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`Paper 154
`Entered: September 27, 2019
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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.,
`Petitioners,
`
`v.
`
`SAINT REGIS MOHAWK TRIBE and ALLERGAN, INC.,
`Patent Owners.
`_______________
`
`Case IPR2016-01130
`Patent 8,633,162 B21
`_______________
`
`Before SHERIDAN K. SNEDDEN, TINA E. HULSE, and
`CHRISTOPHER G. PAULRAJ, Administrative Patent Judges.
`
`SNEDDEN, Administrative Patent Judge.
`
`
`
`JUDGMENT
`Final Written Decision
`Determining All Challenged Claims Unpatentable
`35 U.S.C. § 318(a)
`
`
`
` 1
`
` Cases IPR2017-00583 and IPR2017-00599 have been joined with
`IPR2016-01130.
`
`
`
`IPR2016-01130
`Patent 8,633,162 B2
`
`
`
`ORDERS
`Dismissing Petitioner’s Motion to Exclude (Paper 50)
`37 C.F.R. § 42.64(c)
`
`Dismissing Patent Owner’s Motion to Exclude (Paper 43)
`37 C.F.R. § 42.64(c)
`
`I. INTRODUCTION
`This Final Written Decision is issued pursuant to 35 U.S.C. § 318(a)
`and 37 C.F.R. § 42.73. Mylan Pharmaceuticals Inc., Teva Pharmaceuticals
`USA, Inc., and Akorn Inc. (collectively, “Petitioner”) bears the burden of
`proving unpatentability of the challenged claims, and that burden of
`persuasion never shifts to Patent Owner. Dynamic Drinkware, LLC v. Nat’l
`Graphics, Inc., 800 F.3d 1375, 1378 (Fed. Cir. 2015). To prevail, Petitioner
`must prove unpatentability by a preponderance of the evidence. 35 U.S.C. §
`316(e); 37 C.F.R. § 42.1(d).
`For the reasons that follow, we determine that Petitioner has shown,
`by a preponderance of the evidence, that claims 1–24 of U.S. Patent No.
`8,633,162 B2 (Ex. 1001, “the ’162 patent”) are unpatentable.
`
`A. Procedural History
`Petitioner filed a Petition to institute an inter partes review of claims
`124 of the ’162 patent. Paper 3 (“Pet.”). Allergan, Inc. (“Patent Owner”)
`filed a Patent Owner Preliminary Response. Paper 7. Upon consideration of
`the Petition and Preliminary Response, we instituted an inter partes review
`of claims 1–24 of the ’162 patent on each ground of unpatentability set forth
`in the Petition, which are as follows:
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`Ground
`
`Reference[s]
`
`Claims Challenged
`Basis
`§ 103(a) 1–10, 12–14, 16–20,
`and 22–24
`§ 103(a) 11 and 21
`
`1
`
`2
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`3
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`Ding ’9792 and Sall3
`Ding ’979, Sall, and
`Acheampong4
`Ding ’979, Sall, and Glonek5 § 103(a) 15
`
`
`Paper 8 (“Decision on Institution” or “Dec.”).
`Subsequently, Patent Owner filed a Patent Owner Response (Paper
`16; “PO Resp.”), Petitioner filed a Reply (Paper 34; “Reply”), and Patent
`Owner filed a Sur-Reply (Paper 42; “Sur-Reply”).6
`Teva Pharmaceuticals USA, Inc. (“Teva”) and Akorn, Inc. (“Akorn”)
`each filed Petitions requesting an inter partes review of claims 1–24 of the
`
`
`
` 2
`
` Ding et al., US 5,474,979, issued December 12, 1995 (Ex. 1006, “Ding
`’979”).
`3 Kenneth Sall et al., Two Multicenter, Randomized Studies of the Efficacy
`and Safety of Cyclosporine Ophthalmic Emulsion in Moderate to Severe Dry
`Eye Disease, 107 OPHTHALMOLOGY 631639 (2000) (Ex. 1007, “Sall”).
`4 Acheampong et al., Cyclosporine Distribution into the Conjunctiva,
`Cornea, Lacrimal Gland, and Systemic Blood Following Topical Dosing of
`Cyclosporine to Rabbit, Dog, and Human Eyes, LACRIMAL GLAND, TEAR
`FILM, AND DRY EYE SYNDROMES 2: BASIC SCIENCE AND CLINICAL
`RELEVANCE 1001–04 (David A. Sullivan et al. eds., 1998) (Ex. 1008,
`“Acheampong”).
`5 Glonek et al., US 5,578,586, issued Nov. 26, 1996 (Ex. 1009, “Glonek”).
`6 On September 8, 2017, the Saint Regis Mohawk Tribe (the “Tribe”)
`entered an appearance as the purported Patent Owner. Paper 63. We denied
`the Tribe’s Motion to Terminate on sovereign immunity grounds and
`Allergan’s Motion to Withdraw. Paper 127; Paper 129.
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`’162 patent in cases IPR2017-00583 and IPR2017-00599, respectfully.
`IPR2017-00583, Paper 4; IPR2017-00599, Paper 2. Teva and Akorn each
`filed a motion to join their respective cases with this case. IPR2017-00583,
`Paper 3; IPR2017-00599, Paper 3. We granted Teva and Akorn’s Petitions
`and each of their motions for joinder. IPR2017-00583, Paper 9; IPR2017-
`00599, Paper 9.
`Per the parties’ request, an oral hearing was not held for this
`proceeding. Paper 150.
`
`B. Related Proceedings
`In addition to this proceeding challenging the ’162 patent, Petitioner
`has sought inter partes review of all claims of U.S. Patent No. 8,685,930 B2
`(“the ’930 patent”) in IPR2016-00127; U.S. Patent No. 8,629,111 B2 (“the
`’111 patent”) in IPR2016-01128; U.S. Patent No. 8,642,556 B2 (“the ’556
`patent”) in IPR2016-01129; U.S. Patent No. 8,648,048 B2 (“the ’048
`patent”) in IPR2016-01131; and U.S. Patent No. 9,248,191 B2 ( “the ’191
`patent”) in IPR2016-01132 (collectively, “the Challenged Patents”).
`Four of the six Challenged Patents—the ’111, ’048, ’930, and ’191
`patents—were also at issue in Allergan, Inc. v. Teva Pharmaceuticals USA,
`Inc., No. 2:15-cv-01455 (E.D. Tex.) (“Allergan v. Teva”). The dispute in
`Allergan v. Teva was a “Hatch-Waxman Act case relate[d] to a condition
`known as ‘dry eye’ and a pharmaceutical product known as ‘Restasis’ that is
`intended to address that condition.” Ex. 1164, 1. “Restasis is an emulsion
`consisting of various components, including the active ingredient
`cyclosporin A, an immunosuppressant, which is dissolved in castor oil, a
`fatty acid glyceride.” Id. The product Restasis is protected by the
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`Challenged Patents and each of the Challenged Patents is listed in the FDA’s
`Orange Book as patents that claim Restasis, “with respect to which a claim
`of patent infringement could reasonably be asserted.”7 Id. at 1, 27–29 (citing
`21 U.S.C. § 355(b)(1), (c)(2)).
`In Allergan v. Teva, the district court found thirteen representative
`claims from those four Challenged Patents invalid as obvious. Ex. 1164.
`The court explained that its obviousness analysis served to invalidate all
`claims of those four patents. Id. at 32–108. The Federal Circuit affirmed the
`district court’s decision by Rule 36 judgment. Allergan, Inc. v. Teva
`Pharms. USA, Inc., 742 F. App’x 511 (Mem.) (Fed. Cir. Nov. 13, 2018) (Ex.
`1172). Patent Owner’s petition for a writ of certiorari was denied. Allergan,
`Inc. v. Teva Pharms. USA, Inc., 139 S. Ct. 2674 (Mem.) (2019).
`During the district court litigation, Patent Owner agreed to treat the
`thirteen litigated claims as representative of all claims of the Challenged
`Patents and states that “judgment as to those thirteen claims can be properly
`applied to all claims of those four patents.” PO Supp. Br. 9. With the
`Federal Circuit’s affirmance and the Supreme Court’s denial of review, the
`district court’s judgment invalidating all claims of the ’111, ’048, ’930, ’191
`patents is now final.
`In light of the parallel proceeding and the finding of obviousness of
`the representative claims, we authorized supplemental briefing on the impact
`of the Federal Circuit’s Rule 36 affirmance on the patentability issues in
`
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` The district court refers to the Challenged Patents as the “Restasis patents.”
`Ex. 1164, 23–24.
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`these proceedings. Paper 139, 3. Pursuant to our order, Petitioner filed their
`Supplemental Briefing (“Pet. Supp. Br.,” Paper 140) and Patent Owner filed
`its response (“PO Supp. Br.,” Paper 142).
`
`C. The ’162 Patent (Ex. 1001)
`In Allergan v. Teva, the district court found that the specifications of
`the six Challenged Patents are identical with only minor variations.
`Ex. 1164, 23. Accordingly, we find the ’162 specification to be
`representative of the six Challenged Patents.
`The ’162 patent discloses methods of providing therapeutic effects
`using cyclosporin components, and more specifically to a formulation
`containing cyclosporin-A (“CsA”) and castor oil emulsions for treating dry
`eye syndrome (i.e., keratoconjunctivitis sicca). Ex. 1001, 1:18–20, 1:58–65,
`2:63–64. According to the Specification, the prior art recognized the use of
`emulsions containing CsA and CsA-derivatives to treat ophthalmic
`conditions. Id. at 1:26–65. The Specification notes, however, that “[o]ver
`time, it has become apparent that cyclosporin A emulsions for ophthalmic
`use preferably have less than 0.2% by weight of cylcosporin A.” Id. at 1:66–
`2:1. Moreover, if reduced amounts of cyclosporin are used, reduced
`amounts of castor oil are needed because one of the functions of castor oil is
`to solubilize CsA. Id. at 1:66–2:6.
`Accordingly, the Specification states that “[i]t has been found that the
`relatively increased amounts of hydrophobic component together with
`relatively reduced, yet therapeutically effective, amounts of cyclosporin
`component provide substantial and advantageous benefits.” Id. at 2:36–39.
`The relatively high concentration of hydrophobic component provides for a
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`more rapid breaking down of the emulsion in the eye, which reduces vision
`distortion and/or facilitates the therapeutic efficacy of the composition. Id.
`at 2:43–49. Furthermore, using reduced amounts of cyclosporin component
`mitigates against undesirable side effects or potential drug interactions. Id.
`at 2:49–52.
`The patent identifies two particular compositions that were selected
`for further testing, Composition I and Composition II. The table below
`provides a list of the components in the two compositions.
`
`
`
`Id. at 14:20–30. Based on the results of a Phase 3 clinical study, the
`Specification concludes that “Composition II . . . provides overall efficacy in
`treating dry eye disease substantially equal to that of Composition I.” Id. at
`14:44–48. The patent indicates that “[t]his is surprising for a number of
`reasons.” Id. at 14:49. According to the Specification, a reduced
`concentration of CsA in Composition II would have been expected to result
`in reduced overall efficacy in treating dry eye disease. Id. at 14:49–52.
`Moreover, although the large amount of castor oil relative to the amount of
`CsA in Composition II might have been expected to cause increased eye
`irritation, it was found to be substantially non-irritating in use. Id. at 14:52–
`57. Accordingly, the Specification states that physicians can prescribe
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`Composition II “to more patients and/or with fewer restrictions and/or with
`reduced risk of the occurrence of adverse events, e.g., side effects, drug
`interactions and the like, relative to providing Composition I.” Id. at 15:12–
`15.
`
`D. Illustrative Claims
`Petitioner challenges claims 1–24 of the ’162 patent, of which claims
`1, 18, and 23 are independent claims. Claim 23 is illustrative, and is
`reproduced below:
`23. A method of treating dry eye disease, the method
`comprising the step of topically administering to an eye of
`a human in need thereof an emulsion at a frequency of
`twice a day, the emulsion comprising:
`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;
`glycerine in an amount of about 2.2% by weight;
`sodium hydroxide; and
`water;
`wherein the emulsion is effective in treating dry eye
`disease.
`
`E. Summary of Asserted Prior Art
`
`1. Ding ’979 (Ex. 1006)
`Ding ’979, assigned to Patent Owner, relates to ophthalmic emulsions
`including cyclosporin, castor oil, and polysorbate 80 that have a high
`comfort level and low irritation potential. Ex. 1006, cover code (73), 1:4–9.
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`Ding ’979 explains that cyclosporins have “known immunosuppressant
`activity” and have been found “effective in treating immune medicated
`keratoconjunctivitis sicca (KCS or dry eye disease) in a patient suffering
`therefrom.” Id. at 1:10–16. Although the solubility of cyclosporins in water
`is extremely low, cyclosporins have some solubility in oily preparations
`containing higher fatty acid glycerides such as castor oil. Id. at 1:40–41,
`2:39–42. Ding ’979 notes, however, that formulations with a high
`concentration of oils have several drawbacks, including exacerbation of the
`symptoms of dry eyes and low thermodynamic activity of cyclosporin,
`which leads to poorer drug bioavailability. Id. at 2:42–57. Accordingly,
`Ding ’979 “is directed to an emulsion system which utilizes higher fatty acid
`glycerides but in combination with polysorbate 80 which results in an
`emulsion with a high comfort level and low irritation potential suitable for
`delivery of medications to sensitive areas such as ocular tissues.” Id. at
`2:65–3:3.
`Ding ’979 discloses that the preferable weight ratio of cyclosporin to
`castor oil is below 0.16, and more preferably between 0.12 and 0.02. Id. at
`3:15–20. Specifically, Ding ’979 discloses several compositions as Example
`1, shown below:
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`Id. at 4:32–43. Example 1 is a table identifying compositions A through E
`and their corresponding amounts of cyclosporin A, castor oil, polysorbate
`80, Pemulen® (an acrylate/C10-30 alkyl acrylate cross-polymer), glycerine,
`sodium hydroxide, and purified water, at a pH range of 7.2–7.6. Id.
`According to Ding ’979, the formulations of Example 1 were “made for
`treatment of keratoconjunctivitis sicca (dry eye) syndrome.” Id. at 5:10–12.
`
`2. Sall (Ex. 1007)
`Sall describes the results of two identical clinical trials—supported by
`a grant from Patent Owner—in which patients were treated twice daily with
`either cyclosporin A 0.05% or 0.1% ophthalmic emulsions or vehicle for six
`months. Ex. 1007, Abstract. The study sought to compare the efficacy and
`safety of cyclosporin A 0.05% and 0.1% to vehicle in patients with moderate
`to severe dry eye disease. Id. Sall found that topical treatment with either
`cyclosporin A 0.05% or 0.1% resulted in significantly greater improvements
`than vehicle treatment in two objective signs of dry eye disease. Id. at 637.
`Sall also found that treatment with cyclosporin A 0.05% resulted in
`significantly greater improvements in several subjective parameters. Id.
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`Sall also found that trough blood concentrations of cyclosporin A were
`undetectable in all samples of cyclosporin A 0.05%, whereas cyclosporin A
`was quantifiable in only six samples for six different patients in the
`cyclosporin 0.1% group. Id.
`Sall notes that the only treatments available for dry eye disease are
`palliative in nature. Id. at 638. In light of the results of the study, Sall states
`that it “represents the first therapeutic treatment specifically for dry eye
`disease and a significant breakthrough in the management of this common
`and frustrating condition.” Id.
`
`3. Acheampong (Ex. 1008)
`Acheampong describes a study by Patent Owner as part of its
`evaluation of the clinical efficacy of 0.05%–0.4% cyclosporin emulsion for
`the treatment of immuno-inflammatory eye diseases such as dry eye
`syndrome. Ex. 1008, 3. Acheampong describes the results of its research to
`determine the ocular tissue distribution of cyclosporin in rabbits and dogs,
`and to compare tissue concentrations in rabbits, dogs, and humans after
`topical administration. Id.
`In the study of humans, the subjects with dry eye disease received an
`eyedrop of vehicle or 0.05%, 0.1%, 0.2%, or 0.4% cyclosporin emulsions
`twice daily for 12 weeks. Id. at 4. Blood samples were collected from all
`subjects at morning troughs after 1, 4, and 12 weeks of dosing, and from
`certain subjects at 1, 2, and 4 hours after the last dose at week 12. Id.
`Acheampong found that the human blood cyclosporin A concentrations were
`less than 0.2 ng/ml for each emulsion, which is lower than the 20–100 ng/ml
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`blood trough concentration used for monitoring the safety of patients
`receiving systemic cyclosporin therapy. Id. at 6.
`
`4. Glonek (Ex. 1009)
`Glonek relates to a composition for augmenting and maintaining a
`stable tear film over the ocular surface and delivering a medicine to the eye
`without causing substantial blurring of vision. Ex. 1009, 1:21–29. Glonek
`explains that an emulsion over the surface of the eye is expected to cause
`blurring, which is likely to occur until the emulsion differentiates. Id. at
`6:37–42. If the emulsion is too stable, excess emulsion will be discharged
`from the eye. Id. at 6:42–44. Thus, Glonek states that it is preferred that an
`emulsion be stable for long term storage, but rapidly differentiate in the eye.
`Id. at 6:48–50.
`
`II. DISCUSSION
`
`A. Collateral Estoppel
`
`1. Legal Principles
`Collateral estoppel, also known as issue preclusion, precludes a party
`from relitigating an issue “when an issue of fact or law is actually litigated
`and determined by a valid and final judgment, and the determination is
`essential to the judgment,” in which case “the determination is conclusive in
`a subsequent action between the parties, whether on the same or a different
`claim.” Restatement (Second) of Judgments § 27 (1982). The Supreme
`Court
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`has long recognized that “the determination of a question directly
`involved in one action is conclusive as to that question in a
`second suit.” The idea is straightforward: Once a court has
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`decided an issue, it is ‘forever settled as between the parties,”
`thereby “protect[ing]” against “the expense and vexation
`attending multiple lawsuits, conserv[ing] judicial resources, and
`foster[ing] reliance on judicial action by minimizing the
`possibility of inconsistent verdicts.” In short, “a losing litigant
`deserves no rematch after a defeat fairly suffered.”
`B & B Hardware, Inc. v. Hargis Indus., Inc., 135 S. Ct. 1293, 1302–03
`(2015) (internal citations omitted). The Federal Circuit has articulated the
`following test for determining the proper application of collateral estoppel:
`
`(1) a prior action presents [the] identical issue;
`(2) the prior action actually litigated and adjudged that issue;
`(3) the judgment in that prior action necessarily required
`determination of the identical issue; and
`(4) the prior action featured full representation of the estopped
`party.8
`VirnetX Inc. v. Apple, Inc., 909 F.3d 1375, 1377 (Fed. Cir. 2018) (quoting
`Stephen Slesinger, Inc. v. Disney Enters., Inc., 702 F.3d 640, 644 (Fed. Cir.
`2012)).
`The Federal Circuit has applied collateral estoppel in the context of
`inter partes reviews. Maxlinear, Inc. v. CF CRESPE LLC, 880 F.3d 1373,
`1376 (Fed. Cir. 2018) (“It is well established that collateral estoppel . . .
`applies in the administrative context.”). Moreover, application of collateral
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` The fourth factor of the collateral estoppel test has sometimes been
`referred to as “(4) the party defending against preclusion had a full and fair
`opportunity to litigate the issues.” Levi Strauss & Co. v. Abercrombie &
`Fitch Trading Co., 719 F.3d 1367, 1371 (Fed. Cir. 2013). We consider the
`analysis to be the same regardless of how that factor is articulated.
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`estoppel in inter partes reviews “is not limited ‘to patent claims that are
`identical. Rather, it is the identity of the issues that were litigated that
`determines whether collateral estoppel should apply.’” Nestle USA, Inc. v.
`Steuben Foods, Inc., 884 F.3d 1350, 1352 (Fed. Cir. 2018) (quoting Ohio
`Willow Wood Co. v. Alps S., LLC, 735 F.3d 1333, 1342 (Fed. Cir. 2013)
`(emphasis in original)). The collateral-estoppel effect of an administrative
`decision of unpatentability generally requires the invalidation of related
`claims that present identical issues of patentability. Maxlinear, Inc., 880
`F.3d at 1377. “If the differences between the unadjudicated patent claims
`and adjudicated patent claims do not materially alter the question of
`invalidity, collateral estoppel applies.” Id.; see also Soverain Software LLC
`v. Victoria’s Secret Direct Brand Mgmt., LLC, 778 F.3d 1311, 1315 (Fed.
`Cir. 2015); Bourns, Inc. v. United States, 537 F.2d 486, 493 (Ct. Cl. 1976)
`(per curiam).
`
`2. The identical issue was presented in Allergan v. Teva—that is,
`the court considered whether the subject matter of the
`Challenged Patents would have been obvious
`A primary issue before the court in Allergan v. Teva was the
`obviousness of the subject matter of the claims in the Challenged Patents.
`The Challenged Patents contain a total of 157 claims, including both product
`and method claims. Ex. 1164, 23. The court found:
`
`A limitation that is common to all of the claims (with slight
`variations in wording) is the formulation for Restasis, which is
`an emulsion “comprising 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
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`about 0.05% by weight; glycerine in an amount of about 2.2% by
`weight; sodium hydroxide; and water.”
`Id. The Challenged Patents also include claims directed to methods of using
`Restasis, such as in methods for treating dry eye and increasing tear
`production. Id. at 31.
`The parties explain that, in Allergan v. Teva, Patent Owner originally
`asserted all of the Challenged Patents, but during the course of that litigation
`and prior to trial, Patent Owner agreed to use thirteen claims from four of the
`six Challenged Patents as representative claims for the purposes of
`streamlining the case. Pet. Supp. Br. 1–2; PO Supp. Br. 4; Ex. 2118;
`Ex. 1164 at 29–30 (“Allergan selected 13 claims from four of the Restasis
`patents to be litigated at trial.”). Those Representative Claims are: claims 26
`and 27 of the ’111 patent; claims 1, 11, 13, 14, and 23 of the ’048 patent;
`claim 35 of the ’930 patent; and claims 13, 16, 22, 26, and 27 of the ’191
`patent. Pet. Supp. Br. 1–2; PO Supp. Br. 4; Ex. 1164, 30.
`The claims of the ’048 patent are most similar to claims of the ’162
`patent. Representative Claims 1, 11, 13, 14, and 23 of the ’048 patent (as
`well as independent claim 22 from which claim 23 depends) are set forth
`below:
`
`1. A method of increasing tear production in the eye of a
`human, 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
`increasing tear production.
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`11. The method of claim 1, wherein the emulsion is
`administered to an eye of a human in an effective amount in
`increasing tear production, the blood of the human has
`substantially no detectable concentration of cyclosporin A.
`13. The method of claim 1, wherein the emulsion is as
`substantially therapeutically effective as a second emulsion
`administered to a human in need thereof at a frequency of twice
`a day, the second emulsion comprising cyclosporin A in an
`amount of 0.1% by weight and castor oil in an amount of 0.5%
`by weight.
`14. The method of claim 1, wherein the emulsion achieves
`at least as much therapeutic effectiveness as a second emulsion
`administered to a human in need thereof at a frequency of twice
`a day, the second emulsion comprising cyclosporin A in an
`amount of 0.1% by weight and castor oil in an amount of 1.25%
`by weight.
`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;
`glycerine in an amount of about 2.2% by weight;
`sodium hydroxide; 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.
`Ex. 1164, 31–32.
`The ʼ162 patent is one of the two Challenged Patents that is not
`represented by the Representative Claims. As in the ’048 patent, however,
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`IPR2016-01130
`Patent 8,633,162 B2
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`the claims of the ʼ162 patent are similarly directed to methods of using the
`Restasis emulsion formulation.9 We begin with a comparison between claim
`1 of the ’162 patent and claims 1 and 22 of the ’048 patent. Claims 1 and 22
`of the ’048 patent were held to be invalid as obvious by the district court.
`Exs. 1164, 1165. It is readily apparent from a side-by-side comparison of
`claim 1 of the ’162 and claims 1 and 22 of the ’048 patent that there is
`substantial identity between the claims. The following chart provided by
`Petitioner is a claim chart comparing the text of claim 1 of the ’162 to the
`text of claims 1 and 22 of the ’048 patent.
`
`
`
` 9
`
`
`
` We adopt the district court’s findings that each of the claims of the
`Challenged Patents, which includes the 24 claims of the ʼ162 patents, covers
`Restasis. Ex. 1164, 23.
`
`17
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`IPR2016-01130
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`IPR2016-01130
`Patent 8,633,162 B2
`Patent 8,633,162 B2
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`
`‘ 1152 Patent
`“048 Patent
`”048 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 fi'equency
`of twice a day. wherein
`the emulsion comprises
`
`cyclosporin A in an
`amount of about 0.05%
`
`by weight.
`
`polysorbate 30.
`
`ac1ylatefC10-30 alkyl
`acrylate cross-polymer.
`
`water. and
`
`castor oil in an amotult
`
`of about 1.25% by
`weight:
`
`and wherein the topical
`ophthalmic emulsion is
`effective in increasing
`tear production.
`
`
`
`Pet. Supp. Br. 8.
`Pet. Supp. Br. 8.
`
`22. A method comprising:
`
`administering an emulsion
`topically to the eye of a
`human haying
`keratoconjtmctiyitis sicca
`at a frequency of twice a
`day. wherein the emulsion
`comprises:
`
`cyclosporin A in an amount
`of about 0.05% by weight;
`
`dry eye disease.
`
`the method comprising
`topically administering to
`the eye of a human in
`need thereof an emulsion
`
`at a fiequency of twice a
`day. wherein the
`emulsion comprises
`
`cyclosporin A in an
`amount of about 0.05%
`
`castor oil in an amount of
`
`about 1.25% by weight;
`
`by weight.
`
`polysorbate 80 in an
`amount of about 1.0% by
`weight:
`
`acrylatet'C10-30 alkyl
`acrylate cros s-polymer in
`an amount of aboutl].05%
`
`by weight:
`
`polysorbate 80.
`
`acrylateiC10-30 alkyl
`acrylate cross-polymer.
`
`water. and
`
`[...]and water: and
`
`castor oil in an amount of
`
`wherein the emulsion is
`
`about 1.25% by weight:
`
`effective in increasing tear
`production in the human
`haying keratoconjunctiyitis
`sicca.
`
`and wherein the topical
`ophthahnic emulsion is
`effective in treating dry
`
`eye disease
` 1. A method of treating
`
`23. The method of claim
`
`22. wherein the emulsion
`
`has a pH in the range of
`about 7.2 to about 7.6.
`
`
`
`
`
`18
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`18
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`IPR2016-01130
`Patent 8,633,162 B2
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`
`As shown in the table above, independent claim 1 of the ’048 patent
`and independent claim 1 of the ’162 patent both recite a “method comprising
`topically administering to the eye of [the/a] human in need thereof an
`emulsion at a frequency of twice a day, wherein the emulsion comprises”
`a) “cyclosporine A in an amount of about 0.05% by weight;” b) “polysorbate
`80;” c) “acrylate/C10-30 alkyl acrylate cross-polymer;” d) “water;” and
`e) “castor oil in an amount of about 1.25% by weight.” The only difference
`between the claims is that claim 1 of the ’048 patent recites a “method of
`increasing tear production . . . wherein the topical ophthalmic emulsion is
`effective in increasing tear production,” while claim 1 of the ’162 patent
`recites a “method of treating dry eye disease . . . wherein the topical
`ophthalmic emulsion is effective in treating dry eye disease.” Dependent
`claims 2–17 of the ʼ162 patent are otherwise identical to dependent claims
`2–17 of the ʼ048 patent.
`Claims 18–22 of the ʼ162 patent are identical to claims 18–21 of the
`ʼ048 patent with one exception: claim 18 of the ʼ162 patent recites a
`“method of reducing side effects in a human being treated for dry eye
`syndrome” while claim 18 of the ʼ048 patent recites “method of treating
`keratoconjunctivitis sicca.”10
`Claims 23–24 of the ʼ162 patent are identical to claims 22–23 of the
`ʼ048 patent with one exception: the ʼ162 patent recites a “method of treating
`
`
`
`10 The extra claim in the ʼ162 patent, claim 22, requires the claimed
`emulsion to be “effective in treating dry eye disease,” which is similar to the
`recitation in claim 1.
`
`19
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`IPR2016-01130
`Patent 8,633,162 B2
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`dry eye disease” while the ʼ048 patent recites a method of “administering an
`emulsion topically to the eye of a human having keratoconjunctivitis sicca.”
`Accordingly, in view of the above, we determine that the differences
`between the claims of the ’162 and ’048 patents are minor and relate only to
`the terms of the condition being treated by the emulsion—namely dry eye,
`symptoms of dry eye (insufficient tear production), or particular conditions
`of dry eye such as keratoconjunctivitis sicca. Indeed, each of those
`variations of dry eye-related symptoms and conditions were at issue in
`Allergan v. Teva, and thoroughly considered by the district court. Ex. 1164,
`34–108. In this regard, we note that the district court found that
`“keratoconjunctivitis sicca” (or KCS) refers to “[t]he condition in which dry
`eye is associated with inflammation and involves a deficiency in aqueous
`tear production.” Id. at 3. As there is nothing of record to suggest
`otherwise, we adopt the same finding for purposes of our analysis. The
`parties have treated the claims in a similar manner and made the same
`arguments regardless of the particular condition recited in the claims. See
`Pet. 22–32 (applying same prior art teachings and arguments for independent
`claims 1, 18, and 23 of the ’162 patent); PO Resp. 18–40 (making the same
`unexpected results arguments as to all independent claims). Patent Owner
`has not persuasively identified any meaningful difference between the
`subject matter claimed in the ’162 patent and the subject matter claimed in
`the ’048 patent that would have affected the patentability analysis. See
`generally PO Supp. Br. Similar to the claims compared in Ohio Willow
`Wood, the claims of the ’162 and ’048 patents “use slightly different
`language to describe substantially the same invention.” 735 F.3d at 1342.
`
`
`
`20
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`IPR2016-01130
`Patent 8,633,162 B2
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`Moreover, the district court considered the obviousness of the subject
`matter claimed by the Representative Claims in view of Ding ’979,11 Sall,
`and Acheampong, which are the same references asserted in this case.
`Ex. 1164, 34–108. The district court also considered the obviousness of the
`claimed composition and methods in view of Patent Owner’s assertion that
`the Restasis formulation covered by the claims exhibited unexpected results
`compared to the prior art, which is the same argument Patent Owner has
`asserted in this case. Compare Ex. 1167, 34–108, with PO Resp. 21–35.
`Accordingly, we find that the district court in the prior case, Allergan v.
`Teva, considered the identical issue before us in this case, i.e., the
`obviousness of the subject matter in light of Ding ’979, Sall, and
`Acheampong as well as Patent Owner’s arguments of unexpected results.
`Having considered the question of obviousness at issue in the district
`court proceeding, we find that the unpatentability analysis in this case would
`not be materially different in order to account for the difference between the
`sc