`
`
`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 OPPOSITION
`TO BAUSCH’S MOTION TO EXCLUDE
`37 C.F.R. §42.64(c)
`
`
`
`1 IPR2023-00016 has been joined with this proceeding.
`
`
`
`TABLE OF CONTENTS
`
`Page
`Introduction .......................................................................................................... 1
`I.
`II. Reasons for Denial ............................................................................................... 1
`A. EX1067 (EPO Prosecution History) is Admissible ......................................... 1
`1. EX1067 is an admissible record of a public office .................................... 1
`2. The EP file history is not hearsay .............................................................. 3
`3. Dr. Currie’s EPO submission is admissible as a more reliable
`comparator than Bausch’s submission .................................................... 4
`4. Bausch had access to the complete EPO file and identifies nothing
`in need of a cure ...................................................................................... 6
`B. The Challenged Paragraphs of EX1063 (Second Peterson
`Declaration) Are Admissible ......................................................................... 8
`1. Dr. Peterson’s testimony is highly relevant and not otherwise
`inadmissible ............................................................................................. 8
`2. Dr. Peterson is amply qualified to testify regarding the subject
`matter of this trial .................................................................................... 9
`C. Bausch’s Motion to Exclude Under §42.65 Is Meritless............................... 14
`III. Conclusion ......................................................................................................... 15
`
`
`
`
`
`
`-i-
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`
`
`TABLE OF AUTHORITIES
`
`Pages
`
`Cases
`Abbott Vascular, Inc. v. FlexStent, IPR2019-00882, Paper 48 (2020) ....................15
`Altaire Pharm., Inc. v. Paragon Bioteck, Inc., PGR2015-00011, Paper 48
`(2016), rev’d on other grounds, 889 F.3d 1274 (Fed. Cir. 2018) ......................15
`Emerson Electric Co. v. IPCO, LLC, IPR2017-00213, Paper 42 (2018) ................15
`Gemtron Corp. v. Saint-Gobain Corp., 572 F.3d 1371 (Fed. Cir. 2009) .................. 6
`Huddleston v. United States, 485 U.S. 681 (1988) .................................................... 7
`University of Strathclyde v. Clear-Vu Lighting LLC, 17 F.4th 155 (Fed.
`Cir. 2021) ............................................................................................................14
`Valve Corp. v. Ironburg Inventions Ltd., 8 F.4th 1364 (Fed. Cir. 2021)................... 2
`Statutes
`5 U.S.C. §554(b) ........................................................................................................ 8
`Rules
`Federal Rule of Evidence 106 ........................................................................... 6, 7, 8
`Federal Rule of Evidence 703 ................................................................... 6, 9, 11, 14
`Federal Rule of Evidence 801 ................................................................................3, 4
`Federal Rule of Evidence 802 .................................................................................... 1
`Federal Rule of Evidence 803 ........................................................................... 2, 4, 9
`Federal Rule of Evidence 804 ................................................................................4, 9
`Federal Rule of Evidence 806 ................................................................................4, 9
`Federal Rule of Evidence 807 .................................................................................... 5
`Regulations
`37 CFR §42.65 .................................................................................................. 14, 15
`
`-ii-
`
`
`
`European Patent Convention Rule 145 ...................................................................... 2
`Other Authorities
`European Patent Guide §5.3.006 ............................................................................... 2
`
`-iii-
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`
`
`I.
`
` INTRODUCTION
`
`The Board should deny Bausch’s motion (Paper 53, MtE) to exclude
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`EX1067, which provides relevant excerpts from the patent prosecution history of
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`the European analogue to the involved patent, and portions of the Second Peterson
`
`Declaration (EX1063) that discuss EX1067. The prosecution history is a public
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`record from the European Patent Office, an organ of the European Patent
`
`Organization, a public international organization of nearly 40 member states.2
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`Bausch seeks to exclude EX1067 in its entirety as hearsay under Federal Rule of
`
`Evidence (FRE) 802. MtE 1. Bausch argues specific paragraphs of EX1063
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`discussing EX1067 are irrelevant, prejudicial, confusing, a waste of time, and
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`hearsay. MtE 6-7. None of Bausch’s arguments justify its requested relief.
`
`II. REASONS FOR DENIAL
`A. EX1067 (EPO Prosecution History) is Admissible
`1. EX1067 is an admissible record of a public office
`Exceptions to the rule against admitting hearsay include any record of a
`
`
`
`public office that (i) sets out the office’s activities; (ii) sets out matters observed
`
`while under a legal duty to report; or (iii) sets out factual findings from a legally
`
`
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`2 https://www.epo.org/about-us/foundation/member-states.html.
`
`-1-
`
`
`
`
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`authorized investigation. FRE 803(8). Patent office documents are public records,
`
`are not hearsay “or fall within an exception.” Valve Corp. v. Ironburg Inventions
`
`Ltd., 8 F.4th 1364, 1370 n.6 (Fed. Cir. 2021); FRE 803(8); FRE 801(d)(2).
`
`
`
`EX1067 is admissible for the same reason USPTO prosecution histories are
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`admissible. Like the USPTO, the EPO carries out substantive consideration of
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`patent applications and challenges filed against patents, and makes its collection of
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`patent documents available to the public for free via the internet.3 EX1067
`
`provides excerpts of the EPO prosecution file history of the involved patent’s
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`European analogue, which file history is a record of the EPO’s activities (including
`
`documents received and issued). The EPO must accurately report these activities.
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`European Patent Convention Rule 145;4 European Patent Guide §5.3.006.5
`
`Moreover, the EPO prosecution history sets out factual findings from the EPO’s
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`legally authorized investigation. EX1067 is thus admissible under each prong of
`
`FRE 803(8). Bausch fails to show that any other circumstances indicate a lack of
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`trustworthiness in this EPO record. Accordingly, Bausch’s motion to exclude
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`EX1067 should be denied.
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`
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`3 https://www.epo.org/about-us/services-and-activities/services.html.
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`4 https://new.epo.org/en/legal/epc/2020/r145.html.
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`5 https://new.epo.org/en/legal/guide-epc/2022/ga_c5_3.html.
`
`-2-
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`
`
`2. The EP file history is not hearsay
`A statement is not hearsay when offered for a purpose other than to prove
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`
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`the truth of the matter asserted. FRE 801(c). EX1067 is admissible to show
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`publicly-available content in the EPO file regardless of the truth of that content, so
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`Bausch’s motion should be denied.
`
`
`
`Mylan’s opposition to Bausch’s motions to seal provides a specific and
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`highly relevant example of EX1067 being offered for what was said rather than for
`
`its truth. Paper 56, 2, 6-10. As Mylan’s opposition explained, EX1067 shows
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`information Bausch certified as confidential is publicly available, as Bausch must
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`know. The public availability of these Bausch statements in no way depends on
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`whether Bausch was being truthful.
`
`
`
`As another example, to support its unexpected-results arguments, Bausch
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`cites experiments comparing pure topoisomer A of [Glu3]-human uroguanylin to a
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`mixture of so-called active and “inactive” human-uroguanylin topoisomers
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`because, as Bausch repeatedly asserted to the EPO, it was “impossible” to purify
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`uroguanylin. EX1067, 140; Reply, 23; but see EX1067, 59 (EPO finding
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`“contradiction” in Bausch’s positions about purifying uroguanylin). The EPO’s
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`finding directly contradicts Bausch’s current assertions that it has shown
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`unexpected results for the closest prior art (an apples-to-oranges comparison with
`
`an impure sample).
`
`-3-
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`
`
`
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`Understandably, Bausch does not want its own contradictory statements to
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`remain in the record, but Bausch’s concern does not make those statements hearsay
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`or inadmissible. FRE 801(d)(2) (admission by party opponent not hearsay),
`
`FRE 803(14)-(15) (records affecting interest in property admissible);
`
`FRE 804(b)(3) (statements against interest); FRE 806. Bausch urges exclusion of
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`“the entirety of Exhibit 1067” (Paper 53, 1), which is plainly inappropriate. Bausch
`
`has forfeited any alternative relief not requested in its motion.
`
`3. Dr. Currie’s EPO submission is admissible as a more
`reliable comparator than Bausch’s submission
`Bausch argues that Mylan relies on statements of Mark Currie recorded in
`
`
`
`EX1067 for their truth. MtE 1. As an initial matter, Bausch mischaracterizes the
`
`record. Both quotes rely on the testimony of Dr. Peterson, who is explaining what
`
`Dr. Currie said he found.6 Dr. Peterson evaluated Dr. Currie’s submission in
`
`comparison to Bausch’s submission (much like peer review of a submitted
`
`manuscript), and concluded that Dr. Currie’s submission was more reliable than
`
`what Bausch filed. EX1063, ¶154. Dr. Peterson explained that Dr. Currie’s
`
`submission is more reliable than Bausch’s because, inter alia, Dr. Currie included
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`error bars, evaluation of statistical significance, and multiple relevant data points,
`
`
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`6 Reply, 22; EX1063, ¶149 (citing EX1067, 102-103, 139-140).
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`-4-
`
`
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`all indicia of reliability that Bausch’s submission lacked. EX1063, ¶¶154-56, 159.
`
`Dr. Peterson also explained that Bausch’s data failed to compare to the closest
`
`prior art. EX1063, ¶153. Dr. Currie’s submission is admissible regardless of the
`
`truth of the matters asserted to show that Bausch did not perform relevant
`
`experiments and failed to include indicia of reliability required for an appropriate
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`scientific analysis. Bausch thus fails to show Dr. Currie’s submission is hearsay.
`
`
`
`In any case, the Board may admit hearsay if it is trustworthy and more
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`probative than alternatives. FRE 807. Bausch itself relies on Dr. Currie when it
`
`suits Bausch. Paper 27 (POR), 2, 15, 21, 24, 34, 36, 37. Bausch provides no reason
`
`why Dr. Currie is trustworthy when Bausch relies on him, but not when he
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`disagrees with Bausch. No expert testimony supports Bausch’s contention that Dr.
`
`Currie’s submission is unreliable. MtE, 2-3. In contrast, Dr. Peterson explained at
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`length why Dr. Currie’s submission was more reliable than Bausch’s. EX1063,
`
`¶¶154-56, 159. Just like Bausch’s own data—which sometimes reports a higher
`
`cGMP activity level in T84 cells for [Glu3]-human uroguanylin than for human
`
`uroguanylin and sometimes reports the reverse relationship—Dr. Currie’s
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`submission “is entirely consistent with Dr. Currie’s conclusion that the results
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`showed no statistical or material difference between the two peptides.” Id., ¶¶157-
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`59 (emphasis added). Bausch’s criticisms of Dr. Currie’s submission merely serve
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`to indict its own unexpected-results case presented here. Bausch did not cross
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`-5-
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`
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`examine Dr. Peterson about this testimony but now (belatedly) argues the
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`submission is not reliable. MtE 2. Bausch’s “unsworn attorney argument is not
`
`evidence and cannot rebut admitted evidence.” Gemtron Corp. v. Saint-Gobain
`
`Corp., 572 F.3d 1371, 1380 (Fed. Cir. 2009) (simplified). Bausch’s attempt to bury
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`the EPO record should be denied.
`
`
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`Finally, the Federal Rules of Evidence expressly permit an expert to rely on
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`hearsay in forming an opinion (FRE 703), and indeed all four experts (and even
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`Bausch’s fact witness) have testified based on hearsay sources (e.g., EX2027,
`
`EX2028). Any expert opinion based on books, patents, or articles ordinarily
`
`depends on hearsay: the test is whether experts in the particular field would
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`reasonably rely on those kinds of facts or data in forming an opinion on the
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`subject. Id. As explained above, no expert testimony supports Bausch’s contention
`
`that Dr. Currie’s submission is unreliable; instead, Dr. Peterson carefully explained
`
`why Dr. Currie’s submission was reliable for rebutting Bausch’s less reliable
`
`submission, and Bausch chose not to challenge this testimony in cross-
`
`examination. EX1063, ¶¶154-56, 159. Bausch’s tactical decision to avoid
`
`challenging Dr. Peterson about the greater reliability of Dr. Currie’s submission as
`
`compared to Bausch’s submission does not, and cannot, inure to Bausch’s benefit.
`
`4. Bausch had access to the complete EPO file and
`identifies nothing in need of a cure
`Bausch argues EX1067 is incomplete under FRE 106. MtE 5. The cure for
`-6-
`
`
`
`
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`an incomplete file is for the opposing party to introduce “any other part…that in
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`fairness ought to be considered at the same time.” FRE 106. When EX1067 was
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`introduced, Dr. Peterson noted that it was publicly available. EX1063, 24 n.3. In
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`response to Bausch’s objection, Mylan provided Bausch with a complete electronic
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`copy of the EPO file. EX1074 (the full EP file history). EX1075 (April 7, 2023
`
`Exhibit List). Bausch did not cite EX1074 or otherwise rely on “missing” portions
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`of the EPO file in its surreply. Hence, Bausch has failed to provide any basis for
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`exclusion and Mylan has nothing to cure. Neither Mylan nor the Board should
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`have to wait for Bausch’s reply to identify the issues; its argument is forfeited.
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`
`
`Petitioner will file the entirety of the file history of EP No. 1 379 224
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`(EX1074) if the Board desires to have “nearly 1,500 pages” (MtE 5) uploaded to
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`its servers. Yet the more than 1000 additional pages remain uncited, making
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`Bausch’s objection both futile and prejudicial to Mylan and the Board, which
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`would be required to deal with this large document for no apparent reason.
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`Accordingly, Mylan awaits Board instructions before filing EX1074. If the Board
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`orders submission of the entire file history, however, Mylan requests that it be
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`limited under FRE 105 to the purpose for which it was cited to minimize prejudice
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`as much as possible. Huddleston v. United States, 485 U.S. 681, 691-92 (1988).
`
`
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`Bausch also argues EX1067 is “not even in order” and “[a]s a result,
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`Exhibit 1067 is highly prejudicial and should be excluded under FRE 106. MtE 5.
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`-7-
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`
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`Bausch does not—and cannot—explain where FRE 106 addresses the order of the
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`exhibit, because it does not. Nor does Bausch provide any example of resulting
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`prejudice from submission of the exhibit in the EPO’s original, reverse-
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`chronological order. Bausch provides no basis for its assertion that the exhibits
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`should have a different order. 5 U.S.C. §554(b) (requiring notice). Bausch’s
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`request should be denied.
`
`B. The Challenged Paragraphs of EX1063 (Second Peterson
`Declaration) Are Admissible
`Mylan served EX1063 and provided Bausch with an opportunity to cross
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`
`
`examine. EX2069 (Peterson transcript, dated April 25, 2023). Bausch seeks to
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`exclude ¶¶34, 149, 152-57, 160, 162-64, and 166-67 (“challenged paragraphs”) of
`
`EX1063 but comes nowhere close to justifying its request.
`
`1. Dr. Peterson’s testimony is highly relevant and not
`otherwise inadmissible
`Bausch argues the challenged paragraphs are irrelevant, prejudicial,
`
`
`
`confusing, a waste of time, and hearsay. MtE 6-7. Bausch does not correlate these
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`distinct alleged defects to specific challenged paragraphs. Instead, Bausch’s
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`argument appears to be premised on alleged inadmissibility of EX1067. MtE 6
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`(“These paragraphs cite to and rely on Exhibit 1067, which should be excluded for
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`the reasons explained above.”). Bausch’s arguments against EX1063 should thus
`
`be denied for all the reasons discussed above regarding EX1067. Moreover, as
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`-8-
`
`
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`explained above (section II.A.3), Dr. Peterson is entitled to rely on EX1067 in
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`forming an opinion. FRE 703.
`
`
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`Bausch also argues “no admissible evidence on which Dr. Peterson could
`
`base his opinions” exists. MtE 6. This sweeping argument is simply wrong. For
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`example, Dr. Peterson cites EX1060 in ¶34 and EX2011 in ¶152, neither of which
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`Bausch challenges. Moreover, even where Dr. Peterson cites EX1067, he often is
`
`citing Bausch’s statements, e.g., ¶¶34, 149, 152, 153, 157, 160, 162, 167.
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`FRE 803(14); FRE 804(b)(3); FRE 806. Because Bausch’s arguments are factually
`
`wrong (where other evidence is cited) or irrelevant (where Bausch’s statements are
`
`cited), at least for these paragraphs Bausch’s request should be denied.
`
`2. Dr. Peterson is amply qualified to testify regarding
`the subject matter of this trial
`Bausch argues the challenged paragraphs should be excluded, alleging Dr.
`
`
`
`Peterson is incompetent to testify. MtE 6. Dr. Peterson’s academic and
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`professional accomplishments belie Bausch’s argument. EX1003. His research for
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`over two decades is directed toward understanding and developing small molecule
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`probes for biological systems, including peptides, the synthesis and evaluation of
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`antiviral agents and anticancer agents, and the identification of biological targets of
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`small molecules. EX1002, ¶1.
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`
`
`Dr. Peterson is the John W. Wolfe Chair in Cancer Research with a focus on
`
`Medicinal Chemistry and Chemical Biology at The Ohio State University (OSU),
`-9-
`
`
`
`with faculty appointments from 1998 to the present. EX1002, ¶1. He is a Professor
`
`of Medicinal Chemistry and Pharmacognosy at OSU, Chair of the Division of
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`Medicinal Chemistry and Pharmacognosy at OSU, Co-Leader of the Translational
`
`Therapeutics Program of the OSU Comprehensive Cancer Center (CCC), and Co-
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`Director of the Medicinal Chemistry Shared Resource of the OSU CCC. Id., ¶2. He
`
`was a Regents Distinguished Professor in the Department of Medicinal Chemistry
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`at the University of Kansas (KU) School of Pharmacy from 2008-2019, and was
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`for seven years Co-Leader of the Synthetic Chemical Biology Core Facility at the
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`KU. Id., ¶3. Before that, he was an Assistant Professor and Associate Professor in
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`the Department of Chemistry at The Pennsylvania State University (PSU), where
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`he was a member of the Life Sciences Consortium, the Center for Biomolecular
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`Structure and Function, the Cancer Center, and the Experimental Therapeutics
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`Program of the PSU Hershey Medical School. Id., ¶4. His faculty appointments
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`encompass 23 years of experience with teaching and research in organic chemistry,
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`medicinal chemistry, and chemical biology. Id., ¶5.
`
`
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`He earned a Ph.D. in Chemistry from the University of California, Los
`
`Angeles, with research in bioorganic chemistry. Id., ¶6. He was a postdoctoral
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`fellow in Chemical Biology at Harvard University, with research in biochemistry,
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`molecular biology, and chemical biology, using genetic assays and biochemical
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`systems to investigate the molecular basis of interactions of transcription factor
`
`-10-
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`
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`proteins. Id., ¶7. His work has been published in prestigious journals, including
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`Journal of the American Chemical Society and Angewandte Chemie, and he has
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`over 80 peer reviewed publications, has authored or co-authored two book
`
`chapters, and has provided manuscript reviews for over 200 publications in
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`upwards of 60 scientific journals, including Proceedings of the National Academy
`
`of Sciences USA, Nature Methods, and Journal of the American Chemical Society.
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`Id., ¶10. Dr. Peterson is unequivocally qualified to testify as a POSA. Pet., 13;
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`Paper 16 (Institution Decision), 12-13; POR 25-26.
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`
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`Bausch suggests now, near the end of litigation, that Dr. Peterson must have
`
`personal experience with GC-C receptors/agonists, including personal use of T84
`
`cell bioassays, and must be an expert in statistics or biostatistics. MtE 6-7. But
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`Bausch never asserted such personal experience was required for a POSA. Indeed,
`
`Bausch’s own expert Dr. Davies testified at length about GC-C receptors and T84
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`cell bioassays without claiming any personal experience with them. EX2024, ¶7
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`(like Dr. Peterson, graduate studies in chemistry), ¶¶5-13 (qualifications do not
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`disclose personal experience specifically with GC-C receptors or T84 cell
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`bioassays); EX2029 (Davies curriculum vitae) (same). And Bausch cites no
`
`authority for its present argument that an expert like Dr. Peterson cannot
`
`reasonably rely on scientific literature regarding GC-C receptors/agonists and T84
`
`cell bioassays rather than personal experience. FRE 703 (“expert may base an
`
`-11-
`
`
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`opinion on facts or data in the case that the expert has been made aware of”).
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`Moreover, Dr. Peterson has extensive personal experience relevant to GC-C
`
`receptors/agonists, bioassays, and biostatistics. He has studied receptor-ligand
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`interactions for over 30 years, including studying over 20 different biological
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`receptors and hundreds of ligands. EX2026, 16:22-17:8. This included work with
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`systems related to GC-C. Id.; see also id. 20:10-12 (“I’ve studied related receptor
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`ligand interactions” to plecanatide with GC-C); see also id., 26:17-20 (“I am very
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`familiar with pharmacology. I’ve been doing research at the interface between
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`chemistry and biology for over 20 years.”); 27:1-3 (pharmacokinetics); 29:11-12
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`(evolutionary biology); 30:6-11 (design of peptides with single Asp or Glu
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`modifications); 31:2-4 (consultation on design and synthesis of pharmaceuticals);
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`32:4-6 (same); 32:22-33:5 (expert in structural organic chemistry and PhD in
`
`organic chemistry). Dr. Peterson also relied on the testimony of Dr. Epstein
`
`(EX1063, passim), who had experience with GC-C receptors. EX1064, ¶3;
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`EX2070, 26:5-14. Dr. Peterson is well-qualified to offer his opinions.
`
`
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`Bausch cherry-picks and distorts Dr. Peterson’s testimony to suggest
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`otherwise. Contrary to Bausch’s motion, Dr. Peterson testified that he had
`
`-12-
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`
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`expertise to review GC-C literature. EX2069, 10:3-5.7 His responses at 15:22-16:2
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`do not support what Bausch says. His responses at 10:15-12:18 demonstrate his
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`competence to review T84 cell bioassays. While Bausch asked a nonsensical
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`question about “qualif[ying]…as an expert in statistics” at 114:14-19, Dr.
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`Peterson’s clearly shows professional competence in applying statistics to this
`
`subject matter throughout his testimony. Similarly, Bausch mischaracterizes Dr.
`
`Peterson’s testimony as conceding that Dr. Currie’s results “deviated” from the
`
`literature (MtE 7), but in fact Dr. Peterson was simply summarizing Bausch’s
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`characterization of Dr. Currie’s statements before explaining why Bausch’s
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`characterization of Dr. Currie was wrong. EX1063, ¶160. While Bausch’s
`
`attorneys dismiss Dr. Peterson’s testimony as “jump[ing] to [a] conclusion”
`
`(MtE 7, citing EX1063, ¶160), this mere attorney argument casts no shade on
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`actual expert testimony. Gemtron, 572 F.3d at 1380. Bausch’s unhappiness with
`
`Dr. Peterson’s testimony does not reflect on his competence or bases.
`
`
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`7 The 10:6-9 citation is a nonsensical question about the Board “qualif[ying]… an
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`expert in the biochemistry of GC-C receptors.” Dr. Peterson merely confirmed he
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`has not previously testified as an expert. EX2026, 13:15. Bausch fails to show the
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`Board “qualifies” experts or that the Board discriminates against first-time experts.
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`-13-
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`
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`C. Bausch’s Motion to Exclude Under §42.65 Is Meritless
`Bausch argues EX1067, and the challenged paragraphs of EX1063 relying
`
`
`
`on it, do not accord with 37 C.F.R. §42.65(b). MtE 3. Bausch cites no basis in the
`
`Federal Rules of Evidence for exclusion. Thus, Bausch’s argument should be
`
`dismissed because Bausch has not requested, and the Board has not authorized, any
`
`motion to strike.
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`If the Board entertains Bausch’s motion, it should be denied. Dr. Peterson’s
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`testimony discloses all the facts and data on which his opinions are based. Just as
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`neither Dr. Davies nor Dr. Waldman purported to have evaluated the raw data
`
`underlying EX2027 and EX2028, Dr. Peterson never purported to have evaluated
`
`the raw data underlying EX1067. Dr. Peterson is an expert witness and was not
`
`required to conduct a study himself to provide testimony relying on data disclosed
`
`within another document. Univ. of Strathclyde v. Clear-Vu Lighting LLC, 17 F.4th
`
`155, 164 (Fed. Cir. 2021) (reversing decision under §42.65(a) where expert relied
`
`on data reported by another); FRE 703. Bausch’s argument would require
`
`excluding its Liu reference (EX2046) on which Bausch relies for unexpected
`
`binding affinity without providing a declaration from Liu’s authors. POR 66.
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`Bausch’s argument is contradicted by precedent and Bausch’s own actions here.
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`Moreover, Bausch does not contest the admissibility of EX1063, ¶165, in
`
`which Dr. Peterson testifies, “the data from Dr. Currie’s lab is more reliable than
`
`-14-
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`
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`the data provided by Bausch.” As discussed above, Dr. Peterson testified his
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`opinions are based on facts and data that an expert in his field would reasonably
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`rely upon in forming an opinion on the subject. Dr. Peterson disclosed all the
`
`information in his possession (EX1067) necessary for the Board to evaluate the
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`effect of that data on his opinions. See e.g. EX1063, ¶¶34, 149, 152-57, 160, 162-
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`64, 166-67. Bausch’s challenge to EX1067 under §42.65(b) thus falls short.
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`
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`Bausch’s cited cases are each distinguishable and only confuse the issue. Its
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`first case concerned tests the expert had himself conducted, where additional
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`existing information had been omitted. Abbott Vascular, Inc. v. FlexStent,
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`IPR2019-00882, Paper 48 at 35-36 (2020). In Bausch’s second case, the expert
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`again performed the test himself but cited documents not of record in the
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`proceeding. Emerson Electric Co. v. IPCO, LLC, IPR2017-00213, Paper 42 at 25
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`(2018). Bausch’s final case involved data the declarant produced while refusing to
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`describe the proprietary experimental procedure. Altaire Pharm., Inc. v. Paragon
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`Bioteck, Inc., PGR2015-00011, Paper 48 at 16-17 (2016), rev’d on other grounds,
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`889 F.3d 1274 (Fed. Cir. 2018). In contrast, here no data was generated by Dr.
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`Peterson, Mylan, or anyone affiliated with them, and Dr. Currie provided sufficient
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`detail for the purposes for which Dr. Peterson relies upon EX1067.
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`III. CONCLUSION
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`
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`Bausch’s motion to exclude should be denied.
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`-15-
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`
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`Dated: May 31, 2023
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`
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` Respectfully submitted,
`
`
`
`
`/Jad A. Mills/
`Jad A. Mills, Reg. No. 63,344
`Counsel for Mylan Pharmaceuticals Inc.
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`-16-
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`
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`CERTIFICATE OF SERVICE
`I certify that today this paper and EX1075 were served by email on Bausch’s
`
`counsel at:
`
`Justin J. Hasford
`
`Bryan C. Diner
`
`Joshua Goldberg
`
`Caitlin O’Connell
`
`Kyu Yun Kim
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`Kassandra Officer
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`and on MSN’s counsel at:
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`Andrew Larsen
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`Melissa Hayworth
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`
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`Dated: May 31, 2023
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`
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`justin.hasford@finnegan.com
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`bryan.diner@finnegan.com
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`joshua.goldberg@finnegan.com
`
`caitlin.o’connell@finnegan.com
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`kyuyun.kim@finnegan.com
`
`kassandra.officer@finnegan.com
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`alarsen@merchantgould.com
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`mhayworth@merchantgould.com
`
`
`Respectfully submitted,
`
`/Christopher Kielman/
`Christopher Kielman
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`
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`-17-
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`
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