Case 1:22-cv-00061-TSK-JPM Document 523 Filed 06/05/23 Page 1 of 8 PageID #: 41436
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE NORTHERN DISTRICT OF WEST VIRGINIA
`
`REGENERON PHARMACEUTICALS, INC.,
`
`Plaintiff,
`
`v.
`
`MYLAN PHARMACEUTICALS INC.,
`
`Defendant.
`
`Civil Action No. 1:22-cv-00061-TSK
`
` STIPULATION AND ORDER JOINING
`BIOCON BIOLOGICS INC. AS DEFENDANT
`
`WHEREAS, on or about October 29, 2021, Mylan Pharmaceuticals Inc. (“Mylan”)
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`submitted Biologics License Application No 761274 (the “BLA”) to the U.S. Food and Drug
`
`Administration (the “FDA”), seeking licensure to market M710 (or YESAFILITM) for injection
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`(the “BLA Product”), as a biosimilar version of Regeneron Pharmaceuticals, Inc.’s (“Regeneron”)
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`EYLEA® product, before expiration of various patents owned by Regeneron;
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`WHEREAS, on or about August 2, 2022, Regeneron filed this suit against Mylan, alleging
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`that the submission of Mylan’s BLA and the commercial manufacture, use, sale, offer for sale
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`and/or importation of the BLA Product are acts of infringement of certain patents (the “Asserted
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`Patents”) owned by Regeneron;
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`WHEREAS, Mylan denies infringement, and has filed counterclaims seeking judicial
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`declarations that the Asserted Patents are invalid, unenforceable and/or not infringed;
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`WHEREAS, Biocon Biologics Inc. (“BBI”) has represented that it is the successor in
`
`interest to all of Mylan’s rights, title, and interest in and to the BLA and BLA Product;
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`1
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`Regeneron Pharmaceuticals, Inc. Exhibit 2001 Page 1
`Biocon Biologics Inc. v. Regeneron Pharamceuticals, Inc. IPR2024-00201
`
`

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`Case 1:22-cv-00061-TSK-JPM Document 523 Filed 06/05/23 Page 2 of 8 PageID #: 41437
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`WHEREAS, the FDA has accepted the transfer of ownership of the BLA from Mylan to
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`BBI, effective as of March 17, 2023;
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`NOW THEREFORE, the parties hereby stipulate, including pursuant to FED. R. CIV. P. 25(c), and
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`subject to the approval of the Court, that:
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`1.
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`BBI is hereby joined as a Defendant-Counterclaim Plaintiff to this suit for all
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`purposes, and with respect to all claims, defenses and counterclaims, and rulings of the Court, as
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`successor in interest to all of Mylan’s rights, title and interest in and to the BLA and BLA Product.
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`BBI hereby adopts all representations, contentions, admissions, positions, and stipulations made
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`by Mylan in this action to date and agrees to be bound by those representations, contentions,
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`admissions, positions, and stipulations to the same extent as Mylan is or would be bound. Any
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`evidence that supports a finding of infringement as to Mylan will support a finding of infringement
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`as to BBI. Regeneron hereby acknowledges that any representations, contentions, admissions,
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`positions, and stipulations made to Mylan by Regeneron in this action to date shall also apply
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`equally to BBI. For clarity, neither Mylan nor BBI will allege that any finding or judgment as to
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`infringement, validity, enforceability, remedies, or any finding subsidiary thereto, shall not issue
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`or apply on the basis that BBI, rather than Mylan, has any interest in the BLA or BLA Product.
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`For further clarity, any statutory protections afforded Mylan for the actions taken by Mylan and/or
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`Regeneron during the pre-suit exchanges pursuant to Biologics Price Competition and Innovation
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`Act (“BPCIA”) shall also equally apply to BBI.
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`2.
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`3.
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`The current trial schedule shall be unaffected by this Stipulation and Order.
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`Upon filing of this Stipulation, BBI shall be a party to the Stipulated Protective
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`Order, and may provide a list of no more than three proposed In-House Counsel who it wishes to
`
`2
`
`Regeneron Pharmaceuticals, Inc. Exhibit 2001 Page 2
`Biocon Biologics Inc. v. Regeneron Pharamceuticals, Inc. IPR2024-00201
`
`

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`Case 1:22-cv-00061-TSK-JPM Document 523 Filed 06/05/23 Page 3 of 8 PageID #: 41438
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`have access to Confidential information pursuant to ¶ 6(i) of the Protective Order, on the terms
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`and conditions provided for by the Protective Order.
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`4.
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`BBI is prepared to produce, via electronic transfer, the entirety of its BLA and
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`regulatory correspondence with the FDA concerning the BLA Product following transfer of
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`ownership to BBI, including any documents reflecting, documenting, or summarizing oral
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`communications with FDA concerning the BLA product, and will produce that material to
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`Regeneron within 2 business days of the parties’ filing of this Stipulation with the Court. BBI
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`accepts a continuing obligation to produce such material on an ongoing basis, consistent with FED.
`
`R. CIV. P. 26(e). BBI will produce such material in compliance with the terms of the parties’
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`Stipulated Protective Order and will not argue that ¶ 1(m) or other provisions of the Protective
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`Order permit BBI to designate its FDA correspondence “OCEO” on a theory that documents
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`relevant to BBI’s prospective product necessarily merit OCEO protection.
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`5.
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`Neither BBI nor Mylan will use this Stipulation as an admission or basis to seek to
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`have Mylan dismissed from this action. Similarly, nothing in this Stipulation prejudices
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`Regeneron from opposing any request to have Mylan dismissed from this action, and this
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`Stipulation does not constitute a statement by Regeneron that it no longer has claims against
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`Mylan.
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`6.
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`Neither BBI nor Mylan will seek to dismiss or transfer any portion of this action
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`based on any argument the Court lacks personal jurisdiction over BBI or Mylan or any argument
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`that venue in the Northern District of West Virginia is improper or inconvenient.
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`7.
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`The Clerk is directed to amend the caption to add BBI as a Defendant-Counterclaim
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`Plaintiff, as noted below.
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`3
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`Regeneron Pharmaceuticals, Inc. Exhibit 2001 Page 3
`Biocon Biologics Inc. v. Regeneron Pharamceuticals, Inc. IPR2024-00201
`
`

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`Case 1:22-cv-00061-TSK-JPM Document 523 Filed 06/05/23 Page 4 of 8 PageID #: 41439
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE NORTHERN DISTRICT OF WEST VIRGINIA
`
`REGENERON PHARMACEUTICALS, INC.,
`
`Plaintiff,
`
`v.
`
`MYLAN PHARMACEUTICALS INC. and
`BIOCON BIOLOGICS INC.,
`
`Defendants.
`
`Civil Action No. 1:22-cv-00061-TSK
`
`4
`
`Regeneron Pharmaceuticals, Inc. Exhibit 2001 Page 4
`Biocon Biologics Inc. v. Regeneron Pharamceuticals, Inc. IPR2024-00201
`
`

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`Case 1:22-cv-00061-TSK-JPM Document 523 Filed 06/05/23 Page 5 of 8 PageID #: 41440
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`Date: June 2, 2023
`
` CAREY DOUGLAS KESSLER & RUBY, PLLC
`
`Of Counsel:
`
`David I. Berl (admitted PHV)
`Ellen E. Oberwetter (admitted PHV)
`Thomas S. Fletcher (admitted PHV)
`Andrew V. Trask (admitted PHV)
`Teagan J. Gregory (admitted PHV)
`Shaun P. Mahaffy (admitted PHV)
`Sean M. Douglass (admitted PHV)
`Kathryn S. Kayali (admitted PHV)
`Arthur J. Argall III (admitted PHV)
`Adam Pan (admitted PHV)
`Nicholas Jordan (admitted PHV)
`Haylee Bernal Anderson (admitted PHV)
`Renee Griffin (admitted PHV)
`Rebecca Carter (admitted PHV)
`WILLIAMS & CONNOLLY LLP
`680 Maine Avenue, SW
`Washington, DC 20024
`(202) 434-5000
`dberl@wc.com
`eoberwetter@wc.com
`tfletcher@wc.com
`atrask@wc.com
`tgregory@wc.com
`smahaffy@wc.com
`sdouglass@wc.com
`kkayali@wc.com
`aargall@wc.com
`apan@wc.com
`njordan@wc.com
`handerson@wc.com
`rgriffin@wc.com
`rebeccacarter@wc.com
`
` /s/ Steven R. Ruby
`Steven R. Ruby (WVSB No. 10752)
`David R. Pogue (WVSB No. 10806)
`707 Virginia Street East
`901 Chase Tower (25301)
`P.O. Box 913
`Charleston, West Virginia 25323
`(304) 345-1234
`sruby@cdkrlaw.com
`drpogue@cdkrlaw.com
`
`Of Counsel:
`
`Andrew E. Goldsmith (admitted PHV)
`Evan T. Leo (admitted PHV)
`Jacob E. Hartman (admitted PHV)
`Mary Charlotte Y. Carroll (admitted PHV)
`Sven E. Henningson (admitted PHV)
`KELLOGG, HANSEN, TODD, FIGEL &
`FREDERICK, P.L.L.C.
`1615 M Street, N.W., Suite 400
`Washington, D.C. 20036
`TEL: (202) 326-7900
`agoldsmith@kellogghansen.com
`eleo@kellogghansen.com
`jhartman@kellogghansen.com
`mcarroll@kellogghansen.com
`shenningson@kellogghansen.com
`
`Counsel for Plaintiff Regeneron
`Pharmaceuticals, Inc.
`
`5
`
`Regeneron Pharmaceuticals, Inc. Exhibit 2001 Page 5
`Biocon Biologics Inc. v. Regeneron Pharamceuticals, Inc. IPR2024-00201
`
`

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`Case 1:22-cv-00061-TSK-JPM Document 523 Filed 06/05/23 Page 6 of 8 PageID #: 41441
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`Dated: June 2, 2023
`
`STEPTOE & JOHNSON PLLC
`
`Of Counsel (admitted pro hac vice):
`William A. Rakoczy
`Deanne M. Mazzochi
`Heinz J. Salmen
`Eric R. Hunt
`Jeff A. Marx
`Neil B. McLaughlin
`Lauren M. Lesko
`L. Scott Beall
`Thomas H. Ehrich
`Steven J. Birkos
`Katie A. Boda
`Abraham J. Varon
`Jake R. Ritthamel
`RAKOCZY MOLINO MAZZOCHI SIWIK LLP
`6 W. Hubbard St., Suite 500
`Chicago, IL 60654
`(312) 527-2157
`wrakoczy@rmmslegal.com
`dmazzochi@rmmslegal.com
`hsalmen@rmmslegal.com
`ehunt@rmmslegal.com
`jmarx@rmmslegal.com
`nmclaughlin@rmmslegal.com
`llesko@rmmslegal.com
`sbeall@rmmslegal.com
`tehrich@rmmslegal.com
`sbirkos@rmmslegal.com
`kboda@rmmslegal.com
`avaron@rmmslegal.com
`jritthamel@rmmslegal.com
`
` /s/ Gordon H. Copland
`Gordon H. Copland (WVSB #828)
`William J. O’Brien (WVSB #10549)
`400 White Oaks Boulevard
`Bridgeport, WV 26330
`(304) 933-8162
`gordon.copland@steptoe-johnson.com
`william.obrien@steptoe-johnson.com
`
`Counsel for Defendant
`Mylan Pharmaceuticals Inc.
`
`6
`
`Regeneron Pharmaceuticals, Inc. Exhibit 2001 Page 6
`Biocon Biologics Inc. v. Regeneron Pharamceuticals, Inc. IPR2024-00201
`
`

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`Case 1:22-cv-00061-TSK-JPM Document 523 Filed 06/05/23 Page 7 of 8 PageID #: 41442
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`Having reviewed the parties’ stipulation, the provisions thereof are APPROVED and
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`it is SO ORDERED.
`
`June 5, 2023
`DATED: ____________________
`
`________________________________________
`THOMAS S. KLEEH, CHIEF JUDGE
`NORTHERN DISTRICT OF WEST VIRGINIA
`
`7
`
`Regeneron Pharmaceuticals, Inc. Exhibit 2001 Page 7
`Biocon Biologics Inc. v. Regeneron Pharamceuticals, Inc. IPR2024-00201
`
`

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`Case 1:22-cv-00061-TSK-JPM Document 523 Filed 06/05/23 Page 8 of 8 PageID #: 41443
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`CERTIFICATE OF SERVICE
`I hereby certify that on the 2nd day of June, 2023, I served the foregoing " Stipulation and
`
`Order Joining Biocon Biologics Inc. as Defendant” by electronically filing the same with the Clerk
`
`using the Court’s CM/ECF system, which will send notification of the filing to all counsel of
`
`record.
`
` /s/ Gordon H. Copland
`Gordon H. Copland (WVSB #828)
`William J. O’Brien (WVSB #10549)
`400 White Oaks Boulevard
`Bridgeport, WV 26330
`(304) 933-8162
`gordon.copland@steptoe-johnson.com
`william.obrien@steptoe-johnson.com
`
`Attorneys for Defendant
`Mylan Pharmaceuticals Inc.
`
`8
`
`Regeneron Pharmaceuticals, Inc. Exhibit 2001 Page 8
`Biocon Biologics Inc. v. Regeneron Pharamceuticals, Inc. IPR2024-00201
`
`