Case 1:24-cv-00053-TSK Document 16-2 Filed 05/31/24 Page 1 of 503 PageID #: 1949
`Case 1:24-cv-00053-TSK Document 16-2 Filed 05/31/24 Page 1 of 503 PagelD #: 1949
`
`
`
`
`
`
`
`APPENDIX B
`APPENDIX B
`
`AMGEN INC. FILINGS MADE BEFORE
`AMGENINC. FILINGS MADE BEFORE
`THE UNITED STATES JUDICIAL PANEL ON
`THE UNITED STATES JUDICIAL PANEL ON
`MULTIDISTRICT LITITAGTION IN
`MULTIDISTRICT LITITAGTION IN
`IN RE AFLIBERCEPT PATENT LITIGATION,
`IN RE AFLIBERCEPTPATENTLITIGATION,
`MDL NO. 3103
`MDL NO.3103
`
`
`
`
`
`

`

`Case 1:24-cv-00053-TSK Document 16-2 Filed 05/31/24 Page 2 of 503 PageID #: 1950
`
`
`
`
`
`
`
`APPENDIX B-1
`
`Amgen Inc.’s Corporate Disclosure Statement (Dkt. 8),
`filed on January 26, 2024
`
`
`
`
`

`

`Case MDL No. 3103 Document 8 Filed 01/26/24 Page 1 of 8Case 1:24-cv-00053-TSK Document 16-2 Filed 05/31/24 Page 3 of 503 PageID #: 1951
`
`UNITED STATES JUDICIAL PANEL ON MULTIDISTRICT LITIGATION
`
`3103
`Aflibercept Patent Litigation
`MDL No. _____________ & TITLE - IN RE: __________________________________
`
`Case Caption (Include Plaintiff, District, and Civil Action No.) (attach list if necessary):
`
`Regeneron Pharmaceuticals, Inc. v. Amgen Inc, C.D. California, 2:24-cv-00264-JWH-E
`_________________________________________________________________
`
`CORPORATE DISCLOSURE STATEMENT
`
`Amgen Inc.
`The undersigned counsel for ___________________________, (attach list if necessary) certifies that this
`party is a non-governmental corporate party and that:
`
`This party's parent corporation(s) are listed below:
`
`The following publicly-held corporation(s) own 10% or more of the party's stock (attach list if
`necessary):
`
`OR
`✔
`
`This party does not have any parent corporations; and no publicly-held corporation owns 10% or
`more of the party's stock.
`
`s/ Siegmund Y. Gutman
`Proskauer Rose LLP
`_____________________________ __________________________________
` Signature of Attorney
` Name of Firm
`
`2029 Century Park East, Suite 2400
`Los Angeles, CA 90067
`___________________________ ___________________________________
` Address
` City/State/Zip Code
`
`January 26, 2024
`Date _____________________
`
`Instructions:
`
`1. Download the form. Fill out the form and save as a PDF document. All documents filed with the Judicial Panel should be in PDF Format including attachments and
`exhibits. The Corporate Disclosure Statement is to be filed as a separate document. Any documents submitted with the Corporate Disclosure Statement are attachments.
`2. Select MDL from the menu bar at the top of the ECF screen.
`3. Click on Corporate Disclosure Statement. Select Next.
`4. Enter the three or four digit number (without the MDL letters) and click the Find This Case button.
`5. If this is the correct MDL No., select next. Also, select next for the following screen.
`6. Choose the cases for which the Disclosure Statement is being filed.
`7. Select the party filing the Disclosure Statement
`8. Select the document to which the Corporate Disclosure relates. (Note: Disclosures filed in new litigations will be linked to the initial Motion for Transfer and Disclosures
`filed in transferred litigations should be linked to the Conditional Transfer Order (CTO) or Motion and Brief to Vacate CTO).
`9. Upload the Corporate Disclosure Form and any attachments as a PDF document.
`10. Submit the Disclosure Statement by selecting the Next button.
`
`

`

`
`
`Case MDL No. 3103 Document 8 Filed 01/26/24 Page 2 of 8Case 1:24-cv-00053-TSK Document 16-2 Filed 05/31/24 Page 4 of 503 PageID #: 1952
`
`BEFORE THE UNITED STATES JUDICIAL PANEL
`ON MULTIDISTRICT LITIGATION
`
`
`
`In re Aflibercept Patent Litigation
`
`
`
`MDL No. 3103
`
`
`PROOF OF SERVICE
`
`In compliance with Rule 4.1(a) of the Rules of Procedure for the United States Judicial
`
`Panel on Multidistrict Litigation, I hereby certify that copies of the foregoing Corporate
`
`Disclosure Statement and this Proof of Service were served by electronic mail on January 26,
`
`2024 to the following:
`
`
`
`COUNSEL FOR PLAINTIFFS REGENERON PHARMACEUTICALS, INC. IN
`C.D. OF CALIFORNIA & N.D. OF WEST VIRGINIA CASES (SERVED VIA EMAIL)
`
`David I. Berl
`Ellen E. Oberwetter
`Thomas S. Fletcher
`Andrew V. Trask
`Teagan J. Gregory
`Shaun P. Mahaffy
`Kathryn S. Kayali
`Arthur J. Argall, III
`Adam Pan
`Rebecca A. Carter
`Haylee Bernal Anderson
`Renee M. Griffin
`Jennalee Beazley
`Rhochelle Krawetz
`Sean M. Douglass
`Nicholas Jordan
`WILLIAMS & CONNOLLY LLP
`680 Maine Avenue, S.W.
`Washington, DC 20024
`dberl@wc.com
`eoberwetter@wc.com
`tfletcher@wc.com
`atrask@wc.com
`tgregory@wc.com
`
`Counsel for Plaintiff Regeneron
`Pharmaceuticals, Inc.
`
`Regeneron Pharmaceuticals, Inc., v. Mylan
`Pharmaceuticals Inc., N.D. W. Va., C.A. No.
`1:22-cv-00061
`
`Regeneron Pharmaceuticals, Inc. v. Celltrion,
`Inc., N.D. W. Va., C.A. No. 1:23-cv-00089
`
`Regeneron Pharmaceuticals, Inc. v. Samsung
`Bioepis Co. Ltd., N.D. W. Va., C.A. No. 1:23-
`cv-00094
`
`Regeneron Pharmaceuticals, Inc. v.
`Formycon AG, N.D. W. Va., C.A. No. 1:23-
`cv-00097
`
`Regeneron Pharmaceuticals, Inc. v. Samsung
`Bioepis Co. Ltd., N.D. W. Va., C.A. No. 1:23-
`cv-00106
`
`Regeneron Pharmaceuticals, Inc. v. Amgen
`Inc., C.D. Cal., C.A. No. 2:24-cv-00264
`
`

`

`
`
`Case MDL No. 3103 Document 8 Filed 01/26/24 Page 3 of 8Case 1:24-cv-00053-TSK Document 16-2 Filed 05/31/24 Page 5 of 503 PageID #: 1953
`
`
`
`Counsel for Plaintiff Regeneron
`Pharmaceuticals, Inc.
`
`Regeneron Pharmaceuticals, Inc., v. Mylan
`Pharmaceuticals Inc., N.D. W. Va., C.A. No.
`1:22-cv-00061
`
`Regeneron Pharmaceuticals, Inc. v. Celltrion,
`Inc., N.D. W. Va., C.A. No. 1:23-cv-00089
`
`Regeneron Pharmaceuticals, Inc. v. Samsung
`Bioepis Co. Ltd., N.D. W. Va., C.A. No. 1:23-
`cv-00094
`
`Regeneron Pharmaceuticals, Inc. v.
`Formycon AG, N.D. W. Va., C.A. No. 1:23-
`cv-00097
`
`Regeneron Pharmaceuticals, Inc. v. Samsung
`Bioepis Co. Ltd., N.D. W. Va., C.A. No. 1:23-
`cv-00106
`
`
`smahaffy@wc.com
`kkayali@wc.com
`aargall@wc.com
`apan@wc.com
`rebeccacarter@wc.com
`handerson@wc.com
`rgriffin@wc.com
`jbeazley@wc.com
`rkrawetz@wc.com
`sdouglass@wc.com
`njordan@wc.com
`
`Elizabeth S. Weiswasser
`Anish R. Desai
`Natalie C. Kennedy
`Tom Yu
`Yi Zhang
`Kathryn Leicht
`Rocco Recce
`Zhen Lin
`Kellie C. Van Beck
`Jennifer Melien Brooks Crozier
`WEIL GOTSHAL & MANGES LLP
`767 5th Avenue
`New York, NY 10153
`elizabeth.weiswasser@weil.com
`anish.desai@weil.com
`natalie.kennedy@weil.com
`tom.yu@weil.com
`yi.zhang@weil.com
`kathryn.leicht@weil.com
`rocco.recce@weil.com
`zhen.lin@weil.com
`kellie.vanbeck@weil.com
`jennifer.crozier@weil.com
`
`Christopher M. Pepe
`Priyata Y. Patel
`Matthew D. Sieger
`WEIL GOTSHAL & MANGES LLP
`2001 M Street, N.W., Suite 600
`Washington, DC 20036
`christopher.pepe@weil.com
`priyata.patel@weil.com
`matthew.seiger@weil.com
`
`
`

`

`
`
`Case MDL No. 3103 Document 8 Filed 01/26/24 Page 4 of 8Case 1:24-cv-00053-TSK Document 16-2 Filed 05/31/24 Page 6 of 503 PageID #: 1954
`
`Andrew E. Goldsmith
`Jacob E. Hartman
`Evan T. Leo
`Mary Charlotte Y. Carroll
`Sven E. Henningson, III
`Grace W. Knofczynski
`KELLOGG, HANSEN, TODD, FIGEL &
`FREDERICK, P.L.L.C.
`1615 M Street, N.W., Suite 400
`Washington, DC 20036
`agoldsmith@kellogghansen.com
`eleo@kellogghansen.com
`jhartman@kellogghansen.com
`mcarroll@kellogghansen.com
`shenningson@kellogghansen.com
`gknofczynski@kellogghansen.com
`
`Michael W. Carey
`Steven R. Ruby
`David R. Pogue
`Raymond S. Franks, II
`S. Benjamin Bryant
`CAREY DOUGLAS KESSLER & RUBY, PLLC
`707 Virginia Street East
`901 Chase Tower (25301)
`P.O. Box 913
`Charleston, West Virginia 25353
`mwcarey@cdkrlawfirm.com
`sruby@cdkrlaw.com
`drpogue@cdkrlaw.com
`rfranks@cdkrlaw.com
`sbbryant@cdkrlaw.com
`
`Adam J. Bernstein
`Arunabha Bhoumik
`James Evans
`Larry Coury
`Petra Scamborova
`Regeneron Pharmaceuticals, Inc.
`777 Old Saw Mill River Road
`Tarrytown, NY 10591-6717
`adam.bernstein@regeneron.com
`arunabha.bhoumik@regeneron.com
`james.evans@regeneron.com
`larry.coury@regeneron.com
`petra.scamborova@regeneron.com
`
`

`

`
`
`Case MDL No. 3103 Document 8 Filed 01/26/24 Page 5 of 8Case 1:24-cv-00053-TSK Document 16-2 Filed 05/31/24 Page 7 of 503 PageID #: 1955
`
`
`
`
`
`
`
`
`Tony Bisconti
`BIENERT KATZMAN LITTRELL WILLIAMS
`LLP
`903 Calle Amanecer, Suite 350
`San Clemente, CA 92673
`tbisconti@bklwlaw.com
`
`
`Counsel for Plaintiff Regeneron
`Pharmaceuticals, Inc.
`
`Regeneron Pharmaceuticals, Inc. v. Amgen
`Inc., C.D. Cal., C.A. No. 2:24-cv-00264
`
`
`COUNSEL FOR DEFENDANTS IN N.D. OF WEST VIRGINIA CASES
`(SERVED VIA EMAIL)
`
`Counsel for Defendants/Counter Claimants
`Mylan Pharmaceuticals Inc. and Biocon
`Biologics Inc.
`
`Regeneron Pharmaceuticals, Inc. v. Mylan
`Pharmaceuticals Inc., N.D. W. Va., C.A. No.
`1:22-cv-00061
`
`
`
`Abraham J. Varon
`Deanne M. Mazzochi
`Eric R. Hunt
`Heinz J. Salmen
`Jake R. Ritthamel
`Jeffery A. Marx
`Katie A. Boda
`Lauren M. Lesko
`Lawrence Scott Beall
`Neil B. McLaughlin
`Steven J. Birkos
`Thomas H. Ehrich
`William A. Rakoczy
`RAKOCZY, MOLINO, MAZZOCHI & SIWIK,
`LLP
`6 W. Hubbard St., Suite 500
`Chicago, IL 60654
`avaron@rmmslegal.com
`dmazzochi@rmmslegal.com
`ehunt@rmmslegal.com
`hsalmen@rmmslegal.com
`jritthamel@rmmslegal.com
`jmarx@rmmslegal.com
`kboda@rmmslegal.com
`llesko@rmmslegal.com
`sbeall@rmmslegal.com
`nmclaughlin@rmmslegal.com
`sbirkos@rmmslegal.com
`tehrich@rmmslegal.com
`wrakoczy@rmmslegal.com
`
`Garrett Matthew Spiker
`
`

`

`
`
`Case MDL No. 3103 Document 8 Filed 01/26/24 Page 6 of 8Case 1:24-cv-00053-TSK Document 16-2 Filed 05/31/24 Page 8 of 503 PageID #: 1956
`
`Gordon H. Copland
`John D. Pizzo
`William J O'Brien
`Stephenee Raychel Gandee
`STEPTOE & JOHNSON PLLC
`400 White Oaks Blvd.
`Bridgeport, WV 26330
`garrett.spiker@steptoe-johnson.com
`gordon.copland@steptoe-johnson.com
`john.pizzo@steptoe-johnson.com
`william.obrien@steptoe-johnson.com
`stephenee.gandee@steptoe-johnson.com
`
`Laura C. Davis
`MANCHIN FERRETTI, PLLC
`408 West King Street
`Martinsburg, WV 25401
`ldavis@wvjusticelawyers.com
`
`
`Aviv Zalcenstein
`Lora Green
`Gemini Law LLP
`40 W. 24th Street, Suite 6N
`New York, NY 10010
`azalcenstein@geminilaw.com
`lgreen@geminilaw.com
`
`Andrew C. Robey
`Carl Winfield Shaffer
`Max C. Gottlieb
`Michael B. Hissam
`HISSAM FORMAN DONOVAN RITCHIE PLLC
`700 Virginia Street East, Suite 210
`P.O. Box 3983 (25339)
`Charleston, WV 25301
`arobey@hfdrlaw.com
`cshaffer@hfdrlaw.com
`mgottlieb@hfdrlaw.com
`mhissam@hfdrlaw.com
`
`
`
`
`
`
`
`
`
`
`
`
`Counsel for Intervenor Celltrion, Inc.
`
`Regeneron Pharmaceuticals, Inc. v. Mylan
`Pharmaceuticals Inc., N.D. W. Va., C.A. No.
`1:22-cv-00061
`
`
`Counsel for Defendant Celltrion, Inc.
`
`Regeneron Pharmaceuticals, Inc. v. Celltrion,
`Inc., N.D. W. Va., C.A. No. 1:23-cv-00089
`
`
`
`

`

`
`
`Case MDL No. 3103 Document 8 Filed 01/26/24 Page 7 of 8Case 1:24-cv-00053-TSK Document 16-2 Filed 05/31/24 Page 9 of 503 PageID #: 1957
`
`Counsel for Defendant Samsung Bioepis Co.
`Ltd.
`
`Regeneron Pharmaceuticals, Inc. v. Samsung
`Bioepis Co. Ltd., N.D. W. Va., C.A. No. 1:23-
`cv-00094
`
`Regeneron Pharmaceuticals, Inc. v. Samsung
`Bioepis Co. Ltd., N.D. W. Va., C.A. No. 1:23-
`cv-00106
`
`
`
`
`
`
`
`
`
`
`Laura L. Fairneny
`Matthew D. Robson
`Matthew A. Traupman
`Raymond N. Nimrod
`QUINN EMANUEL URQUHART & SULLIVAN,
`LLP - NY
`51 Madison Avenue
`22nd Floor
`New York, NY 10010
`laurafairneny@quinnemanuel.com
`matthewrobson@quinnemanuel.com
`matthewtraupman@quinnemanuel.com
`raynimrod@quinnemanuel.com
`
`Zachariah B. Summers
`QUINN EMANUEL URQUHART & SULLIVAN,
`LLP - LA
`865 S. Figueroa Street, 10th Floor
`Los Angeles, CA 90017
`zachsummers@quinnemanuel.com
`
`Chad L. Taylor
`Frank E. Simmerman, Jr.
`Frank Edward Simmerman, III
`SIMMERMAN LAW OFFICE PLLC
`254 E Main St
`Clarksburg, WV 26301
`clt@simmermanlaw.com
`fes@simmermanlaw.com
`trey@simmermanlaw.com
`
`Sandra K. Law
`SCHRADER COMPANION DUFF & LAW,
`PLLC
`401 Main Street
`Wheeling, WV 26003
`skl@schraderlaw.com
`
`
`
`
`
`
`

`

`
`
`Case MDL No. 3103 Document 8 Filed 01/26/24 Page 8 of 8Case 1:24-cv-00053-TSK Document 16-2 Filed 05/31/24 Page 10 of 503 PageID #: 1958
`
`Counsel for Defendant Formycon AG
`
`Regeneron Pharmaceuticals, Inc. v.
`Formycon AG, N.D. W. Va., C.A. No. 1:23-
`cv-00097
`
`
`
`
`
`
`
`PROSKAUER ROSE LLP
`
`By: /s/ Siegmund Y. Gutman
`Siegmund Y. Gutman
`
`
`
`Louis E. Fogel
`Shaun M. Van Horn
`Terri L. Mascherin
`JENNER & BLOCK LLP - CHICAGO
`353 North Clark Street
`Chicago, IL 60654
`lfogel@jenner.com
`svanhorn@jenner.com
`tmascherin@jenner.com
`
`Bryant J. Spann
`M. David Griffith, Jr.
`THOMAS COMBS & SPANN, PLLC
`300 Summers Street, Suite 1380 (25301)
`P.O. Box 3824
`Charleston, WV 25338-3824
`bspann@tcspllc.com
`dgriffith@tcspllc.com
`
`
`
`Dated: January 26, 2024
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`

`

`Case 1:24-cv-00053-TSK Document 16-2 Filed 05/31/24 Page 11 of 503 PageID #: 1959
`
`
`
`
`
`
`
`APPENDIX B-2
`
`Amgen’s Opposition to Plaintiff’s Motion for Transfer
`to the Northern District of West Virginia
`Pursuant to 28 U.S.C. § 1407 (Dkt. 27),
`filed on February 2, 2024
`
`
`
`
`

`

`
`
`Case MDL No. 3103 Document 27 Filed 02/02/24 Page 1 of 25Case 1:24-cv-00053-TSK Document 16-2 Filed 05/31/24 Page 12 of 503 PageID #: 1960
`
`BEFORE THE UNITED STATES JUDICIAL PANEL
`ON MULTIDISTRICT LITIGATION
`
`
`In re Aflibercept Patent Litigation
`
`
`
`
`MDL No. 3103
`
`
`
`
`AMGEN’S OPPOSITION TO PLAINTIFF’S MOTION FOR TRANSFER TO THE
`NORTHERN DISTRICT OF WEST VIRGINIA PURSUANT TO 28 U.S.C. § 1407
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`

`

`
`
`Case MDL No. 3103 Document 27 Filed 02/02/24 Page 2 of 25Case 1:24-cv-00053-TSK Document 16-2 Filed 05/31/24 Page 13 of 503 PageID #: 1961
`
`TABLE OF CONTENTS
`
`INTRODUCTION .............................................................................................................. 1 
`
`ARGUMENT ...................................................................................................................... 4 
`
`I. 
`
`II. 
`
`A. 
`
`Differences predominate the primary issues to be tried among the cases. ............. 5 
`
`1. 
`
`2. 
`
`3. 
`
`There are factual differences because Amgen’s biosimilar
`product is unique and made using proprietary processes. ........................... 6 
`
`There are unlikely to be common claim construction issues
`because Amgen has a different product and process. ................................. 9 
`
`Centralization unnecessarily complicates the actions because
`there are many non-overlapping issues for each defendant. ....................... 9 
`
`B. 
`
`Centralization is at odds with the “just and efficient” conduct of the
`actions. .................................................................................................................. 10 
`
`1. 
`
`2. 
`
`3. 
`
`4. 
`
`The defendants in four cases have moved to dismiss or transfer
`their actions from West Virginia. .............................................................. 11 
`
`Amgen has not waived its Lexecon rights. ................................................ 12 
`
`There are limited efficiencies to be gained from the prior Mylan
`action. ........................................................................................................ 12 
`
`Management of a centralized case is complicated because the
`defendants are also competitors. ............................................................... 13 
`
`C. 
`
`D. 
`
`There are no efficiencies to be gained by transferring Amgen to West
`Virginia for preliminary injunction proceedings. ................................................. 14 
`
`Centralization in West Virginia will not serve the convenience of the
`parties and witnesses. ............................................................................................ 17 
`
`1. 
`
`2. 
`
`The small number of actions weighs against centralization. .................... 18 
`
`Informal coordination is preferable to transfer under § 1407. .................. 18 
`
`III. 
`
`CONCLUSION ................................................................................................................. 20 
`
`
`
`
`
`
`
`i
`
`

`

`
`
`Case MDL No. 3103 Document 27 Filed 02/02/24 Page 3 of 25Case 1:24-cv-00053-TSK Document 16-2 Filed 05/31/24 Page 14 of 503 PageID #: 1962
`
`TABLE OF AUTHORITIES
`
`Cases 
`Disney Enters., Inc. v. VidAngel, Inc.,
`869 F.3d 848 (9th Cir. 2017) .................................................................................................... 16
`
`In re Alexsam, Inc. (’608 & ’787) Pat. & Contract Litig.,
`437 F. Supp. 3d 1374 (J.P.M.L. 2020) ........................................................................................ 8
`
`In re ArrivalStar S.A. Fleet Mgmt. Sys. Pat. Litig.,
`802 F. Supp. 2d 1378 (J.P.M.L. 2011) ........................................................................................ 9
`
`In re Blue Spike, LLC, Pat. Litig.,
`278 F. Supp. 3d 1379 (J.P.M.L. 2017) .................................................................................. 7, 10
`
`In re Constellation Techs. LLC Pat. Litig.,
`38 F. Supp. 3d 1392 (J.P.M.L. 2014) .................................................................................... 2, 10
`
`In re Droplets, Inc., Pat. Litig.,
`908 F. Supp. 2d 1377 (J.P.M.L. 2012) .............................................................................. 8, 9, 18
`
`In re Eli Lilly & Co. Oraflex Prods. Liab. Litig.,
`578 F. Supp. 422 (J.P.M.L. 1984) ............................................................................................... 4
`
`In re Genetic Techs. Ltd. (’179) Pat. Litig.,
`883 F. Supp. 2d 1337 (J.P.M.L. 2012) ........................................................................................ 8
`
`In re Gerber Probiotic Prods. Mktg. & Sales Practices Litig.,
`899 F. Supp. 2d 1378 (J.P.M.L. 2012) ................................................................................ 12, 20
`
`In re JumpSport, Inc., (’845 & ’207) Pat. Litig.,
`338 F. Supp. 3d 1356 (J.P.M.L. 2018) ........................................................................ 4, 6, 15, 18
`
`In re Nat’l Student Mktg. Litig.,
`368 F. Supp. 1311 (J.P.M.L. 1972) ........................................................................................... 11
`
`In re Nelnet Servicing, LLC, Customer Data Sec. Breach Litig.,
`648 F. Supp. 3d 1377 (J.P.M.L. 2022) ...................................................................................... 18
`
`In re Proton–Pump Inhibitor Prods. Liab. Litig.,
`273 F. Supp. 3d 1360 (J.P.M.L. 2017) ...................................................................................... 13
`
`In re Select Retrieval, LLC, (’617) Pat. Litig.,
`883 F. Supp. 2d 1353 (J.P.M.L. 2012) ........................................................................................ 5
`
`In re SLB Enter. Rico Litig.,
`412 F. Supp. 3d 1350 (J.P.M.L. 2019) ...................................................................................... 18
`
`ii
`
`

`

`
`
`Case MDL No. 3103 Document 27 Filed 02/02/24 Page 4 of 25Case 1:24-cv-00053-TSK Document 16-2 Filed 05/31/24 Page 15 of 503 PageID #: 1963
`
`In re Spray Polyurethane Foam Insulation Prods. Liab. Litig.,
`949 F. Supp. 2d 1364 (J.P.M.L. 2013) ...................................................................................... 13
`
`In re Uniloc USA, Inc., & Uniloc Luxembourg, S.A., HPE Portfolio Pat. Litig.,
`304 F. Supp. 3d 1356 (J.P.M.L. 2018) .................................................................................. 7, 10
`
`In re Uponor, Inc., F1960 Plumbing Fittings Prod. Liab. Litig.,
`895 F. Supp. 2d 1346 (J.P.M.L. 2012) ........................................................................................ 5
`
`In re Zeroclick, LLC,
`437 F. Supp. 3d 1362 (J.P.M.L. 2020) ...................................................................................... 18
`
`Lexecon Inc. v. Milberg Weiss Bershad Hynes & Lerach,
`523 U.S. 26 (1998) .................................................................................................................... 12
`
`Winter v. Nat. Res. Def. Council, Inc.,
`555 U.S. 7 (2008) ...................................................................................................................... 16
`
`Statutes 
`21 U.S.C. § 355 ............................................................................................................................. 15
`
`28 U.S.C. § 1404 ........................................................................................................................... 11
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`28 U.S.C. § 1407 ............................................................................................................. 1, 4, 10, 20
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`35 U.S.C. § 273 ............................................................................................................................... 8
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`42 U.S.C. § 262 ....................................................................................................................... 14, 16
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`Rules 
`21 C.F.R. § 314.53 ........................................................................................................................ 14
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`Fed. R. Civ. P. 1 ............................................................................................................................ 11
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`Case MDL No. 3103 Document 27 Filed 02/02/24 Page 5 of 25Case 1:24-cv-00053-TSK Document 16-2 Filed 05/31/24 Page 16 of 503 PageID #: 1964
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`Pursuant to Panel Rule 6.1(c), Defendant Amgen Inc. (“Amgen”) respectfully submits this
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`opposition to Regeneron’s Motion for Transfer of Action to the Northern District of West Virginia
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`Pursuant to 28 U.S.C. § 1407 for Coordinated Pretrial Proceedings (the “Motion”).
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`I.
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`INTRODUCTION
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`Regeneron’s request that this Panel centralize an action against Amgen in the Central
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`District of California with five other actions in the Northern District of West Virginia should be
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`rejected because the common issues are few and the differences are many. When examined
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`carefully, the specific circumstances of the actions show that Regeneron cannot demonstrate that
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`there are enough efficiencies to be gained through centralization, which is fatal when compared to
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`the risk of prejudice to Amgen and the other defendants.
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`Glossing over the facts, Regeneron overreaches in arguing that this Panel’s Hatch-Waxman
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`Act precedent controls whether this action, which arises under the Biologics Price and Competition
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`Act (“BPCIA”), should be centralized. There are key differences between the two statutory
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`schemes, including the subject matter they govern. These differences produce important legal and
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`factual distinctions relevant to whether centralization is appropriate. The BPCIA governs
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`“biosimilars,” which are biologic medicines—large, complex molecules produced using living
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`organisms permitting only similarity, not identity, with the reference product—and include
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`medicines such as antibodies and vaccines. The Hatch-Waxman Act governs “generics,” which
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`are less complex chemically synthesized drugs (small molecules) that are, as a result, structurally
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`identical to a reference product. Although biosimilars are highly similar to an approved reference
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`product, biosimilars, unlike generics, generally exhibit high molecular complexity and sensitivity
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`to changes in manufacturing processes.
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`In recognition of these differences and the importance of processes used to manufacture
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`biologics, the BPCIA requires a biosimilar applicant to provide manufacturing information to the
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`reference product sponsor and provides a framework for litigating patent infringement claims
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`relating to manufacturing processes. In contrast, the Hatch-Waxman Act limits the type of patents
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`that reference sponsors can list in an FDA database known as the “Orange Book”—a listing that
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`forms the basis for the subsequent patent litigation. Manufacturing process patents are expressly
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`prohibited from being listed in the Orange Book. This means Hatch-Waxman cases usually involve
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`a much smaller set of overlapping, statutorily limited patents, and infringement is often conceded
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`by generic manufacturers. BPCIA litigation, on the other hand, generally involves litigation of a
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`much larger individualized and fact-specific list of patents for each biosimilar applicant.
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`That is the case here, as Regeneron has asserted 32 patents against Amgen but only 13 that
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`are common among all defendants. Importantly, Regeneron fails to mention that the common
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`patents are primarily directed either to pharmaceutical formulations of aflibercept or protein
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`manufacturing processes. Each defendant, including Amgen, independently developed its own
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`aflibercept formulation, and its own processes for producing aflibercept. Thus, they will differ
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`from each other in material respects. Regeneron ignores these differences and proclaims that the
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`actions involve “nearly identical” products. But these differences will be at the heart of the disputes
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`and produce unique infringement, validity, and claim construction issues for each defendant.
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`Moreover, the number of common patents pales when compared to the large number of non-
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`overlapping patents that Regeneron has asserted. Thus, “the potential for [this litigation, if
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`centralized,] to become mired in the unique factual and legal issues raised in each action . . . is
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`significant.” In re Constellation Techs. LLC Pat. Litig., 38 F. Supp. 3d 1392, 1393 (J.P.M.L. 2014).
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`Centralization is also directly at odds with the “just and efficient” conduct of these actions.
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`Despite claiming that Amgen will “not be prejudiced in any way” from having its case transferred
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`to West Virginia, Regeneron’s opening submission declines to mention that three of the other
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`defendants have sought to dismiss or transfer their actions from West Virginia for improper
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`personal jurisdiction. If these motions are granted, the net effect of centralization would be unjust:
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`Amgen would be forced to defend suit in a jurisdiction where it could not have been properly sued,
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`with only one other party (Mylan) that has already had a trial decision on the merits.
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`Furthermore, Amgen has not waived its Lexecon right to have its case transferred back to
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`California after pretrial proceedings. This further diminishes the likelihood that any meaningful
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`efficiencies would be achieved through centralization.
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`Regeneron’s motion is largely predicated on an argument that centralization is necessary
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`to achieve efficiencies associated with preliminary injunction proceedings. In fact, far from
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`promoting efficiency, the procedural status of the actions shows that centralization will
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`unnecessarily complicate case management of the West Virginia actions. The West Virginia Court
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`has already set a schedule for preliminary injunction proceedings against three other defendants.
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`That schedule is expedited, because each of those defendants has already provided its 180-day
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`notice of commercial marketing. The schedule is tailored to allow the parties sufficient time for
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`discovery and briefing in advance of a hearing set for May 2, 2024, and presumably a decision by
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`the court before expiration of Regeneron’s regulatory exclusivity on May 18, 2024. Dkt. 1-7 at 3.
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`In sharp contrast to this compressed schedule, the parties in the Amgen action are not even set to
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`discuss a preliminary injunction briefing schedule with the court until April 5, 2024. Ex. 1 at 3.
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`Centralizing and forcing Amgen to litigate on the same schedule as the other litigants in West
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`Virginia, as Regeneron demands, is unrealistic, unnecessary, disruptive, and unfair to Amgen.
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`Finally, centralization in West Virginia will not serve the convenience of the parties or
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`witnesses. There is nothing convenient about West Virginia for Amgen or Regeneron. Most of
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`Amgen’s documents and witnesses are in California, not West Virginia. Most of Regeneron’s
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`documents and witnesses are likely in New York, not West Virginia. Amgen will not be on the
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`same schedule for injunction proceedings. Informal coordination amongst the parties would be a
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`more efficient and preferable alternative. Should the need arise, given the limited number of cases
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`and overlapping counsel, the parties and courts can rely on informal coordination to avoid
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`unnecessarily burdening witnesses or counsel with appearing in duplicative pre-trial proceedings.
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`There will be significant differences between the Amgen action and the other actions.
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`Centralization is not only unnecessary, as Regeneron has failed to meet its burden of showing
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`sufficient efficiencies, but also threatens to disrupt and unnecessarily complicate the ongoing
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`actions in West Virginia and prejudice Amgen. This Panel should deny Regeneron’s motion.
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`II.
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`ARGUMENT
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`Transfer may be ordered only when (1) the actions sought to be centralized and transferred
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`share common issues of fact, (2) transfer would promote the just and efficient conduct of the
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`actions, and (3) transfer would serve the convenience of the parties and witnesses. 28 U.S.C. §
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`1407; In re Eli Lilly & Co. Oraflex Prods. Liab. Litig., 578 F. Supp. 422, 423 (J.P.M.L. 1984)
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`(denying centralization because the Panel was “not persuaded that these common questions of fact
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`will, in the future course of this litigation, predominate over individual questions of fact present in
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`each action”). Because “only a minimal number of actions are involved,” Regeneron bears “a
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`heavier burden to demonstrate that centralization is appropriate.” In re JumpSport, Inc., (’845 &
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`’207) Pat. Litig., 338 F. Supp. 3d 1356, 1357 (J.P.M.L. 2018).
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`Amgen’s case is about a unique biosimilar product, with its own formulation, made using
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`confidential processes developed independently by Amgen scientists and engineers. Any
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`“efficiencies” to be gained are unlikely to be achieved in view of the technology and procedural
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`differences between the cases, and because Amgen has not waived its Lexecon rights. By contrast,
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`the risk and prejudice to Amgen and the other defendants is significant. The relatively small
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`number of asserted patents that are common to all defendants means that a centralized proceeding
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`would be a complicated conglomerate of issues and disputes. And because all the other defendants
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`in the pre-trial stage have moved to dismiss or transfer their actions from West Virginia, there is a
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`distinct possibility that Amgen would be required to conduct pre-trial proceedings in a court where
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`it could not have been sued and where there are no other defendants in the pre-trial stage.
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`A.
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`Differences predominate the primary issues to be tried among the cases.
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`Regeneron begins by arguing this Panel’s prior decisions in Hatch-Waxman cases should
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`control whether centralization is appropriate for these BPCIA matters. Dkt. 1-1 at 1-2, 5-6. The
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`Panel, however, has never addressed centralization of BPCIA cases. As discussed above, BCPIA
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`cases arise under a materially different statutory scheme than the Hatch-Waxman cases cited by
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`Regeneron.1 Contrary to the central theme of Regeneron’s brief, “[c]entralization of any
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`litigation—including patent cases—is not automatic, and will necessarily depend on the facts,
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`parties, procedural history and other circumstances in a given litigation.” In re Select Retrieval,
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`LLC, (’617) Pat. Litig., 883 F. Supp. 2d 1353, 1354 (J.P.M.L. 2012) (citation omitted); In re
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`Uponor, Inc., F1960 Plumbing Fittings Prod. Liab. Litig., 895 F. Supp. 2d 1346, 1348 (J.P.M.L.
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`2012) (“Centralization is not a cure-all for every group of complicated cases.”).
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`When viewed in their totality, the specific facts and circumstances here demonstrate that
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`any efficiencies to be gained through centralization are speculative, and there is significant risk of
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`both unnecessary complication and disruption of the matters against the other defendants, and
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`prejudice to Amgen. Material differences predominate the underlying liability issues among the
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`cases. Regeneron see