`571-272-7822
`
`Paper 13
`Date: September 22, 2021
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`MYLAN PHARMACEUTICALS INC.,
`Petitioner,
`v.
`REGENERON PHARMACEUTICALS, INC.,
`Patent Owner.
`
`IPR2021-00880 (Patent 9,669,069 B2)
`IPR2021-00881 (Patent 9,254,338 B2)1
`
`
`
`
`
`
`
`
`
`Before ERICA A. FRANKLIN, JOHN G. NEW, and
`SUSAN L. C. MITCHELL, Administrative Patent Judges.
`NEW, Administrative Patent Judge.
`
`
`
`
`ORDER
`Authorizing Additional Briefing
`37 C.F.R. § 42.5
`
`
`
`
`1 This Order addresses the same issue for the above-identified proceedings.
`Therefore, we exercise our discretion to issue one order to be filed in each
`proceeding. The parties are not authorized, however, to use this style
`heading in any subsequent papers.
`
`
`
`
`
`IPR2021-00880 (Patent 9,669,069 B2)
`IPR2021-00881 (Patent 9,254,338 B2)
`For each of the captioned proceedings, Mylan Pharmaceuticals Inc.
`(“Petitioner”) has requested, via email indicating prior conferral between
`counsel for Petitioner and Patent Owner Regeneron Pharmaceuticals, Inc.
`(“Patent Owner”), authorization to file a consolidated (dual-captioned)
`Reply Brief in Response to Patent Owner’s Preliminary Response (Paper
`10). A telephone conference was held on September 8, 2021, with counsel
`for both parties, and the transcript of that conference has been made a part of
`the record. Ex. 1086.
`Specifically, Petitioner seeks authorization to file a Reply Brief for the
`limited purpose of addressing Patent Owner’s arguments with respect to our
`discretion to deny institution under 35 U.S.C. § 325(d) and the factors set
`forth with respect to that discretion in Becton, Dickinson & Co. v. B. Braun
`Melsungen AG, IPR2017-01586, Paper 8 (Dec. 15, 2017)).
`Petitioner argues that good cause exists for authorization to file a
`Reply Brief because it is necessary to illustrate how Patent Owner’s
`preliminary responses allegedly do not present a fair interpretation of either
`the Petitions or the relevant facts and law here. Ex. 1086, 8. It is
`Petitioner’s position that under the facts of the challenged patents, and their
`respective file histories, that the cited prior art, and Petitioner’s arguments
`are not cumulative of anything the Examiner asserted or evaluated during
`prosecution. Id. For that reason, argues Petitioner, it could not have
`anticipated Patent Owner's argument with respect to the Becton, Dickinson
`factors involving the same or substantially the same art or arguments as a
`basis for denying institution. Id.
`Patent Owner opposes Petitioner’s request. According to Patent
`Owner, there is no good cause for granting Petitioner’s request for additional
`briefing because Advanced Bionics, LLC v. MED-EL Elektromedizinische
`
`2
`
`
`
`IPR2021-00880 (Patent 9,669,069 B2)
`IPR2021-00881 (Patent 9,254,338 B2)
`Geräte GmbH, IPR2019-01469, Paper 6 (PTAB Feb. 13, 2020) makes clear
`that the previously-presented art includes art that was made of record by the
`Examiner, including in an IDS. Ex. 1086, 12. Patent Owner asserts that
`Petitioner did nothing to address this issue in either of its petitions in the
`above-referenced cases, failing to anticipate this position in its Petition. Id.
`
`Having considered the circumstances involved and the reasoning
`presented by both parties, we determine that further briefing would be useful
`for our determination whether to institute trial. Accordingly, we authorize
`Petitioner to file a consolidated Reply with respect to both cases, and we
`similarly authorize Patent Owner to file a consolidated Sur-Reply to address
`the issue in both cases. The Reply and Sur-Reply briefings are each limited
`to ten pages, and are subject to the requirements of 37 C.F.R. § 42.6(a).
`Petitioner’s Reply shall be submitted no later than one week following the
`issuance of this order, and if Patent Owner elects to file a Sur-Reply, it shall
`be filed no later than one week subsequent to the filing of Petitioner’s Reply.
`No additional briefing is authorized.
`
`ORDER
`It is therefore,
`ORDERED that Petitioner is authorized to file in each of the
`captioned proceedings a consolidated Reply Brief on issue set forth in the
`preceding discussion, said Reply Brief not to exceed ten pages, and to be
`filed no later than September 29, 2021, and
`FURTHER ORDERED that Patent Owner is authorized in each of the
`captioned proceedings to file a consolidated Sur-Reply in response to
`Petitioner’s Reply, said Sur-Reply not to exceed ten pages, and to be filed no
`later than one week after Petitioner’s Reply is filed.
`
`3
`
`
`
`IPR2021-00880 (Patent 9,669,069 B2)
`IPR2021-00881 (Patent 9,254,338 B2)
`
`For PETITIONER:
`
`Paul Molino
`Neil McLaughlin
`RAKOCZY MOLINO MAZZOCHI SIWIK LLP
`paul@rmmslegal.com
`nmclaughlin@rmmslegal.com
`
`
`For PATENT OWNER:
`
`
`Deborah Fishman
`Amanda Antons
`Alice Sin Yu Ho
`ARNOLD & PORTER KAYE SCHOLER LLP
`Amanda.antons@arnoldporter.com
`Alice.ho@arnoldporter.com
`Deborah.fishman@arnoldporter.com
`
`
`4
`
`
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