Trials@uspto.gov
`571-272-7822
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`
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` Paper No. 8
` Entered: December 8, 2016
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`MYLAN PHARMACEUTICALS, INC.,
`Petitioner,
`
`v.
`
`ALLERGAN, INC.,
`Patent Owner.
`____________
`
`Case IPR2016-01128
`Patent 8,629,111 B2
`____________
`
`
`
`Before SHERIDAN K. SNEDDEN, TINA E. HULSE, and
`CHRISTOPHER G. PAULRAJ, Administrative Patent Judges.
`
`PAULRAJ, Administrative Patent Judge.
`
`DECISION
`Institution of Inter Partes Review
`37 C.F.R. § 42.108
`
`
`
`
`
`
`
`571-272-7822
`
`
`
`
`
` Paper No. 8
` Entered: December 8, 2016
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`MYLAN PHARMACEUTICALS, INC.,
`Petitioner,
`
`v.
`
`ALLERGAN, INC.,
`Patent Owner.
`____________
`
`Case IPR2016-01128
`Patent 8,629,111 B2
`____________
`
`
`
`Before SHERIDAN K. SNEDDEN, TINA E. HULSE, and
`CHRISTOPHER G. PAULRAJ, Administrative Patent Judges.
`
`PAULRAJ, Administrative Patent Judge.
`
`DECISION
`Institution of Inter Partes Review
`37 C.F.R. § 42.108
`
`
`
`
`
`
`
`
`IPR2016-01128
`Patent 8,629,111 B2
`
`I.
`
`INTRODUCTION
`
`Mylan Pharmaceuticals, Inc. (“Petitioner”) filed a Petition (Paper 3,
`“Pet.”), requesting institution of an inter partes review of claims 1–27 of
`U.S. Patent No. 8,629,111 B2 (Ex. 1001, “the ’111 patent”). Allergan, Inc.
`(“Patent Owner”) timely filed a Preliminary Response (Paper 7,
`“Prelim. Resp.”).
`We have jurisdiction under 35 U.S.C. § 314, which provides that an
`inter partes review may not be instituted “unless . . . there is a reasonable
`likelihood that the petitioner would prevail with respect to at least 1 of the
`claims challenged in the petition.” Upon consideration of the Petition and
`the Preliminary Response, and for the reasons explained below, we
`determine that Petitioner has shown that there is a reasonable likelihood that
`it would prevail with respect to at least one of the challenged claims. We
`thus institute an inter partes review of claims 1–27 of the ’111 patent.
`
`A. Related Proceedings
`An IPR petition for the ’111 patent was previously filed by Apotex
`Corp. and Apotex Inc. as IPR2015-01282, as were petitions for related U.S.
`Patent Nos. 8,648,048 (IPR2015-01284), 8,633,162 (IPR2015-01278),
`8,642,556 (IPR2015-01286 ), and 8,685,930 (IPR2015-01283), but all were
`terminated prior to institution decisions. Pet. 11. Additionally, concurrent
`IPR petitions for related patents were filed by Petitioner in IPR2016-1127,
`IPR2016-01129, IPR2016-01130, IPR2016-01131, and IPR2016-01132. Id.
`Furthermore, Petition and Patent Owner identify the following related
`litigation matters: Allergan, Inc. v. Teva Pharmaceuticals USA, Inc., et al.,
`No. 2:15-cv-01455 (E.D. Texas); Allergan, Inc., v. Innopharma, Inc. and
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`Pfizer, Inc., No. 2:15-cv-1504 (E.D. Texas); and Allergan, Inc. v. Famy
`Care, Ltd., No. 2:16-cv-0401 (E.D. Texas). Pet. 11; Paper 6, 2.
`
`B. The ’111 Patent (Ex. 1001)
`The ’111 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 been 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 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
`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.
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`The patent identifies two particular compositions that were selected
`for further testing, as shown below:
`
`
`
`Id. at 14:20–30. 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
`14:35–40. The patent indicates that “[t]his is surprising for a number of
`reasons.” Id. at 14:41. 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
`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 15:5–8.
`C. Illustrative Claims
`Petitioner challenges claims 1–27 of the ’111 patent. Independent
`claim 1 is illustrative, and is reproduced below:
`
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`1. A topical ophthalmic emulsion for treating an eye of a human
`comprising 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 cyclosporin A is the only peptide present in the topical
`ophthalmic emulsion.
`
`
`Independent claims 13 and 18 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 the other components.
`
`D. The Asserted Grounds of Unpatentability
`Petitioner challenges the patentability of the claims of the ’111 patent
`on the following grounds:
`References
`Ding ’9791
`
`Claims challenged
`1–27
`
`Basis
`§ 102(b)
`
`Ding ’979 and Sall2
`
`Ding ’979, Sall, and
`Acheampong3
`
`
`§ 103(a)
`
`§ 103(a)
`
`1–27
`
`11 and 16
`
`
`1 Ding et al., US 5,474,979, issued Dec. 12, 1995 (Ex. 1003).
`2 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 631–39 (2000).
`3 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).
`
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`Petitioner further relies upon the declaration of Dr. Mansoor Amiji
`(Ex. 1002).
`II. ANALYSIS
`
`A. Claim Construction
`
`We interpret claims using the “broadest reasonable construction in
`light of the specification of the patent in which [they] appear[].” 37 C.F.R.
`§ 42.100(b); see also Cuozzo Speed Techs., LLC v. Lee, 136 S. Ct. 2131,
`2144–46 (2016). Under the broadest reasonable construction standard, claim
`terms are generally given their ordinary and customary meaning, as would
`be understood by one of ordinary skill in the art at the time of the invention.
`In re Translogic Tech., Inc., 504 F.3d 1249, 1257 (Fed. Cir. 2007). “Absent
`claim language carrying a narrow meaning, the PTO should only limit the
`claim based on the specification . . . when [it] expressly disclaim[s] the
`broader definition.” In re Bigio, 381 F.3d 1320, 1325 (Fed. Cir. 2004).
`“Although an inventor is indeed free to define the specific terms used to
`describe his or her invention, this must be done with reasonable clarity,
`deliberateness, and precision.” In re Paulsen, 30 F.3d 1475, 1480 (Fed. Cir.
`1994).
`
`1. “therapeutically effective”
`Dependent claims 20-27 state the emulsion is “therapeutically
`effective” in increasing tear production, treating dry eye disease or treating
`KCS. Petitioner asserts that because the plain meaning of the word
`“therapeutic” includes palliative as well as curative treatments, the broadest
`reasonable interpretation of the term includes “an emulsion that is effective
`in increasing tear production is an example of an emulsion therapeutically
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`effective in treating dry eye disease/KCS palliative and curative treatments.
`Pet. 14–15 (citing Ex. 1002 ¶¶ 43–44; Ex. 1022, 7)
`Patent Owner argues that Petitioner’s proposed construction is too
`broad, and that the claims should be construed to require that “the emulsion
`treat the underlying disease,” and not just its symptoms. Prelim. Resp. 21–
`23. Patent Owner argues that its construction is supported by a dictionary
`definition of “therapeutic,” defined as “[r]elating to therapeutics or to the
`treatment, remediating, or curing of a disease or disorder.” Id. (citing Exs.
`2005, 2006). Patent Owner contrasts this definition of “therapeutic” with the
`definition of “palliative,” defined as “reducing the severity of: denoting the
`alleviation of symptoms without curing the underlying disease,” thereby
`suggesting that the phrase “therapeutically effective” would not include
`palliative effects. Id. at 21–22 n.2 (citing Ex. 2007). We disagree. The
`definition of “therapeutic” provided by the Patent Owner is not limited to a
`cure of a disease or disorder, but also includes either treatment or
`remediating of a disease or disorder. We thus conclude, on the current
`record, that the ordinary meaning of the phrase “therapeutically effective” is
`not so limited as to exclude palliative effects.
`Patent Owner further argues that the Specification supports its
`construction because “the ‘111 patent specification does not use the word
`‘therapeutic’ to refer to the activity of the other components of the emulsion,
`including castor oil.” Prelim. Resp. 22. We disagree. Contrary to Patent
`Owner’s assertion, the specification does refer to the “therapeutic effects” of
`castor oil: “it is believed that castor oil includes a relatively high
`concentration of ricinoleic acid which itself may be useful in benefitting
`ocular tissue and/or in providing one or more therapeutic effects when
`
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`administered to an eye.” Ex. 1001, 9:53–57 (emphasis added). Thus,
`notwithstanding Patent Owner’s extrinsic evidence it offers in support of its
`more-limited construction (Prelim. Resp. 21–23), we decline to construe the
`claims in a manner inconsistent with the specification.
`Accordingly, at this stage of the proceeding, we find that
`“therapeutically effective” and similar terms encompass both palliative and
`curative treatments of dry eye disease.
`
`2. Remaining Claim Terms
`Petitioner proposes constructions for a number of additional claim
`terms. At this stage of the proceeding, we determine that no explicit
`construction of any other claim term is necessary to determine whether to
`institute a trial in this case. See Wellman, Inc. v. Eastman Chem. Co., 642
`F.3d 1355, 1361 (Fed. Cir. 2011) (“[C]laim terms need only be construed ‘to
`the extent necessary to resolve the controversy.’”) (quoting Vivid Techs.,
`Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)). At this
`stage of the proceeding, we have not made a final determination as to the
`construction of any claim term.
`
`B. Principles of Law
`An inter partes review may be instituted only if “the information
`presented in the [Petition and Preliminary Response] shows that there is a
`reasonable likelihood that the petitioner would prevail with respect to at
`least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a). To
`prevail in its challenges to the patentability of the claims, a petitioner must
`establish facts supporting its challenges by a preponderance of the evidence.
`35 U.S.C. § 316(e); 37 C.F.R. § 42.1(d).
`
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`We analyze the proposed grounds of unpatentability in accordance
`with the following stated principles.
`
`1. Law of Anticipation
`The Court of Appeals for the Federal Circuit summarized the
`analytical framework for determining whether prior art anticipates a claim as
`follows:
`
`If the claimed invention was “described in a printed publication”
`either before the date of invention, 35 U.S.C. § 102(a), or more
`than one year before the U.S. patent application was filed, 35
`U.S.C. § 102(b), then that prior art anticipates the patent.
`Although § 102 refers to “the invention” generally, the
`anticipation inquiry proceeds on a claim-by-claim basis. See
`Hakim v. Cannon Avent Group, PLC, 479 F.3d 1313, 1319 (Fed.
`Cir. 2007). To anticipate a claim, a single prior art reference
`must expressly or inherently disclose each claim limitation.
`Celeritas Techs., Ltd. v. Rockwell Int’l Corp., 150 F.3d 1354,
`1361 (Fed. Cir. 1998). But disclosure of each element is not
`quite enough—this court has long held that “[a]nticipation
`requires the presence in a single prior art disclosure of all
`elements of a claimed invention arranged as in the claim.”
`Connell v. Sears, Roebuck & Co., 722 F.2d 1542, 1548 (Fed. Cir.
`1983) (citing Soundscriber Corp. v. United States, 175 Ct. Cl.
`644, 360 F.2d 954, 960 (1966) (emphasis added)).
`Finisar Corp. v. DirecTV Grp., Inc., 523 F.3d 1323, 1334–35 (Fed. Cir.
`2008). We must analyze prior art references as a skilled artisan would. See
`Scripps Clinic & Res. Found. v. Genentech, Inc., 927 F.2d 1565, 1576 (Fed.
`Cir. 1991) (to anticipate, “[t]here must be no difference between the claimed
`invention and the reference disclosure, as viewed by a person of ordinary
`skill in the field of the invention”).
`When a patent claims a range, that range is anticipated by a prior art
`reference if the reference discloses a point within the broader range.
`
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`Titanium Metals Corp. v. Banner, 778 F.2d 775, 782 (Fed. Cir. 1985). If the
`prior art discloses its own range, rather than a specific point, then the prior
`art is anticipatory insofar as it describes the claimed range with sufficient
`specificity. See ClearValue, Inc. v. Pearl River Polymers, Inc., 668 F.3d
`1340, 1345 (Fed. Cir. 2012); Atofina v. Great Lakes Chem. Corp., 441 F.3d
`991, 999 (Fed. Cir. 2006).
`
`2. Law of Obviousness
`A patent may not be obtained if the differences between the subject
`matter sought to be patented and the prior art are such that the subject matter
`as a whole would have been obvious at the time the invention was made to a
`person having ordinary skill in the art to which the subject matter pertains.
`35 U.S.C. § 103(a). The legal question of obviousness is resolved on the
`basis of underlying factual determinations, including: (1) the scope and
`content of the prior art; (2) any differences between the claimed subject
`matter and the prior art; (3) the level of skill in the art; and (4) objective
`evidence of nonobviousness, i.e., secondary considerations. See Graham v.
`John Deere Co., 383 U.S. 1, 17–18 (1966).
`In KSR International Co. v. Teleflex Inc., the Supreme Court stated
`that an invention may be found obvious if trying a course of conduct would
`have been obvious to a person having ordinary skill:
`
`When there is a design need or market pressure to solve a
`problem and there are a finite number of identified, predictable
`solutions, a person of ordinary skill has good reason to pursue
`the known options within his or her technical grasp. If this leads
`to the anticipated success, it is likely the product not of
`innovation but of ordinary skill and common sense. In that
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`instance the fact that a combination was obvious to try might
`show that it was obvious under § 103.
`550 U.S. 398, 421 (2007). “KSR affirmed the logical inverse of this
`statement by stating that § 103 bars patentability unless ‘the improvement is
`more than the predictable use of prior art elements according to their
`established functions.’” In re Kubin, 561 F.3d 1351, 1360 (Fed. Cir. 2009)
`(citing KSR, 550 U.S. at 417).
`The factual inquiries for an obviousness determination also include
`secondary considerations based on evaluation and crediting of objective
`evidence of nonobviousness. Graham, 383 U.S. at 17. Notwithstanding
`what the teachings of the prior art would have suggested to one with
`ordinary skill in the art at the time of the invention, the totality of the
`evidence submitted, including objective evidence of nonobviousness, may
`lead to a conclusion that the claimed invention would not have been obvious
`to one with ordinary skill in the art. In re Piasecki, 745 F.2d 1468, 1471–72
`(Fed. Cir. 1984).
`Such a conclusion, however, requires the finding of a nexus to
`establish that the evidence relied upon traces its basis to something novel in
`the claim and not to something in the prior art. Institut Pasteur & Universite
`Pierre et Marie Curie v. Focarino, 738 F.3d 1337, 1347 (Fed. Cir. 2013).
`Generally, objective evidence of nonobviousness must be shown to have a
`nexus. In re GPAC Inc., 57 F.3d 1573, 1580 (Fed. Cir. 1995) (nexus
`generally); In re Kao, 639 F.3d 1057, 1069 (Fed. Cir. 2011) (unexpected
`results); In re Huang, 100 F.3d 135, 140 (Fed. Cir. 1996) (commercial
`success); Rambus Inc. v. Rea, 731 F.3d 1248, 1256 (Fed. Cir. 2013) (long-
`felt need).
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`Objective evidence of nonobviousness also must be reasonably
`commensurate in scope with the claim. Kao, 639 F.3d at 1068. This does
`not mean that the proffered evidence must reach every embodiment within
`the scope of the claim, so long as there is an “adequate basis to support the
`conclusion that other embodiments falling within the claim will behave in
`the same manner.” Id.
`
`C. Content of the Prior Art
`Petitioner relies upon the following prior art in its challenges.
`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, 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
`
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`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 CsA 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:
`
`
`
`Id. at 4:32–43. Example 1 identifies compositions A through E, which
`contain varying amounts of CsA, 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 was “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 CsA 0.05% or 0.1% ophthalmic emulsions or vehicle for six months.
`Ex. 1007, Abstract, 631. The study sought to compare the efficacy and
`safety of CsA 0.05% and 0.1% to vehicle in patients with moderate to severe
`
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`dry eye disease. Id. Sall found that topical treatment with either CsA 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 CsA 0.05% resulted in significantly greater
`improvements in several subjective parameters. Id. Sall also found that
`trough blood concentrations of CsA were undetectable in all samples of CsA
`0.05%, whereas CsA was quantifiable in only six samples for six different
`patients in the CsA 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, 1001. 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 1002. 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.
`
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`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
`blood trough concentration used for monitoring the safety of patients
`receiving systemic cyclosporin therapy. Id. at 1004.
`
`D. Anticipation of Claims 1–27 by Ding ’979
`Petitioner contends that claims 1−27 of the ’111 patent are anticipated
`by Ding ’979. Pet. 20−34. In support of its assertion that Ding ’979 teaches
`each element of the challenged claims, Petitioner sets forth the teachings of
`Ding ’979 discussed above. Petitioner also provides a detailed claim chart
`including citations to Ding ’979 and the Amiji Declaration. Id. at 29–34.
`Patent Owner argues that Ding ’979 does not disclose the specific
`composition of the challenged claims having 0.05% by weight CsA, 1.25%
`by weight castor oil, polysorbate 80, and an acrylate/C10-30 alkyl acrylate
`polymer. Prelim. Resp. 24. Patent Owner acknowledges that Ding ’979
`discloses that the weight ratio of cyclosporin to castor oil is below 0.16 and
`preferably between 0.12 and 0.02, but contends this range is “very broad.”
`Prelim. Resp. 24; Pet. 19−20; Ex. 1006, 3:15−20. Patent Owner further
`acknowledges that Ding ’979 discloses five specific compositions having the
`following CsA/castor oil ratios: 0.40%/5.00% (Sample A), 0.20%/5.00%
`(Sample B), 0.20%/2.50% (Sample C), 0.10%/1.25% (Sample D), and
`0.05%/0.625% (Sample E). Prelim. Resp. 24. (citing Ex. 1003, 4:30−45).
`Patent Owner contends, however, that Ding ’979 fails to disclose a specific
`composition containing 0.05% cyclosporin/1.25% castor oil. Prelim. Resp.
`24–25.
`On the current record, there appears to be no dispute between the
`parties that a composition containing 0.05% cyclosporin/1.25% castor oil
`
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`yields a weight ratio of cyclosporin to castor oil of 0.04, which falls within
`the range disclosed in Ding ’979. Prelim. Resp. 23−28. Rather, the dispute
`between the parties appears to be whether Ding ’979 describes the claimed
`amounts with sufficient specificity to anticipate this limitation of the
`challenged claims.
`As stated by the Federal Circuit:
`It is well established that the disclosure of a genus in the prior
`art is not necessarily a disclosure of every species that is a
`member of that genus. There may be many species
`encompassed within a genus that are not disclosed by a mere
`disclosure of the genus. On the other hand, a very small genus
`can be a disclosure of each species within the genus.
`Atofina, 441 F.3d at 999 (internal citation omitted). In reaching our
`conclusion with regard to anticipation, we must determine whether Ding
`’979 discloses a broad genus such that different portions of the broad range
`would work differently. ClearValue, 668 F.3d at 1345; see also Ineos USA
`LLC v. Berry Plastics Corp., 783 F.3d 865, 871 (Fed. Cir. 2015) (“Ineos is
`also correct that when the prior art discloses a range, rather than a point, the
`court must evaluate whether the patentee has established that the claimed
`range is critical to the operability of the claimed invention.”).
`In Atofina, the Federal Circuit reversed the district court’s finding of
`anticipation where the claims recited temperature between 330–450 degrees
`Celsius and the prior art disclosed a “broad temperature range” of 100–500
`degrees Celsius. Atofina, 441 F.3d at 999. The key to the court’s conclusion
`in Atofina “was the fact that the evidence showed that a person of ordinary
`skill in the art would have expected the [method] to operate differently, or
`not [at] all, outside of the temperature range claimed in the patent-in-suit.”
`Ineos, 783 F.3d at 869 (citing Atofina, 441 F.3d at 999; ClearValue, 668
`
`
`
`16
`
`
`
`IPR2016-01128
`Patent 8,629,111 B2
`
`F.3d at 1345). Here, based on the current record, there is insufficient
`evidence demonstrating the criticality of the claimed amounts or any
`difference across the range disclosed in the prior art.4 See ClearValue, 668
`F.3d at 1345 (explaining the importance of establishing the criticality of a
`claimed range to the claimed invention in order to avoid anticipation by a
`prior art reference disclosing a broader range); see also Ineos, 783 F.3d at
`870 (Fed. Cir. 2015) (finding that patentee failed to establish that certain
`properties would differ if range from prior art patent was substituted for
`range of limitation); OSRAM Sylvania, Inc. v. Am. Induction Techs., Inc.,
`701 F.3d 698, 705−06 (Fed. Cir. 2012) (emphasizing that “how one of
`ordinary skill in the art would understand the relative size of a genus or
`species in a particular technology is of critical importance”).
`Accordingly, on the current record, we determine that there is a
`reasonable likelihood that Petitioner would prevail in demonstrating the
`unpatentability of claims 1−27 as anticipated by Ding ’979.
`
`E. Obviousness of Claims 1–27 Over the Combination of Ding ’979
`and Sall
`
`Petitioner contends that claims 1–27 are rendered obvious by the
`combined teachings of Ding ’979 and Sall. Pet. 35–42. Petitioner has
`
`
`4 To the extent that Patent Owner relies upon the Examiner’s conclusion that
`“the specific combination of 0.05% by weight cyclosporin A with 1.25%
`castor oil is surprisingly critical for the therapeutic effectiveness in the
`treatment of dry eye or keratoconjuctivitis sicca,” which was based on the
`same declarations relied upon to assert unexpected results in response to
`Petitioner’s obviousness challenges, we determine at this preliminary stage
`that it is more appropriate to allow further evidence to be developed during
`trial regarding any such alleged criticality. Prelim. Resp. 17–18 (citing Ex.
`1004, 443).
`
`
`
`17
`
`
`
`IPR2016-01128
`Patent 8,629,111 B2
`
`included claim charts for exemplary claims 11, 17, 18, and 19 specific to this
`ground. Id. at 39–42. The issue before us is whether it would have been
`obvious to use the particular concentrations of 0.05% CsA and 1.25% castor
`oil recited in the challenged claims.
`As noted above, Ding ’979 specifically identifies examples that
`include 0.05% CsA and 1.25% castor oil, albeit not as part of the same
`composition. Ex. 1006, 4:32–43. Petitioner contends, however, that “Sall
`also provides a strong rationale to deliver 0.05% CsA using the 1.25% castor
`oil vehicle taught by Ding ’979 (Example 2C).” Pet. 36. Petitioner contends
`that Sall teaches that either the 0.05% or 0.10% CsA emulsion is
`therapeutically effective in increasing tear production and treating dry eye
`disease/KCS. Id. (citing Ex. 1007, 632; Ex. 1002 ¶¶ 81–82, 111–113).
`Petitioner contends that Sall discloses that the vehicle used is the study
`reported in Sall (castor oil) “contributed to the overall improvements
`observed in all treatment groups in this study.” Id. (citing Ex. 1007, 632,
`638; Ex. 1002 ¶¶ 83, 112). Petitioner further contends that “[t]he 1.25%
`castor oil vehicle is the only vehicle from Ding ʼ979 Example 2 for which
`both 0.05% and 0.10% CsA have a ratio of CsA-to-castor oil inside Ding
`’979’s more preferred range of between 0.12 and 0.02 . . . and also within
`the ratio range found with each of the Example 1 emulsions (0.04–0.08).”
`Id. (citing Ex. 1006, 3:17–20). Finally, Petitioner provides the following
`rationale for combining Ding ’979 and Sall:
`
`In light of Ding ’979 and Sall, a person of ordinary skill
`would have had a reasonable expectation that this emulsion
`would be effective in treating dry eye disease based on at least
`the success described by Sall: “Treatment with CsA, 0.05% or
`0.1% gave significantly (P ≤ 0.05) greater improvements than
`vehicle in two objective signs of dry eye disease.” Id. at 631;
`
`
`
`18
`
`
`
`IPR2016-01128
`Patent 8,629,111 B2
`
`
`EX1002, ¶¶107–08. As explained by Dr. Amiji, it would have
`been a routine matter for a skilled artisan to make and then
`confirm the efficacy of the emulsion comprising 1.25% castor
`oil and 0.05% CsA. EX1002, ¶¶ 96, 107, 110; EX1001, 14:14–
`16 (“These compositions are produced in accordance with well
`known techniques[.]”).
`Id. at 37.
`Patent Owner argues in its preliminary response that this case is
`closely analogous to Allergan, Inc. v. Sandoz Inc., 796 F.3d 1293, 1302
`(Fed. Cir. 2015), in which the court addressed the obviousness of claims
`requiring specific amounts of about 0.01% bimatoprost and about 200 ppm
`benzalkonium chloride (BAK) over prior art that generally taught a
`formulation comprising 0.001%–1% bimatoprost and 0–1000 ppm BAK.
`Prelim. Resp. 29–32. We agree that the issues are similar. In Allergan, the
`court reiterated the framework for evaluating obviousness in the context of a
`claimed invention falling within a broader range disclosed in the prior art:
`
`[W]here there is a range disclosed in the prior art, and the
`claimed invention falls within that range, a relevant inquiry is
`whether there would have been a motivation to select the
`claimed composition from the prior art ranges …. In those
`circumstances, “the burden of production falls upon the
`patentee to come forward with evidence that (1) the prior art
`taught away from the claimed invention; (2) there were new and
`unexpected results relative to the prior art; or (3) there are other
`pertinent secondary considerations.”
`796 F.3d at 1304–05 (quoting Galderma Labs., L.P. v. Tolmar, Inc., 737
`F.3d 731, 738 (Fed. Cir. 2013)).
`Upon consideration of the arguments set forth in the Petition and
`Preliminary Responses, we conclude that Petitioner has shown a reasonable
`likelihood that a skilled artisan would have found it obvious to make the
`
`
`
`19
`
`
`
`IPR2016-01128
`Patent 8,629,111 B2
`
`castor oil concentration in the emulsion to reach the claimed amount of
`1.25% by balancing the need to minimize any undesirable effects associated
`with castor oil used
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