`571-272-7822
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` Paper 49
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` Entered: August 21, 2019
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`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`AMNEAL PHARMACEUTICALS LLC AND
`AMNEAL PHARMACEUTICALS OF NEW YORK, LLC,
`Petitioner,
`
`v.
`
`ALLERGAN, INC.,
`Patent Owner.
`____________
`
`Case IPR2018-00608
`Patent 9,161,926 B2
`____________
`
`Before GRACE KARAFFA OBERMANN, SHERIDAN K. SNEDDEN,
`and CHRISTOPHER G. PAULRAJ, Administrative Patent Judges.
`
`SNEDDEN, Administrative Patent Judge.
`
`
`
`ORDER
`Conduct of the Proceeding
`37 C.F.R. § 42.5
`
`
`
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`
`
`
`IPR2018-00608
`Patent 9,161,926 B2
`
`
`Petitioner supports its Petition with information to show that U.S.
`Patent No. 9,161,926 B2 (“the ’926 patent”) is listed in the FDA’s Orange
`Book as a drug product patent related to the now-approved ACZONE® Gel,
`7.5% product. Pet. 7; Ex. 1033.
`During oral argument, counsel for Patent Owner indicated that
`Petitioner was served with a copy of a letter from the Patent Owner to the
`FDA that requested delisting of the ’926 patent (Ex. 3001; “FDA Letter”) as
`a patent that covers the ACZONE® Gel, 7.5% product. Paper 48, 46:8.
`Also during oral argument, Patent Owner requested entry of the FDA Letter
`into the record. Id. at 47, 7–11. Petitioner indicated that it does not oppose
`Patent Owner’s request. Id. at 47, 15.
`In an email to the Board dated June 5, 2019, Patent Owner provided
`the panel with a copy of the Letter to the FDA Requesting Delisting of the
`’926 Patent (Ex. 3001) and requested entry of the letter into the record.
`Having considered the parties positions and nature of the request,
`summarized above, Patent Owner’s request is hereby granted and the
`aforementioned FDA Letter is entered into the record as Ex. 3001.
`
`It is
`
`SO ORDERED.
`
`
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`
`
`
`
`2
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`
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`IPR2018-00608
`Patent 9,161,926 B2
`
`PETITIONER:
`Dennies Varughese
`Adam C. LaRock
`STERNE KESSLER GOLDSTEIN & FOX
`dvarughe-ptab@sternekessler.com
`alarock-ptab@sternekessler.com
`
`
`PATENT OWNER:
`
`James Trainor
`Ewa Davison
`Elizabeth Hagan
`FENWICK & WEST
`jtrainor@fenwick.com
`edavison@fenwick.com
`ehagan@fenwick.com
`
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`3
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