throbber
Trials@uspto.gov
`571-272-7822
`
`
`
` Paper: 17
`
`Entered: August 7, 2015
`
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________
`
`INNOPHARMA LICENSING, INC., INNOPHARMA LICENSING LLC,
`INNOPHARMA INC., INNOPHARMA LLC,
`MYLAN PHARMACEUTICALS INC., and MYLAN INC.,
`Petitioner,
`
`v.
`
`SENJU PHARMACEUTICAL CO., LTD., BAUSCH & LOMB, INC., and
`BAUSCH & LOMB PHARMA HOLDINGS CORP.,
`Patent Owner.
`________________
`
`Case IPR2015-00902
`Patent 8,669,290 B2
`________________
`
`
`Before FRANCISCO C. PRATS, ERICA A. FRANKLIN, and
`GRACE KARAFFA OBERMANN, Administrative Patent Judges.
`
`OBERMANN, Administrative Patent Judge.
`
`
`
`DECISION
`Instituting Inter Partes Review
`37 C.F.R. § 42.108
`
`I. BACKGROUND
`
`On March 19, 2015, Petitioner filed a request for an inter partes
`
`review of claims 1–30 of U.S. Patent No. 8,669,290 B2 (Ex. 1001, “the ’290
`
`patent”). Paper 2 (“Pet.”). Patent Owner filed a Preliminary Response.
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`

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`IPR2015-00902
`Patent 8,669,290 B2
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`Paper 13 (“Prelim. Resp.”). Also on March 19, 2015, Petitioner filed a
`
`Motion for Joinder (Paper 3) of this case with Metrics, Inc. v. Senju
`
`Pharmaceutical Co., Ltd., IPR2014-01043. We address the Motion for
`
`Joinder in an Order filed concurrently herewith.
`
`We have jurisdiction under 35 U.S.C. § 314(a), which provides that an
`
`inter partes review may be instituted upon a showing of “a reasonable
`
`likelihood that the petitioner would prevail with respect to at least 1 of the
`
`claims challenged in the petition.” Petitioner makes that showing with
`
`respect to claims 1–30; therefore, we institute review as to those claims.
`
`Our findings of fact and conclusions of law are based on the record
`
`developed thus far, prior to Patent Owner’s Response. This is not a final
`
`decision as to the patentability of any challenged claim. If a final decision is
`
`issued in this case, it will be based on the full record developed during trial.
`
`A. Related Proceedings
`
`Petitioner identifies eight district court actions involving the ’290
`
`patent, including one that involves Petitioner as a defendant. Pet. 11–13; see
`
`Senju Pharmaceutical Co. v. InnoPharma Licensing, Inc., C.A. No. 1:14-
`
`CV-06893-JBS-KMW (D.N.J. filed Nov. 3, 2014).
`
`Concurrently herewith, we issue a decision to institute in IPR2015-
`
`00903, involving the same parties and directed to U.S. Patent No. 8,129,431
`
`B2 (the ’431 patent). The ’290 patent claims priority to the ’431 patent.
`
`B. The ’290 Patent (Ex. 1001)
`
`The ’290 patent relates to an aqueous liquid preparation comprising
`
`two components: (1) bromfenac (or its salts and hydrates); and (2)
`
`tyloxapol. Ex. 1001, 12:2–13 (independent claim 1). Bromfenac is a non-
`
`steroidal anti-inflammatory drug (“NSAID”). Id. at 1:26–49. Tyloxapol is
`
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`present in the preparation “in an amount sufficient to stabilize” the
`
`bromfenac. Id. at 12:10–11. The preparation is useful for ophthalmic
`
`administration, such as an eye drop to treat blepharitis, conjunctivitis,
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`scleritis, and postoperative inflammation. Id., Abstract; 12:12.
`
`An object of the invention is to provide an aqueous liquid preparation
`
`of bromfenac that “is stable within a pH range giving no irritation to eyes”
`
`when preserved with a quaternary ammonium compound, such as
`
`benzalkonium chloride (“BAC”). Id. at 2:16–24. The inventors claim to
`
`have discovered that addition of an alkyl aryl polyether alcohol type
`
`polymer, such as tyloxapol, provides the sought-after stability, giving no
`
`irritation to the eyes. Id. at 2:35–49. The inventors acknowledge that
`
`tyloxapol “is a non-ionic surfactant.” Id. at 4:37–39.
`
`C. Illustrative Claim
`
`Petitioner seeks inter partes review of claims 1–30 of the ’290 patent.
`
`Independent claim 1, reproduced below, is illustrative of the subject matter.
`
`1. A stable aqueous liquid preparation comprising: (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; and wherein said stable liquid preparation is
`formulated for ophthalmic administration.
`
`Ex. 1001, 12:2–13.
`
`
`
`
`
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`
`D. The Applied Prior Art
`
`Petitioner relies upon the following prior art references:
`
`Ogawa et al., U.S. Patent No. 4,910,225, issued Mar. 20, 1990
`(Ex. 1004) (“Ogawa”).
`
`Sallmann et al., U.S. Patent No. 6,107,343, issued Aug. 22,
`2000 (Ex. 1009) (“Sallmann”).
`
`E. The Asserted Grounds of Unpatentability
`
`Petitioner challenges the patentability of claims 1–30 of
`
`the ’290 patent on a single ground, specifically, unpatentability over
`
`Ogawa and Sallmann under 35 U.S.C. § 103. Pet. 18. Petitioner
`
`relies on a declaration of Dr. Paul A. Laskar. Ex. 1003.1
`
`II. ANALYSIS
`
`A. Claim Construction
`
`
`
`In an inter partes review, claim terms in an unexpired patent are
`
`interpreted according to their 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, No. 2014–1301, 2015 WL 4097949, at *5–*8
`
`(Fed. Cir. July 8, 2015). Claim terms are given their ordinary and customary
`
`meaning, as understood by one of ordinary skill in the art in the context of
`
`the entire disclosure. In re Translogic Tech., Inc., 504 F.3d 1249, 1257
`
`
`1 Dr. Laskar has a Ph.D. in Pharmaceutical Sciences and is the founder of a
`pharmaceutical development consulting firm focused on development and
`evaluation of pharmaceuticals, including ophthalmic products. Ex. 1003
`¶¶ 14–15, 19. Dr. Laskar has significant experience in the development and
`assessment of ophthalmic preparations. Ex. 1003 ¶¶ 16, 18. He appears on
`this record to have the requisite familiarity with ophthalmic preparations to
`opine on the views of a hypothetical person of ordinary skill in the art at the
`time of the invention. See id. at ¶¶ 12–19. At this stage of the proceeding,
`we find his testimony credible and persuasive.
`
`
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`Patent 8,669,290 B2
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`(Fed. Cir. 2007). If an inventor acts as his or her own lexicographer, the
`
`definition must be set forth in the specification with reasonable clarity,
`
`deliberateness, and precision. Renishaw PLC v. Marposs Societa’ per
`
`Azioni, 158 F.3d 1243, 1249 (Fed. Cir. 1998). The construction that stays
`
`true to the claim language, and most naturally aligns with the inventor’s
`
`description, is likely the correct interpretation. Id. at 1250.
`
`Neither Petitioner nor Patent Owner proposes a specific claim
`
`construction for any claim term. Pet. 16; Prelim. Resp. 14. At this stage of
`
`the proceeding, we determine that the claim terms are clear on their face, and
`
`none is specially defined in the written description of the ’290 patent. No
`
`claim term requires express construction for the purposes of this decision.
`
`B. The Applied Prior Art
`
`We next turn to the prior art references applied in the Petition and, in
`
`particular, to what those references would have conveyed to an ordinary
`
`artisan about the state of the art at the time of the invention of the ’290
`
`patent. At this stage of the proceeding, we consider the applied prior art as
`
`representative of the level of ordinary skill in the art. We discuss facts as
`
`presented thus far in the record. Any inferences or conclusions drawn from
`
`those facts are neither final nor dispositive of any issue.
`
`i. Ogawa (Ex. 1004)
`
`Ogawa’s Example 6 discloses a stable aqueous liquid preparation,
`
`formulated for ophthalmic administration, which comprises bromfenac, as
`
`the sole pharmaceutical active ingredient, and polysorbate 80. Ex 1004,
`
`10:5–18, 49–57 (for stable aqueous liquid preparation); 10:5–9 (for
`
`bromfenac, as sole pharmaceutical active ingredient, and polysorbate 80);
`
`14:45–50 (Table 11, reporting 100% stability for the Example 6
`
`
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`preparation). The ophthalmic preparation of Ogawa’s Example 6 includes
`
`BAC, which, as a pharmaceutically inactive ingredient, is not excluded by
`
`the terms of claim 1. Ex. 1004, 10:5–9. On this record, Petitioner shows
`
`sufficiently that the preparation of Ogawa’s Example 6 meets every
`
`limitation of claim 1, but for the recited use of tyloxapol, in place of
`
`polysorbate 80, “in an amount sufficient to stabilize” the bromfenac.
`
`Ex. 1001, 12:10–11; see Pet. 21–22 (claim chart for claim 1).
`
`ii. Sallmann (Ex. 1009)
`
`Sallmann discloses tyloxapol as a non-ionic surfactant in an
`
`ophthalmic preparation of an NSAID—although Sallmann discloses
`
`diclofenac potassium, and not bromfenac, as the NSAID. Specifically,
`
`Sallmann’s Example 2 discloses an aqueous ophthalmic preparation that
`
`includes diclofenac and tyloxapol. Ex 1009, 8:1–15. Petitioner shows
`
`sufficiently that the remaining ingredients of Sallmann’s Example 2 would
`
`not have been expected to adversely affect the stability or preservative
`
`efficacy of the preparation. Ex. 1003 ¶ 58. Bromfenac and diclofenac share
`
`several structural similarities, for example, a phenylacetic acid moiety.
`
`Pet. 26 (citing Ex. 1003 ¶ 29). Like Ogawa’s Example 6, Sallmann’s
`
`Example 2 discloses a preparation including BAC. Ex. 1009, 8:1–10.
`
`The ’290 patent discloses that the tyloxapol range, effective to
`
`stabilize a bromfenac-BAC preparation, is from about 0.01 and 0.5 w/v %.
`
`Ex. 1001, 5:37–38. Petitioner shows sufficiently that Sallmann’s Example 2
`
`employs tyloxapol in a concentration of 0.1 w/v %, which falls within that
`
`disclosed range. Pet. 39 (citing Ex. 1003 ¶ 80). On this record, Petitioner
`
`shows sufficiently that Sallmann’s Example 2 meets every limitation of
`
`claim 1, but for the use of bromfenac in place of diclofenac. See Pet. 25–29
`
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`(directing us to information that an ordinary artisan would have understood
`
`that bromfenac was superior to diclofenac and, moreover, would have
`
`recognized those two NSAIDs as interchangeable based on their similar
`
`pharmacological properties).
`
`C.
`
`Analysis of the Ground of Unpatentability
`
`We next turn to whether an ordinary artisan, equipped with the
`
`combined disclosures of Ogawa and Sallman, would have had a reason to
`
`replace polysorbate 80 in Ogawa’s Example 6 with tyloxapol in an amount
`
`“sufficient to stabilize” the bromfenac. Ex. 1001, 12:10–11. Alternatively,
`
`we consider whether that artisan would have been led to replace diclofenac
`
`with bromfenac in the ophthalmic preparation of Sallmann’s Example 2. On
`
`this record, either substitution results in a preparation that satisfies every
`
`limitation of claim 1.
`
`We then address whether the information presented is adequate to
`
`show that the subject matter of the other challenged claims, that is, claims 2–
`
`30, would have been obvious over Ogawa and Sallmann. We conclude with
`
`an analysis of Patent Owner’s contentions as to secondary considerations of
`
`non-obviousness.
`
`i. Replacing Polysorbate 80 with Tyloxapol in Ogawa
`
`We agree with Patent Owner that “Ogawa is completely silent on the
`
`function of polysorbate 80, ascribing no express role to it” in the ophthalmic
`
`preparation of Ogawa’s Example 6. Prelim. Resp. 21; see generally
`
`Ex. 1004. Notwithstanding that fact, however, the information presented is
`
`sufficient to show that, at the time of the invention, polysorbate 80 and
`
`tyloxapol were added to aqueous ophthalmic preparations as surface-active
`
`agents. Pet. 23–24; see Ex. 1003 ¶¶ 34, 40, 54 (Dr. Laskar’s declaration
`
`
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`testimony). At this stage, Patent Owner does not refute adequately that, at
`
`the time of the invention, an ordinary artisan would have recognized
`
`polysorbate 80 as a non-ionic surfactant in this art. Prelim. Resp. 10
`
`(referring to “polysorbate 80” and “tyloxapol” as “surfactants”); Prelim.
`
`Resp. 28–29 (bridging paragraph, suggesting that polysorbate 80 and
`
`tyloxapol are both non-ionic surfactants, but arguing that how they function
`
`in different mediums “is highly unpredictable”).
`
`On this record, moreover, Petitioner shows sufficiently that Sallmann
`
`adds tyloxapol to an NSAID-BAC preparation in an amount that falls within
`
`the preferred amount disclosed in the ’290 patent. See Pet. 39 (citing
`
`Ex. 1003 ¶ 80) (Sallmann’s Example 2 discloses a tyloxapol concentration
`
`of 0.1 w/v %); Ex. 1001, Ex. 1001, 5:37–38 (the ’290 patent, disclosing that
`
`the tyloxapol range, effective to stabilize a bromfenac-BAC preparation, is
`
`from about 0.01 and 0.5 w/v %). Based on the record developed at this early
`
`stage of the proceeding, we accept that a person of ordinary skill in the art,
`
`when replacing polysorbate 80 with tyloxapol in Ogawa’s Example 6, would
`
`have used the concentration of tyloxapol that is disclosed in Sallmann’s
`
`Example 2. Pet. 19–25; Ex. 1003 ¶¶ 49–51.
`
`Patent Owner contends that Ogawa does not add polysorbate 80 to
`
`stabilize the preparation of Example 6 and, on that basis, contends that
`
`Petitioner fails to establish that an ordinary artisan would have included
`
`tyloxapol for a stabilizing purpose. Prelim. Resp. 21–22; compare
`
`Ex. 1003 ¶ 54 (Dr. Laskar’s opinion that polysorbate 80 enhances the
`
`stability of Ogawa’s preparation) to Ex. 1004, 3:7–15 (Ogawa, discussing
`
`the factors that enhance stability, without indicating that polysorbate 80
`
`affects the stability of the preparation). Specifically, Patent Owner directs us
`
`
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`to disclosures suggesting that Ogawa uses a water soluble polymer
`
`(polyvinyl pyrrolidone) and a sulfite (sodium sulfite) to stabilize the
`
`bromfenac preparation. Prelim. Resp. 21–22 (discussing Experimental
`
`Examples 4–6).
`
`As Patent Owner readily admits, however, those disclosures do not
`
`speak to the function of polysorbate 80 and, accordingly, do not establish
`
`that polysorbate 80 serves no stabilizing function in the preparation. Id.
`
`at 21 (“Ogawa is completely silent on the function of polysorbate 80,
`
`ascribing no express role to it.”) Petitioner, by contrast, directs us to
`
`information that an ordinary artisan would have recognized that
`
`polysorbate 80 is a non-ionic surfactant in Ogawa’s Example 6, and would
`
`have understood that tyloxapol was interchangeable with polysorbate 80 as a
`
`non-ionic surfactant in ophthalmic preparations. Pet. 23–24; see Ex. 1003
`
`¶¶ 34, 40, 54 (Dr. Laskar’s declaration testimony).
`
`We acknowledge that Patent Owner has not yet filed a Response and
`
`that the Preliminary Response necessarily rests on argument unsupported by
`
`new testimonial evidence. See 37 C.F.R. § 42.107(c) (no new testimonial
`
`evidence may be submitted with a preliminary response). However, the
`
`disclosures in the references advanced in the Preliminary Response, standing
`
`alone, are insufficient to establish Patent Owner’s factual assertions.
`
`Specifically, Patent Owner has not refuted adequately, at this stage of the
`
`proceeding, that polysorbate 80 and tyloxapol were used interchangeably as
`
`surfactants in ophthalmic preparations. See Prelim. Resp. 10 (referring to
`
`both “polysorbate 80” and “tyloxapol” as “surfactants”).
`
`Based on the information presented at this stage of the proceeding, the
`
`interchangeability of those components is suggested by the combined
`
`
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`teachings of the applied art, where Ogawa includes a non-ionic surfactant,
`
`polysorbate 80, in a stable NSAID-containing ophthalmic preparation, and
`
`Sallmann similarly includes a non-ionic surfactant, tyloxapol, in a stable
`
`NSAID-containing ophthalmic preparation. At this early stage, Patent
`
`Owner’s factual contentions, regarding what the applied references would
`
`have conveyed to an ordinary artisan, rest on attorney argument, whereas
`
`Petitioner’s assertions are supported by the declaration testimony of
`
`Dr. Laskar.
`
`For example, Patent Owner argues that the undesirable “red insoluble
`
`particles” in Ogawa’s preparation are caused by dimerization of bromfenac,
`
`rather than complexation of bromfenac and BAC. Prelim. Resp. 20. Patent
`
`Owner further argues that polysorbate 80 “plays no role in preventing the
`
`oxidative degradation of bromfenac” in Ogawa’s Example 6. Id. at 21.
`
`Neither of those facts, however, is adequately supported at this stage of the
`
`proceeding. On this record, moreover, we are not persuaded that Petitioner
`
`must establish that an ordinary artisan would have grasped exactly how
`
`polysorbate 80 or tyloxapol interacts with the components of the aqueous
`
`preparation. See Prelim. Resp. 22 (arguing that Dr. Laskar’s testimony, that
`
`polysorbate 80 stabilizes bromfenac in Ogawa’s Example 6 preparation, “is
`
`fundamental to” Petitioner’s challenge).
`
`The issue is whether a person of ordinary skill in the art would have
`
`had a reason (such as a simple substitution) to use tyloxapol, instead of
`
`polysorbate 80, in an amount that would have stabilized Ogawa’s Example 6
`
`preparation—whether or not that artisan would have recognized any
`
`stabilizing benefit of doing so. See Ex parte Obiaya, 227 USPQ 58, 60
`
`(BPAI 1985) (The fact that a patent applicant may have “recognized another
`
`
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`advantage which would flow naturally from following the suggestion of the
`
`prior art cannot be the basis for patentability when the differences would
`
`otherwise be obvious.”).
`
`Based on the information presented, we determine that Petitioner
`
`shows sufficiently that an ordinary artisan would have recognized that
`
`“tyloxapol and polysorbate 80 had previously been used interchangeably as
`
`surfactants in ophthalmic formulations.” Pet. 23 (citing Ex. 1003 ¶ 40) (Dr.
`
`Laskar’s testimony that, at the time of the invention, “tyloxapol was a
`
`widely-used non-ionic surfactant in aqueous liquid preparations comprising
`
`anti-inflammatory agents, and was used interchangeably with polysorbate
`
`80”). That known interchangeability, absent persuasive objective evidence
`
`to the contrary, is enough to support the proposed substitution. An express
`
`suggestion to substitute one known equivalent non-ionic surfactant for
`
`another in Ogawa’s ophthalmic preparation is not needed to render the
`
`substitution obvious. See In re Fout, 675 F.2d 297, 301 (CCPA 1982); In re
`
`Siebentritt, 372 F.2d 566, 568 (CCPA 1967); see also In re Mayne, 104 F.3d
`
`1339, 1340 (Fed. Cir. 1997) (“Because the applicants merely substituted one
`
`element known in the art for a known equivalent, this court affirms [the
`
`conclusion of obviousness].”).
`
`At this stage of the proceeding, absent evidence to the contrary, it
`
`would have been well within the level of ordinary skill in the art to replace
`
`one non-ionic surfactant (polysorbate 80) with another non-ionic surfactant
`
`(tyloxapol) in Ogawa’s Example 6, because both were known to be useful as
`
`surfactants in ophthalmic preparations. See KSR Int’l Co. v. Teleflex Inc.,
`
`550 U.S. 398, 417 (2007) (“If a person of ordinary skill in the art can
`
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`implement a predictable variation, and would see the benefit of doing so,
`
`§ 103 likely bars its patentability.”).
`
`ii. Replacing Diclofenac with Bromfenac in Sallmann
`
`Alternatively, Petitioner is reasonably likely to prevail in showing that
`
`an ordinary artisan would have replaced diclofenac with bromfenac in the
`
`ophthalmic preparation of Sallmann’s Example 2. Pet. 25–28; Ex. 1003
`
`¶¶ 29, 43–44, 57; see Ex. 1009, 8:1–15 (Sallmann’s Example 2, disclosing
`
`an ophthalmic preparation that meets every limitation of claim 1, except that
`
`Sallmann uses diclofenac and not bromfenac as the NSAID); see also
`
`Ex. 1003 ¶¶ 66–69 (Dr. Laskar’s testimony that, at the time of the invention,
`
`bromfenac and diclofenac would have been recognized as interchangeable
`
`NSAIDs suitable for use in aqueous liquid ophthalmic preparations).
`
`Sallmann in Example 2 discloses that diclofenac is useful as the
`
`NSAID in an ophthalmic preparation of an NSAID and BAC. Ex. 1009,
`
`8:1–15. Ogawa in Example 6 discloses that bromfenac is useful as the
`
`NSAID in an ophthalmic preparation of an NSAID and BAC. Ex. 1004,
`
`10:5–9. At the time of the invention, bromfenac and diclofenac were known
`
`to share several structural features. Pet. 26; Ex. 1003 ¶ 29. Furthermore,
`
`based on the information presented, a person of ordinary skill in the art at the
`
`time of the invention would have recognized the two NSAIDs as “suitable
`
`and desirable for ophthalmic administration.” Pet. 26; Ex. 1003 ¶¶ 25–28.
`
`Accordingly, on the current record, Petitioner shows sufficiently that
`
`an ordinary artisan would have expected diclofenac and bromfenac to work
`
`interchangeably in an ophthalmic preparation of an NSAID and BAC.
`
`Pet. 28–29; Ex. 1003 ¶¶ 66–69. Patent Owner’s counterviews—including
`
`that structural and functional differences between the two NSAIDs would
`
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`have dissuaded an ordinary artisan from making the proposed substitution—
`
`are not adequately supported on this record and, therefore, are insufficient to
`
`persuade us to deny review. See Prelim. Resp. 32–41, 51–52.
`
`Specifically, Patent Owner contends that a person of ordinary skill in
`
`the art “would not have replaced diclofenac potassium with bromfenac
`
`sodium” because one would have known that “[d]oing so would have
`
`destroyed the entire purpose and essence of Sallmann’s invention.” Id.
`
`at 32. By way of support, Patent Owner avers to “Sallmann’s indisputable
`
`preference for potassium salts.” Id. at 33. Patent Owner also avers that a
`
`person of ordinary skill in the art would have “more likely honed in on
`
`Sallmann’s Examples 8 and 11” instead of Example 2. Id. at 34. Patent
`
`Owner suggests that an ordinary artisan would have recognized that
`
`cyclodextrins in Sallmann’s Example 2 “can unpredictably impact the
`
`stability of a formulation.” Id. Patent Owner argues that the ordinary artisan
`
`“would have recognized from Ogawa that bromfenac degraded via
`
`oxidation.” Id. at 35–36. Patent Owner also attempts to establish that, as
`
`between bromfenac and diclofenac, a difference in the amine moiety “affects
`
`at least polarity and electron density distribution.” Id. at 40. On the current
`
`record, however, Patent Owner’s conclusion—that these facts show that an
`
`ordinary artisan would not have considered bromfenac and diclofenac to be
`
`interchangeable, ophthalmically-suitable NSAIDs—is based on attorney
`
`argument that is not shown to reflect the perspective of an ordinary artisan.
`
`At this stage of the proceeding, given the evidence before us,
`
`including that discussed above, we are persuaded that Petitioner shows
`
`sufficiently that it would have been obvious to a person of ordinary skill in
`
`the art to replace diclofenac with bromfenac, including bromfenac’s sodium
`
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`salt as required in some of the challenged claims, in the preparation of
`
`Sallmann’s Example 2, because diclofenac and bromfenac were recognized
`
`as interchangeable, alternative NSAIDs serving the same function in an
`
`ophthalmic preparation. Pet. 25–29; Ex. 1003 ¶¶ 25–29, 57, 66–68; see KSR
`
`Int’l Co., 550 U.S. at 417 (a claim likely is obvious if it is no “more than the
`
`predictable use of prior art elements according to their established
`
`functions”).
`
`iii. The Remaining Challenged Claims
`
`Petitioner also alleges that subject matter of claims 2–30 would have
`
`been obvious over the combined teachings of Ogawa and Sallmann. Pet. 18.
`
`Based on the information presented, we determine that there is a reasonable
`
`likelihood that Petitioner also will prevail on those other challenged claims.
`
`Pet. 29–48. We have taken account of the counterarguments presented in
`
`the Preliminary Response, but on this record, we determine that Petitioner
`
`has made a showing sufficient to support institution of an inter partes review
`
`on claims 2–30. Prelim. Resp. 51–59.
`
`In particular, on this record, we are satisfied that, where the
`
`challenged claims reflect ranges that do not overlap the prior art ranges, they
`
`are close enough that an ordinary artisan would have expected them to have
`
`the same properties. See Pet. 40 (citing Titanium Metals Corp. v. Banner,
`
`778 F.2d 775, 783 (Fed. Cir. 1985). To the extent that a claimed range is
`
`critical, the information presented supports a reasonable inference that an
`
`ordinary artisan would have arrived at the specified range using only routine
`
`experimentation. Pet. 41; see In re Aller, 220 F.2d 454, 456–58 (CCPA
`
`1955) (“[W]here the general conditions of a claim are disclosed in the prior
`
`art, it is not inventive to discover the optimum or workable ranges by routine
`
`
`
`14
`
`

`

`IPR2015-00902
`Patent 8,669,290 B2
`
`experimentation.” (citations omitted)); In re Peterson, 315 F.3d 1325, 1330
`
`(Fed. Cir. 2003) (“The normal desire of scientists or artisans to improve
`
`upon what is already generally known provides the motivation to determine
`
`where in a disclosed set of percentage ranges is the optimum combination of
`
`percentages.”).
`
`iv. Secondary Considerations
`
`We have taken account of the information presented in the
`
`Preliminary Response, but on this record, we determine that Petitioner has
`
`made a showing sufficient to support institution of an inter partes review.
`
`For example, we have taken account of the information advanced by Patent
`
`Owner in support of secondary considerations of non-obviousness. Prelim.
`
`Resp. 42–50. We have noted in particular Petitioner’s concession that “[t]he
`
`subject matter of many of the challenged claims of the ’290 patent is
`
`commercially embodied by Prolensa®, a product marketed by” Patent
`
`Owner. Pet. 9. Nonetheless, at this early stage of the proceeding, before the
`
`filing of Patent Owner’s Response, many of Patent Owner’s factual
`
`assertions, regarding the commercial success of Prolensa®, are not
`
`adequately supported.
`
`Patent Owner contends that “[t]yloxapol’s stabilization effect
`
`permitted formulating Prolensa® at pH 7.8;” that such a pH is “closer to the
`
`pH of natural tears” than other bromfenac preparations; that the lowered pH
`
`is “less irritating to the patient,” which “improve[s] bromfenac’s intraocular
`
`penetration and permit[s] a lowering of its concentration” compared to a
`
`different product; and that Prolensa®, therefore, “advantageously puts less
`
`drug in contact with surgically compromised ocular tissue without a
`
`reduction in efficacy.” Prelim. Resp. 48–49 (bridging paragraph). At this
`
`
`
`15
`
`

`

`IPR2015-00902
`Patent 8,669,290 B2
`
`stage, however, Patent Owner refers to entire exhibits, without any pin-cites,
`
`and supplies no cogent explanation of how the exhibits support these fact-
`
`laden contentions, or whether the asserted properties were unexpected or
`
`otherwise unobvious. Id. at 48, n.6 (citing Ex. 2013, Ex. 2026, Ex. 2027,
`
`Ex. 2030). Similarly, Patent Owner refers to sales data for Prolensa®, as
`
`projected by a competitor, but at this stage of the proceeding, comes forward
`
`with no objective evidence of revenues based on actual sales. Id. at 49.
`
`Patent Owner also refers to test results to establish that tyloxapol is a
`
`better stabilizer of bromfenac, compared to polysorbate 80—but advances
`
`no information that the asserted results would have been considered truly
`
`“surprising” or “unexpected” by a person of ordinary skill in the art. Id. at
`
`45–48. At this early stage, Patent Owner’s position on that point rests
`
`entirely on attorney argument. Id.; see In re Geisler, 116 F.3d 1465, 1471
`
`(Fed. Cir. 1997) (argument of counsel cannot take the place of evidence).
`
`The record is devoid of objective evidence in that regard. Not even the
`
`inventors described tyloxapol as “surprising” or “unexpected” in its
`
`stabilizing effect: When comparing tyloxapol to other alkyl aryl polyether
`
`alcohol type polymers, the inventors described tyloxapol as “especially
`
`preferable.” Ex. 1001, 4:65–67.
`
`In sum, Patent Owner’s information, at this stage of the proceeding,
`
`depends on attorney argument as to what the combined teachings of the
`
`applied art would have conveyed to a person of ordinary skill in the art.
`
`Prelim. Resp. 36–41, 51–59. And Patent Owner’s information, at this stage,
`
`regarding secondary considerations, similarly lacks adequate objective
`
`support. Id. at 42–50. As such, Patent Owner does not persuade us to
`
`
`
`16
`
`

`

`IPR2015-00902
`Patent 8,669,290 B2
`
`decline to institute an inter partes review, given the teachings in Ogawa and
`
`Sallmann, and the supporting testimony of Dr. Laskar.
`
`III. CONCLUSION
`
`Taking account of the information presented in the Petition and the
`
`Preliminary Response, we institute an inter partes review of claims 1–30
`
`based on obviousness over Ogawa and Sallmann under 35 U.S.C. § 103. We
`
`institute an inter partes review on that ground. Our findings and conclusions
`
`are not final and may change upon consideration of the whole record
`
`developed during trial.
`
`It is:
`
`IV. ORDER
`
`ORDERED that an inter partes review is instituted, as to claims 1–30
`
`of the ’290 patent, as unpatentable over Ogawa and Sallmann under
`
`35 U.S.C. § 103;
`
`FURTHER ORDERED that no other ground of unpatentability is
`
`authorized; and
`
`FURTHER ORDERED that notice is hereby given of the institution of
`
`a trial commencing on the entry date of this decision. 35 U.S.C. § 314(c);
`
`37 C.F.R. §42.4.
`
`
`
`
`
`
`
`17
`
`

`

`IPR2015-00902
`Patent 8,669,290 B2
`
`
`
`
`PETITIONER:
`
`Jitendra Malik
`Bryan L. Skelton
`Lance Soderstrom
`ALSTON & BIRD LLP
`Jitty.Malik@alston.com
`bryan.skelton@alston.com
`lance.soderstrom@alston.com
`
`
`
`PATENT OWNER:
`
`Bryan Diner
`M. Andrew Holtman
`Justin Hasford
`Jonathan R. Stroud
`Joshua Goldberg
`FINNEGAN, HENDERSON, FARABOW, GARRETT & DUNNER, LLP
`bryan.diner@finnegan.com
`andy.holtman@finnegan.com
`justin.hasford@finnegan.com
`jonathan.stroud@finnegan.com
`joshua.goldberg@finnegan.com
`
`
`
`18
`
`

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