`To:
`Cc:
`Subject:
`Date:
`
`Robert Counihan
`Trials
`UCB-Xyzal; Malik, Jitty; Soderstrom, Lance A.; Janusz, Joe; Pacchioli, Alissa M.; Jim Trainor; Erica Sutter
`UCB v. Apotex - IPR2019-00400
`Wednesday, July 24, 2019 4:36:53 PM
`
`Confidential
`
`Your Honors:
`
` I
`
` am counsel for Patent Owner UCB Biopharma Sprl in IPR2019-00400 involving U.S. Patent No.
`8,633,194.
`
`In its July 15, 2019 Decision on Institution of Inter Partes Review of U.S. Patent No. 8,633,194 B2
`(IPR2019-00400, Paper 17), the Board requested clarification as to why only UCB entities were
`named as the real parties-in-interest when Petitioner’s tentative FDA approval letter and the current
`Orange Book listing for various Xyzal® formulations lists Sanofi Aventis US LLC as the NDA holder.
`(Paper 17 at 2, fn. 1).
`
`Patent Owner respectfully clarifies that the named party, UCB Biopharma Sprl, is the assignee of the
`’194 patent and party to the district court litigation involving the ’194 patent (UCB, Inc. v. Apotex
`Inc., No. 0-18-cv-60846 (S.D. Fla.)). The other UCB entities are identified as real parties-in-interest
`because UCB S.A. is the ultimate parent company of UCB Biopharma Sprl, UCB Pharma S.A. and UCB
`Manufacturing Inc. both own shares of UCB Biopharma Sprl, and UCB, Inc. is the second plaintiff in
`the ’194 district court litigation.
`
`With respect to Sanofi Aventis, while Sanofi is listed as the NDA holder for various Xyzal®
`formulations, Sanofi is
`. Accordingly, Patent Owner
`understands that Sanofi is not a real party-in-interest to this matter.
`
`Patent Owner is available to provide further clarification to the Board if necessary.
`
`Counsel for Petitioner Apotex has been copied on this email.
`
`Regards,
`Robert Counihan
`
`ROBERT COUNIHAN
`Partner | Fenwick & West LLP | Office: 212-430-2748 | Mobile: 917-880-6137 |
`rcounihan@fenwick.com
`Admitted to practice only in New York.
`
`
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