Case IPR2020-01263
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`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`____________________
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________________
`Biocon Pharma Limited
`Petitioner,
`v.
`Novartis Pharmaceutical Corporation
`Patent Owner.
`U.S. Patent No. 8,101,659 to Ksander et al.
`Issue Date: January 24, 2012
`Title: Methods of Treatment and Pharmaceutical Composition
`____________________
`Inter Partes Review No.: IPR2020-01263
`____________________
`
`Petitioner’s Authorized Reply to Patent Owner’s Preliminary Response
`
`
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`____________________
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________________
`Biocon Pharma Limited
`Petitioner,
`v.
`Novartis Pharmaceutical Corporation
`Patent Owner.
`U.S. Patent No. 8,101,659 to Ksander et al.
`Issue Date: January 24, 2012
`Title: Methods of Treatment and Pharmaceutical Composition
`____________________
`Inter Partes Review No.: IPR2020-01263
`____________________
`
`Petitioner’s Authorized Reply to Patent Owner’s Preliminary Response
`
`
`
`TABLE OF AUTHORITIES
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`Case IPR2020-01263
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` Page(s)
`
`Cases
`Actavis LLC v. Abraxis Bioscience, LLC,
`IPR2017-01103, Paper 7 (October 10, 2017) ....................................................... 3
`Advanced Bionics,
`IPR2019-01469 ..................................................................................................... 3
`Apple Inc. v. Corephotonics Ltd., IPR2020-00861, Paper 7 at
`41(PTAB, Dec. 9, 2020) ...................................................................................... 1
`In re Huai-Hung Kao,
`639 F.3d 1057 (Fed. Cir. 2011) ............................................................................ 2
`Other Authorities
`37 C.F.R. § 42.6(e) ..................................................................................................... 5
`35 U.S.C. § 325(d) ................................................................................................. 1, 3
`
`i
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`Case IPR2020-01263
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`§325(d) requires an examination of whether “the same or substantially the
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`same prior art or arguments previously were presented to the Office.” To begin
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`with, Novartis does not dispute that many of the references (e.g., Gomez-
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`Monterrey, PDR, Shetty, and Ksander) relied upon by Biocon in its Petition were
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`not before the Examiner. Petition, 64; Apple Inc. v. Corephotonics Ltd., IPR2020-
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`00861, Paper 7 at 41(PTAB, Dec. 9, 2020). Instead, in the conclusory manner,
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`Novartis states that based on the other art that was before the Examiner, Biocon’s
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`“arguments are substantially the same.” POPR, 22-23. Rather than providing any
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`meaningful analysis, Novartis’ proof is the single, terse footnote 19. POPR, n.19.
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`The specific, detailed teachings from EP ’072, Shetty, Gomez-Monterrey,
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`Ksander, PDR and EP ’072 are laid out in Biocon’s petition. Simply because
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`“[t]he Examiner cited the ’996 Patent (Ex. 1009) and the ’578 Patent (Ex. 1008)
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`for all claim limitations” (POPR, n.19) does not mean that the specific arguments
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`with the combinations advanced in the Petition were before the Examiner.
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`Biocon’s Petition did not rest with a simple showing that the claims limitations
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`were present (POPR, n.19) but included specific arguments and rationales based on
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`the combination of the specific references used Grounds 1 & 2. Apple, IPR2020-
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`00861 at 41 (“Petitioner relies on different prior art (i.e., Martin, Togo, and Levey),
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`combined in ways not contemplated during prosecution”).
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`Case IPR2020-01263
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`Turning to the Webb declaration: during prosecution, Novartis repeatedly
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`stressed the alleged unexpected results contained therein (EX1010, pp.156, 206).
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`The alleged unexpected results of the Webb Declaration persuaded the Examiner to
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`allow the claims. Id. at p.240 (Examiner’s “Reasons for Allowance”). But
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`astonishingly, Novartis’ own arguments in its POPR now undercuts the Webb
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`Declaration’s alleged unexpected results. In an effort to distinguish EP ’072’s
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`teaching of synergistic effects directed to heart failure, Novartis’ POPR now
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`makes clear that the Webb Declaration’s alleged synergistic effects are limited
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`only to antihypertensive effect—something it did not feel the need to expressly
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`explain to the Examiner (as now it does to the PTAB). POPR, 7-8; 27-31.
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`The ’659 patent only has four claims. Claims 1, 3 and 4 of the ’659 patent
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`are not limited to any specific condition, whereas Claim 2 recites “hypertension or
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`heart failure.” “Evidence of secondary considerations must be reasonably
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`commensurate with the scope of the claims.” In re Huai-Hung Kao, 639 F.3d
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`1057, 1068 (Fed. Cir. 2011). As Novartis explains in its POPR, its alleged
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`unexpected results are only limited to an antihypertensive effect; Novartis has
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`nothing to offer directed to “heart failure.” Novartis’s unexpected results are not
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`commensurate with the scope of the claims. Id.
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`But there is more. During prosecution of the ’659 patent, Novartis
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`opportunistically (and repeatedly) told the Examiner that because of the Webb
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`Case IPR2020-01263
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`Declaration it had “already overcome the prima facie case for obviousness, as
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`demonstrated by the issuance of U.S. Patent 7,468,390.” EX1010, pp. 156, 206.
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`At the same time, however, Novartis neglected to inform the Examiner that the
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`claims of the parent ’390 patent recited only an “anti-hypertensive effect.”
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`EX1014, Claims 1 & 3. In contrast, the ’659 patent’s claims are not so limited
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`with all but one of them not even reciting any specific condition, and with Claim 2
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`reciting “hypertension or heart failure.” As Novartis concedes, the “unexpected
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`results based on the Webb Declaration were a key part of the ’659 Patent’s
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`prosecution.” POPR, 37. Novartis’ representation, however, that it had “already
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`overcome the prima facie case for obviousness” because of the Webb Declaration
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`in the parent ’390 patent while failing to inform the Examiner of the differing
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`claim scopes of the parent and the ’659 patents was simply disingenuous.
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`Finally, as explained in Biocon’s Petition, the PTAB routinely defers
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`detailed consideration of any objective indicia until after institution. Petition, 59
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`(citing cases). The fact that Novartis has to rely so heavily on an uncontested
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`unexpected results declaration submitted during prosecution undercuts its entire
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`§325(d) argument. Actavis LLC v. Abraxis Bioscience, LLC, IPR2017-01103,
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`Paper 7 at 8 (October 10, 2017) (“testimonial evidence that was not subject to
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`cross-examination in determining patentability”). For all of the above reasons,
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`Biocon’s Petition should not be denied on the basis of §325(d).
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`3
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`Date: December 11, 2020
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`Case IPR2020-01263
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`Respectfully submitted,
`Katten Muchin Rosenman LLP
`By: /Christopher B. Ferenc/
`Christopher B. Ferenc
`(Reg. No. 59,365)
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`4
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`Case IPR2020-01263
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`CERTIFICATION OF SERVICE ON PATENT OWNER
`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 paper was served on December 11, 2020, by
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`delivering a copy via electronic mail on the following attorneys of record.
`
`Nicholas N. Kallas
`Christina Schwarz
`Shannon Clark
`Laura K. Fishwick
`VENABLE LLP
`1290 Avenue of the Americas
`New York, New York 10104
`(212) 218-2100
`nkallas@venable.com
`cschwarz@venable.com
`skclark@venable.com
`lfishwick@venable.com
`
`Respectfully submitted,
`Katten Muchin Rosenman LLP
`
`By: /Christopher B. Ferenc/
`Christopher B. Ferenc
`Reg. No. 59,365
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