UNITED STATES PATENT AND TRADEMARK OFFICE
`
`__________
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`__________
`
`
`
`PAR PHARMACEUTICAL, INC.,
`
`and
`
`LUPIN LTD. and LUPIN PHARMACEUTICALS, INC.,
`
`Petitioners
`
`v.
`
`HORIZON THERAPEUTICS, INC.,
`
`Patent Owner
`
`__________
`
`
`
`Case IPR2015-01117*
`Patent 8,642,012
`
`__________
`
`
`
`PATENT OWNER’S OPPOSITION TO PETITIONER’S
`MOTION TO EXCLUDE EVIDENCE
`
`
`* Case IPR2015-00283, instituted on a petition filed by Lupin Ltd. and Lupin
`Pharmaceuticals, Inc., has been joined with this proceeding.
`
`
`
`
`
`
`
`__________
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`__________
`
`
`
`PAR PHARMACEUTICAL, INC.,
`
`and
`
`LUPIN LTD. and LUPIN PHARMACEUTICALS, INC.,
`
`Petitioners
`
`v.
`
`HORIZON THERAPEUTICS, INC.,
`
`Patent Owner
`
`__________
`
`
`
`Case IPR2015-01117*
`Patent 8,642,012
`
`__________
`
`
`
`PATENT OWNER’S OPPOSITION TO PETITIONER’S
`MOTION TO EXCLUDE EVIDENCE
`
`
`* Case IPR2015-00283, instituted on a petition filed by Lupin Ltd. and Lupin
`Pharmaceuticals, Inc., has been joined with this proceeding.
`
`
`
`
`
`
`
`TABLE OF CONTENTS
`
`I.
`
`II.
`
`III.
`
`INTRODUCTION ........................................................................................... 1
`
`EXHIBIT 2027 (SHERWIN ’33) IS RELEVANT AND ADMISSIBLE ...... 1
`
`PETITIONER’S MOTION VIOLATES PTAB RULES AND IS
`UNSUPPORTED ............................................................................................. 5
`
`A.
`
`Patent Owner’s Statements in the POR are Supported by the Evidence
`of Record ............................................................................................... 8
`
`IV. EXHIBIT 2028 IS RELEVANT AND ADMISSIBLE .................................14
`
`V.
`
`CONCLUSION ..............................................................................................15
`
`
`
`
`
`IPR2015-01117
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`Page i
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`TABLE OF AUTHORITIES
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`Cases
`
`Ariosa Diagnostics v. Isis Innovation,
`IPR2012-00022, Paper 24 (PTAB March 19, 2013) ............................................15
`
`Belden Inc. v. Berk-Tek LLC, 805 F.3d 1064 (Fed. Cir. 2015) ................................. 6
`
`Euro-Pro Operating LLC v. Acorne Enterprises, LLC,
`IPR2014-00351, Paper 38 (PTAB July 9, 2015) .................................................... 7
`
`In re De Blauwe,
`736 F. 2d 699 (Fed. Cir. 1984) ............................................................................... 7
`
`In re Geisler,
`116 F.3d 1465 (Fed. Cir. 1997) .............................................................................. 7
`
`Liberty Mutual Insurance Co. v. Progressive Casualty Insurance Co., CBM2012-
`00002, Paper 66 (PTAB January 23, 2014) .......................................................2, 5
`
`Nissan North America, Inc. v. Norman IP Holdings, LLC,
`IPR2014-00564, Paper 36 (PTAB August 26, 2015) .........................................2, 6
`
`Rules
`
`Federal Rules of Evidence 401, 403 .......................................................................... 2
`
`Regulations
`
`37 C.F.R. § 42.20(c) ...............................................................................................1, 2
`
`37 C.F.R. § 42.23 ....................................................................................................... 1
`
`37 C.F.R. § 42.64 ....................................................................................................... 1
`
`37 C.F.R. § 42.64(b)(1) .............................................................................................. 6
`
`37 C.F.R. § 42.64(c) ................................................................................................... 6
`
`
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`IPR2015-01117
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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 37 C.F.R. § 42.23, Patent Owner Horizon
`
`Therapeutics, Inc. (“Patent Owner” or “Horizon”) files this opposition to Par
`
`Pharmaceutical, Inc.’s (“Petitioner” or “Par”) Motion to Exclude Evidence (Paper
`
`No. 38). Par’s Motion is legally and substantively defective and should be denied.
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`In its Motion, Petitioner seeks to expunge relevant evidence from the record
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`because it is not favorable to Petitioner’s positions in this inter partes review
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`(“IPR”). In addition, under the guise of a motion to exclude evidence, Petitioner
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`improperly supplements its reply brief by arguing that large sections of Horizon’s
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`Patent Owner Response (“POR”) should be excluded because Horizon chose not to
`
`file a confirmatory expert declaration. In each instance, Petitioner’s position is
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`meritless, Petitioner fails to demonstrate that it is entitled to the relief requested,
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`and Petitioner has waived its objections to the alleged “evidence;” thus,
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`Petitioner’s Motion should be denied in its entirety. 37 C.F.R. § 42.20(c).
`
`II. EXHIBIT 2027 (SHERWIN ’33) IS RELEVANT AND ADMISSIBLE
`Petitioner filed its objection to Exhibit 2027 with the Board more than two
`
`months late (Paper No. 34)1; thus, pursuant to 37 C.F.R. 42.64(c)(1), such
`
`objections are not timely and should be deemed waived. Nevertheless, Petitioner’s
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`request to exclude Exhibit 2027 (“Sherwin ’33”) arises not from an evidentiary
`
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`1 Par’s Motion to file its objections out of time (Paper 34) is currently pending.
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`defect but rather from Petitioner’s concern that Sherwin ’33 discredits Sherwin ’19
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`(Exhibit 1016), one of Petitioner’s key prior art references.
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`
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`In its Motion, Petitioner argues that Sherwin ’33 is not relevant because it
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`allegedly does not discredit Sherwin ’19; however, such argument only goes to the
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`weight and not the admissibility of the evidence. See e.g., Liberty Mutual
`
`Insurance Co. v. Progressive Casualty Insurance Co., CBM2012-00002, Paper 66
`
`at 61 (P.T.A.B. Jan. 23, 2014) (“A motion to exclude must explain why the
`
`evidence is not admissible (e.g., relevance or hearsay), but may not be used to
`
`challenge the sufficiency of the evidence to prove a particular fact.”); Nissan North
`
`America, Inc. v. Norman IP Holdings, LLC, IPR2014-00564, Paper 36 at 34
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`(P.T.A.B. Aug. 26, 2015) (“[A] motion to exclude addresses the admissibility of
`
`evidence, and not how much weight to give an argument.”). Petitioner also asserts
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`that Sherwin ’33 should be excluded because it allegedly confuses the issues;
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`however, Petitioner fails to provide any support for its position. Thus, Petitioner
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`has failed to meet its burden to demonstrate that Sherwin ’33 lacks relevance under
`
`FRE 401 or 402 or will confuse the issues under FRE 403, and its motion should
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`be denied. 37 C.F.R. § 42.20(c).
`
`Furthermore, contrary to Petitioner’s claim, the questions addressed, the
`
`methodologies used, and the studies performed in Sherwin ’33 are highly relevant
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`to this proceeding. A key issue in this IPR is whether the prior art, including
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`Sherwin ’19, discloses or suggests “about 60%” conversion (or detoxication) of
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`phenylacetic acid (“PAA”) to phenylacetylglutamine (“PAGN”). Sherwin ’33,
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`titled “Further Studies on the Detoxication of Phenylacetic Acid” and co-authored
`
`by the same Carl Sherwin as Sherwin ’19, is squarely relevant because it discredits
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`the data and conclusions in Sherwin ’19. (Ex. 2027 (emphasis added).)
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`Sherwin ’33 states that “[i]n the previous work on detoxication of
`
`phenylacetic acid in this laboratory we have never been able to account for more
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`than half of it as the glutamine conjugate in the human urine.” (Id. at 669.)
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`Sherwin’s previous work on detoxication of PAA was published as Sherwin ’19.
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`Sherwin ’33 describes an experiment specifically designed to test the accuracy of
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`the method of analysis used in Sherwin ’19 to extract PAGN from urine. In
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`Sherwin ’19, PAGN was extracted from the subjects’ urine using a method that
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`was later described and referenced in P. B. Hawk and O. Bergeim, Practical
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`Physiological Chemistry, (9th Ed.) at 304-5, n. 2 (1926) (Ex. 2029) (“the Sherwin
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`’19 method”). (Ex. 1016 at 114-15.) Sherwin ’33 tested whether the Sherwin ’19
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`method was to blame for the low recovery of PAGN by dissolving an amount of
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`PAGN in urine, extracting it using the Sherwin ’19 method and then measuring the
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`amount recovered. (Ex. 2027 at 672-73, FN5.) Using the Sherwin ’19 method,
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`Sherwin only recovered 47.4% of the original amount of PAGN dissolved in the
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`urine. (Id. at 673.) Sherwin ’33 concludes that “[t]he apparently incomplete
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`conjugation of phenylacetic acid with glutamine when it is ingested by the human
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`subject
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`in moderate doses may best be ascribed
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`to
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`the hydrolysis of
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`phenylacetylglutamine when the urine containing it is evaporated on the water
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`bath.” (Id. at 675.) Thus, Sherwin ’33 is highly relevant because it demonstrates
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`that it was known in the art that the Sherwin ’19 data and conclusions concerning
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`conversion of PAA to PAGN are unreliable. Sherwin ’33 is also relevant to rebut
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`Petitioner’s assertion that the prior art taught that conversion of PAA to PAGN was
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`incomplete because it concludes that “[a]bout 95 per cent of the phenylacetic acid
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`ingested in moderate doses by the human subject is detoxicated with glutamine. . .”
`
`(Id.)
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`The Petition asserts that a person of ordinary skill in the art (“POSA”) would
`
`consider prior art relating to the clinical effects of PAA treatment on healthy
`
`subjects, and that prior art clearly includes Sherwin ’33. (Par Petition, Paper 1
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`(“Pet.”) at 17.). Petitioner also asserts that a POSA reading Sherwin ’19 would
`
`have been motivated to look to another publication, Shiple (Exhibit 1017) because
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`the articles have a common author. (Id.) By the same logic, a POSA reading
`
`Sherwin ’19 would consider Sherwin ’33 because of their common author.
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`Further, the Petition asserts that a POSA would have considered prior art
`
`disclosing the conversion rate of PAA to PAGN in healthy subjects. (Pet. at 25.)
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`Thus, under Petitioner’s analysis, the subject matter of the Sherwin ’33 reference is
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`squarely relevant to a POSA. Unsurprisingly, Petitioner’s expert, Dr. Sondheimer,
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`admitted as much at his deposition. (Ex. 2012, 30:11-23.) Dr. Sondheimer also
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`admitted that a POSA would have considered references cited in the ’647 patent
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`(Ex. 1018). (Ex. 2012 at 104:3-7.) The ’647 patent cites Sherwin ’33 and
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`confirms that it “reported that they found 98% of orally administered phenylacetic
`
`acid . . . was excreted in the urine as phenylacetylglutamine.” (Ex. 1018, col. 2:53-
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`64.) Thus, Petitioner’s assertion that Sherwin ’33 is not relevant to this IPR fails.
`
`III. PETITIONER’S MOTION VIOLATES PTAB RULES AND IS
`UNSUPPORTED
`
`Petitioner’s request that the Board exclude sections of Horizon’s POR
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`because Horizon chose not to file an expert declaration in support constitutes
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`improper supplemental reply briefing in violation of PTAB rules because such
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`arguments go to the weight and not the admissibility of Horizon’s statements in its
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`POR. In addition, the Board has rejected such arguments. Furthermore,
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`Petitioner’s assertions are meritless because, as explained below, Patent Owner’s
`
`“statements” are fully supported by the evidence of record.
`
`A motion to exclude is the proper vehicle to challenge the admissibility of
`
`evidence and not an opportunity for a party to supplement its substantive briefing.
`
`See e.g., Liberty Mutual Insurance Co. v. Progressive Casualty Insurance Co.,
`
`CBM2012-00002, Paper 66 (P.T.A.B. Jan, 23, 2014) (“A motion to exclude must
`
`explain why the evidence is not admissible (e.g., relevance or hearsay), but may
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`not be used to challenge the sufficiency of the evidence to prove a particular fact”);
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`see also Nissan North America, Inc. v. Norman IP Holdings, LLC, IPR2014-00564,
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`Paper 36 (P.T.A.B. Aug. 26, 2015).
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`In its Motion, Petitioner repeats the meritless argument in its Reply (Paper
`
`No. 30 at 2-6) that the Board should assign no weight to large portions of
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`Horizon’s POR simply because Horizon did not attach an expert declaration in
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`support. Petitioner’s inclusion of such argument in its Motion is improper and
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`violates 37 C.F.R. § 42.64(c) because it does not concern the admissibility of
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`evidence but rather attacks the sufficiency of Patent Owner’s rebuttal arguments.
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`Petitioner’s Motion should be denied on this basis alone. Furthermore, Petitioner
`
`never objected to any portion of the POR in its “Objections under 37 C.F.R. 42.64”
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`as required by 37 C.F.R. § 42.64(b)(1); thus, Petitioner’s objections should now be
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`deemed waived.
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`In addition, the Federal Circuit has expressly rejected Petitioner’s position
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`that a POR must be accompanied by an expert declaration. See e.g., Belden Inc. v.
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`Berk-Tek LLC, 805 F.3d 1064, 1079 (Fed. Cir. 2015) (“No rule requires a Petition
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`to be accompanied by any declaration, let alone one from an expert guiding the
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`Board as to how it should read prior art”). Moreover, Board members have the
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`technical expertise necessary to understand the prior art references. Belden, 805
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`F.3d at 1079 (“Board members, because of expertise, may more often find it easier
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`to understand and soundly explain the teachings and suggestions of prior art
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`without expert assistance”). Aside from repeating its argument concerning the
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`absence of an expert declaration, Petitioner fails to provide any factual basis for its
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`assertions that the Patent Owner “statements” quoted in its Motion are improper
`
`attorney argument. Furthermore, Petitioner provides no support for its generalized
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`allegation that unspecified statements in the POR are improper expert testimony.
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`The case law Petitioner cites in support is inapposite because those cases
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`discuss the weight to be assigned to conclusory assertions of counsel that lacked
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`any factual basis in the record and not the admissibility of such statements. See In
`
`re Geisler, 116 F.3d 1465, 1470 (Fed. Cir. 1997) (holding that “an assertion of
`
`what seems to follow from common experience [without a basis in the record] is
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`just attorney argument and not the kind of factual evidence that is required to rebut
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`a prima facie case of obviousness”); In re De Blauwe, 736 F. 2d 699, 705 (Fed.
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`Cir. 1984) (holding that conclusory statements in the specification [without factual
`
`support] concerning unexpected results were insufficient to support assertion of
`
`unexpected results); Euro-Pro Operating LLC v. Acorne Enterprises, LLC,
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`IPR2014-00351, Paper 38, at 15 (PTAB July 9, 2015) (holding that Patent Owner’s
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`rebuttal argument was entitled to no weight because Patent Owner provided no
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`evidence or technical reasoning in support of its position). However, as explained
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`below, Patent Owner’s statements in the POR are supported by the objective
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`evidence of record.
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`A.
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`Patent Owner’s Statements in the POR are Supported by the
`Evidence of Record
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`None of the statements cited in Petitioner’s Motion constitute improper
`
`unsupported attorney argument. On the contrary, as explained below, Patent
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`Owner’s assertion is supported by the objective evidence discussed in the POR.
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`Accordingly, Petitioner’s Motion to exclude the portions of the POR quoted below
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`lacks merit and should be denied.
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`POR at p. 5: “Although Dr. Sondheimer ignores Sherwin ’33 [Ex.
`2027], he concedes that a POSA would have considered later
`publications concerning PAA to PAGN conversion to be relevant,
`including references cited in the ’674 patent [Ex. 1018]—which cites
`Sherwin ’33 [Ex. 2027].”
`Patent Owner’s assertion at p. 5 of the POR (above) is supported by Dr.
`
`Sondheimer’s testimony and the prior art of record, as explained in detail in the
`
`POR at, for example, p. 46. At his deposition, Dr. Sondheimer admitted that a
`
`POSA would have considered later publications concerning conversion of PAA to
`
`PAGN in healthy subjects, including the references cited in the ’674 patent, which
`
`includes Sherwin ’33. (Ex. 2012 at 30:11-23; 104:3-7.)
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`POR at p. 7: “However, even if a POSA faced with Brusilow ’91 [Ex.
`1012] were to search for additional references concerning PAA-to-
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`PAGN conversion, they would not have relied on Sherwin ’19 [Ex.
`1016] because its conclusions concerning PAA-to-PAGN conversion
`were expressly discredited by Sherwin ’33 [Ex. 2027].”
`POR at pp. 42-43: “Furthermore, a POSA would not have combined
`the disclosure of Brusilow ’91 [Ex. 1012] with Sherwin [Ex. 2027]
`because Sherwin’s conclusions concerning incomplete conversion of
`PAA conversion to UPAGN were later expressly overturned by
`Sherwin 1933 [Ex. 2027], a publication by the same group.”
`POR at p. 45: “Even assuming for the sake of argument that a POSA
`faced with Brusilow ’91 [Ex. 1012] would have sought out additional
`references concerning conversion of PAA to PAGN, they would not
`have relied on Sherwin ’19 [Ex. 1016] because Sherwin ’19’s [Ex.
`1016] conclusions concerning incomplete conversion were expressly
`disproved by the same research group.”
`POR at p. 45-46: “Thus, Patent Owner asserts that a POSA would not
`have relied on the Sherwin [Ex. 1016] reference for data concerning
`PAA to PAGN in healthy subjects because they would have been
`aware that the data in Sherwin [Ex. 1016] was flawed due to the
`method of extraction used and, as such, does not identify the “true rate
`of conversion.””
`POR at p. 47: “As discussed above, Sherwin ’33 [Ex. 2027]
`demonstrates that Sherwin’s [Ex. 1016] 1919 data concerning
`conversion of PAA to PAGN was flawed and unreliable; thus, a POSA
`would not have used such data to determine a mean conversion.”
`POR at p. 51: “Furthermore, for the reasons discussed above, a POSA
`would not have combined the disclosure of Brusilow ’91 [Ex. 1012]
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`with Sherwin ’19 [Ex. 1016], a discredited reference.”
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`Patent Owner’s statements at pp. 7, 42-43, 45-47 and 51 of the POR (above)
`
`are supported by the prior art of record, as explained in detail in the POR at, for
`
`example, pp. 19 and 42-46. As discussed in the POR and above, Sherwin ’33
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`discredits the data and conclusions in Sherwin ’19 concerning the percentage
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`conversion of PAA to PAGN in healthy subjects.
`
`POR at p. 7: “Further, if a POSA were to combine Brusilow ’91 [Ex.
`1012] with Shiple [Ex. 1017] or Comte [Ex. 1025], they could not
`have arrived at the claimed methods because Shiple [Ex. 1017]
`discloses near 100% conversion at a therapeutically relevant dosage
`and Comte [Ex. 1025] provides no conclusions concerning overall
`conversion of PAA to PAGN.”
`POR at p. 36: “Furthermore, a POSA would not have understood
`Shiple [Ex. 1017] and Comte [Ex. 1025] to teach or suggest
`incomplete conversion of PAA to UPAGN in healthy subjects.”
`POR at p. 47: “Additionally, because Comte [Ex. 1025] only collected
`urine for 8 hours following administration of a single dose of PAA, a
`POSA would have recognized (and Dr. Sondheimer agrees) that
`Comte [Ex. 1025] makes no conclusions concerning the total amount
`of PAGN that would have been excreted over 24 hours, which would
`have allowed for complete metabolism.”
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`POR at p. 50: “Because Comte’s [Ex. 1025] study only analyzed the
`urine of healthy patients collected over 8 hours after a single dose of
`sodium phenylbutyrate and notes that the excretion of PAGN was still
`ongoing after 8 hours, a POSA would not have understood Comte [Ex.
`1025] to provide any definitive conclusions concerning conversion of
`PAA to PAGN in healthy subjects or UCD patients.”
`POR at p. 50: “Comte [Ex. 1025], likewise, fails to cure the
`deficiencies of Brusilow ’91 [Ex. 1012] since a POSA would not have
`understood Comte [Ex. 1025] to provide any definitive teaching
`concerning the overall percentage conversion of PAA to PAGN.”
`POR at p. 53: “Thus, a POSA would not have understood the data in
`Kasumov [Ex. 1015] to be predictive of the total UPAGN excretion in
`UCD patients receiving standard clinical dosages.”
`POR at pp. 53-54: “Accordingly, a POSA would not have relied upon
`Kasumov [Ex. 1015] in reaching any conclusions concerning
`conversion of PAA to UPAGN in healthy subjects and would not have
`considered Kasumov [Ex. 1015] in making dosing decisions in UCD
`patients.”
`Patent Owner’s statements at pp. 7, 47, 50 and 53-54 of the POR (above) are
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`supported by Dr. Sondheimer’s testimony and the prior art of record, as explained
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`in detail in the POR at, for example, pp. 32-34, 48, 50 and 53-54.
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`POR at p. 22: “The FDA-approved 2003 prescribing information for
`Buphenyl (sodium phenylbutyrate) [Ex. 2025], a PAA prodrug used to
`treat UCD patients prior to August 2008, also indicates that, more than
`ten years after Brusilow’s 1991 [Ex. 1012] publication, POSAs
`assumed complete or nearly complete conversion of PAA to PAGN in
`UCD patients.”
`Patent Owner’s statement at p. 22 of the POR (above) is supported by the
`
`prior art of record, as explained in detail in the POR at, for example, pp. 21 and 41.
`
`POR at p. 42: “However, as explained below, a POSA would not have
`ignored the Brusilow ’91 [Ex. 1012] data concerning near complete
`conversion of PAA to PAGN.”
`POR at p. 43: “Thus, a POSA faced with Brusilow ’91 [Ex. 1012]
`would have understood that conversion was complete in UCD patients
`and thus, would have had no reason to seek out other publications to
`determine the “true rate of conversion” of PAA to PAGN.”
`POR at p. 44: “However, even if a POSA were to conclude (which
`they would not) based on Brusilow ’91 [Ex. 1012] that conversion of
`PAA to PAGN was not 100%, Dr. Sondheimer provides no reason
`why a POSA would have completely ignored the data in Brusilow ’91
`[Ex. 1012], which at a minimum demonstrated 80-90% conversion,
`and instead rely solely on data dating from seventy years earlier in
`determining the “true rate of conversion.””
`Patent Owner’s conclusion at p. 42, 43 and 44 (above) is supported by the
`
`prior art of record, as explained in the POR at, for example, pp. 20-21 and 35-41,
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`43-44.
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`POR at pp. 46-47: “Aside from Sherwin ’19 [Ex. 1016] and Brusilow
`’91 [Ex. 1012], a POSA would also not have combined the teachings
`of Comte [Ex. 1025] with Brusilow ’91 [Ex. 1012] because Comte
`[Ex. 1025] is concerned with identification of new metabolites of
`phenylbutyrate metabolism in healthy subjects and not on
`quantification of the amount of PAA prodrug converted to UPAGN.”
`POR at p. 53: “At the outset, a POSA would not have combined the
`teachings of Kasumov [Ex. 1015] with Brusilow ’91 [Ex. 1012]
`because Kasumov [Ex. 1015] is focused on identification of new
`metabolites of phenylbutyrate metabolism in healthy subjects and not
`on quantification of the amount of PAA prodrug converted to PAGN
`or on treating UCD patients with PAA prodrugs.”
`Patent Owner’s assertions at pp. 46-47 and 53 (above) are supported by the
`
`prior art of record as explained in the POR at, for example, pp. 33-34, 46-47 and
`
`53.
`
`POR at p. 47: “Even if a POSA were to combine the disclosures of
`Sherwin ’19 [Ex. 1016] and Shiple [Ex. 1017] with that of Brusilow
`’91 [Ex. 1012] (which they would not), a POSA would not have
`arrived at the inventions recited in the challenged claims.”
`Patent Owner’s assertion at p. 47 (above) is supported by the prior art of
`
`record, as explained in detail in the POR at for example, pp. 17-22 and 47-51.
`
`POR at p. 47: “As an initial matter, a POSA faced with Brusilow ’91
`[Ex. 1012], Sherwin and Shiple [Ex. 1017] prior to August 2008,
`would not have concluded that the prior art taught incomplete
`conversion of PAA to PAGN, let alone a “mean conversion of about
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`60%.”
`POR at p. 48: “Thus, if a POSA were to combine these data points,
`which would qualify as relevant data under Dr. Sondheimer’s analysis
`(therapeutic dose of PAA, dosing throughout the day, and a 24-hour
`recovery of urine), a POSA would understand conversion of PAA to
`PAGN to be near complete in UCD patients and not “a mean
`conversion of about 60%” as recited in the challenged claims.”
`POR at p. 49: “Thus, contrary to Dr. Sondheimer’s assertions, a
`POSA would have recognized that the prior-art consensus prior to
`August 2008 was that conversion of PAA to PAGN in UCD patients
`and in healthy subjects was complete or near complete.”
`Patent Owner’s assertions at pp. 47- 49 (above) are supported by the prior
`
`art of record as discussed in the POR at, for example, pp. 17-22 and 47-49.
`
`IV. EXHIBIT 2028 IS RELEVANT AND ADMISSIBLE
`Petitioner filed its objection to Exhibit 2028 with the Board more than two
`
`months late (Paper 31); thus, pursuant to 37 C.F.R. § 42.64(c)(1) such objections
`
`are untimely and should be deemed waived. In any case, Petitioner’s request to
`
`exclude Exhibit 2028 lacks merit and should be denied. As evidenced by Exhibit
`
`2028, Petitioner previously agreed with Patent Owner that the claim term “about
`
`60%” should be construed as “approximately 60%.” (Ex. 2028 at B-3.) Par now
`
`advocates for a narrower construction, i.e., 53-67%. (Pet. at 10.) Petitioner fails to
`
`explain why it proffered a broader construction of the term “about 60%” in related
`
`district court litigation than in the current IPR. Thus, it appears that Petitioner’s
`
`IPR2015-01117
`
`
`
`Page 14
`
`
`
`current construction is motivated by a desire to construe the challenged claims to
`
`read on the alleged prior art rather than to properly construe the claim term. As
`
`such, Exhibit 2028 is relevant to the Board’s understanding of Par’s previous
`
`construction of the claim term “about 60%.” See e.g., Ariosa Diagnostics v. Isis
`
`Innovation, IPR2012-00022, Paper 24, at 8 (PTAB Mar. 19, 2013) (PTAB noted
`
`declaration by patent owner’s expert filed in litigation “is very relevant to claim
`
`interpretation, as it reflects how the patent owner is interpreting the claims such
`
`that the alleged infringing product is covered by the asserted claim.”)
`
`V. CONCLUSION
`For the reasons provided herein, Patent Owner asserts that Petitioner’s
`
`Motion to Exclude Exhibits 2027, 2028 and alleged “improper attorney argument,”
`
`should be denied.
`
`Date: 2016 June 30
`
`
`Respectfully submitted,
`
`By: / M.C. Phillips /
`Matthew C. Phillips
`Registration No. 43,403
`Backup Counsel for Patent Owner
`
`IPR2015-01117
`
`
`
`Page 15
`
`
`
`CERTIFICATE OF SERVICE
`
`
`
`I hereby certify that on June 30, 2016, copies of the foregoing PATENT
`
`OWNER’S OPPOSITION TO PETITIONER’S MOTION TO EXCLUDE
`
`EVIDENCE was served via electronic mail, as agreed to by counsel, upon the
`
`following counsel for the Petitioners:
`
`David H. Silverstein: dsilverstein@axinn.com
`
`Aziz Burgy: aburgy@axinn.com
`
`Elizabeth J. Holland: eholland@goodwinproctor.com
`
`Cynthia Lambert Hardman: chardman@goodwinprocter.com
`
`/ M.C. Phillips /
`Matthew C. Phillips
`Registration No. 43,403
`
`
`
`IPR2015-01117
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