`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`__________
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`__________
`
`
`PAR PHARMACEUTICAL INC.,
`Petitioner
`
`v.
`
`HORIZON THERAPEUTICS, LLC,
`Patent Owner
`
`__________
`
`
`Case IPR2017-01767
`Patent 9,254,278
`
`__________
`
`
`
`PATENT OWNER’S REQUEST FOR RECONSIDERATION
`37 C.F.R. 42.71(d)
`
`
`
`IPR2017-01767
`U.S. Patent No. 9,254,278
`
`
`TABLE OF CONTENTS
`INTRODUCTION AND STATEMENT OF RELIEF REQUESTED ........... 1
`I.
`LEGAL STANDARDS ................................................................................... 1
`II.
`III. ARGUMENT ................................................................................................... 1
`IV. CONCLUSION ................................................................................................ 3
`
`
`
`i
`
`
`
`IPR2017-01767
`U.S. Patent No. 9,254,278
`
`
`TABLE OF AUTHORITIES
`
`Cases
`Ultratec, Inc. v. CaptionCall, LLC,
` 872 F.3d 1267 (Fed. Cir. 2017) ..........................................................................2, 3
`Regulations
`37 C.F.R. § 42.71(d) .................................................................................................. 1
`37 C.F.R. § 42.123(a) ................................................................................................. 1
`37 C.F.R. § 42.123(b) ................................................................................................ 1
`
`
`ii
`
`
`
`INTRODUCTION AND STATEMENT OF RELIEF REQUESTED
`Pursuant to 37 C.F.R. § 42.71(d) and the Board’s Order (Paper 38), Horizon
`
`IPR2017-01767
`U.S. Patent No. 9,254,278
`
`
`I.
`
`respectfully requests reconsideration of the Board’s Order (Paper 37) denying it
`
`authorization to submit with its sur-reply the Declaration of Dr. Neal Sondheimer,
`
`Petitioner Par’s expert in the instant IPR, as submitted recently by Par in IPR2018-
`
`01550, Par Pharm., Inc. v. Horizon Therapeutics, LLC (“the ’197 Declaration”).
`
`II. LEGAL STANDARDS
`A request for rehearing “must specifically identify all matters the party
`
`believes the Board misapprehended or overlooked, and the place where each
`
`matter was previously addressed in a motion, an opposition, or a reply.” 37 C.F.R.
`
`§ 42.71(d). To submit supplemental information under 37 C.F.R. § 42.123(b), a
`
`party must show why it reasonably could not have been obtained earlier and that its
`
`consideration is in the interests of justice.
`
`
`III. ARGUMENT
`The ’197 Declaration contains relevant evidence in the form of sworn
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`testimony from Dr. Sondheimer that conflicts with positions he adopted in the
`
`present IPR. Specifically, Dr. Sondheimer opined that a POSA would have been
`
`motivated to continue increasing the dosage of RAVICTI® given to a patient to
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`achieve fasting plasma ammonia levels below half the ULN. He testified that the
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`prior art taught to “reduce plasma ammonia levels as low as possible,” including to
`
`1
`
`
`
`“one tenth ULN.” (Ex. 1002 at ¶¶ 89-91, 97, 130-32, 134.) He expressed no
`
`IPR2017-01767
`U.S. Patent No. 9,254,278
`
`
`concern about the possibility of the increased dosages causing toxicity due to
`
`increased levels of PAA in the patient.
`
`However, in his ’197 Declaration, Dr. Sondheimer testified that there was
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`prior art concern that increased dosages of PAA-prodrugs (such as RAVICTI®
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`(“GPB”)) could cause PAA neural toxicity. (’197 Decl. at, e.g., ¶¶ 27-35, 53-60,
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`64, 66-71 (relying on art which predates the ’278 patent’s priority date).) He
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`testified that a POSA “would have known about the saturability of the PAA-to-
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`PAGN conversion process, which would have further bolstered concerns about the
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`well-known toxicity of PAA.” (Id. at ¶ 33.) He further testified that “it was well-
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`known that at a certain plasma concentration, PAA begins to cause neurotoxicity,”
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`and a POSA “would have expected PAA’s efficacy in removing waste nitrogen
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`could not be increased once there was saturation [of its conversion].” (Id. at ¶¶ 27,
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`33.) Dr. Sondheimer did not express such concern in this IPR when testifying
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`regarding the motivation to increase dosage for patients already within the normal
`
`range for plasma ammonia.
`
`The ’197 Declaration is thus relevant to the Board’s evaluation of Par’s
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`obviousness grounds and Dr. Sondheimer’s credibility, and should be considered
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`in the interests of justice. Ultratec, Inc. v. CaptionCall, LLC, 872 F.3d 1267,
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`1272-75 (Fed. Cir. 2017) (finding the Board abused its discretion in failing to
`
`2
`
`
`
`admit previously unavailable and inconsistent expert testimony.)1 Such evidence
`
`IPR2017-01767
`U.S. Patent No. 9,254,278
`
`
`could not have reasonably been obtained earlier as it was not available to Horizon
`
`prior to Par’s filing of the IPR2018-01550 petition. Granting Horizon’s request
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`would also further the AIA’s purpose in providing an efficient and less costly
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`forum by making it unnecessary to re-depose Dr. Sondheimer to elicit the same
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`testimony already in the ’197 Declaration.
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`IV. CONCLUSION
`Because the ’197 Declaration contains previously unavailable testimony
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`which undermines Dr. Sondheimer’s obviousness theories in the instant IPR, the
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`Board should allow Horizon to submit it as supplemental information. 2
`
`Date: 2018 September 11
`
`Respectfully submitted,
`
`By: / M.C. Phillips /
`Matthew C. Phillips
`Registration No. 43,403
`Backup Counsel for Patent Owner
`
`
`1 This evidence is also relevant to Par’s assertion of estoppel over the Decision in
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`IPR2015-01127, where Par also relied upon Dr. Sondheimer. (Paper 31 at 2-4.)
`
`2 Horizon notes that it disagrees with the Board’s prohibition of filing such
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`evidence herewith. Ultratec, 872 F.3d at 1273 (criticizing the Board’s “den[ying]
`
`a request to admit evidence without ever seeing the evidence it was denying.”).
`
`3
`
`
`
`CERTIFICATE OF SERVICE
`
`
`
`I hereby certify that on September 11, 2018, copies of the foregoing PATENT
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`OWNER’S REQUEST FOR RECONSIDERATION and all documents filed with it
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`were served via electronic mail, as agreed to by counsel, upon the following counsel
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`for the Petitioner:
`
`David G. Silverstein: dsilverstein@axinn.com
`
`Aziz Burgy:
`
`aburgy@axinn.com
`
`Dan Feng Mei: dmei@axinn.com
`Ravicti@axinn.com
`
`Christopher Gallo: cgallo@axinn.com
`
`
`
`/ M.C. Phillips /
`Matthew C. Phillips
`Registration No. 43,403
`
`
`
`
`
`
`
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