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`UNITED STATES PATENT AND TRADEMARK OFFICE
`__________________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`__________________
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`MYLAN PHARMACEUTICALS INC.,
`MSN LABORATORIES PRIVATE LTD.,
`and MSN PHARMACEUTICALS INC.,
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`Petitioner,
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`v.
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`BAUSCH HEALTH IRELAND LIMITED,
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`Patent Owner.
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`__________________
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`Case IPR2022-007221
`U.S. Patent No. 7,041,786
`__________________
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`PATENT OWNER’S REPLY
`IN SUPPORT OF ITS MOTION TO EXCLUDE
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`1 IPR2023-00016 has been joined with this proceeding.
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`Case IPR2022-00722
`Patent No. 7,041,786
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`I.
`II.
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`TABLE OF CONTENTS
`EXHIBIT 1067 SHOULD BE EXCLUDED .................................................. 1
`EXHIBIT 1063 ¶¶ 34, 149, 152-57, 160, 162-64, and 166-67
`SHOULD BE EXCLUDED ............................................................................ 3
`III. CONCLUSION ................................................................................................ 5
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`TABLE OF AUTHORITIES
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`Case IPR2022-00722
`Patent No. 7,041,786
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` Page(s)
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`Federal Cases
`Lyman v. St. Jude Med. S.C., Inc.,
`580 F. Supp. 2d 719 (E.D. Wis. 2008) ................................................................. 4
`Univ. of Strathclyde v. Clear-Vu Lighting LLC,
`17 F.4th 155 (Fed. Cir. 2021) ............................................................................... 5
`Rules
`FRE 703 ..................................................................................................................... 4
`FRE 803 ..................................................................................................................... 1
`Regulations
`37 C.F.R. § 42.61 ....................................................................................................... 1
`37 C.F.R. § 42.65 ................................................................................................... 1, 5
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`ii
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`I.
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`EXHIBIT 1067 SHOULD BE EXCLUDED
`Petitioner argues that Exhibit 1067 is an admissible “record of a public office”
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`Case IPR2022-00722
`Patent No. 7,041,786
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`under FRE 803(8). Opp., 1. Petitioner is wrong. Exhibit 1067 is an incomplete and
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`out-of-order EPO file history excerpt. Exhibit 1067 does not include the EPO’s final
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`decision upholding the plecanatide patent, which issued on September 5, 2015.
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`Further, the applicant’s October 14, 2011 submission (Ex. 1067, 138-40) is preceded
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`by its enclosed annexes and followed by a cut-off claim list, creating confusion.
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`Because Exhibit 1067 is not a public record but an untrustworthy excerpt, FRE
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`803(8) is inapplicable. FRE 803(8)(B). An EPO file history is also distinguishable
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`from a USPTO file history, which is expressly admissible under 37 C.F.R. § 42.61.
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`Petitioner further argues that Exhibit 1067 is not hearsay because it was
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`submitted not for its truth but for what was said. Opp., 3. As an initial matter,
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`Petitioner incorrectly asserts that that the EPO found “‘contradiction’ in Bausch’s
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`positions about purifying uroguanylin.” Opp., 3 (citing Ex. 1067, 59). The cited
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`section does not set forth the EPO’s findings; rather, it summarizes the opponent’s
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`positions. Ex. 1067, 58-59. As such, Petitioner’s non-hearsay argument should be
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`rejected. In any event, Petitioner’s use of Exhibit 1067 for additional purposes does
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`not justify its hearsay use of Exhibit 1067. Indeed, Petitioner does not dispute that it
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`offered Exhibit 1067 for the truth of Currie’s testing and results. Nor does it contend
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`that it submitted the affidavit required by 37 C.F.R. § 42.65(b). At minimum, pages
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`Patent No. 7,041,786
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`88-98 and 120-127 of Exhibit 1067 therefore should be excluded.
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`Petitioner’s assertion that Currie’s data should be admitted because it is more
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`reliable than Patent Owner’s data is meritless. Opp., 5. Petitioner argues that Dr.
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`Peterson said so and “[n]o expert testimony supports Bausch’s contention that Dr.
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`Currie’s submission is unreliable.” Id. But Petitioner cited Currie’s data in its Reply
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`for the first time, preventing Patent Owner from providing expert testimony
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`regarding Petitioner’s reliance on Currie’s data. Further, contrary to Petitioner’s
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`argument, Patent Owner did cross examine Dr. Peterson, who testified that he is not
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`an expert in GCC receptors or receptor agonists and that he has never conducted a
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`T84 cell bioassay. Ex. 2069, 10:6-9, 15:22-16:2, 10:15-20. Petitioner misleads the
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`Board by arguing that “Bausch itself relies on Dr. Currie when it suits Bausch.”
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`Opp., 5 (citing POR 2, 15, 21, 24, 34, 36, 37). Patent Owner never cited or relied on
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`Currie’s data currently at issue (Exhibit 1067). Indeed, the cited pages refer to
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`Exhibit 1005 (Petitioner’s primary reference) and the undisputed fact that Dr. Currie
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`selected an heat-stable enterotoxin in developing Linzess®. Fundamentally, the issue
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`is the wholly uncorroborated data upon which Petitioner relies.
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`Petitioner further asserts that it provided Patent Owner with a complete copy
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`of the EPO file history as supplemental evidence but, notably, did not file and has
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`not filed the complete copy. Petitioner attempts to excuse its failure by pointing to
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`the size of the file history. Opp., 7. This argument is disingenuous at best. In
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`2
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`Patent No. 7,041,786
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`proceedings concerning four additional patents covering Trulance®, Petitioner cited
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`a small portion of the prosecution history of one of the challenged patents in the
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`petitions and uploaded the complete prosecution history in all four proceedings,
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`amounting to more than 20,000 pages in total. IPR2022-01102, -3,- 4,- 5 at Ex. 1022.
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`Petitioner’s assertion that the deficiency in Exhibit 1067 was cured because
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`Patent Owner had access to the complete EPO file history is unpersuasive. Opp., 7.
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`The deficiency remains uncured at least because Petitioner has not filed the complete
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`EPO file history, despite having ample opportunity to do so. It is undisputed that
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`EPO declined to invalidate the plecanatide patent. Petitioner’s request to “limit” the
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`effect of “the entire file history” is improper, especially when it argues that an EPO
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`file history is a trustworthy and accurate record of the EPO’s activities. Opp., 2, 7.
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`II. EXHIBIT 1063 ¶¶ 34, 149, 152-57, 160, 162-64, and 166-67 SHOULD BE
`EXCLUDED
`Petitioner first argues that it is wrong for Patent Owner to state that “no
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`admissible evidence on which Dr. Peterson could base his opinions” exists because
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`several other citations are present in the challenged paragraphs. Opp., 9. Petitioner
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`again mischaracterizes Patent Owner’s Motion. It is clear from the Motion that
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`Patent Owner meant that no other admissible evidence regarding Currie’s testing
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`and results exists. Mot., 4 (“These paragraphs concern technical opinion testimony
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`regarding how Currie’s data were generated and how it should be interpreted.”)
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`3
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`Patent No. 7,041,786
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`Petitioner’s argument based on one cherry-picked paragraph in the Motion, without
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`considering nearby sentences, should be rejected.
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`Petitioner further argues that Dr. Peterson is a qualified chemist but does not
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`and cannot dispute that he is not an expert in GCC receptors or receptor agonists and
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`that he has never conducted a T84 cell bioassay. Ex. 2069 at 10:6-9, 15:22-16:2,
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`10:15-20. Petitioner inaccurately states that Patent Owner asked Dr. Peterson a
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`“nonsensical question” about his expertise. Opp., 13. In fact, Patent Owner was
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`forced to ask Dr. Peterson repeated variations of the same question because Dr.
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`Peterson was evasive with his responses, which further warrants exclusion of Dr.
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`Peterson’s opinions. Ex. 2069 at 9:21-10:9. While Petitioner argues that “Dr.
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`Peterson also relied on the testimony of Dr. Epstein,” Dr. Epstein’s testimony cannot
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`help Dr. Peterson assess Currie’s data because Dr. Epstein’s experience with GCC
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`is limited to clinical experience. Ex.1063, 26:2-17.
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`Petitioner ignores that experts must base their opinions on “facts or data” that
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`other experts in the field “would reasonably rely on.” FRE 703 (emphasis added).
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`No expert would reasonably rely on Currie’s data at least because Currie’s data were
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`generated solely for litigation purposes, are internally inconsistent, and deviate from
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`data reported in the literature. Dr. Peterson’s opinions relying on Currie’s data are
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`thus inadmissible and should be excluded. See Lyman v. St. Jude Med. S.C., Inc.,
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`580 F. Supp. 2d 719, 722 (E.D. Wis. 2008) (“Rule 703 is not intended to abolish the
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`4
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`Case IPR2022-00722
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`Patent No. 7,041,786
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`hearsay rule and to allow a witness, under the guise of giving expert testimony, to in
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`effect become the mouthpiece of the witnesses on whose statements or opinions the
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`expert purports to base his opinion.”)
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`Further, contrary to Petitioner’s characterization, Patent Owner did not argue
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`that experts themselves must conduct testing to verify the data under 37 C.F.R.
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`§ 42.65(a). The issue is that Currie’s data are wholly unreliable and unverified. Univ.
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`of Strathclyde v. Clear-Vu Lighting LLC, 17 F.4th 155, 164 (Fed. Cir. 2021) is
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`distinguishable. Opp., 14. In Univ. of Strathclde, Dr. Goodrich, whose expertise in
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`the field is undisputed, relied on data in a peer reviewed journal for what it would
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`have taught a POSA. Id. But here, Dr. Peterson, who admittedly is not an expert in
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`the field of GCC receptors, relied on Currie’s submission generated solely for
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`litigation purposes for the truth of the results and reliability thereof. Petitioner’s
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`reliance on Univ. of Strathclde therefore is inapposite.
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`III. CONCLUSION
`Patent Owner respectfully requests that the Board exclude the entirety of
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`Exhibit 1067 and paragraphs 34, 149, 152-57, 160, 162-64, 166-67 of Exhibit 1063.
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`Respectfully submitted,
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`Date: June 7, 2023
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`By: /Justin J. Hasford/
`Justin J. Hasford, Reg. No. 62,180
`Lead Counsel
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`Counsel for the Patent Owner
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`5
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`CERTIFICATE OF SERVICE
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`Case IPR2022-00722
`Patent No. 7,041,786
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`The undersigned certifies that a copy of the foregoing Patent Owner’s Reply
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`in Support of Its Motion to Exclude was served electronically via email on June
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`7, 2023, to counsel of record for the Petitioner at the following:
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`Jad A. Mills
`Wilson Sonsini Goodrich & Rosati PC
`701 Fifth Avenue, Suite 5100
`Seattle, WA 98104-7036
`jmills@wsgr.com
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`Richard Torczon
`Tasha M. Thomas
`Wilson Sonsini Goodrich & Rosati PC
`1700 K Street N.W., 5th Floor
`Washington, DC 20006
`rtorczon@wsgr.com
`tthomas@wsgr.com
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`Dennis D. Gregory
`Wilson Sonsini Goodrich & Rosati PC
`900 South Capital of Texas Highway, Las Cimas IV, Fifth Floor
`Austin, TX 78746-5546
`dgregory@wsgr.com
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`4863-5899-2145@mail.vault.netdocuments.com
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`Andrew O. Larsen
`Merchant & Gould, P.C.
`500 Fifth Avenue, Suite 4100
`New York, NY 10110
`alarsen@merchantgould.com
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`Melissa Hayworth
`Merchant & Gould, P.C.
`1900 Duke, Street, Suite 600
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`Date: June 7, 2023
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`Case IPR2022-00722
`Patent No. 7,041,786
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`Alexandria, VA 22314
`mhayworth@merchantgould.com
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`Christopher J. Sorenson
`Merchant & Gould, P.C.
`150 South Fifth Street, Suite 2200
`Minneapolis, MN 55402
`csorenson@merchantgould.com
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`plecanatidemerchant@merchantgould.com
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`By: /Geneva Eaddy/
`Geneva Eaddy
`Case Manager
`FINNEGAN, HENDERSON, FARABOW,
`GARRETT & DUNNER, LLP
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