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`Paper No. 6
`Filed: June 29, 2022
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`MYLAN PHARMACEUTICALS INC.,
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`Petitioner,
`
`V.
`
`BAUSCH HEALTH IRELAND LIMITED,
`
`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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`Paper No. 6
`Filed: June 29, 2022
`
`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
`U.S. Patent No. 7,041,786
`
`PATENT OWNER'S PRELIMINARY RESPONSE
`
`
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`TABLE OF CONTENTS
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`Case IPR2022-00722
`Patent No. 7,041,786
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`Page
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`I.
`
`II.
`
`INTRODUCTION ........................................................................................... 1
`
`BACKGROUND ............................................................................................. 8
`
`A.
`
`B.
`
`Claims of the '786 Patent. ..................................................................... 8
`
`Grounds 1-4 of the Petition ................................................................... 9
`
`ARGUMENT
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`I.
`
`The Board Should Deny Institution because the Petition Improperly
`Failed to Disclose Real Parties in Interest. .................................................... 11
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`1
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`III. The Board Should Deny Institution Under 35 U.S.C. § 325(d) .................... 26
`
`A.
`
`B.
`
`Legal Framework ................................................................................ 26
`
`The Petition Relies on the Same or Substantially the Same Art
`or Arguments Overcome During Prosecution ..................................... 28
`
`1.
`
`2.
`
`Currie (EX1005) ...................................................................... .29
`
`Li (EX1006) .............................................................................. 32
`
`C.
`
`The Petitioner Has Not Demonstrated That the Office Erred in a
`Manner Material to the Patentabili ty of Challenged Claims .............. 3 6
`
`IV. The Petition Should Be Denied Because the Petitioner Has Failed to
`Establish That Any of the Claims Are Unpatentable .................................... 39
`
`A.
`
`B.
`
`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.
`
`2.
`
`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
`
`3.
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`Trial Should Not Be Instituted on All Grounds ........................ 62
`
`V.
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`Conclusion ..................................................................................................... 63
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`TABLE OF AUTHORITIES
`
`Case IPR2022-00722
`Patent No. 7 041 786
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`Page(s)
`
`Cases
`
`Advanced Bionics, LLC v. MED-EL Elektromedizinische Gerate
`GmbH, IPR2019-01469, Paper No. 6 (P.T.A.B. Feb. 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 y s ,
`619 F.3d 1346 (Fed. Cir. 2010) ................ ..... .................. ... ... ...................... .40, 42
`
`Institut Pasteur & Universite Pierre-et-Marie-Curie v. Focarino ,
`738 F.3d 1337 (Fed. Cir. 2013) ..... .. ...... .. .... .................. ..... .. ................... ....... ... .49
`
`KSR Int'! Co. v. Teleflex Inc. ,
`550 U.S. 398 (2007) ..... ... ..... .................. ........ ........................ ......................... .... 53
`
`Mylan Lab y s Ltd. v. Janssen Pharm. Nv,
`IPR2020-00440, Paper No. 17 (P.T.A.B. Sept. 16, 2020) ..... .................. ... .passim
`
`Ortho-McNeil Pharm. , Inc. v. Mylan Lab y s, Inc. ,
`520 F.3d 1358 (Fed. Cir. 2008) ............ .... .... ......... ................. .............. ........ 53 , 57
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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. v. Seven Networks, LLC,
`IPR2018-0l 108, Paper 22 (P.T.A.B. Nov. 28, 2018) .... ..................................... l l
`
`Star Scientific, Inc. v. R.J Reynolds Tobacco Co. ,
`655 F.3d 1364 (Fed. Cir. 2011) ................... .................. ...... .. ....... ............. ......... 55
`
`Takeda Chem. Indus. , Ltd. v. Alp hap harm Pty., Ltd. ,
`492 F.3d 1350 (Fed. Cir. 2007) ........... ......... ................. ...... .. ....... ...... .... 39, 40, 57
`
`Uniloc 2017 LLCv. Facebookinc.
`989 F.3d 1018 (Fed. Cir. 2021) .......................................................................... 12
`
`Weatherford Int '!, 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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`Zerto, Inc. v. EMC Corp.,
`IPR2014-01254, Paper No. 35 (P.T.A.B. March 3, 2015) ................................. 11
`
`Federal Statutes
`
`35 U.S.C. § 102 ............................................................................................ 30, 31, 32
`
`35 U.S.C. § 312(a) ................................................................................................... 10
`
`35 U.S.C. § 314(a) .................................................................................. .4, 14, 15, 39
`
`35 U.S.C. § 325(d) ........................................................................................... .passim
`
`Hatch-Waxman Act. ......................................................................................... . passim
`
`Patent Act ................................................................................................................. 10
`
`Regulations
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`37 C.F.R § 42.8 ........................................................................................................ 10
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`37 C.F.R § 42.104 .................................................................................................... 10
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`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.
`
`7,041,786 ("the '786 patent") filed by Mylan Pharmaceuticals Inc. ("Mylan" or "the
`
`Petitioner").
`
`I.
`
`INTRODUCTION
`
`The '786 patent discloses and claims novel guanylate cyclase receptor agonist
`
`peptides that bind to intestinal receptors and enhance the intracellular production of
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`cyclic guanosine monophosphate ( cGMP). Many naturally-occurring peptides,
`
`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
`
`(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.
`
`The inventors of the '786 patent postulated that guanylate cyclase receptor
`
`agonist peptides could be useful in the treatment of various diseases, including
`
`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.
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`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.
`
`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
`
`fails to disclose real parties-in-interest;
`
`(3) the petition
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`relies on the same or substantially the same art already considered and overcome
`
`during prosecution; and (4) on the merits, because the Petitioner has failed to
`
`establish that it is likely to prevail in showing that any of the challenged claims are
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`unpatentable.
`
`First, the petition improperly fails to disclose all Real Parties-in-Interest
`
`("RPis"), including Mylan Inc. and Viatris Inc. The petition merely discloses that
`
`the Petitioner is a "co-defendant" with Mylan Laboratories Ltd., Agila Specialties
`
`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(cid:173)
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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
`
`this case, notwithstanding that the Petitioner repeatedly has identified both Mylan
`
`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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`Third, the petition also should be denied as a threshold matter under 35 U.S.C.
`
`§ 325( d) because it relies on the same or substantially the same art relied on or
`
`considered by the Examiner during prosecution. The Petitioner effectively offers
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`only one ground of unpatentability----Ground I-with respect to claim 1, which
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`covers the novel peptide plecanatide. See infra § 11.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 (EX 1006) 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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`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
`
`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
`
`why a POSA would have selected a particular lead compound over other compounds
`
`in the art. See, e.g., Otsuka Pharm. v. Sandoz, Inc., 678 F.3d 1280, 1291-92 (Fed.
`
`Cir. 2012). The Petitioner here has failed to meet this basic requirement, which
`
`renders the petition fatally flawed. It certainly provides no explanation whatsoever
`
`as to why a POSA would have selected the sequence ofuroguanylin as the POSA's
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`starting point, especially in light of other sequences having superior bioactivity, such
`
`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
`
`sequence with glutamate. In fact, the prior art taught that a substitution of Asp3
`
`would impair the bioactivity ofuroguanylin. The Petitioner argues that positions 2
`
`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
`
`risked that property by substituting a different amino acid at position 3. In addition,
`
`the Petitioner's analysis, which is laser-focused on rat uroguanylin's alleged
`
`position 3 glutamate ("Glu3
`
`1
`")
`
`, while ignoring all the differences between human
`
`uroguanylin and rat uroguanylin, is predicated on impermissible hindsight. The
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`Petitioner's hindsight-based obviousness arguments are
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`therefore
`
`internally
`
`inconsistent and cannot support a finding ofunpatentability.
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`Even further assuming that a POSA would have been motivated to make the
`
`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.
`
`The Petitioner's own references point toward a number of amino acid substitutions
`
`or other modifications such as introducing other moieties. But the petition simply
`
`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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`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.
`
`II.
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`BACKGROUND
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`A. Claims of the '786 Patent
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`The claims of the '786 patent are directed to a novel peptide consisting of the
`
`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
`
`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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`consisting of: a cGMP dependent phosphodiesterase inhibitor, an anti(cid:173)
`inflammatory agent, an antiviral agent and an anticancer agent.
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`4. The composition of either claim 2 or 3, wherein the unit dose form is
`selected from the group consisting of a tablet, a capsule, a solution and
`an inhalation formulation.
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`5. The composition of either 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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`EXl00l at 37:4-38 :10.
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`B. 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 1 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, which is directed to a peptide conjugate
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`comprising polyethylene glycol attached to plecanatide.
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`Ground
`
`Claims
`
`Obvious from the Combined Teachings of
`
`1
`
`2
`
`3
`
`4
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`1
`
`2 4-5
`'
`3-5
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`6
`
`Currie (EX1005) and Li (EX1006)
`
`Currie, Li, and Narayani (EX1007)
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`Currie, Li, Narayani, and Campieri (EX1008)
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`Currie, Li, and Ekwuribe (EX1009)
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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 I-alleged obviousness over Currie (EX1005) in view
`
`of Li (EXl 006). Therefore, if the Petitioner fails to establish unpatentability of claim
`
`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.
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`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
`
`The petition should be denied because (1) the petition improperly fails to
`
`disclose real parties in interest;
`
`-
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`(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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`The Board Should Deny Institution because the Petition Improperly
`Failed to Disclose Real Parties in Interest
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`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 ofRPis, 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
`
`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
`
`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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`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
`
`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 Aktiengesellschafl, 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.J'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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`III. The Board Should Deny Institution Under 35 U.S.C. § 325(d)
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`A.
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`Legal Framework
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`Under 35 U.S.C. § 325(d), the Board may decline to institute where "the same
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`or substantially the same prior art or arguments previously were presented to the
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`Office." 35 U.S.C. § 325(d); see also Becton, Dickinson & Co. v. B. Braun
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`Melsungen AG, IPR2017-01586, Paper No. 8 at 17 (P.T.A.B. Dec. 15, 2017)
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`(precedential); Advanced Bionics, LLC v. MED-EL Elektromedizinische Geriite
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`GmbH, IPR2019-01469, Paper No. 6 at 7 (P.T.A.B. Feb. 13, 2020) (precedential).
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`The Board applies a two-part framework when considering whether to deny
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`institution under § 325(d). First, the Board considers whether "the same or
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`substantially the same art previously was presented to the Office or whether the same
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`or substantially the same arguments previously were presented to the Office."
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`Advanced Bionics, Paper No. 6 at 8. Second, "if either condition of [the] first part
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`of the framework is satisfied, [the Board considers] whether the petitioner has
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`demonstrated that the Office erred in a manner material to the patentability of
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`challenged claims." Id.
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`In connection with this framework, the Board weighs the non-exclusive
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`factors set forth in Becton Dickinson: (a) the similarities and material differences
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`between the asserted art and the prior art involved during examination; (b) the
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`cumulative nature of the asserted art and the prior art evaluated during examination;
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`( c) the extent to which the asserted art was evaluated during examination, including
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`whether the prior art was the basis for rejection; (d) the extent of the overlap between
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`the arguments made during examination and the manner in which the petitioner
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`relies on the prior art or the Patent Owner distinguishes the prior art; ( e) whether the
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`petitioner has pointed out sufficiently how the Examiner erred in its evaluation of
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`the asserted prior art; and ( f) the extent to which additional evidence and facts
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`presented in the Petition warrant reconsideration of prior art or arguments. See
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`Advanced Bionics, Paper No. 6 at 10; Becton Dickinson, Paper No. 8 at 17-18.
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`Becton Dickinson factors (a), (b), and (d) relate to the first prong of the inquiry
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`(whether the same or substantially the same art or arguments were presented during
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`prosecution), while Becton Dickinson factors (c), (e), and (f) relate to whether the
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`petition has established a material error during prosecution. Advanced Bionics,
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`Paper No. 6 at 10.
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`B.
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`The Petition Relies on the Same or Substantially the Same
`Art or Arguments Overcome During Prosecution
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`The Petitioner offers only one ground ofunpatentability with respect to claim
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`1, which is Ground 1. 4 See Pet. at 4. The Petitioner asserts that claim 1 of the '786
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`patent would have been obvious over Currie (EX1005) in view of Li (EX1006). Id.
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`But this ground relies on the same or substantially the same art already considered
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`and/or overcome during the prosecution of the '786 patent. Becton Dickinson factors
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`(a), (b), and (d) thus favor denial.
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`4 As discussed above (supra§ 11.B.), Grounds 2-4 do not raise any additional
`arguments regarding unpatentability of claim 1, but address only claims 2-6. If the
`novel plecanatide peptide of claim 1 is determined to be non-obvious, claims 2-6
`should also be determined non-obvious, at least because claims 2-5 recite
`compositions comprising plecanatide, and claim 6 recites a conjugate of plecanatide.
`Thus, if Ground 1 is found to be unpersuasive, the petition should be denied.
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`1.
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`Currie (EXl 005)
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`a.
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`The Examiner considered Currie (EX1005) during
`prosecution
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`The Petitioner cites Currie (EXl 005) as the pnmary reference for its
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`obviousness position. Currie (EX1005) was considered by the Examiner. Currie
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`(EX1005) is listed-in fact, listed.first-on the face of the '786 patent (EX1001 at
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`1) and was included in the IDS filed during prosecution of the application. EX1004
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`at 68. The Examiner indicated that he considered Currie (EX1005) by including his
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`initials next to Currie's patent number in the IDS form. See EX1004 at 176.
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`Advanced Bionics, Paper No. 6 at 7-8 ( explaining that art not applied but previously
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`presented in an IDS can form the basis for exercising discretion and denying
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`institution under§ 325( d)).
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`Currie (EX1005) was included in the Examiner's search results at least seven
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`times during prosecution. See EX100
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