UNITED STATES PATENT AND TRADEMARK OFFICE
`______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`______________
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`
`SANDOZ INC.,
`Petitioner,
`
`v.
`
`ACERTA PHARMA B.V.,
`Patent Owner.
`_________________________________________________
`
`
`Case IPR 2023-00478
`Patent No. 10,272,083
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`_________________________________________________
`
`PATENT OWNER’S AUTHORIZED SUR-REPLY
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`______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`______________
`
`
`SANDOZ INC.,
`Petitioner,
`
`v.
`
`ACERTA PHARMA B.V.,
`Patent Owner.
`_________________________________________________
`
`
`Case IPR 2023-00478
`Patent No. 10,272,083
`
`_________________________________________________
`
`PATENT OWNER’S AUTHORIZED SUR-REPLY
`
`
`
`
`
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`Case No. IPR2023-00478
`U.S. Patent No. 10,272,083
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`I.
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`Section 325(d) – The Same or Substantially the Same Art and
`Arguments Were Previously Presented to the Patent Office.
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`There is no merit to the three arguments Sandoz raises in its Reply.
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`First, Sandoz contends that Barf is not the “same” as Barf-PCT. Reply, 1.
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`But the relevant legal standard is whether Barf and Barf-PCT are “substantially the
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`same.” The specifications of Barf and Barf-PCT are identical, providing what
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`Sandoz admits are the “same disclosures” as Barf’s claims, Pet., 2, including
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`acalabrutinib, treatment of MCL, and the dosing range. The Examiner considered
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`those disclosures in Barf-PCT. POPR, 20-21. Sandoz’s Reply does not address the
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`numerous cases where the Board has found references with a common specification
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`but different claims to be substantially the same. Id., 21-22 (citing cases).
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`Second, Sandoz argues that Cheson is not cumulative because Smyth and
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`Evarts’ statements were “generic” rather than providing “specific motivations.”
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`Reply, 2. To the contrary, the Examiner considered the motivation provided by
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`Smyth and Evarts to dose more than once daily. The Examiner initially found, for
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`example, that it would be obvious to “follow” the teachings in Smyth and Evarts
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`related to twice-daily dosing of compounds like ibrutinib to treat lymphomas.
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`POPR, 23, 34; EX1004, 1035. Cheson thus discloses “the same proposition as
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`previously presented prior art.” Panduit Corp. v. Corning Optical Communications
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`LLC, IPR2021-01562, Paper 20 at 15-16 (P.T.A.B. April 6, 2022); POPR, 23.
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`1
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`Case No. IPR2023-00478
`U.S. Patent No. 10,272,083
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`Third, Sandoz asserts the Examiner cited Barf-PCT “only as a secondary
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`reference,” and while “Patent Owner included Barf-PCT’s dosing range in a block
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`quote . . . the Examiner never cited or relied on it.” Reply, 2-3. Those points are
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`irrelevant. Art “previously presented to the Office” under § 325(d) includes “art
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`made of record by the Examiner, and art provided to the Office by the applicant.”
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`Advanced Bionics, LLC v. MED-EL Elektromedizinische Gerӓte GmbH, IPR2019-
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`01469, Paper 6 at 7-8 (P.T.A.B. Feb. 13, 2020) (precedential); Keysight
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`Technologies, Inc. v. Centripetal Networks, Inc., IPR2022-01421, Paper 9 at 9-10
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`(P.T.A.B. March 22, 2023) (rejecting argument that § 325(d) requires Examiner to
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`discuss particular reference). The fact that Applicant quoted the relevant disclosure
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`to the Examiner ensured that he considered it.
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`Sandoz also contends the Examiner “did not consider the Petition’s arguments
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`that a skilled artisan would have arrived at the claimed dosing regimen using clinical
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`data, FDA guidance, and routine animal studies.” Reply, 3. Not so. The Examiner
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`considered arguments of routine dose finding and optimization when he initially
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`concluded it would be obvious to “optimize the treatment of leukemia.” POPR, 26.
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`II.
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`Section 325(d) – The Examiner Did Not Materially Err.
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`The Examiner reasonably concluded the art as a whole—rather than
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`cherrypicked soundbites from select references—pointed the POSA away from the
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`claimed 100 mg, twice-daily dose. The prevailing wisdom at the priority date
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`U.S. Patent No. 10,272,083
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`required a “a large, once daily dosing” of a BTK inhibitor for an effective treatment
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`of blood cancers. POPR, 40-42. The art focused on ibrutinib’s FDA-approved 560
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`mg dose, and higher clinical doses for CC-292. Id., 51-52. In light of that art, the
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`Examiner found it unexpected that the Byrd 2016 study and Example 2 of the ’083
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`patent would demonstrate superior, sustained levels of BTK inhibition, and an
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`improved safety profile, using a 100 mg, twice-daily dose of acalabrutinib. Id., 15,
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`40-42. Byrd is a preeminent researcher in the field and Sandoz’s references
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`extensively cite his clinical work. E.g., EX1008, 4, 10; EX1019, 5; EX1029, 9.
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`Given Byrd’s direct involvement in ibrutinib clinical trials and data analysis, Byrd
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`2016’s conclusions about the unexpected benefits of acalabrutinib’s dosing regimen
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`over ibrutinib’s are highly probative. The Examiner did not err in crediting Patent
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`Owner’s evidence of unexpected properties grounded in the Byrd study.
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`Nor did Patent Owner “ignore” Advani and the FDA review, which Sandoz
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`argues provide the expectation the Examiner found to be missing. Reply, 3-4; Pet.
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`31-33. Patent Owner addressed these arguments and the data at the heart of those
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`references. POPR, 51. Patent Owner cited Advani in the provisional application to
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`which the ’083 patent claims priority, EX1004, 527, 573, and in the patent, EX1001,
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`56:19-26, 72:3-12. The Examiner further considered Advani’s data when reviewing
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`an IDS reference, WO 2013/059738, that had the same data. EX1004, 1048
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`3
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`U.S. Patent No. 10,272,083
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`(reference), 1052 (signature/initials). The data in the FDA review that Sandoz and
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`its expert cite is the same Advani data. Pet., 19-20, Reply, 4.1
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`The Board has repeatedly exercised its § 325(d) discretion to deny institution
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`where, as here, the Examiner’s treatment of unexpected properties was reasonable.
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`Apotex Inc. et al. v. Auspex Pharmaceuticals, Inc., IPR2021-01507, Paper 9 at 33-
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`36 (P.T.A.B. Mar. 9, 2022); Biocon Pharma Limited v. Novartis Pharmaceuticals
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`Corp., IPR2020-01263, Paper 12 at 15-18 (P.T.A.B. Feb. 16, 2021); Initiative for
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`Medicines, Access & Knowledge, Inc. v. Gilead Pharmasset LLC, IPR2018-00125,
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`Paper 9 at 17-18 (P.T.A.B. May 24, 2018); Risen Pharma Tech. Co. Ltd. v. Alzheon,
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`Inc., IPR2022-01200, Paper 14 at 31-35 (P.T.A.B. Jan. 9, 2023).
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`III. A Certificate of Correction Would Remove Barf as Prior Art.
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`Sandoz argues a certificate of correction “would not apply retroactively to this
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`proceeding.” Reply, n.1. Acerta has filed an authorized motion for leave to seek the
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`certificate. Paper 11. The Director has issued certificates regarding joint research
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`agreements promptly, making it likely that, if filed, a certificate will be of record
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`early in the proceeding. Commonwealth Sci. Indus. Research Org. v. Basf Plant,
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`PGR2020-00033, Paper 33 (P.T.A.B. May 20, 2021). Where a certificate affects the
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`1 The Examiner not having the expert declaration is irrelevant; opponent declarations
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`are rare in prosecution. The data cited in the declaration was before the Examiner.
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`4
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`U.S. Patent No. 10,272,083
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`prior art status of a reference, the Board has assumed it would be granted until “a
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`contrary decision on the requested Certificate … by the Director.” Intuitive Surgical,
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`Inc., v. Ethicon LLC, IPR2020-00050, Paper 13 at 6 (P.T.A.B. Feb. 26, 2020).
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`Sandoz’s only authority is inapposite. In Emerson Electric, the Board
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`declined to exercise discretion to apply a certificate retroactively because the
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`certificate issued five months after the Board issued a FWD. See Emerson Elec. Co.
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`v. SIPCO, LLC, IPR2016-00984, Paper 52 at 25-26 (P.T.A.B. Jan. 24, 2020).
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`Emerson Electric does not govern where the proceeding is “ongoing,” as opposed to
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`where “the final decision had been entered.” Intuitive Surgical, IPR2020-00050,
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`Paper 51, Ex. 2101 at 30. A newly issued certificate would apply in ongoing
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`proceedings.
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` See, e.g., id. Paper 13 at 6; Dukane Corp. v. Hermann
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`Ultraschalltechnik, IPR2016-00066, Paper 15 at 6 n.4 (P.T.A.B. Apr. 26, 2017).
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`IV. The Board Should Exercise Its Discretion Pursuant to § 314(a).
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`Sandoz’s proposed “Sotera” stipulation lacks practical effect.
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` This
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`proceeding, if instituted, will not review “grounds that the parallel district court
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`litigation will not resolve,” Interim Procedure (USPTO Dir. June 21, 2022) at 7-8,
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`nor will this proceeding be a “true alternative to the district court proceeding.” Sotera
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`Wireless, v. Masimo Corp., IPR2020-01019, Paper 12 at 19 (P.T.A.B. Dec. 1, 2020).
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`The district court could decide the same issues because the co-defendants are not
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`bound by this proceeding. POPR, 61.
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`5
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`Date: June 2, 2023
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`Case No. IPR2023-00478
`U.S. Patent No. 10,272,083
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`Respectfully submitted,
`
`/Stanley E. Fisher/
`Stanley E. Fisher (Reg. No. 55,820)
`David I. Berl (Reg. No. 72,751)
`WILLIAMS & CONNOLLY LLP
`680 Maine Avenue SW,
`Washington, D.C., 20024
`T: (202) 434-5000
`F: (202) 434-5029
`sfisher@wc.com
`dberl@wc.com
`
`
`Counsel for Patent Owner
`Acerta Pharma B.V.
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`6
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`Case No. IPR2023-00478
`U.S. Patent No. 10,272,083
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`CERTIFICATION UNDER 37 C.F.R. § 42.6(e)
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`Pursuant to 37 C.F.R. § 42.6(e), the undersigned hereby certifies that a true
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`and correct copy of the foregoing was served on June 2, 2023, by delivering a copy
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`via electronic mail on the following attorneys of record:
`
`Jovial Wong (Reg. No. 60,115)
`Charles B. Klein
`Sharon Lin
`WINSTON & STRAWN LLP
`1901 L Street NW
`Washington, DC 20036
`Telephone: (202) 282-5867
`Facsimile: (202) 282-5100
`jwong@winston.com
`cklein@winston.com
`slin@winston.com
`
`Eimeric Reig-Plessis
`WINSTON & STRAWN LLP
`101 California Street
`San Francisco, CA 94111
`Telephone: (415) 591-1000
`Facsimile: (415) 591-1400
`ereigplessis@winston.com
`
`
`/Stanley E. Fisher/
`Stanley E. Fisher
`Reg. No. 55,820
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`
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