`UNITED STATES PATENT AND TRADEMARK OFFICE
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`LUPIN LTD. AND LUPIN PHARMACEUTICALS INC.,
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`Petitioner
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`v.
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`HORIZON THERAPEUTICS, LLC,
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`Patent Owner
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`Case IPR2016-00829
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`Patent 9,095,559
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`PATENT OWNER’S OPPOSITION TO PETITIONER’S
`MOTION TO EXCLUDE
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`TABLE OF CONTENTS
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`I.
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`II.
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`INTRODUCTION ........................................................................................... 1
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`EXHIBIT 2019 IS RELEVANT AND ADMISSIBLE ................................... 2
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`III. DR. ENNS’S TESTIMONY CONCERNING THE KNOWLEDGE
`OF A POSA BEFORE THE PRIORITY DATE IS RELEVANT AND
`ADMISSIBLE ................................................................................................. 5
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`IV. EXHIBIT 2041 IS RELEVANT AND ADMISSIBLE ................................... 7
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`V.
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`CONCLUSION ................................................................................................ 8
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`IPR2016-00829
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`Page i
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`TABLE OF AUTHORITIES
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`Cases
`Dell Inc. v. Elec. & Telecommns. Research Inst.,
`IPR2013-00635, Paper 39 (P.T.A.B. Feb. 27, 2015) ............................................. 3
`
`Disney Enter., Inc. v. Kappos,
`923 F. Supp. 2d 788 (E.D. Va. 2013) ..................................................................... 3
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`Ex parte Erlich,
`22 U.S.P.Q.2d 1463, 1992 WL 93132 (Bd. Pat. App. & Inter. 1992) ................... 3
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`Gould v. Quigg,
`822 F.2d 1074 (Fed. Cir. 1987) .............................................................................. 3
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`In re Epstein,
`32 F.3d 1559 (Fed. Cir. 1994) ................................................................................ 3
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`In re Hogan,
`559 F.2d 595 (C.C.P.A. 1977) ................................................................................ 3
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`In re Wilson,
`311 F.2d 266 (C.C.P.A. 1962) ................................................................................ 3
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`Liberty Mut. Ins. Co. v. Progressive Cas. Ins. Co.,
`CBM2012-00002, Paper 66 (P.T.A.B. Jan. 23, 2014) .............................. 2, 4, 6, 8
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`Nissan N. Am., Inc. v. Norman IP Holdings, LLC,
`IPR2014-00564, Paper 36 (P.T.A.B. Aug. 26, 2015) ............................................ 5
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`Rules
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`FRE 401 ........................................................................................................ 2, 6, 7, 8
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`FRE 402 .................................................................................................................2, 7
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`Regulations
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`37 C.F.R. § 42.23 ....................................................................................................... 1
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`37 C.F.R. § 42.64 ....................................................................................................... 1
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`37 C.F.R. § 42.64(c) .......................................................................................... 2, 6, 8
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`IPR2016-00829
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`Page ii
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`I.
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`INTRODUCTION
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`Pursuant to 37 C.F.R. §§ 42.64 and 42.23 and the Board’s Scheduling Order
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`(Paper No. 8), Patent Owner Horizon Therapeutics, LLC (“Patent Owner” or
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`“Horizon”) files this opposition to Lupin Ltd. and Lupin Pharmaceuticals Inc.’s
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`(collectively “Petitioner” or “Lupin”) Motion to Exclude Evidence (Paper No. 35).
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`In its motion, Petitioner improperly seeks to exclude relevant evidence from the
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`record, including testimony of Horizon’s expert concerning the state of the prior
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`art.1 As explained below, Petitioner’s motion is meritless and would erroneously
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`remove evidence from the record that rebuts its obviousness argument. Moreover,
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`Petitioner’s arguments for exclusion of evidence go to the weight of the evidence
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`rather than its admissibility, which is not appropriate in a motion to exclude.
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`Liberty Mut. Ins. Co. v. Progressive Cas. Ins. Co., CBM2012-00002, Paper 66 at
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`1 Petitioner refers to Exhibit 2019 as a “purported” copy of a 2012 article by
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`Häberle et al. Petitioner did not object, however, to this exhibit on the basis of
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`authenticity (Paper No. 28 at 6) or move to exclude it on this basis (Paper No. 35).
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`Similarly, Petitioner refers to Exhibit 2041 as a “purported” copy of the
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`Prescribing Information for RAVICTI®, but did not move to exclude this exhibit
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`for lacking authenticity (Paper No. 35). Any implied objections to these exhibits
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`for lack of authenticity should therefore be rejected.
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`IPR2016-00829
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`Page 1
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`61 (P.T.A.B. Jan. 23, 2014); see also 37 C.F.R. § 42.64(c). For these reasons,
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`Petitioner’s motion is legally defective and should be denied.
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`II. EXHIBIT 2019 IS RELEVANT AND ADMISSIBLE
`Petitioner objects to Exhibit 2019 (“Häberle”) as irrelevant and unduly
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`prejudicial because it published after the priority date of the ’559 patent and/or is
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`cumulative of other evidence. But Häberle is squarely relevant under FRE 401 and
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`402 because it reflects prior art guidelines for urea cycle disorder (“UCD”)
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`treatment that conflict with Petitioner’s theory that a person of skill in the art
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`(“POSA”) would have been motivated to perform the methods recited in the
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`challenged claims. See FRE 401 (evidence being relevant if “it has any tendency
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`to make a fact more or less probable than it would be without the evidence”).
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`Petitioner’s assertion that Häberle is not relevant because it fails to establish
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`the prior art practices of a POSA is inconsistent with the teachings of the reference
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`itself. Häberle is titled “Suggested guidelines for the diagnosis and management of
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`urea cycle disorders,” and provides that “[d]evelopment of these guidelines
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`spanned the time period, October 2008 until August 2011,” which is immediately
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`prior to the September 30, 2011, priority date of the ’559 patent. (Ex. 2019 at 2
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`(emphasis added).) Thus, although published on May 29, 2012, Häberle
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`exemplifies the state of the art with respect to UCD treatment guidelines prior to
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`the ’559 patent priority date and, thus, is relevant and admissible. See e.g., Gould
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`IPR2016-00829
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`Page 2
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`v. Quigg, 822 F.2d 1074, 1078 (Fed. Cir. 1987) (“This court has approved use of
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`later publications as evidence of the state of the art existing on the filing date of an
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`application”) (citing In re Hogan, 559 F.2d 595, 605 (C.C.P.A. 1977)); Ex parte
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`Erlich, 22 U.S.P.Q.2d 1463, 1992 WL 93132, at *3 (Bd. Pat. App. & Inter. 1992);
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`In re Wilson, 311 F.2d 266, 268-269 (C.C.P.A. 1962); Disney Enter., Inc. v.
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`Kappos, 923 F. Supp. 2d 788, 801 (E.D. Va. 2013) (citing In re Epstein, 32 F.3d
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`1559 (Fed. Cir. 1994)); Dell Inc. v. Elec. & Telecommns. Research Inst., IPR2013-
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`00635, Paper 39 at 6, n.1 (P.T.A.B. Feb. 27, 2015). And Horizon’s expert, Dr.
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`Gregory Enns (“Dr. Enns”), a recognized expert in the field of UCD treatment, has
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`testified that Häberle reflects the knowledge of a POSA as of prior to September
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`30, 2011. (Ex. 2006 at ¶¶ 117-118.)
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`The specific teachings of Häberle are highly relevant to the issues in dispute
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`in this IPR because they rebut Petitioner’s assertion that a POSA would have been
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`motivated to perform the methods of the challenged claims of the ’559 patent.
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`Häberle discloses a table (“Table 4”) of suggested actions for a POSA to take in
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`rendering treatment to symptomatic patients based on their ammonia level. (Ex.
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`2006 at ¶ 118; Paper No. 26 at 42-43; Ex. 2019 at Table 4.) Notably, Table 4 does
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`not suggest any action when a patient exhibits normal plasma ammonia. (Id.)
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`Importantly, when the ammonia level rises to “above upper limit of normal,”
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`Häberle does not recommend increasing the dosage of nitrogen scavenging drugs
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`IPR2016-00829
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`Page 3
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`but instead recommends stopping protein intake, administering IV glucose, and
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`continued monitoring of plasma ammonia. (Id.) It is only once the ammonia level
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`rises to the next stage—well-above the upper limit of normal (e.g., >100
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`μmol/L)—that Häberle recommends increasing the dosage of nitrogen scavenging
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`drugs. (Id.) Thus, consistent with Dr. Enns’s testimony on this point, Häberle
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`disproves Petitioner’s and Dr. Vaux’s theory that a POSA would have been
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`motivated to increase the dosage of nitrogen scavenging medication for a UCD
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`patient having a normal fasting plasma ammonia level as required by the claims of
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`the ’559 patent.
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`Significantly, Petitioner does not dispute the teachings of Häberle, or assert
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`that its disclosure is inconsistent with prior art practices. Indeed, Petitioner
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`inconsistently asserts that much of Häberle’s teachings are cumulative of other
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`undisputedly relevant prior art references. Petitioner’s assertion that Häberle
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`should be excluded simply because of its publication date has no merit.
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`Petitioner’s motion to exclude Exhibit 2019 should therefore be denied.
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`Petitioner’s motion should also be denied because, although presented as a
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`motion to exclude, its arguments are directed to the weight of the evidence rather
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`than its admissibility. The Board has repeatedly held that a motion to exclude is
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`not an opportunity for a party to supplement its substantive briefing. See, e.g.,
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`Liberty Mut., CBM2012-00002, Paper 66 at 61 (“A motion to exclude must explain
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`IPR2016-00829
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`Page 4
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`why the evidence is not admissible (e.g., relevance or hearsay), but may not be
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`used to challenge the sufficiency of the evidence to prove a particular fact”); see
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`also Nissan N. Am., Inc. v. Norman IP Holdings, LLC, IPR2014-00564, Paper 36 at
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`33-34 (P.T.A.B. Aug. 26, 2015) (“[A] motion to exclude addresses the
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`admissibility of evidence, and not how much weight to give an argument.”) Here,
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`Petitioner is attempting to attack the sufficiency of the evidence corroborating Dr.
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`Enns’s knowledgeable and credible testimony that, prior to the priority date, a
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`POSA would not have been motivated to increase the dosage of nitrogen
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`scavenging medication for a UCD patient with normal fasting plasma ammonia
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`levels, as claimed. Thus, Petitioner’s argument to exclude Häberle only goes to the
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`weight and not admissibility of the reference and should therefore be rejected.
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`III. DR. ENNS’S TESTIMONY CONCERNING THE KNOWLEDGE OF
`A POSA BEFORE THE PRIORITY DATE IS RELEVANT AND
`ADMISSIBLE
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`In addition to improperly seeking to exclude Häberle, Petitioner asks that the
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`Board exclude more than ten paragraphs of testimony of Horizon’s expert, Dr.
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`Enns, concerning the state of the art and the knowledge of a POSA before the
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`priority date (Ex. 2006 ¶¶ 28, 33-37, 41, 43, 87, 113 and 118) because he cites to
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`Häberle (among many other references) as additional support for his opinion. The
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`Board should reject this argument for the same reasons as discussed above with
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`respect to Häberle.
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`IPR2016-00829
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`Page 5
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`Dr. Enns’s testimony concerning the motivation of a POSA to perform the
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`claimed methods prior to the September 30, 2011 priority date is clearly relevant
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`and admissible under FRE 401. Petitioner’s argument for exclusion of Dr. Enns’s
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`testimony should also be rejected as improper because it attacks the sufficiency of
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`the evidence to support Patent Owner’s rebuttal position and not the admissibility.
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`See 37 C.F.R. § 42.64(c); see also Liberty Mut., CBM2012-00002, Paper 66 at 61.
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`At issue in this IPR is whether a POSA would have been motivated to
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`administer an increased dosage of medication based on a normal fasting plasma
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`ammonia level. Dr. Enns testified that a POSA would not have been motivated to
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`increase the dosage of nitrogen scavenging drug for a patient having a normal
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`fasting plasma ammonia level as of the priority date. (Ex. 2006 at ¶¶ 117, 120.)
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`Dr. Enns’s testimony is derived from his expertise in UCD treatment, including
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`years of experience treating UCD patients prior to the 2011 priority date. (Ex.
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`2006 at ¶¶ 6, 10-11.) Contrary to Petitioner’s assertion, Dr. Enns does not rely on
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`Häberle or any other reference to “prove” the state of the prior art. But unlike
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`Petitioner’s expert, Dr. Vaux, who has not independently corroborated his
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`obviousness theory, Dr. Enns cites to the prior art, including Table 4 of Häberle, as
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`additional support for his opinions. (Ex. 2006 at ¶ 118, citing Ex. 2019 at Table 4.)
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`Tellingly, Table 4 contradicts the testimony of Dr. Vaux. Petitioner’s argument to
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`IPR2016-00829
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`Page 6
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`exclude portions of Dr. Enns’s testimony is an overreaching attempt to remove
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`relevant evidence that conflicts with Petitioner’s obviousness position.
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`Additionally, as discussed above with respect to Häberle, Petitioner’s
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`argument to exclude Dr. Enns’s testimony goes to the sufficiency of the evidence
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`to support Patent Owner’s position and not the admissibility of Dr. Enns’s
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`testimony, and should be denied.
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`IV. EXHIBIT 2041 IS RELEVANT AND ADMISSIBLE
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`Exhibit 2041 is relevant under FRE 401 and admissible pursuant to FRE
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`402. Petitioner objects to Exhibit 2041 on the basis that it is not prior art to the
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`claimed inventions. However, Petitioner’s argument fails because Patent Owner
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`only cites to Exhibit 2041 as additional evidence of undisputed facts regarding the
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`state of the prior art that are already established by Petitioner’s own prior art
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`reference, the ’859 Publication.
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`Petitioner’s assertion that Patent Owner relies on Exhibit 2041 to argue that
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`a POSA would not have been motivated to combine Simell (Ex. 1005) with the
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`’859 Publication (Ex. 1007) is incorrect. Exhibit 2041 is the FDA-approved
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`Prescribing Information for Horizon’s RAVICTI® (glycerol phenylbutyrate oral
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`liquid) product, updated as of September 2016. Despite the 2016 date on this
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`updated label, it is undisputed that prior to September 2011, the same drug in
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`RAVICTI®, glycerol phenylbutyrate, was known in the art as an oral medication to
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`IPR2016-00829
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`Page 7
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`be used for chronic management of UCD. (See, e.g., Ex. 1007 at [0015]-[0016],
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`[0020]-[0021].) In fact, both parties cite the ’859 Publication for that proposition.
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`(See Paper No. 3 at 5; Paper No. 26 at 26.) Horizon cites to Exhibit 2041, the
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`FDA-approved prescribing information, for additional support of the undisputed
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`fact that glycerol phenylbutyrate is an oral medication used for chronic treatment
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`of UCD patients. (Paper No. 26 at 26.) Such information is clearly relevant even
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`if it does not qualify as prior art. See FRE 401. Notably, Petitioner does not
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`dispute the disclosure of Exhibit 2041. Thus, Petitioner’s motion to exclude Ex.
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`2041 on grounds of prejudice and relevance has no merit and should be denied.
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`As with Exhibit 2019, Petitioner’s concerns about Exhibit 2041 are
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`arguments more properly aimed at the weight to be afforded to that reference and
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`its sufficiency to support Patent Owner’s argument rather than its admissibility.
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`Thus, Petitioner’s Motion to exclude Exhibit 2041 should also be denied. See 37
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`C.F.R. § 42.64(c); Liberty Mut., CBM2012-00002, Paper 66 at 61.
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`V. CONCLUSION
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`For at least the reasons discussed above, Petitioner’s Motion to Exclude
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`Exhibits 2019 and 2041 and the portions of Dr. Enns’ Declaration relying on or
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`citing to Exhibit 2019 should be denied.
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`IPR2016-00829
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`Page 8
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`Date: 2017 June 26
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`Respectfully submitted,
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`By: / M.C. Phillips /
`Matthew C. Phillips
`Registration No. 43,403
`Backup Counsel for Patent Owner
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`IPR2016-00829
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`Page 9
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`CERTIFICATE OF SERVICE
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`I hereby certify that on June 26, 2017, copies of the foregoing PATENT
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`OWNER’S OPPOSITION TO PETITIONER’S MOTION TO EXCLUDE and all
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`documents filed with it were served via electronic mail, as agreed to by counsel,
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`upon the following counsel for the Petitioners:
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`Elizabeth J. Holland: eholland@goodwinproctor.com
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`Cynthia Lambert Hardman: chardman@goodwinprocter.com
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`Robert V. Cerwinski: rcerwinski@goodwinprocter.com
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`/ M.C. Phillips /
`Matthew C. Phillips
`Registration No. 43,403
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`IPR2016-00829
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