Trials
`Matthew Traupman; Trials
`Brausa, Adam R.; Durie, Daralyn J.; Davis, Kira A; Weires, Rebecca; Regeneron-MoFo-IPR@mofo.com; Ray
`Nimrod; Landon Smith; QE - Samsung Bioepis
`RE: IPR2023-00884 -- Request for leave to file Reply to POPR
`Wednesday, September 6, 2023 4:08:42 PM
`
`From:
`To:
`Cc:
`
`Subject:
`Date:
`
`Counsel,
`
`From the Board –
`
`Petitioner’s email of September 5, 2023 (below), requests authorization to file a 10-page Reply to
`Patent Owner’s Preliminary Response to address “newly submitted evidence” concerning the priority
`to be accorded the ’572 patent’s claims in light of changes to the Patent Act per the AIA. That the
`parties met and conferred on this matter prior to reaching out to the Board for relief is appreciated.
` We understand that Patent Owner opposes Petitioner’s request, but we find good cause exists to
`grant it because certain evidence cited by Patent Owner in its Preliminary Response and the related
`arguments appear to have been previously unknown and not available outside of Patent Owner (see,
`e.g., Paper 7 – PO Motion to Seal describing evidence as internal or non-public). Accordingly,
`Petitioner is authorized to submit a 10-page Reply to address evidence cited in the Preliminary
`Response on this issue that was not previously available to Petitioner and to explain its opposition to
`Patent Owner’s positions on prior conception/reduction to practice in view of Petitioner’s asserted
`prior art. Patent Owner is authorized to file 5-page Sur-reply to Petitioner’s Reply. No new
`arguments or evidence is authorized.
`
`Petitioner’s Reply is due no later than September 18, 2023.
`
`Patent Owner’s Sur-reply is due no later than September 28, 2023.
`
`This email will be entered into the record as Board’s Exhibit 3001. No conference call is believed
`necessary on this issue, but if the parties disagree or have any questions, they should contact the
`Board.
`
`Regards,
`
`Esther Goldschlager
`Supervisory Paralegal Specialist
`Patent Trial & Appeal Board
`U.S. Patent & Trademark Office
`
`From: Matthew Traupman <matthewtraupman@quinnemanuel.com>
`Sent: Tuesday, September 5, 2023 11:37 AM
`To: Trials <Trials@USPTO.GOV>
`Cc: Brausa, Adam R. <ABrausa@mofo.com>; Durie, Daralyn J. <DDurie@mofo.com>; Davis, Kira A
`<KiraDavis@mofo.com>; Weires, Rebecca <RWeires@mofo.com>; Regeneron-MoFo-
`IPR@mofo.com; Ray Nimrod <raynimrod@quinnemanuel.com>; Landon Smith
`
`Exhibit 3001
`
`

`

`<landonsmith@quinnemanuel.com>; QE - Samsung Bioepis <qe-
`samsungbioepis@quinnemanuel.com>
`Subject: IPR2023-00884 -- Request for leave to file Reply to POPR
`
`CAUTION: This email has originated from a source outside of USPTO. PLEASE CONSIDER THE SOURCE before
`responding, clicking on links, or opening attachments.
`
`Dear Patent Trial and Appeal Board:
`
`We represent Petitioner Samsung Bioepis Co., Ltd. (“Samsung”) in IPR2023-00884 concerning U.S.
`Patent No. 11,253,572. Patent Owner, Regeneron Pharmaceuticals, Inc. (“Regeneron”), filed its
`Preliminary Response to Samsung’s Petition in IPR2023-00884 on August 25, 2023.
`
`Samsung seeks leave to submit a 10-page reply to Regeneron’s Preliminary Response for purposes of
`responding to Regeneron’s newly submitted evidence and argument that: (1) the claims of the ’572
`patent are allegedly subject to the first-to-invent provisions of pre-AIA 35 U.S.C. §§ 102 and 103,
`rather than post- AIA versions of 35 U.S.C. §§ 102 and 103, because the claims of the ’572 patent are
`supported by the January 21, 2011 provisional application; and (2) Regeneron’s 2010 press releases
`are not prior art because the subject matter claimed the ’572 patent was allegedly conceived and
`reduced to practice before those references were published or were derived from the inventor
`himself.
`
`There is good cause because, inter alia, Regeneron bears the burden of production on both of these
`issues, and Regeneron includes new, confidential exhibits in support of the alleged inventorship of
`the ’572 patent by Dr. Yancopoulos. For instance, Samsung did not have the opportunity to address
`confidential internal email communications and presentations that Regeneron alleges show
`conception and the alleged inventorship of Dr. Yancopoulos. Samsung seeks leave to address this
`previously unavailable evidence and why Regeneron has not shown sufficient conception and
`reduction to practice for purposes of swearing behind its 2010 press releases. See, e.g., Medtronic
`Inc., et al. v. Teleflex Innovations S.A.R.L., IPR2020-00132, Paper 22 at 10-11; Associated British
`Foods, plc et al v. Cornell Research Foundation, Inc., IPR2019-00577, Paper 25 at 31. In addition,
`Regeneron argues that a single paragraph in the January 21, 2011 provisional application provides a
`literal description of the invention recited in claim 25. Samsung seeks the opportunity to respond to
`Regeneron’s characterizations of the disclosures in the ’572 patent and the January 21, 2011
`provisional application, which Samsung believes contain several inaccurate statements.
`
`If the Board grants this request, Samsung proposes submitting the reply 10 days after the Board’s
`order. Samsung would not oppose Regeneron’s filing of a sur-reply of equal length due 10 days after
`the filing of Samsung’s reply. Regeneron has indicated that it is amenable to a 5-page reply, limited
`to the evidence and argument that Regeneron's 2010 press releases are not prior art. Regeneron
`opposes Samsung’s request as to the issue of whether the claims of the ’572 patent are allegedly
`subject to the first-to-invent provisions of pre-AIA 35 U.S.C. §§ 102 and 103, rather than the AIA,
`because Regeneron contends Samsung could, and should have raised that issue in its Petition.
`Samsung maintains its position that it could not have anticipated Regeneron’s mischaracterization of
`the disclosures of the ’572 patent and the January 21, 2011 provisional application, and a 10-page
`
`

`

`reply addressing both issues outlined above is warranted.
`
`If a conference call would be helpful to the Board, we are happy to propose times when both parties
`are available.
`
`Regards,
`Matt Traupman
`Backup Counsel for Petitioner Samsung Bioepis
`
`Matthew Traupman
`Partner
`Quinn Emanuel Urquhart & Sullivan, LLP
`
`51 Madison Avenue, 22nd Floor
`New York, NY 10010
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`www.quinnemanuel.com
`
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