UNITED STATES PATENT AND TRADEMARK OFFICE
`
`————————————————
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`————————————————
`
`MYLAN PHARMACEUTICALS INC.,
`Petitioner,
`
`v.
`
`BAUSCH HEALTH IRELAND LIMITED,
`Patent Owner.
`
`————————————————
`Case IPR2022-00722
`Patent 7,041,786
`————————————————
`
`PETITIONER’S REPLY TO
`PATENT OWNER’S PRELIMINARY RESPONSE (PAPER 6)
`AND PETITIONER’S MOTION TO AMEND
`REAL PARTY-IN-INTEREST STATEMENT1
`
`1 This Paper was authorized by Board Order (Paper 12) on July 29, 2022.
`
`
`
`————————————————
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`————————————————
`
`MYLAN PHARMACEUTICALS INC.,
`Petitioner,
`
`v.
`
`BAUSCH HEALTH IRELAND LIMITED,
`Patent Owner.
`
`————————————————
`Case IPR2022-00722
`Patent 7,041,786
`————————————————
`
`PETITIONER’S REPLY TO
`PATENT OWNER’S PRELIMINARY RESPONSE (PAPER 6)
`AND PETITIONER’S MOTION TO AMEND
`REAL PARTY-IN-INTEREST STATEMENT1
`
`1 This Paper was authorized by Board Order (Paper 12) on July 29, 2022.
`
`
`
`TABLE OF CONTENTS
`
`Page
`ANALYSIS OF §325(d) FAVORS INSTITUTION ....................................... 1
`A.
`The Examiner Never Made Any Obviousness Rejection ..................... 1
`B.
`The Petition Presents New and Different Evidence .............................. 2
`REAL PARTY-IN-INTEREST UPDATE AND MOTION ........................... 4
`
`I.
`
`II.
`
`TABLE OF AUTHORITIES
`
`Page
`
`Cases
`Adello Biologics LLC v. Amgen Inc., PGR2019-00001, Paper 11 ............................ 5
`NRG Energy, Inc. v. Midwest Energy Emissions Corp., IPR2020-00832,
`Paper 17 ................................................................................................................ 4
`PNC Bank, N.A. v. USAA, IPR2021-01073, Papers 20, 25 ....................................... 5
`SharkNinja Operating LLC v. iRobot Corp., IPR2020-00734, Paper 11 .................. 5
`Valeo N. Am., Inc. v. Magna Elecs., Inc., IPR2014-00220, Paper 45 ....................... 5
`Statutes
`35 U.S.C. §102 .......................................................................................................1, 4
`35 U.S.C. §112 .................................................................................................. 1, 2, 4
`35 U.S.C. §325 ........................................................................................................... 1
`Regulations
`37 C.F.R §42.8 ........................................................................................................... 5
`
`-ii-
`
`
`
`I.
`
`ANALYSIS OF §325(d) FAVORS INSTITUTION
`The POPR exaggerates the relevance of the examination to the current
`
`grounds, misrepresents examiner findings, and overlooks substantial differences.
`
`Bausch concedes the petition presents a new reference (Li, EX1006) the Office
`
`never previously considered, in combination with Currie (EX1005), which the
`
`examiner never applied in any rejection. POPR, 4-5. Bausch argues the petition’s
`
`asserted combination is cumulative to the examiner’s assertion of Hidaka 1998
`
`(EX2008) in an anticipation rejection and brief citation of Hidaka 2000 (EX2009)
`
`in a written description rejection. POPR, 30-36. But Bausch does not assert—nor
`
`could it—that the examiner ever issued any obviousness rejection. Nor does
`
`Bausch identify any reliance by the examiner on disclosures comparable to the
`
`petition’s Currie and Li combination to support modifying uroguanylin as part of
`
`an obviousness analysis. The examiner failed to recognize prior art disclosure of
`
`the proposed conservative substitution and never considered its unpredictability.
`
`A. The Examiner Never Made Any Obviousness Rejection
`The examiner’s only rejections concerned an earlier version of claim 1 that
`
`permitted sequence variants of up to three residues, and only under §102 and §112.
`
`EX1004, 160-62, 172-73. Bausch amended claim 1 (id., 188) and argued that the
`
`amended claim was not anticipated because “Hikada [sic] teaches a peptide
`
`-1-
`
`
`
`sequence of uroguanylin 15 amino acids[2] in length where the residue at position 3
`
`is an aspartic acid, but does not teach the peptide sequence of SEQ ID NO: 20.”
`
`Id., 192. The examiner allowed claim 1 without further rejection. Id., 271-76. The
`
`examiner was unaware of any prior art teaching “a variant of uroguanylin having a
`
`glutamate residue at position 3, rather than the naturally occurring aspartate
`
`residue.” EX1004, 173 (limited list of “pertinent” art). While Bausch misrepresents
`
`the examiner’s §112 findings about the outer limits of Bausch’s earlier and much
`
`broader claims as an obviousness determination (POPR, 34-36), the examiner
`
`never addressed predictability of the proposed conservative (i.e., very predictable)
`
`substitution supported by an analogous sequence identified in the art. EX1006, 53;
`
`EX1002, ¶123; Advanced Bionics, IPR2019-01469, Paper 6, at 8.
`
`B. The Petition Presents New and Different Evidence
`Bausch urges the Board to ratify the examiner’s facially insufficient
`
`examination based on unsupported attorney argument, despite uncontroverted
`
`expert testimony. Critically, Bausch dismisses Li as cumulative despite Li’s clear
`
`comparison and alignment of rat, opossum, and human uroguanylins—which
`
`suggest the conservative substitution proposed as obvious in Ground 1. POPR, 33-
`
`2 Reference to “truncated” uroguanylin traces to Bausch’s characterization of
`
`Hidaka 1998 during prosecution, despite Bausch’s current position. POPR, 31 n.5.
`
`-2-
`
`
`
`34; Pet., 24-26 (Li shows the aspartic and glutamic acid residues in the second and
`
`third positions and identifies them as important for uroguanylin’s desirable activity
`
`level); EX1006, 52-53 & FIG. 6; EX1002, ¶¶109, 121-124 (Li on positions 2 and
`
`3); id., ¶¶92-94, 120 (Currie on rat relevance). Li thus provides significant linking
`
`prior art context in Ground 1 that Hidaka 1998 lacked.
`
`Bausch also contends Li is cumulative to Hidaka 2000 (EX2009), a portion
`
`of which the examiner cited in a written description rejection. POPR, 33-35
`
`(arguing Fig. 1 “explicitly disclos[ed] rat uroguanylin’s sequence.”). But the
`
`examiner only cited Hidaka 2000 to establish that “a mutant peptide” in which the
`
`first two residues were deleted lacked the ability to form the correct disulfide
`
`pairing. EX1004, 164-65. Thus, the examiner concluded “the structural features of
`
`SEQ ID NO: 20 are not particularly representative of the claimed genus.” Id. But
`
`no POSA would equate deleting the first two residues with using Li’s naturally-
`
`occurring amino acid sequences (DE, ED, and DD) for positions 2 and 3. E.g., Pet.
`
`19, 25. Bausch identifies no evidence suggesting the examiner was aware of Li’s
`
`prior art uroguanylin variant having a glutamate residue at position 3, let alone Li’s
`
`alignment of the rat and human uroguanylin orthologs and disclosure, based on that
`
`alignment, of the importance of having acidic residues at positions 2-3. Record
`
`evidence supported by expert testimony, including prior art disclosure of the
`
`alignment/comparison, overcomes Bausch’s unsupported attorney arguments.
`
`-3-
`
`
`
`Bausch also fails to meaningfully address Currie. POPR, 29-31. While
`
`Bausch contends the petition relied on Currie just to disclose uroguanylin’s
`
`sequence, the record establishes that Currie also provides reasons why uroguanylin
`
`was a known, promising starting point and suggests the analogy between human
`
`and rat uroguanylin. See, e.g., Pet., 17, 22-24, 35-36; EX1002, ¶¶59-60. For
`
`example, Currie suggests exploiting uroguanylin’s natural laxative effects for
`
`treating constipation, discloses that uroguanylin’s activity was desirable because it
`
`was stronger than guanylin’s but not so strong as enterotoxin’s pathogenic activity,
`
`and discloses peptide synthesis was straightforward. Id. Bausch’s narrow focus on
`
`uroguanylin’s sequence ignores the petition’s reliance on Currie for far more,
`
`including its support for uroguanylin as a natural lead for a synthetic ligand.
`
`The Board should reject Bausch’s arguments that the asserted combination
`
`of Currie and Li is cumulative to the examiner’s §102 or §112 rejection. Institution
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`should be granted because the petition presents new art, a new combination, new
`
`arguments, and new evidence that were not previously considered and that
`
`demonstrate a reasonable likelihood of showing at least one claim is obvious.
`
`II.
`
`REAL PARTY-IN-INTEREST UPDATE AND MOTION
`The petition identified all known potential RPIs in its “Real Parties-in-
`
`Interest” disclosure to avoid any cost or inefficiency of litigating the identity of
`
`RPIs. Pet., 2; NRG Energy, Inc. v. Midwest Energy Emissions Corp., IPR2020-
`
`-4-
`
`
`
`00832, Paper 17, 8-10 (no particular form required ). Because no potential time-bar
`
`existed, the Board and parties need not incur cost or inefficiency considering
`
`whether the petition correctly identified all RPIs. SharkNinja Oper. LLC v. iRobot
`
`Corp., IPR2020-00734, Paper 11, 18-20 (prec.); PNC Bank, N.A. v. USAA,
`
`IPR2021-01073, Papers 20 & 25, 35-37. Bausch does not contend that any other
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`entity should have been named or that any RPI was time barred. POPR, 11-14.
`
`Bausch also concedes that both Bausch and the Board were well aware that Mylan
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`Inc. and Viatris Inc. are parent companies of Mylan Pharmaceuticals Inc. (“MPI”)
`
`Id. Nevertheless, Bausch still questioned the petition’s RPI listing.
`
`MPI’s petition was a good faith attempt to identify all potential RPIs under
`
`37 C.F.R §42.8, not any effort at intentional concealment. MPI updated its
`
`mandatory notices within 21 days of Bausch raising the issue, to confirm that MPI
`
`does not dispute the status of its parent companies. Paper 9; see Valeo N. Am., Inc.
`
`v. Magna Elecs., Inc., IPR2014-00220, Paper 45, 2-4 (update authorized 10 months
`
`after merger; filed within 21 days of PO raising the issue). It is in the interests of
`
`justice to authorize MPI to update its notices to remove any doubt that Viatris Inc.
`
`and Mylan Inc. are parent companies of MPI and are RPIs. See Adello Biologics
`
`LLC v. Amgen Inc., PGR2019-00001, Paper 11, 2-3 (prec.). MPI respectfully
`
`requests the Board grant this authorization with no impact on the petition filing
`
`date. Id.
`
`-5-
`
`
`
`Dated: 8 August 2022
`
` Respectfully submitted,
`
`/Jad Mills/
`Jad Mills, Reg. No. 63,344
`Counsel for Mylan Pharmaceuticals Inc.
`
`-6-
`
`
`
`CERTIFICATE OF SERVICE
`I certify that today this paper was served by email on Bausch’s counsel at:
`
`Justin J. Hasford
`
`justin.hasford@finnegan.com
`
`Bryan C. Diner
`
`bryan.diner@finnegan.com
`
`Joshua Goldberg
`
`joshua.goldberg@finnegan.com
`
`Caitlin O’Connell
`
`caitlin.o’connell@finnegan.com
`
`Kyu Yun Kim
`
`kyuyun.kim@finnegan.com
`
`Dated: 8 August 2022
`
`Respectfully submitted,
`
`/Jad Mills/
`Jad Mills
`
`-7-
`
`
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