throbber

`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`————————————————
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`————————————————
`
`MYLAN PHARMACEUTICALS INC.,
`MSN LABORATORIES PRIVATE LTD.,
`and MSN PHARMACEUTICALS INC.,
`Petitioners,
`
`v.
`
`BAUSCH HEALTH IRELAND LIMITED,
`Patent Owner.
`
`————————————————
`Case IPR2022-007221
`Patent 7,041,786
`————————————————
`
`PETITIONER MYLAN’S
`MOTION TO EXCLUDE
`37 C.F.R. §42.64(c)
`
`
`
`1 IPR2023-00016 has been joined with this proceeding.
`
`

`

`
`
`TABLE OF CONTENTS
`
`I. 
`II. 
`
`C. 
`D. 
`
`Page
`Introduction ...................................................................................................... 1 
`Reasons for Exclusion ..................................................................................... 1 
`A. 
`EX2001-EX2007 – Fintiv Exhibits ....................................................... 1 
`B. 
`EX2024 (Davies Declaration) and EX2025 (Waldman
`Declaration) ........................................................................................... 1 
`EX2027, EX2028 – Shailubhai Reports ................................................ 9 
`EX2040 – Unauthenticated Hearsay Attributed to Dr.
`Pennington ........................................................................................... 10 
`III.  Conclusion ..................................................................................................... 14 
`
`
`
`
`
`
`-i-
`
`

`

`
`
`TABLE OF AUTHORITIES
`
`Pages
`
`Cases 
`Altana Pharma AG. v. Teva Pharms., 566 F.3d 999 (Fed. Cir. 2009) ...................... 2
`Apator Miitors ApS v. Kamstrup A/S, 887 F.3d 1293 (Fed. Cir. 2018) ..................... 9
`Huddleston v. United States, 485 U.S. 681 (1988) ................................... 1, 9, 10, 14
`Intelligent Bio-Systems v. Illumina Cambridge, 821 F.3d 1359 (Fed. Cir.
`2016) ..................................................................................................................... 4
`Kumho Tire Co. v. Carmichael, 526 U.S. 137 (1999) ...........................................1, 2
`U.S. Gypsum Co. v. Lafarge N. Am. Inc., 670 F. Supp. 2d 737 (N.D. Ill.
`2009) ..................................................................................................................... 2
`Rules 
`Fed. R. Evid. 105 ............................................................................................ 1, 9, 10
`Fed. R. Evid. 402 ....................................................................................................... 1
`Fed. R. Evid. 403 ............................................................................................ 1, 9, 10
`Fed. R. Evid. 603 ....................................................................................................... 1
`Fed. R. Evid. 702 ....................................................................................................... 1
`Fed. R. Evid. 802 ............................................................................................ 1, 9, 10
`Fed. R. Evid. 901 ............................................................................................ 1, 9, 10
`Regulations 
`37 C.F.R. §42.64(c) .................................................................................................... 1
`37 C.F.R. §42.65 .................................................................................................... 1, 2
`Statutes 
`35 U.S.C. §103 ........................................................................................................... 3
`
`-ii-
`
`

`

`
`
`I.
`
`INTRODUCTION
`Petitioner (Mylan) requests exclusion of patentee (Bausch) exhibits
`
`EX2001-EX2007, EX2024, EX2025, EX2027, EX2028, and EX2040 for failure to
`
`comply with the Federal Rules of Evidence (FRE). 37 C.F.R. §§42.64(c), 42.65.
`
`II. REASONS FOR EXCLUSION
`A. EX2001-EX2007 – Fintiv Exhibits
`Mylan timely objected to EX2001-EX2007 under FRE 402 and FRE 403,
`
`
`
`and requested a limiting instruction under FRE 105. Paper 18, 1-2. These exhibits
`
`were offered to support a pre-institution argument—Fintiv—that was not preserved
`
`during trial. These exhibits are not relevant to any pending issue and are unduly
`
`prejudicial to the extent that they could be used to resuscitate a forfeited issue now
`
`or on appeal. These exhibits should be excluded. To the extent these exhibits are
`
`admitted, their scope should be restricted to minimize prejudice so far as possible.
`
`Huddleston v. United States, 485 U.S. 681, 691-92 (1988).
`
`B. EX2024 (Davies Declaration) and EX2025 (Waldman
`Declaration)
`Mylan timely objected to each of EX2024 and EX2025 under FRE 402,
`
`
`
`FRE 403, FRE 603, FRE 702, FRE 802, and FRE 901; and requested a limiting
`
`instruction under FRE 105. Paper 30, 1-2. The Board must ensure that expert
`
`testimony is both relevant and reliable. Kumho Tire Co. v. Carmichael, 526 U.S.
`
`137, 147 (1999). Whether testimony is based on experience or knowledge, it must
`
`-1-
`
`

`

`
`
`employ the level of intellectual rigor characterizing experts in the field. Id. at 152,
`
`153 (the district court “excluded the testimony because, despite those
`
`qualifications, it initially doubted, and then found unreliable” the methodology and
`
`the “basis, if any”). This inquiry does not focus on reliability in a general sense,
`
`but rather reliability for the proffered purpose. Id. at 154; see also 37 C.F.R.
`
`§42.65 (requiring basis for expert opinion).
`
`
`
`Expert testimony should be excluded when it is based on a legally erroneous
`
`standard. See, e.g., U.S. Gypsum Co. v. Lafarge N. Am. Inc., 670 F. Supp. 2d 737,
`
`745 (N.D. Ill. 2009) (“Having applied the incorrect legal standard …, Davis will
`
`not be permitted to testify on that topic.”). The Board correctly noted in its
`
`institution decision that Bausch advanced legal error by arguing that uroguanylin
`
`was not a lead compound because it asserted that ST enterotoxin was a more
`
`promising lead compound. Paper 16 at 22-23 (noting “our reviewing court has
`
`cautioned that it would be overly restrictive to” require only a single lead
`
`compound); Altana Pharma AG. v. Teva Pharms., 566 F.3d 999, 1007-08 (Fed.
`
`Cir. 2009) (legally impermissible to require the prior art to “point to only a single
`
`lead compound”). Drs. Davies and Waldman nonetheless argue repeatedly that
`
`uroguanylin was not a lead compound because Dr. Currie allegedly (and
`
`subsequently) selected a particular heat-stable enterotoxin as a lead compound for
`
`further development and allegedly modified it to invent linaclotide. E.g., EX2024,
`
`-2-
`
`

`

`
`
`¶¶92, 99, 140-41; EX2025, ¶¶68-69. But just as patentability cannot be negated by
`
`the path the inventors took, it is legal error for Drs. Davies and Waldman to use the
`
`post-critical date path taken by a different inventor to conclude that uroguanylin
`
`was not a lead compound for further modification. 35 U.S.C. §103.
`
`
`
`Drs. Davies and Waldman also repeatedly treat uroguanylin and STs as
`
`mutually-exclusive alternatives such that the availability of one must necessarily
`
`have dissuaded modification of the other. E.g., EX2024, ¶¶136-41 (arguing greater
`
`alleged potency of STs made them “more attractive” and therefore would have
`
`dissuaded modification of uroguanylin), 131-135 (arguing that alleged natural in
`
`vivo topoisomeric interconversion of natural ligand uroguanylin made STs more
`
`attractive, therefore would have dissuaded selection of uroguanylin); EX2025,
`
`¶¶64-73 (arguing that one of the STs produced by enterotoxigenic strains of
`
`bacteria would have been an ideal starting point for further improvement and that
`
`their inducement of fatal diarrhea “would not have dissuaded a person of ordinary
`
`skill in the art from selecting heat-stable enterotoxins over human uroguanylin”).
`
`Dr. Davies’s and Dr. Waldman’s lead compound testimony should be excluded in
`
`its entirety for erroneously requiring a single lead compound.
`
`
`
`Dr. Davies also applied a legally erroneous standard for reasonable
`
`expectation of success. Dr. Davies was correctly instructed that the legal standard
`
`for reasonable expectation of success is for making “the invention as claimed.”
`
`-3-
`
`

`

`
`
`EX2024, ¶25. Indeed, reasonable expectation of success is only required for what
`
`is claimed. Intelligent Bio-Systems v. Illumina Cambridge, 821 F.3d 1359, 1367
`
`(Fed. Cir. 2016); Paper 16, 20 (Board finding at institution that petition showed
`
`“that a POSA would have been motivated to substitute glutamic acid for the Asp3
`
`in human uroguanylin and would have had a reasonable expectation of success in
`
`doing so.”). Here, claim 1 merely recites the [Glu3]-human uroguanylin peptide
`
`sequence. EX1063, ¶¶114-117; EX1060, 20:3-14 (“Claim 1 is for a peptide of the
`
`given sequence, and that’s all”), 111:17-112:13, 108:22-110:15 (SEQ ID NO. 20
`
`“just gives you the linear sequence”). It is undisputed that a POSA could make
`
`[Glu3]-human uroguanylin easily using known methods. See, e.g., Pet., 21-22,
`
`EX1002, ¶¶66-67; Pet., 24, EX1002, ¶¶130-31; Pet., 35-36; EX1005, 3:8-45;
`
`EX1002, ¶¶130-31. This evidence is unrebutted. EX1060, 130:9-20, 126:10-128:4;
`
`EX1063, ¶¶8, 115. Accordingly, there is no genuine dispute that Mylan has
`
`satisfied its burden regarding reasonable expectation of success.
`
`
`
`Ignoring the requirements of the law, the Board’s institution decision, and
`
`the instructions he was given, Dr. Davies repeatedly argues that a POSA lacked
`
`reasonable expectation of success for making things that are not claimed. E.g.,
`
`EX2024, ¶¶36 (conclusory argument of no REOS), iii, 39, 124, 204-205, et seq.
`
`(alleging stability, potency, heat stability, and binding affinity undermine REOS).
`
`The challenged claims do not recite stability, potency, heat stability, or binding
`
`-4-
`
`

`

`
`
`affinity. EX1001, claims. Nor does Dr. Davies ever demonstrate that all
`
`topoisomers falling within the scope of the claims (which are not limited to a
`
`particular topoisomer or a particular topoisomeric purity) have the stability,
`
`potency, heat stability, or binding affinity that Dr. Davies relies upon for his
`
`“reasonable expectation of success” argument. Dr. Davies’s misunderstanding of
`
`the applicable legal standard again renders his testimony unreliable and baseless.
`
`
`
`The opinions of Drs. Davies and Waldman that Li (Fig. 3) “provides
`
`comparative activity information” and demonstrates that opossum uroguanylin was
`
`more potent than rat uroguanylin (e.g., EX2024, ¶¶75-79, 88, 90, 161-65, 170;
`
`EX2025, ¶¶57, 66, 82) should be excluded for being unreliable and lacking basis.
`
`Dr. Davies recognized that Li attributed increased affinity “to the acidic residue at
`
`positions 2, 3, and 9” (EX2024, ¶188), and Li expressed the expectation that rat
`
`uroguanylin’s potency would be shown in future dose/response experiments to be
`
`“comparable to that of opossum or human uroguanylin” because it conserves acidic
`
`residues at those positions (EX1006, 54). EX1063, ¶¶78-82. Li Fig. 3 evaluated
`
`whether preincubation with endogenous protease enhanced the activity of fractions
`
`extracted from rat intestines and from synthetic standards but did not purport to
`
`compare the activity of one peptide to another. EX1063, ¶¶82-87; EX1006, 49-51,
`
`Fig. 3 & Caption; EX1060, 177:3-178:8, 182:1-183:16, 184:16-186:2. As became
`
`clear during Dr. Davies’s deposition, he misunderstood Li because he did not
`
`-5-
`
`

`

`
`
`analyze it completely. EX1063, ¶¶83-84; EX1060, 139:19-144:20, 160:15-166:12,
`
`168:2-171:22, 172:1-173:19. Dr. Waldman adopted strikingly similar errors in his
`
`own declaration without independent analysis or other explanation. Their
`
`misinterpretation of Li led them to the erroneous conclusion that rat guanylin is
`
`more potent than opossum uroguanylin (EX2024, ¶188), contrary to Hamra
`
`1993’s teachings that potency differed 10-fold in the opposite direction. EX1063,
`
`¶¶88-89; EX1006, 49 (Fig. 3); EX1012, Abstract, 10465-67; EX1060, 131:4-
`
`137:22. Because their teaching away opinions were predicated on this
`
`misinterpretation of Li Fig. 3, they should be excluded as unreliable and as lacking
`
`basis.
`
`
`
`Dr. Davies’s opinions based on buried amino acid residues (e.g., pKa in
`
`EX2024, ¶¶174-86 and amino acid prevalence in EX2024, ¶¶101-06, 147, 153-
`
`156, 214) should be excluded for being unreliable and lacking basis. For example,
`
`Dr. Davies relies on references discussing the pKa of “the buried aspartic acid,” an
`
`amino acid “placed in the hydrophobic core of nuclease,” and “internal ionizable
`
`groups” as compared to “the free amino acid” in which the side chain is “exposed”
`
`to water. EX2024, ¶¶179-81, 184; EX1063, ¶¶101-103; EX2043, 2; EX2044, 567-
`
`70, Table 1; EX2045, 34-35, 37, Table 1. Dr. Davies provides no basis for his
`
`argument that the buried-residue pKa values are relevant to position 3 of the
`
`human uroguanylin peptide chain, because the first three N-terminus residues were
`
`-6-
`
`

`

`
`
`known to be not buried and to be unstructured (as described in additional detail
`
`below). EX1063, ¶¶102-103; EX2010, 235 Fig. 4A-C. Dr. Davies also provides no
`
`basis for his arguments that conservation of buried-Asp structures are relevant to
`
`position 3 of human uroguanylin. EX1063, ¶¶63-65; EX2036, Abstract, 225-28;
`
`EX2010, 233, 235. Drs. Davies and Waldman selected the same incomplete
`
`graphic of human uroguanylin from EX2010 Fig. 4 (below left) that excluded
`
`position 3 (EX2024, ¶66; EX2025, ¶48), obscuring the fact that position 3 is not
`
`buried, as shown in the graphic that includes position 3 (below right). Because
`
`their opinions about buried amino acids find no basis in the unstructured, water-
`
`exposed position 3 of human uroguanylin, they should be excluded.
`
`
`
`
`
`The opinions of Drs. Davies and Waldman alleging human uroguanylin was
`
`prone to undesirable levels of topoisomeric interconversion (e.g., EX2024, ¶¶127-
`
`133, 135-147, 216-243; EX2025, ¶¶46-53, 55, 57) should be excluded for being
`
`unreliable and lacking basis. Their topoisomeric interconversion arguments are
`
`predicated on human uroguanylin being stored at 37°C at a pH of 4.5 for 24 hours.
`-7-
`
`

`

`
`
`EX2024, ¶131; EX2025, ¶52; EX2010, 236. But they never demonstrated that
`
`human uroguanylin generally was required to be stored or used at 37°C or at a pH
`
`of 4.5, much less doing so for 24 hours. This is true for synthesis, purification, or
`
`manufacturing as well as in vivo use. Bausch presented no evidence rebutting the
`
`testimony of Drs. Peterson and Epstein that a POSA normally would have expected
`
`orally administered uroguanylin not to be exposed to this low pH for over an hour,
`
`with no more than 1% interconversion, and that uroguanylin was known to be
`
`stable and effective in vivo after oral administration. EX1063, ¶¶25-27; EX1064,
`
`¶¶25-31, 39; EX2010, 236; EX1070; EX1018, G641-G642; EX2021, 2:28-3:1. The
`
`Board should therefore exclude all testimony of Drs. Davies and Waldman about
`
`topoisomerism as unreliable and lacking basis.
`
`
`
`The Board also should exclude all testimony of Drs. Davies and Waldman
`
`that relies upon exhibits that are not admissible (e.g., EX2027, EX2028, EX2040,
`
`as discussed below). E.g., EX2024, ¶¶58, 128 (EX2040), 204-238 (EX2027,
`
`EX2028); EX2025, ¶¶89, 95-111 (EX2027, EX2028). Though Drs. Davies and
`
`Waldman cite EX2027 and EX2028 (and Dr. Davies also cited EX2040), they
`
`never testified that experts in the particular field would reasonably rely on these
`
`kinds of exhibits in forming an opinion on the subject. Having failed to establish
`
`proper basis for expert testimony relying on EX2027, EX2028, and EX2040, their
`
`testimony relying on them should itself be excluded.
`
`-8-
`
`

`

`
`
`
`
`If any of these exhibits is admitted, its scope should be restricted to
`
`minimize prejudice so far as possible. Huddleston, 485 U.S. at 691-92.
`
`C. EX2027, EX2028 – Shailubhai Reports
`Mylan timely objected to EX2027 and EX2028 under FRE 403, FRE 802,
`
`
`
`and FRE 901; and requested a limiting instruction under FRE 105. Paper 30, 2-3.
`
`The documents purport to be reports created in 2015, more than a decade after the
`
`claimed critical date of the invention, signed only by the first named inventor,
`
`Kunwar Shailubhai.2 The reports purport to amend earlier reports (still more than
`
`six years after the critical date) purportedly co-signed by another named inventor,
`
`Gary Jacob, who has not provided testimony in this proceeding. The Federal
`
`Circuit has described an inventor corroborating his own corroborating documents
`
`as a “catch-22.” Apator Miitors ApS v. Kamstrup A/S, 887 F.3d 1293, 1296-97
`
`(Fed. Cir. 2018). Neither inventor signed under oath.
`
`
`
`Moreover, these reports purport to describe studies conducted in late 2001
`
`(EX2027, 1; EX2028, 1), nearly seven years before the unamended reports and
`
`nearly fourteen years before the amended reports (all long after the critical date).
`
`The reports purport to be based on the work of “Dr. Surendra Dheer,” who has not
`
`provided any testimony in this proceeding. To the extent the statements, including
`
`
`
`2 January 17, 2002. EX1001, cover page (54), (60).
`
`-9-
`
`

`

`the data, are offered for their truth, they are hearsay without exception.
`
`
`
`Moreover, the reliability of the reports as reflecting the undisclosed data
`
`allegedly obtained by Dr. Dheer is subject to grave doubt. Indeed, the earlier
`
`version of the report touted an alleged 10-fold difference in potency between
`
`peptides that was retracted by the later version of the report. EX1063, ¶124;
`
`EX2027, 20; EX1060, 66:1-70:5. Far from being contemporaneous, well-attested
`
`corroborating evidence, these exhibits are belated, self-serving, and
`
`unauthenticated derivations purportedly of someone else’s unpublished notebooks.
`
`They have no legitimate probative value and are unduly prejudicial to the extent
`
`they have been offered as proof of anything.
`
`
`
`If these exhibits are admitted, their scope should be restricted to minimize
`
`prejudice so far as possible. Huddleston, 485 U.S. at 691-92.3
`
`D. EX2040 – Unauthenticated Hearsay Attributed to Dr.
`Pennington
`Mylan timely objected to EX2040 under FRE 403, FRE 802, and FRE 901;
`
`
`
`and requested a limiting instruction under FRE 105. Paper 30, 2-3. Patent Owner’s
`
`
`
`3 Although these documents have been filed under seal and are the basis for filing
`
`other documents under seal, much of the data is publicly available. Compare, e.g.,
`
`EX1067, 102 with EX2027, 11, and EX1067, 129-130 with EX2028, 10, 12.
`
`-10-
`
`

`

`
`
`exhibit list describes EX2040 as a post-filing date (March 31, 2004) letter from
`
`Michael Pennington, Ph.D, to Dr. Kunwar Shailubhai. EX2040 identifies Michael
`
`Pennington as the President and C.O.O. of Bachem Bioscience, Inc., and addresses
`
`varying assertions to “Dear Shailu,” a personal nickname for Dr. Kunwar
`
`Shailubhai (employed at the time at Callisto Pharmaceuticals). EX2040; EX1061,
`
`28:6-12. EX2040 asserts that Dr. Shailubhai was receiving “priority treatment”
`
`from Bachem and appears on its face to have been generated for the purposes of
`
`litigating whether SP-304 “will afford a much better synthetic product” than
`
`uroguanylin. Dr. Shailubhai testified during his deposition that he initially used
`
`two other companies to make “the peptides” but could not recall receiving or
`
`keeping a similar letter from either of them. EX1061, 30:1-31:12.
`
`
`
`Bausch did not produce Dr. Pennington to verify EX2040 or any assertions
`
`contained therein. Hence, to the extent the letter is offered to prove the truth of the
`
`matters stated, the assertions are hearsay without exception. The document is not
`
`sworn or attested, or otherwise verified.
`
`
`
`To the extent Bausch’s Dr. Shailubhai was offered to authenticate EX2040,
`
`he was unfamiliar with its content, any facts underlying that content, and its
`
`provenance, and denied receiving any similar contemporaneous letters from other
`
`vendors on the same matter. EX1061, 24:7-31:12. Dr. Shailubhai denied any part
`
`in drafting EX2040, providing any of its contents, or knowing any of “the details”
`
`-11-
`
`

`

`
`
`about the syntheses discussed therein. EX1061, 27:3-28:5. Dr. Shailubhai denied
`
`ever speaking with Dr. Pennington about EX2040. EX1061, 29:8-11. Dr.
`
`Shailubhai could not confirm based on the fax number in EX2040 that it was faxed
`
`to him, to where it was faxed, or even that it was faxed at all. EX1061, 28:13-29:1
`
`(“I don’t recall that either.”). Dr. Shailubhai did not personally retain EX2040 and
`
`does not know who provided EX2040 for his declaration. EX1061, 29:2-7. He
`
`never testified that he was the custodian of EX2040, never identified any person or
`
`organization as the custodian of EX2040, and never described the record-keeping
`
`practices of any such custodian. Dr. Shailubhai did not testify that he recognized
`
`the signature on the exhibit. EX1061, 29:11-22. Despite being given repeated
`
`opportunities during his deposition to disclose personal knowledge to authenticate
`
`EX2040, Dr. Shailubhai responded: “All I can say is that it’s supposed to be the
`
`signature of Michael Pennington.” EX1061, 29:13-14. Dr. Shailubhai provided no
`
`competent testimony regarding the provenance of EX2040 or the veracity of the
`
`assertions contained therein, and he cannot be used to launder its hearsay assertions
`
`into this proceeding in any event.
`
`
`
`Accounting for Dr. Shailubhai’s testimony, there was no competent
`
`testimony from anyone having personal knowledge that the assertions contained in
`
`EX2040 were actually made by Dr. Pennington, that Dr. Pennington had personal
`
`knowledge to support the assertions in EX2040, or that, at the time of occurrence
`
`-12-
`
`

`

`
`
`of matters set forth therein, it was the regularly conducted business practice of
`
`Bachem Biosciences to make the assertions contained in EX2040. Among other
`
`assertions attributed to Dr. Pennington, EX2040 asserts that certain (though
`
`unspecified) laboratory work was performed at some unspecified point in time in
`
`the past. For example, EX2040 refers to Bachem’s “initial work on this product”
`
`and unspecified observations about behavior “during both solid-phase syntheses as
`
`well as during folding and purification.” EX2040 then asserts various conclusions
`
`about the peptides (“much better synthetic product”; “extremely difficult to
`
`purify”; “superior physical properties, which is no longer subject to this
`
`interconversion”; “large-scale production viable”; “Purification was greatly
`
`simplified”). But EX2040 does not purport to have been created at or near the time
`
`of the referenced experiments or conclusions. EX2040 does not assert that Dr.
`
`Pennington performed or witnessed the experiments, which would seem an
`
`unlikely task for the President and C.O.O. of a company. The letter does not
`
`purport to be a record kept by Bachem in the course of its regularly conducted
`
`activity. Nor is there any testimony that making (i.e., writing) the letter was a
`
`regular practice of Bachem’s business activity (as opposed to something
`
`manufactured at the request of the patent owner for the purposes of litigation).
`
`
`
`Finally, the date Bausch ascribes to the allegedly private communication in
`
`EX2040 (March 31, 2004) is more than two years after the claimed critical date of
`
`-13-
`
`

`

`the invention and Bausch provides no argument or evidence that EX2040 was
`
`available to a POSA before the critical date. EX2040 does not assert that
`
`uroguanylin could only be produced at a quantity of 50 mg and at a price of $5000,
`
`but merely that Bachem will “gladly” provide 50 mg of uroguanylin at that price.
`
`EX2040 never provides a quotation for 1 g of uroguanylin for $100,000 and never
`
`asserts that the price of manufacturing 50 mg (e.g., for testing) reflected a floor for
`
`manufacturing price at scale. The strategically-selected language in EX2040
`
`underscores Bausch’s failure to produce any witness who is knowledgeable about
`
`its contents or provenance. EX2040 is unreliable and any relevance it might have is
`
`outweighed by undue prejudice from its dubious provenance, its late date, and the
`
`failure to provide its alleged author for cross examination.
`
`
`
`If this exhibit is admitted, its scope should be restricted to minimize
`
`prejudice so far as possible. Huddleston, 485 U.S. at 691-92.
`
`III. CONCLUSION
`
`EX2001-EX2007, EX2024, EX2025, EX2027, EX2028, and EX2040 should
`
`be excluded; if not excluded, they should be given no weight or at the very least
`
`restricted to minimize prejudice so far as possible.
`
`
`
`
`
`
`
`Dated: May 24, 2023
`
`
`
`
`
`
`
`
`
`
`
`
` Respectfully submitted,
`
`
`
`
`/Jad A. Mills/
`Jad A. Mills, Reg. No. 63,344
`Counsel for Mylan Pharmaceuticals Inc.
`
`-14-
`
`

`

`
`
`CERTIFICATE OF SERVICE
`I certify that today this paper was served by email on Bausch’s counsel at:
`
`Justin J. Hasford
`
`Bryan C. Diner
`
`Joshua Goldberg
`
`Caitlin O’Connell
`
`Kyu Yun Kim
`
`Kassandra Office
`r
`
`
`and on MSN’s counsel at:
`
`
`Andrew Larsen
`
`Melissa Hayworth
`
`
`
`
`
`
`Dated: May 24, 2023
`
`
`
`justin.hasford@finnegan.com
`
`bryan.diner@finnegan.com
`
`joshua.goldberg@finnegan.com
`
`caitlin.o’connell@finnegan.com
`
`kyuyun.kim@finnegan.com
`
`kassandra.officer@finnegan.com
`
`alarsen@merchantgould.com
`
`mhayworth@merchantgould.com
`
`
`Respectfully submitted,
`
`/Christopher Kielman/
`Christopher Kielman
`
`
`
`-15-
`
`

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