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`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 IPR2023-00478
`Patent 10,272,083 B2
`_____________________
`
`PETITIONER’S AUTHORIZED REPLY TO
`PATENT OWNER’S PRELIMINARY RESPONSE
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`I.
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`IPR2023-00478 (10,272,083 B2)
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`Patent Owner’s request to deny review under § 325(d) is unwarranted.
`Under both parts of the Advanced Bionics test (Pet. 67–68; Prelim. Resp.
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`19), there is no basis to deny institution of the Petition under 35 U.S.C. § 325(d).
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`A. The same prior art and arguments were not previously presented.
`Patent Owner’s assertion that the same or substantially the same art and
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`arguments were presented under Advanced Bionics Part 1 is incorrect. Prelim.
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`Resp. 19–28. Two out of three references were not before the Examiner, and the
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`arguments the Examiner considered are materially different than Petitioner’s.
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`First, it is undisputed that Petitioner’s primary reference, Barf (EX1005),
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`was not before the Examiner. Patent Owner argues only that Barf is “substantially”
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`the same as Barf-PCT (EX1006) (Prelim. Resp. 20), yet it admits that only Barf
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`specifically claims “a method of treating MCL with the compound now known as
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`acalabrutinib” using a dosing range that overlaps with the ’083 patent’s claimed
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`regimen (Prelim. Resp. 11; EX1005, cls. 1, 12). These claims, which are presumed
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`enabled (Pet. 31), are not in Barf-PCT and thus were not before the Examiner.1
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`1 Patent Owner also argues that “Barf is not prior art” (Prelim. Resp. 20) but later
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`clarifies that Barf merely “would not qualify as prior art” if the ’083 patent were
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`“correct[ed]” to identify parties to an alleged joint research agreement (id. at 45
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`(emphasis added)). No such certificate of correction has been issued or even
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`-1-
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`IPR2023-00478 (10,272,083 B2)
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`Second, it is undisputed that Petitioner’s combination reference, Cheson
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`(EX1008), also was not before the Examiner. Patent Owner argues only that
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`Cheson is “cumulative” of references cited by the Examiner as teaching dosage
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`forms that potentially “can be administered twice daily” or “as much as 2 to 4
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`times a day.” Prelim. Resp. 23 (emphasis added). These generic statements that
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`dosage forms “can” be administered multiple times a day are not cumulative of
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`Cheson’s specific motivations that “BTK inhibitors are being evaluated in a twice-
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`daily schedule in an attempt to overcome the synthesis of new BTK molecules,”
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`which “appeared to be more effective, perhaps with more rapid responses,” than
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`once-daily dosing. EX1008, 4, 10 (emphasis added); Pet. 40–41.
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`Third, while Barf-PCT in Ground 2 was disclosed, the Examiner cited it
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`only as a secondary reference in combination with two other references—Smyth
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`and Evarts—that Petitioner does not rely on. As Patent Owner admits, the
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`Examiner applied Smyth as a primary reference teaching a different dosing
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`regimen for ibrutinib and only cited Barf-PCT to substitute acalabrutinib’s
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`structure. Prelim. Resp. 13–14; EX1004, 908–09. The Examiner later added
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`requested. Regardless, any hypothetical correction after the Petition was filed
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`would not apply retroactively to this proceeding. See, e.g., Emerson Elec. Co. v.
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`SIPCO, LLC, IPR2016-00984, Paper 52 at 17–25 (PTAB Jan. 24, 2020).
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`-2-
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`IPR2023-00478 (10,272,083 B2)
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`Evarts as teaching yet another dosing regimen. Prelim. Resp. 16; EX1004, 1034–
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`35. While Patent Owner included Barf-PCT’s dosing range in a block quote
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`(Prelim. Resp. 15; EX1004, 1000), the Examiner never cited or relied on it.
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`Moreover, while the Examiner generically found a skilled artisan could “optimize
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`the treatment of leukemia” (Prelim. Resp. 26; EX1004, 1035), the Examiner did
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`not consider the Petition’s arguments that a skilled artisan would have arrived at
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`the claimed dosing regimen using clinical data, FDA guidance, and routine animal
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`studies (Pet. 29–44). Thus, substantially the same arguments were not presented.
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`B.
`The Examiner materially erred in allowing the claims.
`Even if the same art and arguments were considered, discretionary denial
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`would still be unwarranted under Advanced Bionics Part 2 because the Examiner
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`materially erred in allowing the claims. As Patent Owner admits, the claims were
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`allowed based on alleged unexpected results. Prelim. Resp. 32–33; EX1004, 1382.
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`The Petition and Petitioner’s declarant, Dr. Fruehauf, show extensively how these
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`results were neither probative nor unexpected. Pet. 55–63; EX1002 ¶¶ 227–44.
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`In defending the notice of allowance, Patent Owner merely rehashes its
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`argument from prosecution that it was unexpected the claimed 100 mg twice-daily
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`dose of acalabrutinib (totaling 200 mg per day) would achieve maximal BTK
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`occupancy because ibrutinib was approved at a higher once-daily dose of 560 mg.
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`Prelim. Resp. 40. Patent Owner ignores the Petition’s detailed showing that this
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`-3-
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`IPR2023-00478 (10,272,083 B2)
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`result was expected because both the Advani study and FDA’s own clinical
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`pharmacology reviews showed that a far lower dose of ibrutinib—2.5 mg/kg,
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`equivalent to 175 mg for an average weight of 70 kg—“resulted in maximum BTK
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`occupancy and maximum clinical response,” suggesting that “doses lower than the
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`[FDA-approved] doses are expected to have sustained occupancy of the BTK
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`active site in vivo.” EX1017, 5, 20; Pet. 57–59; see also EX1009, 12.
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`Neither FDA’s pharmacology reviews nor Advani were considered by the
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`Examiner, who also lacked the benefit of Dr. Fruehauf’s declaration applying these
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`references to show that the alleged results were expected. EX1002 ¶¶ 232–35.
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`Even where a petition relies on the same prior art cited during prosecution, panels
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`have repeatedly instituted review where, as here, the petition addresses alleged
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`unexpected results that were the basis for allowance. See Red Diamond, Inc. v.
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`Southern Visions, LLP, PGR2019-00045, Paper 9 at 20 (PTAB Oct. 15, 2019)
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`(“Petitioner’s arguments that the Examiner erred in allowing the claims based on
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`alleged unexpected results persuade us that we should not exercise our discretion
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`to deny the Petition under § 325(d).”); Prollenium US Inc. v. Allergan Industrie,
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`SAS, IPR2020-00084, Paper 12 at 45 (PTAB April 10, 2020) (“[H]ad [Petitioner’s]
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`evidence been before the Examiner, there is a reasonable likelihood that the
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`Examiner would have sustained the prima facie conclusion of obviousness under
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`Section 103, discounting what was then interpreted as evidence of unexpected
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`-4-
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`IPR2023-00478 (10,272,083 B2)
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`results.”); Abbott Vascular, Inc. v. FlexStent, LLC, IPR2019-00882, Paper 11 at 27
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`(PTAB Oct. 7, 2019) (“[T]he additional facts and evidence presented in the Petition
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`warrant reconsideration of the Examiner’s findings regarding unexpected
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`results.”); Incyte Corp. v. Concert Pharms., Inc., IPR2017-01256, Paper 14 at 11
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`(PTAB April 9, 2018) (“We find Petitioner’s effort to address the applicants’
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`unexpected results evidence in the Petition outweighs the fact that [the same art]
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`was considered and relied upon by the Examiner during prosecution.”).
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`II.
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`Patent Owner’s request to deny review under § 314(a) is unwarranted.
`Patent Owner has no basis to request discretionary denial under 35 U.S.C.
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`§ 314(a). The Director’s Interim Procedure could not be clearer: “Consistent with
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`Sotera Wireless, Inc., the PTAB will not discretionarily deny institution in view of
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`parallel district court litigation where a petitioner presents a stipulation not to
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`pursue in a parallel proceeding the same grounds or any grounds that could have
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`reasonably been raised before the PTAB.” Interim Procedure 3 (USPTO Dir. June
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`21, 2022). Patent Owner cites Nokia of America Corp. v. Godo Kaisha IP Bridge 1
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`(Prelim. Resp. 61), but that decision is inapposite because there the petitioner’s
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`stipulation was limited to the prior art combination in the petition and thus was
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`“narrower than the stipulation in Sotera.” IPR2022-00755, Paper 9 at 13 (PTAB
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`Nov. 2, 2022). By contrast, here, Petitioner has agreed to a Sotera stipulation. Pet.
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`67. Thus, the Board should reject Patent Owner’s arguments and grant institution.
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`-5-
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`
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`Dated: May 26, 2023
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`WINSTON & STRAWN LLP
`1901 L Street NW
`Washington, DC 20036
`Telephone: 202-282-5000
`Fax: 202-282-5100
`Email: acalabrutinibIPR@winston.com
`
`IPR2023-00478 (10,272,083 B2)
`
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`Respectfully submitted,
`
` /Jovial Wong/
`Jovial Wong
`Reg. No. 60,115
`
`Lead Counsel for Petitioner
`
`Charles B. Klein
`(admitted pro hac vice)
`Eimeric Reig-Plessis
`(admitted pro hac vice)
`
`Back-Up Counsel for Petitioner
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`-6-
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`
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`IPR2023-00478 (10,272,083 B2)
`
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`CERTIFICATE OF SERVICE
`Pursuant to 37 C.F.R. §§ 42.6(e) and 42.105(a), I certify that, on May 26,
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`2023, I caused to be served true and correct copies of “PETITIONER’S
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`AUTHORIZED REPLY TO PATENT OWNER’S PRELIMINARY RESPONSE,”
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`by electronic mail on counsel of record for Patent Owner as follows:
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`Stanley E. Fisher (Reg. No. 55,820)
`David I. Berl (Reg. No. 72,751)
`Williams & Connolly LLP
`680 Maine Avenue SW
`Washington, DC 20024
`sfisher@wc.com
`dberl@wc.com
`Calquence-AZ@wc.com
`
`
`
`Dated: May 26, 2023
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`WINSTON & STRAWN LLP
`1901 L Street NW
`Washington, DC 20036
`Telephone: 202-282-5000
`Fax: 202-282-5100
`Email: acalabrutinibIPR@winston.com
`
`
`Respectfully submitted,
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`
` /Jovial Wong/
`Jovial Wong
`Reg. No. 60,115
`
`Lead Counsel for Petitioner
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`-7-
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