Trials@uspto.gov
`571-272-7822
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`
`
`
`Paper 9
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` Entered: October 27, 2015
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`LUPIN LTD. and LUPIN PHARMACEUTICALS INC.,
`Petitioner,
`
`v.
`
`SENJU PHARMACEUTICAL CO., LTD.,
`Patent Owner.
`________________
`
`Case IPR2015-01100
`Patent 8,927,606 B1
`________________
`
`
`Before FRANCISCO C. PRATS, ERICA A. FRANKLIN, and
`GRACE KARAFFA OBERMANN, Administrative Patent Judges.
`
`FRANKLIN, Administrative Patent Judge.
`
`DECISION
`Institution of Inter Partes Review
`37 C.F.R. § 42.108
`
`
`571-272-7822
`
`
`
`
`
`
`Paper 9
`
`
` Entered: October 27, 2015
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`LUPIN LTD. and LUPIN PHARMACEUTICALS INC.,
`Petitioner,
`
`v.
`
`SENJU PHARMACEUTICAL CO., LTD.,
`Patent Owner.
`________________
`
`Case IPR2015-01100
`Patent 8,927,606 B1
`________________
`
`
`Before FRANCISCO C. PRATS, ERICA A. FRANKLIN, and
`GRACE KARAFFA OBERMANN, Administrative Patent Judges.
`
`FRANKLIN, Administrative Patent Judge.
`
`DECISION
`Institution of Inter Partes Review
`37 C.F.R. § 42.108
`
`
`
`IPR2015-01100
`Patent 8,927,606 B1
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`
`
`INTRODUCTION
`I.
`Lupin Ltd. and Lupin Pharmaceuticals Inc. (collectively, “Petitioner”)
`filed a Petition requesting an inter partes review of claims 1–30 of U.S.
`Patent No. 8,927,606 B1 (Ex. 1004, “the ’606 patent”). Paper 1 (“Petition”
`or “Pet.”). Senju Pharmaceutical Co., Ltd. (“Patent Owner”) filed a
`Preliminary Response to the Petition. Paper 8 (“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.” 35 U.S.C. § 314(a). Upon considering
`the Petition and Preliminary Response, we determine that Petitioner has
`shown a reasonable likelihood that it would prevail in showing the
`unpatentability of claims 1–30. Accordingly, we institute an inter partes
`review of those claims.
`
`Related Proceedings
`A.
`Petitioner and Patent Owner identify a number of related district court
`proceedings involving the ’606 patent, including one that involves both
`parties in this proceeding: Senju Pharmaceutical Co., Ltd., et al. v. Lupin,
`Ltd.et al., C.A. No. 1:15-cv-00335-JBS-KMW (D.N.J). Pet. 2–3; Paper 5,
`2–3.
`
`The parties identify also inter partes proceedings involving two
`patents to which the ’606 patent claims priority. Pet. 3; Paper 5, 3. An inter
`partes review of claims of U.S. Patent No. 8,669,290 B2 was instituted in
`Metrics, Inc. v. Senju Pharmaceutical Co., Ltd., IPR2014-01043 (trial
`terminated after settlement, IPR2014-01043, Paper 39) and in InnoPharma
`Licensing Inc. v. Senju Pharmaceutical Co., Ltd., IPR2015-00902 (trial in
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`progress). An inter partes review of claims of U.S. Patent No. 8,129,431
`was instituted in Metrics, Inc. v. Senju Pharmaceutical Co., Ltd., IPR2014-
`01041 (trial terminated after settlement, IPR2014-01041, Paper 39) and in
`InnoPharma Licensing Inc. v. Senju Pharmaceutical Co., Ltd., IPR2015-
`00903 (trial in progress).
`Additionally, Petitioners have filed petitions requesting inter partes
`review of claims of U.S. Patent 8,754,131 and U.S. Patent 8,871,813, to
`which the ’606 patent claims priority. Pet. 3; Paper 5, 3.
`B.
`The ’606 Patent (Ex. 1004)
`The ’606 patent relates to methods for treating an inflammatory
`disease of an eye by administering to the eye a stable aqueous liquid
`ophthalmic preparation comprising: (a) 2-amino-3-(4-bromobenzoyl)
`phenylacetic acid, or a pharmacologically acceptable salt or a hydrate
`thereof, also known by its generic name, “bromfenac”; and (b) tyloxapol.
`Ex. 1004, 1:7–31; 2:26–28.
`The Specification explains that, prior to the invention, bromfenac was
`known as a non-steroidal anti-inflammatory agent (“NSAID”) effective
`against inflammatory diseases of the anterior and posterior segments of the
`eye, such as blepharitis, conjunctivitis, scleritis, and postoperative
`inflammation. Id. at 1:33–38. According to the Specification, the inventors
`of the ’606 patent found that by adding an alkyl aryl polyether alcohol type
`polymer, such as tyloxapol, which is an non-ionic surfactant, to an aqueous
`liquid preparation of bromfenac, the preparation “becomes stable within a
`pH range giving no irritation to eyes, and change of the [bromfenac] . . . over
`time can be inhibited, and furthermore, when the aqueous solution contains a
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`preservative, deterioration in the preservative effect of said preservative can
`be inhibited for a long period of time.” Id. at 2:26–38; 4:21–22.
`
`Experimental Example 1 of the ’606 patent compares the stability of
`bromfenac-containing ophthalmic solutions comprising 0.15 w/v%
`tyloxapol, 0.02 w/v% tyloxapol, 0.15 w/v% polysorbate 80, or 0.15 w/v%
`polyoxyl 40 stearate. See id. at 6:46–7:22. The stability of each preparation
`was tested under conditions of pH 7.0 at 60° C for 4 weeks. Id. at 7:12–14.
`The results of the comparison are shown in Table 1, reproduced below:
`
`
`
`
`
`
`Id. at 6:55–7:9, Table 1. As seen in Table 1, the bromfenac activity
`remaining in each of the tyloxapol-containing preparations (73.8% for the
`0.15 w/v% tyloxapol-containing preparation and 89.6% for the 0.02 w/v%
`tyloxapol-containing preparation) was greater than the remaining activity in
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`either the polysorbate 80-containing preparation (51.3%) or the polyoxyl 40
`stearate-containing preparation (63.7%). Id.
`C.
`Illustrative Claims
`Claims 1, 9, and 11 of the ’606 patent are illustrative and reproduced
`below:
`1. A method for treating an inflammatory disease of an eye,
`the method comprising administering to said eye a stable
`aqueous
`liquid preparation
`that comprises:
`(a) a
`first
`component; and (b) a second component; wherein the first
`component is 2-amino-3-(4-bromobenzoyl)phenylacetic acid or
`a pharmacologically acceptable salt thereof or a hydrate thereof;
`wherein the hydrate is at least one selected from a 1/2 hydrate,
`1 hydrate, and 3/2 hydrate; the first component is the sole
`pharmaceutical active ingredient contained in the preparation;
`the second component is tyloxapol and is present in said liquid
`preparation in an amount sufficient to stabilize said first
`component; wherein said stable liquid preparation is formulated
`for ophthalmic administration; and wherein said
`liquid
`preparation is administered to said eye at a dose and a
`frequency effective to treat said inflammatory disease.
`
`The method according to claim 1; wherein the stable
`9.
`aqueous liquid preparation consists essentially of:
`(a) 2-amino-3-(4-bromobenzoyl)phenylacetic acid sodium salt,
`[(b) tyloxapol, (c) boric acid,] (d) sodium tetraborate, (e) EDTA
`sodium salt,
`(f) benzalkonium chloride,
`(g) polyvinyl-
`pyrrolidone, and (h) sodium sulfite, wherein said liquid
`preparation
`is formulated for ophthalmic administration,
`wherein the concentration of the 2-amino-3-(4-bromobenzoyl)
`phenylacetic acid sodium salt is from about 0.02 w/v % to
`about 0.1 w/v %.
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`11. A method for treating an inflammatory disease of an eye,
`the method comprising administering to said eye a stable
`aqueous
`liquid preparation
`that comprises:
`(a) a
`first
`component; and (b) a second component; wherein the first
`component is 2-amino-3-(4-bromobenzoyl)phenylacetic acid or
`a pharmacologically acceptable salt thereof or a hydrate thereof;
`wherein the hydrate is at least one selected from a 1/2 hydrate,
`1 hydrate, and 3/2 hydrate; the first component is the sole
`pharmaceutical active ingredient contained in the preparation;
`the second component is tyloxapol; wherein said stable liquid
`preparation
`is formulated for ophthalmic administration;
`wherein the stable aqueous liquid preparation is characterized in
`that greater than 90% of the original amount of the first
`component remains in the preparation after storage at about 60°
`C. for 4 weeks; and wherein said liquid preparation is
`administered to said eye at a dose and a frequency effective to
`treat said inflammatory disease.
`
`Ex. 1004, 11:17–31, 55–63; 11:66–12:15.
`D.
`The Prior Art
`Petitioner relies upon the following prior art references:
`
`Ogawa
`
`Ex. 1010
`
`
`Ex. 1014
`
`
`Ex. 1021
`
`Ogawa et al., U.S. Patent No. 4,910,225,
`issued Mar. 20, 1990.
`
`Fu et al., EP 0 306 984 A1, published Mar.
`15, 1989.
`
`Sallman et al., U.S. Patent No. 5,891,913,
`issued Apr. 6, 1999.
`
`
`Petitioner also relies upon the Declaration of M. Jayne Lawrence,
`Ph.D. (Ex. 1005).
`The Asserted Grounds of Unpatentability
`E.
`Petitioner challenges the patentability of claims 1–30 of the ’606
`patent on the following grounds (Pet. 12):
`
`Fu
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`Sallmann
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`Claims Challenged
`1–30
`
`1–30
`
`Basis
`§ 103(a)
`
`§ 103(a)
`
`Reference
`Ogawa and Fu
`
`Sallmann and Ogawa
`
`
`
`
`ANALYSIS
`II.
`Claim Construction
`A.
`In an inter partes review, the Board interprets claim terms in an
`unexpired patent according to the broadest reasonable construction in light
`of the specification of the patent in which they appear. 37 C.F.R.
`§ 42.100(b); In re Cuozzo Speed Techs., LLC, 793 F.3d 1268, 1278–79 (Fed.
`Cir. 2015). Under that standard, and absent any special definitions, we give
`claim terms 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). Any special
`definitions for claim terms must be set forth with reasonable clarity,
`deliberateness, and precision. In re Paulsen, 30 F.3d 1475, 1480 (Fed.
`Cir. 1994).
`Neither Petitioner nor Patent Owner proposes a specific construction
`for any claim term. Pet. 5; Prelim. Resp. 14. In view of our analysis, we
`determine that express construction of any claim term is not necessary for
`purposes of this Decision.
`B. Obviousness over the Combination of Sallmann and Ogawa
`Petitioner asserts that claims 1–30 of the ’606 patent would have been
`obvious over the combination of Sallmann and Ogawa. Pet. 36–55. Patent
`Owner disagrees. Prelim. Resp. 34–43.
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`Sallmann
`1.
`Sallmann is directed, in part, to ophthalmic compositions to treat
`
`inflammatory conditions of the eye. Ex. 1021, 1:7–10. Sallmann’s
`composition comprises diclofenac potassium, an NSAID, as the only active
`ingredient. Id. at 1:7–8, 29–31. The composition comprises also a
`solubilizer, wherein tyloxapol is disclosed as one of the preferred
`solubilizers. Id. at 4:64. Sallmann teaches that the concentration of the
`solubilizer may be from 0.1 to 5000 times the concentration of the active
`ingredient. Id. at 5:1–2.
`
`2. Ogawa
`Ogawa is directed to stable aqueous ophthalmic compositions for
`
`treating inflammatory eye disease topically. Ex. 1010, 1:15–17. In Example
`6, Ogawa discloses a formulation comprising sodium salt of bromfenac
`monohydrate, an NSAID, as the only active ingredient, in an amount of 0.1
`g/ 100 ml, i.e., 0.1 w/v%, and polysorbate 80 in an amount of 0.15 g/100 ml,
`i.e., 0.15 w/v%. Id. at 10:5–18. The composition comprises also a water-
`soluble polymer, i.e., polyvinyl pyrrolidone, and a sulfite, both of which
`Ogawa credits for the “remarkably enhanced” stability of its compositions.
`Id. at 3:48–52, 10:5–18.
`
`3. Analysis
`Petitioner asserts that the formulation disclosed in Ogawa’s
`
`Example 6 includes each of the elements of independent claims 1, 11, and
`19, except for the tyloxapol component. Pet. 40. Petitioner contends,
`among other things, that it would have been obvious to a person of ordinary
`skill in the art to modify Ogawa’s formulation by substituting tyloxapol for
`the polysorbate 80 ingredient. Id. Petitioner asserts that, at the time of the
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`invention, it was known in the art that polysorbate 80 could be substituted
`for tyloxapol in ophthalmic formulations. Id. In support of this assertion,
`Petitioner relies upon the Declaration of Dr. Lawrence. Id. (citing Ex. 1005
`¶ 559). According to Dr. Lawrence, at the time of the invention, it was
`known that “polysorbate 80 and tyloxapol could be used interchangeably”
`and that “substituting tyloxapol for polysorbate 80 in ophthalmic
`formulations had been shown to improve the stability of acidic group-
`containing drugs.” Ex. 1005 ¶ 559 (citing Ex. 1022, 6:57–7:45)
`(“Yasueda”).1
`
`Moreover, Petitioner asserts that a person of ordinary skill in the art
`would have understood from Sallmann that tyloxapol was a suitable additive
`in a formulation comprising a carboxyl group-containing NSAID, i.e.,
`diclofenac or bromfenac. Pet. 40. As exemplary support, Dr. Lawrence
`describes a known bromfenac ophthalmic formulation that includes
`tyloxapol as a suitable surfactant. Ex. 1005 ¶ 559 (citing Ex. 1012, 3:13–45)
`(“Desai”).2 According to Dr. Lawrence, a skilled artisan would have
`understood that diclofenac and bromfenac have similar properties and are
`subject to similar formulation issues, such that the two compounds “could be
`successfully formulated in the same way.” Id.
`
`Patent Owner asserts that “there would not have been any reason,
`other than hindsight, to use tyloxapol with bromfenac.” Prelim. Resp. 39.
`According to Patent Owner, a person of ordinary skill in the art would not
`have been motivated to add tyloxapol as a solubilizer to Ogawa’s bromfenac
`
`
`1 Yasueda et al., U.S. Patent No. 6,274,609 B1, issued Aug. 14, 2001
`(“Yasueda”).
`2 Desai et al., U.S. Patent No. 5,603,929, issued Feb. 18, 1997 (“Desai”).
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`formulation because bromfenac was known to readily dissolve in water. Id.
`at 38–39. Moreover, Patent Owner asserts that Ogawa did not disclose
`polysorbate 80 as a solubilizer. Id. at 39. Further, Patent Owner asserts that
`Yasueda indicates that the solubility of polysorbate 80 is superior to
`tyloxapol. Id. (citing Ex. 1022, Table 1). Additionally, Patent Owner
`asserts that a skilled artisan would not have added tyloxapol to address the
`oxidation of bromfenac. Id. at 38.
`
`At this stage of the proceeding, we are not persuaded by Patent
`Owner’s arguments that Petitioner has not established sufficiently that a
`person of ordinary skill in the art would have been motivated to substitute
`tyloxapol for the polysorbate 80 included Ogawa’s formulation. Patent
`Owner’s arguments address the solubility of tyloxapol and its function as a
`solubilizer. The motivation that Petitioner describes for substituting
`polysorbate 80 with tyloxapol, however, is not dependent only upon those
`characteristics of tyloxapol. Indeed, as Patent Owner asserts, bromfenac, the
`only active ingredient in Ogawa’s formulation, “was known to readily
`dissolve in water,” and thus, did not require a solubilizer. On the current
`record, what is persuasive about Petitioner’s argument, supported by the
`Declaration of Dr. Lawrence, is that tyloxapol and polysorbate 80 are non-
`ionic surfactants that were known to be used interchangeably in ophthalmic
`formulations, including those comprising bromfenac.
`
`Patent Owner asserts also that bromfenac and diclofenac are
`“sufficiently structurally different that a [person of ordinary skill in the art]
`. . . would not have predicted or understood that they ‘. . . could be
`successfully formulated in the same way.’” Prelim. Resp. 41. For example,
`Patent Owner asserts that the structure of the compounds differ in a way that
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`“affects at least polarity and electron density distribution,” impacting the
`solubility of the compounds. Id. at 42–43. At this stage of the proceeding,
`however, Patent Owner has not explained how the asserted structural and
`solubility differences between bromfenac and diclofenac would cause a
`person of ordinary skill in the art to view tyloxapol as an unsuitable
`substitute for polysorbate 80 in an aqueous bromfenac ophthalmic
`formulation.
`
`Patent Owner asserts also that Petitioner has not addressed certain
`elements of the challenged claims. Id. at 53–60. Regarding claims 1 and 5,
`Patent Owner asserts that Petitioner has not identified any teaching in the art
`to use an amount of tyloxapol “sufficient to stabilize” bromfenac, as
`required by claim 1, such as “from about 0.01 w/v% to about 0.05 w/v %,”
`as required by the claim 5. Id. at 53–54.
`
`We disagree with Patent Owner, as Petitioner specifically addresses
`the amount of tyloxapol required by the challenged claims. In particular,
`Petitioner asserts that Sallmann discloses a concentration range for tyloxapol
`that is based upon the concentration of the active ingredient. Pet. 50.
`Petitioner explains how that disclosure, when applied to Ogawa’s
`formulation, encompasses the range for tyloxapol recited in claim 5, and
`thus satisfies the amount required by independent claim 1. Id. Patent Owner
`has not established otherwise at this preliminary stage of the proceeding.
`Thus, based on the current record, Petitioner’s explanation is considered to
`reasonably address the claim requirements that the amounts of tyloxapol be
`“sufficient to stabilize” bromfenac.
`
`Regarding claims 11 and 15, Patent Owner asserts that Petitioner has
`not identified any disclosure in the prior art establishing that Ogawa’s
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`modified formulation would be expected to have “greater than about 90% of
`the original amount of [bromfenac] remain[ing] in the preparation after
`storage at about 60°C. for 4 weeks.” Prelim. Resp. 54–55. However, as
`Petitioner and Dr. Lawrence explained, Ogawa disclosed that, after four
`weeks at 60° C, the solution described in Example 6 maintained 100.9 % of
`its original bromfenac activity. Pet. 42 (citing Ex. 1005 ¶ 562; Ex. 1010,
`Table 11). As Ogawa credits components other than the polysorbate 80 as
`providing this “remarkably enhanced” stability of its compositions,
`Ex. 1010, 3:48–52, we are persuaded, based on the current record, that a
`person of ordinary skill in the art would have similarly expected Ogawa’s
`formulation with the polysorbate 80 substituted for tyloxapol to exhibit
`similar stability. Indeed, according to Petitioner and Dr. Lawrence, the
`proposed modification of Ogawa’s Example 6 is similar to Composition A-
`04 of the ’606 patent, which was reported to retain greater than 90% of
`bromfenac after storage at 60° C for four weeks. Pet. 42 (citing Ex. 1005
`¶ 562; Ex. 1004, Table 2).
`
`Patent Owner asserts that Petitioner has pointed to nothing in the prior
`art disclosing that the proposed modification of Ogawa’s formulation would
`further satisfy the EP-Criteria B standard of the European Pharmacopoeia
`for preservative efficacy, as required by claim 29. Prelim. Resp. 56.
`However, Petitioner relies upon the Declaration of Dr. Lawrence to support
`that showing. Pet. 53–54. Specifically, Dr. Lawrence explains that the
`proposed modification of Ogawa’s Example 6 formulation is similar to
`Composition A-04 of the ’606 patent, reported to satisfy the more
`demanding EP-criteria A of the European Pharmacopoeia. Ex. 1005 ¶ 597
`(citing Ex. 1004, Experimental Examples 2–3). Absent evidence to the
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`contrary, we are persuaded that Petitioner’s information establishes a
`reasonable likelihood that the proposed modification of Ogawa’s Example 6
`meets the limitations of claim 29.
`
`Additionally, Patent Owner asserts that the Petitioner has not
`established “that the additional components in the art of record would not
`materially affect the basic and novel characteristics of the claimed
`preparations,” as required by claims 18 and 25, which recite the transitional
`phrase “consists essentially of.” Prelim. Resp. 58. We are not persuaded by
`this argument at this stage, however, as Patent Owner has not explained how
`the proposed substitution of Sallmann’s tyloxapol for the polysorbate 80 in
`Example 6 of Ogawa would result in a composition that contained any
`ingredients beyond those recited in claims 18 and 25.
`
`We have also considered Patent Owner’s contention that objective
`evidence exists establishing that an ordinary artisan would not have
`considered the claimed aqueous formulations obvious. Id. at 44–50. Factual
`inquiries for an obviousness determination include secondary considerations
`based on evaluation and crediting of objective evidence of nonobviousness.
`Graham v. John Deere Co., 383 U.S. 1, 17 (1966). Notwithstanding what
`the teachings of the prior art would have suggested to one of 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).
`Patent Owner asserts that the claimed treatment methods produce
`unexpected results. Prelim. Resp. 47. According to Patent Owner, the
`preparations recited in the challenged claims unexpectedly result in more
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`stabile bromfenac formulations due to the superior stabilizing effect of
`tyloxapol. Id. In support of this assertion, Patent Owner refers to Table 1 of
`the ’606 patent that sets forth comparative results from a stability test of
`various bromfenac formulations, as previously discussed. Id. Patent Owner
`refers also to Ogawa’s reported stability results for its Formulation A-2,
`comprising bromfenac and polysorbate 80, “corroborate values obtained for
`Comparison Example 1 in the ’606 patent,” in that Ogawa reported a
`remaining rate percent of bromfenac as 54.2%. Id. at 48 (citing Ex. 1010,
`Experimental Ex. 4, Table 8).
`Additionally, Patent Owner refers to Table 2 of the ’606 patent, listing
`Formulations A-04, A-05, and A-06, which contained respectively, 0.02 g,
`0.05 g, and 0.03 g of tyloxapol per 100 ml of solution, and resulted in
`92.6%, 90.9%, and 92.0% remaining bromfenac activity after four weeks at
`60° C and a pH of 8.15 (A-04, A-06) or 8.16 (A-05). Prelim. Resp. 48;
`Ex. 1004, Table 2. According to Patent Owner, “despite using an amount of
`tyloxapol that was about 1/3, 1/5, and 1/8 the amount of polysorbate 80 used
`by Ogawa, these formulations achieved comparable stabilization results to
`Ogawa’s Example 6,” which results were “entirely unexpected in view of
`Ogawa,” particularly given the ’606 patent’s omission of sodium sulfite,
`credited, in part, by Ogawa for its enhanced stability results. Id. at 48–49.
`
`Based on the current record, we are not persuaded by Patent Owner’s
`argument. In particular, we are not persuaded that the formulations
`providing the asserted superior results are commensurate in scope with each
`of the challenged claims. See In re Grasselli, 713 F.2d 731, 743 (Fed. Cir.
`1983). For example, independent claims 1, 11, and 19, require only two
`components, bromfenac and tyloxapol, whereas the formulations asserted to
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`provide unexpected results include additional ingredients. Moreover, we are
`not persuaded that Patent Owner has established that the asserted superior
`properties reported by the ’606 patent would have been unexpected to a
`person of ordinary skill in the art. Pfizer, Inc. v. Apotex, Inc., 480 F.3d
`1348, 1371 (Fed. Cir. 2007). Indeed, we note that Patent Owner has not
`directed us to any description in the Specification of the ’606 patent, or in
`any other evidence of record, characterizing or otherwise establishing that
`the asserted superior results would have been “unexpected.”
`
`Additionally, Patent Owner asserts evidence exists regarding the
`acclaim and projected sales of Prolensa®, an ophthalmic bromfenac (0.07%)
`solution that Patent Owner asserts is covered by patents including the ’606
`patent. Prelim. Resp. 2, 47. However, what is missing from this argument is
`a discussion explaining how the challenged claims are commensurate in
`scope with Prolensa®. All types of objective evidence of nonobviousness
`must be shown to have nexus. In re GPAC Inc., 57 F.3d 1573, 1580 (Fed.
`Cir. 1995) (nexus generally); Rambus Inc. v. Rea, 731 F.3d 1248, 1256 (Fed.
`Cir. 2013) (long-felt need); In re Huang, 100 F.3d 135, 140 (Fed. Cir. 1996)
`(commercial success).
`
`Moreover, Patent Owner has not explained how a product brochure
`for Prolensa®, Ex. 2014, and a webpage listing other bromfenac-containing
`commercial products, Ex. 2031, establish industry acclaim. Prelim. Resp.
`51. Nor has Patent Owner explained how the asserted projected sales for
`Prolensa® establish commercial success. Id. at 51–52.
`Patent Owner asserts also that six companies have each submitted an
`Abbreviated New Drug Application (“ANDA”) “seeking to market exact
`copies of Prolensa[®].” Id. at 52. However, Patent Owner has not
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`IPR2015-01100
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`established sufficiently that those applications copy the challenged claims.
`Moreover, as our reviewing court has explained, “evidence of copying in the
`ANDA context is not probative of nonobviousness because a showing of
`bioequivalence is required for FDA approval.” Bayer Healthcare Pharm.,
`Inc. v. Watson Pharm., Inc., 713 F.3d 1369, 1377 (Fed. Cir. 2013).
`Patent Owner asserts further that Apotex, Paddock, and Metrics
`“recently licensed the [’606] patent and took consent judgments and
`injunctions specifically acknowledging the’606 patent’s validity.” Prelim.
`Resp. 52–53 (citing Exs. 2027, 2028, 2029). As does our reviewing court,
`we “specifically require affirmative evidence of nexus where the evidence of
`commercial success presented is a license, because it is often ‘cheaper to
`take licenses than to defend infringement suits.’” Iron Grip Barbell Co. v.
`USA Sports, Inc., 392 F.3d 1317, 1324 (Fed. Cir. 2004) (citing EWP Corp. v.
`Reliance Universal Inc., 755 F.2d 898, 908 (Fed. Cir. 1985)). Patent Owner
`has not explained specifically how the cited consent judgment documents
`demonstrate that licenses were actually taken, the circumstances of the
`alleged licensing activity, or why a nexus exists between claimed subject
`matter and the alleged licensing. Nor does Patent Owner explain with any
`specificity how or why the facts of the instant case align with the facts of
`Institut Pasteur & Universite Pierre et Marie Curie v. Focarino, 738 F.3d
`1337, 1347 (Fed. Cir. 2013), cited by Patent Owner, Prelim. Resp. 53, such
`that the asserted licensing activity should be considered probative to the
`same extent as in Institut Pasteur.
`Thus, based on the information presented at this stage of the
`proceeding, Patent Owner does not persuade us that the asserted secondary
`evidence of nonobviousness demonstrates that Petitioner failed to establish a
`
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`reasonable likelihood of prevailing in showing that the claimed methods
`comprising administering aqueous liquid preparations recited in claims 1–30
`would have been obvious to an ordinary artisan. Rather, having reviewed
`the arguments and evidence advanced by the parties at this stage of the
`proceeding, Petitioner persuades us that it has established a reasonable
`likelihood of prevailing in showing that the challenged claims would have
`been obvious to a person of ordinary skill in the art in view of Sallmann and
`Ogawa.
`Accordingly, we institute an inter partes review of claims 1–30 of the
`
`’606 patent based on the combination of Sallmann and Ogawa.
`C. Remaining Ground
`The remaining ground and alternative arguments asserted by
`Petitioner challenge the same claims as those involved in the ground
`discussed. Accordingly, we exercise our discretion by declining to proceed
`on the remaining ground and alternative arguments. See 37 C.F.R.
`§ 42.108(a).
`
`
`CONCLUSION
`III.
`For the foregoing reasons, we determine that the information
`presented in the Petition establishes that there is a reasonable likelihood that
`Petitioner would prevail in showing that claims 1–30 of the ’606 patent are
`unpatentable.
`At this stage of the proceeding, the Board has not made a final
`determination as to patentability of any challenged claim.
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`IV. ORDER
`In consideration of the foregoing, it is hereby:
`ORDERED that pursuant to 35 U.S.C. §314 (a), an inter partes
`review is instituted as to claims 1–30 of the ’606 patent on the following
`ground of unpatentability:
`Claims 1–30 under 35 U.S.C. § 103(a) as obvious over Sallmann and
`Ogawa;
`FURTHER ORDERED that no other proposed ground of
`unpatentability is authorized.
`FURTHER ORDERED that pursuant to 35 U.S.C. § 314(c) and
`37 C.F.R. § 42.4, notice is hereby given of the institution of a trial
`commencing on the entry date of this decision.
`
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`PETITIONER:
`
`Deborah H. Yellin
`Jonathan Lindsay
`CROWELL & MORING LLP
`DYellin@Crowell.com
`JLindsay@Crowell.com
`
`
`PATENT OWNER:
`
`Bryan C. Diner
`M. Andrew Holtman
`Joshua L. Goldberg
`Justin J. Hasford
`Finnegan, Henderson, Farabow, Garrett & Dunner, LLP
`bryan.diner@finnegan.com
`andy.holtman@finnegan.com
`joshua.goldberg@finnegan.com
`justin.hasford@finnegan.com
`
`
`
`
`
`19
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