IPR2016-01111
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`_______________
`
`
`
`DR. REDDY’S LABORATORIES, LTD. AND DR. REDDY’S
`LABORATORIES, INC.,
`Petitioners
`
`v.
`
`MONOSOL RX, LLC,
`Patent Owner
`_______________
`
`Case: IPR2016-01111
`
`Patent 8,603,514
`_______________
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`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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`IPR2016-01111
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`TABLE OF CONTENTS
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`INTRODUCTION ........................................................................................... 1
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`BACKGROUND ............................................................................................. 3
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`III. CLAIM CONSTRUCTION ............................................................................ 7
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`A.
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`“dried without loss of substantial uniformity” (Claims 1 and 62) ........ 8
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`IV. PETITIONERS HAVE NOT DEMONSTRATED “A REASONABLE
`LIKELIHOOD OF PREVAILING” AGAINST AT LEAST ONE CLAIM
`OF THE ’514 PATENT UNDER 35 U.S.C. § 314(A) ................................... 9
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`A.
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`Petitioners fail to establish a reasonable likelihood that any challenged
`claim is unpatentable in light of the prior art. ..................................... 10
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`1.
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`2.
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`Bess and Chen fail to disclose or teach each element of the
`challenged independent claims. ................................................ 11
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`Chen and Cremer fail to disclose or teach each element of the
`challenged independent claims. ................................................ 26
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`B.
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`Petitioners’ use of other proceedings is misplaced. ............................ 28
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`1.
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`2.
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`Petitioners’ cited reexamination proceedings have no bearing
`on these proceedings. ................................................................ 29
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`Petitioners fail to notify the Board of highly relevant findings
`by the Board and the District of Delaware concerning Chen and
`the ’514 patent. .......................................................................... 31
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`V.
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`CONCLUSION .............................................................................................. 34
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`ii
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`IPR2016-01111
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`TABLE OF AUTHORITIES
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`
`CASES
`Abbott Labs. v. Sandoz, Inc.,
`544 F.3d 1341, 1352 (Fed. Cir. 2008) ................................................................ 17
`
`Page(s)
`
`ACTV, Inc. v. Walt Disney Co.,
`346 F.3d 1082, 1088 (Fed. Cir. 2003) .................................................................. 9
`
`Apple Inc. v. ContentGuard Holdings, Inc.,
`IPR2015-00441, Paper 11 (PTAB July 13, 2015) .............................................. 21
`
`Cardiac Pacemakers, Inc. v. St. Jude Med., Inc.,
`381 F.3d 1371, 1377 (Fed. Cir. 2004) ................................................................ 17
`
`Cuozzo Speed Techs., LLC v. Lee,
`136 S. Ct. 2131, 2136 (2016) ................................................................................ 7
`
`In re Oelrich,
`666 F.2d 578 (CCPA 1981) ................................................................................ 25
`
`In re Rijckaert,
`9 F.3d 1531, 1534 (Fed. Cir. 1993) .................................................................... 25
`
`In re Suitco Surface, Inc.,
`603 F.3d 1255, 1259–60 (Fed. Cir. 2010) ............................................................ 7
`
`Insite Vision Inc. v. Sandoz, Inc.,
`783 F.3d 853, 858 (Fed. Cir. 2015) .................................................................... 17
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`Institut Pasteur v. Focarino,
`738 F.3d 1337, 1346 (Fed. Cir. 2013) ................................................................ 17
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`InTouch Techs., Inc. v. VGO Commc’ns, Inc.,
`751 F.3d 1327, 1347 (Fed. Cir. 2014) ................................................................ 18
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`K/S HIMPP v. Hear-Wear Techs., LLC,
`751 F.3d 1362, 1366 (Fed. Cir. 2014) ................................................................ 16
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`KSR Int’l Co. v. Teleflex Inc.,
`550 U.S. 398, 421 (2007) .............................................................................. 17, 18
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`IPR2016-01111
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`Microsoft Corp. v. Proxyconn, Inc.,,
`IPR2012-00026, Paper 17 (PTAB Dec. 21, 2012) ....................................... 17, 18
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`Perfect Web Techs., Inc. v. InfoUSA, Inc.,
`587 F.3d 1324, 1329 (Fed. Cir. 2009) ................................................................ 18
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`Pfizer, Inc. v. Apotex, Inc.,
`480 F.3d 1348, 1367 (Fed. Cir. 2007) ................................................................ 16
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`Phillips v. AWH Corp.,
`415 F.3d 1303, 1314 (Fed. Cir. 2005) (en banc) .................................................. 9
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`Plantronics, Inc. v. Aliph, Inc.,
`724 F.3d 1343, 1354 (Fed. Cir. 2013) ................................................................ 22
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`Reckitt Benckiser Pharmaceuticals Inc. et al. v. Teva Pharmaceuticals USA,
`Inc.,Civil Case No. 1:14-01451 (D. Del. Dec. 2, 2014) ....................................... 6
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`Reckitt Benckiser Pharmaceuticals Inc. v. Watson Laboratories, Inc. et al.,
`Civil Case No. 1:13-1674 (D. Del. June 3, 2016) (Richard G. Andrews,
`J.) ..................................................................................................................passim
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`TriMed, Inc. v. Stryker Corp.,
`608 F.3d 1333, 1343 (Fed. Cir. 2010) ................................................................ 16
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`STATUTES
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`35 U.S.C. § 103 .......................................................................................................... 1
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`35 U.S.C. § 313 .......................................................................................................... 1
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`35 U.S.C. § 314(A) .................................................................................................... 9
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`35 U.S.C. § 315(b) ..................................................................................................... 6
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`CODE OF FEDERAL REGULATIONS
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`37 C.F.R. 42.107 ........................................................................................................ 1
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`37 C.F.R. § 42.100(b) ................................................................................................ 7
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`OTHER AUTHORITIES
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`OTHER AUTHORITIES
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`IPR2016-01111
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`IPR2016-01111
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`77 Fed. Reg. 48756, 48766 (Aug. 14, 2012) ............................................................. 7
`77 Fed. Reg. 48756, 48766 (Aug. 14, 2012) ........................................................... ..7
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`EXHIBIT
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`2001
`2002
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`2003
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`2004
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`2005
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`2006
`2007
`2008
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`2009
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`2010
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`2011
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`2012
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`2013
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`IPR2016-01111
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`PATENT OWNER’S EXHIBIT LIST
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`
`DESCRIPTION
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`Transcript of Conference Call of August 1, 2015
`Redline comparison of Teva petition in IPR2016-00282
`and Dr.Reddy’s petition in IPR2016-01112
`Redline comparison of Dr. Das declaration in Teva
`IPR2016-00282 and Dr. Mumper declaration in Dr.
`Reddy’s IPR2016-01112
`“Dr. Reddy’s to acquire product portfolio from TEVA
`for US Market,” Press Release, June 11, 2016
`Email from Dr. Reddy’s counsel summarizing meet and
`confer teleconference conducted July 6, 2016
`Teva/Allergan Divestiture Products Table
`FTC Complaint with list of products
`“Teva Pharm finalizing asset sales to clear Allergan
`deal: source,” Reuters, May 5, 2016
`June 3, 2016 Trial Opinion, Reckitt v. Watson, 1:13-cv-
`1674 (D. Del.) (Richard G. Andrews, J.)
`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).
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`vi
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`IPR2016-01111
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`Patent Owner MonoSol Rx, LLC (“MonoSol”) respectfully submits this
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`Preliminary Response to the Petition seeking inter partes review of U.S. Patent No.
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`8,603,514 (“the ’514 patent”) filed by Dr. Reddy’s Laboratories, Ltd. and Dr.
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`Reddy’s Laboratories, Inc. (“Petitioners”). This filing is timely under 35 U.S.C. §
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`313 and 37 C.F.R. 42.107, because it is within three months of the June 6, 2016
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`date of the Notice granting the Petition a filing date. (Paper No. 3, Notice of Filing
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`Date, May 31, 2016).
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`I.
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`INTRODUCTION
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`MonoSol respectfully submits that inter partes review of the ’514 patent
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`should not be instituted in this matter because Petitioners have failed to meet their
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`burden of demonstrating in their Petition that there is a reasonable likelihood of
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`prevailing with respect to any of the challenged claims.1 Specifically, the Petition
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`falls short for at least the following reasons.
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`First, none of the asserted prior art references disclose or teach an essential
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`claim element—sample-to-sample uniformity of content of an active ingredient
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`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
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`of Petitioners’ 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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`that does not vary by more than 10% of the desired amount. Petitioners tacitly
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`IPR2016-01111
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`concede this. Petition at 27. Petitioners therefore argue that a skilled artisan
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`would have needed only routine experimentation to achieve the claimed invention
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`or, alternatively, that the claimed uniformity is inherent to the prior art. Neither is
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`true. And, a district court has already considered the ’514 patent in light of
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`Petitioners’ art and rejected those exact same arguments. See Ex. 2009, Reckitt
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`Benckiser Pharmaceuticals Inc. v. Watson Laboratories, Inc. et al., Civil Case No.
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`1:13-1674, slip op. at 38-40 (D. Del. June 3, 2016) (Richard G. Andrews, J.)
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`(Reckitt v. Watson). Three days after the Petition was filed, the court found that
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`the same references cited here do not teach uniformity within the claimed range,
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`that such uniformity was a “significant challenge” based on later references, 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. Moreover, the court held that the
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`combination of these references cannot be made due to conflicting teachings about
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`particle size. Id.
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`Second, Petitioners’ reliance on other proceedings is misplaced because the
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`claims at issue in those proceedings are not similar to the claims of the ’514 patent.
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`Rather, what are relevant, but Petitioners ignore, are the Board’s decisions in
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`IPR2015-00165, IPR2015-00168 and IPR2015-00169 (collectively, “the ’167
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`IPRs”)—which reviewed claims of U.S. Patent No. 8,765,167 (“the ’167 patent”).
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`2
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`Unlike the patents considered in the proceedings cited by Petitioners, the ’167
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`IPR2016-01111
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`patent claims have language more similar to that of the challenged claims of the
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`’514 patent, namely the requirement that the amount of active does not vary by
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`more than 10% of the desired amount. In all three of the ’167 IPRs, Final
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`Decisions have been entered finding the challenged claims patentable over the
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`same or similar references cited in this Petition after the Board found that none of
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`these references taught or suggested, inter alia, a distribution of active that does
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`not vary by more than 10% of the desired amount of the active.2 See, e.g.,
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`IPR2015-00165, Paper 70 at 30; IPR2015-00169, Paper 69 at 37.
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`II. BACKGROUND
`The ’514 patent challenged by Petitioners in these proceedings is listed in
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`the FDA’s Orange Book for Suboxone® Film, a treatment for opioid dependence
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`that 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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`claim in full:
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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.
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`3
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`IPR2016-01111
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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 particulate active [or combined particulate and taste-
`masking agent] 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.
`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;
`wherein said matrix has a viscosity sufficient to aid in substantially
`maintaining non-self-aggregating uniformity of the active in the matrix;
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`IPR2016-01111
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`(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).
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`Challenged claims 1 and 62 thus both require that the amount of active in
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`individual unit doses cut from the final film do not vary by more than 10% of the
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`desired amount (drug content uniformity (DCU) limitation). See id. Those two
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`challenged claims are independent claims from which all other challenged claims
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`depend. See Petition at 1; Ex. 1001, ’514 patent at Claims 1–3, 9, 15, 62–65, 69–
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`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
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`independent claims, “wherein said variation of drug content is less than 5% by
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`5
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`weight per film dosage unit.” Ex. 1001, ’514 patent at Claims 9, 65 (emphasis
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`IPR2016-01111
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`added).
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`MonoSol has asserted the ’514 patent in Hatch-Waxman litigation against
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`several defendants, including Teva Pharmaceuticals USA, Inc. (Teva), related to
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`potential generic versions of Suboxone® Film. See, e.g., Reckitt Benckiser
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`Pharmaceuticals Inc. et al. v. Teva Pharmaceuticals USA, Inc., Civil Case No.
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`1:14-01451 (D. Del. filed December 2, 2014). Teva Pharmaceuticals USA, Inc.
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`(Teva) filed a petition for inter partes review of the same claims of the ’514 patent
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`that are challenged in these proceedings. See IPR2016-00281 (“Teva IPR”). The
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`Board denied institution in the Teva IPR because Teva did not file its petition
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`within one year of service of the complaint as required by 35 U.S.C. § 315(b). See
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`IPR2016-00281, Paper 21.
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`On May 31, 2016, eight days after the Board determined that Teva’s petition
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`was time-barred, Petitioners filed this proceeding challenging the ’514 patent.
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`IPR2016-01111.3 With few exceptions, the petition is identical to the petitions
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`3 A few days later, Dr. Reddy’s announced that it had entered into an agreement
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`with Teva to acquire a number of ANDAs, including Teva’s ANDAs for
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`Suboxone® Film. Based on its acquisition of Teva’s ANDAs, Petitioners will
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`likely be substituted for Teva in the district court litigation. MonoSol, therefore,
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`reserves the right to raise privity issues if and when they become ripe for the
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`filed in the Teva IPR. Both petitions seek review of the same claims, rely on the
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`IPR2016-01111
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`same arguments and prior art, contain substantially identical text, and rely on
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`substantially identical expert declarations. See, e.g., Exs. 2002 & 2003 (redline
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`comparisons of petitions and declarations, respectively).
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`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.” Cuozzo Speed Techs., LLC v. Lee, 136 S. Ct. 2131, 2136
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`(2016); see also id. at 2144-45; 37 C.F.R. § 42.100(b); Office Patent Trial Practice
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`Guide, 77 Fed. Reg. 48756, 48766 (Aug. 14, 2012). The broadest reasonable
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`interpretation must be consistent with the specification. In re Suitco Surface, Inc.,
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`603 F.3d 1255, 1259–60 (Fed. Cir. 2010) (“[C]laims should always be read in light
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`of the specification and teachings in the underlying patent” when determining their
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`broadest reasonable construction).
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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 at p. 24 (PTAB Dec. 21, 2012)
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`(explaining that “[a]s this argument is premised on Petitioner’s erroneous claim
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`construction we are not persuaded of a reasonable likelihood of prevailing.”).
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`Board’s consideration.
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`Because Petitioners have not offered a reasonable claim construction of the
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`IPR2016-01111
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`limitation “dried without loss of substantial uniformity,” Petitioners have not
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`demonstrated that it has a reasonable likelihood of showing that the claims are
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`unpatentable.
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`“dried without loss of substantial uniformity” (Claims 1 and 62)
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`A.
`Petitioners assert that it is construing the claim limitation “dried without loss
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`of substantial uniformity,” but it only addresses the word “drying” in isolation,
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`ignoring the rest of the phrase which expressly provides that the drying must not
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`result in the loss of substantial uniformity. Specifically, the Petitioners state:
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`For these reasons, under the broadest reasonable interpretation
`standard, “dried without the loss of substantial uniformity” should be
`construed at least as broadly as Patent Owner’s proposed construction
`in the district court, i.e., “any method of drying.”
`Petition at 15 (emphasis added). Without explanation, Petitioners exclude the
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`words “without
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`the
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`loss of substantial uniformity” from
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`their proposed
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`construction. As such, Petitioners have failed to propose a reasonable construction
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`for the claim limitation.
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`By addressing only the term “drying,” Petitioners effectively read out the
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`explicit requirement of the claims that the drying occur without the loss of
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`substantial uniformity. This cannot be the broadest reasonable construction, as
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`Petitioners disregard the language of the claim and the disclosure of the
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`8
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`specification. See Phillips v. AWH Corp., 415 F.3d 1303, 1314 (Fed. Cir. 2005)
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`IPR2016-01111
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`(en banc) (“[T]he context in which a term is used in the asserted claim can be
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`highly instructive.”); ACTV, Inc. v. Walt Disney Co., 346 F.3d 1082, 1088 (Fed.
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`Cir. 2003) (“While certain terms may be at the center of the claim construction
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`debate, the context of the surrounding words of the claim also must be considered
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`in determining the ordinary and customary meaning of those terms.”)
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`For the foregoing reasons, the Petitioners’ proposed incorrect construction
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`should not be adopted, and the broadest reasonable construction of the claim term
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`as a whole—i.e., “dried without loss of substantial uniformity”—should be its
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`plain meaning.
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`IV. PETITIONERS HAVE NOT DEMONSTRATED “A REASONABLE
`LIKELIHOOD OF PREVAILING” AGAINST AT LEAST ONE
`CLAIM OF THE ’514 PATENT UNDER 35 U.S.C. § 314(A)
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`MonoSol respectfully submits that the Petition should be denied because
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`Petitioners fail to establish that any prior art reference or combination of references
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`teaches how to achieve drug content uniformity that “do[es] not vary by more than
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`10%” from the desired amount. Moreover, Petitioners fail to establish that a
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`person having ordinary skill in the art (POSA) would have needed only routine
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`experimentation to achieve the claimed level of uniformity and fail to provide any
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`evidence that the claimed invention is inherently taught by the asserted references.
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`IPR2016-01111
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`A.
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`Petitioners fail to establish a reasonable likelihood that any
`challenged claim is unpatentable in light of the prior art.
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`Petitioners have failed to establish a reasonable likelihood that the
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`challenged claims are unpatentable over the asserted references. Claims 1 and 62
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`are independent claims from which all other challenged claims depend, and each
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`contains a 10% drug content uniformity (DCU) element that Petitioners fail to
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`demonstrate is disclosed or even suggested by the prior art. Because Petitioners
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`have not shown a reasonable likelihood that claims 1 and 62 would have been
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`obvious over the prior art, MonoSol requests denial of inter partes review as to all
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`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
`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.
`Without question, none of Petitioners’ asserted references disclose a final
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`film, post casting and drying, wherein the uniformity “do[es] not vary by more
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`than 10% of said desired amount of said at least one active.” Indeed, other than
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`Chen’s Figure 5, Petitioners have not alleged that any reference explicitly teaches a
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`10% DCU in a final film as set forth in the challenged claims. See, e.g., Petition at
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`27, 29, and 42. And, even as to Chen’s Figure 5, both a district court and the
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`10
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`Board have already found that Chen does not contain this teaching. Specifcally, a
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`IPR2016-01111
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`US district court has found that the DCU “reported in Figure 5 of Chen was not
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`within 10% of the desired amount of active.” Ex. 2009, Reckitt v. Watson, at 34
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`(Finding of Fact No. 4). The Board has also found that nothing in Chen teaches
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`the 10% DCU claim limitation. See, e.g., IPR2015-00165 Final Written Decision,
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`for example, at 21. None of the other prior art also teaches or suggests a final film
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`DCU that “do[es] not vary by more than 10%” as required by the challenged
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`claims. Indeed, the cited evidence makes no mention whatsoever of the 10% DCU
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`limitation, or of any measure of final film DCU.
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`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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`Petitioners have 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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`Bess and Chen fail to disclose or teach each element of the
`challenged independent claims.
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`Bess, which was considered by the examiner during prosecution, inarguably
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`does not teach or suggest any uniformity of any ingredient in a final film post
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`casting and drying. Rather, Bess only discusses uniformity with respect to an
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`intermediate gel formed prior to casting and drying. See, e.g., ’514 patent, page 2,
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`right column; see also Ex. 1002, ’514 File History, April 4, 2011 Amendment and
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`11
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`Response at 2 and 5. Petitioners’ claim charts point to Bess’s summary section,
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`which includes a step of, prior to casting and drying, “adding the oil mixture to the
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`hydrated polymer gel and mixing to provide a uniform gel.” Ex. 1004 at 2:23-24.
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`The inventors of the ’514 patent, however, sought to overcome problems with non-
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`uniformity in the final product, including non-uniformity caused by particle
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`agglomeration that can occur in a gel state during casting and drying. ’514 patent
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`at 2:18-3:13. The Bess reference does not even acknowledge the possibility that a
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`film may lose uniformity during casting and drying, much less propose a solution
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`to that problem.
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`Additionally, Petitioners’ reliance on the weight data in Bess to demonstrate
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`uniformity is misplaced. As the Board already held in the ’167 IPRs, the total
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`weight of the entire composition cannot be used as a proxy for measuring the
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`amount of active as required by the claims. See, e.g., IPR2015-00165 Final
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`Written Decision at 21 (“Consistent dosage unit weight of films is not the
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`uniformity standard recited in claim 1 of the ’167 patent. Rather, claim 1 expressly
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`requires a determination of the amount of active component.”); see also IPR2015-
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`00168 Final Written Decision at 17-18; IPR2015-00169 Final Written Decision at
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`23-24.
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`Due to the deficiencies of Bess, Petitioners turn to Chen as a secondary
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`reference, asserting that “Chen emphasizes the ‘significant role’ of viscosity in
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`determining the properties of the film, Chen at 13:1-4, as well as the possibility of
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`‘disper[ing] … uniformly’ ingredients within the gel.” Petition at 42 (edits in
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`original). But at most, Chen, similar to Bess, only references uniformity of an
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`intermediate liquid, not of a final, dried film.
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`Petitioners note that Chen (Ex. 1005) “describes a casting process,” that
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`“employs adequate viscosity, and degassing . . . to ensure uniformity during
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`casting and drying,” and that Chen’s matrix has a viscosity range overlapping the
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`’514 patent’s most preferred range. Petition at 32. Those parameters of Chen,
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`however, say nothing about whether Chen disclosed maintaining uniformity
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`throughout casting and drying to achieve a final film with DCU within 10%.
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`Bess’s (Ex. 1004) mention of a “uniform gel” (Petition at 39, 42), relates only to
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`the liquid matrix at a point in its processing prior to drying and says nothing about
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`uniformity of the final cast film. As Patent Owner’s expert Dr. Robert Langer
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`testified in extensive detail in related litigation, there are a host of forces that come
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`into play after mixing and during casting and drying that can cause drug migration
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`and aggregation and thus result in a lack of the desired DCU. Ex. 1010, Tr. 486:1-
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`490:15.
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`Petitioners assert that “Chen’s Fig. 5 shows low variance in the desired
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`amount of the active” (Petition at 42), but Figure 5 teaches nothing of the sort. As
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`the district court judge found, “[t]he drug content uniformity of the entire range of
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`samples subjected to dissolution testing reported in Figure 5 of Chen was not
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`within 10% of the desired amount of active.” Ex. 2009, Reckitt v. Watson at 34
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`(Finding of Fact No. 4). The court noted that “Figure 5 of Chen is a graph of
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`results of dissolution testing done to measure the release profile of certain
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`films.” Opinion at 39; Ex. 1005 at 16:24-28. But as the defendants’ expert
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`conceded at trial, the Chen reference does not disclose any actual data underlying
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`the figure, “so it is difficult to see what the precise numbers would be.” Opinion at
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`39 (citing Tr. 382:1-6; see also Tr. 336:23- 337:2, 370:8- 22 (Dyar)). The court
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`further agreed with Plaintiffs’ expert that “even if one were to make all
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`assumptions in Defendants’ favor, Figure 5 does not disclose drug content
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`uniformity within 10%” because the error bars in the Figure do not actually reflect
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`the full range of samples, and that “looking at the entire range of sample
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`measurements in the dissolution tests reflected in Figure 5, the drug content
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`uniformity achieved in Chen would not have been within 10%.” Opinion at 39
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`(citing Tr. 510:8- 511:19; Tr. 517:4-520:1 (Langer)).
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`The general statements in Chen about “uniformity” and “homogeneity” do
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`not cure this deficiency. The district judge found that the only discussion in Chen
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`of homogeneity relates to mixing before the active ingredient is added, which does
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`not address at all the uniformity of the active in the matrix after it is added, during
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`the casting and drying steps, or in the final film. Ex. 2009, Reckitt v. Watson at 39
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`(“the statements in Chen about uniformity and homogeneity refer only to the wet
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`matrix and not the final, dried film.”); Ex. 1010 at Tr. 504:8-508:15 (Langer).
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`Similarly, the Board has also found that Chen’s mere disclosure of a homogeneous
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`mixture during processing is insufficient. IPR2015-00168, Final Written Decision
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`at 19 (“Petitioner further contends that Chen teaches the substantially-uniform-
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`distribution limitation because ‘Chen’s process begins by forming a homogeneous
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`mixture,’ and because ‘[m]aintaining uniformity in the intermediate steps and in
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`the final product would have been obvious.’ We are not persuaded.”) (citations
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`omitted); see also generally id. at 19-21. In short, the deficiencies in Chen
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`identified by the court and by the Board are the same as those in Bess – merely
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`referring to uniformity of a hydrated gel prior to casting and drying does not teach
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`or disclose a final film having the claimed 10% or 5% level of DCU.
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`a. A person having ordinary skill in the art would not fill in
`the gaps to cure the deficiencies of Bess and Chen.
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`Despite a total lack of teaching or suggestion in the references, Petitioners
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`assert that a skilled artisan would have needed only routine experimentation to
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`achieve the claimed 10% or 5% level of DCU or, alternatively, that the claimed
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`uniformity is inherent to the prior art. See, e.g., Petition at 27, 29, and 34. These
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`bare assertions are factually unsupported by Petitioners’ exhibits and contrary to
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`the case law.
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`Petitioners
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`fail
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`to provide any evidence showing what “routine
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`experimentation” means. The Federal Circuit admonishes against relying on such
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`baseless statements because it risks improperly emphasizing the manner of
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`discovery at the expense of the central inquiry—particularly in complex
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`technologies such as pharmaceutical films—. See Pfizer, Inc. v. Apotex, Inc., 480
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`F.3d 1348, 1367 (Fed. Cir. 2007). “[G]eneral conclusions about what is ‘basic
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`knowledge’ or ‘common sense’” cannot serve “as a replacement for documentary
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`evidence for core factual findings in a determination of patentability.” K/S HIMPP
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`v. Hear-Wear Techs., LLC, 751 F.3d 1362, 1366 (Fed. Cir. 2014); TriMed, Inc. v.
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`Stryker Corp., 608 F.3d 1333, 1343 (Fed. Cir. 2010) (“Merely saying that an
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`invention is a logical, commonsense solution to a known problem does not make it
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`so.”). Here, Petitioners have not proffe