UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`CIPLA LTD.,
`Petitioner
`
`v.
`
`ABRAXIS BIOSCIENCE, LLC,
`Patent Owner
`
`
`
`Case IPR2018-00163
`Patent 7,923,536 B2
`Issued: April 12, 2011
`
`Title: COMPOSITIONS AND METHODS OF
`DELIVERY OF PHARMACOLOGICAL AGENTS
`
`
`
`PETITIONER’S REQUEST FOR REHEARING
`
`
`
`
`
`
`
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`CIPLA LTD.,
`Petitioner
`
`v.
`
`ABRAXIS BIOSCIENCE, LLC,
`Patent Owner
`
`
`
`Case IPR2018-00163
`Patent 7,923,536 B2
`Issued: April 12, 2011
`
`Title: COMPOSITIONS AND METHODS OF
`DELIVERY OF PHARMACOLOGICAL AGENTS
`
`
`
`PETITIONER’S REQUEST FOR REHEARING
`
`
`
`
`
`
`
`
`
`
`I.
`
`II.
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`IPR2018-00163 (7,923,536 B2)
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`TABLE OF CONTENTS
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`Page
`PRECISE RELIEF REQUESTED .................................................................. 1
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`BASIS FOR RELIEF ....................................................................................... 1
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`A.
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`Rehearing is Requested on Ground I (anticipation) .............................. 3
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`1.
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`2.
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`3.
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`4.
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`5.
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`The Board Misapprehended the Petitioner’s
`Anticipation Rationale, Which Is Not Based on
`Inherency ..................................................................................... 3
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`The Board Misapprehended the Law of Anticipation ................ 5
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`The Board Misapprehended Dr. Berkland’s Testimony ............. 6
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`The Board Misapprehended Dr. Desai’s Statements ................ 10
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`The Board Misapplied Its Own Rule ........................................ 11
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`B.
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`Rehearing on Ground II Requested (obviousness) ............................. 13
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`1.
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`The Board Weighed Patent Owner’s Testimony More
`Favorably than Petitioner’s Testimony ..................................... 13
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`III. CONCLUSION .............................................................................................. 15
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`i
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`IPR2018-00163 (7,923,536 B2)
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`TABLE OF AUTHORITIES
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` Page(s)
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`Cases
`Actavis v. Abraxis BioScience LLC,
`No. IPR2017-01103, Paper No. 7 (P.T.A.B. Oct. 10, 2017) .............. 2, 11, 12, 14
`
`Amgen Inc. v. Hoechst Marion Roussel, Inc.,
`314 F.3d 1313 (Fed. Cir. 2003) ............................................................................ 9
`
`Arthrocare Care Corp. v. Smith & Nephew, Inc.,
`406 F.3d 1365 (Fed. Cir. 2005) ............................................................................ 3
`
`In re Antor Media Corp.,
`689 F.3d 1282, 1287–88 (Fed. Cir. 2012) ............................................................ 9
`
`
`In re Baxter Travenol Labs.,
`952 F.2d 388 (Fed. Cir. 1991) .............................................................................. 5
`
`In re Preda,
`401 F.2d 825 (C.C.P.A. 1968) .............................................................................. 5
`
`In re Sasse,
`629 F.2d 675 (C.C.P.A. 1980) .............................................................................. 9
`
`Juniper Networks, Inc. v. Mobile Telecomms. Techs., LLC,
`IPR2017-00640, Paper No. 16 (P.T.A.B. July 28, 2017) ............................. 12, 13
`
`nXn P’ners, LLC v. Nissan Chem. Indus., Ltd.,
`IPR2016-00694, Paper No. 7 (P.T.A.B. Aug. 31, 2016) ................................... 12
`
`Pungkuk EDM Wire Mfg. Co. v. Ki Chul Seong,
`IPR2016-00763, Paper No. 14 (P.T.A.B. Sept. 8, 2016) .................................... 12
`
`REG Synthetic Fuels, LLC v. Neste Oil Oyj,
`841 F.3d 954 (Fed. Cir. 2016) .............................................................................. 5
`
`Sony Corp. v. Fujifilm Corp.,
`IPR2017-00618, Paper No. 11 (P.T.A.B. Dec. 18, 2017) ................................ 4, 5
`
`ii
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`
`
`Statutes
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`IPR2018-00163 (7,923,536 B2)
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`35 U.S.C. § 102 .......................................................................................................... 5
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`35 U.S.C. § 314 .......................................................................................................... 2
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`Other Authorities
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`37 C.F.R. § 1.68 ....................................................................................................... 11
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`37 C.F.R. § 42.2 ....................................................................................................... 11
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`37 C.F.R. § 42.63 ..................................................................................................... 11
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`37 C.F.R. § 42.71 ....................................................................................................... 1
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`37 C.F.R. § 42.108 ......................................................................................... 2, 11, 12
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`Fed. R. Evid. 602 ..................................................................................................... 11
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`iii
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`I.
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`PRECISE RELIEF REQUESTED
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`IPR2018-00163 (7,923,536 B2)
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`Pursuant to 37 C.F.R. § 42.71(c)–(d), Petitioner Cipla Ltd. (“Cipla”)
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`respectfully requests rehearing of the Board’s decision (Paper No. 10, “Decision”)
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`denying institution of inter partes review of claims 1–16 (“challenged claims”) of
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`U.S. Patent No. 7,923,536 (“the ’536 patent”). Petitioner details the basis for this
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`Motion below, specifically identifying all matters Cipla believes “the Board
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`misapprehended or overlooked” and “the place where each matter was previously
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`addressed” in the Petition. 37 C.F.R. § 42.71(d). Petitioner requests that the Board
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`grant rehearing and institute a trial on all challenged claims.1
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`II. BASIS FOR RELIEF
`Cipla seeks rehearing on Grounds I (anticipation) and II (obviousness).
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`These grounds rely on the disclosure in Desai2, as understood by a person of
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`ordinary skill in the art (“POSA”), to meet each claim’s requirement that the
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`“weight ratio of albumin to paclitaxel in the composition is about 1:1 to about 9:1”
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`(“the disputed ratio limitation”).
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`Cipla respectfully requests that the Board grant rehearing and institute the
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`Petition because the Board misapprehended or overlooked that: (1) the Petition
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`1 Cipla does not seek rehearing on the Board’s decision Dismissing Petitioner’s
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`Motion for Joinder (Paper No. 3).
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`2 WO 99/00113 A1, published Jan. 7, 1999 (EX1006, “Desai”).
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`1
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`
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`argues anticipation based on what Desai discloses to a POSA, and not necessarily
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`IPR2018-00163 (7,923,536 B2)
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`inherency (§ II.A.1 below); (2) the law does not limit anticipation to ipsis verdis
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`disclosure and inherency (§ II.A.2 below); (3) Dr. Berkland’s testimony, which the
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`Decision cites as supporting Patent Owner’s position, actually refutes it (§ II.A.3
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`below); (4) Dr. Desai’s letter submitted during prosecution of an Indian Patent
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`Application is irrelevant and excludable (§ II.A.4 below); and (5) for both
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`anticipation and obviousness, the Board misapplied Rule 42.108(c) by crediting
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`Patent Owner’s declarants over Petitioner’s declarant (§§ II.A.5 and II.B.1 below).
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`For the purpose of deciding whether to institute an inter partes review, the
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`record is limited to the Petition and Preliminary Patent Owner Response (35 U.S.C.
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`§ 314(a)), and genuine issues of material fact due to conflicting testimony should
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`be viewed most favorably to Petitioner. 37 C.F.R. § 42.108(c). The Decision in
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`this case is unprecedented because the Board had already granted the nearly
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`identical Petition. Actavis LLC v. Abraxis BioScience LLC, IPR2017-01103, Paper
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`No. 7 (P.T.A.B. Oct. 10, 2017) (“Actavis Decision”). The difference here is that
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`Patent Owner had the opportunity to study the Actavis Decision, depose the
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`Declarant, Dr. Berkland, and add four new declarants to counter Cipla’s Petition,
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`all without Cipla having an opportunity to correct the record. Given the lopsided
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`nature of the evidentiary record, misapprehension is understandable.
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`2
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`IPR2018-00163 (7,923,536 B2)
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`A. Rehearing is Requested on Ground I (anticipation)
`Ground I posed the question of whether claims 1–16 are anticipated by
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`Example 1 in Desai. Pet. at 1, 7–8, 23–34.
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`1.
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`The Board Misapprehended the Petitioner’s Anticipation
`Rationale, Which Is Not Based on Inherency
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`Petitioner’s argument for express anticipation is based on two premises.
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`First, Example 1 of Desai indisputably teaches the mixing of paclitaxel (30 mg)
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`and albumin (270 mg)––literally a 9:1 ratio. Pet. at 27–28. Second, a POSA
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`would not expect any change in the final ratio after completing the process of
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`Example 1. Id. at 32 (citing EX1002 ¶ 106 (“a skilled artisan would not have
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`expected the method of Example 1 of Desai to result in any loss of paclitaxel. . .
`
`.”)). Therefore, a POSA reading Example 1 in light of his or her knowledge and
`
`experience would understand the final ratio to be 9:1. See Pet. at 27–28.
`
`A skilled artisan would have known that [Example 1] results in a
`composition with an albumin-paclitaxel weight ratio of 270:30––i.e., a
`ratio of exactly 9:1. EX1002 ¶ 100. That is an express disclosure of
`the claimed 9:1 ratio.
`
`Id.; see Arthrocare Care Corp. v. Smith & Nephew, Inc., 406 F.3d 1365, 1373–74
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`(Fed. Cir. 2005) (“[E]ven if a piece of prior art does not expressly [ipsis verbis]
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`disclose a limitation, it anticipates if a person of ordinary skill in the art would
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`understand the prior art to disclose the limitation and could combine the prior art
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`description with his own knowledge to make the claimed invention.”).
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`3
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`IPR2018-00163 (7,923,536 B2)
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`The Board misapprehended Petitioner’s argument as one of inherency. See
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`Dec. at 16 (“Example 4 does not necessarily demonstrate 97% recovery of the
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`complete Example 1 production process”); see also id. at 20 (“the disclosure does
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`not show that Example 1 necessarily produces the required final albumin to
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`paclitaxel ration [sic] of ‘about 1:1 to 9:1.’”).3
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`Petitioner did not contend that the final weight ratio of 9:1 inherently
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`follows from the starting ratio of 9:1 based on Example 1.4 Whether the process of
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`Example 1 inherently produces a final 9:1 weight ratio is irrelevant to Petitioner’s
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`anticipation argument: Regardless of inherency, a POSA reading Example 1 in
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`light of his or her knowledge and experience would understand the final ratio to be
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`9:1. See Pet. at 27–28. In similar situations when the Board misapprehended an
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`anticipation argument as one of inherency, the Board granted rehearing. See, e.g.,
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`Sony Corp. v. Fujifilm Corp., IPR2017-00618, Paper No. 11 (P.T.A.B. Dec. 18,
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`2017) (granting request for rehearing and instituting inter partes review).
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`3 Patent Owner mischaracterized Cipla’s argument as one of inherency. See, e.g.,
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`Paper No. 8 at 16–17 (“[i]n effect . . . an inherency argument”; “necessarily
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`present”). Patent Owner set up a strawman and then set out to rebut it.
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`4 Petitioner stated that the 9:1 starting ratio inherently follows (indeed,
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`mathematically follows) from mixing of 30 mg of paclitaxel with 27.0 mL of 1%
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`(w/v) human serum albumin solution. Pet. at 27–28.
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`4
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`IPR2018-00163 (7,923,536 B2)
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`The Board Misapprehended the Law of Anticipation
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`2.
`The Board’s Decision mentions that “[a] claim is unpatentable under 35
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`U.S.C. § 102 if a single prior art reference expressly or inherently describes each
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`and every limitation . . . .” Dec. at 8. The Board, however, misapprehended that
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`express anticipation does not require ipsis verbis disclosure in the prior art. “[T]he
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`dispositive question regarding anticipation [is] whether one skilled in the art would
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`reasonably understand or infer” that the prior art discloses the claim limitation. In
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`re Baxter Travenol Labs., 952 F.2d 388, 390 (Fed. Cir. 1991).
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`The Board misapprehended the law of express anticipation by treating
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`express anticipation as requiring ipsis verbis disclosure in the prior art. See Sony
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`Corp., IPR2017-0618, Paper No. 11 at 4–5; see also In re Preda, 401 F.2d 825,
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`826 (C.C.P.A. 1968) (“[I]n considering the disclosure of a reference, it is proper to
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`take into account not only specific teachings of the reference but also the
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`inferences which one skilled in the art would reasonably be expected to draw
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`therefrom.”); REG Synthetic Fuels, LLC v. Neste Oil Oyj, 841 F.3d 954, 960–61
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`(Fed. Cir. 2016) (finding claimed limitation met by anticipatory reference despite
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`absence of ipsis verbis disclosure, and noting “[t]his is not an inherency issue”).
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`As a result of this misapprehension, the Board overlooked Petitioner’s anticipation
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`5
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`argument: The Decision does not address whether a POSA would understand
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`IPR2018-00163 (7,923,536 B2)
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`Example 1 to disclose a 9:1 ratio based on the disclosure of Desai. 5
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`The Board Misapprehended Dr. Berkland’s Testimony
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`3.
`Berkland’s original opinion testimony was clear: Example 1 states the
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`starting ratio of albumin to paclitaxel is 9:1 (simple math), and a POSA would not
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`expect any change in the final ratio. EX1002 ¶¶ 98, 106. Therefore, a POSA
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`would have understood Example 1 to teach a 9:1 final weight ratio of albumin to
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`paclitaxel. EX1002 ¶¶ 98, 104–112. At his deposition, Berkland articulated
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`exactly the same opinion.
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`First, Berkland insisted that Example 1 mentions the starting ratio of
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`albumin to paclitaxel is 9:1:
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`Q. Okay. If you--if you look at paragraph 106 and 107 of
`your declaration, so in these paragraphs you discuss this
`example, and you use the starting ratio to calculate a
`starting--you calculate a starting ratio of 9:1, right?
`A. Yes.
`Q. So you’re just, again, you’re just looking at the amounts of
`the starting materials and you’re just doing the arithmetic
`to get a ratio, right?
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`5 Patent Owner incorrectly insisted that express anticipation requires explicit
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`measurements of the final ratios. Paper No. 8 at 15.
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`6
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`IPR2018-00163 (7,923,536 B2)
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`A. Yeah. That was based on what I saw in the ’229 patent for
`the ratio was calculated. And it’s unclear in that if they
`calculate starting material or if they calculate--there’s no
`data to show they calculated at the end, so I don’t know.
`In my declaration that is the starting ingredients ratio.
`Q. Right. So just so we’re on the same page, we’ve already
`talked about how in the ’229 you looked at some examples
`and you did math on the starting ingredients. I guess I’m
`asking you the same question here, for example, the Desai
`publication.
`A. That’s the only thing that’s disclosed is the starting
`ingredients.
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`EX2070 at 132:15–133:14. Second, Berkland insisted that you would not expect
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`any change in the final ratio:
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`Q. [Y]our POSA in 2002 could practice Example 1 of Desai
`as it’s written here without making mistakes and they
`could lose paclitaxel. When they analyze the final ratio
`they will see they have lost paclitaxel; is that correct?
`A. I don’t think so.
`Q. Why not?
`A. Well, I’m going to paraphrase what I said before, and that
`is, essentially, if you judiciously run these processes, you
`wouldn’t be expecting to lose paclitaxel, and, furthermore,
`a person of skill in the art would know from the prior art
`and their experience how to minimize if not avoid loss of
`paclitaxel.
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`7
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`IPR2018-00163 (7,923,536 B2)
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`* * * *
`Q. What I’m hearing you say is that your POSA in 2002 could
`practice Example 1 as written without making mistakes
`and they could still lose paclitaxel even though they would
`understand how to attempt to minimize that loss. Is that
`accurate?
`A. And my response was a POSA would know how to do this
`such that the loss of paclitaxel was minimized if not
`eliminated.
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`Id. at 141:11–25; 143:12–19. Third, Berkland insisted that the prior art teaches
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`the final ratio:
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`Q. [T]he prior art doesn’t tell you what the final ratio is either
`. . . . ?
`A. I think it does.
`Q. Well, we’ll talk about that.
`A. Okay.
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`Id. at 115:14–20. Berkland’s opinion never wavered: A POSA reading Desai
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`would have understood Example 1 to disclose a 9:1 final ratio. EX1002 ¶¶ 9, 104–
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`106.
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`
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`No one disputes that Example 1 describes the mixing of a 9:1 ratio of
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`albumin to paclitaxel. Patent Owner admits this, including Dr. Desai. EX2069 ¶ 5
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`(“the starting components was 9:1.”). Berkland’s opinion is simply that given that
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`starting ratio, a POSA would expect and understand the final ratio to be 9:1. The
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`8
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`law of conservation of mass dictates no loss, and Example 1 provides no
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`IPR2018-00163 (7,923,536 B2)
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`measurement data suggesting that the final ratio for the sample described in
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`Example 1 differed from the starting ratio. Prior art is presumed enabled, and the
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`Board misapprehended that Celgene owed the burden to show that achieving a 9:1
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`final ratio using Example 1 was not operable. See In re Antor Media Corp., 689
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`F.3d 1282, 1287–88 (Fed. Cir. 2012); In re Sasse, 629 F.2d 675, 679–80 (C.C.P.A.
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`1980); Amgen Inc. v. Hoechst Marion Roussel, Inc., 314 F.3d 1313, 1355 (Fed.
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`Cir. 2003).6
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`When Berkland answered counsel’s question, “And Example 1, it doesn’t
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`tell you what the final ratio is, right,” by saying, “That’s correct” (EX2070 at
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`133:15–17), Berkland was merely stating the fact that Example 1 provides no
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`measurement data confirming the final ratio of the sample described in Example 1.
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`This statement does not contradict Berkland’s opinion that a POSA reading Desai
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`would have understood Example 1 to disclose a 9:1 final weight ratio of albumin
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`to paclitaxel. Patent Owner’s counsel failed to ask the critical question, “Is it your
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`6 The Board also overlooked how a POSA would have understood Example 1 in
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`view of the recovery rates disclosed in Examples 4 and 5. Dec. at 12, 18. Example
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`4 of Desai shows 97% recovery of paclitaxel, and Example 5 acknowledges the
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`potential 100% recovery of paclitaxel. Dec. at 12, 18; see also EX1002 ¶ 106.
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`9
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`opinion that a POSA would not have understood Example 1 to disclose a final 9:1
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`IPR2018-00163 (7,923,536 B2)
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`weight ratio of albumin to paclitaxel?”
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`
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`Patent Owner mischaracterized Berkland’s testimony as an admission that
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`Example 1 does not teach a final 9:1 ratio. Dec. at 16. A review of his entire
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`transcript, however, shows there was no “gotcha” admission. Berkland stated the
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`trivial facts that Example 1 fails to provide measurement data on final ratio; but
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`also that a POSA would have understood Example 1 to disclose a 9:1 final weight
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`ratio. If Actavis had not settled with Celgene, that instituted inter partes review
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`proceeding would have continued and Berkland would have had the opportunity to
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`correct Patent Owner’s mischaracterization.
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`The Board Misapprehended Dr. Desai’s Statements
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`4.
`The Board misapprehended Dr. Desai’s statements in his April 9, 2014 non-
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`notarized letter originally submitted in an Indian proceeding involving Indian
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`Patent Application No. 2899/DELNP/2005 (“Desai Letter”). Dec. at 17–18. In
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`particular, the Board misapprehended the following statement by Desai: “the
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`estimated albumin/paclitaxel ratio in the resulting nanoparticle albumin-bound
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`paclitaxel composition [for Example 1] was about 13.3:1.” Id. (emphasis added)
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`(citing EX2069 ¶ 5). This statement does not address the critical question for
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`Petitioner’s anticipation argument: Would a POSA have understood the disputed
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`ratio limitation to be disclosed by Example 1 when read in the light of a POSA’s
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`10
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`knowledge and experience? Desai is not giving an opinion as to what a POSA
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`IPR2018-00163 (7,923,536 B2)
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`would understand, and therefore, his statement is immaterial.
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`Desai is not even speaking from personal knowledge. Fed. R. Evid. 602.
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`Desai did not state that he has personal knowledge of the final ratio in Example 1
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`or that he measured the final amounts. 7 Desai’s unsubstantiated and self-serving
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`guestimate as to the final ratio without personal knowledge is excludable.
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`Furthermore, the Desai Letter is neither a witnessed affidavit nor sworn
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`declaration. 37 C.F.R. §§ 1.68, 42.2, 42.63. The letter is technically excludable
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`because it does not indicate that he was “warned that willful false statements and
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`the like are punishable by fine or imprisonment. . . .” 37 C.F.R. § 1.68.
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`The Board Misapplied Its Own Rule
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`5.
`When the Board’s rules were amended in 2016 to allow new testimonial
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`evidence with a Preliminary Patent Owner Response, an important restriction was
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`imposed requiring that any “genuine issue of material fact created by such
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`testimonial evidence will be viewed in the light most favorable to the petitioner
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`solely for purposes of deciding whether to institute an inter partes review.” 37
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`7 Desai does not provide any corroborating evidence supporting his estimate that
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`Example 1 produced a 13.1:1 ratio. In the Actavis Decision, the Board invited
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`Celgene to produce actual evidence that the process of Example 1 produces a ratio
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`other than 9:1, and instead, Celgene produced the Desai letter.
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`11
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`C.F.R. § 42.108(c); Juniper Networks, Inc. v. Mobile Telecomms. Techs., LLC,
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`IPR2018-00163 (7,923,536 B2)
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`IPR2017-00640, Paper No. 16 at 21–22 (P.T.A.B. July 28, 2017) (“[C]onflicting
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`testimony creates a genuine issue of material fact. We view these issues in the
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`light most favorable to Petitioner at this stage of the proceeding.”); nXn P’ners,
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`LLC v. Nissan Chem. Indus., Ltd., IPR2016-00694, Paper No. 7 at 18 (P.T.A.B.
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`Aug. 31, 2016) (same); Pungkuk EDM Wire Mfg. Co. v. Ki Chul Seong, IPR2016-
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`00763, Paper No. 14 at 15 (P.T.A.B. Sept. 8, 2016) (same).
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`The Board overlooked Rule 42.108(c) in this case. In particular, the Board
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`viewed Dr. Desai’s unsworn statements more favorably than Dr. Berkland’s
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`testimony. Dec. at 16, 19 (“we credit Dr. Desai’s testimony”; “Berkland’s opinion
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`on Desai’s disclosure is not reliable.”). This is also evident from the fact that the
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`non-testimonial record for Cipla’s Petition is virtually identical to the record in
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`Actavis’s Petition, where the Board found that “Desai teaches a cancer treatment
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`using a final pharmaceutical composition with a ratio of albumin to paclitaxel that
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`is ‘about 9:1’. . . .” Actavis Dec. at 17. The only new evidence relied upon by the
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`Board in its Decision on Ground I against Cipla was Patent Owner’s submission of
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`the Desai Letter and Dr. Berkland’s deposition testimony. In reaching the exact
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`opposite conclusion for Cipla’s Petition, the Board viewed testimonial evidence in
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`light most favorable to the Patent Owner––the opposite of Rule 42.108(c).
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`12
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`IPR2018-00163 (7,923,536 B2)
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`B. Rehearing on Ground II Requested (obviousness)
`Ground II posed two questions: (II.A) whether Desai alone renders disputed
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`ratio limitation obvious; and (II.B) whether the combined teachings of Desai,
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`Kadima, and Liversidge motivate a POSA to decrease the 13:1 ratio of Capxol to
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`9:1. Pet. at 2–3, 7–8, 34–62.
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`1.
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`The Board Weighed Patent Owner’s Testimony More
`Favorably than Petitioner’s Testimony
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`The Board again overlooked Rule 42.108(c) when it credited Patent Owner’s
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`declarants over Petitioner’s declarant. See, e.g., Dec. at 28 (“we credit the
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`statement of Dr. Oupicky”); 28 (“We credit Dr. Oupicky’s statement”); 34 (“we
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`credit Dr. Oupicky’s statement”); 34 (“we credit Dr. Vellturo’s . . . statement”); 37
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`(“we credit Dr. Oupicky’s statement”). The Board should view these issues based
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`on conflicting testimony “in the light most favorable to Petitioner at this stage of
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`the proceeding.” Juniper Networks, IPR2017-00640 at 21–22.
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`This error is also evident because the Board has now come to antithetical
`
`conclusions on the same petitions for inter partes review, first granting Actavis’s
`
`Petition and now denying Cipla’s nearly identical Petition. The only new portion
`
`of the record was Patent Owner’s addition of new testimonial evidence, including
`
`Oupicky, Vellturo, Desai, and Tkaczuk––in addition to its original expert, Peppas.
`
`It should not matter if Patent Owner hired twenty declarants.
`
`13
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`
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`IPR2018-00163 (7,923,536 B2)
`
`For example, and with respect Ground II.A, the Board weighed Berkland’s
`
`testimony in the Actavis case (identical to this case) against Peppas’s testimony
`
`and concluded that “applying Desai’s disclosed lower preferred dose of 0.5 % to
`
`Example 1 of Desai would result in a starting albumin-paclitaxel ratio of 4.5:1,
`
`clearly overlapping the claimed range” (Actavis Dec. at 27–28), and Desai
`
`motivates reducing albumin to create “high concentrations of paclitaxel in order to
`
`reduce infusion volumes” and “minimize patient discomfort” (id. at 28–29). This
`
`time, however, the Board credited the testimony of Oupicky (Dec. at 28–31); the
`
`Board was no longer “sufficiently persuaded” by Dr. Berkland’s testimony (id. at
`
`29); and the Board concluded that the “record does not support Petitioner’s
`
`position that Desai discloses overlapping albumin to paclitaxel weight ratio
`
`ranges” (id. at 30–31).
`
`With respect Ground II.B, the Board previously weighed Berkland’s
`
`testimony in the Actavis case (identical to this case) against Peppas and found
`
`Kadima provides “additional reasons” to reduce albumin because it teaches a
`
`“reduced cost of a paclitaxel dose by reducing the amount of human serum
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`albumin,” and found that Liversidge teaches “overlapping ranges and particles
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`sizes” of taxol and serum albumin. Actavis Dec. at 31. This time, however, the
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`Board credited the testimony of Oupicky (Dec. at 34–37) and Vellturo (id. at 34).
`
`Although acknowledging Berkland’s contrary testimony (id. at 34–36), the Board
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`14
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`found “insufficient evidence” to decrease Desai’s albumin-paclitaxel ratio based on
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`IPR2018-00163 (7,923,536 B2)
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`Kadima or Liversidge (id. at 34, 36). The Board did not view issues of material
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`fact most favorably to Cipla.
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`III. CONCLUSION
`For the reasons above, Cipla respectfully requests that the Board grant this
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`request for rehearing, vacate the Decision, and institute inter partes review on
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`Grounds I and II. Cipla also requests oral argument to the extent the Board would
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`find it helpful in deciding this rehearing request.
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`
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`Dated: June 6, 2018
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`
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`
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`Respectfully submitted,
`
`/Michael J. Freno/
`Michael J. Freno (Reg. No. 57,163)
`K&L GATES LLP
`925 Fourth Avenue, Suite 2900
`Seattle, WA 98104
`T: 206.370.7947
`F: 206.623.7022
`michael.freno@klgates.com
`
`Lead Counsel for Petitioner
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`15
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`IPR2018-00163 (7,923,536 B2)
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`CERTIFICATE OF COMPLIANCE WITH PAGE LIMITATION
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`Pursuant to 37 C.F.R. § 42.24, I certify that the foregoing PETITIONER’S
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`REQUEST FOR REHEARING is 15 pages or less.
`
`Respectfully submitted,
`
`/Michael J. Freno/
`Michael J. Freno (Reg. No. 57,163)
`K&L GATES LLP
`925 Fourth Avenue, Suite 2900
`Seattle, WA 98104
`T: 206.370.7947
`F: 206.623.7022
`michael.freno@klgates.com
`
`Lead Counsel for Petitioner
`
`
`
`
`
`
`Dated: June 6, 2018
`
`
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`IPR2018-00163 (7,923,536 B2)
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`CERTIFICATE OF SERVICE
`
`Pursuant to 37 C.F.R. § 42.6(e)(4), I certify that, on June 6, 2018, true and
`
`correct copies of the foregoing PETITIONER’S REQUEST FOR REHEARING,
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`were caused to be served electronically on the following counsel of record for
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`Patent Owner at the following email addresses:
`
`Christopher J. Harnett
`charnett@jonesday.com
`Lisamarie LoGiudice, Ph.D.
`llogiudice@jonesday.com
`JONES DAY
`250 Vesey Street
`New York, NY 10281
`
`Anthony M. Insogna
`aminsogna@jonesday.com
`Cary Miller, Ph.D.
`cmiller@jonesday.com
`JONES DAY
`4655 Executive Drive, Suite 1500
`San Diego, CA 92121
`
`F. Dominic Cerrito
`nickcerrito@quinnemanuel.com
`Andrew S. Chalson
`andrewchalson@quinnemanuel.com
`Frank C. Calvosa
`frankcalvosa@quinnemanuel.com
`Daniel C. Wiesner
`danielwiesner@quinnemanuel.com
`QUINN EMANUEL URQUHART & SULLIVAN, LLP
`51 Madison Avenue, 22nd Floor
`New York, NY 10010
`
`
`
`
`
`
`J. Patrick Elsevier, Ph.D.
`pelsevier@celgene.com
`CELGENE CORPORATION
`86 Morris Ave
`Summit, NJ 07901
`
`
`IPR2018-00163 (7,923,536 B2)
`
`
`
`/Michael J. Freno/
`Michael J. Freno (Reg. No. 57,163)
`K&L GATES LLP
`925 Fourth Avenue, Suite 2900
`Seattle, WA 98104
`T: 206.370.7947
`F: 206.623.7022
`michael.freno@klgates.com
`
`Lead Counsel for Petitioner
`
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