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`_________________________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`_________________________
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`SAMSUNG BIOEPIS CO., LTD.,
`Petitioner,
`
`v.
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`REGENERON PHARMACEUTICALS, INC.,
`Patent Owner.
`_________________________
`
`Case IPR2023-00884
`
`U.S. Patent No. 11,253,572
`_________________________
`
`PETITIONER’S MOTION FOR DISCOVERY
`PURSUANT TO 37 C.F.R. § 42.51(b)
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`
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`TABLE OF EXHIBITS
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`Exhibit(s)
`1001-1068
`1069
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`1070
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`1071
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`1072
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`1073
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`1074
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`1075
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`Description
`
`Previously presented
`Email Correspondence Between Petitioner Samsung Bioepis and
`Third Party Mylan Pharmaceuticals, Inc. Regarding Discovery
`Email Correspondence Between Petitioner Samsung Bioepis and
`Patent Owner Regeneron Regarding Discovery
`Transcript of Bench Trial (June 12, 2023) in Regeneron Pharms.,
`Inc. v. Mylan Pharms. Inc., No. 22-cv-00061-TSK (N.D.W. Va.
`January 31, 2024) (ECF No. 558)
`Transcript of Bench Trial (June 20, 2023) in Regeneron Pharms.,
`Inc. v. Mylan Pharms. Inc., No. 22-cv-00061-TSK (N.D.W. Va.
`January 31, 2024) (ECF No. 564)
`Transcript of Bench Trial (June 21, 2023) in Regeneron Pharms.,
`Inc. v. Mylan Pharms. Inc., No. 22-cv-00061-TSK (N.D.W. Va.
`January 31, 2024) (ECF No. 566)
`Partial Transcript of Yancopoulos Deposition in Regeneron
`Pharms., Inc. v. Mylan Pharms. Inc., No. 22-cv-00061-TSK
`(N.D.W. Va. January 31, 2024) (ECF No. 624) (REDACTED)
`Transcript of Karen Chu Deposition in Regeneron Pharms., Inc.
`v. Mylan Pharms. Inc., No. 22-cv-00061-TSK (N.D.W. Va.
`January 31, 2024) (ECF No. 432-12)
`
`i
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`
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`Pursuant to 37 C.F.R. § 42.51(b) and the Board’s May 7 email authorizing
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`this motion, Petitioner Samsung Bioepis Co., Ltd. (“Petitioner”) respectfully
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`requests that the Board order Patent Owner Regeneron Pharmaceuticals, Inc.
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`(“Patent Owner”) to produce certain materials from a parallel district court litigation,
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`Regeneron Pharmaceuticals, Inc. v. Mylan Pharmaceuticals, Inc., Case No. 22-
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`cv-61-TSK (N.D.W. Va.) (the “Mylan Litigation”) involving the same patent,
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`U.S. Patent No. 11,253,572, as this proceeding. Specifically, Petitioner requests
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`that Patent Owner produce transcripts and underlying exhibits of prior testimony
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`from Karen Chu and George Yancopoulos and exhibits cited in the District
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`Court’s decision invalidating the ’572 patent (collectively, “Requested Materials”
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`and more specifically listed in Ex. 3003 at 2).
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`Ms. Chu and Dr. Yancopoulos have both submitted declarations here
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`attempting to antedate certain prior art references. Exs. 2063; 2064. Ms. Chu and
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`Dr. Yancopoulos also testified relating to the same or similar subject matter
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`relating to the patentability of the ’572 patent in the Mylan Litigation. See Exs.
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`1071 at 87-250; 1072 at 3-44; 1073 at 44-130; 1074; 1075. The district court
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`considered this testimony in reaching its decision, citing Ms. Chu’s personal
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`testimony on “the history of Eylea’s clinical development as well as Dr.
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`Yancopoulos’s involvement” and Rule 30(b)(6) testimony on “Patent Owner’s
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`clinical trials, secondary considerations and reduction to practice of the claimed
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`
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`inventions,” and similar testimony from Dr. Yancopoulos regarding “his work
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`leading to the methods of treatment claimed in the [’572 patent].” Ex. 2093 at
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`64-65. This is useful information in evaluating the patentability of the ’572
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`patent in this proceeding, especially given that Patent Owner relies on
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`declarations from the same witnesses regarding the same patent. As explained
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`below, the Requested Materials are required routine discovery and meet the five
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`factors set forth in Garmin Int’l, Inc. v. Cuozzo Speed Tech. L.L.C., IPR2012-
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`00001, Paper 26 (P.T.A.B. Mar. 5, 2013) for additional discovery.
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`I.
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`FACTUAL BACKGROUND
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`The Mylan Litigation.
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`In the Mylan Litigation, the district court
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`invalidated claims 6 and 25 of the ’572 patent. See generally Paper 55 (Joint
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`Summary of Related Proceedings). Dr. Yancopoulos and Ms. Chu testified live
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`at trial, and excerpts of Ms. Chu’s deposition were also played at trial. Neither
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`witness’s complete deposition testimony, including any of their deposition
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`exhibits, are publicly available, nor are the exhibits cited by the district court in
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`the portion of its opinion on the ’572 patent.
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`Correspondence with Regeneron Regarding Requested Materials.
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`Petitioner deposed Ms. Chu on April 11, and Dr. Yancopoulos the next day. One
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`business day after Dr. Yancopoulos’s deposition, Petitioner requested that Patent
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`Owner produce,
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`inter alia, the Requested Materials. Ex. 1070 at 11-12.
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`2
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`Following Petitioner diligently pushing the meet and confer process forward, the
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`parties reached an impasse on May 3, and Petitioner emailed the Board that same
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`day to request authorization to file this motion. Ex. 3003. The Board authorized
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`Petitioner’s motion on May 7.
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`Id. Petitioner’s Reply is not due until June 10,
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`2024, over four weeks after briefing on this motion will be complete. Paper 54.
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`During the meet and confer, Patent Owner made numerous requests of
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`Petitioner. Ex. 1070 at 7. Petitioner agreed to the following conditions on
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`production: (1) amend the protective order to allow for production on an
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`“Outside Counsel’s Eyes Only” basis for materials produced on that basis in the
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`Mylan Litigation and (2) agree not to seek additional depositions of Ms. Chu or
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`Dr. Yancopoulos unless Patent Owner submits additional declarations. Id. at 8.
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`Petitioner did not agree to Patent Owner’s proposal to redact the Requested Materials
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`of non-relevant information. As Petitioner explained, “it’s not clear how Patent
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`Owner would be able to determine what is relevant versus what is not, and
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`performing the redactions only requires more burden and delay in producing the
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`materials.” Id. at 8. Finally, Mylan has confirmed that it does not oppose
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`production of these materials. Ex. 1069.
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`II.
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`PETITIONER’S REQUEST SHOULD BE GRANTED
`Routine Discovery Petitioner’s request is routine discovery under 37 C.F.R.
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`§ 42.51(b)(1)(iii). The District Court found that the requested testimony and
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`3
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`evidence did not support a finding of patentability—the position advanced by
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`Regeneron here. Such information is required to be disclosed under 37 C.F.R.
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`§ 42.51(b)(1)(iii) (“a party must serve relevant information that is inconsistent with
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`a position advanced”). If the Board does not order disclosure, Petitioner reserves all
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`rights to pursue sanctions against Patent Owner for “fail[ure] to meet its duty of
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`candor and fair dealing” if withheld information is later found “inconsistent with
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`[Patent Owner’s] arguments.” Spectrum Solutions LLC v. Longhorn Vaccines,
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`LLC, IPR2021-00847, Papers 111, 112 (P.T.A.B. May 3, 2023).
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`Additional Discovery Each of the Garmin factors is met here. As an initial
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`matter, there can be no dispute that three out of the five Garmin factors are met.
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`Specifically, Garmin factors 2-4 support Petitioner’s request. Petitioner’s requests
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`are targeted at Patent Owner’s witness testimony and underlying exhibits and not
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`seeking to unearth any litigation positions (Garmin factor 2). Because the Requested
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`Materials are not publicly available, Petitioner has no other methods available to
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`ascertain this information (Garmin factor 3). And finally, the Requested Materials
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`are easily understood (Garmin factor 4) as Petitioner provided a tailored list of
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`specific materials and exhibits from the Mylan Litigation. Ex. 1070 at 12. This
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`leaves only the first and fifth Garmin factor.
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`The first Garmin factor favors Petitioner. Petitioner will obtain relevant and
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`useful information on the validity of the ’572 patent. The Board has granted similar
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`4
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`requests for testimony of IPR declarants from related district court litigation. See,
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`e.g., Amneal Pharmaceuticals LLC, et al., v. Alemirall, LLC, IPR2019-00207, Paper
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`39 at 8 (PTAB Dec. 31, 2019). In Amneal, the Board found that the request was not
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`“merely speculative, but [] tailored, based on Petitioner’s knowledge, to obtain the
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`limited production of relevant evidence.” Id. at 5 (emphasis added). Petitioner
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`similarly seeks evidence from the district court litigation covering the same subject
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`matter that Ms. Chu and Dr. Yancopoulos addressed in their declarations—the
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`development of the patented invention—that is highly relevant to Patent Owner’s
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`attempt to antedate three prior art references. The fact that the challenged patent
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`was invalidated only makes the testimony and exhibits more useful.
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`The fifth Garmin factor favors Petitioner. Petitioner’s request is both limited
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`in scope and not overly burdensome. Petitioner seeks only the deposition testimony,
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`and related exhibits, of two witnesses in the Mylan Litigation as well as the exhibits
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`cited in relevant portions of the district court decision. These materials are readily
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`available to Patent Owner from the ongoing Mylan Litigation. Further, there is no
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`additional burden based on the timing of Petitioner’s request. Petitioner’s reply is
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`not due until June 10, leaving several weeks for Patent Owner to complete what
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`should be a straightforward production of a small set of specifically enumerated
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`items. Finally, Patent Owner still has the opportunity to file its sur-reply and has not
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`identified any prejudice.
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`5
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`DATED: May 10, 2024
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`Respectfully submitted,
`
`By /Raymond N. Nimrod/
`Raymond N. Nimrod (Reg. No. 31,987)
`raynimrod@quinnemanuel.com
`QUINN EMANUEL URQUHART
`& SULLIVAN LLP
`51 Madison Avenue, 22nd Floor
`New York, NY 10010
`Tel:
`(212) 849-7000
`Fax: (212) 849-7100
`
`Lead Counsel for Petitioner Samsung Bioepis
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`6
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`CERTIFICATE OF SERVICE
`The undersigned certifies that a copy of the foregoing Motion for Additional
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`Discovery pursuant to 37 C.F.R. § 42.10(b) was served on May 10, 2024, to the
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`following: Counsel for Petitioner via email to Regeneron-MoFo-IPR@mofo.com;
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`Counsel for Biocon Biologics, Inc. at MYL_REG_IPR@rmmslegal.com; and
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`Counsel for Celltrion, Inc. at lgreen@geminilaw.com, fchu@geminilaw.com,
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`rcerwinski@geminilaw.com,
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`azalcenstein@geminilaw.com,
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`and
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`bmorris@geminilaw.com.
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`DATED: May 10, 2024
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`Respectfully submitted,
`By /Raymond N. Nimrod/
`Raymond N. Nimrod (Reg. No. 31,987)
`raynimrod@quinnemanuel.com
`QUINN EMANUEL URQUHART
` & SULLIVAN, LLP
`51 Madison Ave., 22nd Floor
`New York, NY 10010
`Tel: (212) 849-7000
`Fax: (212) 849-7100
`
`7
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