Trials@uspto.gov
`Tel: 571-272-7822
`
`
`
`
` Paper 71
`Entered: July 13, 2022
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`
`
`
`
`
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`MYLAN PHARMACEUTICALS INC., CELLTRION, INC., and
`APOTEX, INC.,
`Petitioner,
`
`v.
`
`REGENERON PHARMACEUTICALS, INC.,
`Patent Owner.
`
`
` IPR2021-00880 (Patent 9,669,069 B2)1
` IPR2021-00881 (Patent 9,254,338 B2)2
`
`
`Before ERICA A. FRANKLIN, JOHN G. NEW, and
`SUSAN L. C. MITCHELL, Administrative Patent Judges.
`
`PER CURIAM.
`
`
`ORDER3
`Granting Patent Owner’s Unopposed Motions for Entry
`of Default Protective Order and to Seal and Petitioner’s Motion to Seal
`37 C.F.R. § 42.54
`
`
`1 IPR2022-00257 and IPR2022-00301 have been joined with this
`proceeding.
`2 IPR2022-00258 and IPR2022-00298 have been joined with this
`proceeding.
`3 The combined caption is for administrative convenience only and does not
`indicate that IPR2021-00880 and IPR2021-00881 have been joined. The
`parties are not authorized to use this caption without express permission of
`the Board.
`
`
`Tel: 571-272-7822
`
`
`
`
` Paper 71
`Entered: July 13, 2022
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`
`
`
`
`
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`MYLAN PHARMACEUTICALS INC., CELLTRION, INC., and
`APOTEX, INC.,
`Petitioner,
`
`v.
`
`REGENERON PHARMACEUTICALS, INC.,
`Patent Owner.
`
`
` IPR2021-00880 (Patent 9,669,069 B2)1
` IPR2021-00881 (Patent 9,254,338 B2)2
`
`
`Before ERICA A. FRANKLIN, JOHN G. NEW, and
`SUSAN L. C. MITCHELL, Administrative Patent Judges.
`
`PER CURIAM.
`
`
`ORDER3
`Granting Patent Owner’s Unopposed Motions for Entry
`of Default Protective Order and to Seal and Petitioner’s Motion to Seal
`37 C.F.R. § 42.54
`
`
`1 IPR2022-00257 and IPR2022-00301 have been joined with this
`proceeding.
`2 IPR2022-00258 and IPR2022-00298 have been joined with this
`proceeding.
`3 The combined caption is for administrative convenience only and does not
`indicate that IPR2021-00880 and IPR2021-00881 have been joined. The
`parties are not authorized to use this caption without express permission of
`the Board.
`
`
`
`IPR2021-00880 (Patent 9,669,069 B2)
`IPR2021-00881 (Patent 9,254,338 B2)
`
`
`Regeneron Pharmaceuticals Inc. (“Patent Owner”) moves, in each of
`
`the captioned proceedings, for entry of its proposed default protective
`(“Proposed Protective Order”). See Paper 34.4 Patent Owner additionally
`seeks to seal Exhibits 2048, 2049, 2059, 2060, 2073, 2096, and 2128. Paper
`37. In IPR2021-00881, Patent Owner has also filed a corrected motion
`seeking to seal Exhibits 2052, 2138, 2140, and 2163 and, subsequently, an
`additional motion to seal Exhibit 2289. IPR2021-00881, Paper 42, 2 and
`Paper 74, 2. Patent Owner has indicated that Mylan Pharmaceuticals Inc.
`(“Petitioner”) does not oppose these motions. Paper 34, 2 and Paper 37, 5.
`
`Petitioner has also filed a motion to seal portions of Petitioner’s Reply
`to Patent Owners’ Response and portions of Exhibits 1114, 1108, and 1111.
`Paper 55, 2. In IPR2021-00881, Petitioner seeks to seal portions of
`Petitioner’s Reply and Exhibits 1137, 1108, 1111, and 1151. IPR2021-
`00881, Paper 60, 2. Petitioner reports that Patent Owner does not oppose
`this motion. See, e.g., Paper 55 2
`
`For the reasons set forth below, Patent Owner’s unopposed motion of
`entry of its default protection order, and both parties’ unopposed motions to
`seal are GRANTED.
`
`
`DISCUSSION
`
`
`1. Default Protective Order
`
`
`Patent Owner certifies, pursuant to 37 C.F.R. § 42.54, that the parties
`
`have conferred and that Petitioner does not oppose entry of the default
`
`
`4 Unless otherwise indicated, references to papers are those filed in
`IPR2021-00880.
`
`
`
`2
`
`
`
`IPR2021-00880 (Patent 9,669,069 B2)
`IPR2021-00881 (Patent 9,254,338 B2)
`
`
`protective order. Paper 34 Addendum A. Patent Owner represents that good
`cause exists because Patent Owner intends to submit non-public confidential
`research, development and commercial information with its forthcoming
`Patent Owner’s Response that it seeks to maintain as confidential. Id. at 2.
`
`“The Board may, for good cause, issue an order to protect a party or
`person from disclosing confidential information, including, … (7) Requiring
`that a trade secret or other confidential research, development, or
`commercial information not be revealed or be revealed only in a specified
`way.” 37 C.F.R. § 42.54 (a)(7). We agree with Patent Owner that good
`cause exists for entry of the default protective order, and Patent Owner’s
`motion is consequently granted.
`
`Patent Owner’s and Petitioner’s Motions to Seal
`2.
`The parties must each show good cause for the relief requested,
`
`including why the information is appropriate to be filed under seal.
`37 C.F.R. § 42.54. The Office Patent Trial Practice Guide notes that
`37 C.F.R. § 42.54 identifies confidential information in a manner consistent
`with Federal Rule of Civil Procedure 26(c)(1)(G), which provides for
`protective orders for trade secret or other confidential research,
`development, or commercial information. 77 Fed. Reg. at 48,760. In
`Argentum Pharms. LLC v. Alcon Research, Ltd., IPR2017-01053, Paper 27
`at 3–4 (P.T.A.B. January 19, 2018) (informative), the Board set forth the
`factors we consider when deciding whether to grant a motion to seal
`
`
`
`3
`
`
`
`IPR2021-00880 (Patent 9,669,069 B2)
`IPR2021-00881 (Patent 9,254,338 B2)
`
`
`documents asserted to contain confidential information. Those factors
`include, whether the moving party has demonstrated adequately that:
`(1) the information sought to be sealed is truly confidential, (2) a
`concrete harm would result upon public disclosure, (3) there
`exists a genuine need to rely in the trial on the specific
`information sought to be sealed, and (4), on balance, an interest
`in maintaining confidentiality outweighs the strong public
`interest in having an open record.
`
`
`Id.
`
`Patent Owner’s Motions to Seal
`A.
`
`In each of its motions to seal, Patent Owner describes each of the
`
`exhibits that it seeks to seal. See, e.g., Paper 37, 1. For each exhibit, Patent
`Owner filed an unredacted version as a “Board Only” version, and a
`redacted version as a “Public” version.
`
`Briefly, Patent Owner argues that: (1) Exhibit 2073 is a confidential
`partner technical document; (2) Exhibits 2059, 2060, 2200, 2218, 2229,
`2263, and 2285 are confidential regulatory, commercial, or financial
`documents; (3) Exhibits 2096 and 2128 are confidential agreements
`regarding clinical trials; and (4) Exhibits 2048, 2049, 2052, and 2289 are
`declarations including or describing confidential information. Paper 37, 3–
`4; IPR2021-00881, Paper 74, 2–3. Furthermore, in IPR2021-00881, Patent
`Owner asserts that Exhibits 2169, 2170, 2060, 2200, 2218, 2229, 2263, and
`2285 are confidential commercial or financial documents. IPR2021-00881,
`Paper 37 at 6–7. For each of these, Patent Owner asserts that the
`information contained in these exhibits are not publicly available and would
`
`
`
`4
`
`
`
`IPR2021-00880 (Patent 9,669,069 B2)
`IPR2021-00881 (Patent 9,254,338 B2)
`
`
`cause competitive harm to Patent Owner if disclosed on the public docket.
`Petitioner does not oppose Patent Owner’s motion to seal. Id. at 2.
`
`Upon considering the arguments and evidence, we determine that
`Patent Owner has satisfied the above-listed factors we consider when
`deciding whether to grant a motion to seal documents asserted to contain
`confidential information. We have reviewed the unredacted “Board Only”
`version of the exhibits. Based upon our review of the content of those
`exhibits, we find that they contain highly sensitive confidential information
`that would likely result in harm to Patent Owner if accessed by its
`competitors.
`
`Accordingly, we determine that Patent Owner has shown good cause
`for the relief requested.
`
`Petitioner’s Motion to Seal
`B.
`
`Petitioner asserts that: (1) Exhibits 1114 and 1137 are declarations
`
`including or describing confidential information; and (2) Exhibits 1108,
`1111, and 1151 are cross-examination deposition transcripts of Patent
`Owner’s witnesses taken in this IPR proceeding. Paper 55. 4–5 and Paper
`60, 3–5. Additionally, Petitioner seeks to seal the portions of Petitioner’s
`Reply in each trial that discuss Patent Owner’s confidential information in
`Exhibits 2096 and 2259 and Petitioner’s Exhibits s 1137, 1108, 1111, and
`1151. Paper 55, 3 and Paper 60, 3.
`
`Petitioner seeks to seal those portions of the Reply, declaration, or
`transcripts that describe and include Patent Owner’s confidential protective
`order material, which Petitioner is obligated to file under seal. Id. Petitioner
`
`
`
`5
`
`
`
`IPR2021-00880 (Patent 9,669,069 B2)
`IPR2021-00881 (Patent 9,254,338 B2)
`
`
`states that it understands that, if such material were to be publicly disclosed,
`it would cause competitive harm to Patent Owner. Id. (citing Paper 42, 7–9).
`
`Upon considering the arguments and evidence, we determine that
`Petitioner has satisfied the above-listed factors we consider when deciding
`whether to grant a motion to seal documents asserted to contain confidential
`information. We have reviewed the unredacted “Board Only” version of the
`exhibits. Based upon our review of the content of those exhibits, we find
`that they contain highly sensitive confidential information that would likely
`result in harm to Patent Owner if accessed by its competitors.
`
`Accordingly, we determine that Petitioner has shown good cause for
`the relief requested.
`
`
`ORDER
`In consideration of the foregoing, it is hereby:
`
`ORDERED, that, in each of the above-noted proceedings, Patent
`
`Owner’s Motions for Entry of the Proposed Protective Order and to Seal are
`granted;
`
`FURTHER ORDERED that, in each of the above-noted proceedings,
`Petitioner’s Motion to Seal is granted; and
`
`FURTHER ORDERED that the Proposed Protective Order is hereby
`entered in these proceedings and shall govern the treatment and filing of
`confidential information.
`
`
`
`
`6
`
`
`
`IPR2021-00880 (Patent 9,669,069 B2)
`IPR2021-00881 (Patent 9,254,338 B2)
`
`
`PETITIONER:
`
`Paul Molino
`William Rakoczy
`Neil McLaughlin
`Heinz Salmen
`RAKOCZY MOLINO MAZZOCHI SIWIK LLP
`paul@rmmslegal.com
`wrakoczy@rmmslegal.com
`nmclaughlin@rmmslegal.com
`hsalmen@rmmslegal.com
`
`Teresa Rea
`Deborah Yellin
`Shannon Lentz
`CROWELL & MORING LLP
`trea@crowell.com
`dyellin@crowell.com
`slentz@crowell.com
`
`Lora Green
`Yahn-Lin Chu
`WILSON SONSINI GOODRICH & ROSATI
`lgreen@wsgr.com
`ychu@wsgr.com
`
`PATENT OWNER:
`
`Deborah Fishman
`Amanda Antons
`Alice Sin Yu Ho
`ARNOLD & PORTER KAYE SCHOLER LLP
`deborah.fishman@kayescholer.com
`amanda.antons@arnoldporter.com
`alice.ho@arnoldporter.com
`
`
`
`7
`
`
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