`
`Date Filed: December 18, 2020
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`Filed On Behalf Of:
`Novartis Pharmaceuticals Corporation
`
`By:
`Nicholas N. Kallas
`nkallas@Venable.com
`(212) 218-2243
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`
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`BIOCON PHARMA LIMITED,
`Petitioner,
`
`v.
`
`NOVARTIS PHARMACEUTICALS CORPORATION,
`Patent Owner.
`
`
`Case IPR2020-01263
`Patent 8,101,659
`
`
`
`NOVARTIS’S PRE-INSTITUTION SUR-REPLY
`
`
`
`
`
`
`
`TABLE OF AUTHORITIES
`
`Cases
`Actavis LLC v. Abraxis Bioscience LLC,
`IPR2017-01103, Paper 7 (PTAB Oct. 10, 2017) .................................................. 3
`Apple Inc. v. Corephotonics Ltd.,
`IPR2020-00861, Paper 7 (PTAB, Dec. 9, 2020) .................................................. 1
`In re Ackermann,
`444 F.2d 1172 (CCPA 1971) ................................................................................ 2
`In re Chupp,
`816 F.2d 643 (Fed. Cir. 1987) .............................................................................. 2
`Statutes
`35 U.S.C. § 325(d) ..................................................................................................... 1
`
`
`i
`
`
`
`
`
`Pursuant to Board authorization (Paper 9), Novartis responds to Biocon’s
`
`Reply (Paper 10, “Reply”). Nothing in Biocon’s Reply compels institution.
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`First, Biocon complains that Novartis’s § 325(d) analysis was insufficiently
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`detailed. Reply at 1. But in contrast to Apple Inc. v. Corephotonics Ltd. IPR2020-
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`00861, Paper 7 at 41 (PTAB, Dec. 9, 2020), where the petitioner cited new non-
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`cumulative art, Biocon has not identified any material difference between the art
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`cited in the petition and the art considered by the Examiner, let alone any art or
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`argument that would have led the Examiner to a different conclusion on prima
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`facie obviousness. Biocon’s art discussing ARBs (including valsartan) and NEP
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`inhibitors (including sacubitril) is cumulative of the art considered by the
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`Examiner, who also found the claims prima facie obvious, albeit using a different
`
`combination of references.1 Paper 7, POPR at 23–25; Ex. 1010, at 170–74, 195–99.
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`For unexpected results, Biocon relies on EP ’072, which was indisputably
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`presented to the Office. Paper 7, POPR at 25–26. This is precisely the type of case
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`where § 325(d) denial is appropriate.
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`Second, Biocon baselessly complains that the unexpected synergistic anti-
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`hypertensive results are not commensurate in scope with the ’659 patent claims,
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`1 The claims ultimately were allowed for unexpected results. Ex. 1010, ’659
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`prosecution history at 240; Paper 1, Petition at 11.
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`1
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`
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`although its argument is difficult to follow. Reply at 2. Biocon ignores that claims
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`1–4 are composition claims. See Paper 1, Petition at 1 (“The challenged claims …
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`are directed to pharmaceutical compositions…”); see also 43 (“Claim 2 recites the
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`pharmaceutical composition of claim 1…”). For such claims, showing unexpected
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`superiority for one property is sufficient to overcome a prima facie showing of
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`obviousness. In re Chupp, 816 F.2d 643, 646 (Fed. Cir. 1987) (“Evidence that a
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`compound is unexpectedly superior in one of a spectrum of common properties, as
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`here, can be enough to rebut a prima facie case of obviousness.”) (emphasis
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`added); In re Ackermann, 444 F.2d 1172, 1176 (CCPA 1971). With respect to
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`claim 2, which Biocon specifically challenges, Biocon conflates the composition
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`claim element “amounts effective to treat . . . heart failure” with the composition’s
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`unexpected anti-hypertensive synergy.
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`Because a single unexpected property is sufficient to support unexpected
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`results for all four composition claims, Biocon’s suggestion that Novartis misled
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`the Examiner about the ’390 patent claims scope (Reply at 2–3) is both irrelevant
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`and incorrect. Reply at 2–3. The prosecution history confirms the Examiner was
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`aware of the scope of the ’390 patent claims, including because she was the
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`Examiner who allowed them and because she relied on them to issue a double
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`patenting rejection. Ex. 1015 at 1089–95; Ex. 1010 at 219. Likewise, Novartis
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`never suggested the synergistic data was directed to heart failure (contra Reply at
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`
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`2
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`
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`2); Novartis described the data as showing “a synergistic, unexpected and
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`surprising antihypertensive effect.” Ex. 1010 at 156, 206 (emphasis added).
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`In sum, Biocon has not shown that the Examiner erred in finding unexpected
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`results. Moreover, Biocon now surprisingly admits that the EP ’072 “synergistic”
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`results pertain to heart failure (Reply at 2), not hypertension—an admission that
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`directly contradicts the primary argument in Biocon’s Petition (Paper 1 at 5) that
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`EP ’072 and the Webb Declaration showed the “same synergistic effect.” Thus, it
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`is Biocon who is trying to mislead, not Novartis.
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`Finally, Biocon’s suggestion that the Board should institute trial so that the
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`Webb Declaration can be considered further (Reply at 3) is baffling, particularly as
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`neither Biocon nor its expert have disputed that it shows anti-hypertensive synergy.
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`As unexpected results raised during prosecution should be addressed in pre-
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`institution papers, permitting Biocon to challenge these results for the first time in
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`a post-institution reply would be highly prejudicial. See Paper 7, POPR at 36–37
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`(citing cases requiring petition to address unexpected results raised in prosecution);
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`see also id. at 35 (distinguishing Actavis LLC v. Abraxis Bioscience LLC,
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`IPR2017-01103, Paper 7 (PTAB Oct. 10, 2017)).
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`December 18, 2020
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`Respectfully submitted,
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`/Nicholas N. Kallas/
`Nicholas N. Kallas (Reg. No. 31,530)
`
`
`
`3
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`
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`CERTIFICATE OF SERVICE
`
`I certify that a copy of Novartis’s Pre-Institution Sur-Reply was served on
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`December 18, 2020 by causing it to be sent by email to counsel for Petitioner at the
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`following email addresses:
`
`Christopher Ferenc (christopher.ferenc@katten.com)
`
`Brian Sodikoff (brian.sodikoff@katten.com)
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`
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`Dated: December 18, 2020
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`
`
`/Nicholas N. Kallas/
`Nicholas N. Kallas (Reg. No. 31,530)
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`4
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