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 IPR2021-00816
`U.S. Patent No. 9,220,631 B2
`________________________
`
`PETITIONER’S UPDATED MANDATORY NOTICES
`PURSUANT TO 37 C.F.R. § 42.8
`
`
`
`
`
`
`
`
`______________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`______________________
`
`
`REGENERON PHARMACEUTICALS, INC.,
`Petitioner,
`
`v.
`
`NOVARTIS PHARMA AG,
`NOVARTIS TECHNOLOGY LLC,
`NOVARTIS PHARMACEUTICALS CORPORATION,
`Patent Owner.
`
`________________________
`
`Case IPR2021-00816
`U.S. Patent No. 9,220,631 B2
`________________________
`
`PETITIONER’S UPDATED MANDATORY NOTICES
`PURSUANT TO 37 C.F.R. § 42.8
`
`
`
`
`
`
`
`
`
`
`
`Petitioner Regeneron Pharmaceuticals, Inc. hereby submits its updated
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`mandatory notices pursuant to 37 C.F.R. § 42.8(a)(3).
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`A. Real Party-In-Interest (37 C.F.R. § 42.8(b)(1)) - Unchanged
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`The real party-in-interest is Regeneron Pharmaceuticals, Inc.
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`B. Related Matters (37 C.F.R. § 42.8(b)(2)) – Unchanged
`On June 19, 2020, Novartis Pharma AG, Novartis Pharmaceuticals
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`
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`Corporation, and Novartis Technology LLC (collectively, “Novartis”) filed a
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`complaint at the International Trade Commission (“ITC”) alleging that Regeneron
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`infringes claims 1-6 and 11-26 of the ’631 Patent, and that a domestic industry
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`exists with respect to certain claims. On April 8, 2021, Novartis filed a motion to
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`terminate the ITC Investigation on the basis of withdrawal of the complaint. On
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`April 8, 2021, the Administrative Law Judge issued an initial determination
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`terminating the ITC Investigation. On May 3, 2021, the ITC issued a notice
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`formally terminating the ITC investigation.
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`
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`On June 19, 2020, Novartis filed a complaint in the United States District
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`Court for the Northern District of New York (N.D.N.Y. 1:20-cv-00690-TJM-CFH)
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`alleging that Petitioner infringes at least claim 1 of the ’631 Patent. That case was
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`stayed pursuant to 28 U.S.C. § 1659 on July 30, 2020. On June 14, 2021, the Court
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`lifted the stay. On November 4, 2021, Case No. 1:20-cv-00690-TJM-CFH was
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`1
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`reassigned within the Northern District of New York, where it remains pending as
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`Case No. 1:20-cv-00690-DNH-CFH.
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`
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`On July 16, 2020, Regeneron filed IPR2020-01317 and IPR2020-01318
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`challenging claims 1-26 of the ’631 Patent. On December 2, 2020, Regeneron filed
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`a motion to terminate IPR2020-01318 and the Board issued a determination
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`terminating the proceeding on December 7, 2020. On January 15, 2021, the Board
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`exercised its discretion under 35 U.S.C. § 314(a) and denied institution of
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`IPR2020-01317 based on the co-pending ITC Investigation.
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`
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`On July 17, 2020, Regeneron filed a complaint in the United States District
`
`Court for the Southern District of New York against Novartis and Vetter Pharma
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`International GmbH (“Vetter”) (S.D.N.Y. 1:20-cv-00502-AJN) seeking judgment
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`that (i) Novartis’s and Vetter’s conduct violates Section 1 of the Sherman Act, 15
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`U.S.C. § 1; (ii) Novartis’s conduct violates Section 2 of the Sherman Act, 15
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`U.S.C. § 2; and (iii) the ’631 Patent be declared unenforceable. On September 21,
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`2021, the Southern District of New York transferred Case No. 1:20-cv-00502-AJN
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`to the Northern District of New York. Case No. 1:21-cv-01066-DNH-CFH
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`(NDNY). On January 31, 2022, the Court granted Novartis’s and Vetter’s motion
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`to dismiss Regeneron’s complaint.
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`2
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`
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`C. Lead and Back-Up Counsel and Service Information (37 C.F.R. §
`42.8(b)(3)-(4)) – Updated
`
`Petitioner identifies the following lead and back-up counsel and service
`
`
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`information:
`
`Lead Counsel
`Anish R. Desai (Updated)
`Weil, Gotshal & Manges LLP
`767 Fifth Avenue
`New York, NY 10153
`T: 212-310-8730
`F: 212-310-8007
`anish.desai@weil.com
`USPTO Reg. No. 73,760
`
`
`Back-Up Counsel
`Elizabeth Stotland Weiswasser (Updated)
`Weil, Gotshal & Manges LLP
`767 Fifth Avenue
`New York, NY 10153
`T: 212-310-8022
`F: 212-310-8007
`elizabeth.weiswasser@weil.com
`USPTO Reg. No. 55,721
`
`Christopher M. Pepe
`Weil, Gotshal & Manges LLP
`2001 M Street, N.W., Suite 600
`Washington, D.C. 20036
`T: 202-682-7000
`F: 202-857-0940
`christopher.pepe@weil.com
`USPTO Reg. No. 73,851
`
`Robert T. Vlasis
`Admitted Pro Hac Vice
`Weil, Gotshal & Manges LLP
`2001 M Street, N.W., Suite 600
`Washington, D.C. 20036
`T: 202-682-7000
`F: 202-857-0940
`robert.vlasis@weil.com
`
`Matthew D. Sieger
`Weil, Gotshal & Manges LLP
`2001 M Street, N.W., Suite 600
`Washington, D.C. 20036
`T: 202-682-7000
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`3
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`
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`F: 202-857-0940
`matthew.sieger@weil.com
`USPTO Reg. No. 76,051
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`Natalie Kennedy
`Weil, Gotshal & Manges LLP
`767 Fifth Avenue
`New York, NY 10153
`T: 212-310-8730
`F: 212-310-8007
`natalie.kennedy@weil.com
`USPTO Reg. No. 68,511
`
`Andrew Gesior
`Weil, Gotshal & Manges LLP
`767 Fifth Avenue
`New York, NY 10153
`T: 212-310-8730
`F: 212-310-8007
`andrew.gesior@weil.com
`USPTO Reg. No. 76,588
`
`Petra Scamborova
`Admitted Pro Hac Vice
`Regeneron Pharmaceuticals, Inc.
`777 Old Saw Mill River Road
`Tarrytown, NY 10591
`914-847-7611
`petra.scamborova@regeneron.com
`
`James T. Evans
`Regeneron Pharmaceuticals, Inc.
`777 Old Saw Mill River Road
`Tarrytown, NY 10591
`914-847-7000
`james.evans@regeneron.com
`USPTO Reg. No. 64,377
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`4
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`Please address all correspondence to lead and backup counsel. Petitioner
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`consents to service by electronic mail at the following address:
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`Regeneron.IPR.Service@weil.com.
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`Date: March 7, 2022 Respectfully submitted,
`
` /s/ Anish R. Desai
`Anish R. Desai
`Reg. No. 73,760
`Lead Counsel for Petitioner
`Weil, Gotshal & Manges LLP
`767 Fifth Avenue
`New York, NY 10153
`T: 212-310-8730
`anish.desai@weil.com
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`5
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`CERTIFICATE OF SERVICE
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`
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`The undersigned hereby certifies that on March 7, 2022 the foregoing
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`PETITIONER’S UPDATED MANDATORY NOTICES PURSUANT TO 37
`
`C.F.R. § 42.8 was served via electronic mail upon the following:
`
`Elizabeth J. Holland
`Allen & Overy LLP
`1221 Avenue of the Americas
`New York, NY 10020
`elizabeth.holland@allenovery.com
`
`Nicholas K. Mitrokostas
`Allen & Overy LLP
`1 Beacon Street
`Boston, MA 02108
`nicholas.mitrokostas@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
`
`Duncan Greenhalgh
`Joshua Weinger
`Goodwin Procter LLP
`100 Northern Avenue
`Boston, MA 02210
`dgreenhalgh@goodwinlaw.com
`jweinger@goodwinlaw.com
`DG-NovartisPFS@goodwinlaw.com
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`6
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`/Daniela Toribio/
`Daniela Toribio
`IP Paralegal
`Weil, Gotshal & Manges LLP
`2001 M Street, NW, Suite 600
`Washington, D.C. 20036
`T: 202-682-7000
`daniela.toribio@weil.com
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`7
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