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`Paper No. 6
`Filed: June 29, 2022
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`__________________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`__________________
`
`
`MYLAN PHARMACEUTICALS INC.,
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`Petitioner,
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`v.
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`BAUSCH HEALTH IRELAND LIMITED,
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`Patent Owner.
`
`__________________
`
`Case IPR2022-00722
`U.S. Patent No. 7,041,786
`__________________
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`PATENT OWNER’S PRELIMINARY RESPONSE
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`Case IPR2022-00722
`Patent No. 7,041,786
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`TABLE OF CONTENTS
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`Page
`INTRODUCTION ........................................................................................... 1
`BACKGROUND ............................................................................................. 8
`Claims of the ’786 Patent ...................................................................... 8
`Grounds 1-4 of the Petition ................................................................... 9
`ARGUMENT
`
`I.
`
`I.
`II.
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`II.
`
`The Board Should Deny Institution because the Petition Improperly
`Failed to Disclose Real Parties in Interest ..................................................... 11
`The Board Should Deny Institution Under 35 U.S.C. § 314(a) .................... 14
`Legal Framework ................................................................................ 15
`Factor 1: A Stay Has Not Been, and Is Unlikely to Be, Entered ....... 15
`Factor 2: Trial in the Related Litigations Is Likely to Occur
`Shortly After the Deadline for the Final Written Decision ................. 16
`1.
`The MSN Action ....................................................................... 17
`2.
`The Mylan Action ..................................................................... 17
`Factor 3: The Parties and the Court Will Invest Significant
`Resources in the Related Litigation .................................................... 18
`1.
`The MSN Action ....................................................................... 18
`2.
`The Mylan Action ..................................................................... 19
`Factor 4: The Petition Relies on Substantially the Same Art and
`Arguments Likely to Be Presented in The Parallel Proceeding .......... 20
`1.
`The MSN Action ....................................................................... 21
`2.
`The Mylan Action ..................................................................... 21
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`2.
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`Patent No. 7,041,786
`Factor 5: The Petitioner Is a Defendant in the Related
`Litigation ............................................................................................. 23
`Factor 6: All Other Circumstances Further Support Denial .............. 24
`III. The Board Should Deny Institution Under 35 U.S.C. § 325(d) .................... 26
`Legal Framework ................................................................................ 26
`The Petition Relies on the Same or Substantially the Same Art
`or Arguments Overcome During Prosecution ..................................... 28
`1.
`Currie (EX1005) ....................................................................... 29
`2.
`Li (EX1006) .............................................................................. 32
`The Petitioner Has Not Demonstrated That the Office Erred in a
`Manner Material to the Patentability of Challenged Claims .............. 36
`IV. The Petition Should Be Denied Because the Petitioner Has Failed to
`Establish That Any of the Claims Are Unpatentable .................................... 39
`Person of Ordinary Skill in the Art and Claim Construction .............. 39
`Trial Should Not Be Instituted on Any Grounds for Any Claims
`of the ’786 Patent ................................................................................ 39
`1.
`The Petition Fails to Perform a Lead Compound Analysis
`to Explain Why the POSA Would Have Started with
`Human Uroguanylin .................................................................. 40
`The Petition’s Argument About a POSA’s Alleged
`Motivation to Make an “Asp3” Substitution Is Internally
`Inconsistent and Flawed ............................................................ 49
`Trial Should Not Be Instituted on All Grounds ........................ 62
`3.
`Conclusion ..................................................................................................... 63
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`V.
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`ii
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`TABLE OF AUTHORITIES
`
`Case IPR2022-00722
`Patent No. 7,041,786
`
` Page(s)
`
`Cases
`Advanced Bionics, LLC v. MED-EL Elektromedizinische Geräte
`GmbH, IPR2019-01469, Paper No. 6 (P.T.A.B. Feb. 13, 2020) .................passim
`Apple Inc. v. Fintiv, Inc., IPR2020-00019, Paper No. 11 (P.T.A.B.
`Mar. 20, 2020); Paper No. 15 (P.T.A.B. May 13, 2020) .............................passim
`Applications in Internet Time, LLC v. RPX Corp.,
`897 F.3d 1336 (Fed. Cir. 2018) .......................................................................... 13
`Becton, Dickinson & Co. v. B. Braun Melsungen AG,
`IPR2017-01586, Paper No. 8 (P.T.A.B. Dec. 15, 2017) .............................passim
`Daiichi Sankyo Co. v. Matrix Lab’ys,
`619 F.3d 1346 (Fed. Cir. 2010) .................................................................... 40, 42
`Gen. Plastic Indus. Co., Ltd. v. Canon Kabushiki Kaisha,
`IPR2016-01357, Paper No. 19 (P.T.A.B. Sept. 6, 2017) .................................... 25
`Institut Pasteur & Université Pierre-et-Marie-Curie v. Focarino,
`738 F.3d 1337 (Fed. Cir. 2013) .......................................................................... 49
`KSR Int’l Co. v. Teleflex Inc.,
`550 U.S. 398 (2007) ............................................................................................ 53
`Mylan Lab’ys Ltd. v. Janssen Pharm. Nv,
`IPR2020-00440, Paper No. 17 (P.T.A.B. Sept. 16, 2020) ...........................passim
`NHK Spring Co. v. Intri-Plex Techs., Inc.,
`IPR2018-00752, Paper 8 (P.T.A.B. Sept. 12, 2018)........................................... 14
`Novo Nordisk A/S v. Caraco Pharm. Lab’ys., Ltd.,
`601 F.3d 1359 (Fed. Cir. 2010), abrogated on other grounds, 566
`U.S. 399 (2012) ................................................................................................... 24
`Ortho-McNeil Pharm., Inc. v. Mylan Lab’ys, Inc.,
`520 F.3d 1358 (Fed. Cir. 2008) .................................................................... 53, 57
`
`iii
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`Patent No. 7,041,786
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`OSI Pharms., Inc. v. Mylan Pharms. Inc.,
`858 F. Supp. 2d 341 (D. Del. 2012).................................................................... 41
`Otsuka Pharm. v. Sandoz, Inc.,
`678 F.3d 1280 (Fed. Cir. 2012) ...................................................................passim
`Plantronics, Inc. v. Aliph, Inc.,
`724 F.3d 1343 (Fed. Cir. 2013) .......................................................................... 53
`Procter & Gamble Co. v. Teva Pharm. USA, Inc.,
`566 F.3d 989 (Fed. Cir. 2009) ............................................................................ 39
`Radware, Inc. v. F5 Networks, Inc.,
`IPR2017-01185, 2017 WL 4570445 (P.T.A.B. Oct. 11, 2017) .......................... 13
`Ruiz v. A.B. Chance Co.,
`357 F.3d 1270 (Fed. Cir. 2004) .......................................................................... 53
`Samsung Elecs. Co., Ltd. v. Ancora Techs., Inc.,
`No. IPR2020-01184, 2021 WL 42429 (P.T.A.B. Jan. 5, 2021) ................... 22, 23
`Samsung Elecs. Co. v. Seven Networks, LLC,
`IPR2018-01108, Paper 22 (P.T.A.B. Nov. 28, 2018) ......................................... 11
`Sotera Wireless, Inc. v. Masimo Corp.,
`IPR2020-01019, Paper 12, 19 (P.T.A.B. Dec. 1, 2020) ..................................... 22
`Star Scientific, Inc. v. R.J. Reynolds Tobacco Co.,
`655 F.3d 1364 (Fed. Cir. 2011) .......................................................................... 55
`Takeda Chem. Indus., Ltd. v. Alphapharm Pty., Ltd.,
`492 F.3d 1350 (Fed. Cir. 2007) .............................................................. 39, 40, 57
`Uniloc 2017 LLC v. Facebook Inc.,
`989 F.3d 1018 (Fed. Cir. 2021) .......................................................................... 12
`Weatherford Int’l, LLC v. Packers Plus Energy Servs., Inc.,
`IPR2016-01514, Paper 23 (P.T.A.B. Feb. 22, 2017) .......................................... 12
`Yamanouchi Pharm. Co., Ltd. v. Danbury Pharmacal, Inc.,
`231 F.3d 1339 (Fed. Cir. 2000) .......................................................................... 40
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`iv
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`Patent No. 7,041,786
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`Zerto, Inc. v. EMC Corp.,
`IPR2014-01254, Paper No. 35 (P.T.A.B. March 3, 2015) ................................. 11
`Federal Statutes
`21 U.S.C. § 355(j)(5)(F)(ii) ................................................................................ 15, 16
`35 U.S.C. § 102 ............................................................................................ 30, 31, 32
`35 U.S.C. § 103 ........................................................................................................ 21
`35 U.S.C. § 312(a) ................................................................................................... 10
`35 U.S.C. § 314(a) ................................................................................... 4, 14, 15, 39
`35 U.S.C. § 325(d) ............................................................................................passim
`America Invents Act .......................................................................................... 25, 26
`Hatch-Waxman Act ...........................................................................................passim
`Patent Act ................................................................................................................. 10
`Regulations
`37 C.F.R § 42.8 ........................................................................................................ 10
`37 C.F.R § 42.104 .................................................................................................... 10
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`v
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`Case IPR2022-00722
`Patent No. 7,041,786
`Patent Owner Bausch Health Ireland Limited (“the Patent Owner”) submits
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`this Preliminary Response to the Petition for Inter Partes Review of U.S. Patent No.
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`7,041,786 (“the ’786 patent”) filed by Mylan Pharmaceuticals Inc. (“Mylan” or “the
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`Petitioner”).
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`I.
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`INTRODUCTION
`The ’786 patent discloses and claims novel guanylate cyclase receptor agonist
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`peptides that bind to intestinal receptors and enhance the intracellular production of
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`cyclic guanosine monophosphate (cGMP). Many naturally-occurring peptides,
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`including uroguanylin, guanylin, and E. coli heat-stable enterotoxin (ST), bind to
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`guanylate cyclase receptors and stimulate intracellular production of cGMP. This
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`results in the activation of the cystic fibrosis transmembrane conductance regulator
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`(CFTR), an atypical membrane channel for efflux of chloride from enterocytes lining
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`the intestinal tract. Activation of CFTR and the subsequent enhancement of
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`transepithelial secretion of chloride leads to stimulation of sodium and water
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`secretion into the intestinal lumen.
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`The inventors of the ’786 patent postulated that guanylate cyclase receptor
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`agonist peptides could be useful in the treatment of various diseases, including
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`diseases of the bowel. Indeed, another group of inventors in this field synthesized
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`the peptide linaclotide using ST as a lead compound. Linaclotide is the active
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`ingredient in the marketed drug product Linzess®, which is indicated for treatment
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`of irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic
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`constipation (CIC).
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`Having postulated that guanylate cyclase receptor agonist peptides could be
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`useful as therapeutic compounds, the inventors of the ’786 patent used molecular
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`modeling to design various novel peptides and tested these new compounds for
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`enhancement of intracellular cGMP production. The inventors’ molecular modeling
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`involved energy calculations for uroguanylin, guanylin, and ST, which allowed the
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`inventors to design novel compounds having significantly increased bioactive
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`conformations to interact with guanylate cyclase receptors. The inventors
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`considered approximately 180,000 conformations for each of the cyclic moieties,
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`and the inventors ultimately and surprisingly discovered that one of the novel
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`compounds they synthesized, namely plecanatide, gave the greatest enhancement of
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`intracellular cGMP production of all the compounds tested.
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`The inventors’ work ultimately led to the approval of Trulance®, the first and
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`only drug product to contain the active pharmaceutical ingredient plecanatide, which
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`is covered by claim 1 of the ’786 patent. Because plecanatide is undisputedly a new
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`peptide, the FDA granted new chemical entity exclusivity for Trulance®, providing
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`five years of market exclusivity. The success of Trulance® ultimately has resulted
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`in multiple generic competitors, including the Petitioner, seeking to market generic
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`copies of Trulance® prior to the expiration of the ’786 patent.
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`The Petitioner has launched a multi-front attack on the validity of the ’786
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`patent, including by filing this petition for inter partes review. But the petition
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`should be denied for any one of the following reasons: (1) the petition improperly
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`fails to disclose real parties-in-interest; (2) two Hatch-Waxman litigations are co-
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`pending in district courts, challenging validity of the same patent; (3) the petition
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`relies on the same or substantially the same art already considered and overcome
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`during prosecution; and (4) on the merits, because the Petitioner has failed to
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`establish that it is likely to prevail in showing that any of the challenged claims are
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`unpatentable.
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`First, the petition improperly fails to disclose all Real Parties-in-Interest
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`(“RPIs”), including Mylan Inc. and Viatris Inc. The petition merely discloses that
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`the Petitioner is a “co-defendant” with Mylan Laboratories Ltd., Agila Specialties
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`Inc, Mylan API US LLC, Mylan Inc., and Viatris Inc. in a related litigation. The
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`identification of “co-defendants” in this case, however, is insufficient because co-
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`defendants in a related litigation, without more, are not considered RPIs. The
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`Petitioner fails to disclose Mylan Inc.’s and Viatris Inc.’s corporate relatedness in
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`this case, notwithstanding that the Petitioner repeatedly has identified both Mylan
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`Inc. and Viatris Inc. as corporate parents in other IPR cases. Here, the Petitioner
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`should have identified Mylan Inc. and Viatris Inc. as RPIs, especially because they
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`share a common legal department that controls their activities in the present
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`proceeding. For at least this reason, trial should not be instituted.
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`Second, the petition also should be denied, as a threshold matter under 35
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`U.S.C. § 314(a), in light of two co-pending Hatch-Waxman litigations involving the
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`same ’786 patent. Each of Mylan and another group of defendants, MSN (see infra
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`§ Argument II), seeking to obtain the benefits of the Hatch-Waxman framework,
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`filed an ANDA with a Paragraph IV Certification challenging the validity of the ’786
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`patent. Mylan is now attempting to mount a duplicative challenge through this
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`petition. These two co-pending Hatch-Waxman litigations have been underway for
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`over a year and are unlikely to be stayed, even if this IPR is instituted. The validity
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`of the ’786 patent will be a central issue in these two litigations, and there likely will
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`be complete overlap in the obviousness theories presented in the petition. The Board
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`should exercise its discretion and deny institution under 35 U.S.C. § 314(a) because
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`granting this petition would result in significant duplication of efforts and would be
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`an inefficient use of the Board’s and the parties’ resources.
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`Third, the petition also should be denied as a threshold matter under 35 U.S.C.
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`§ 325(d) because it relies on the same or substantially the same art relied on or
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`considered by the Examiner during prosecution. The Petitioner effectively offers
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`only one ground of unpatentability—Ground 1—with respect to claim 1, which
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`covers the novel peptide plecanatide. See infra § II.B. Ground 1 relies on only two
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`references, Currie (EX1005) and Li (EX1006). Currie (EX1005) unquestionably
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`was considered by the Examiner during prosecution. While Li (EX1006) was not
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`itself of record, the art of record includes the same substantive teachings. Despite
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`this, the Petitioner makes no attempt to show any error by the Examiner in allowing
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`the claims of the ’786 patent. The Board thus should exercise its discretion and deny
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`institution under 35 U.S.C. § 325(d) because the petition relies on the same or
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`substantially the same art already applied and overcome or considered by the
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`Examiner.
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`Fourth, should the Board reach the merits, there are multiple defects in the
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`petition that further warrant denial of institution. The Petitioner does not contend
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`that the claimed plecanatide compound is anticipated, and if the Board institutes trial,
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`the Patent Owner will offer evidence in support of its non-obviousness. But this
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`case should never proceed that far because the petition is facially deficient, internally
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`inconsistent, and fails to establish a reasonable likelihood that the Petitioner would
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`prevail in showing that any challenged claim of the ’786 patent is unpatentable for
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`obviousness.
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`Each of the petition’s Grounds is premised on the notion that, of all the
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`potential peptides a person of ordinary skill in the art (“POSA”) could engineer, a
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`POSA somehow would have had a reason to (a) start with human uroguanylin, (b)
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`substitute one specific amino acid at position 3 (“Asp3”) among an enormous
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`Patent No. 7,041,786
`plethora of potential candidates, despite Asp3’s known importance for human
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`uroguanylin’s enhanced bioactivity, (c) substitute that particular amino acid with a
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`glutamate, and (d) make no other modifications. A POSA would not have had any
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`motivation to do these things, let alone any reasonable expectation at successfully
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`doing them. But even taking the Petitioner’s arguments on their own terms, their
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`fatal gaps and internal inconsistencies cause them to fall apart even before any
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`evidentiary submission from the Patent Owner.
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`At the outset, the Petitioner offers no meaningful explanation as to why a
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`POSA would have sought to begin from the peptide sequence of human uroguanylin.
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`Parties, like the Petitioner, that challenge a chemical compound claim must explain
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`why a POSA would have selected a particular lead compound over other compounds
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`in the art. See, e.g., Otsuka Pharm. v. Sandoz, Inc., 678 F.3d 1280, 1291-92 (Fed.
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`Cir. 2012). The Petitioner here has failed to meet this basic requirement, which
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`renders the petition fatally flawed. It certainly provides no explanation whatsoever
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`as to why a POSA would have selected the sequence of uroguanylin as the POSA’s
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`starting point, especially in light of other sequences having superior bioactivity, such
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`as the ST sequence that was the lead compound for the successful development of
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`the active pharmaceutical ingredient linaclotide in Linzess®. The petition should be
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`denied institution for this reason alone.
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`Even if the petition had engaged in the necessary lead compound analysis,
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`which it did not, the petition fails to provide a legally sufficient explanation as to
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`why a POSA would have had a reason to substitute the Asp3 of uroguanylin’s
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`sequence with glutamate. In fact, the prior art taught that a substitution of Asp3
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`would impair the bioactivity of uroguanylin. The Petitioner argues that positions 2
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`and 3 of human uroguanylin are known to be “required” and “responsible” for its
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`enhanced bioactivity, but it offers no explanation as to why a POSA then would have
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`risked that property by substituting a different amino acid at position 3. In addition,
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`the Petitioner’s analysis, which is laser-focused on rat uroguanylin’s alleged
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`position 3 glutamate (“Glu3”)1, while ignoring all the differences between human
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`uroguanylin and rat uroguanylin, is predicated on impermissible hindsight. The
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`Petitioner’s hindsight-based obviousness arguments are therefore internally
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`inconsistent and cannot support a finding of unpatentability.
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`Even further assuming that a POSA would have been motivated to make the
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`substitution of Asp3 with Glu3 as the Petitioner alleges, which is wrong, it provides
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`no explanation as to why a POSA would have stopped making modifications there.
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`The Petitioner’s own references point toward a number of amino acid substitutions
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`or other modifications such as introducing other moieties. But the petition simply
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`1 As discussed below, Li (1006) shows that the glutamate amino acid in rat
`uroguanylin is at position 6, not position 3. See infra § Argument IV.B.2.
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`Patent No. 7,041,786
`ignores these teachings and further fails to explain why a POSA would have
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`modified Asp3 with Glu3 and no others, which a POSA would not have done.
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`The Petitioner does not establish a reasonable likelihood that any claim of the
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`’786 patent is unpatentable. Trial should not be instituted.
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`II. BACKGROUND
` Claims of the ’786 Patent
`The claims of the ’786 patent are directed to a novel peptide consisting of the
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`amino acid sequence of SEQ ID NO:20 (claim 1), compositions comprising this
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`peptide (claims 2-5) and a peptide conjugate comprising polyethylene glycol
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`attached to this peptide (claim 6).
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`Claim 1 recites:
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`1. A peptide consisting of the amino acid sequence of SEQ ID NO:20.
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`EX1001 at cols. 35-36, 37:2-3. The petition concedes, as it must, that the peptide of
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`claim 1 of the ’786 patent is plecanatide. Pet. at 5.
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`Claims 2-6 recite:
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`2. A composition in unit dose comprising a guanylate cyclase receptor
`agonist peptide consisting of the amino acid sequence of SEQ ID NO:20.
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`3. A composition in unit dose form comprising: a) a guanylate cyclase
`receptor agonist peptide consisting of the amino acid sequence of SEQ
`ID NO: 20; and b) at least one compound selected from the group
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`Patent No. 7,041,786
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`consisting of: a cGMP dependentphosphodiesterase inhibitor, an anti-
`inflammatory agent, an antiviral agent and an anticancer agent.
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`4. The composition ofeither claim 2 or 3, wherein the unit dose form is
`selected from the group consisting ofa tablet, a capsule, a solution and
`an inhalation formulation.
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`5. The composition ofeither claim 2 or 3, further comprising one or
`more excipients.
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`6. A peptide conjugate comprising polyethylene glycol (PEG)attached to
`a peptide consisting of the amino acid sequence SEQ ID NO:20.
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`EX1001 at 37:4-38:10.
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`B.
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`Grounds 1-4 of the Petition
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`The Petitioner proposes four obviousness combinations. But in fact, with
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`respect to claim | that covers the novel peptide plecanatide, the petition proposes
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`only one ground of unpatentability (Ground 1) for alleged obviousness. Grounds 2-
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`3 challenge claims 2-5, which are directed to various compositions including
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`plecanatide. Ground 4 challenges claim 6, whichis directed to a peptide conjugate
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`comprising polyethylene glycol attached to plecanatide.
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`Obvious from the Combined Teachings of
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`Currie (EX1005) and Li (EX1006)
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`Currie, Li, and Narayani (EX1007)
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`Currie, Li, and Ekwuribe (EX1009)
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`1
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`1
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`Currie, Li, Narayani, and Campieri (EX1008)
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`Pet. at 4. Grounds 2-4 do not raise any additional arguments regarding the alleged
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`obviousness of claim 1 but address only the additional elements that claims 2-6
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`recite. The Petitioner thus proposes only one ground of unpatentability with respect
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`to the novel peptide of claim 1—alleged obviousness over Currie (EX1005) in view
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`of Li (EX1006). Therefore, if the Petitioner fails to establish unpatentability of claim
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`1 via Ground 1, the petition must be denied institution because Grounds 2-4
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`effectively are constructed based on Ground 1. In other words, if the novel
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`plecanatide peptide of claim 1 is determined to be non-obvious, claims 2-6 should
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`also be determined non-obvious, at least because claims 2-5 recite compositions
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`comprising plecanatide, and claim 6 recites a conjugate of plecanatide.
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`ARGUMENT
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`The petition should be denied because (1) the petition improperly fails to
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`disclose real parties in interest; (2) two co-pending district court litigations are
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`examining validity of the ’786 patent, and this proceeding is duplicative under
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`Fintiv; (3) the petition relies on the same or substantially the same art relied on or
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`considered by the Examiner during prosecution; and (4) the petition has failed to
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`establish that any of the challenged claims are likely unpatentable.
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`I.
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`Patent No. 7,041,786
`The Board Should Deny Institution because the Petition Improperly
`Failed to Disclose Real Parties in Interest
`The Patent Act requires a petition to identify all RPIs without qualification.
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`See 35 U.S.C. § 312(a); 37 C.F.R. §§ 42.8 and 42.104. Prior to institution, when a
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`Patent Owner provides sufficient evidence that reasonably brings into question the
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`accuracy of a Petitioner’s identification of RPIs, the overall burden remains with the
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`Petitioner to establish that it has complied with the statutory requirement to identify
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`all RPIs. Zerto, Inc. v. EMC Corp., IPR2014-01254, Paper No. 35 at 6-7 (P.T.A.B.
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`March 3, 2015)
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`Under the heading “Real Parties-In-Interest,” the petition discloses that the
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`Petitioner is a “co-defendant” with Mylan Laboratories Ltd., Agila Specialties Inc,
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`Mylan API US LLC, Mylan Inc., and Viatris Inc. in a related litigation. Pet. at 2.
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`Unlike in other inter partes review petitions involving these entities, the petition
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`here does not disclose the corporate relationship between the Petitioner and these
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`other entities, and the petition does not state without qualification—or at all—that
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`any of these entities is an RPI with the Petitioner. Compare Pet. at 2 with Mylan
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`Pharms. Inc. v. Regeneron Pharms., Inc., IPR2021-00880, Paper 1 at 4 (identifying
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`that “Viatris Inc. and Mylan Inc. are parent companies of Petitioner Mylan
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`Pharmaceuticals Inc.
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` Accordingly, Viatris Inc., Mylan Inc., and Mylan
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`Patent No. 7,041,786
`Pharmaceuticals Inc. are identified as real parties-in-interest to the current
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`Petition.”).
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`The Petitioner’s mere identification of “co-defendants” here is insufficient
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`because the law is clear that co-defendants in a related litigation, without more, are
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`not considered RPIs. Samsung Elecs. Co. v. Seven Networks, LLC, IPR2018-01108,
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`Paper 22 at 12 (P.T.A.B. Nov. 28, 2018) (finding that a co-defendant in a related
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`district court case is not an RPI); Weatherford Int’l, LLC v. Packers Plus Energy
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`Servs., Inc., IPR2016-01514, Paper 23 at 12-16 (P.T.A.B. Feb. 22, 2017) (similar);
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`see also Uniloc 2017 LLC v. Facebook Inc., 989 F.3d 1018, 1028 (Fed. Cir. 2021)
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`(holding that “filing of its own IPR petition and joinder motion [challenging the
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`same patent] does not by itself make LG an RPI to Facebook’s IPR.”) Accordingly,
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`it is not clear whether the estoppel, if trial is instituted, should extend to all of the
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`identified “co-defendants.”
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`Moreover, the Petitioner failed to disclose Mylan Inc. and Viatris Inc.’s
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`corporate interrelatedness in this case. By contrast, the Petitioner has repeatedly
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`disclosed Mylan Inc. and Viatris Inc. as corporate parents in other cases that the
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`Petitioner previously filed. See, e.g., Mylan Pharms. Inc. v. Regeneron Pharms.,
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`Inc., IPR2021-00880, Paper 1 at 4 (identifying RPIs that “Viatris Inc. and Mylan
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`Inc. are parent companies of Petitioner Mylan Pharmaceuticals Inc. Accordingly,
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`Viatris Inc., Mylan Inc., and Mylan Pharmaceuticals Inc. are identified as real
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`parties-in-interest to the current Petition.”) (emphasis added); Mylan Pharms. Inc. v.
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`Regeneron Pharms., Inc., IPR2021-00881, Paper 1 at 3 (same); and Mylan Pharms.
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`Inc. v. Bayer Pharma Aktiengesellschaft, IPR2022-00517, Paper 1 at 1-2 (similar).
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`Here, the Petitioner should have identified Mylan Inc. and Viatris Inc. as
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`corporate parents, especially because they share a common legal department that
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`controls their activities in the present proceeding. Applications in Internet Time,
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`LLC v. RPX Corp., 897 F.3d 1336, 1342 (Fed. Cir. 2018) (stating “[c]onsiderations
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`[for RPI] may include, for example, whether a non-party exercises control over a
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`petitioner’s participation in a proceeding, or whether a non-party is funding the
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`proceeding or directing the proceeding.”); Radware, Inc. v. F5 Networks, Inc.,
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`IPR2017-01185, 2017 WL 4570445, at *6-7 (P.T.A.B. Oct. 11, 2017) (holding that
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`a parent company wholly owning the IPR petitioner entity was an RPI when, inter
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`alia, the two companies shared common legal counsel in related litigation.).
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`In a co-pending Hatch Waxman litigation, the Petitioner did not dispute that
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`its corporate parents’ legal department is responsible for day-to-day oversight of the
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`Petitioner’s litigation matters. Bausch Health Ireland Ltd. v. Mylan Lab’ys Ltd., 21-
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`cv-573 (W.D. Pa.), ECF No. 62-13 at 5. Likewise, the Petitioner has candidly
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`admitted to the PTAB that its corporate parents’ legal department handles the
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`Petitioner’s IPR matters. Mylan Pharms. Inc. v. Nissan Chemical Industries Ltd.,
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`IPR2015-01069, EX1045. Specifically, in another case, Thomas W. Jenkins stated
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`in a sworn declaration that Mylan Inc. was “responsible for managing the litigation,”
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`although like here only Mylan Pharmaceutical Inc. was named as a petitioner in that
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`case. Id. at 2. Mr. Jenkins’s declaration further states that Mylan Inc., but not Mylan
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`Pharmaceutical Inc., “decided to prepare and file the petition for inter partes review”
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`and that “[t]hat decision was solely made by [Mylan Inc.]’s in-house counsel.” Id.
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`at 3.
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`Unlike in its other cases, here the Petitioner failed to disclose Mylan Inc. and
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`Viatris Inc. as RPIs despite their corporate interrelatedness. For at least this reason,
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`trial should not be instituted.
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`II. The Board Should Deny Institution Under 35 U.S.C. § 314(a)
`The Board should exercise its discretion to deny institution under 35 U.S.C.
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`§ 314(a) in view of two Hatch-Waxman actions pending in two different district
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`courts: (1) one involving the same patents and party: Bausch Health Ireland Ltd. et
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`al. v. Mylan Pharms. Inc, Civil Action No. 1:22-cv-00020 (N.D. W. Va.) (“the
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`Mylan action”) and (2) the other involving the same patents and different parties:
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`Bausch Health Ireland Ltd. et al. v. MSN Lab’ys Private Ltd. et al., Civil Action No.
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`2:21-cv-10057 (D.N.J.) (“the MSN action”). The Board should deny institution
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`under § 314(a) to avoid the inefficient use of the Board’s resources and unnecessary
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`duplication of efforts. See NHK Spring Co. v. Intri-Plex Techs., Inc., IPR2018-
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`00752, Paper 8 at 20 (P.T.A.B. Sept. 12, 2018) (precedential); Apple Inc. v. Fintiv,
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`Inc., IPR2020-00019, Paper No. 15 at 17 (P.T.A.B. May 13, 2020) (informative).
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` Legal Framework
`Under 35 U.S.C. § 314(a), the “Board may consider events in other
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`proceedings related to the same patent, either at the Office, in district courts, or the
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`ITC.” Fintiv, Paper No. 15 at 7 (internal quotations omitted).
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`In considering whether to deny institution under § 314(a), the Board considers
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`six factors “which relate to whether efficiency, fairness, and the merits support the
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`exercise of authority to deny institution.” Fintiv, Paper No. 15 at 8. “In evaluating
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`the factors, the Board takes a holistic view of whether efficiency and integrity of the
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`system are best served by denying or instituting review.” Id.
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`
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`Factor 1: A Stay Has Not Been, and Is Unlikely to Be,
`Entered
`Under the first Fintiv factor, the Board may consider “whether the court
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`granted a stay or evidence exists that one may be granted if a proceeding is
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`in