`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`__________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`__________________
`
`
`MYLAN PHARMACEUTICALS INC.,
`MSN LABORATORIES PRIVATE LTD.,
`and MSN PHARMACEUTICALS INC.,
`
`Petitioner,
`
`v.
`
`BAUSCH HEALTH IRELAND LIMITED,
`
`Patent Owner.
`
`__________________
`
`Case IPR2022-007221
`U.S. Patent No. 7,041,786
`__________________
`
`PATENT OWNER’S OBJECTIONS TO
`PETITIONER’S EVIDENCE
`
`
`1 IPR2023-00016 has been joined with this proceeding.
`
`
`
`Case IPR2022-00722
`Patent No. 7,041,786
`
`I.
`
`INTRODUCTION
`Patent Owner Bausch Health Ireland Limited objects to Petitioner Mylan
`
`Pharmaceuticals Inc.’s Exhibits for failure to comply with the Federal Rules of
`
`Evidence (FRE). 37 C.F.R. §§ 42.62(a), 42.64(b)(1).
`
`II. OBJECTIONS
`A. Mylan’s Technical Exhibits (EX1065, EX1066, EX1070) are hearsay
`without exception and unauthenticated.
`
`Mylan offers EX1065, EX1066, and EX1070 as non-testimony evidence to
`
`prove the truth of the matter Mylan asserts, without identifying any exception to
`
`support such use, in violation of FRE 802. Mylan’s reliance on statements Patent
`
`Owner cannot cross examine is prejudicial. Additionally, Mylan makes no attempt
`
`to establish the authenticity of EX1065, EX1066, and EX1070, in violation of FRE
`
`901.
`
`
`
`B. Mylan’s File History Excerpt of European Patent (EX1067) is
`incomplete, hearsay without exception, and not in accordance with
`37 CFR § 42.65(b).
`
`Mylan offers an incomplete and selective excerpt of file history of European
`
`Patent No. 1 379 224 (EX1067), and EX1067 should be excluded for that reason
`
`alone. See FRE 106. Mylan offers EX1067 as non-testimony evidence to prove the
`
`truth of the matter Mylan asserts, without identifying any exception to support such
`
`use, in violation of FRE 802. Mylan’s reliance on statements Patent Owner cannot
`
`cross examine is prejudicial. Mylan relies on a technical test or data included in
`1
`
`
`
`
`Case IPR2022-00722
`Patent No. 7,041,786
`EX1067 without providing an affidavit as required by 37 CFR § 42.65(b), and
`
`EX1067 should be excluded for that additional reason.
`
`C. The Peterson Reply Declaration (EX1063) is hearsay without
`exception and not in accordance with 37 CFR § 42.65(a).
`
`EX1063 ¶¶ 34, 149, 152-57, 160, 162-64, 166-67 should be excluded because
`
`it relies on EX1067, which does not sufficiently disclose underlying facts or data.
`
`37 CFR § 42.65(a). Also, EX1063 ¶¶ 34, 149, 152-57, 160, 162-64, 166-67 should
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`be excluded because its likelihood to cause confusion and undue prejudice
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`outweighs any possible probative value it might have. FRE 402; FRE 403. EX1063
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`should be excluded as presenting opinion testimony, including on an ultimate issue,
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`from witnesses without qualification or proper basis. FRE 701-FRE 705. EX1063
`
`should be excluded as hearsay without exception, including hearsay within hearsay.
`
`FRE 802.
`
`D. Mylan’s Technical Exhibit (EX1066) and highlights of prescribing
`Information of Linzess® (EX1072) are not prior art.
`
`Mylan offers a technical exhibit (EX1066) and highlights of prescribing
`
`Information (EX1072) for Linzess®, which Mylan has not established are prior art.
`
`Thus, Patent Owner objects to Mylan’s reliance on EX1066 and EX1072 for any
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`prior art purpose.
`
`2
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`
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`Case IPR2022-00722
`Patent No. 7,041,786
`E. Each Mylan’s exhibit must be restricted to the purpose for which
`Mylan offered the exhibit.
`
`Each Mylan exhibit must be restricted to the purpose for which Mylan offered
`
`the exhibit. See FRE 105. Should Mylan rely on an exhibit for a different purpose
`
`than that for which it has been offered, Patent Owner reserves the right to make
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`additional objections.
`
`III. CONCLUSION
`Patent Owner submits these objections as authorized by Board rules.
`
`
`
`Date: March 31, 2023
`
`Respectfully submitted,
`
`
`
`
`/Justin J. Hasford/
`By:
`Justin J. Hasford, Reg. No. 62,180
`Bryan C. Diner, Reg. No. 32,409
`Joshua L. Goldberg, Reg. No. 59,369
`Caitlin E. O’Connell, Reg. No. 73,934
`Kyu Yun Kim. Reg. No. 72,783
`
`Finnegan, Henderson, Farabow,
` Garrett & Dunner, LLP
`
`Counsel for the Patent Owner
`
`3
`
`
`
`
`Case IPR2022-00722
`Patent No. 7,041,786
`
`
`
`CERTIFICATE OF SERVICE
`
`The undersigned certifies that a copy of this paper was served electronically
`
`via email on March 31, 2023, in their entirety on the following:
`
`Jad A. Mills
`Wilson Sonsini Goodrich & Rosati PC
`701 Fifth Avenue, Suite 5100
`Seattle, WA 98104-7036
`jmills@wsgr.com
`
`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
`
`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
`
`4863-5899-2145@mail.vault.netdocuments.com
`
`Andrew O. Larsen
`Merchant & Gould, P.C.
`500 Fifth Avenue, Suite 4100
`New York, NY 10110
`alarsen@merchantgould.com
`
`Melissa Hayworth
`Merchant & Gould, P.C.
`1900 Duke, Street, Suite 600
`Alexandria, VA 22314
`mhayworth@merchantgould.com
`
`
`
`
`
`Case IPR2022-00722
`Patent No. 7,041,786
`
`Christopher J. Sorenson
`Merchant & Gould, P.C.
`150 South Fifth Street, Suite 2200
`Minneapolis, MN 55402
`csorenson@merchantgould.com
`
`plecanatidemerchant@merchantgould.com
`
`
`
`The Petitioner has consented to service by electronic mail.
`
`
`
`
`
`
`
`
`
`
`
`/Geneva Eaddy/
`Geneva Eaddy
`Case Manager
`FINNEGAN, HENDERSON, FARABOW,
` GARRETT & DUNNER LLP
`
`Dated: March 31, 2023
`
`
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