UNITED STATES PATENT AND TRADEMARK OFFICE
`
`————————————————
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`————————————————
`
`MYLAN PHARMACEUTICALS INC.,
`Petitioner,
`
`v.
`BAUSCH HEALTH IRELAND LIMITED,
`Patent Owner.
`
`————————————————
`IPR2022-01104
`Patent 9,919,024 B2
`————————————————
`
`REQUEST FOR REHEARING
`37 C.F.R. §42.71(d)(2)
`
`
`
`————————————————
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`————————————————
`
`MYLAN PHARMACEUTICALS INC.,
`Petitioner,
`
`v.
`BAUSCH HEALTH IRELAND LIMITED,
`Patent Owner.
`
`————————————————
`IPR2022-01104
`Patent 9,919,024 B2
`————————————————
`
`REQUEST FOR REHEARING
`37 C.F.R. §42.71(d)(2)
`
`
`
`TABLE OF CONTENTS
`
`I.
`II.
`
`Introduction ...................................................................................................... 1
`Incorrect Obviousness Analysis ...................................................................... 2
`A.
`Background ........................................................................................... 2
`B.
`Argument ............................................................................................... 7
`1.
`Peptides are Generally Sensitive to Moisture ............................. 7
`2.
`Plecanatide is a Peptide ............................................................. 10
`3.
`Proper Obviousness Standard is Less Rigid ............................. 11
`4.
`Bausch’s Evidence Supports Obviousness ............................... 15
`III. Conclusion ..................................................................................................... 15
`
`-i-
`
`
`
`TABLE OF AUTHORITIES
`Cases
`Galderma Labs., L.P. v. Tolmar, Inc., 737 F.3d 731 (Fed. Cir. 2013) ....................14
`Google LLC v. Parus Holdings, IPR2022-00805, Paper 7 (2022) ..........................11
`In re Dillon, 919 F.2d 688 (Fed. Cir. 1990) (en banc) ..................................... 11, 12
`In re NuVasive, 841 F.3d 966 (Fed. Cir. 2016) .......................................................13
`In re Skoll, 523 F.2d 1392 (CCPA 1975) ................................................................10
`Kashiv Biosciences v. Amgen Inc., IPR2019-00797, Paper 16 (2019) ....................10
`KSR International v. Teleflex, 550 U.S. 398 (2007) ......................................... 12, 13
`Novartis Pharm. Corp. v. Watson Labs., Inc., 611 F. App’x 988 (Fed.
`Cir. 2015) ........................................................................................................2, 13
`Nuseed Americas v. BASF Plant Science, IPR2017-02176, Paper 16
`(2018) .................................................................................................................... 9
`Richardson-Vicks Inc. v. Upjohn Co., 122 F.3d 1476 (Fed. Cir. 1997) ..................14
`TradeStation Group, Inc. v. Trading Techs. Int’l, Inc., CBM2015-00161,
`Paper 67 (2016) ..................................................................................................... 5
`Rule
`Fed. R. Evid. 703 ....................................................................................................... 8
`Regulations
`37 C.F.R. §42.15(a)(1) .............................................................................................14
`37 C.F.R. §42.71(d)(2) ............................................................................................... 1
`Constitutional Provision
`U.S. Const., amdt. V ................................................................................................14
`
`-ii-
`
`
`
`I.
`
`INTRODUCTION
`
`Petitioner (Mylan) respectfully requests rehearing of the decision (Paper 15,
`
`Dec.) denying institution. The decision misapprehends both law and fact, imposing
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`a limitless obligation on Mylan to prove a negative when no contrary contention is
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`even alleged, much less shown, and where all evidence of record, including the
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`evidence of Patent Owner (Bausch), shows Mylan is correct on the very point—
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`peptide moisture sensitivity—the decision considered lacking. Where, as here,
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`Mylan’s showing is exactly the same as the Office’s earlier uncontroverted holding
`
`on the same point, only powerful evidence of a previous error could justify an
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`inconsistent Board decision. The decision provides no reason for the agency’s
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`shifting position, and Mylan had no warning of this shift.
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`The decision also arbitrarily imposes an unlawfully heightened burden on
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`Mylan—far beyond of the likelihood standard required for institution—without
`
`providing Mylan an opportunity to reply. Mylan asked to brief Bausch’s
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`unreasonably high standard, yet the Board denied this request without a hearing.
`
`The Federal Circuit en banc rejected this heightened requirement, and the Supreme
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`Court has similarly rejected any specific-motivation requirement. To the extent
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`Bausch raised any colorable issue at all, it justifies a trial rather than dismissal. The
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`Board should withdraw its decision in Paper 15 and institute review. This request
`
`is timely. 37 C.F.R. §42.71(d)(2).
`
`-1-
`
`
`
`II.
`
`INCORRECT OBVIOUSNESS ANALYSIS
`
`A. Background
`Mylan filed a petition (Paper 2, Pet.) supported in relevant part by an expert
`
`declaration from Dr. Graham Buckton (EX1002). The petition points to Dr.
`
`Buckton’s testimony, a background survey article (EX1016, Lai), and an art
`
`handbook (EX1006, Remington) as support for the mundane, uncontroverted
`
`technical fact that peptides (like the claimed peptide) are moisture sensitive. Pet.,
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`17, 27, 46, 64-65; EX1002, ¶¶104, 140, 144; EX1016, 489 (Introduction: many
`
`protein and peptide drugs “are formulated as lyophilized or freeze-dried products
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`to prolong their shelf life” because of their “susceptibility to chemical degradation
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`in solution,” but “residual moisture” can still impact their chemical stability).
`
`Indeed, Dr. Buckton noted that the Office, citing Lai generally, had already made
`
`the same finding regarding peptides, leaving no reason to believe the issue was
`
`seriously in question. EX1002, ¶62, citing EX1022 (prosecution history), 4136-48.
`
`In response, Bausch miscited a nonprecedential decision as authority for a
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`legally-erroneous heightened-obviousness standard. Paper 8 (POPR), 53 (“But
`
`Mylan has failed to identify any teaching or suggestion in the prior art that
`
`plecanatide is moisture sensitive.”), citing Novartis Pharm. Corp. v. Watson Labs.,
`
`Inc., 611 F. App’x 988, 995-96 (Fed. Cir. 2015) . As will be explained below,
`
`controlling precedent establishes a general teaching is sufficient. Bausch conceded
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`-2-
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`
`
`Lai teaches peptide moisture sensitivity (POPR, 53), but focused on inapplicable
`
`exceptions where low moisture may cause problems, without showing the
`
`exceptions applied to plecanatide, to peptides structurally like plecanatide, or to
`
`peptides otherwise representative of plecanatide. Indeed, the inference Bausch
`
`insinuated is not even attorney argument. Bausch never actually alleged
`
`plecanatide lacks the moisture sensitivity common to peptides or that plecanatide
`
`was likely sensitive to low moisture. Bausch never identified any reason to think
`
`plecanatide followed an exception rather than the rule. Significantly, the involved
`
`patent neither identifies a low-moisture problem with plecanatide nor demonstrates
`
`the inventors solved one.
`
`Specifically, Bausch referenced Maillard reactions (POPR, 53, citing
`
`EX1016, 492, 494), but never squarely asserted, much less proved that plecanatide
`
`is sensitive to Maillard reactions. Moreover, the Board overlooked that the
`
`involved patent does not mention Maillard reactions, Schiff bases, glucose, or
`
`condensation as causing problems for plecanatide that the inventors overcame. If
`
`Maillard reactions were a problem for plecanatide, and given the lack of notice in
`
`the prior art or the involved patent, the onus should have been on Bausch to at least
`
`explain why a POSA would expect the exceptions rather than the general rule (on
`
`which Mylan reasonably relied) to apply specifically to plecanatide.
`
`Bausch also broadly pointed to other factors that might affect peptide
`
`-3-
`
`
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`stability. POPR, 53, citing EX1016, 493-97 as a block. Logically, this argument is
`
`irrelevant. The fact that peptides may also face other issues does not prove that a
`
`POSA would ignore moisture. Bausch further insinuated that Lai says the effect of
`
`moisture on solid-state peptides is not widely reported or understood. POPR, 53. In
`
`fact, Lai says (citations omitted):
`
`The importance of temperature, moisture, and formulation excipients in
`determining the solid-state stability of small molecule drugs has been
`widely reported and accepted. However, the effects of these factors on
`the solid state chemical stability of proteins and peptides are not as
`widely reported or understood.
`
`In sum, Lai only says the effects for peptides are not as widely reported and
`
`understood as they are for small molecules. This observation falls well short of
`
`unpredictability (particularly given the Office’s prior finding to the contrary), and
`
`at most creates a triable fact issue. To the extent the Board adopted Bausch’s
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`argument, it misapprehended what Lai actually said.
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`The decision further overlooks that Bausch does not (and honestly cannot)
`
`actually link a low-moisture problem to plecanatide. Even if Bausch had made
`
`such a link, however, this mere attorney argument would have warranted a trial on
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`the merits to test Bausch’s assertion. Instead, the decision assumed without basis
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`that plecanatide followed an exception rather than the rule, contrary to the Office’s
`
`earlier finding on the same issue with the same background reference, and contrary
`
`-4-
`
`
`
`to the unrebutted testimony of a distinguished expert.
`
`Mylan requested a surreply to address Bausch’s heightened obviousness
`
`standard. EX1039.1 Pursuant to Board practice, the email requested a telephone
`
`hearing, and only sketched the problem2 to avoid the Board’s stricture against
`
`argumentative emails,3 with the expectation that the argument would be presented
`
`during the call. Instead, the Board denied the request without a call and without
`
`explanation. Id. (“Having considered the parties’ positions in their joint email, the
`
`panel has determined that there is good cause for a reply…but not issue (2) (legal
`
`1 Good cause exists to enter this Board ruling, which is not in the record.
`
`2 EX1039, 1-2: “Patent Owner’s heightened legal standard for obviousness,
`
`including its ‘lead composition’ argument for formulation claims” and “The replies
`
`will address mischaracterizations of fact and law in the preliminary responses that
`
`were not anticipated. Petitioner believes … briefing is appropriate because of the
`
`… fact-specific application of Patent Owner’s erroneous legal standard for
`
`obviousness in the preliminary response.”
`
`3 E.g., TradeStation Group, Inc. v. Trading Techs. Int’l, Inc., CBM2015-00161,
`
`Paper 67, 3-4 (2016) (“[T]he request should be limited to a short statement
`
`regarding the purpose of the call only and should not contain substantive
`
`communications to the Board”) (original emphasis).
`
`-5-
`
`
`
`standard for obviousness/lead compound).”). Thus, Mylan never had an
`
`opportunity to address Bausch’s erroneous legal standard.
`
`The decision misapprehends the relevant law by adopting Bausch’s improper
`
`standard—requiring specific motivation—relying on the same nonprecedential
`
`case. Dec., 16. The decision goes so far as to say, “But other evidence Petitioner
`
`cites reflects that moisture content is a factor that influences degradation of all
`
`drug formulations, whether they comprise small molecules or peptides.” Dec., 15.
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`Thus, under the decision’s standard, if a problem is well-known, a POSA would
`
`not address it. The decision misapprehends that a POSA would expect a general
`
`teaching would apply to members of a class absent a showing of an exception.
`
`The decision also goes beyond what Bausch argued (providing Mylan with
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`even less notice), pointing to other instances of a “bell-shaped relationship” with
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`moisture for specific, much larger proteins (bovine serum albumin, recombinant
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`human interleukin-1 receptor agonist, ovalbumin, glucose oxidase, β-lactoglobulin,
`
`recombinant human albumin). Dec., 16-17, citing EX1016, 494. But the decision
`
`never explains why the exceptions for these specific proteins necessarily apply to
`
`the small peptide, plecanatide. Again, at best, this is a triable issue Mylan will
`
`rebut if Bausch asserts it.
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`Indeed, the decision quotes Lai as reporting “[r]esidual moisture is often
`
`thought to be responsible for protein and peptide chemical instability in the solid-
`
`-6-
`
`
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`state”. Dec., 16, citing EX1016, 494. Yet the decision overlooks the next sentence:
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`“In general, lyophilized protein formulations are more stable at lower water
`
`contents.” EX1016, 494 (emphasis added). In the decision, the uncorrelated
`
`exceptions swallow the general rule without explanation or evidence or even any
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`affirmative assertion of fact by Bausch.
`
`B. Argument
`The decision (Paper 15, 14-18) focuses on the testimony of Dr. Buckton
`
`(EX1002), an expert whose credibility and experience are unquestioned, and a
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`background reference from the Journal of Pharmaceutical Sciences (Lai, EX1016).
`
`Significantly, Lai is not a ground reference but simply background support for the
`
`indisputable proposition that peptides are generally sensitive to moisture. The
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`decision misapprehends the law and the record in dismissing Dr. Buckton’s
`
`testimony as “conclusory” and the Lai reference as “equivocal”. Dec., 15, 17-18.
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`The decision overlooks that the general teaching of moisture sensitivity of peptides
`
`is not (and cannot seriously) be disputed. The decision misapprehends well-settled
`
`law rejecting any requirement for a specific teaching in the prior art that
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`plecanatide—an undisputed peptide—is especially sensitive to water.
`
`1. Peptides are Generally Sensitive to Moisture
`
`As the decision notes, Dr. Buckton, an emeritus professor of pharmaceutics
`
`with a long and distinguished career (EX1003), provided the unremarkable
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`-7-
`
`
`
`testimony that “In particular, it was well known that peptides in particular are
`
`generally subject to degradation from moisture during storage.” EX1002, ¶104,
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`cited in Dec., 17-18; also citing EX1002, ¶144. Indeed, Dr. Buckton had earlier
`
`noted the examiner—citing Lai—made the same finding. EX1002, ¶62, citing
`
`EX1022, 4136-48. As an expert, Dr. Buckton can testify on the basis of his
`
`uncontested personal experience in the art when stating what a POSA would have
`
`known (id., ¶83), as well as on the basis of an article on which others in the art
`
`would rely. Fed. R. Evid. 703. Dr. Buckton did both: first stating his opinion (not
`
`quoting Lai), then citing Lai as a supporting example. Id. , ¶104 (“See, e.g.,
`
`EX1016 (Lai), 489.”) (footnote omitted). In citing Lai, for the same proposition the
`
`examiner cited Lai, Dr. Buckton had no reason to suspect that extensive
`
`explanation was necessary for a background proposition that was not disputed
`
`during prosecution. EX1022, 4139 (“The stability of peptide drugs was known to
`
`be sensitive to temperature, moisture and excipients taught by Lai et al. in the
`
`Abstract (J Pharm Sci. 1999 May;88(5):489-500. Review.).”). Indeed, Bausch
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`obtained allowance of the claims by arguing during prosecution that a POSA
`
`would have assumed plecanatide had storage instability common to peptides and
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`by arguing that plecanatide turned out to be unexpectedly stable in storage without
`
`the aid of additional stabilizing excipients beyond the low-moisture carrier. Pet., 2,
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`8-10, 60-65, citing EX1022, 0369-86, 4973-77, 5079-89, 5090-94, 5098, EX1021,
`
`-8-
`
`
`
`0409-19, 0720-29; also citing EX1002, ¶¶72-79, 590-601. For example, Bausch
`
`argued “GCC agonist peptide formulated with a low moisture carrier are [sic] more
`
`stable than expected compared to formulations comprising a regular-grade
`
`carrier.”) EX1022, 0379 (emphasis added). A switch to a low-moisture carrier
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`could not have resulted in a formulation more stable than expected unless a POSA
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`would have expected the low-moisture formulation to be stable.
`
`Yet before the Board, Bausch insinuated that moisture is not generally a
`
`concern for peptides, while failing to prove this inconsistent point. Similarly, the
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`decision acknowledges moisture is one known concern for peptides. Dec., 15. To
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`the extent the Board has doubts about Dr. Buckton’s unrebutted expert opinion—
`
`which follows the Office’s prior finding on the same point—the Board may note it
`
`as an issue for further development during trial. The Office should not make
`
`contrary findings without powerful new evidence. Vicor Corp. v. SynQor, Inc.,
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`869 F.3d 1309, 1321-22 (Fed. Cir. 2017) (inconsistent USPTO decisions indicate
`
`error). In rejecting well-settled fact without any semblance of contrary evidence,
`
`the decision overlooks the evidence of record, misapprehends the role of expert
`
`testimony, and requires a word-limited petitioner to anticipate in the petition issues
`
`not posed by the intrinsic evidence or prosecution history. Cf. Nuseed Americas
`
`Inc. v. BASF Plant Sci. GmbH, IPR2017-02176, Paper 16, 7 (2018) (“[I]t would be
`
`impractical to require petitioners to prove infinite negatives”); Kashiv Biosciences
`
`-9-
`
`
`
`v. Amgen Inc., IPR2019-00797, Paper 16, 23 (2019) (explaining a petitioner cannot
`
`anticipate and refute every possible counter argument).
`
`2. Plecanatide is a Peptide
`
`Mylan established a basic logical syllogism: peptides generally are moisture-
`
`sensitive, plecanatide is a peptide, thus a POSA would expect plecanatide to be
`
`moisture-sensitive. Against this basic observation, Bausch noted that other
`
`considerations might apply, but does not even squarely allege—much less prove—
`
`that any of these concerns were likely with plecanatide. At best, Bausch’s
`
`assertions created a triable issue, Instead, the decision placed without notice a
`
`burden for Mylan to eliminate prospectively all conceivable exceptions. Yet, in this
`
`case, Bausch’s own evidence confirms the general expectation: less moisture
`
`correlates to improved stability. Cf. In re Skoll, 523 F.2d 1392, 1397 (CCPA 1975)
`
`(“Expected beneficial results are evidence of obviousness of a claimed invention”).
`
`No one disputes plecanatide is a peptide. Indeed, plecanatide is sixteen
`
`amino acids connected by hydrolysable peptide bonds:
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`Pet., 23, citing EX1001; see also EX1016, 489 (“bond cleavage”).
`
`Rather than prove or even assert that plecanatide is immune to peptides’
`
`general moisture problems, Bausch instead argues, citing Lai, that low moisture
`
`can be a problem for some peptides but without tying (or even squarely alleging
`
`-10-
`
`
`
`relevance for) this specific problem to this specific peptide. While Lai notes a few
`
`specific low-moisture problems for specific (non-plecanatide) peptides, the only
`
`general problem it identifies is Maillard reactions (in foods). EX1016, 491-92.
`
`Bausch never even asserted, much less demonstrated, the conditions for a Maillard
`
`reaction are present in the claimed formulation or, if present, are actually a
`
`problem. Bausch’s specification indicates otherwise by its silence. Again, a word-
`
`limited petitioner cannot reasonably be expected to anticipate and prospectively
`
`rebut every imaginable attorney-argument. If Bausch believes Maillard reactions
`
`are a significant formulation concern, it may try to prove it at trial. The decision
`
`overlooked the utter lack (or even proffer) of basis for Bausch’s putative teaching
`
`away or expectation of failure. Cf. Google LLC v. Parus Holdings, IPR2022-
`
`00805, Paper 7, 27-28 (2022) (“Petitioner’s showing is sufficient to satisfy the
`
`standard we apply at this stage of the proceeding. Patent Owner’s distinctions…are
`
`not, at this time, supported by testimonial or other extrinsic evidence, and such
`
`distinctions may meaningfully be developed during the trial.”).
`
`3. Proper Obviousness Standard is Less Rigid
`
`Long before even KSR, the Federal Circuit rejected the sort of specific
`
`obviousness-as-anticipation argument Bausch advances, i.e., requiring the prior art
`
`to provide the inventor’s specific motivation for obviousness. In re Dillon,
`
`919 F.2d 688 (Fed. Cir. 1990) (en banc). In Dillon, a chemical formulation case,
`
`-11-
`
`
`
`the court expressly rejected the dissent’s proposition that “where an applicant
`
`asserted that an invention possessed properties not known to be possessed by the
`
`prior art, no prima facie case was established unless the reference also showed the
`
`novel activity.” Id. at 696. Rather, “prior art close enough to the claimed invention
`
`to give one skilled in the relevant chemical art the motivation to make close
`
`relatives (homologs, analogs, isomers, etc.) of the prior art compound(s), then there
`
`arises what has been called a presumption of obviousness or a prima facie case of
`
`obviousness.” Id. That is, where the relevant structure (here, peptides) is the same,
`
`motivation exists to apply the teaching (reduce moisture), and the burden of
`
`production shifts to the patentee to show this facially obvious modification is
`
`wrong. KSR International v. Teleflex, 550 U.S. 398, 418 (2007) (“As our
`
`precedents make clear, however, the analysis need not seek out precise teachings
`
`directed to the specific subject matter of the challenged claim, for a court can take
`
`account of the inferences and creative steps that a person of ordinary skill in the art
`
`would employ.”); see also id. at 416 (“combination of familiar elements according
`
`to known methods is likely to be obvious when it does no more than yield
`
`predictable results”).
`
`-12-
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`
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`Controlling precedent4 uniformly rejects the idea that a general motivation is
`
`insufficient for obviousness and does so because this idea is paradoxical.
`
`Categorically rejecting general motivation would mean that the more an option is
`
`known in the art, the less legally obvious it would be. This is why the Supreme
`
`Court admonishes against such “[r]igid preventative rules that deny factfinders
`
`recourse to common sense”. Id. at 421. Mylan tried to alert the panel to the legal
`
`error Bausch was inviting, but Mylan was not permitted to explain, much less
`
`brief, its concern. EX1039;5 cf. In re NuVasive, 841 F.3d 966, 970-971 (Fed. Cir.
`
`2016) (Board “rules and practices protect against such loss in a given case only
`
`4 Novartis actually supports Mylan. The district court had found no evidence to
`
`support a need for an antioxidant, while here the record supports that the facially-
`
`ordinary peptide plecanatide would behave as peptides generally do absent
`
`evidence to the contrary. Significantly, the decision affirmed in Novartis was made
`
`after a full trial, including witness credibility determinations and evidence from
`
`Novartis showing why the prior art was not probative in view of relevant structural
`
`differences, a showing utterly missing here. Novartis thus actually shows a trial is
`
`warranted.
`
`5 Board policy bars argumentative emails, which limited the detail Mylan could
`
`provide. The Board ruled without granting the requested conference call.
`
`-13-
`
`
`
`when, upon a proper request, the PTO actually provides the opportunities
`
`required by the APA and due process”) (emphasis added).
`
`Similarly, to the extent Lai identifies other potential problems, neither
`
`Bausch nor the decision cite any authority that a proposed modification must solve
`
`all possible problems. Indeed, the case law instead recognizes that a POSA can
`
`choose to make known trade-offs. Galderma Labs., L.P. v. Tolmar, Inc., 737 F.3d
`
`731, 738-39 (Fed. Cir. 2013) (expected increase in side effects would not
`
`discourage); Richardson-Vicks Inc. v. Upjohn Co., 122 F.3d 1476, 1484 (Fed. Cir.
`
`1997) (loss of flexibility would not discourage). Here the use of a low-moisture
`
`excipient in exchange for expected improved stability is precisely the sort of trade-
`
`off a POSA would consider conventional.
`
`In the present case, Mylan alerted the Board to Bausch’s use of an
`
`improperly heightened obviousness standard, but the Board did not authorize
`
`Mylan to address the issue. EX1039. As a result, the Board required Mylan to have
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`prospectively proven a negative—the absence of every possible exception to the
`
`rule—without requiring Bausch in response to allege explicitly that any specific
`
`exception was expected for plecanatide. The decision thus imposed an impossible
`
`burden on Mylan. By imposing this improper standard—particularly, on the
`
`current record—the decision failed to afford Mylan the due process to which it was
`
`entitled. 37 C.F.R. §42.15(a)(1); U.S. Const., amdt. V.
`
`-14-
`
`
`
`4. Bausch’s Evidence Supports Obviousness
`
`Bausch contended before the examiner and in its preliminary response that a
`
`lower-moisture formulation unexpectedly improved plecanatide’s stability. Yet
`
`improved stability is exactly what a POSA would expect with a low-moisture
`
`carrier for most peptides. Pet., 65, citing EX1002, ¶¶600-601; EX1016, 494. Mylan
`
`explained at length why this result was not unexpectedly good, but rather an
`
`expected improvement. Pet., 3, 60-65, especially 64. Adapt Pharma Ops. v. Teva
`
`Pharms. USA, Inc., 25 F.4th 1354, 1374 (Fed. Cir. 2022) (an expected
`
`improvement is not an unexpected result). A telling irony is that Bausch is
`
`claiming an improvement for a problem that it now insinuates (without actually
`
`saying) does not exist. The Board should not reward such game-playing.
`
`III. CONCLUSION
`
`The challenged claims are likely to be unpatentable on the present record.
`
`The Board misapprehended the controlling obviousness standard and overlooked
`
`the ample evidence supporting obviousness, while shifting the agency’s position on
`
`this very same issue with no explanation or notice, and imposing an impossible
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`burden on Mylan. Mylan respectfully requests the institution decision be
`
`withdrawn, the IPR be instituted, and the involved claims be canceled.
`
`-15-
`
`
`
`Dated: February 3, 2023
`
`Respectfully submitted,
`
`
`
`/Richard Torczon/
`Richard Torczon
`Reg. No. 34,448
`for Mylan Pharmaceuticals Inc.
`
`-16-
`
`
`
`CERTIFICATE OF SERVICE
`
`I certify this paper was served today electronically on Bausch’s counsel at:
`
`Justin J. Hasford
`
`justin.hasford@finnegan.com
`
`Bryan C. Diner
`
`bryan.diner@finnegan.com
`
`Joshua Goldberg
`
`joshua.goldberg@finnegan.com
`
`Kassandra M. Officer Kassandra.officer@finnegan.com
`
`Lauren J. Robinson
`
`lauren.robinson@finnegan.com
`
`Caitlin O’Connell
`
`caitlin.o’connell@finnegan.com
`
`Kyu Yun Kim
`
`kyuyun.kim@finnegan.com
`
`Dated: February 3, 2023
`
`/Robyn Moriarty/
`Robyn Moriarty
`
`
`
`-17-
`
`
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