IPR2017-00200
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`_______________
`
`
`
`MYLAN TECHNOLOGIES, INC.
`Petitioner
`
`v.
`
`MONOSOL RX, LLC,
`Patent Owner
`_______________
`
`Case: IPR2017-00200
`
`Patent 8,603,514
`_______________
`
`PRELIMINARY RESPONSE TO PETITION FOR INTER PARTES
`REVIEW OF US PATENT NO. 8,603,514
`
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`

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`I.
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`II.
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`III.
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`IV.
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`IPR2017-00200
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`TABLE OF CONTENTS
`
`INTRODUCTION .............................................................................................................. 1
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`BACKGROUND ................................................................................................................ 4
`
`CLAIM CONSTRUCTION ................................................................................................ 7
`
`A. “flowable” film-forming matrix .................................................................................... 8
`
`B. “viscosity sufficient to aid in substantially maintaining non-self-aggregating
`uniformity” .................................................................................................................... 8
`
`C. “active substantially uniformly stationed in the matrix” ............................................ 10
`
`D. “taste-masking of the active” ...................................................................................... 11
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`E. “capable of being dried without loss of substantial uniformity” ................................ 11
`
`PETITIONER HAS NOT DEMONSTRATED “A REASONABLE LIKELIHOOD OF
`PREVAILING” AGAINST AT LEAST ONE CLAIM OF THE ’514 PATENT UNDER
`35 U.S.C. § 314(A) ........................................................................................................... 11
`
`A. Petitioner fails to establish a reasonable likelihood that any challenged claim is
`unpatentable in light of the prior art. .......................................................................... 12
`
`1. DCU was a significant problem that was solved by the ’514 inventors ............... 13
`
`2. Ilango fails to disclose or teach each element of the challenged independent
`claims. ................................................................................................................... 16
`
`a. Ilango does not teach or disclose how to use matrix viscosity combined with
`drying to form a uniform cast film .................................................................. 17
`
`b. Ilango does not teach or disclose a particulate active with a particle size of 200
`microns or less. ............................................................................................... 21
`
`c. Ilango does not teach or disclose how to make a film having the claimed
`uniformity. ...................................................................................................... 22
`
`d. Ilango’s other disclosures are also insufficient. .............................................. 27
`
`ii
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`

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`V.
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`IPR2017-00200
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`3. Petitioner’s additional reference has already been considered by the Board and
`found insufficient. ................................................................................................. 30
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`CONCLUSION ................................................................................................................. 32
`
`
`iii
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`

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`IPR2017-00200
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`Page(s)
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`TABLE OF AUTHORITIES
`
`
`
`
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`
`
`Cases
`Abbott Labs. v. Sandoz, Inc.,
`544 F.3d 1341 (Fed. Cir. 2008) .......................................................................... 13
`
`ACTV, Inc. v. Walt Disney Co.,
`346 F.3d 1082 (Fed. Cir. 2003) .......................................................................... 10
`
`Biodelivery Sciences Int’l, Inc. v. MonoSol Rx, LLC,
`IPR2015-00165, Paper 70 (PTAB March 24, 2016) ................................ 4, 24-25
`
`Biodelivery Sciences Int’l, Inc. v. MonoSol Rx, LLC,
`IPR2015-00165, Paper 76 (PTAB August 11, 2016) ........................................... 4
`
`Biodelivery Sciences Int’l, Inc. v. MonoSol Rx, LLC,
`IPR2015-00167, Paper 9 (PTAB November 12, 2015) ........................................ 4
`
`Biodelivery Sciences Int’l, Inc. v. MonoSol Rx, LLC,
`IPR2015-00168, Paper 69 (PTAB March 24, 2016) .......................................... 25
`
`Biodelivery Sciences Int’l, Inc. v. MonoSol Rx, LLC,
`IPR2015-00168, Paper 73 (PTAB August 11, 2016) ........................................... 4
`
`Biodelivery Sciences Int’l, Inc. v. MonoSol Rx, LLC,
`IPR2015-00169, Paper 69 (PTAB March 24, 2016) ...................................... 4, 25
`
`Biodelivery Sciences Int’l, Inc. v. MonoSol Rx, LLC,
`IPR2015-00169, Paper 74 (PTAB August 11, 2016) ........................................... 4
`
`Cardiac Pacemakers, Inc. v. St. Jude Med., Inc.,
`381 F.3d 1371 (Fed. Cir. 2004) .......................................................................... 13
`
`Cuozzo Speed Techs., LLC v. Lee,
`136 S. Ct. 2131 (2016) .......................................................................................... 7
`
`Dr. Reddy’s Laboratories, Ltd. v. MonoSol Rx, LLC,
`IPR2016-01111, Paper 14 ( PTAB Dec. 5, 2016) ................................................ 3
`
`iv
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`

`

`
`
`In re Suitco Surface, Inc.,
`603 F.3d 1255 (Fed. Cir. 2010) ............................................................................ 7
`
`IPR2017-00200
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`Insite Vision Inc. v. Sandoz, Inc.,
`783 F.3d 853 (Fed. Cir. 2015) ............................................................................ 14
`
`Institut Pasteur v. Focarino,
`738 F.3d 1337 (Fed. Cir. 2013) .......................................................................... 14
`
`Microsoft Corp. v. Proxyconn, Inc.,
`IPR2012-00026, Paper 17 (PTAB Dec. 21, 2012) ............................................... 7
`
`Phillips v. AWH Corp.,
`415 F.3d 1303 (Fed. Cir. 2005) (en banc) ............................................................ 9
`
`Teva Pharmaceuticals USA, Inc. v. MonoSol Rx, LLC,
`IPR2016-00281, Paper 21 (PTAB May 23, 2016) ............................................... 3
`
`
`
`Statutes
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`35 U.S.C. § 103 .......................................................................................................... 1
`
`35 U.S.C. § 313 .......................................................................................................... 1
`
`35 U.S.C. § 314(A) ............................................................................................ 11, 32
`
`Other Authorities
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`37 C.F.R. 42.107 ........................................................................................................ 1
`
`37 C.F.R. § 42.100(b) ................................................................................................ 7
`
`77 Fed. Reg. 48756, 48763, 48766 (Aug. 14, 2012) ..................................... 7, 22, 25
`
`v
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`

`

`IPR2017-00200
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`PATENT OWNER’S EXHIBIT LIST
`
`DESCRIPTION
`
`Trial Transcript, Reckitt Benckiser Pharms
`Inc. v. Watson Laboratories, Inc. et al., CA
`No. 14-1574-RGA (Nov. 3-4, 2015) (“Trial
`Tr.”)
`Reckitt Benckiser Pharmaceuticals Inc. v.
`Watson Laboratories, Inc. et al., Civil Case
`No. 1:13-1674, slip opinion (D. Del. June 3,
`2016) (Richard G. Andrews, J.) (Reckitt v.
`Watson)
`J. O. Morales and J. T. McConville,
`Manufacture and Characterization of
`Mucoadhesive Buccal Films, European
`Journal of Pharmaceutics and v
`Biopharmaceutics 77, pp. 187-99 (2011)
`A. F. Borges et al., Oral Films: Current Status
`and Future Perspectives II – Intellectual
`Property, Technologies and Market Needs,
`Journal of Controlled Release 206, pp. 108-21
`(2015)
`V.A. Perumal et al., Investigating a New
`Approach to Film Casting for Enhanced Drug
`Content Uniformity in Polymeric Films, Drug
`Dev. & Indust. Pharm. 34, pp. 1036-47 (2008)
`H. Kathpalia and A. Gupte, An Introduction to
`Fast Dissolving Oral Thin Film Drug Delivery
`Systems: A Review, Drug Delivery &
`Formulation 10, pp. 667-84 (2013)
`
`
`
`
`
`
`EXHIBIT
`
`
`
`2001
`
`2002
`
`2003
`
`2004
`
`2005
`
`2006
`
`
`
`vi
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`

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`IPR2017-00200
`
`Patent Owner MonoSol Rx, LLC (“MonoSol”) respectfully submits this
`
`Preliminary Response to the Petition seeking inter partes review of U.S. Patent No.
`
`8,603,514 (“the ’514 patent”) filed by Mylan Technologies, Inc. (“Petitioner”).
`
`This filing is timely under 35 U.S.C. § 313 and 37 C.F.R. 42.107, because it is
`
`within three months of the November 16, 2016 date of the Notice granting the
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`Petition a filing date. (Paper No. 3, Notice of Filing Date, November 4, 2016).
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`I.
`
`INTRODUCTION
`MonoSol respectfully submits that inter partes review of the ’514 patent
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`should not be instituted in this matter because Petitioner has failed to meet its
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`burden of demonstrating in its Petition that it has a reasonable likelihood of
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`prevailing with respect to any of the challenged claims.1 The ’514 patent, which
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`addresses issues in maintaining drug content uniformity in pharmaceutical film,
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`has withstood multiple validity challenges in district court and before this Board.
`
`Petitioner again challenges using references that are no better than those used in
`
`the prior challenges. Specifically, the Petition falls short for at least the following
`
`1 Patent Owner’s election not to address (in this Preliminary Response) the
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`substance of claim construction, all of the prior art references, or all of the merits
`
`of Petitioner’s arguments based on 35 U.S.C. § 103 does not constitute a waiver of
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`these arguments or an admission that any prior art reference anticipates or renders
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`obvious the claims of the ’514 patent.
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`1
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`

`

`
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`reasons.
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`IPR2017-00200
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`First, the Ilango prior art reference does not teach or disclose any of the
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`essential claim elements. Ilango does not teach uniformity of content of an active
`
`ingredient that does not vary by more than 10% from the desired amount. Ilango
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`also does not teach anything about the roles of viscosity or controlled drying in
`
`maintaining drug content uniformity. At best, Ilango describes an alternative film
`
`to those claimed in the ’514 patent.
`
`Second, a district court and the Board have already considered the ’514
`
`patent in light of some of Petitioner’s cited references and found that the patent
`
`was not invalid. For example, the United States District Court for the District of
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`Delaware held that Defendants’ prior art references, including the Chen reference
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`cited by Mylan in the Petition, “do not disclose or render obvious the asserted
`
`claims’ requirement that drug content uniformity of the matrix subsequent to
`
`casting and drying does not vary by more than 10% of the desired amount of
`
`active.” Ex. 2002, Reckitt Benckiser Pharmaceuticals Inc. v. Watson Laboratories,
`
`Inc. et al., Civil Case No. 1:13-1674, slip op. at 42 (D. Del. June 3, 2016) (Richard
`
`G. Andrews, J.) (Reckitt v. Watson). The District Court further held that
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`“Defendants failed to meet their burden with respect to expectation of success in
`
`achieving drug content uniformity within 10%” and “Plaintiffs showed that the
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`’514 patent and its drug content uniformity limitation garnered praise in the
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`2
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`

`

`
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`industry.” Id. Based on later references, the district court also found that
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`IPR2017-00200
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`achieving uniformity within the claimed range was a “significant challenge,” and
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`that a person having ordinary skill in the art could not fill in all of the gaps through
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`mere routine testing or knowledge in the art. Id. at 38-40.
`
`Similarly, the Board has already rejected challenges and denied IPR
`
`institutions regarding the same claims of the ’514 Patent by two other accused
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`infringers based on one of the same references discussed in Mylan’s Petition
`
`(Chen). In one case, the challenge was rejected as statutorily barred (Teva
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`Pharmaceuticals USA, Inc. v. MonoSol Rx, LLC, IPR2016-00281, Paper 21). In
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`another, the challenge was rejected on the merits (IPR2016-01111, Paper 14
`
`(hereafter “the DRL IPR Decision”). In the latter case, the Board held: “For all of
`
`the foregoing reasons, we determine
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`that Petitioner has not established
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`persuasively that a person of ordinary skill in the art would have found it obvious
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`to combine the teachings of Bess and Chen in a manner that resulted in a cast film
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`drug delivery system wherein the uniformity subsequent to casting and drying the
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`matrix is measured by substantially equally sized individual unit doses which do
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`not vary by more than 10% of the active agent, as required by independent claims
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`1 and 62.” Id. at 17.
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`The Board has also considered a related patent in Biodelivery Sciences Int’l,
`
`Inc. v. MonoSol Rx, LLC, IPR2015-00165, IPR2015-00168 and IPR2015-00169
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`3
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`

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`
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`(collectively, “the ’167 IPRs”), which reviewed claims of U.S. Patent No.
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`IPR2017-00200
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`8,765,167 (“the ’167 patent”). The ’167 patent claims have language similar to
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`that of the challenged claims of the ’514 patent, namely the requirement that the
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`amount of active in individual unit doses does not vary by more than 10% of the
`
`desired amount. In all three of the ’167 IPRs, the Board entered Final Decisions
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`finding the challenged claims patentable over the same or similar references cited
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`in this Petition and concluded that none of these references taught or suggested,
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`inter alia, a distribution of active that does not vary by more than 10% of the
`
`desired amount of the active.2 See, e.g., IPR2015-00165, Paper 70 at 30; IPR2015-
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`00169, Paper 69 at 37.
`
`II. BACKGROUND
`The ’514 patent challenged by Petitioner in these proceedings is listed in the
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`FDA’s Orange Book for Suboxone® Film, a treatment for opioid dependence that
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`is the first sublingual pharmaceutical film ever approved by the FDA. The
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`challenged claims are directed to cast films containing, among other things, a
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`particulate active having a specific level of uniformity. Claims 1 and 62 each
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`2 A fourth IPR, IPR2015-00167, was also filed against the ’167 patent, but the
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`Board denied institution of this petition entirely. The Board has also denied
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`requests for rehearing in all four cases. See IPR2015-00165, Paper 76; IPR2015-
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`00167, Paper 9; IPR2015-00168, Paper 73; IPR2015-00169, Paper 74.
`
`4
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`

`

`
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`claim in full:
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`IPR2017-00200
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`Claim 1. A drug delivery composition comprising:
`(i) a cast film comprising a flowable water-soluble or water
`swellable film-forming matrix comprising one or more substantially
`water soluble or water swellable polymers; and a desired amount of at
`least one active;
`wherein said matrix has a viscosity sufficient to aid in substantially
`maintaining non-self-aggregating uniformity of the active in the matrix;
`(ii) a particulate active substantially uniformly stationed in the
`matrix; and
`(iii) a taste-masking agent coated or intimately associated with
`said particulate to provide taste-masking of the active;
`wherein the combined particulate and taste-masking agent have a
`particle size of 200 microns or less and said flowable water-soluble or
`water swellable film-forming matrix is capable of being dried without
`loss of substantial uniformity in the stationing of said particulate active
`therein; and
`wherein the uniformity subsequent to casting and drying of the
`matrix is measured by substantially equally sized individual unit doses
`which do not vary by more than 10% of said desired amount of said at
`least one active.
`Claim 62. A drug delivery composition comprising:
`(i) a cast film comprising a flowable water-soluble or water
`swellable film-forming matrix comprising one or more substantially
`water soluble or water swellable polymers; and a desired amount of at
`least one active;
`
`5
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`

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`
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`IPR2017-00200
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`wherein said matrix has a viscosity sufficient to aid in substantially
`maintaining non-self-aggregating uniformity of the active in the matrix;
`(ii) a particulate active substantially uniformly stationed in the
`matrix; and
`(iii) a taste-masking agent selected from the group consisting of
`flavors, sweeteners, flavor enhancers, and combinations thereof to
`provide taste-masking of the active;
`wherein the particulate active has a particle size of 200 microns or
`less and said flowable water-soluble or water swellable film-forming
`matrix is capable of being dried without loss of substantial uniformity in
`the stationing of said particulate active therein; and
`wherein the uniformity subsequent to casting and drying of the
`matrix is measured by substantially equally sized individual unit doses
`which do not vary by more than 10% of said desired amount of said at
`least one active.
`Ex. 1001, ’514 patent at Claims 1, 62 (emphasis added).
`
`As is apparent from the claim language, challenged claims 1 and 62 both
`
`require that the amount of active in individual unit doses cut from the final film do
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`not vary by more than 10% of the desired amount (drug content uniformity (DCU)
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`limitation). See id. Those two challenged claims are independent claims from
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`which all other challenged claims depend. See Pet. at 1; Ex. 1001, ’514 patent at
`
`Claims 1–3, 9, 15, 62–65, 69–73, 75.
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`Dependent claims 9 and 65 require an even higher degree of drug content
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`uniformity. They are directed to the drug delivery composition of the respective
`
`6
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`

`

`
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`independent claims, “wherein said variation of drug content is less than 5% by
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`IPR2017-00200
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`weight per film dosage unit.” Ex. 1001, ’514 patent at Claims 9, 65 (emphasis
`
`added).
`
`III. CLAIM CONSTRUCTION
`In an inter partes review, claim terms are interpreted according to their
`
`“broadest reasonable construction in light of the specification of the patent in
`
`which it appears.” Cuozzo Speed Techs., LLC v. Lee, 136 S. Ct. 2131, 2136
`
`(2016); see also id. at 2144–45; 37 C.F.R. § 42.100(b); Office Patent Trial Practice
`
`Guide, 77 Fed. Reg. 48756, 48766 (Aug. 14, 2012). The broadest reasonable
`
`interpretation must be consistent with the specification. In re Suitco Surface, Inc.,
`
`603 F.3d 1255, 1259–60 (Fed. Cir. 2010) (“[C]laims should always be read in light
`
`of the specification and teachings in the underlying patent” when determining their
`
`broadest reasonable construction).
`
`In the absence of a reasonable claim construction, a petitioner cannot show a
`
`reasonable likelihood of success on its grounds for unpatentability. See Microsoft
`
`Corp. v. Proxyconn, Inc., IPR2012-00026, Paper 17 at p. 24 (PTAB Dec. 21, 2012)
`
`(explaining that “[a]s this argument is premised on Petitioners’ erroneous claim
`
`construction we are not persuaded of a reasonable likelihood of prevailing.”).
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`Because Petitioner has not offered a reasonable claim construction for several of
`
`the proposed claim terms, that deficiency is an independent reason why Petitioner
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`7
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`
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`has not demonstrated that it has a reasonable likelihood of showing that the claims
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`IPR2017-00200
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`are unpatentable.
`
`“flowable” film-forming matrix
`
`A.
`Petitioner asserts that the term “flowable” should be construed as “having a
`
`flowable film-forming matrix before drying.” Pet. at 25. There is no need to
`
`construe this term as it has no effect on the Board’s analysis, and it should be given
`
`its plain and ordinary meaning. This is consistent with the district court’s
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`construction of this term. Ex. 1024 at 14.
`
`B.
`
`“viscosity sufficient to aid in substantially maintaining non-self-
`aggregating uniformity”
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`Petitioner next asserts that the phrase “viscosity sufficient to aid in
`
`substantially maintaining non-self-aggregating uniformity” should be construed as
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`“a viscous solution in which the particulate active is dispersed uniformly with
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`continuous mixing.” Pet. at 26. In effect, by eliminating the plainly understood
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`language of “viscosity sufficient to aid in substantially maintaining,” this proposed
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`construction reads the viscosity limitation out of the claim and replaces it with a
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`“continuous mixing” limitation. Another effect of this improper construction is to
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`suggest that viscosity only plays a role in maintaining uniformity during the initial
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`mixing step of the casting process. But no further mixing is conducted during
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`casting and drying and, as the patent explains, viscosity continues to play a role
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`during those crucial post-mixing phases of the overall casting process. Ex. 1001,
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`8
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`

`

`
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`23:7–11 (“In addition, the faster drying time allows viscosity to quickly build-up
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`IPR2017-00200
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`within the film, further encouraging a uniform distribution of components and
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`decrease in aggregation of components in the final film product.”).
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`In support of its unreasonable position, Petitioner relies on a misreading of
`
`the district court’s prior decisions. Pet. at 26 (citing 1023 at 49–50 and 1024 at
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`15). In the district court case, the Court found simply that viscosity alone need not
`
`create the desired uniformity. See Claim 62 (viscosity must be “sufficient to aid in
`
`substantially maintaining non-self-aggregating uniformity” (emphasis added)).
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`Rather, other processing aspects such as mixing may also contribute to uniformity,
`
`and the contribution of mixing to uniformity does not automatically put an accused
`
`infringer outside the scope of the claims. The Court did not find that mixing can
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`replace the viscosity limitation as Petitioner suggests. Ex. 1023 at 49–50 (“Claim
`
`62 requires that viscosity be ‘sufficient to aid’ in maintaining drug content
`
`uniformity in the matrix. (’514 patent, 73:53–55; D.I. 156 at 15). That the
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`viscosity of [Par’s prototype film] was able to prevent dis-uniformity caused by
`
`settlement is evidence that it contributes to uniformity in the matrix, even if mixing
`
`also contributes significantly.”). For the foregoing reasons, Petitioner’s proposed
`
`incorrect construction should be rejected, and the broadest reasonable construction
`
`of the claim term should be its plain meaning.
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`9
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`IPR2017-00200
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`“active substantially uniformly stationed in the matrix”
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`C.
`Petitioner next asserts that the phrase “active substantially uniformly
`
`stationed in the matrix” should be construed as “an active that is dispersed
`
`uniformly in the matrix.” Pet. at 26. With this proposed construction, Petitioner
`
`reads “substantially” out of the term. This term must be read in the context of the
`
`rest of the claim, which defines “substantial uniformity” as uniformity which “does
`
`not vary by more than 10% of the intended amount of the active.” See Phillips v.
`
`AWH Corp., 415 F.3d 1303, 1314 (Fed. Cir. 2005) (en banc) (“[T]he context in
`
`which a term is used in the asserted claim can be highly instructive.”); ACTV, Inc.
`
`v. Walt Disney Co., 346 F.3d 1082, 1088 (Fed. Cir. 2003) (“While certain terms
`
`may be at the center of the claim construction debate, the context of the
`
`surrounding words of the claim also must be considered in determining the
`
`ordinary and customary meaning of those terms.”) This is important because, if
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`the desired uniformity is not obtained in the matrix, it will not be improved in the
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`subsequent casting and drying steps. Ex. 2001, Tr. at 474:17–476:13. As the
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`district court has already found, when read in view of the entire claim, this claim
`
`term should be construed to mean “[s]tationed in the matrix such that individual
`
`dosage units do not vary by more than 10% from the intended amount of active for
`
`that dosage unit.” Ex. 1024 at 16. This is consistent with giving the phrase its
`
`plain meaning when read in the context of the entire claim. If construction is
`
`10
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`

`
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`deemed necessary, the district court’s construction should be adopted as it
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`IPR2017-00200
`
`addresses the claim language as a whole.
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`“taste-masking of the active”
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`D.
`Petitioner next asserts that the phrase “taste-masking of the active” should be
`
`construed in claim 62 to include “taste-masking agents that do not coat and are not
`
`intimately associated with the active.” Pet. at 28. Although Patent Owner does not
`
`disagree with this as the broadest reasonable construction, there is no need to
`
`construe this term, as doing so would have no effect on the Board’s analysis; and it
`
`should be given its plain and ordinary meaning.
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`“capable of being dried without loss of substantial uniformity”
`
`E.
`Petitioner next asserts that the phrase “capable of being dried without loss of
`
`substantial uniformity” should be construed as “a film matrix that is capable of
`
`being dried such that individual dosage units do not vary by more than 10% from
`
`the intended amount of active for that dosage unit.” Pet. at 28-29. The Board has
`
`already construed this term to have its plain meaning. DRL IPR Decision at 6.
`
`IV. PETITIONER HAS NOT DEMONSTRATED “A REASONABLE
`LIKELIHOOD OF PREVAILING” AGAINST AT LEAST ONE
`CLAIM OF THE ’514 PATENT UNDER 35 U.S.C. § 314(A)
`
`MonoSol respectfully submits that the Petition should be denied because
`
`Petitioner fails to establish that any prior art reference or combination of references
`
`teaches how to achieve drug content uniformity subsequent to casting and drying
`
`of the matrix, where such uniformity is measured by substantially equally sized
`
`11
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`

`

`
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`individual unit doses which “do[es] not vary by more than 10%” from the desired
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`IPR2017-00200
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`amount. Ilango also does not teach anything about how to achieve content
`
`uniformity in a cast film of the type described in the ’514 patent, including the
`
`absence of any discussion, much less teaching, about the roles of viscosity or
`
`controlled drying in maintaining drug content uniformity. At best, Ilango describes
`
`an alternative film to those claimed in the ’514 patent. Because none of the other
`
`references cited by Petitioner cures this deficiency (indeed, Petitioner relies on the
`
`Ilango reference only for this essential claim limitation), the Petition should be
`
`denied.
`
`A.
`
`Petitioner fails to establish a reasonable likelihood that any
`challenged claim is unpatentable in light of the prior art.
`
`Petitioner has failed to establish a reasonable likelihood that the challenged
`
`claims are unpatentable over the asserted references. Claims 1 and 62 are
`
`independent claims from which all other challenged claims depend, and each
`
`contains a 10% drug content uniformity (DCU) element that Petitioner fails to
`
`demonstrate is disclosed or even suggested by the prior art. Because Petitioner has
`
`not shown a reasonable likelihood that claims 1 and 62 would have been obvious
`
`over the prior art, MonoSol requests denial of inter partes review as to all claims.
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`Challenged independent claims 1 and 62 each require an element that is
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`taught nowhere in the prior art. Specifically, the claims each set forth that:
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`… the uniformity subsequent to casting and drying of the matrix is
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`measured by substantially equally sized individual unit doses which do
`not vary by more than 10% of said desired amount of said at least one
`active.
`Because the references fail to disclose the 10% DCU of the challenged
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`claims, the references also do not disclose the more limited 5% DCU limitation.
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`The Petition should also be denied as to claims 9 and 65 on the separate basis that
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`Petitioner has failed to show a reasonable likelihood that the 5% uniformity
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`limitation of those claims is disclosed or suggested by the prior art.
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`1.
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`DCU was a significant problem that was solved by the ’514
`inventors
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`Petitioner ignores the uncontroverted facts regarding the actual development
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`of pharmaceutical cast films. The first pharmaceutical film was not approved and
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`launched until 2009, more than a decade after the prior art that Petitioner claims
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`made the invention of the ’514 patent obvious. Ex. 2001, Tr. 473:5–14 (Langer).
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`And as discussed below, several publications after the 2002 priority date for the
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`’514 patent credit its inventors with not only identifying the problem in
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`maintaining DCU in cast films throughout the casting and drying process, but also
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`uniquely solving that problem by addressing a number of factors that can result in
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`disuniformity. Such factors include, among other things, choosing a matrix of
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`sufficient viscosity to aid in substantially preventing particle aggregation and using
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`controlled drying conditions.
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`Additionally, even if a person of ordinary skill would have been motivated
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`to achieve the claimed DCU, “[r]ecognition of a need does not render obvious the
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`achievement that meets that need. . . . Recognition of an unsolved problem does
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`not render the solution obvious.” Cardiac Pacemakers, Inc. v. St. Jude Med., Inc.,
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`381 F.3d 1371, 1377 (Fed. Cir. 2004); see also Abbott Labs. v. Sandoz, Inc., 544
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`F.3d 1341, 1352 (Fed. Cir. 2008) (same). Rather, a finding of obviousness requires
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`both “a design need or market pressure to solve a problem and . . . a finite number
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`of identified, predictable solutions.” Insite Vision Inc. v. Sandoz, Inc., 783 F.3d
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`853, 858 (Fed. Cir. 2015) (quoting KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 421
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`(2007) (emphasis added)); see also Institut Pasteur v. Focarino, 738 F.3d 1337,
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`1346 (Fed. Cir. 2013). Petitioner tellingly has not identified a single solution to the
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`DCU problem, much less a finite number of identified, predictable solutions.
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`Nor could Petitioner point to such solutions, because as the district judge
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`found, “[d]rug content uniformity was a significant challenge in the manufacture of
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`pharmaceutical films before and after the priority date of the ’514 patent.” Ex.
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`2002, Reckitt v. Watson at 34 (Finding of Fact No. 5). “[A]chieving drug content
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`uniformity was not something that could be accomplished before the priority date
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`of the ’514 patent by applying identified strategies to achieve predictable results.”
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`Id. at 40.
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`Indeed, far from mere knowledge in the art or “routine experimentation,”
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`achieving DCU was a challenging undertaking recognized as such by the scientific
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`community; multiple articles in peer-reviewed journals considered the ’514 patent
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`“seminal” and were “highly complementary” toward the inventors’ discovery of
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`why pharmaceutical films may show poor DCU and its solution to the DCU
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`problem. Ex. 2001, Tr. 494:2–496:13 (Langer); Ex. 2003 at 191 (McConville)
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`(“Since the early development of medicated films, content uniformity has been a
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`major challenge for the pharmaceutical scientist.”); Ex. 2004 at 116 (Borges). The
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`Borges article, authored in 2015, lauds MonoSol as “one of the pioneer companies
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`in the oral film industry.” Ex. 2001, Tr. 502:6–503:2 (Langer); Ex. 2004 at 109
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`(Borges). Moreover, both the McConville and Perumal articles credited the ’514
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`patent inventors with discovering that the agglomeration of active particles that led
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`to non-uniformity was caused by “the relatively long drying times, which
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`facilitated intermolecular attractive forces, convection forces, and air flow which
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`aided in the formation of such conglomerates.” Ex. 2005 at 1038 (Perumal); see
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`also Ex. 2003 at 191 (McConville); Ex. 2001, Tr. 483:2–484:14, 494:2–496:13,
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`502:6–503:17 (Langer). Such praise by skilled artisans would hardly have been
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`warranted, had achieving desirable uniformity been a simple matter of “routine
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`experimentation” or something that was already well-known in the art.
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`Additionally, the literature indicates that others had tried, but failed, to
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`achieve uniform pharmaceutical cast films. See, e.g., Ex. 2005 at 1038–39
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`(Perumal) (discussing difficulties and failures both in the art and with experiments
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`conducted in an attempt to achieve uniform films); Ex. 2003 at 188, 191
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`(McConville) (espousing the benefits of film dosage forms, and explaining failures
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`in achieving uniform films); Ex. 2006 at 667–68 (Kathpalia) (stating that “[f]ast
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`dissolving drug delivery systems” like oral thin films had been around since the
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`“late 1970s,” but that “[d]ose uniformity is difficult to maintain” in oral thin films)
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`(emphasis added). These failures were not for lack of trying. There was a long-
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`felt need to develop a pharmaceutical film with DCU sufficient to receive FDA
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`approval, because the prior art did not teach how to achieve DCU for a
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`pharmaceutical cast film. Ex. 2001, Tr. 472:5–473:14 (Langer), 323:7–326:4
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`(Dyar); Ex. 2003 at 191 (McConville); Ex. 1001, ’514 patent at 2:38–46. And
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`DCU was widely vi