Trials@uspto.gov
`Tel: 571-272-7822
`
`
`
`
`
`Paper 154
`Entered: September 27, 2019
`
`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 IPR2016-01129
`Patent 8,642,556 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 IPR2017-00579 and IPR2017-00598 have been joined with
`IPR2016-01129.
`
`
`Tel: 571-272-7822
`
`
`
`
`
`Paper 154
`Entered: September 27, 2019
`
`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 IPR2016-01129
`Patent 8,642,556 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 IPR2017-00579 and IPR2017-00598 have been joined with
`IPR2016-01129.
`
`
`
`IPR2016-01129
`Patent 8,642,556 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 1–20 of U.S. Patent No.
`8,642,556 B2 (Ex. 1001, “the ’556 patent”) are unpatentable.
`
`A. Procedural History
`Petitioner filed a Petition to institute an inter partes review of claims
`120 of the ’556 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 1–20 of the ’556 patent on each ground of unpatentability set forth
`in the Petition, which are as follows:
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`
`Ground
`
`Reference[s]
`
`Ding ’9792
`
`Claims Challenged
`Basis
`§ 102(b) 1–20
`
`1
`
`2
`
`3
`
`4
`
`5
`
`Ding ’979 and Sall3
`
`§ 103(a) 1–20
`
`Ding ’979, Sall, and Glonek4 § 103(a) 14 and 19
`Ding ’979, Sall, and
`Acheampong5
`Ding ’979, Sall, Glonek, and
`Acheampong
`
`§ 103(a) 11, 18, and 20
`
`§ 103(a) 19
`
`
`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
`
`
` 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 Glonek et al., US 5,578,586, issued Nov. 26, 1996 (Ex. 1009, “Glonek”).
`5 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”).
`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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`Teva Pharmaceuticals USA, Inc. (“Teva”) and Akorn, Inc. (“Akorn”)
`each filed Petitions requesting an inter partes review of claims 1–20 of the
`’556 patent in cases IPR2017-00579 and IPR2017-00598, respectfully.
`IPR2017-00579, Paper 4; IPR2017-00598, Paper 2. Teva and Akorn each
`filed a motion to join their respective cases with this case. IPR2017-00579,
`Paper 3; IPR2017-00598, Paper 3. We granted Teva and Akorn’s Petition
`and each of their motions for joinder. IPR2017-00579, Paper 9; IPR2017-
`00598, Paper 9.
`Per the parties’ request, an oral hearing was not held for this
`proceeding. Paper 147.
`
`B. Related Proceedings
`In addition to this proceeding challenging the ’556 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. 8,633,162 B2 (“the ’162
`patent”) in IPR2016-01130; 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
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`cyclosporin A, an immunosuppressant, which is dissolved in castor oil, a
`fatty acid glyceride.” Id. The product Restasis is protected by the
`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
`and patents is now final.
`
`
`
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`
`
` The district court refers to the Challenged Patents as the “Restasis patents.”
`Ex. 1164, 23–24.
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`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
`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 ’556 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 ’556 specification to be
`representative of the six Challenged Patents.
`The ’556 patent generally relates to methods of providing therapeutic
`effects using cyclosporin components, and more specifically to a
`formulation containing, inter alia, 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
`cyclosporin A.” Id. at 1:66–2:1. Moreover, if reduced amounts of CsA are
`used, reduced amounts of castor oil are needed because one of the functions
`of castor oil is to solubilize cyclosporin A. 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
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`relatively reduced, yet therapeutically effective, amounts of cyclosporin
`component provide substantial and advantageous benefits.” Id. at 2:35–38.
`The relatively high concentration of hydrophobic component provides for a
`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 2:42–48. Furthermore, using reduced amounts of cyclosporin component
`mitigates against undesirable side effects or potential drug interactions. Id.
`at 2:48–51.
`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 15:1–13. Based on the results of a Phase III 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
`15:18–22. The patent indicates that “[t]his is surprising for a number of
`reasons.” Id. at 15:23. 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 15:24–26.
`Moreover, although the large amount of castor oil relative to the amount of
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`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 15:26–
`32. Accordingly, the Specification states that physicians can prescribe
`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 15:54–
`58.
`
`D. Illustrative Claims
`Petitioner challenges claims 1–20 of the ’556 patent. Independent
`claim 1 is illustrative, and is reproduced below:
`1. A first topical ophthalmic emulsion for treating an eye
`of a human, wherein the first topical ophthalmic 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 first topical ophthalmic emulsion is
`therapeutically effective in treating dry eye disease; and
`wherein the first topical ophthalmic emulsion provides
`overall efficacy substantially equal to a second topical
`ophthalmic emulsion comprising cyclosporin A in an amount of
`about 0.1% by weight and castor oil in an amount of about
`1.25% by weight.
`
`Independent claims 13, 14, and 15 also recite a topical
`ophthalmic emulsion comprising CsA in an amount of about 0.05%
`by weight and castor oil in an amount of 1.25% by weight, and further
`specify particular amounts for other components.
`
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`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.
`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
`
`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
`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 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
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`claim of patent infringement could reasonably be asserted.”9 Id. at 1, 27–29
`(citing 21 U.S.C. § 355(b)(1), (c)(2)).
`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
`about 0.05% by weight; glycerine in an amount of about 2.2% by
`weight; sodium hydroxide; and water.”
`
`Id.
`
`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;
`
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` The district court refers to the Challenged Patents as the “Restasis patents.”
`Ex. 1164, 23–24.
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`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 ’191 patent are most similar to claims of the ’556
`patent. Representative Claims 13, 16, 22, 26, and 27 of the ’191 patent (as
`well as claim 21, from which claims 22, 26, and 27 depend) are set forth
`below:
`
`13. A method of enhancing tearing in a human eye, the
`method comprising topically administering to a human eye in
`need thereof a first topical ophthalmic emulsion at a frequency
`of twice a day,
`wherein the first topical ophthalmic 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;
`wherein the method is therapeutically effective in treating
`dry eye disease and
`wherein the method achieves at least as much therapeutic
`efficacy as administration of a second topical ophthalmic
`emulsion to a human eye in need thereof at a frequency of twice
`a day, the second emulsion comprising cyclosporin A in an
`amount of about 0.1% by weight and castor oil in an amount of
`about 1.25% by weight; and
`wherein the method results in a concentration of
`cyclosporin A in the blood of the human of less than about 0.1
`ng/ml.
`16. The method of claim 13, wherein the method is
`effective in enhancing lacrimal gland tearing.
`21. A method of restoring tearing, the method comprising
`topically administering to a human eye in need thereof a first
`topical ophthalmic emulsion at a frequency of twice a day,
`wherein the first topical ophthalmic 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;
`
`
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`16
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`IPR2016-01129
`Patent 8,642,556 B2
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`wherein the method demonstrates a reduction in adverse
`events in the human, compared to administration of a second
`topical ophthalmic emulsion to a human eye in need thereof at a
`frequency of twice a day, the second topical ophthalmic emulsion
`comprising cyclosporin A in an amount of about 0.1% by weight
`and castor oil in an amount of about 1.25% by weight; and
`wherein the method achieves at least as much therapeutic
`efficacy as administration of the second topical ophthalmic
`emulsion to a human eye in need thereof at a frequency of twice
`a day.
`22. The method of claim 21, wherein the method results in
`a concentration of cyclosporin A in the blood of the human of
`less than about 0.1 ng/ml.
`26. The method of claim 21, wherein the method is
`effective in restoring lacrimal gland tearing.
`27. The method of claim 21, wherein the adverse events
`are selected from the group consisting of visual distortion and
`eye irritation and wherein the method results in a concentration
`of cyclosporin A in the blood of the human of less than about 0.1
`ng/ml.
`Ex. 1164, 31–32.
`The ʼ556 patent is one of the two Challenged Patents that does not
`include any Representative Claim. The claims of the ʼ191 patent, however,
`are directed to methods of using the products encompassed by the claims of
`the ’556 patent. Those method claims of the ʼ191 patent were held to be
`invalid as obvious by the district court. Exs. 1164, 1165.10 Petitioner
`explains, and we agree, that a comparison between the claims of the ’556
`
`
`
`10 We adopt the district court’s findings that each of the claims of the
`Challenged Patents, which includes the 20 claims of the ʼ556 patents, covers
`Restasis. Ex. 1164, 23.
`
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`IPR2016-01129
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`patent and the claims of the ’191 patent reveals that there are no limitations
`unique to the claims of the ’556 patent and that there is substantial identity
`between the products recited by the claims. Pet. Supp. Br. 10–14. Rather,
`we find that the claims of the ʼ191 patent, previously invalidated by the
`district court, merely recite methods of using the product claimed by the
`’556 patent. For instance, both claim 1 of the ’556 patent and claim 13 of
`the ’191 patent recite a “first topical ophthalmic emulsion” that “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.” Additionally, both those claims require
`that the emulsion or the method to be “therapeutically effective in treating
`dry eye disease” and provide an efficacy that is at least substantially equal to
`“a second topical ophthalmic emulsion comprising cyclosporin A in an
`amount of about 0.1% by weight and castor oil in an amount of about 1.25%
`by weight.” Patent Owner has not persuasively identified any meaningful
`difference between the subject matter claimed in the ’556 patent and the
`subject matter claimed in the ’191 patent that would have affected the
`patentability analysis. See generally PO Supp. Br.
`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
`
`
`
`11 Ding ’979 is referred to as Ding I by the district court.
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`IPR2016-01129
`Patent 8,642,556 B2
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`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 any differences between
`the scope of the claims in the ’556 and ’191 patents. The district court’s
`obviousness analysis and conclusions for the method claims of the ’191
`patent necessarily required an assessment of the obviousness of the same
`composition recited in the claims of the ’556 patent. Accordingly, we
`determine that the differences between the claims of the ’556 patent and the
`claims of the Challenged Patents, the ’191 patent in particular, do not
`materially alter the question of patentability presented before us in this
`proceeding.
`
`3. Obviousness of the claimed subject matter was actually
`litigated and adjudged
`In the district court proceedings, the Patent Owner explicitly
`confirmed that the thirteen chosen claims were “representative claims of all
`of the claims in the various patents [Challenged Patents], including the
`unasserted claims.” Pet. Supp. Br, 2 (emphasis omitted) (citing Ex. 1173,
`7:25–8:2 (Pretrial Hearing Transcript)). The court also made clear that the
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`purpose of the representative claims was to streamline the case while also
`“mak[ing] sure that this matter is dispositive of the entire dispute between
`the parties.” Ex. 1173, 7:5–7. Specifically, the court explained the objective
`as follows:
`
`Okay, on representative claims, as I say, you’ve been – it’s been
`very helpful. I just want to make sure again that we’re all on the
`same page here. The objective is to make sure that this matter is
`dispositive of the entire dispute between the parties. Now, I
`understand that there’s a difference between the one -- the
`271(e)(2) infringement claim and potentially down the road if it
`comes to that potential (a) claims and (b) claims. But for
`purposes of the Hatch-Waxman Act proceeding before us, these
`claims, these representative claims, we are all agreed, I take it,
`will be the dispositive -- will dispose of all the disputes between
`the parties. I don’t want to find us, ourselves, after this saying,
`oh, well, but we still have the following invalidity arguments, we
`still have the following infringement arguments, we still have the
`following claims. Now, am I -- do I correctly understand that the
`parties agree that the 13 representative claims will dispose of the
`dispute in this case?
`Id. at 7:3–19. The parties subsequently agreed that any remedy entered as to
`the Representative Claims would apply equally to the unasserted claims. Id.
`at 8:2–4, 9:3–5. Specific to the ’162 and ’556 patents, Patent Owner gave a
`covenant not to sue with regard to those patents and, as such, the ’162 and
`’556 patents were dropped from the case. PO Supp. Br. 5.
`After a bench trial, the district court issued a decision determining the
`Represen
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