Trials@uspto.gov Paper: 6
`571-272-7822 Date: September 22, 2017
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`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`ARGENTUM PHARMACEUTICALS LLC,
`
`Petitioner,
`
`v.
`
`ALCON RESEARCH, LTD.,
`
`Patent Owner.
`_______________
`
`Case IPR2017-01053
`Patent 8,268,299 B2
`_______________
`
`
`
`Before RICHARD E. SCHAFER, GRACE KARAFFA OBERMANN,
`and SUSAN L. C. MITCHELL, Administrative Patent Judges.
`
`OBERMANN, Administrative Patent Judge.
`
`
`DECISION
`Institution of Inter Partes Review
`37 C.F.R. § 42.108
`
`
`
`
`
`
`571-272-7822 Date: September 22, 2017
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`ARGENTUM PHARMACEUTICALS LLC,
`
`Petitioner,
`
`v.
`
`ALCON RESEARCH, LTD.,
`
`Patent Owner.
`_______________
`
`Case IPR2017-01053
`Patent 8,268,299 B2
`_______________
`
`
`
`Before RICHARD E. SCHAFER, GRACE KARAFFA OBERMANN,
`and SUSAN L. C. MITCHELL, Administrative Patent Judges.
`
`OBERMANN, Administrative Patent Judge.
`
`
`DECISION
`Institution of Inter Partes Review
`37 C.F.R. § 42.108
`
`
`
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`I. INTRODUCTION
`Petitioner requests institution of an inter partes review of claims 1–28
`of U.S. Patent No. 8,268,299 B2 (Ex. 1001, “the ’299 patent”). Paper 2
`(“Petition” or “Pet.”). Patent Owner did not file a preliminary response.
`Applying the standard set forth in 35 U.S.C. § 314(a), which requires
`a demonstration of a reasonable likelihood that Petitioner would prevail at
`trial with respect to at least one challenged patent claim, we institute an inter
`partes review of claims 1–28 of the ’299 patent. The following findings of
`fact and conclusions of law are not final, but are made for the sole purpose
`of determining whether Petitioner meets the threshold for initiating review.
`Any final decision shall be based on the full trial record, including any
`response timely filed by Patent Owner. In that regard, any arguments not
`raised by Patent Owner in a timely-filed response shall be deemed waived.
`Taking account of the information provided at this stage of the
`proceeding, we determine that Petitioner shows sufficiently the following
`facts for the purposes of trial institution.
`
`A. Related Matters
`The ’299 patent previously has been the subject of seven district court
`
`actions and one inter partes review. “Petitioner was not a party to any of
`these cases.” Pet. 1. We instituted trial in the prior inter partes review,
`which was terminated after the parties entered a settlement agreement.
`Apotex Corp. v. Alcon Research, Ltd., IPR2013-00428 (“Apotex IPR”),
`Papers 9, 58, 60.
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`B. The ’299 Patent
`The ’299 patent describes “multi-dose, self-preserved ophthalmic
`
`compositions.” Ex. 1001, Abstract. The specification states that
`pharmaceutical compositions, such as irrigating solutions for the eye, “are
`typically utilized multiple times by the patient, and are therefore frequently
`referred to as being of a ‘multi-dose’ nature.” Id. at 1:44–46.
`The specification also explains that, although such compositions can be
`prepared under sterile conditions, see id. at 1:26–39, “[d]ue to the frequent,
`repeated exposure of multi-dose products to the risk of microbial
`contamination, it is necessary to employ a means for preventing such
`contamination from occurring.” Id. at 1:47–50.
`The ’299 patent discloses “multi-dose products that do not require a
`conventional antimicrobial preservative (e.g. benzalkonium chloride)”
`(hereinafter “BAC”), “and yet are preserved from microbial contamination.”
`Id. at 3:10–13. Such compositions are known in the art as “preservative
`free” or “self-preserved.” Id. at 3:14, 19. According to the ’299 patent,
`aqueous ophthalmic compositions may be preserved from microbial
`contamination, despite the absence of conventional preservatives such as
`BAC, by including low concentrations of zinc ions and a borate polyol
`complex in the compositions, and by limiting the concentration of buffering
`anions and metal cations other than zinc in the compositions. See id.
`at 3:33–62. The specification further discloses that the claimed composition
`is “able to satisfy the USP preservative efficacy requirements . . . without
`employing any conventional antimicrobial preservatives” (id. at 4:10–17), in
`a field where the goal is “to use such preservatives at the lowest possible
`concentrations.” Id. at 1:64–65.
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`C. Illustrative Claim
`Claim 1, reproduced below, illustrates the claimed subject matter:
`1. A multi-dose, self-preserved ophthalmic composition, comprising:
`zinc ions at a concentration of 0.04 to 0.4 mM; and
`borate and polyol, the borate being present in the composition at
`a concentration of 0.1 to 2.0% w/v and the polyol being present in the
`composition at a concentration of 0.25 to 2.5% w/v, the polyol
`comprising propylene glycol in the composition at a concentration of
`0.25 to 1.25% w/v and sorbitol in the composition at a concentration of
`0.05 to 0.5% w/v
`wherein: (i) the composition has a concentration of anionic
`species less than 15 mM; and (ii) the composition exhibits sufficient
`antimicrobial activity to allow the composition to satisfy USP 27
`preservative efficacy requirements.
`
`
`Ex. 1001, 25:31–47.
`
`
`D. Asserted Prior Art and Other Evidence
`The Petition asserts the following references as prior art:
`1. Xia et al., WO 2005/097067, “Zinc Preservative Composition and
`Method of Use” (filed March 24, 2005; published October 20, 2005) (“Xia”)
`(Ex. 1003);
`2. Chowhan et al., U.S. Patent No. 6,143,799, “Use of Borate-Polyol
`Complexes in Ophthalmic Compositions” (filed July 2, 1998; issued
`November 7, 2000) (“Chowhan”) (Ex. 1004);
`3. Gadd et al., “Microorganisms and Heavy Metal Toxicity,”
`Microbial Ecology, 4:303-317 (1978) (“Gadd”) (Ex. 1005);
`4. FDA Approved Drug Label “TRAVATAN® (travoprost
`ophthalmic solution) 0.004% Sterile” (2001) (“TRAVATAN® Label”)
`(Ex. 1006); and
`5. Schneider et al., U.S. Patent No. 6,011, 062, “Storage-Stable
`Prostaglandin Compositions” (Filed February 9, 1999; issued January 4,
`2000) (“Schneider”) (Ex. 1007).
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`The Petition is supported by the Declaration of Dr. Erning Xia
`
`(Ex. 1002). Based on the information provided at this preliminary stage of
`the proceeding, we are persuaded that Dr. Xia is qualified to opine from the
`perspective of a person of ordinary skill in the art at the time of the
`invention. Ex. 1002 ¶¶ 6–14 (discussion of technical qualifications and
`bases for opinions); Ex. 1015 (curriculum vitae).
`The Petition also is accompanied by the Declaration of Dr. Richard P.
`Parrish (Ex. 1022), which previously was submitted by Patent Owner as
`Exhibit 2020 in the Apotox IPR. The Parrish Declaration states that
`TRAVATAN Z®, a commercial product alleged to embody the claimed
`invention, satisfied a “long-felt, unmet need for a highly-effective, [BAC]-
`free antiglaucoma drug.” Ex. 1022 ¶ 26. Petitioner also submits the
`Declaration of Dr. Henry Grabowski (Ex. 1037), which, like the Parrish
`Declaration, was submitted by Patent Owner in the Apotox IPR. The
`Grabowski Declaration relies on information in the Parrish Declaration, and
`is directed to a contention that TRAVATAN Z® has enjoyed commercial
`success in the marketplace. See, e.g., Ex. 1037 ¶¶ 18–21, 38.
`The Petition further is supported by the Declaration of Dr. Yvonne
`Buys (Ex. 1021), which identifies alleged “deficiencies” and “points of
`disagreement with” the Parrish Declaration. Ex. 1021 ¶ 11. Specifically,
`Petitioner submits the Buys Declaration to rebut evidence of secondary
`considerations of nonobviousness advanced by Patent Owner in the Apotex
`IPR. Pet. 60–63. Based on the information provided at this preliminary
`stage of the proceeding, we are persuaded that Dr. Buys is qualified to opine
`on the question whether TRAVATAN Z® satisfied a long-felt need in the
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`art for a BAC-free medication for the chronic treatment of glaucoma.
`Ex. 1021 ¶¶ 3–10, 15 (discussion of technical qualifications and bases for
`opinions); Ex. 1023 (curriculum vitae).
`
`E. The Asserted Grounds of Unpatentability
`Petitioner challenges the patentability of claims 1–28 of the ’299
`
`patent on the following grounds:
`
`Claims
`1, 2, 4–8, 16, 17,
`20
`
`28
`
`1–23, 25, 26
`
`24, 27, 28
`
`Basis
`
`§ 103
`
`§ 103
`
`§ 103
`
`§ 103
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`References
`
`Xia, Schneider, Chowhan
`
`Xia, Schneider, Travatan® Label,
`Chowhan
`Xia, Schneider, Chowhan, Gadd
`Xia, Schneider, Travatan® Label,
`Chowhan, Gadd
`
`
`
`II. ANALYSIS
`For reasons that follow, we institute an inter partes review of
`
`claims 1–28 of the ’299 patent under 35 U.S.C. § 314(a).
`
`
`
`A. Level of Ordinary Skill in the Art
`We consider each ground of unpatentability in view of the
`understanding of a person of ordinary skill in the art at the time of the
`invention. Petitioner submits that such a person would have had a Doctorate
`in microbiology or chemistry (or a related field) with at least a few years of
`experience in the development of ophthalmic formulations. Pet. 7.
`Alternatively, in Petitioner’s view, that person would have had a Bachelor’s
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`or Master’s Degree combined with significant (5 years or more) practical
`experience developing ophthalmic formulations. Id.
`Petitioner’s definition is comparable to the level of skill reflected in
`the asserted prior art. For purposes of this decision, we determine that the
`prior art itself is sufficient to demonstrate the level of ordinary skill in the
`art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (prior
`art itself can reflect appropriate level of ordinary skill in the art).
`
`B. Claim Interpretation
`The Board interprets claims in an unexpired patent using the “broadest
`
`reasonable construction in light of the specification of the patent.” 37 C.F.R.
`§ 42.100(b); Cuozzo Speed Techs., LLC v. Lee, 136 S. Ct. 2131, 2144–46
`(2016). Under that construction, we give claim terms their ordinary and
`customary meaning in view of the specification, as 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). In this section, we provide a
`preliminary claim construction for the sole purpose of determining whether
`to institute review. We emphasize that any final claim construction shall be
`based on the full record developed during trial.
`
`Petitioner argues that we should adopt the claim construction resolved
`in the Apotex IPR. Pet. 5–7. At this stage of the proceeding, for reasons set
`forth in our decision instituting review in the Apotex IPR, we find:
`
`(a) The preamble term “self-preserved” breathes life and meaning
`into the claims, and is construed as a limitation of claims 1–28; and
`
`(b) The broadest reasonable interpretation of “self-preserved”
`compositions is “compositions that do not contain a conventional
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`antimicrobial preservative, such as [BAC], polyquaternium-1, chlorite, or
`hydrogen peroxide.” Apotex IPR, Paper 9, 5–6.
`
`Those findings are consistent with the specification, which states that
`“[t]he multi-dose compositions of the present invention, which do not
`contain a conventional antimicrobial preservative, are referred to herein as
`being ‘self-preserved’.” Ex 1001, 3:27–29. The specification also explains
`that BAC, polyquaternium-1, chlorite, and hydrogen peroxide are among
`conventional antimicrobial preservatives which are excluded from self-
`preserved compositions. Id. at 4:23–25.
`
`No other claim term requires express construction for the purposes of
`this decision. See, e.g., Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d
`795, 803 (Fed. Cir. 1999) (only claim terms in controversy need be
`construed, and then only to the extent necessary to resolve the controversy).
`
`C. The Challenge Based on Xia, Schneider, and Chowhan
`
`Petitioner challenges the patentability of claims 1, 2, 4–8, 16, 17, 20
`on the ground that the claimed subject matter would have been obvious at
`the time of the invention over the combined disclosures of Xia, Schneider,
`and Chowhan. Pet. 8. Our analysis focuses on claim 1, the only
`independent claim challenged in this ground. We now turn to whether the
`Petition directs us to information sufficient to show that an ordinary artisan,
`informed by the combined disclosures of Xia, Schneider, and Chowhan,
`would have been led to a self-preserving ophthalmic formulation that
`satisfies the limitations of claim 1.
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`
`Claim 1
`“Self-preserved ophthalmic composition”
`Claim 1 requires—and Xia, Schneider, and Chowhan each describe—
`an ophthalmic composition. Pet. 9 (citing Ex. 1003, 31 (“[A]ccording to one
`embodiment, the composition is an ophthalmic solution”); Ex. 1004, 2:4–12
`(“The ophthalmic compositions of the present invention comprise borate-
`polyol complexes.”); Ex. 1007, 7:7–9 (“Most preferred are compositions
`prepared for topical administration to the eye.”), 9:22–23 (describing
`“topically administrable ophthalmic formulation”). The Petition
`demonstrates that each applied prior art reference discloses that limitation of
`claim 1.
`Xia further discloses that its compositions preferably do not contain
`conventional antimicrobial preservatives. Pet. 9; Ex. 1003, 3 (“The present
`invention relates to a composition that includes a preservative-effective
`amount of a soluble zinc compound and has less than a preservative-
`effective amount of a primary preservative agent, preferably no primary
`preservative agent.”). The Declaration of Dr. Xia, moreover, provides
`evidence that a person of ordinary skill in the art “would have appreciated
`Xia’s disclosure of multi-dose ophthalmic formulations containing a
`prostaglandin glaucoma agent that avoids the use of traditional
`preservatives, including BAC.” Pet. 14 (citing Ex. 1002 ¶¶ 38, 46). On this
`record, Petitioner shows sufficiently that Xia discloses the claim 1 limitation
`that the composition must be self-preserved.
`
`
`1 The Petition refers to original page numbers contained in the Exhibits, not
`those added by Petitioner. We follow that convention in this decision.
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`Zinc ions at a concentration of 0.04 to 0.4 mM
`Claim 1 requires zinc ions at a concentration “of 0.04 to 0.4 mM.”
`Xia discloses zinc citrate and zinc chloride as preferred zinc compounds.
`Pet. 10 (citing Ex. 1003, 5). Xia further discloses:
`[T]he composition has a minimum of about 0.001 wt.%, about 0.005
`wt.%, about 0.01 wt.% or about 0.05 wt.% of a zinc compound per
`total weight of the composition and/or a maximum of about 1 wt.%,
`about 0.5 wt.%, about 0.1 wt.% or about 0.05 wt.% of the zinc
`compound per total weight of the composition.
`
`Id.
`
`Petitioner directs us to information comparing the amounts of zinc
`compound disclosed in Xia with the amounts specified in claim 1. Pet. 10
`n.1 (citing Ex. 1002 ¶¶ 46, 50; Ex. 1008, 365); Pet. 15–16 (citing Ex. 1002
`¶ 50). Petitioner demonstrates adequately that Xia includes zinc ions in the
`concentration specified in claim 1. Pet. 10 (claim chart, citing Ex. 1003, 5).
`On this record, Petitioner shows sufficiently that Xia discloses a self-
`preserving composition that utilizes zinc ions in the required concentration.
`Further, as discussed in the next section, Petitioner provides reasoning with a
`rational underpinning explaining why, in view of Chowhan, one would have
`“taken advantage of Schneider’s borate-polyol complex to boost the anti-
`microbial efficacy of the zinc ions” in Xia’s composition. Pet. 16.
`
`0.1 to 2.0% borate, 0.25 to 1.25% propylene glycol,
`and 0.05 to 0.5% w/v sorbitol
`Claim 1 requires a composition comprising specified ranges of borate,
`propylene glycol, and sorbitol. Petitioner presents a claim chart explaining
`how Schneider, Xia, and Chowhan disclose or suggest those ingredients in
`ranges that overlap the claimed ranges. Pet. 10–11. The Petition also
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`explains adequately why a person of ordinary skill in the art would have
`been led by the combined disclosures of Schneider, Xia, and Chowhan to
`arrive at the claimed ranges, in a self-preserving ophthalmic composition
`that contains the requisite concentration of zinc ions, through routine
`optimization. Id. at 14–18.
`Petitioner comes forward with rational reasons why one would have
`modified the composition of Xia, in view of Chowhan and Schneider, to
`arrive at a composition that meets the requirements of claim 1. Specifically,
`Chowhan discloses compositions utilizing borate-polyol complexes
`preferably present in an amount between about 1.0 to about 2.5 wt %.
`Pet. 11 (claim chart, citing Ex. 1004, 3:44–47). The Petition identifies the
`minimum and maximum weight-to-volume amounts of borate-polyol
`complexes embraced by claim 1 and, further, explains how the borate-to-
`polyol molar ratios of the claimed compositions correspond to those in
`Chowhan’s formulation. Id. (citing Ex. 1004, 3:15–34, 44–47). In
`Chowhan, “[p]referred polyols are . . . propylene glycol and sorbitol.” Id. at
`10 (claim chart, citing Ex. 1004, 3:4–6). The Petition advances evidence
`sufficient to show that one would have understood that Chowhan’s “borate-
`polyol complexes have antimicrobial activity” and, further, “are capable of
`increasing the activity of other antimicrobials.” Pet. 15 (citing Ex. 1004,
`2:4–12).
`In addition, Schneider’s Example 2 discloses a formulation that
`includes 0.3% w/v boric acid and a polyol. Id. at 10 (claim chart, citing
`
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`Ex. 1007, 9:21–42). Referring to Schneider’s disclosure of travoprost2 for
`the treatment of glaucoma, Petitioner directs us to evidence that one “would
`have appreciated that Schneider discloses an ophthalmic formulation
`containing the same active ingredient of Xia” and, accordingly, “would have
`been motivated to combine Xia and Schneider in order to improve
`Schneider’s” formulation “by removing BAC, a known source of toxicity,
`discomfort, and irritation to the eye.” Id. at 14 (citing Ex. 1002 ¶¶ 36, 47).
`Xia itself discloses, in Examples 2 and 3, ophthalmic formulations
`containing 0.85 weight percent of boric acid and 0.090 weight percent of
`sodium borate. Id. (claim chart, citing Ex. 1003, 17–18). Xia also teaches
`the addition of “comfort agents such as . . . propylene glycol.” Id. (citing
`Ex. 1003, 14); see id. at 11 (citing Ex. 1003, 7:21–25 (Xia’s disclosure of
`“suitable agents which may be utilized to adjust the tonicity or osmolality of
`the formulations,” which include “mannitol” and “propylene glycol”)).
`On this record, we are persuaded that Petitioner directs us to evidence
`sufficient to show that an ordinary artisan would have been prompted to
`“optimize the self-preservation and comfort of the formulation while
`maintaining the stability of the active agent, travoprost” in a modified
`composition. Pet. 14 (citing Ex. 1004, 1:64–66). Specifically, Petitioner
`shows sufficiently that an ordinary artisan, through routine optimization of
`the ranges, would have been led to a formulation that falls within the ranges
`required by claim 1. Id. at 15–18 (and citations therein to the asserted prior
`art). Petitioner’s assertions in that regard are supported by the Declaration
`
`
`2 Claims 22, 26, and 27 are the only other independent claims, and each is
`directed to a composition of travoprost.
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`of Dr. Xia. See id. (citing Ex. 1002 ¶¶ 36, 38, 46–48, 50, 52–4, 69–72).
`Any final decision entered in this case, however, will be based on the full
`trial record, including any counterarguments and evidence presented on this
`issue in a response timely filed by Patent Owner.
`Anionic species less than 15 mM
`The Petition identifies evidence sufficient to show that an ordinary
`artisan would have been led to maintain the concentration of anionic species
`in the modified ophthalmic solution at less than 15 mM, as required by
`claim 1. Petitioner adequately demonstrates the absence of significant
`anionic species, other than the borate-polyol complex, in Schneider’s
`Formulation A, and that “one would expect the ionized fraction of borate-
`polyol complex of the optimized formulation” to “be less than 15 mM.”
`Pet. 19. Petitioner further points out that “both Xia and Chowhan disclose
`that their ophthalmic compositions are not necessarily isotonic, but that if
`tonicity is adjusted, it may be adjusted with agents other than sodium
`chloride (e.g., glycerol).” Id. (citing Ex. 1003, 10; Ex. 1004, 4:52).
`The Petition also directs us to Dr. Xia’s declaration, which explains
`why one of ordinary skill in the art would have understood the disclosures of
`Xia and Chowhan to “encompass formulations with chloride salt
`concentrations of zero or at least less than 15 mM.” Id. (citing Ex. 1002
`¶ 56). The Petition identifies specific disclosures in the prior art that would
`have guided an ordinary artisan to “keep the concentration of anionic species
`as low as possible.” Id. at 20 (citing Ex. 1004, 1:45–48; Ex. 1002 ¶ 57)); see
`id. at 12 (claim chart, citing Ex. 1003, 10 (“aqueous solutions of the present
`invention are typically adjusted with tonicity agents”)). For example,
`Chowhan discloses that phosphate ions can interfere with the activity of
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`antimicrobial agents in the compositions. Pet. 12 (claim chart, citing 1004,
`1:45–48 (“phosphate [an anion] is a good buffer but, when used in
`concentrations generally found in ophthalmic formulations, it reduces the
`antimicrobial activity of preservatives.”)).
`On this record, Petitioner directs us to information sufficient to show
`that an ordinary artisan would have maintained the concentration of anionic
`species in the modified ophthalmic solution at less than 15 mM.
`USP 27 preservative efficacy
`Claim 1 specifies a composition that exhibits sufficient antimicrobial
`activity to satisfy USP 27 preservative efficacy requirements. The ’299
`patent sets out criteria for satisfying those USP 27 requirements, see
`Ex. 1001, 7:30–38, stating that the “standards identified . . . for the USP 27
`are substantially identical to the requirements set forth in prior editions of
`the USP, particularly USP 24, USP 25 and USP 26.” Id. at 7:53–55.
`Petitioner argues that both Xia and Chowhan describe standards for
`judging the preservative efficacy of the compositions disclosed in those
`references. Pet. 12 (claim chart, citing Ex. 1003, 3, 14, 15; Ex. 1014, 2002–
`2004; Ex. 1004, 9:38–41). Petitioner further argues that the tests described
`in Xia and Chowhan are more stringent than those of the USP 27
`preservative efficacy requirements. Id. On that point, the Petition directs us
`to evidence sufficient to show that, given those disclosures in the asserted
`prior art, the modified ophthalmic composition would have inherently
`satisfied the USP requirements or, alternatively, would have been attained
`through routine experimentation. Pet. 21–23 (citing Ex. 1002 ¶¶ 60–62).
`Specifically, in Petitioner’s view, Xia discloses that compositions containing
`zinc and borate meet a preservative efficacy standard more stringent than
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`USP 27, despite the absence of a conventional antimicrobial in the
`composition, and Chowhan discloses, as discussed above, that its borate
`polyol complexes potentiate the antimicrobial activity of other preservatives.
`Based on the current record, we find that Petitioner shows sufficiently
`that an ordinary artisan would have had a reasonable expectation that the
`modified ophthalmic composition, containing zinc, borate, propylene glycol,
`and sorbitol, would meet USP 27, even without a conventional antimicrobial
`preservative in the composition.
`
`Secondary considerations of nonobviousness
`The Petition includes information alleged to undercut the Parrish
`Declaration, which was submitted by Patent Owner during the Apotex IPR
`to establish secondary considerations of nonobviousness of the claimed
`invention. Pet. 59–63. For example, the Petition directs us to evidence,
`including Dr. Buys’ declaration testimony, suggesting that the claimed
`invention did not achieve “‘surprisingly superior’ results over the closest
`prior art, which is the Xia reference.” Pet. 59 (citing Ex. 1008, 367;
`Ex. 1003, 5, 15; Ex. 1002 ¶ 163). The Petition also directs us to testimony
`that cuts against a finding that TRAVATAN Z®, an alleged commercial
`embodiment of the claimed invention, “satisfied a long-felt need” in the art.
`Id. at 59–61 (citing Ex. 1021 ¶¶ 12–15). Further, the Petition identifies
`information—including documents relating to a rebate program (Ex. 1027–
`1036) and arguments relating to pricing and sales data—that appears on this
`record to cast doubt on the declaration testimony of Dr. Grabowski, which
`was submitted by Patent Owner during the Apotex IPR to establish the
`commercial success of TRAVATAN Z®. Pet. 62–63.
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`On this record, the evidence of secondary considerations is
`inconclusive. The Petition otherwise tends to establish that the subject
`matter of claim 1 would have been obvious at the time of the invention over
`the combined disclosures of Xia, Schneider, and Chowhan. We recognize,
`however, that Patent Owner did not file a preliminary response; therefore,
`the record at this stage is limited to information provided by Petitioner. Any
`final decision entered in this case shall take account of the full trial record,
`including arguments and evidence contained in any response timely filed by
`Patent Owner.
`
`Conclusion as to Claim 1
`Accordingly, on this record, we are persuaded that Petitioner
`demonstrates a reasonable likelihood of prevailing at trial in showing that
`the subject matter of claim 1 would have been obvious at the time of the
`invention over the combined disclosures of Xia, Schneider, and Chowhan.
`
`Claims 2, 4–8, 16, 17, 20
`Having determined that Petitioner satisfies the threshold showing
`under 35 U.S.C. § 314(a) for institution of trial with respect to at least one
`challenged claim of the ’299 patent, we exercise our discretion under
`37 C.F.R. § 42.108(a) and order that the trial shall proceed on all claims
`challenged in this ground as obvious over Xia, Schneider, and Chowhan.
`
`
`
`D. Other Challenges
`Petitioner asserts three additional grounds, all based on obviousness,
`which respectively rely upon the combined disclosures of: (1) Xia,
`Schneider, Travatan® Label, and Chowhan (claim 28); (2) Xia, Schneider,
`Chowhan, and Gadd (claims1–23, 25, and 26); and (3) Xia, Schneider,
`
`
`
`16
`
`
`
`IPR2017-01053
`Patent 8,268,299 B2
`
`Travatan® Label, Chowhan, and Gadd (claims 24, 27, and 28). These
`additional grounds involve issues that overlap, or are closely related to, those
`raised in connection with the ground based on Xia, Schneider, and
`Chowhan, which we analyze above for purposes of determining whether to
`institute inter partes review. In view of the information contained in the
`Petition, including the claim charts explaining those additional grounds, we
`find that their inclusion will not unduly complicate the trial. Pet. 28–58.
`Based on the particular circumstances presented in this case, we
`determine that inclusion of all grounds of unpatentability stated in the
`Petition will advance our overarching goal of securing the just, speedy, and
`efficient resolution of the parties’ dispute. 35 U.S.C. § 314 (a) (authorizing
`institution of an inter partes review where Petitioner demonstrates a
`reasonable likelihood of prevailing at trial with respect to at least one
`challenged patent claim); 37 C.F.R. §§ 42.1(b), 42.108 (reflecting the
`Board’s mission of securing “the just, speedy, and inexpensive resolution”
`of patentability disputes).
`
`III. CONCLUSION
`Accordingly, we institute an inter partes review of claims 1–28 of
`
`the ’299 patent. Trial shall commence on the entry date of this decision.
`
`IV. ORDER
`
`
`
`It is
`ORDERED that an inter partes review of claims 1–28 of the ‘299
`patent is instituted and a trial shall proceed on the following grounds:
`(1) Whether claims 1, 2, 4–8, 16, 17, and 20 are unpatentable
`under 35 U.S.C. § 103 over Xia, Schneider, and Chowhan; and
`
`
`
`17
`
`
`
`IPR2017-01053
`Patent 8,268,299 B2
`
`
`(2) Whether claim 28 is unpatentable under 35 U.S.C. § 103
`over Xia, Schneider, the Travatan® Label, and Chowhan;
`(3) Whether claims 1–23, 25, and 26 are unpatentable under 35
`U.S.C. § 103 over Xia, Schneider, Chowhan, and Gadd; and
`(4) Whether claims 24, 27, and 28 are unpatentable under 35
`U.S.C. § 103 over Xia, Schneider, the Travatan® Label, Chowhan,
`and Gadd;
`FURTHER ORDERED that no other grounds of unpatentability are
`authorized during the trial; and
`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, which will
`commence on the entry date of this decision.
`
`
`
`
`
`
`
`18
`
`
`
`IPR2017-01053
`Patent 8,268,299 B2
`
`PETITIONER:
`
`Michael R. Houston, Ph.D.
`Joseph P. Meara, Ph.D.
`James P. McParland, Ph.D.
`FOLEY & LARDNER LLP
`mhouston@foley.com
`jmeara-pgp@foley.com
`jmcparland@foley.com
`
`Tyler C. Liu
`ARGENTUM PHARMACEUTICALS LLC
`tliu@agpharm.com
`
`
`
`PATENT OWNER:
`
`David Krinsky
`Christopher Suarez
`WILLIAMS & CONNOLLY LLP
`dkrinsky@wc.com
`csuarez@wc.com
`
`
`
`19
`
`
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