`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`MYLAN PHARMACEUTICALS INC.,
`Petitioner
`
`v.
`
`REGENERON PHARMACEUTICALS, INC.,
`Patent Owner
`
`
`Case IPR2021-00880
`Patent 9,669,069 B2
`
`
`MYLAN PHARMACEUTICALS INC.’S UNOPPOSED
`MOTION TO AMEND ITS MANDATORY NOTICES
`
`
`
`
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`Case IPR2021-00880
`Patent 9,669,069 B2
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`Petitioner (“Mylan”) moves to amend its mandatory notices to identify
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`Janssen Research & Development LLC (“Janssen R&D LLC”) as a real party-in-
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`interest (“RPI”) without altering the May 5, 2021, filing date. On August 16, 2021,
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`Patent Owner (“Regeneron”) filed its Preliminary Response asserting that Janssen
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`Pharmaceuticals Inc. (“JPI”) should have been named as an RPI. Mylan promptly
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`investigated the issue and confirmed that JPI does not currently direct, control, or
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`fund business, or have obligations related to the current petition. Accordingly, JPI
`
`is not an RPI and Mylan’s original mandatory notices are correct in that regard.
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`However, during its investigation, Mylan discovered that Janssen R&D LLC—a
`
`wholly owned subsidiary of Johnson & Johnson, was inadvertently omitted as an
`
`RPI. Mylan informed Regeneron that it intended to approach the Board to seek
`
`permission to amend its mandatory notices and Regeneron indicated that it would
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`not oppose such a motion. On September 1, 2021, Mylan emailed the Board
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`requesting permission to file a motion to amend its mandatory notices. The Board
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`held a conference call on September 8, 2021, and authorized this motion.
`
`I.
`
`The Board Should Allow Mylan’s Amendment to the RPI Listing.
`
`“[I]f a petition fails to identify all real parties in interest under § 312(a)(2), the
`
`Director can, and does, allow the petitioner to add a real party in interest.” Mayne
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`Pharma Int’l Pty. Ltd. v. Merck Sharp & Dohme Corp., 927 F.3d 1232, 1240 (Fed.
`
`Cir. 2019); see also Proppant Express Invs., LLC v. Oren Techs., LLC, No. IPR2017-
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`
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`1
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`
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`Case IPR2021-00880
`Patent 9,669,069 B2
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`01917, Paper 86 at 6-7 (P.T.A.B. Feb. 13, 2019) (precedential); Adello Biologics
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`LLC v. Amgen Inc., No. PGR2019-00001, Paper 11 at 3 (P.T.A.B. Feb. 14, 2019)
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`(precedential). The Board considers the following factors when deciding whether to
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`let a petitioner amend its identification of real parties in interest while maintaining
`
`the filing date: (1) attempts to circumvent the 35 U.S.C. § 315(b) bar or estoppel
`
`rules; (2) bad faith by the petitioner; (3) prejudice to the patent owner caused by the
`
`delay; and (4) gamesmanship by the petitioner. Proppant Express, No. IPR2017-
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`01917, Paper 86 at 6-7. Here, all four factors favor allowing an amendment to
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`Mylan’s mandatory notices to add Janssen R&D LLC as an RPI.
`
`1. Mylan did not attempt to circumvent the § 315(b) bar or
`estoppel rules.
`
`Mylan did not attempt to circumvent the § 315(b) bar or estoppel rules by
`
`inadvertently failing to list Janssen R&D LLC as an RPI—and Regeneron makes no
`
`such allegation. Janssen R&D LLC has not been served a complaint alleging
`
`infringement of U.S. Patent No. 9,669,069, and thus is not subject to the § 315(b)
`
`time bar. Regeneron did not allege, nor is there any evidence, that Mylan attempted
`
`to evade the estoppel rules in 35 USC § 315(e) or 37 CFR § 42.73(d). See Proppant
`
`Express, No. IPR2017-01917, Paper 86 at 9 (finding no attempt to circumvent when
`
`
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`2
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`
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`Case IPR2021-00880
`Patent 9,669,069 B2
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`there were no allegations of same). Thus, this factor favors allowing Mylan’s
`
`amendment to its mandatory notices.
`
`2. Mylan did not act in bad faith or intentionally conceal Janssen
`R&D LLC as an RPI.
`
`Mylan recognizes that it has “a duty of candor and good faith to the Office
`
`during the course of a proceeding,” 37 C.F.R. § 42.11(a), and represents that it did
`
`not act in bad faith or intentionally conceal Janssen R&D LLC as an RPI. When
`
`investigating the merits of Regeneron’s allegation that JPI should have been named
`
`as an RPI, Mylan discovered that Janssen R&D LLC, not JPI, was inadvertently
`
`omitted. Regeneron has not alleged that this omission was intentional or in bad faith.
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`When, like here, there is no evidence of bad faith, the Board can “take Petitioner at
`
`its word.” Aerospace Commc’ns Holdings Co. v. Armor All/STP Products Co., No.
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`IPR2016-00441, 442, Paper 12 at 4 (P.T.A.B. June 28, 2016). Thus, this factor too
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`weighs in favor of allowing Mylan’s amendment to its mandatory notices.
`
`3.
`
`There is no prejudice caused by the delay.
`
`Once Mylan discovered that Janssen R&D LLC should have been named as
`
`an RPI, it promptly informed Regeneron and offered to update its mandatory notices.
`
`Regeneron does not allege that there is any prejudice caused by the delay in
`
`
`
`3
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`
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`Case IPR2021-00880
`Patent 9,669,069 B2
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`disclosing Janssen R&D LLC as an RPI. Thus, this factor favors allowing Mylan’s
`
`amendment.
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`4.
`
`There was no gamesmanship.
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`Finally, there is no evidence of gamesmanship associated with Mylan’s
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`inadvertent omission—and Regeneron does not allege any. Mylan identified four
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`other parties as RPIs in its original petition: Viatris Inc., Mylan Inc., Momenta
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`Pharmaceuticals Inc., and Johnson & Johnson. Upon realizing that Janssen R&D
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`LLC should have been named as an RPI, Mylan informed Regeneron and took steps
`
`to amend its mandatory notices. Thus, this factor too weighs in favor of allowing
`
`Mylan’s amendment.
`
`5.
`
`Allowing Mylan’s amendment promotes the functions set forth
`in the Trial Practice Guide.
`
`The Board should “ensure the just, speedy, and inexpensive resolution of the
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`proceeding” by allowing Mylan’s amendment to its mandatory notices. See Trial
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`Practice Guide, 77 Fed. Reg. 48758 (Aug. 14, 2021). As explained above, the
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`current Petition is not time barred and if Mylan’s amendment to its mandatory
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`notices is not allowed, it would be able to refile a second petition with Janssen R&D
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`LLC included as an RPI. The Board has stated that it “fail[s] to discern how
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`dismissing [a] Petition and later considering a second petition would result in any
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`meaningful gain in achieving a just, speedy, and inexpensive resolution of issues
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`
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`4
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`Case IPR2021-00880
`Patent 9,669,069 B2
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`presented in the Petition.” Zip Top, LLC v. Stasher, Inc., No. IPR2018-01216, Paper
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`9 at 3 (P.T.A.B. Nov. 7, 2018). Thus, to promote the functions set forth in the Trial
`
`Practice Guide, Mylan should be allowed to amend its mandatory notices.
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`II.
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`Conclusion.
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`For the foregoing reasons, Mylan respectfully requests that the Board allow
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`Mylan’s amendment to its mandatory notices.
`
`
`
`
`
`
`
`
`
`Dated: September 14, 2021
`
`
`
`
`
`
`
`
`
`Respectfully Submitted,
`
`RAKOCZY MOLINO MAZZOCHI SIWIK LLP
`
`/Paul J. Molino/
`Paul J. Molino (Reg. No. 45,350)
`6 West Hubbard Street
`Suite 500
`Chicago, IL 60654
`Telephone:
`(312) 222-6300
`Facsimile:
`(312) 222-6320
`paul@rmmslegal.com
`
`Counsel for Petitioner
`
`5
`
`
`
`CERTIFICATE OF SERVICE
`
`The undersigned hereby certifies that a true and correct copy of the foregoing
`
`Mylan Pharmaceuticals Inc.’s Unopposed Motion to Amend Its Mandatory Notices
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`was served on September 14, 2021, via electronic mail by agreement of the parties,
`
`to the following counsel for record of Patent Owners:
`
`Alice S. Ho (Lim. Rec. No. L1162)
`Victoria Reines
`Rebecca Neubauer
`ARNOLD & PORTER KAYE SCHOLER LLP
`601 Massachusetts Ave., N.W.
`Washington D.C. 20001
`Tel: 202.942.5000
`Fax: 202.942.5999
`Alice.Ho@arnoldporter.com
`Victoria.Reines@arnoldporter.com
`Rebecca.Neubauer@arnoldporter.com
`
`
`Deborah E. Fishman (Reg. No. 48,621)
`ARNOLD & PORTER KAYE SCHOLER LLP
`3000 El Camino Real
`Five Palo Alto Square, Suite 500
`Palo Alto, California 94306-3807
`Telephone: 650.319.4519
`Facsimile: 650.319.4573
`Deborah.Fishman@arnoldporter.com
`RegeneronEyleaIPRs@arnoldporter.com
`
`Amanda K. Antons (Reg. No. 65,236)
`ARNOLD & PORTER KAYE SCHOLER LLP
`70 West Madison Street | Suite 4200
`Chicago, Illinois 60602-4321
`Telephone 312.583.2472
`Amanda.Antons@arnoldporter.com
`
`
`
`Dated: September 14, 2021
`
`Respectfully Submitted,
`
`RAKOCZY MOLINO MAZZOCHI SIWIK LLP
`
`/Paul J. Molino/
`
`
`
`
`
`
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