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`Paper No. 19
`Filed: September 28, 2022
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`__________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`__________________
`
`
`MYLAN PHARMACEUTICALS INC.,
`
`Petitioner,
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`v.
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`BAUSCH HEALTH IRELAND LIMITED,
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`Patent Owner.
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`__________________
`
`Case IPR2022-00722
`U.S. Patent No. 7,041,786
`__________________
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`PATENT OWNER’S OBJECTIONS TO PETITIONER’S
`PRE-INSTITUTION EVIDENCE
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`
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`Case IPR2022-00722
`Patent No. 7,041,786
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`I.
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`INTRODUCTION
`Patent Owner Bausch Health Ireland Limited objects to Petitioner Mylan
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`Pharmaceuticals Inc.’s Exhibits for failure to comply with the Federal Rules of
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`Evidence (FRE). 37 C.F.R. §§ 42.62(a), 42.64(b)(1).
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`II. OBJECTIONS
`A. Mylan’s technical exhibits (EX1006-1008, 1010-1053) are hearsay
`without exception and unauthenticated.
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`Mylan offers EX1006-1008, 1010-1053 as non-testimony evidence to prove
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`the truth of the matter Mylan asserts, without identifying any exception to support
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`such use, in violation of FRE 802. Mylan’s reliance on statements the Patent Owner
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`cannot cross examine is prejudicial. Additionally, Mylan makes no attempt to
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`establish the authenticity of EX1006-1008, 1010-1053, in violation of FRE 901.
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`B. Mylan’s Highlights of Prescribing Information (EX1055) is not prior
`art
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`Mylan offers highlights of prescribing Information (EX1055) of Trulance®,
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`which is not prior art. Thus, the Patent Owner objects to Mylan’s reliance on
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`EX1055 for any prior art purpose.
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`1
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`Case IPR2022-00722
`Patent No. 7,041,786
`C. Mylan’s Webpage Article (EX1028) is incomplete and
`unauthenticated
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`Mylan offers an incomplete webpage article (EX1028), as its sentences and
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`Figure 1 are cut off. See FRE 106. Additionally, Mylan makes no attempt to
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`establish the authenticity of EX1028, in violation of FRE 901.
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`D. Each Mylan’s exhibit must be restricted to the purpose for which
`Mylan offered the exhibit
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`Each Mylan exhibit must be restricted to the purpose for which Mylan offered
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`the exhibit. See FRE 105. Should Mylan rely on an exhibit for a different purpose
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`than that for which it has been offered, Bausch reserves the right to make additional
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`objections.
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`III. CONCLUSION
`Bausch submits these objections as authorized by Board rules.
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`
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`Date: September 28, 2022
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`Respectfully submitted,
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`
`
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`/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
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`Finnegan, Henderson, Farabow,
` Garrett & Dunner, LLP
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`Counsel for the Patent Owner
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`2
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`Case IPR2022-00722
`Patent No. 7,041,786
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`CERTIFICATE OF SERVICE
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`The undersigned certifies that a copy of this paper was served electronically
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`via email on September 28, 2022, in their entirety on the following:
`
`Jad Mills
`Richard Torczon
`Nicole Stafford
`Dennis Gregory
`701 Fifth Avenue, Suite 5100,
`Seattle, WA 98104-7036
`jmills@wsgr.com
`rtorczon@wsgr.com
`nstafford@wsgr.com
`dgregory@wsgr.com
`4863-5899-2145@mail.vault.netdocuments.com
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`The Petitioner has consented to service by electronic mail.
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`/Geneva Eaddy/
`Geneva Eaddy
`Case Manager
`FINNEGAN, HENDERSON, FARABOW,
` GARRETT & DUNNER LLP
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`Dated: September 28, 2022
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