`
`
`
`
`
` Paper 33
`
`
`
` Entered: June 8, 2016
`
`Trials@uspto.gov
`571-272-7822
`
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`PAR PHARMACEUTICAL, INC.,
`Petitioner,
`
`v.
`
`HORIZON THERAPEUTICS, INC.,
`Patent Owner.
`
`
`Case IPR2015-01117
`Patent 8,642,012 B2
`
`
`
`Before TONI R. SCHEINER, DEBORAH KATZ, and
`GRACE KARAFFA OBERMANN, Administrative Patent Judges.
`
`SCHEINER, Administrative Patent Judge.
`
`
`ERRATA
`Institution of Inter Partes Review
`37 C.F.R. § 42.108
`
`
`
`IPR2015-01117
`Patent 8,642,012 B2
`
`An error was made on page 19 of our Decision on Institution (Paper
`
`13) in that the ’979 patent, although relied on in the body of the decision,
`was inadvertently omitted from the header of Section II.F. The error is
`corrected as follows:
`
`F. Claims 6 and 11—Asserted Obviousness over Brusilow ’91,
`Sherwin, Shiple, [and] Kasumov, and the ’979 patent
`
`Claims 6 and 11 depend from claims 1 and 8, respectively, and recite
`that the PAA prodrug is HPN-100.
`Petitioner acknowledges that none of Brusilow ’91, Sherwin, or
`Shiple discloses HPN-100 as the nitrogen scavenging drug.
`However, Petitioner argues that it would have been obvious to
`substitute HPN-100 for NaPBA in Brusilow ’91’s method because Kasumov
`discloses that NaPBA may be toxic at high doses (Pet. 34 (citing Ex. 1015,
`10, 13)), and because the ’979 patent also discloses HPN-100, and teaches
`that such drugs are useful to treat patients with diseases of nitrogen
`accumulation.
`Petitioner’s contentions appear to be supported adequately on this
`record, and we are persuaded that Petitioner has demonstrated a reasonable
`likelihood of showing that claims 6 and 11 would have been obvious over
`Brusilow ’91, Sherwin, Shiple, Kasumov, and the ’979 patent.
`
`
`2
`
`
`
`
`IPR2015-01117
`Patent 8,642,012 B2
`
`
`A similar error was made on page 21 of our Decision on Institution, in
`that the ’979 patent was inadvertently omitted from the Order in Section IV.
`The error is corrected as follows:
`
`IV. ORDER
`
`It is
`ORDERED that pursuant to 35 U.S.C. § 314(a), an inter partes
`review is instituted as to claims 1–12 of U.S. Patent No. 8,642,012 B2 on the
`following grounds of unpatentability:
`Claims 1, 3, 4, 7, 8, 10, and 12 under 35 U.S.C. § 103 as unpatentable
`over Brusilow ’91, Sherwin, Comte, and Shiple;
`claim 5 under 35 U.S.C. § 103 as unpatentable over Brusilow ’91,
`Sherwin, Shiple, and Fernandes;
`claims 2 and 9 under 35 U.S.C. § 103 as unpatentable over Brusilow
`’91, Sherwin, Shiple, and the ’647 patent; and
`claims 6 and 11 under 35 U.S.C. § 103 as unpatentable over Brusilow
`’91, Sherwin, Shiple, [and] Kasumov, and the ’979 patent.
`It is
`FURTHER ORDERED that pursuant to 35 U.S.C. § 314(c) and 37
`C.F.R. § 42.4, notice is hereby given of the institution of a trial commencing
`on the entry date of this decision; and
`FURTHER ORDERED that no other grounds of unpatentability are
`authorized for this inter partes review other than those identified above.
`
`3
`
`
`
`
`IPR2015-01117
`Patent 8,642,012 B2
`
`For PETITIONER:
`David H. Silverstein
`dsilverstein@axinn.com
`Aziz Burgy
`aburgy@axinn.com
`
`
`For PATENT OWNER:
`Robert Green
`rgreen@greengriffith.com
`Emer Simic
`esimic@greengriffith.com
`Jessica Tyrus
`jtyrus@greengriffith.com
`
`Lauren Stevens
`lstevens@horizonpharma.com
`
`Dennis Bennett
`dennisbennett@globalpatentgroup.com
`
`Matthew Phillips
`matthew.phillips@renaissanceiplaw.com
`
`
`
`
`4
`
`
`
`
`IPR2015-01117
`
`IPR2015-01117IPR2015-01117
`
`IPR2015-01117
`Patent 8,642,012 B2
`Patent 8,642,012 B2
`
`Patent 8,642,012 B2Patent 8,642,012 B2
`
`
`
`
`
`
`
`
`
`
`
`5
`
`
`
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