`
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`
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`Paper No. ___
`Filed: December 14, 2018
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`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________________________
`
`MYLAN PHARMACEUTICALS INC.,
`TEVA PHARMACEUTICALS USA, INC., and AKORN INC.,1
`Petitioners,
`v.
`SAINT REGIS MOHAWK TRIBE and ALLERGAN, INC.,
`Patent Owners.
`_____________________________
`
`Case IPR2016-01127 (8,685,930 B2)
`Case IPR2016-01128 (8,629,111 B2)
`Case IPR2016-01129 (8,642,556 B2)
`Case IPR2016-01130 (8,633,162 B2)
`Case IPR2016-01131 (8,648,048 B2)
`Case IPR2016-01132 (9,248,191 B2)
`_____________________________
`
`PETITIONERS’ SUPPLEMENTAL BRIEFING
`AUTHORIZED BY PAPER 142
`
`
`
`
`
`1 Cases IPR2017-00576 and IPR2017-00594, IPR2017-00578 and IPR2017-00596,
`IPR2017-00579 and IPR2017-00598, IPR2017-00583 and IPR2017-00599,
`IPR2017-00585 and IPR2017-00600, and IPR2017-00586 and IPR2017-00601,
`have respectively been joined with the captioned proceedings. The word-for-word
`identical paper is filed in each proceeding identified in the caption pursuant to the
`Board’s Scheduling Order (Paper 10).
`
`
`
`
`
`I.
`
`INTRODUCTION
`On October 16, 2017, the district court issued a final judgment invalidating
`
`the claims of four of the six patents in these IPRs. EX1165. The Court issued
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`detailed Findings of Facts and Conclusions of Law (EX1164) addressing 13
`
`representative claims and explaining that this analysis served to invalidate all
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`claims of the four patents. On November 13, 2018, the Federal Circuit summarily
`
`affirmed the district court’s findings of invalidity. EX1172. Consistent with the
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`district court’s holding, and with the way the Patent Owner elected to argue the
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`patentability of all involved claims of all six patents, the Board should hold the
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`claims of all patents unpatentable.
`
`II. BACKGROUND
`In the district court, Patent Owner originally asserted all six involved patents:
`
`U.S. Patent Nos. 8,629,111 (“the ’111 patent”), 8,633,162 (“the ’162 patent”),
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`8,642,556 (“the ’556 patent”), 8,648,048 (“the ’048 patent”), 8,685,930 (“the ’930
`
`patent”), and 9,248,191 (“the ’191 patent”). During the course of that litigation
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`and prior to trial, Patent Owner agreed to use thirteen claims from four of these
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`patents as representative claims, as set forth below (collectively, the
`
`“Representative Claims”):
`
`’111 patent - claims 26 and 27;
`
`’048 patent - claims 1, 11, 13, 14, and 23;
`
`
`
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`
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`’930 patent - claim 35; and
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`’191 patent - claims 13, 16, 22, 26, and 27.
`
`In the district court proceedings, the Patent Owner explicitly confirmed that the
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`above Representative Claims were “representative claims of all of the claims in the
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`various patents [Patents-in-Suit], including the unasserted claims.” Pretrial
`
`Hearing Transcript, EX1173, at 7:25-8:2 (emphasis added). Indeed, Patent Owner
`
`agreed that “any remedy that [Judge Bryson] might enter as to the representative
`
`claims would apply equally to the unasserted claims.” Id. at 8:2-4; see also
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`Findings of Fact and Conclusions of Law, EX1164 at 29-30.
`
`Following a bench trial, the district court issued a Final Judgment on
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`October 16, 2017, holding each of the Representative Claims invalid as obvious.
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`EX1165. After briefing and oral argument, the Federal Circuit summarily affirmed.
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`EX1172.
`
`III. ALL CLAIMS OF ALL INVOLVED PATENTS ARE UNPATENTABLE
`Collateral estoppel precludes Patent Owner2 from contesting in these IPR
`
`proceedings the unpatentability of the Representative Claims. See, e.g., MaxLinear,
`
`
`
`2 After executing assignment and license agreements regarding the involved
`
`patents (EX2086, EX2087), St. Regis Mohawk Tribe consented to join Allergan’s
`
`
`
`-2-
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`
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`Inc. v. CF CRESPE LLC, 880 F.3d 1373, 1376 (Fed. Cir. 2018) (holding that issue
`
`preclusion applies equally where a single issue is before a court and an
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`administrative agency). Notably, although the district court’s final judgment
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`specifically addressed the thirteen Representative Claims, Doc. No. 524 (“Final
`
`Judgment”) at 1, the collateral estoppel effect is not limited to the claims of the
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`Representative Claims. The district court’s judgment extends to all the claims of
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`the Patents-in-Suit in the district court, as well as the two other patents originally
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`asserted by Patent Owner in the district court proceedings: the ’556 patent and’162
`
`patents.
`
`“Precedent does not limit collateral estoppel to patent claims that are
`
`identical…If the differences between the unadjudicated patent claims and the
`
`adjudicated patent claims do not materially alter the question of invalidity,
`
`collateral estoppel applies.” MaxLinear, 880 F.3d at 1377 (citing Ohio Willow,
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`735 F.3d at 1342). When certain claims of one patent have been adjudicated
`
`invalid, the question then becomes “whether the unadjudicated claims present
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`materially different issues that alter the question of patentability, making them
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`patentably distinct from [the adjudicated claims].” MaxLinear, 880 F.3d at 1377.
`
`
`
`infringement lawsuit in the district court and was a party when Judge Bryson
`
`entered final judgment. EX1163 (decision granting joinder) at 10.
`
`
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`-3-
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`
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`In these proceedings, Patent Owner presented the same patentability arguments for
`
`all claims of all six patents at issue in these IPRs and did not separately argue the
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`patentability of any dependent claims of any of the patents. See Patent Owner
`
`Responses. Because Patent Owner presented no materially different patentability
`
`issues for any claims of the ’556 patent or the ’162 patent as compared to the
`
`Representative Claims, the claims of the ’556 patent and the ’162 patent all fall
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`together with those Representative Claims. See MaxLinear, 880 F.3d at 1377.
`
`Because the Representative Claims are invalid as obvious under the district
`
`court’s higher invalidity standard of clear and convincing evidence, it follows that
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`the claims at issue here are certainly unpatentable under the lower preponderance
`
`of the evidence standard applicable in IPRs. Microsoft Corp. v. i4i Ltd.
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`Partnership, 131 S. Ct. 2238, 2253 text & n.11 (2011) (noting lower evidentiary
`
`standard in USPTO proceedings).
`
`IV. THE CLAIMS OF THE ʼ556 AND ʼ162 PATENTS ARE NOT
`PATENTABLY DISTINCT FROM THE INVALID CLAIMS
`Even if Patent Owner had presented patentability arguments regarding any
`
`claims of the ’556 or ’162 patents different than what it argued for the
`
`Representative Claims, the’556 and ’162 patents are nonetheless unpatentable
`
`because they are not patentably distinct from the claims invalidated by the district
`
`court. Patent Owner is thus precluded from contesting their unpatentability. See
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`MaxLinear, 880 F.3d at 1377 (“If the differences between the unadjudicated patent
`
`-4-
`
`
`
`claims and the adjudicated patent claims do not materially alter the question of
`
`invalidity, collateral estoppel applies.”).
`
`As shown in detail below, the claims of the ʼ162 and ʼ556 patents refer to
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`the same emulsion formulation, and to the same methods of using that formulation,
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`as in the invalidated claims. Because no differences between the claims of the’162
`
`and ’556 patents and the Patents-in-Suit materially alter the question of
`
`unpatentability, collateral estoppel applies.
`
`A. KCS/Dry Eye/Increased Tearing Limitations
`The claims of the ʼ162 patent are directed to treating dry eye by topically
`
`administering the same claimed emulsion as in the Patents-in-Suit or reducing side
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`effects when administering that emulsion for the treatment of dry eye. The claims
`
`of the ’556 patent are directed to the same emulsion as in the Patents-in-Suit for
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`treating an eye of a human, including for treating dry eye. The claims of the
`
`Patents-in-Suit recite the same limitations as the ’162 patent and the ’556 patent
`
`but some of them are narrower in that they are directed to treating a species of dry
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`eye (keratoconjunctivitis sicca (“KCS”)) or treating KCS or dry eye by increasing
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`tearing, instead of the broader genus of treating dry eye.
`
`For example, the invalidated ’048 patent claims are to methods of increasing
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`tear production, treating KCS, and administering to the eye of a human having
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`KCS, the methods comprising twice-daily administration of the same emulsion
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`
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`-5-
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`
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`claimed in the ’162 and ’556 patents. EX1001 in IPR2016-01131 (claims 1, 18,
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`and 22). The invalidated ’191 patent claims are to methods of treating dry eye,
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`enhancing tear production and treating dry eye, enhancing lacrimal gland tearing,
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`treating dry eye, and restoring tearing comprising twice-daily administration of the
`
`same emulsion claimed in the ’162 and ’556 patents. EX1001 in IPR2016-01132
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`(claims 1, 13, 16, 17, and 21).
`
`The invalidated ’111 patent claims are to the same emulsion claimed in the
`
`’162 and ’556 patents for treating an eye of a human. EX1001 in IPR2016-01128
`
`(claims 1, 13, and 18).
`
`The invalidated ’930 patent claims are to the same emulsion claimed in the
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`’162 and ’556 patents for treating an eye of a human wherein it is therapeutically
`
`effective in treating KCS or dry eye, or in increasing tear production in the eye of a
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`human having KCS. EX1001, IPR2016-01127 (claims 1, 13, 25); Paper 7, at 21.
`
`Patent Owner’s entire argument has been that the claimed emulsion treats
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`the KCS species of dry eye by increasing tear production. See, e.g., Paper 16, at 1
`
`(“Restasis® is...indicated for increasing tear production in patients suffering
`
`from...dry eye disease. Dry eye is a chronic condition with no known cure in which
`
`the eyes do not make enough tears.”), n.1 (“Keratoconjunctivitis sicca (‘KCS’) is a
`
`type of dry eye disease.”); see also IPR2017-01127, Paper 8, at 8-9 (“Patent Owner
`
`also argues the inability to produce tears is a hallmark of dry eye disease”), 12
`
`
`
`-6-
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`
`
`(noting Ding teaches cyclosporins have been found “effective in treating
`
`keratoconjunctivitis sicca (KCS or dry eye disease)”); IPR2016-01127, Paper 7, at
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`9. Thus, none of the claims of the ’162 patent or the ’556 patent is patentably
`
`distinct from the claims of the Patents-in-Suit.
`
`Moreover, while not dispositive, it is probative that the ’162 and ’556
`
`patents are terminally disclaimed over the Patents-in-Suit and each other (e.g.,
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`IPR’1129 EX 1004 at 122 and IPR’1130 EX 1004 at 115 (terminally disclaiming
`
`over ’162 (“13967179”),’111 (“13967163”), ’048 (“13961168”), ’556
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`(“13967189”), and ’930 (“13961828”)), not least because it reflects a previous,
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`unrebutted USPTO determination that the claims of these patents are not separately
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`patentable.
`
`B.
`The ʼ162 Patent
`Claims 1-17 of the ‘162 Patent: Claims 1-17 of the ʼ162 patent are
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`identical to claims 1-17 of the ʼ048 patent with one exception: the ʼ162 patent
`
`recites “a method of treating dry eye disease” while the ʼ048 patent recites “a
`
`method of increasing tear production” in claims 1-17, a method of treating KCS in
`
`claims 18-21, and a method comprising administering an emulsion effective in
`
`increasing tear production in a human having KCS in claims 22-23. Compare ʼ162
`
`patent, cl. 1 with ʼ048 patent, cl. 1-23.
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`
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`-7-
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`
`
`’048 Patent
`
`’048 Patent
`
`’162 Patent
`
`1. A method of
`increasing tear
`production in the eye of
`a human,
`the method comprising
`topically administering
`to the eye of the human
`in need thereof an
`emulsion at a frequency
`of twice a day, wherein
`the emulsion comprises
`cyclosporin A in an
`amount of about 0.05%
`by weight,
`polysorbate 80,
`acrylate/C10-30 alkyl
`acrylate cross-polymer,
`
`water, and
`castor oil in an amount
`of about 1.25% by
`weight;
`and wherein the topical
`ophthalmic emulsion is
`effective in increasing
`tear production.
`
`1. A method of treating
`dry eye disease,
`the method comprising
`topically administering to
`the eye of a human in
`need thereof an emulsion
`at a frequency of twice a
`day, wherein the
`emulsion comprises
`cyclosporin A in an
`amount of about 0.05%
`by weight.
`
`polysorbate 80,
`
`acrylate/C10-30 alkyl
`acrylate cross-polymer,
`water, and
`castor oil in an amount of
`about 1.25% by weight;
`and wherein the topical
`ophthalmic emulsion is
`effective in treating dry
`eye disease
`
`22. A method comprising:
`administering an emulsion
`topically to the eye of a
`human having
`keratoconjunctivitis sicca
`at a frequency of twice a
`day, wherein the emulsion
`comprises:
`cyclosporin A in an amount
`of about 0.05% by weight;
`castor oil in an amount of
`about 1.25% by weight;
`polysorbate 80 in an
`amount of about 1.0% by
`weight;
`acrylate/C10-30 alkyl
`acrylate cross-polymer in
`an amount of about 0.05%
`by weight;
`[...]and water; and
`wherein the emulsion is
`effective in increasing tear
`production in the human
`having keratoconjunctivitis
`sicca.
`23. The method of claim
`22, wherein the emulsion
`has a pH in the range of
`about 7.2 to about 7.6.
`
`
`
`-8-
`
`
`
`As explained in Section IV.A., supra, in the context of the claimed emulsion,
`
`increasing tear production in patients having dry eye (including KCS) is a species
`
`of treating dry eye. There is thus no patentable distinction between the invalid
`
`claims of the ʼ048 patent and claims 1-17 of the ʼ162 patent. See In re Muchmore,
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`433 F.2d 824, 824-25 (C.C.P.A. 1970) (“Since we agree with the board's
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`conclusion of obviousness as to these narrow claims, the broader claims must
`
`likewise be obvious.”).
`
`Independent Claim 18: Claim 18 of the’162 patent recites a method of
`
`reducing side effects in a human being treated for dry eye syndrome using an
`
`emulsion incorporating the component limitations of claims 1 and 7-9, and the pH
`
`value recited in claim 12. Claim 17 of the ’048 patent recites a method of
`
`increasing tear production in the eye of a human wherein the emulsion
`
`demonstrates a reduction in side effects in the human. Claims 18 and 22 of
`
`the ’048 patent respectively recite that the claimed emulsion is effective in treating
`
`KCS and in increasing tear production in the eye of human having KCS. Claim 18
`
`of the ʼ162 patent is not patentably distinct from claims 17, 18, or 22 of the ʼ048
`
`patent.
`
`Dependent Claims 19-22: Dependent claim 19 of the ʼ162 patent recites the
`
`same additional limitations as dependent claim 5 of the ʼ162 patent addressed
`
`above. Dependent claim 20 of the ʼ162 patent recites the same additional limitation
`
`
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`-9-
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`
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`as dependent claim 3 addressed above. Dependent claim 21 of the ʼ162 patent
`
`recites the same additional limitation that the blood of a human has substantially no
`
`detectable concentration of cyclosporin A (“CsA”) as dependent claim 11 of the
`
`ʼ162 patent, which has been addressed above. Dependent claim 22 of the ʼ162
`
`incorporates the same limitation as found in claim 1 of the ʼ162 patent, i.e., that the
`
`emulsion is effective in treating dry eye disease, which has been addressed above.
`
`Thus, none of claims 19-22 of the ’162 patent is patentably distinct from claims 1-
`
`18 and 22 of the ’048 patent.
`
`Claims 23-24: Independent claim 23 recites a method of treating dry eye
`
`disease by administering an emulsion incorporating the component limitations of
`
`claims 1 and 7-9 to a human eye and recites the same limitation of claim 1 that the
`
`emulsion is effective in treating dry eye disease. Dependent claim 24 recites the
`
`same pH range as dependent claim 12 of the’162 patent and dependent claim 23 of
`
`the ’048 patent. Claims 22-24 of the ’162 patent are not patentably distinct from
`
`claims 1-18 and 22-23 of the ’048 patent.
`
`For the reasons discussed above, all challenged claims of the ’162 patent are
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`unpatentable based on the district court judgment.
`
`C. The ʼ556 Patent
`Claims 1-12: Independent claim 1 of the ’556 patent recites the same
`
`emulsion as in the Patents-in-Suit, and that it is therapeutically effective in treating
`
`
`
`-10-
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`
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`dry eye disease and “provides overall efficacy substantially equal to” a second
`
`topical ophthalmic emulsion comprising twice as much CsA. Claim 11 depends
`
`from claim 1 and further recites that, when the emulsion is administered to the eye
`
`of a human in an effective amount in treating dry eye disease, the blood of the
`
`human has substantially no detectable concentration of CsA. Claim 1 of the ’191
`
`patent recites a method of treating dry eye disease by twice-daily administration of
`
`this same emulsion, that the emulsion is therapeutically effective in treating dry
`
`eye disease, and that it “provides overall efficacy substantially equal to”
`
`administration of a second emulsion comprising twice as much CsA. It further
`
`recites that the method “results in substantially no detectable concentration” of
`
`CsA in the blood of the human. The only difference is that claim 1 of the ’191
`
`patent is narrower than claims 1 and 11 of the ’556 patent in that it recites twice-
`
`daily administration of the emulsion recited in claims 1 and 11 of the ’556 patent.
`
`Claims 1 and 11 of the ʼ556 patent are unpatentable because they are no narrower
`
`than claim 1 of the ’191 patent. See Muchmore, 433 F.2d at 824-25. Dependent
`
`claims 2-10 and 12 of the ’556 patent respectively recite the same limitations as
`
`claims 2-11 of the ’191 patent, and are similarly not patentably distinct from those
`
`claims.
`
`Claims 13-20: Claims 13-15 are independent claims reciting the same
`
`emulsion as in claim 1. Claim 13 additionally recites that the emulsion is
`
`
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`-11-
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`
`
`therapeutically effective in treating dry eye disease, and “achieves at least as much
`
`therapeutic effectiveness” as a second emulsion comprising 0.1% CsA and 1.25%
`
`castor oil. Claim 13 of the ʼ191 patent, which recites the same emulsion as being
`
`therapeutically effective in treating dry eye disease and “achieves at least as much
`
`therapeutic effectiveness” as the emulsion with twice as much CsA, is narrower
`
`than claim 13 of the ’556 patent in that it is directed twice-daily administration of
`
`the same emulsion. Because the narrower claims 13 of the ’191 patent is invalid,
`
`the broader claim 13 of the ’556 patent is likewise unpatentable. Muchmore,
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`433 F.2d at 824-25.
`
`Claim 18 of the ’556 patent depends from claim 13 and further recites that
`
`the blood of the human has substantially no detectable concentration of CsA.
`
`Claims 1 and 12 of the ’191 patent recite that substantially no detectable
`
`concentration of CsA is detected in the blood of the human or that the
`
`concentration of CsA in the blood is less than about 0.1 ng/ml. Claims 13 and 18 of
`
`the ’556 patent are not patentably distinct from claims 1, 12, or 13 of the ’191
`
`patent.
`
`Claim 14 of the ’556 patent recites the same emulsion components as claims
`
`1 and 13 of the ʼ556 patent and further recites that the emulsion “breaks down
`
`more quickly,” thereby reducing vision distortion, as compared to a second
`
`emulsion that contains only about 50% as much castor oil. The “breaks down more
`
`
`
`-12-
`
`
`
`quickly” than an emulsion with twice as much castor oil limitation is recited in
`
`claim 17 of the ʼ191 patent, which is narrower than claim 13 of the ’556 patent in
`
`that it is directed twice-daily administration of the same emulsion. Because the
`
`narrower claim 17 of the ’191 patent is invalid, the broader claim 14 of the ’556
`
`patent is likewise unpatentable. Muchmore, 433 F.2d at 824-25.
`
`Claim 19 depends from claim 14 and further recites that the blood of the
`
`human has substantially no detectable concentration of CsA. Claims 1, 12, and 20
`
`of the ’191 patent recite that substantially no detectable concentration of CsA is
`
`detected in the blood of the human or that the concentration of CsA in the blood is
`
`less than about 0.1 ng/ml. Claim 20 of the ’191 patent depends indirectly from
`
`claim 17. Claims 14 and 19 of the ’556 patent are not patentably distinct from
`
`claims 1, 12, 17, or 20 of the ’191 patent.
`
`Claim 15 of the ’556 patent recites the same emulsion components as claims
`
`1 and 13 of the ʼ556 patent and further recites that the emulsion “demonstrates a
`
`reduction in adverse events” relative to a 0.1% CsA / 1.25% castor oil emulsion.
`
`Claim 16 depends from claim 15 and further recites that the adverse events are side
`
`effects. Claim 17 depends from claim 16 and further recites that the side effects are
`
`selected from visual distortion and eye irritation. The “demonstrates a reduction in
`
`adverse events,” and visual distortion or eye irritation side effect limitations of
`
`claims 15-17 of the ’556 patent are recited in claims 21 and 23 of the ʼ191 patent,
`
`
`
`-13-
`
`
`
`which are narrower than claims 15-17 and 20 of the ’556 patent in that they are
`
`directed to twice-daily administration of the same emulsion. Claims 15-17 of
`
`the ’556 patent are also no narrower than claims 21 and 23 of the ’191 patent
`
`because the former is an emulsion for treating an eye of a human and the latter
`
`administers the emulsion to a human eye as part of a method of restoring tearing.
`
`Because the narrower claims of the ’191 patent are invalid, the broader claims of
`
`the ’556 patent are likewise unpatentable.
`
`Claim 20 of the ’556 patent depends from claim 15 and further recites that
`
`the blood of the human has substantially no detectable concentration of CsA.
`
`Claims 1, 12, 20, 22, and 27 of the ’191 patent recite that substantially no
`
`detectable concentration of CsA is detected in the blood of the human or that the
`
`concentration of CsA in the blood is less than about 0.1 ng/ml. Claims 22 and 27
`
`depend from claim 21. Claims 15 and 20 of the ’556 patent are not patentably
`
`distinct from claims 1, 12, 20-23, or 27 of the ’191 patent.
`
`For the reasons discussed above, all challenged claims of the ’556 patent are
`
`unpatentable based on the district court judgment.
`
`V. RECOMMENDATION
`Petitioners note that Allergan has a copending application (15/585,320) with
`
`even broader claims that is also subject to this issue preclusion. In re Freeman,
`
`30 F.3d 1459, 1466 (Fed. Cir. 1994) (applying issue preclusion in an examination
`
`
`
`-14-
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`
`
`context); see also Q.I. Press Controls, B.V. v. Lee, 752 F.3d 1371, 1383-84 (Fed.
`
`Cir. 2014) (remanding for entry of rejection to avoid inconsistent outcomes). The
`
`Board has authority to draw this preclusion to the examiner’s attention. 37 CFR
`
`§42.73(c) (authorizing recommendation to examiner).
`
`VI. CONCLUSION
`For the foregoing reasons, the Federal Circuit’s affirmance of the district
`
`court’s finding of invalidity of all claims of the ’111 patent, the ’048 patent,
`
`the ’930 patent, and the ’191 patent precludes a finding of patentability before this
`
`tribunal. Furthermore, the claims of the ʼ162 and the ʼ556 patents are not
`
`patentably distinct from the invalidated claims of the patents-in-suit and thus a
`
`finding of patentability is precluded.
`
`
`
`
`
`Dated: December 14, 2018
`
`
`
`
`
`
`
`
`Respectfully submitted,
`
`/ Steven W. Parmelee /
`Steven W. Parmelee
`Reg. No. 31,990
`
`
`
`
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`-15-
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`
`
`LIST OF EXHIBITS
`
`Description
`
`The Patent (U.S. Patent No. 8,685,930; 8,629,111; 8,642,556;
`8,633,162; 8,648,048; or 9,248,191 to Acheampong et al., in
`IPR2016-01127 – IPR2016-01132, respectively)
`
`Declaration of Dr. Mansoor Amiji
`
`Curriculum Vitae of Dr. Mansoor Amiji
`
`File History (U.S. Patent No. 8,685,930; 8,629,111; 8,642,556;
`8,633,162; 8,648,048; or 9,248,191 to Acheampong et al., in
`IPR2016-01127 –01132, respectively)
`
`File history of U.S. Patent Application No. 10/927,857, filed on
`August 27, 2010 to Acheampong et al.
`
`Exhibit
`No.
`
`1001
`
`1002
`
`1003
`
`1004
`
`1005
`
`1006
`
`U.S. Patent No. 5,474,979 to Ding et al., filed May 17, 1994
`
`1007
`
`1008
`
`1009
`
`1010
`
`1011
`
`Sall, K., et al., Two Multicenter, Randomized Studies of the
`Efficacy and Safety of Cyclosporine Ophthalmic Emulsion in
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`Complaint; Allergan, Inc. v. Teva Pharmaceuticals USA, Inc., Teva
`Pharmaceutical Industries Ltd., Apotex, Inc., Apotex Corp.,
`Akorn, Inc., Mylan Pharmaceuticals Inc., and Mylan Inc., No.
`2:15-cv-01455
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`Complaint; Allergan, Inc. v. Teva Pharmaceuticals USA, Inc., Teva
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`Akorn, Inc., Mylan Pharmaceuticals Inc., No. 2:15-cv-01455
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`
`1026
`
`Reserved
`
`Allergan Department of Pharmacokinetics and Drug Metabolism
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`PROTECTIVE ORDER MATERIAL - Allergan R&D Records
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`PROTECTIVE ORDER MATERIAL - Transcript of June 1, 2017
`Deposition of Rhett Schiffman, M.D., M.S.Sc.
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`PROTECTIVE ORDER MATERIAL - Transcript of June 7, 2017
`Deposition of Thorsteinn Loftsson, Ph.D.
`
`Transcript of June 20, 2017 Deposition of John D. Sheppard, M.D.,
`M.S.Sc.
`
`PROTECTIVE ORDER MATERIAL - Transcript of June 22, 2017
`Deposition of Mayssa Attar, Ph.D.
`
`REDACTED - Transcript of June 22, 2017 Deposition of Mayssa
`Attar, Ph.D.
`
`PROTECTIVE ORDER MATERIAL - Declaration of Andrew F.
`Calman, M.D.
`
`PROTECTIVE ORDER MATERIAL - Declaration of Daniel A.
`Bloch, Ph.D.
`
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`
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`FDA Label for Restasis MultiDose™
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