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