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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`ETON PHARMACEUTICALS, INC.,
`Petitioner
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`v.
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`EXELA PHARMA SCIENCES, LLC,
`Patent Owner
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`Case PGR2020-00086
`Patent No. 10,653,719
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`PATENT OWNER’S SUR-REPLY TO PETITIONER’S REPLY TO
`PATENT OWNER’S PRELIMINARY RESPONSE
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`Patent Owner files this sur-reply pursuant to the Board’s Oral Order of
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`Attorney Docket: 48751-0009PS1
`Case No. PGR2020-00086
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`February 8, 2021 (Exhibit 1124).
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`Eton’s Reply further highlights the deficiencies of its Petition. The Reply is
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`based almost entirely on new arguments, despite the Board’s clear admonition not
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`to do so.1 Many of those new arguments come from Requests for Rehearing Eton
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`recently filed in related PGR matters (where the Board declined to institute), on
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`which Eton now relies.2 This approach speaks volumes; Eton has so little
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`confidence in its Petition that it seeks a wholesale redo. But as discussed below,
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`even with its new, improper arguments, Eton cannot remedy the shortcomings of
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`its Petition regarding the reasonable expectation of success and the lack of
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`particularity of Eton’s Ground.
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`I. THE PETITION FAILS TO ESTABLISH A REASONABLE
`EXPECTATION OF SUCCESS
`Eton’s argument regarding what the Sandoz Label discloses to a POSITA as
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`to aluminum content continues to morph throughout these proceedings. Originally,
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`Eton argued that the Sandoz Label discloses “a range of aluminum extending from
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`1 Ex. 1124 at 15:1-8, 18:21-19:5.
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`2 Exs. 1125 and 1126.
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`1
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`0-5,000 ppb,” which “encompasses the claimed range” of aluminum.3 The Board
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`correctly rejected this argument—twice4—and also found that Eton had not
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`provided sufficient evidence to show that a POSITA would have reasonably
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`expected to achieve the claimed aluminum levels through routine optimization.5
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`In its Reply, Eton now argues that a POSITA would have a reasonable
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`expectation of success regardless of how the Sandoz label is interpreted.6 This
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`argument does not appear in Eton’s Petition, as evidenced by Eton’s citation that
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`simply points back to Eton’s defective 0-5,000 ppb range argument.7 Instead,
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`Eton now argues that the aluminum problem “was to a large extent already solved
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`by the Sandoz Label product.”8 This assertion is not only new, but false. As Eton
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`3 Paper 1 at 27, 42.
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`4 Ex. 2015 at 20-22; Ex. 2017 at 19-20
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`5 Ex. 2015 at 22; Ex. 2017 at 19-20.
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`6 Paper 8 at 1.
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`7 Paper 8 at 1-2, n.3 (citing Paper 1 at 27). The footnote also cites the
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`Requests for Rehearing (Ex. 1125 at 9-11 and Ex. 1126 at 9-11), but these passages
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`merely rehash Eton’s argument that the Sandoz Label discloses a range.
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`8 Paper 8 at 4.
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`2
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`acknowledges, “product quality must be guaranteed both at the time of
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`Attorney Docket: 48751-0009PS1
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`manufacture and throughout the product’s expected shelf-life.”9 Even if, as Eton
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`contends, the alleged Sandoz product had low aluminum levels “prior to product
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`release,”10 Eton has admitted those levels were known to increase over the shelf
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`life of the product,11 and for that reason “the POSITA would have interpreted ‘no
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`more than 5,000 [ppb]’ to disclose aluminum levels ranging between 0 up to 5,000
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`ppb, depending on the age of product”12 – the exact problem that Exela’s claimed
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`invention solved. Leaving no doubt, Eton admitted in its Petition that this problem
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`had gone unsolved by Sandoz: “the POSITA would have been motivated to
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`9 Paper 1 at 39; see also id. at 17 (stating that “[t]he ’719 patent is generally
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`directed to ‘compositions for parenteral administration comprising L-cysteine that
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`are stable and have desirable safety attributes for extended periods of time.’”); id.
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`at 36 (“specifications (e.g., tests, procedures, and acceptance criteria) ‘play a major
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`role in assuring the quality of the new drug product at release and during shelf
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`life.’”) (emphasis in original); Ex. 1106 at 16:44‒48 (defining “stable”).
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`10 Paper 8 at 3.
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`11 Paper 1 at 29; Ex. 1003 at ¶ 33.
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`12 Paper 8 at 1-2, n.3 (emphasis added).
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`3
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`substantially reduce and eliminate aluminum from parenteral nutritional drug
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`Attorney Docket: 48751-0009PS1
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`products such as the Sandoz product disclosed by the Sandoz Label.”13
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`Eton also now argues that by 2019, “the POSITA motivated to reduce
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`aluminum contamination would not have opted for the ‘historically’-used glass
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`vials, because they were not coated or otherwise treated to prevent leachables such
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`as aluminum.”14 But again, Eton’s own evidence shows otherwise. According to
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`Eton, the Schott Type I Plus vial with the silicon dioxide lining was available at
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`least as early as 2006.15 Yet, as of May 2019 Sandoz still had not solved the
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`problem and instead sought to license Exela’s low-aluminum ELCYS® product
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`within weeks of Exela’s NDA approval.16 Eton itself (collaborating with AL
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`Pharma) similarly failed; after seeking approval of an L-cysteine injection with
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`“not more than 5,000 ppb aluminum” in January 2018, and that application being
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`13 Paper 1 at 32; see also id. at 39‒40.
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`14 Paper 8 at 5.
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`15 Ex. 1014 at 2, 8 (published in 2006 and describing Schott glass vials
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`coated “with an ultrathin film of silicon dioxide [that] forms a highly efficient
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`diffusion barrier that practically eliminates glass leachables”).
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`16 Paper 6 at 5-6.
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`4
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`rejected by FDA, Eton abandoned its NDA and chose to copy Exela’s ELCYS®
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`product instead.17 This begs the question: if the Schott Type I Plus vial were the
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`simple and obvious solution to solving the aluminum problem of L-cysteine
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`products, why had Sandoz and Eton/AL Pharma still not solved the problem more
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`than 15 years after this vial became available?
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`Eton also still fails to show why the POSITA would have known that
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`particulate matter (cystine precipitates formed from oxidation of L-cysteine) was a
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`problem with the formulation needing optimization, despite making yet another
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`new (and improper) argument in its Reply in an attempt to address this issue.18 In
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`its Petition, Eton treated aluminum and precipitate issues as independent and
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`unrelated variables, apparently failing to appreciate the complexity of the
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`problem.19 As a consequence, Eton failed to show why, upon reducing the
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`aluminum level in an L-cysteine product, a POSITA would have been concerned
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`with addressing oxygen levels beyond replacing the vial headspace with nitrogen,
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`17 Id. at 6-7.
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`18 Paper 6 at 45-53; Paper 8 at 5-6.
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`19 Paper 1 at 32-37.
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`5
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`as described in the Sandoz Label.20 In an attempt to paper over this hole, Eton now
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`introduces a new argument that the POSITA would have reasonably expected that
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`“by substantially eliminating oxygen and controlling pH (and thus the known
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`oxidation of L-cysteine to cystine) the formation of cystine precipitates would be
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`substantially prevented regardless of the alleged stabilizing influence of aluminum
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`on cystine.”21 This argument does not appear in Eton’s Petition, and Eton does not
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`even purport to rely on its expert or any other authority.22 Instead, Eton offers only
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`rank speculation and attorney argument in an attempt to undermine Exela’s
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`discovery of the complexity of the problem at hand.23
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`20 Paper 6 at 52.
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`21 Paper 8 at 5-6.
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`22 Paper 8 at 5-6 (citing Paper 1 at 33-35, 47).
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`23 The interaction of cystine and aluminum is part of the complexity of the
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`claimed solution described in Exela’s Patent Owner Preliminary Response, support
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`for which is provided by Eton’s own cited references. See Paper 6 at 55-59 (citing
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`Eton’s Exs. 1020, 1003, 1059, 1058, 1061, 1008, and 1012).
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`6
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`II. THE PETITION LACKS PARTICULARITY
`Eton’s Reply underscores Eton’s failure to meet the particularity
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`requirement. The “particularity” section of Eton’s Reply begins: “The Petitioner’s
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`sole Ground relies on the four corners of the Sandoz Label …,” and ends with
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`Eton arguing about “the pre-release aluminum levels in the Sandoz Label product
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`manufactured by Allergy Labs…”24 Throughout its entire Reply, as it did
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`throughout its Petition, Eton continues to conflate the Sandoz Label and a “Sandoz
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`product” to improperly backfill holes within the “four corners” of the Sandoz
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`Label.25 Eton even went so far as to coin its own term for the amalgam of the two
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`references—the “Sandoz Label product.”26
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`To be clear, nowhere in its Petition does Eton purport to establish that any
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`particular product qualifies as prior art. Instead, Eton’s petition identifies “[t]he
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`24 Paper 8 at 8, 9.
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`25 Paper 8 at 3-4, 9.
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`26 See, e.g., Paper 8 at 3 (“To the contrary, years before the alleged
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`invention, the Sandoz Label product manufactured by Allergy Labs had the
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`claimed aluminum levels shortly prior to product release…”) (emphasis added);
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`see also Paper 1 at 28, 40; Ex. 1003 at ¶¶ 65, 112.
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`7
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`Sandoz Label” as the only reference in its Ground,27 and Eton argues that “[t]he
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`Sandoz Label (Ex. 1005), revised 2010, was publicly available no later than
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`August 24, 2016…” and “[a]ccordingly, the Sandoz Label qualifies as AIA §
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`102(a) prior art.”28 Eton’s Petition makes no such argument or showing for the
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`alleged “Sandoz Label product.” Despite this, Eton inappropriately mixed-and-
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`matched the contents of the Sandoz Label with the alleged features of a Sandoz
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`product, treating them as a single prior art reference wherever convenient.29
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`Eton’s Reply fares no better. While arguing “no backfilling is required to
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`establish obviousness,”30 Eton injects the new argument (in a footnote, no less) that
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`“the Sandoz Label product manufactured by Allergy qualifies as prior art under 35
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`U.S.C. §102(a).”31 Eton’s new argument only exacerbates the lack of particularity.
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`For example, Eton’s arguments based on the conflated Sandoz Label and
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`product rely on attributes of a product to which a POSITA would not have had
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`27 Paper 1 at 6.
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`28 Id. at 7-8.
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`29 Paper 6 at 27-30.
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`30 Paper 8 at 9.
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`31 Paper 8 at 4, n.6 (citing Ex. 1022 but not the Petition).
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`8
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`access. In its Reply, Eton cites to the aluminum levels in a product manufactured
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`by Allergy Labs “shortly prior to product release,” but provides no explanation as
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`to how a POSITA would have had access to such a product prior to its release.32
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`Indeed, Eton itself acknowledges that the product to which it refers was not
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`publicly available until “post-release.”33 Adding further ambiguity, in its Reply
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`Eton appears to abandon its original argument, which was based on alleged post-
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`release aluminum levels of the alleged Allergy Labs/Sandoz product, perhaps
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`because Eton’s Petition failed to cite any credible evidence in support of those
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`levels.34
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`Finally, Eton argues that it is not required to expressly list “corroborating
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`prior art” in its asserted Grounds.35 But unlike the Petitioner in Google Inc. v.
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`Koninklijke Philips N.V., Eton does not rely on these unlisted references merely to
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`show that the POSITA would have been generally aware of certain techniques. 948
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`F.3d 1330, 1337-38 (Fed. Cir. 2020). Rather, here, as in PGR2020-00064, Eton
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`32 Paper 8 at 3, 9.
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`33 Paper 8 at 4, n.6.
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`34 See Paper 6 at 33-35.
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`35 Paper 8 at 8 (citing Ex. 1125 at 12-13).
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`9
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`incorporates specific teachings of references into its asserted Ground, such as the
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`dissolved oxygen level disclosed in the Butler reference that Eton uses to establish
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`an oxygen range for water and a reason to reduce the oxygen content in the liquid
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`carrier of the product described in the Sandoz Label.36 Thus, Eton is not using
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`these references as “corroborating prior art” at all, but improperly using them to
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`meet claim limitations that the art in its Ground does not. The Board found that
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`this “catch all” approach of relying on unlisted references to establish specific
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`claim limitations fails to meet the particularity requirement of 35 U.S.C. §
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`322(a)(3).37
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`III.
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` DISCRETIONARY DENIAL UNDER 35 U.S.C. § 324(A) IS
`APPROPRIATE
`Eton appears to take the position that a parallel proceeding in the District
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`Court on two related patents involving the same parties, the same issues, and the
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`same prior art references as the current proceeding in front of the Board is an
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`efficient use of judicial and party resources. Exela respectfully disagrees.
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`36 See Paper 6 at 28, n.65; Ex. 2015 at 15-16.
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`37 Ex. 2015 at 14-17. Eton’s assertion that the Board “did not accept” a
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`similar argument in PGR2020-00068 is misleading at best; Exela did not make this
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`“catch all” argument in that matter. See PGR2020-00068 Paper 6 at 22-30.
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`10
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`Attorney Docket: 48751-0009PS1
`Case No. PGR2020-00086
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`Respectfully submitted,
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`/Dorothy P. Whelan/
`Dorothy P. Whelan, Reg. No. 33,814
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`Counsel for Patent Owner
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`Date: February 25, 2021
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`Customer Number 26191
`Fish & Richardson P.C.
`Telephone: (612) 337-2509
`Facsimile: (877) 769-7945
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`11
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`Attorney Docket: 48751-0009PS1
`Case No. PGR2020-00086
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`CERTIFICATE OF SERVICE
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`Pursuant to 37 CFR §§ 42.6(e)(4), the undersigned certifies that on February
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`25, 2021, a complete and entire copy of this Patent Owner’s Sur-Reply to
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`Petitioner’s Reply to Patent Owner’s Preliminary Response was provided via email
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`to the Petitioner by serving the correspondence email addresses of record as
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`follows:
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`Ralph J. Gabric
`Eugene Goryunov
`Judy K. He
`Jeff Wolfson
`Haynes and Boone LLP
`2323 Victory Ave., Suite 700
`Dallas, TX 75219
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`Email: ralph.gabric.ipr@haynesboone.com
`Email: eugene.goryunov.ipr@haynesboone.com
`Email: judy.he.ipr@haynesboone.com
`Email: jeff.wolfson.ipr@haynesboone.com
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`/Edward G. Faeth/
`Edward G. Faeth
`Fish & Richardson P.C.
`60 South Sixth Street, Suite 3200
`Minneapolis, MN 55402
`(202) 626-6420
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`12
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