UNITED STATES PATENT AND TRADEMARK OFFICE
`______________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`______________________
`
`REGENERON PHARMACEUTICALS, INC.,
`Petitioner,
`
`v.
`
`NOVARTIS PHARMA AG,
`NOVARTIS TECHNOLOGY LLC,
`NOVARTIS PHARMACEUTICALS CORPORATION,
`Patent Owner.
`______________________
`
`Case No. IPR2021-00816
`U.S. Patent No. 9,220,631
`______________________
`
`PETITIONER’S THIRD OBJECTIONS TO
`ADMISSIBILITY OF EVIDENCE SUBMITTED BY PATENT OWNER
`
`
`
`
`
`
`
`
`
`______________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`______________________
`
`REGENERON PHARMACEUTICALS, INC.,
`Petitioner,
`
`v.
`
`NOVARTIS PHARMA AG,
`NOVARTIS TECHNOLOGY LLC,
`NOVARTIS PHARMACEUTICALS CORPORATION,
`Patent Owner.
`______________________
`
`Case No. IPR2021-00816
`U.S. Patent No. 9,220,631
`______________________
`
`PETITIONER’S THIRD OBJECTIONS TO
`ADMISSIBILITY OF EVIDENCE SUBMITTED BY PATENT OWNER
`
`
`
`
`
`
`
`
`
`
`Pursuant to 37 C.F.R. § 42.64(b), Petitioner Regeneron Pharmaceuticals, Inc.,
`
`IPR2021-00816
`U.S. 9,220,631
`
`
`
`
`hereby objects as follows to the admissibility of evidence filed by Patent Owners
`
`Novartis Pharma AG, Novartis Technology LLC, Novartis Pharmaceuticals
`
`Corporation, in conjunction with the Patent Owner Sur-Reply, filed on May 26, 2022.
`
`Evidence
`Exhibit 2335
`
`Objections
`FRE 105: To the extent that any portion of this exhibit may
`
`
`
`be deemed admissible, such admissibility should be for a
`
`limited purpose.
`
`FRE 402: The exhibit is not relevant to any ground upon
`
`which trial was instituted.
`
`FRE 403: The exhibit’s probative value to any ground upon
`
`which trial was instituted is substantially outweighed by the
`
`danger of unfair prejudice, confusing the issues, undue
`
`delay, wasting time, or needlessly cumulative evidence.
`
`FRE 802: The entirety of the exhibit is inadmissible hearsay
`
`if offered to prove the truth of any matter allegedly asserted
`
`therein.
`
`37 C.F.R. § 42.23(b): The exhibit is impermissibly filed as
`
`new evidence accompanying a sur-reply.
`
`
`
`2
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`
`
`Evidence
`Exhibit 2336
`
`Objections
`FRE 105: To the extent that any portion of this exhibit may
`
`
`
`be deemed admissible, such admissibility should be for a
`
`IPR2021-00816
`U.S. 9,220,631
`
`limited purpose.
`
`FRE 402: The exhibit is not relevant to any ground upon
`
`which trial was instituted.
`
`FRE 403: The exhibit’s probative value to any ground upon
`
`which trial was instituted is substantially outweighed by the
`
`danger of unfair prejudice, confusing the issues, undue
`
`delay, wasting time, or needlessly cumulative evidence.
`
`FRE 802: The entirety of the exhibit is inadmissible hearsay
`
`if offered to prove the truth of any matter allegedly asserted
`
`therein.
`
`37 C.F.R. § 42.23(b): The exhibit is impermissibly filed as
`
`new evidence accompanying a sur-reply.
`
`Exhibit 2337
`
`FRE 105: To the extent that any portion of this exhibit may
`
`
`
`
`
`be deemed admissible, such admissibility should be for a
`
`limited purpose.
`
`FRE 402: The exhibit is not relevant to any ground upon
`
`which trial was instituted.
`
`3
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`
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`Evidence
`
`IPR2021-00816
`U.S. 9,220,631
`
`Objections
`FRE 403: The exhibit’s probative value to any ground upon
`
`which trial was instituted is substantially outweighed by the
`
`danger of unfair prejudice, confusing the issues, undue
`
`delay, wasting time, or needlessly cumulative evidence.
`
`FRE 802: The entirety of the exhibit is inadmissible hearsay
`
`if offered to prove the truth of any matter allegedly asserted
`
`therein.
`
`37 C.F.R. § 42.23(b): The exhibit is impermissibly filed as
`
`new evidence accompanying a sur-reply.
`
`Exhibit 2339
`
`Petitioner refers to the objections made during the
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`
`
`deposition of James Agalloco, which are incorporated
`
`herein by reference.
`
`Exhibit 2340
`
`Petitioner refers to the objections made during the
`
`
`
`deposition of Joel M. Cohen, which are incorporated herein
`
`by reference.
`
`Exhibit 2341
`
`Petitioner refers to the objections made during the
`
`
`
`
`
`deposition of Kenneth S. Graham, which are incorporated
`
`herein by reference.
`
`4
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`
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`Evidence
`Exhibit 2342
`
`Objections
`FRE 105: To the extent that any portion of this exhibit may
`
`
`
`be deemed admissible, such admissibility should be for a
`
`IPR2021-00816
`U.S. 9,220,631
`
`limited purpose.
`
`FRE 403: The exhibit’s probative value to any ground upon
`
`which trial was instituted is substantially outweighed by the
`
`danger of unfair prejudice, confusing the issues, undue
`
`delay, wasting time, or needlessly cumulative evidence.
`
`FRE 802: The entirety of the exhibit is inadmissible hearsay
`
`if offered to prove the truth of any matter allegedly asserted
`
`therein.
`
`337 C.F.R. § 42.23(b): The exhibit is impermissibly filed as
`
`new evidence accompanying a sur-reply.
`
`Exhibit 2343
`
`FRE 105: To the extent that any portion of this exhibit may
`
`
`
`be deemed admissible, such admissibility should be for a
`
`limited purpose.
`
`FRE 403: The exhibit’s probative value to any ground upon
`
`which trial was instituted is substantially outweighed by the
`
`danger of unfair prejudice, confusing the issues, undue
`
`delay, wasting time, or needlessly cumulative evidence.
`
`5
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`Evidence
`
`IPR2021-00816
`U.S. 9,220,631
`
`Objections
`FRE 802: The entirety of the exhibit is inadmissible hearsay
`
`if offered to prove the truth of any matter allegedly asserted
`
`therein.
`
`37 C.F.R. § 42.23(b): The exhibit is impermissibly filed as
`
`new evidence accompanying a sur-reply.
`
`Exhibit 2344
`
`FRE 105: To the extent that any portion of this exhibit may
`
`be deemed admissible, such admissibility should be for a
`
`limited purpose.
`
`FRE 403: The exhibit’s probative value to any ground upon
`
`which trial was instituted is substantially outweighed by the
`
`danger of unfair prejudice, confusing the issues, undue
`
`delay, wasting time, or needlessly cumulative evidence.
`
`FRE 802: The entirety of the exhibit is inadmissible hearsay
`
`if offered to prove the truth of any matter allegedly asserted
`
`therein.
`
`37 C.F.R. § 42.23(b): The exhibit is impermissibly filed as
`
`new evidence accompanying a sur-reply.
`
`
`
`6
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`
`
`IPR2021-00816
`U.S. 9,220,631
`
`Evidence
`Exhibit 2345
`
`Objections
`Petitioner refers to the objections made during the
`
`
`
`deposition of Dr. Szilard Kiss, which are incorporated
`
`herein by reference.
`
`Exhibit 2346
`
`Petitioner refers to the objections made during the
`
`
`
`deposition of Gerrit Moyer, which are incorporated herein
`
`by reference.
`
`FRE 105: To the extent that any portion of this exhibit may
`
`be deemed admissible, such admissibility should be for a
`
`limited purpose.
`
`FRE 403: The exhibit’s probative value to any ground upon
`
`which trial was instituted is substantially outweighed by the
`
`danger of unfair prejudice, confusing the issues, undue
`
`delay, wasting time, or needlessly cumulative evidence.
`
`FRE 802: The entirety of the exhibit is inadmissible hearsay
`
`if offered to prove the truth of any matter allegedly asserted
`
`therein.
`
`37 C.F.R. § 42.23(b): The exhibit is impermissibly filed as
`
`new evidence accompanying a sur-reply.
`
`7
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`IPR2021-00816
`U.S. 9,220,631
`
`Evidence
`Exhibit 2347
`
`Objections
`Petitioner refers to the objections made during the
`
`
`
`deposition of Horst Koller, which are incorporated herein by
`
`reference.
`
`Exhibit 2348
`
`Petitioner refers to the objections made during the
`
`
`
`deposition of Lisa Cameron, which are incorporated herein
`
`by reference.
`
`Exhibit 2349
`
`FRE 105: To the extent that any portion of this exhibit may
`
`
`
`be deemed admissible, such admissibility should be for a
`
`limited purpose.
`
`FRE 403: The exhibit’s probative value to any ground upon
`
`which trial was instituted is substantially outweighed by the
`
`danger of unfair prejudice, confusing the issues, undue
`
`delay, wasting time, or needlessly cumulative evidence.
`
`FRE 802: The entirety of the exhibit is inadmissible hearsay
`
`if offered to prove the truth of any matter allegedly asserted
`
`therein.
`
`37 C.F.R. § 42.23(b): The exhibit is impermissibly filed as
`
`new evidence accompanying a sur-reply.
`
`8
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`
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`Evidence
`Exhibit 2350
`
`Objections
`FRE 105: To the extent that any portion of this exhibit may
`
`
`
`be deemed admissible, such admissibility should be for a
`
`IPR2021-00816
`U.S. 9,220,631
`
`limited purpose.
`
`FRE 403: The exhibit’s probative value to any ground upon
`
`which trial was instituted is substantially outweighed by the
`
`danger of unfair prejudice, confusing the issues, undue
`
`delay, wasting time, or needlessly cumulative evidence.
`
`FRE 802: The entirety of the exhibit is inadmissible hearsay
`
`if offered to prove the truth of any matter allegedly asserted
`
`therein.
`
`37 C.F.R. § 42.23(b): The exhibit is impermissibly filed as
`
`new evidence accompanying a sur-reply.
`
`Exhibit 2351
`
`FRE 105: To the extent that any portion of this exhibit may
`
`
`
`be deemed admissible, such admissibility should be for a
`
`limited purpose.
`
`FRE 403: The exhibit’s probative value to any ground upon
`
`which trial was instituted is substantially outweighed by the
`
`danger of unfair prejudice, confusing the issues, undue
`
`delay, wasting time, or needlessly cumulative evidence.
`
`9
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`Evidence
`
`IPR2021-00816
`U.S. 9,220,631
`
`Objections
`FRE 802: The entirety of the exhibit is inadmissible hearsay
`
`if offered to prove the truth of any matter allegedly asserted
`
`therein.
`
`37 C.F.R. § 42.23(b): The exhibit is impermissibly filed as
`
`new evidence accompanying a sur-reply.
`
`Exhibit 2352
`
`FRE 105: To the extent that any portion of this exhibit may
`
`
`
`be deemed admissible, such admissibility should be for a
`
`limited purpose.
`
`FRE 403: The exhibit’s probative value to any ground upon
`
`which trial was instituted is substantially outweighed by the
`
`danger of unfair prejudice, confusing the issues, undue
`
`delay, wasting time, or needlessly cumulative evidence.
`
`FRE 802: The entirety of the exhibit is inadmissible hearsay
`
`if offered to prove the truth of any matter allegedly asserted
`
`therein.
`
`37 C.F.R. § 42.23(b): The exhibit is impermissibly filed as
`
`new evidence accompanying a sur-reply.
`
`
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`10
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`Date: June 3, 2022
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`IPR2021-00816
`U.S. 9,220,631
`
`Respectfully submitted,
`
`
`/Anish R. Desai/
`Anish R. Desai (Reg. No. 73,760)
`Elizabeth S. Weiswasser (Reg. No. 55,721)
`Natalie Kennedy (Reg. No. 68,511)
`Andrew Gesior (Reg. No. 76,588)
`Weil, Gotshal & Manges LLP
`767 Fifth Avenue
`New York, NY 10153
`T: 212-310-8000
`F: 212-310-8007
`E: Regeneron.IPR.Service@weil.com
`
`Christopher Pepe (Reg. No. 73,851)
`Robert T. Vlasis (admitted pro hac vice)
`Matthew D. Sieger (Reg. No. 76,051)
`Priyata Y. Patel (Reg. No. 76,861)
`Weil, Gotshal & Manges LLP
`2001 M Street NW, Suite 600
`Washington, DC 20036
`T: 202-682-7000
`F: 202-857-0940
`E: Regeneron.IPR.Service@weil.com
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`11
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`CERTIFICATE OF SERVICE
`
`I hereby certify that on June 3, 2022, copies of the foregoing
`
`IPR2021-00816
`U.S. 9,220,631
`
`PETITIONER’S THIRD OBJECTIONS TO ADMISSIBILITY OF
`
`EVIDENCE SUBMITTED BY PATENT OWNER was served via electronic
`
`mail, upon the following:
`
`Elizabeth J. Holland
`Daniel P. Margolis
`Allen & Overy LLP
`1221 Avenue of the Americas
`New York, NY 10020
`elizabeth.holland@allenovery.com
`daniel.margolis@allenovery.com
`
`Nicholas K. Mitrokostas
`John T. Bennett
`Allen & Overy LLP
`1 Beacon Street
`Boston, MA 02108
`nicholas.mitrokostas@allenovery.com
`john.bennett@allenovery.com
`
`William G. James
`Allen & Overy LLP
`1101 New York Avenue, NW
`Washington, D.C 20005
`william.james@allenovery.com
`
`Linnea Cipriano
`Goodwin Procter LLP
`620 Eighth Avenue
`New York, NY 10018
`lcipriano@goodwinlaw.com
`
`
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`12
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`IPR2021-00816
`U.S. 9,220,631
`
`
`
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`Duncan Greenhalgh
`Joshua Weinger
`Goodwin Procter LLP
`100 Northern Avenue
`Boston, MA 02210
`dgreenhalgh@goodwinlaw.com
`jweinger@goodwinlaw.com
`
`
`
`
`/Sandra Wong/
`Sandra Wong
`Senior IP Paralegal
`Weil, Gotshal & Manges LLP
`767 Fifth Avenue
`New York, NY 10153
`212-310-8000
`sandra.wong@weil.com
`
`13
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`
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