Paper No. 16
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`Trials@uspto.gov
`571.272.7822 Filed: November 22, 2016
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`LUPIN LTD. and LUPIN PHARMACEUTICALS, INC.,
`Petitioners,
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`v.
`
`HORIZON THERAPEUTICS, INC.,
`Patent Owner.
`____________
`
`Case IPR2016-00829
`Patent 9,095,559 B2
`____________
`
`
`
`Before TONI R. SCHEINER, DEBORAH KATZ, and
`GRACE KARAFFA OBERMANN, Administrative Patent Judges.
`
`KATZ, Administrative Patent Judge.
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`
`
`DECISION
`Denying Patent Owner’s Request for Rehearing
`37 C.F.R. § 42.71(d)
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`Patent Owner requests a rehearing of our decision to institute inter
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`partes review of U.S. Patent 9,095,559 (Paper 13, “Decision”). Paper 15
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`(“Request”). When filing a request for rehearing, the challenging party
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`bears the burden of showing the decision should be modified. 37 C.F.R.
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`

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`IPR2016-00829
`Patent 9,095,559 B2
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`§ 42.71(d). The request must specifically identify the matters the party
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`believes the Board misapprehended or overlooked, and the place where each
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`matter was previously addressed in a brief, in this case, Patent Owner’s
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`Preliminary Response. Id. “When rehearing a decision on petition, a panel
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`will review the decision for an abuse of discretion.” 37 C.F.R. § 42.71(c).
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`Patent Owner argues that we erroneously relied on the testimony of
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`Petitioner’s witness, Dr. Vaux, to supply an element of the challenged
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`claims not otherwise taught in the prior art. Request 2. Specifically, Patent
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`Owner argues that we improperly relied on Dr. Vaux’s testimony as
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`evidence that step (c) of its challenged claims1 was known in the art. Id. 4-5.
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`Patent Owner asserts that this is legal error, citing Arendi S.A.R. v. Appel,
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`Inc., 832 F.3d 1355 (Fed. Cir. 2016). Arendi warns that “references to
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`‘common sense’—whether to supply a motivation to combine or a missing
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`limitation—cannot be used as a wholesale substitute for reasoned analysis
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`and evidentiary support, especially when dealing with a limitation missing
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`1 Claim 2 of patent 9,095,559, which Patent Owner asserts is representative,
`recites:
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`A method of treating a subject with a urea cycle disorder who
`has previously been administered an initial dosage of glyceryl tri-[4-
`phenylbutyrate] and who has a fasting plasma ammonia level less than
`the upper limit of normal for plasma ammonia level, the method
`comprising:
`(a) measuring a fasting plasma ammonia level for the subject;
`(b) comparing the fasting plasma ammonia level to the upper
`limit of normal for plasma ammonia level; and
`(c) administering an adjusted dosage of glyceryl tri-[4-
`phenylbutyrate], that is greater than the initial dosage if the fasting
`plasma ammonia level is greater than half the upper limit of normal
`for plasma ammonia level.
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`2
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`

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`IPR2016-00829
`Patent 9,095,559 B2
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`from the prior art references specified.” Id. at 1362.2 In Arendi, the Board
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`did not rely on any evidence to make its determination that searching for a
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`telephone number would have been common sense. In contrast, we relied on
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`the testimony of Dr. Vaux, who, at this point in the proceeding, we
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`determined to be qualified to present opinions on the subject matter at issue.
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`We did not rely on our own determination of what those of skill in the art
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`would have considered to be common sense. We did credit Dr. Vaux’s
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`testimony and found it to be persuasive at this point in the proceeding
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`because it seemed to be reasonable. See Decision 10, 11, and 15.
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`Significantly, we relied on opinion testimony based not on any assertion of
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`“common sense,” but on a rational analysis of objective proof consisting of
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`multiple printed publications. See, e.g., Dec. 10 (citing Ex. 1002 ¶ 65 (citing
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`printed publications, including Exs. 1006, 1012, and 1017)). Petitioner fails
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`to cite to any place in our Decision where we relied on a determination of
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`what is “common sense.” Accordingly, we are not persuaded that we
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`erroneously relied on Dr. Vaux’s testimony or abused our discretion as
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`Patent Owner argues.
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`Patent Owner also argues that the prior art of record fails to support
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`Dr. Vaux’s testimony. Request 5-6. Patent Owner argues that the prior art
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`cited does not teach or suggest increasing the dosage or administering an
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`initial dosage of a nitrogen scavenging drug to a patient having a fasting
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`ammonia level below the upper limit of normal. Id. We stated in our
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`Decision that we were persuaded, at this point in the proceeding, that the
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`2 Patent Owner also cites Cisco Systems Inc. v. C-CATION Techs., Inc.,
`IPR2014- 00454, Paper 12, at 10-13 (PTAB Aug. 29, 2014). Because this is
`a non-precedential decision of the Board regarding a different patent, parties,
`and facts, its holding is not binding in this proceeding.
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`3
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`IPR2016-00829
`Patent 9,095,559 B2
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`evidence cited by Dr. Vaux supports his testimony regarding variation of
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`plasma ammonia levels at different times of the date and after eating.
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`Decision 11, citing Ex. 1006, 1012 and 1017. We did not state that this
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`evidence teaches increasing the dosage or administering nitrogen scavenging
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`drugs to a patient with any particular ammonia level. Patent Owner does not
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`argue that we misapprehended or overlooked anything about that evidence in
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`regard to variations in plasma ammonia levels at different times of the day
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`and after eating. Accordingly, we are not persuaded that we
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`misapprehended or overlooked anything in our Decision.
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`DECISION
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`For the reasons given, Patent Owner’s Request for Rehearing is
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`DENIED.
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`4
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`

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`IPR2016-00829
`Patent 9,095,559 B2
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`PETITIONERS:
`
`Elizabeth J. Holland
`Cynthia Lambert Hardman
`Goodwin Procter, LLP
`eholland@goodwinprocter.com
`chardman@goodwinprocter.com
`
`
`PATENT OWNER:
`
`Robert Green
`Matthew Phillips
`Lauren Stevens
`Dennis Bennett
`Emer Simic
`Jessica Tyrus
`rgreen@greengriffith.com
`matthew.phillips@renaissanceiplaw.com
`lstevens@horizonpharma.com
`dennissbennett@globalpatentgroup.com
`esimic@greengriffith.com
`jtyrus@greengfiffith.com
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`5
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