UNITED STATES PATENT AND TRADEMARK OFFICE
`
`———————
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`———————
`
`ETON PHARMACEUTICALS, INC.,
`
`Petitioner
`
`v.
`
`EXELA PHARMA SCIENCES, LLC,
`
`Patent Owner
`
`———————
`
`U.S. PATENT NO. 10,583,155
`
`PGR2020-00068
`
`PETITIONER’S REQUEST FOR REHEARING
`
`
`
`
`
`
`
`
`
`———————
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`———————
`
`ETON PHARMACEUTICALS, INC.,
`
`Petitioner
`
`v.
`
`EXELA PHARMA SCIENCES, LLC,
`
`Patent Owner
`
`———————
`
`U.S. PATENT NO. 10,583,155
`
`PGR2020-00068
`
`PETITIONER’S REQUEST FOR REHEARING
`
`
`
`
`
`
`
`
`
`
`
`TABLE OF CONTENTS
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`Page
`
`I.
`
`INTRODUCTION .......................................................................................... 1
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`II.
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`BASIS FOR REHEARING ............................................................................ 1
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`III. CONCLUSION ............................................................................................... 9
`
`
`
`i
`
`
`
`
`
`Cases
`
`TABLE OF AUTHORITIES
`
` Page(s)
`
`Blue Coat Systems, Inc. v. Finjan, Inc.,
`IPR2016-01444, Paper 11 (P.T.A.B. July 18, 2017) ............................................ 1
`
`Other Authorities
`
`37 C.F.R. § 42.71(c) ................................................................................................... 1
`
`37 C.F.R. § 42.71(d) .................................................................................................. 1
`
`
`
`ii
`
`
`
`
`
`I.
`
`INTRODUCTION
`
`Pursuant to 37 C.F.R. § 42.71(d), Petitioner requests rehearing of the Board’s
`
`decision denying post grant review entered December 15, 2020 (Paper 11,
`
`hereinafter “Decision”).1
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`II. BASIS FOR REHEARING
`
`A request for rehearing “must specifically identify all matters the party
`
`believes the Board misapprehended or overlooked, and the place where each such
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`matter was previously addressed in a motion, opposition, or reply.” 37 C.F.R. §
`
`42.71(d). The Board will review the decision for an abuse of discretion. 37 C.F.R.
`
`§ 42.71(c). An abuse of discretion results from an erroneous interpretation of law,
`
`a factual finding that is not supported by substantial evidence, or if the decision
`
`represents an unreasonable judgment in weighing the relevant evidence. Blue Coat
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`Systems, Inc. v. Finjan, Inc., IPR2016-01444, Paper 11 at 2 (P.T.A.B. July 18, 2017).
`
`
`
`Respectfully, the Decision’s conclusion that the Petition allegedly failed to
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`demonstrate a reasonable expectation of success (which was the basis for the denial)
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`is premised upon a misapprehension of the Petition, which does not require that the
`
`
`1 On December 18, 2020, Petitioner requested rehearing in the post-grant review
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`(PGR2020-00064) of related patent, U.S. Patent No. 10,478,453, for which the
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`Board previously denied institution.
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`1
`
`
`
`
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`claimed aluminum ranges overlap with those disclosed by the Sandoz Label.
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`Moreover, the Decision’s finding that the ranges do not overlap is not supported by
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`substantial evidence. For either one of these reasons, rehearing is warranted.
`
`The claimed aluminum levels were not new. As the Petition2 demonstrates,
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`numerous batches of the Sandoz product manufactured by Allergy Labs under the
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`Sandoz Label prior to the alleged invention contained aluminum within the claimed
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`ranges shortly after manufacture (i.e., at product release) without Allergy even
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`taking affirmative steps to control aluminum levels; namely, 17 ppb, 61 ppb, 37 ppb,
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`18 ppb, 50 ppb, 54 ppb, 46 ppb, 47 ppb, 48 ppb, and 43 ppb. (Pet., p. 33; Ex. 1022,
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`¶ 15 (Ex. B (pp. 103-112), and Ex. C (pp. 113-123)).)3 Post-release, aluminum was
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`known to leach into the Sandoz product from the glass vials in which the Sandoz
`
`product was stored, and could rise to several hundred ppb by the product’s two-year
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`expiration date (Ex. 1022, ¶ 15), which was within (and as Petitioner asserts, at the
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`lower end of) the “[c]ontains no more than 5,000 [ppb] of aluminum” disclosed on
`
`the Sandoz Label. The POSITA motivated to reduce aluminum would have
`
`
`2 The term “Petition” also includes the cited materials, including the Rabinow
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`Declaration, the Johnson Declaration and the prior art cited in the Petition.
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`3 The Sandoz product attributes are included within the knowledge of the POSITA.
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`(Paper 8, Pet. Reply, p. 1, n.3; Pet., pp. 42-43.)
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`2
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`
`
`
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`reasonably expected that an optimized Sandoz Label product would achieve and
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`maintain low aluminum levels (as claimed) for extended periods of time by simply
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`removing the known sources of aluminum contamination.
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`
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`As the Petition explains, the POSITA would have known that the potential
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`sources of aluminum contamination in the Sandoz Label product included: (1) the
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`drug product starting
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`ingredients, (2)
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`the manufacturing process, and/or
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`(3) aluminum leaching from glass vials in which the Sandoz Label product was
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`stored. By eliminating these known sources of aluminum, the POSITA would have
`
`had a reasonable expectation that the Sandoz Label product could be optimized to
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`substantially eliminate aluminum to the claimed levels over its projected shelf-life.
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`(Pet., pp. 39-40, 42-44.)4 The POSITA would have optimized the Sandoz Label
`
`product in this manner by following these simple and straightforward steps: (1) using
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`starting ingredients substantially free of aluminum, (2) ensuring that the
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`manufacturing process did not contaminate the drug product with aluminum, and
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`(3) storing the optimized Sandoz Label product in a container that substantially
`
`
`4 The challenged claims require a “stable” composition. The specification explains
`
`that a “stable” composition is one that has the claimed aluminum levels when
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`administered in a clinical setting, which can occur, three months post-manufacture
`
`(Pet., p. 30), and likely sooner.
`
`3
`
`
`
`
`
`prevents aluminum from leaching into the drug product post-manufacture, such as
`
`the Schott coated glass vials. (Id., pp. 39-40, 42-44, 50-51.)5 Respectfully, the
`
`Decision overlooks the dispositive impact of this critical knowledge possessed by
`
`the POSITA, which is unrebutted and which demonstrated more than a reasonable
`
`expectation of success.6
`
`
`5 The Schott coated glass vials (aka Schott Type I Plus® vials) were known to
`
`substantially eliminate glass leachables including aluminum. (Ex. 1003, ¶¶ 59, 113;
`
`Ex. 1014 at 7-8 (explaining that the Schott coated glass vials include an inner surface
`
`coated with “an ultrathin film of silicon dioxide [that] forms a highly efficient
`
`diffusion barrier that practically eliminates glass leachables”); Ex. 1048 at 21, 12:20-
`
`39 (the Schott coated glass vials substantially prevent aluminum leachables in an
`
`Ibuprofen Lysine solution) see also Tables 16-18 (aluminum below 9 ppb in
`
`solutions stored in the Schott coated glass vials after 9 months storage).) The
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`POSITA would have reasonably expected similarly low levels by simply packaging
`
`the Sandoz Label product using the coated Schott glass vials. (Ex. 1003, ¶ 113.)
`
`6 The PO argued that cystine levels were allegedly relevant to reducing aluminum
`
`concentration. However, PO provided no evidentiary basis that the POSITA – at the
`
`time of the alleged invention in or about January 2019 – would have been concerned
`
`about cystine levels for purposes of controlling aluminum levels. (Paper 8, Pet.
`
`4
`
`
`
`
`
`
`
`In finding no reasonable expectation of success, the Decision concludes that
`
`the Sandoz Label’s disclosure of “[c]ontains no more than 5,000 ppb” is “reasonably
`
`interpreted to be the upper end” of the expected aluminum concentration “rather than
`
`teaching any lower limit . . . that overlaps with the claimed range” and thus the
`
`Sandoz Label does “not reasonably suggest a range of 0-5,000 [ppb] of the aluminum
`
`amount that would be subject to routine optimization.” (Paper 11, p. 19.) The
`
`Decision’s conclusion, however, (1) misapprehends the Petitioner’s reasonable
`
`expectation of success (and routine optimization) assertions (which do not depend
`
`exclusively on or require overlapping ranges but instead also assert that the claimed
`
`ranges are the expected result of optimizing the Sandoz Label product by eliminating
`
`
`Reply, p. 4, n.7.) For example, Bohrer (Ex. 1012), which was published in 2003,
`
`addresses the role of cystine and cysteine (and other amino acids) in causing
`
`aluminum to leach from uncoated glass vials. By the time of the alleged invention
`
`in January 2019, however, the POSITA would have packaged the Sandoz Label
`
`product in Schott coated glass vials, which were known to substantially prevent
`
`aluminum from leaching into the drug product. Cystine levels, although relevant to
`
`the L-cysteine’s oxidative degradation, would not have been a concern for purposes
`
`of controlling aluminum when the Sandoz Label product is stored in the Schott
`
`coated glass vials.
`
`5
`
`
`
`
`
`the art-recognized sources of aluminum contamination) and (2) overlooks the
`
`unrebutted evidence that demonstrated that the ranges do in fact overlap.
`
`With respect to Petitioner’s first point, regardless of how the Sandoz Label is
`
`interpreted, the Petition nevertheless demonstrates a reasonable expectation of
`
`success. As the Decision acknowledges, the POSITA would have been motivated
`
`“to avoid aluminum toxicity.” (Paper 11, p. 19.) And, as the Petition explains, the
`
`POSITA motivated to reduce aluminum contamination would have optimized the
`
`Sandoz Label product by simply eliminating
`
`the sources of aluminum
`
`contamination. (Pet., pp. 39-40, 42-45, 49-51.) By eliminating the sources of
`
`aluminum, the POSITA—quite logically, and as explained in the Petition—would
`
`have had a reasonable expectation of substantially eliminating aluminum from the
`
`product during its projected shelf-life, regardless of how the “no more than 5,000
`
`[ppb]” on the Sandoz Label was interpreted.7
`
`
`7 Although the Petition also asserts prima facie obviousness based upon overlapping
`
`ranges (Pet., pp. 49-50), neither the motivation for preventing aluminum
`
`contamination nor the reasonable expectation of success are predicated on
`
`overlapping ranges. As the Decision implicitly recognizes, the Petition establishes
`
`that the POSITA would have been motivated to reduce aluminum, regardless of how
`
`the Sandoz Label is interpreted.
`
`6
`
`
`
`
`
`Turning to Petitioner’s second point, the Board, respectfully, abused its
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`discretion in finding that the Sandoz Label’s disclosure of “contains no more than
`
`5,000 [ppb] of aluminum” does not overlap with (or encompass) the 1-250 ppb
`
`aluminum range recited in claim 1 of the ’155 patent. In reaching this conclusion,
`
`the Decision opted to accept the PO’s assertion that the POSITA would have
`
`understood the not more than 5,000 ppb disclosure to be at the “upper end of the
`
`aluminum concentration that is expected in the [Sandoz Label] product rather than a
`
`teaching of any lower limit for aluminum content that overlaps with the claimed
`
`range.” (Paper 11, p. 19.) The Board’s finding, however, in this respect is not
`
`supported by substantial evidence. As Petitioner’s expert (Dr. Rabinow) testified,
`
`the POSITA would have interpreted the Sandoz Label to disclose an aluminum
`
`concentration “falling somewhere within the range of 0 ppb to 5,000 ppb” (i.e., 5,000
`
`ppb aluminum or less) and that the claim 1 range of from about 1-250 ppb aluminum
`
`is within the lower end of the not more than 5,000 ppb levels disclosed by the Sandoz
`
`Label (Ex. 1003, ¶¶ 34, 111; Pet., p. 32, 49-50.) That testimony is unrebutted.8
`
`
`8 PO’s expert (who does not qualify as the POSITA) merely testified that a
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`pharmacist “calculating the potential aluminum exposure . . . would use the 5,000
`
`[ppb] aluminum concentration to do so.” (Ex. 2001, ¶¶ 21-23 (emphasis added).)
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`But that does not address, let alone rebut, Dr. Rabinow’s testimony that the POSITA
`
`7
`
`
`
`
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`Moreover, the aluminum levels in the Sandoz product manufactured by Allergy Labs
`
`under the Sandoz Label corroborate the reasonableness of Dr. Rabinow’s opinion
`
`about how the POSITA would have interpreted the Sandoz Label. On the current
`
`record, the aluminum levels shortly after manufacture (i.e., at product release) were
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`as low as 17 ppb and ranged up to several hundred ppb after two years of storage
`
`(Ex. 1022, ¶ 15), which corroborates the Sandoz Label’s disclosure of aluminum
`
`falling somewhere within the range of 0-5,000 ppb and also overlaps with the 1-250
`
`ppb range set forth in claim 1 of the ’155 patent, as well as with the other, more
`
`narrowly claimed aluminum ranges. In short, the evidence is unrebutted that the
`
`aluminum levels disclosed by the Sandoz Label (and the actual aluminum levels in
`
`the Sandoz product manufactured by Allergy Labs under the Sandoz Label) overlap
`
`with the ranges claimed in the ’155 patent.
`
`
`(who has qualifications beyond those of a pharmacist) would have understood from
`
`the Sandoz Label that the aluminum content was somewhere within the range
`
`extending from 0 to 5,000 ppb, depending on the age of the product. (Paper 8, Pet.
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`Reply, p. 2, n.4.) Notably, the Decision adopted Petitioner’s definition of the
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`POSITA. (Paper 11, p. 9.)
`
`8
`
`
`
`
`
`
`
`trial.
`
`III. CONCLUSION
`
`For these reasons, Petitioner respectfully requests rehearing and institution of
`
`December 22, 2020
`
`
`
`
`
`/s/ Ralph J. Gabric
`
`Ralph J. Gabric (Reg. No 34,167)
`
`HAYNES and BOONE LLP
`2323 Victory Ave. Suite 700
`Dallas, TX 75219
`Tel.: (312) 216-1620
`ralph.gabric.ipr@haynesboone.com
`
`Counsel for Petitioner
`
`
`
`9
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`
`
`
`
`
`
`CERTIFICATE OF SERVICE
`
`Pursuant to 37 C.F.R. §§ 42.105 and 42.6, I certify I caused a true and correct
`
`copy of the forgoing document on Patent Owner as detailed below.
`
`
`
`Date of service December 22, 2020
`
`Person served Dorothy P. Whelan
`PGR48751-0005PS1@fr.com
`
`Alana Mannige
`PTABInbound@fr.com
`
`
`
`
`
`/s/ Ralph J. Gabric
`Ralph J. Gabric (Reg. No 34,167)
`
`HAYNES AND BOONE LLP
`2323 Victory Ave. Suite 700
`Dallas, TX 75219
`Tel.: (312) 216-1620
`ralph.gabric.ipr@haynesboone.com
`Counsel for Petitioner
`
`
`
`
`
`
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