................................................... 4
`37 C.F.R. § 42.101 ................................................................................................... ..4
`37 C.F.R. § 42.101(b) ................................................................................................. 4
`37 C.F.R. § 42.101(b) ............................................................................................... ..4
`OTHER AUTHORITIES
`77 Fed. Reg. 48756, 48766 (Aug. 14, 2012) ............................................................. 6
`77 Fed. Reg. 48756, 48766 (Aug. 14,2012) ........................................................... ..6
`
`OTHER AUTHORITIES
`
`iii
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`iii
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`
`
`EXHBIT
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`
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`*2001
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`*2002
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`*2003
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`*2004
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`*2005
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`*2006
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`*2007
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`*2008
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`
`
`EXHIBIT LIST
`
`DESCRIPTION
`FedEx shipping labels for tracking numbers 7751 1902
`8582; 7751 1902 8983; and 7751 1902 9203 and FedEx
`on-line tracking histories for tracking numbers 7751
`1902 8582; 77511902 8983; and 7751 1902 9203.
`January 8, 2016 emails with PTAB at Trials@uspto.gov.
`
`Email chain regarding Petitioner’s problems.
`
`Summons in Reckitt Benckiser Pharmaceuticals Inc., RB
`Pharmaceuticals Limited, et al v. Teva Pharmaceuticals
`USA, Inc., Civil Action 14-1451 (D. Del.).
`Complaint (without exhibits) in Reckitt Benckiser
`Pharmaceuticals Inc., RB Pharmaceuticals Limited, et al
`v. Teva Pharmaceuticals USA, Inc., Civil Action 14-
`1451 (D. Del.).
`Declaration of Daniel Doran
`
`Declaration of Michael I. Chakansky
`
`USPTO Patent Review Processing System (PRPS) web
`page at http://www.uspto.gov/patents-application-
`process/appealing-patent-decisions/trials/patent-review-
`processing-system-prps-0 (downloaded on March 7,
`2016).
`
`
`*Patent owner’s exhibits 2001-2008 were previously filed and are listed here again
`pursuant to 37 C.F.R. § 42.63.
`
`
`iv
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`
`
`U.S. Patent No. 8,017,150 B2
`
`
`1
`
`IPR2016-00282
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`Patent Owner MonoSol Rx, LLC (“Patent Owner”), pursuant to 35 U.S.C. §
`
`313 and 37 C.F.R. § 42.170, respectfully requests that the Patent Trial and Appeal
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`Board (PTAB or Board) deny institution of IPR2016-00282 (282 IPR). This filing
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`is timely, because it is within three months of the date of the Notice according the
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`Petition in the 282 IPR the filing date of December 4, 2015. Notice, Paper 3.
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`I.
`
`INTRODUCTION
`Patent Owner respectfully submits that inter partes review of U.S. Patent
`
`No. 8,017,150 B2 (‘150 Patent) should not be instituted in this matter because
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`Petitioner has failed to timely file the Petition. Petitioner was served with a
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`complaint on December 3, 2014 alleging infringement of the ‘150 Patent. Because
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`the Petition was filed more than one year after the date on which Petitioner was
`
`served with a complaint alleging infringement of the patent, no inter partes review
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`may be instituted. See 35 U.S.C. § 315(b). 1
`
`
`1 Petitioner filed a motion on February 29, 2016 to change the date of filing in the
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`282 IPR (Paper 9) to December 3, 2015. Patent Owner opposed that motion on
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`March 10, 2016 (Paper 11). Should Petitioner’s motion be denied, there is no
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`dispute that the 282 IPR Petition is time-barred under 35 U.S.C. § 315(b). See
`
`discussion herein.
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`
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`
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`U.S. Patent No. 8,017,150 B2
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`
`2
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`IPR2016-00282
`
`Additionally, as shown below, the Petitioner has failed to demonstrate that it
`
`has a reasonable likelihood of prevailing with respect to any of the challenged
`
`claims of the ʼ150 Patent.
`
`The challenged claims of the ’150 Patent specify a mucoadhesive, opiate-
`
`containing film with a particular polymer profile, including an emphasis on
`
`polyethylene oxides (“PEOs”) of specified molecular weights and the option of
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`combination with hydrophilic cellulosic polymer (“HCP”). The inventors
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`unexpectedly discovered that the claimed films provide a suitable release profile
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`for an analgesic opiate, and still provide a suitable dosage form with the desired
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`mucoadhesion and tear resistance.
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`Patent Owner submits that inter partes review should not be instituted in this
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`matter because Petitioner has failed to demonstrate that it has a reasonable
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`likelihood of prevailing with respect to any of the challenged claims of the ʼ150
`
`Patent. Specifically, the Petition fails for at least three fundamental reasons.
`
`First, Petitioner’s contention (Grounds 1 and 2)
`
`that
`
`the claimed
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`pharmaceutical film product is obvious relies on an insupportable combination of
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`references directed to two disparate technologies: a mucoadhesive film and a
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`plastic outer coating for a capsule. Petitioner has failed to articulate any reason
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`
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`
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`U.S. Patent No. 8,017,150 B2
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`why a person of ordinary skill in the art (“POSA”) would have even considered
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`IPR2016-00282
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`3
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`combining such different dosage forms.
`
`Second, Petitioner’s contention (Ground 3) that the parent application of the
`
`’150 Patent renders the challenged claims obvious is faulty as the parent
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`application is not prior art. As explained below, the ’150 Patent is entitled to a
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`priority date of May 28, 2003, which is well before the 2005 publication date of the
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`parent application.
`
`Third, as shown below, Petitioner’s Ground 3 relies, in part, on an incorrect
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`claim construction.
`
`II. THE PETITION IS TIME-BARRED UNDER § 315(b)
`Petitioner certified in the 282 IPR petition that it had standing and was not
`
`barred, inter alia, by the 1-year bar of 35 U.S.C. § 315(b). Paper 1, Pet., p. 4. That
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`certification depended on Petitioner receiving a December 3, 2015 filing date (id.),
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`which it did not. The PTAB accorded the 282 IPR Petition a filing date of
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`December 4, 2015.2 However, December 4, 2015 is outside the statutory bar date
`
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`2 Indeed, without acknowledgement to the PTAB, Petitioner only attempted service
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`by tendering incomplete sets of documents to FedEx on December 4, 2015 (Ex
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`2007, Chakansky Dec. ¶¶ 2-8; Ex 1050 Yost Dec. ¶ 35.
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`
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`
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`U.S. Patent No. 8,017,150 B2
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`because Petitioner was served with a complaint claiming infringement of the
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`IPR2016-00282
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`4
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`patents on December 3, 2014.3 Thus, the 282 IPR petition filed more than 1-year
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`after Petitioner was served with the complaint is barred.
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`The statute and the associated regulation are clear that no inter partes review
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`may be instituted more than one year after Petitioner was served with a complaint
`
`alleging infringement of the patent. 35 U.S.C. § 315(b); 37 C.F.R. § 42.101. Even
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`if Petitioner is only one day late, no inter partes review may be instituted. See, e.g.,
`
`Terremark N. Am. LLC v. Joao Control & Monitoring Sys., LLC, IPR2015-01482,
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`Paper 10 at p. 5 (PTAB, December 28, 2015) (“Because at least one of the
`
`petitioning parties was served with a complaint on June 23, 2014 (Exs. 2002–
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`2005), the statutory bar date for IPR2015-01485 is June 23, 2015. 35 U.S.C. §
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`315(b); 37 C.F.R. § 42.101(b).” Petitioner, however, was accorded a filing date of
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`June 24, 2015. Paper 3. “[T]he Petition falls outside the one-year time bar set
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`forth in 35 U.S.C. § 315(b). We, thus, deny inter partes review of the ’363 patent.”
`
`
`3 “Petitioner was served with a complaint asserting the ’150 patent on December 3,
`
`2014 in Reckitt Benckiser Pharmaceuticals, Inc., RB Pharmaceuticals Limited, et al
`
`v. Teva Pharmaceuticals USA, Inc., Civil Action 14-1451 (D. Del.).” Paper 1, Pet.,
`
`p. 4.
`
`
`
`
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`U.S. Patent No. 8,017,150 B2
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`Id., at 16.); see also Lannett Holdings, Inc. v. Astrazeneca AB, IPR 2015-01629,
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`IPR2016-00282
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`5
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`Paper 14 (PTAB, Jan 27, 2016) (denying institution where Petition was filed one
`
`day after one year statutory bar date). As the Supreme Court has explained:
`
`Filing deadlines, like statutes of limitations, necessarily operate
`harshly and arbitrarily with respect to individuals who fall just on
`the other side of them, but if the concept of a filing deadline is to
`have any content, the deadline must be enforced. Any less rigid
`standard would risk encouraging a lax attitude toward filing dates
`… A filing deadline cannot be complied with, substantially or
`otherwise, by filing late — even by one day.
`
`United States v. Locke, 471 U.S. 84, 100-101 (1985) (emphasis added)
`(citations omitted).
`
`Here, it is not disputed that Petitioner was served with a complaint on
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`December 3, 2014 alleging infringement of the ’150 Patent.4 It is also not disputed
`
`that if Petitioner’s Motion to Change the Filing Date from December 4 to
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`4 Petitioner admits “Petitioner was served with a complaint asserting the ’150 patent
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`on December 3, 2014 in Reckitt Benckiser Pharmaceuticals Inc., RB
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`Pharmaceuticals Limited, et al v. Teva Pharmaceuticals USA, Inc., Civil Action
`
`14-1451 (D. Del.).” Paper 1, Pet., p. 4.
`
`
`
`
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`U.S. Patent No. 8,017,150 B2
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`December 3, 2015 is denied, the Petition is time-barred under § 315(b).5
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`IPR2016-00282
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`6
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`Accordingly, Patent Owner requests that the Board deny institution of inter partes
`
`review in the 282 IPR under 35 U.S.C. § 315(b).
`
`III. CLAIM CONSTRUCTION
`In an inter partes review, claim terms are interpreted according to their
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`"broadest reasonable construction in light of the specification of the patent in
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`which it appears.” In re Cuozzo Speed Techs., LLC, 793 F.3d 1268, 1275–79 (Fed.
`
`Cir. 2015)6; 37 C.F.R. § 42.100(b); Office Patent Trial Practice Guide, 77 Fed.
`
`Reg. 48756, 48766 (Aug. 14, 2012). The Office must give claims their broadest
`
`reasonable interpretation consistent with the specification. In re Suitco Surface,
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`5 See Teva Pharms. USA, Inc. v. Indivior UK Ltd., IPR 2016-00280, Paper 8 at p. 2
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`(PTAB Feb. 18, 2016) (“Both parties agreed that an effective filing date of
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`December 4, 2015, for the Petition in this case would implicate a time bar under 35
`
`U.S.C. § 315(b).”).
`
`6 reh’g en banc denied, 793 F.3d 1297 (Fed. Cir. 2015), cert. granted, 2016 WL
`
`205946 (U.S. Jan. 15, 2016) (No. 15-446). Should the Supreme Court change this
`
`standard, Patent Owner may at that time request leave to address the impact of
`
`such a ruling.
`
`
`
`
`
`U.S. Patent No. 8,017,150 B2
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`Inc., 603 F.3d 1255, 1259-60 (Fed. Cir. 2010) (“[C]laims should always be read in
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`IPR2016-00282
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`7
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`light of the specification and teachings in the underlying patent” when determining
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`their broadest reasonable construction).
`
`Here, Petitioner has both ignored the intrinsic evidence and mischaracterized
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`Patent Owner’s position on claim construction. Specifically, Petitioner misstates
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`Patent Owner’s construction of the clause containing the term “up to” in Claims 1
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`and 10 as meaning that HCP “is not a limitation of the claims.” (Paper 1, Pet., pp.
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`12-13.) As discussed below, Patent Owner’s actual position in the related
`
`litigation against Teva7 is that the intrinsic evidence, including the claims, makes
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`clear that HCP is an optional component which, if included, cannot be present in
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`more than the amount allowed by the claims. Thus, in the co-pending litigation,
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`Patent Owner has proposed the following claim constructions:
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`1. “at
`
`least one water-soluble polymer component consisting of
`
`polyethylene oxide in combination with a hydrophilic cellulosic
`
`polymer; wherein: the water-soluble polymer component comprises
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`greater than 75% polyethylene oxide and up to 25% hydrophilic
`
`
`7 Reckitt Benckiser Pharmaceuticals Inc. et al. v. Teva Pharmaceuticals USA, Inc.,
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`Case No. 1-14-cv-01451 (D. Del.).
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`
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`
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`U.S. Patent No. 8,017,150 B2
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`8
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`IPR2016-00282
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`cellulosic polymer” means “at least one water-soluble polymer
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`component consisting of polyethylene oxide and optionally
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`hydrophilic cellulosic polymer, wherein the polyethylene oxide is in
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`an amount of greater than 75% of the polymer component and there
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`may be up to 25% hydrophilic cellulosic polymer in the polymer
`
`component.”
`
`2. “at
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`least one water-soluble polymer component consisting of
`
`polyethylene oxide in combination with a hydrophilic cellulosic
`
`polymer; wherein: the water-soluble polymer component comprises
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`the hydrophilic cellulosic polymer in a ratio of up to about 4:1 with
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`the polyethylene oxide” means “at least one water-soluble polymer
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`component consisting of polyethylene oxide and optionally
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`hydrophilic cellulosic polymer, wherein the ratio of hydrophilic
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`cellulosic polymer to polyethylene may be up to about 4:1.”
`
`(Ex. 1009, Joint Claim Construction Chart (Ex A), Dkt. No. 91-1 at pp.
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`4-5.)8
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`8 All references to page numbers are to printed page numbers since Petitioner has
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`failed to uniquely number each page in sequence, as required by 37 C.F.R. § 42.63.
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`U.S. Patent No. 8,017,150 B2
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`9
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`IPR2016-00282
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`These claim terms are directed to a “water-soluble polymer component
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`consisting of polyethylene oxide [PEO] in combination with a hydrophilic
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`cellulosic polymer [HCP] wherein the polymer component comprises either (1)
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`“greater than 75% [PEO] and up to 25% [HCP],” or (2) “[HCP] in a ratio of up to
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`about 4:1 with the [PEO].” As shown by the claim language itself, these terms
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`impose a limitation on the maximum amount of HCP that may be present but do
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`not require any HCP be present (i.e., there can be zero HCP), thus HCP is, as the
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`specification also makes clear, an optional ingredient, and the claims include films
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`that contain HCP as well as films that do not contain HCP. Therefore, when
`
`properly construed, these claim terms encompass “at least one water-soluble
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`polymer component” made of 100% PEO and no HCP. This interpretation is
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`consistent both with the meaning of the “up to” claim language read in the context
`
`of the claims, as well as the disclosure of the specification of the ’150 Patent.
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`The Federal Circuit’s predecessor has held that the meaning of “the phrase
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`‘up to’ [in a disputed term] includes zero as the lower limit.” In re Mochel, 470
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`F.2d 638, 640 (C.C.P.A. 1972); see also Arness v. Franks, 138 F.2d 213, 216
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`(C.C.P.A. 1943) (stating “up to 30%” means “anything from zero to 30%”). Thus,
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`the claim’s use of the phrase “up to 25% [HCP]” includes 0% HCP.
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`U.S. Patent No. 8,017,150 B2
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`10
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`IPR2016-00282
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`This construction is also consistent with the specification of the ’150 Patent,
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`which repeatedly states that HCP is an optional component of the water-soluble
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`polymer component. (Ex. 1001, Abstract, 1:34-36 (“The films contain a polymer
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`component, which includes polyethylene oxide optionally blended with
`
`hydrophilic cellulosic polymers.”), 17:27-42 (“Additionally, polyethylene oxide
`
`(PEO), when used alone or in combination with a hydrophilic cellulosic polymer,
`
`achieves flexible, strong films.”), 47:67-48:32 (“Accordingly, it may be desirable
`
`to employ polymer components as in Compositions CQ-CY, particularly about
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`20% to 100% PEO in the polymer component optionally combined with about 0%
`
`to 80% HPC or HPMC.”), 49:47-50:2 (“As indicated above, each of Compositions
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`DC-DG contained about 20% to 100% PEO in the polymer component, optionally
`
`in combination with varying levels of HPC or HPMC.”) (emphases added in all).)
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`In addition, in Table 22, the ’150 Patent provides several “examples of the present
`
`invention” where the compositions contain both PEO and HCP, or just PEO and no
`
`HCP in the water-soluble polymer component. (Id. at 50:7-34 (“The following
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`examples of the present invention describe films that include PEO or PEO-HPC
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`polymer blends.”).)
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`Indeed, the ’150 Patent expressly discloses that “[i]n accordance with the
`
`present invention, PEO desirably ranges from about 20% to about 100% by
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`U.S. Patent No. 8,017,150 B2
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`weight” and “[HCP] ranges from about 0% to about 80% by weight, or in a ratio of
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`IPR2016-00282
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`11
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`up to about 4:1 with the PEO . . . .” (Id. at 17:52-57, emphasis added.)9 The “up
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`to” language used here is repeated in the claims, further demonstrating the claims
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`should be read consistently with the specification.
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`Accordingly, contrary to Petitioner’s description (Paper 1, Pet., pp. 12-13),
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`Patent Owner’s proposed construction includes films that contain HCP as well as
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`films that do not contain HCP. In other words, HCP is optional.
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`In the absence of a reasonable claim construction, a petitioner cannot show a
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`reasonable likelihood of success on its grounds for unpatentability. See Microsoft
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`Corp. v. Proxyconn, Inc., IPR2012-00026, Paper 17, p. 24 (PTAB Dec. 21, 2012)
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`(stating that "[a]s this argument is premised on Petitioner's erroneous claim
`
`construction we are not persuaded of a reasonable likelihood of prevailing.”). For
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`at least these reasons, Petitioner has not demonstrated that it has a reasonable
`
`likelihood of prevailing to show the claims are unpatentable.
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`9 The term “combination” in the claim is used in the same way the term
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`“ratio” is used in this passage in the specification—namely, to mean that the
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`amount of HCP in the ratio or combination with PEO can be from 0% up to 25% in
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`Claim 1 and up to 80% in Claim 10.
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`
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`U.S. Patent No. 8,017,150 B2
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`IV. PRIORITY DATE
`The ’150 Patent claims priority to U.S. Provisional Application No.
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`IPR2016-00282
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`12
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`60/473,902 (“the ’902 Application”), which was filed on May 28, 2003 and shares
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`the same “Detailed Description of the Invention” in relevant part. Petitioner
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`incorrectly asserts (Paper 1, Pet., pp. 13-14) that the priority date of the challenged
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`claims depends on whether the Board “determines that HCP is not a limitation of
`
`the challenged claims.” (Id. at 13 (emphasis in original).). Regardless of whether
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`the claimed films are construed as optionally containing HCP, the challenged
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`claims of the ’150 Patent are all entitled to claim priority to the May 28, 2003
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`filing date of the ’902 Application.
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`The challenged claims recite films wherein the polymer component is
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`comprised of a low molecular weight (“MW”) PEO, a high MW PEO, and
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`optionally HCP. Additionally, the claims recite that the low MW PEO comprises
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`at least 60% of the total polymer component. Although Petitioner acknowledges
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`that the ’902 Application discloses the combination of PEO and HCP (Paper 1,
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`Pet., p. 15) and the combination of low and high MW PEO (Id. at 15-16),
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`Petitioner alleges that it does not also disclose “a combination of PEO and
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`[hydrophilic cellulosic polymer] plus a specific percentage of low MW weight
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`PEO.” (Id. at 15; Ex. 1003, Das Dec. ¶ 46.) However, as Patent Owner’s expert,
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`U.S. Patent No. 8,017,150 B2
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`Dr. Prud’homme, explained in the co-pending litigation, the ’902 Application
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`IPR2016-00282
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`13
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`disclosed to a POSA that the inventors had possession of the invention where the
`
`claimed products have about 60% or more of the low molecular weight PEO in the
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`polymer component, which includes PEO and any HCP. (Ex. 1016, Reckitt
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`Benckiser Pharmaceuticals Inc., et al v. Watson Laboratories, Inc. et al, C.A. No.
`
`13-cv-01674-RGA, November 4, 2015 Trial Tr. 661:14-669:18, 688:9-690:12
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`(Prud’homme).) See Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351
`
`(Fed. Cir. 2010) (en banc) (written description requirement met where disclosure
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`“reasonably conveys” to POSA the inventor possessed claimed subject matter).
`
`As noted above, the ‘902 Application shares the same Description of the
`
`Invention section in its specification, in relevant part, as the ’150 Patent. The ‘902
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`Application, like the ’150 Patent, used the term “polymer component” to refer to
`
`all polymers in the formulation, including low MW PEO, high MW PEO, and any
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`HCP. (Ex. 1016, Trial Tr. 662:21-666:8 (Prud’homme); Ex. 1011 at 28-29, 81; see
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`also Ex. 1016, Trial Tr. 441:21-443:2 (Amiji).)10
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`10 Petitioner’s expert, Dr. Das, states “The first disclosure of a film in which
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`the polymer component as a whole was made up of low molecular weight PEO
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`appeared in the claims of the application that would become the ’150 patent, filed
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`U.S. Patent No. 8,017,150 B2
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`IPR2016-00282
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`As Patent Owner’s expert explained, the ’902 Application discloses
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`“combining small amounts of high molecular weight PEOs with larger amounts of
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`lower molecular weight PEOs” and that “[d]esirably, such compositions contain
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`about 60% or greater levels of the lower molecular weight PEO in the PEO-blend
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`polymer component,” and a POSA would understand that such “polymer
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`component” includes both PEO and any HCP. (Ex. 1011 at 29 (emphasis added);
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`Ex. 1016, Trial Tr. 665:7-666:8 (Prud’homme) (“And [‘]desirably, such
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`compositions contain about 60% or greater levels of the lower molecular weight
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`PEO in the PEO-blend polymer component.[’] It’s talking about the blend
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`polymer component and polymer component has been defined as PEO plus HPMC
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`or HPC, if it is, in fact, there. So I think it’s connecting this term that polymer
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`component means all the polymers in the system. And it’s saying that a desirable
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`formulation is one that has 60 percent or greater levels. So I think this speaks
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`directly to claim 1.”) (quoting Ex. 1011 at 29) (emphasis added).)
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`on April 22, 2008.” Ex. 1003, ¶ 43) (emphasis added.) The challenged claims do
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`not require that the polymer component “as a whole” is made up of low molecular
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`weight PEO as Dr. Das asserts.
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`U.S. Patent No. 8,017,150 B2
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`The ’902 Application also contains other disclosures of compositions having
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`a polymer component comprised of about 60% or more of the low MW PEO
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`together with high MW PEO and HCP, stating, for example, that the inventive
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`films “may include about 50% to 75% low molecular weight PEO, optionally
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`combined with a small amount of a higher molecular weight PEO, with the
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`remainder of the polymer component containing a hydrophilic cellulosic polymer
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`(HPC or HPMC).” (Ex. 1011 at 29 (emphasis added); Ex. 1016, Trial Tr. 666:9-
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`668:5 (Prud’homme).)
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`Accordingly, the challenged claims have a priority date of May 28, 2003
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`because the ’902 Application clearly discloses that the inventors were in
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`possession of an invention wherein the claimed products have about 60% or more
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`of the low MW PEO in the polymer component, which is comprised of PEO and
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`any HCP. (Ex. 1016, Trial Tr. 662-669, 692-694 (Prud’homme).)
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`V.
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`PETITIONER HAS NOT SHOWN A REASONABLE LIKELIHOOD
`THAT THE CHALLENGED CLAIMS OF THE ’150 PATENT ARE
`UNPATENTABLE
`A. The Challenged Claims Would Not Have Been Obvious Over
`Schiraldi In View of Verma
`The ’150 Patent teaches a rapidly dissolving film with a prescription drug, in
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`particular, an analgesic opiate, and methods of its preparation. The film provides a
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`balance of fast dissolution along with mucoadhesiveness and good tear resistance.
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`U.S. Patent No. 8,017,150 B2
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`The film achieves these desired attributes through a particular combination of
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`IPR2016-00282
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`16
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`polymers in particular amounts and having particular molecular weight ranges
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`which is not taught by any of the references cited in the Petition. (Ex. 1001 at
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`17:19-18:28, 50:5-51:45.)
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`1.
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`U.S. Patent No. 4,713,243 (“Schiraldi”) (Ex. 1004)
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`Schiraldi, a patent that issued in 1987, was among the prior art considered by
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`the Patent Office before it issued the ’150 Patent and found all of the claims of the
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`’150 Patent valid and non-obvious. (Ex. 1001 at “References Cited – U.S.
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`PATENT DOCUMENTS”.)
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`Schiraldi does not disclose or suggest using PEO of different molecular
`
`weights. It is also clear upon reading the disclosure as a whole, that its focus is on
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`using very high molecular weight PEO, such as Polyox WSR-301, which has a
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`nominal molecular weight of 4,000,000 to 5,000,000. (Ex. 1004, Schiraldi at 4:24-
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`31.) All of the examples in Schiraldi use this preferred molecular weight PEO,
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`which is at least four times higher than the “higher” molecular weight range
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`recited in the claims of the ’150 Patent. (Id. at Examples 1-7.) Moreover,
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`Schiraldi teaches away from the PEO ratios in the challenged claims – which
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`require at least 60% of the low MW PEO in the polymer component – while
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`U.S. Patent No. 8,017,150 B2
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`Schiraldi requires lower amounts of PEO (~24% to 60%) and higher amounts of
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`IPR2016-00282
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`17
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`HCP (40-95%). (Id. at 4:7-12, 2:30-43, Examples 1-7.)
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`Further, Schiraldi does not disclose an analgesic opiate pharmaceutical
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`active. It lists several classes of preferred actives, including anesthetics/analgesics
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`and provides benzocaine, dyclonine HCl, phenol, aspirin, phenacetin,
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`acetaminophen and potassium nitrate as examples (none of which are opiates).
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`(Ex. 1004, Schiraldi at 3:41-44.)
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`For all of the foregoing reasons, Petitioner has failed to show that a POSA
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`reading Schiraldi would have been motivated to make a film having the polymer
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`profile claimed in the ’150 Patent.
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`2.
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`U.S. Patent No. 6,322,811 (“Verma”) (Ex. 1005)
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`Verma does not remedy the deficiencies of Schiraldi. Petitioner has failed to
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`show that a POSA would be motivated to combine Schiraldi with Verma.
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`Although Petitioner suggests that Verma is similar to Schiraldi, it is not. (Paper 1,
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`Pet., pp. 23-24.) As an initial matter, the polymers disclosed in Verma are used to
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`make outer shells of capsules, not mucoadhesive films. (Ex. 1005, Verma at
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`Abstract, 5:1-46.) Unlike mucoadhesive films such as those claimed in the ’150
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`Patent, which must dissolve in the oral cavity to deliver the drug through the
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`lining of the mouth, the capsule shells disclosed in Verma are used to enclose the
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`U.S. Patent No. 8,017,150 B2
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`liquid filling materials contained in the capsule and must remain intact in the
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`IPR2016-00282
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`18
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`mouth. (Id. at Abstract.) The films of Verma must also be mechanically hard for
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`capsule integrity (compared to the flexible films of the ’150 Patent). (Id. at 5:31-
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`39; 9:11-12.) Moreover, since they are used as a polymer film coating, the capsule
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`shells themselves do not contain any pharmaceutical active.
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`For all of these reasons, Petitioner and its expert (whose discussion of
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`motivation is entirely conclusory) has failed to show that a POSA would have been
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`motivated to combine the contradictory teachings of Schiraldi and Verma, which
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`pertain to two completely different dosage forms, let alone have a reasonable
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`expectation of arriving at the claimed films of the ’150 Patent. Thus, the
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`combination of Schiraldi and Verma would not have rendered the challenged
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`claims of the ’150 Patent obvious.
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`B.
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`The Challenged Claims Would Not Have Been Obvious Over
`Schiraldi In View of Verma And Khan
`U.S. Patent No. 5,656,296 (“Khan”) (Ex. 1046) does not remedy the
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`deficiencies of Schiraldi or Verma. Khan was cited solely for the disclosure of
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`specific sweeteners or for the presence of one or more buffers (Paper 1, Pet., pp.
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`32-33), and does not speak to the claimed polymer profile. Thus, the challenged
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`claims are not obvious over Schiraldi in view of Verma and Khan for the same
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`reasons discussed above with respect to Schiraldi and Verma.
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`U.S. Patent No. 8,017,150 B2
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`C. The Challenged Claims Would Not Have Been Obvious Over
`Yang
`U.S. Patent Appln. Publn. No. 2005/0037055 (“Yang”) (Ex. 1006) is the
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`parent application of the ’150 Patent; the ’150 Patent was filed as a divisional of
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`Yang following a restriction requirement, and has the same inventors and assignee.
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`(Ex. 1001 at 1; Ex. 1006, Yang at 1; Ex. 1002, Response to Office Action, July 29,
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`2010 at 7-8 (pdf pages 164-165).)
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`Yang, which was published on February 17, 2005, is not prior art because as
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`explained above, the ’150 Patent has priority to at least May 28, 2003.
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`Accordingly, Yang could not render obvious the challenged claims of the ’150
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`Patent.
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`VI. CONCLUSION
`Petitioner has failed to establish a reasonable likelihood that the challenged
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`claims are unpatentable. Because Petitioner has failed to demonstrate that the
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`limitations of the challenged claims are disclosed or suggested by any of the prior
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`art and has failed to show why a POSA would have been motivated to combine the
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`cited references, Patent Owner requests that the PTAB deny inter partes review as
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`to all claims for Grounds 1 and 2. The PTAB should also deny the Ground 3 of the
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`U.S. Patent No. 8,017,150 B2
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`Petition as Petitioner’s priority argument is based on a faulty claim construction
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`and Petitioner has failed to establish that the Yang reference is prior art.
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`For the foregoing reasons, (i) Pet
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