`_____________________
`
`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 IPR2015-011171
`Patent 8,642,012
`_____________________
`
`PETITIONERS’ OPPOSITION TO
`PATENT OWNER’S MOTION TO EXCLUDE EVIDENCE
`
`
`
`Mail Stop “PATENT BOARD”
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`1 Case IPR2015-00283, instituted on a petition filed by Lupin Ltd. and Lupin
`
`Pharmaceuticals, Inc., has been joined with this proceeding.
`
`
`
`
`
`
`
`IPR2015-01117
`Patent No. 8,642,012
`Petitioners’ Opp. to PO’s Motion to Exclude
`
`TABLE OF CONTENTS
`
`
`
`I.
`II.
`
`INTRODUCTION ........................................................................................... 1
`ARGUMENT ................................................................................................... 1
`A.
`Patent Owner’s Motion to Exclude is an Improper Vehicle to
`Address the Permissible Scope of Testimony. ....................................... 1
`Patent Owner’s Attempt to Exclude Testimony Regarding Dr.
`Sondheimer’s Background and Experience and Exhibits 1031
`and 1033 is Unreasonable. ..................................................................... 3
`Dr. Sondheimer’s Testimony Regarding the Definition of a
`Person of Ordinary Skill in the Art is Proper. ........................................ 5
`Patent Owner Should Not be Allowed to Complain about Dr.
`Sondheimer’s Testimony Regarding the Instituted Prior Art. ............... 5
`Fernandes .................................................................................... 6
`1.
`Blau ............................................................................................. 7
`2.
`Typical gelatin capsule volume, density and dosage of
`3.
`sodium phenylbutyrate in Brusilow ’91 ...................................... 8
`Patent Owner’s Bid to Disqualify Testimony as to the Relevant
`Time Period for a POSA’s Evaluation of Prior Art is Improper. ........... 8
`III. CONCLUSION ................................................................................................ 9
`
`
`B.
`
`C.
`
`D.
`
`E.
`
`
`
`i
`
`
`
`IPR2015-01117
`Patent No. 8,642,012
`Petitioners’ Opp. to PO’s Motion to Exclude
`
`
`I.
`
`INTRODUCTION
`
`Patent Owner’s motion to exclude should be denied because it is both
`
`procedurally and substantively flawed. As to the former, the Board has
`
`consistently held that a motion to exclude is not the proper mechanism to argue
`
`whether new arguments have been raised. Yet Patent Owner seeks to exclude
`
`certain testimony of Petitioners’ expert, Dr. Neal Sondheimer, and exhibits used
`
`during his deposition because such evidence is allegedly beyond the scope of his
`
`cross-examination testimony. Notwithstanding Patent Owner’s procedural failure
`
`that such arguments are improperly raised in a motion to exclude, the disputed
`
`evidence should not be excluded because Dr. Sondheimer’s deposition testimony
`
`and reliance on certain exhibits respond to topics and, in some cases, the exact
`
`same questions Patent Owner’s counsel raised during cross-examination.
`
`Accordingly, the Board should deny Patent Owner’s Motion to Exclude.
`
`II. ARGUMENT
`A.
`Patent Owner’s Motion to Exclude is an Improper Vehicle to
`Address the Permissible Scope of Testimony.
`
`The Board has repeatedly and consistently held that a motion to exclude is
`
`not the proper vehicle for a party to raise the issue of permissible scope of
`
`testimony. See Vibrant Media Inc. v. General Electric Co., No. IPR2013-00170,
`
`slip op. at 31, 2014 WL 2965703 at *19 (P.T.A.B. June 26, 2014); see Lib. Mut.
`
`
`
`1
`
`
`
`IPR2015-01117
`Patent No. 8,642,012
`Petitioners’ Opp. to PO’s Motion to Exclude
`
`Ins. Co. v. Progressive Cas. Ins. Co., No. CBM2012-00004, 2014 WL 2213411 at
`
`*27 (P.T.A.B. Feb. 11, 2014) (holding that a motion to exclude is not the vehicle to
`
`argue whether new arguments have been raised); see also ABB Inc. v. Roy-G-Biv
`
`Corp., No. IPR2013-00063, Paper 71 at 13-14 (P.T.A.B. Aug. 1, 2014). Instead, a
`
`motion to exclude, for example, must state why the evidence is inadmissible (e.g.,
`
`based on relevance or hearsay). See Vibrant Media Inc., No. IPR2013-00170, slip
`
`op. at 31.
`
`Here, Patent Owner seeks to exclude certain deposition testimony and
`
`exhibits used at Dr. Sondheimer’s deposition based on the allegation that such
`
`evidence exceeded the scope of Dr. Sondheimer’s cross-examination testimony.
`
`Patent Owner makes no claim of inadmissibility of such evidence under the
`
`Federal Rules of Evidence. As noted above, a motion to exclude is not the proper
`
`vehicle for a party to raise the issue of permissible scope of testimony.2 Patent
`
`Owner, therefore, wastes the Board’s and Petitioners’ resources by improperly
`
`raising these issues in a motion to exclude. Patent Owner’s motion to exclude
`
`should be denied for at least this reason.
`
`2 As Patent Owner concedes, Petitioner has not attempted to rely upon the
`
`evidence sought to be excluded. (Paper 36 at 2.) As such, Patent Owner’s request
`
`to exclude such evidence is further improper because it is premature at best.
`
`
`
`2
`
`
`
`IPR2015-01117
`Patent No. 8,642,012
`Petitioners’ Opp. to PO’s Motion to Exclude
`
`Notwithstanding the foregoing, the testimony of Dr. Sondheimer and
`
`exhibits sought to be excluded do not exceed the scope of evidence permitted by
`
`reply. As discussed below, such evidence is directly responsive to Patent Owner’s
`
`cross-examination questioning.
`
`B.
`
`Patent Owner’s Attempt to Exclude Testimony Regarding Dr.
`Sondheimer’s Background and Experience and Exhibits 1031 and
`1033 is Unreasonable.
`
`Patent Owner seeks to exclude Dr. Sondheimer’s testimony about his
`
`qualifications and experience treating UCD patients as well as his updated
`
`curriculum vitae (Exhibit 1031). (Paper 36 at 4-5, 13.) But Dr. Sondheimer
`
`discussed his background and qualifications in his declaration (See Exhibit 1002 at
`
`¶¶ 8-14.) And during his cross examination, Patent Owner’s counsel questioned
`
`Dr. Sondheimer regarding his declaration and his experience treating UCD
`
`patients. (See, e.g., Exhibit 2012 at 4:14-5:10, 19:17-25, 20:2-10, 24:7-13, 128:23-
`
`129:6.) Indeed, Exhibit 1033, is a prior art publication, cited in Dr. Sondheimer’s
`
`declaration in support of the petition (Exhibit 1002 at ¶ 12), where he managed and
`
`treated patients with urea cycle disorders using ammonia scavenging drugs based
`
`on that patient’s fasting ammonia level. Exhibit 1033 is background prior art
`
`reflecting the state of the art at the time. Therefore, Dr. Sondheimer’s testimony
`
`
`
`3
`
`
`
`IPR2015-01117
`Patent No. 8,642,012
`Petitioners’ Opp. to PO’s Motion to Exclude
`
`about his qualifications, experience, and the state of the art are all within the
`
`purview of his original declaration and the topics raised during cross examination.
`
`Patent Owner argues for the exclusion of Exhibit 1031 and swaths of related
`
`redirect examination testimony simply because Patent Owner did not explicitly
`
`question Dr. Sondheimer on his background and experience during cross-
`
`examination. But Patent Owner’s argument,
`
`if accepted, would allow
`
`gamesmanship
`
`to preclude
`
`the
`
`introduction of
`
`indisputably
`
`relevant
`
`evidence. Patent Owner’s position further strains credulity because Exhibit 1031 is
`
`just an updated version of Dr. Sondheimer’s curriculum vitae, which, well prior to
`
`Dr. Sondheimer’s deposition, was served on Patent Owner along with Dr.
`
`Sondheimer’s declaration and was
`
`filed with
`
`the Board as Exhibit
`
`1003. Moreover, Patent Owner placed Dr. Sondheimer’s background and
`
`experience within the ambit of Par’s redirect examination when it questioned Dr.
`
`Sondheimer regarding his declaration (see, e.g., Exhibit 2012 at 4:14-6:11), which
`
`includes an entire section on his background and qualifications as well as his
`
`attached curriculum vitae. Because Patent Owner has failed to state a cogent
`
`reason why a clearly relevant exhibit - indeed one that is merely a routine update of
`
`a previous exhibit - should be excluded, Petitioners respectfully request that the
`
`Board deny Patent Owner’s attempt to exclude Exhibit 1031.
`
`
`
`4
`
`
`
`IPR2015-01117
`Patent No. 8,642,012
`Petitioners’ Opp. to PO’s Motion to Exclude
`
`C. Dr. Sondheimer’s Testimony Regarding the Definition of a Person
`of Ordinary Skill in the Art is Proper.
`
`Patent Owner next tries to exclude Dr. Sondheimer’s testimony regarding a
`
`person of ordinary skill in the art. (Paper 36 at 6-7.) Again, not only does Dr.
`
`Sondheimer’s declaration define a person of ordinary skill in the art (Exhibit 1002
`
`at ¶ 24.), but Patent Owner’s counsel specifically questioned Dr. Sondheimer about
`
`how a person of ordinary skill in the art would understand certain of the instituted
`
`prior art references. (See, e.g., Exhibit 2012 at 4:19-11:10, 19:7-14, 26:4-11, 28:9-
`
`31:8.) Dr. Sondheimer’s testimony about his definition of a person of ordinary
`
`skill in the art and whether he qualifies as a person of ordinary skill in the art is the
`
`foundational predicate to Patent Owner’s questions regarding how a POSA would
`
`interpret the instituted prior art. Moreover, Dr. Sondheimer set forth his
`
`qualifications and his definition of a POSA in his declaration in support of the
`
`petition and, as such, there is no prejudice to Patent Owner even if such testimony
`
`were considered to be outside the scope of cross examination.
`
`D.
`
`Patent Owner Should Not be Allowed to Complain about Dr.
`Sondheimer’s Testimony Regarding the Instituted Prior Art.
`
`Despite opening the door and exhaustively questioning Dr. Sondheimer
`
`regarding the Fernandes, Blau, and Brusilow ’91 references, Patent Owner now
`
`protests his testimony during re-direct examination about those very same topics.
`
`
`
`5
`
`
`
`IPR2015-01117
`Patent No. 8,642,012
`Petitioners’ Opp. to PO’s Motion to Exclude
`
`As explained below, each snippet of testimony Patent Owner criticizes as beyond
`
`the scope of cross-examination directly rebuts questioning by Patent Owner’s
`
`counsel.
`
`Fernandes
`
`1.
`Patent Owner alleges that Dr. Sondheimer improperly testified on re-direct
`
`regarding other chapters of Fernandes (Chapter 17), whether a POSA would
`
`currently use the guidelines in Figure 17.2 of Fernandes to treat UCD patients, and
`
`whether a POSA would have specific disagreements with its teachings. (Paper 36
`
`at 7-8.)
`
`Patent Owner’s allegations that Dr. Sondheimer testified about “other
`
`chapters” is disingenuous. Dr. Sondheimer did not testify about other chapters.
`
`Rather, Dr. Sondheimer merely authenticated the portion of Fernandes he relied
`
`upon as shown by his testimony below:
`
`Q. And other than chapter 17 of Fernandes from which figure 17.2 comes,
`
`do other chapters concern urea cycle disorder?
`
`MS. SIMIC: Objection to scope.
`
`THE DEPONENT: No. This is the chapter [17] that was written to discuss
`
`the defects of the urea cycle.
`
`
`
`6
`
`
`
`IPR2015-01117
`Patent No. 8,642,012
`Petitioners’ Opp. to PO’s Motion to Exclude
`
`(Exhibit 2012 at 242:10-16.) There simply was no other testimony by Dr.
`
`Sondheimer about any other chapters in Fernandes and, as such, Patent Owner’s
`
`complaint rings hollow.
`
`
`
`Patent Owner’s objections regarding whether a POSA would currently use
`
`Figure 17.2 or have any disagreements about Fernandes is similarly misplaced.
`
`Patent Owner’s counsel specifically asked Dr. Sondheimer whether he himself
`
`referred to Fernandes in treating UCD patients. (Exhibit 2012 at 128:23-129:6)
`
`(asking Dr. Sondheimer if he “had cause to refer to Fernandes for guidance in
`
`treating UCD patients”). And Patent Owner’s counsel also queried Dr.
`
`Sondheimer whether he disagreed with any part of chapter 17 of Fernandes.
`
`(Exhibit 2012 at 129:7-15) (asking “is there any parts of chapter 17 that you
`
`disagree with”). As shown by the testimony, Patent Owner’s attempt to now object
`
`to these topics is contemptible because these exact topics and/or questions were
`
`first posed by Patent Owner.
`
`Blau
`
`2.
`Patent Owner contends that Dr. Sondheimer’s re-examination testimony
`
`concerning hypothetical deviations from the specimen collection guidelines set
`
`forth in Table 11.9 of Blau is impermissible. (Paper 36 at 11-12.) Patent Owner
`
`carelessly makes this argument in its motion to exclude, but the Blau reference is
`
`
`
`7
`
`
`
`IPR2015-01117
`Patent No. 8,642,012
`Petitioners’ Opp. to PO’s Motion to Exclude
`
`not a prior art reference the Board instituted review on in this IPR. Rather, Blau is
`
`a prior art reference of record in the ’215 patent IPR (IPR2015-01127).
`
`3.
`
`Typical gelatin capsule volume, density and dosage of sodium
`phenylbutyrate in Brusilow ’91
`
`Patent Owner complains about Dr. Sondheimer’s testimony regarding
`
`typical gelatin capsule volume, density of sodium phenylbutyrate, and the
`
`calculation of the amount of sodium phenylbutyrate dosed in Brusilow ’91. (Paper
`
`36 at 9-10.) Dr. Sondheimer cites extensively to Brusilow ’91 in his declaration to
`
`illustrate what a POSA would have understood as of the priority date of the patent,
`
`including extensive discussions regarding dosage adjustments based on using a
`
`target amount of urinary PAGN to calculate the dose of sodium phenylbutyrate.
`
`(See, e.g., Exhibit 1002 at ¶¶ 33-36). Patent Owner therefore cannot argue that the
`
`testimony and reliance on Exhibit 1032, which provides the density and molecular
`
`weight for sodium phenylbutyrate, is outside the permissible scope.
`
`E.
`
`Patent Owner’s Bid to Disqualify Testimony as to the Relevant
`Time Period for a POSA’s Evaluation of Prior Art is Improper.
`
`Patent Owner disputes the propriety of Dr. Sondheimer’s re-direct testimony
`
`as to the relevant time period regarding the rate of conversion of PAA to PAGN.
`
`(Paper 36 at 10-11.) Patent Owner’s objection is ill-founded because Patent
`
`Owner’s counsel specifically asked Dr. Sondheimer about the rate of conversion
`
`
`
`8
`
`
`
`IPR2015-01117
`Patent No. 8,642,012
`Petitioners’ Opp. to PO’s Motion to Exclude
`
`found in the various prior art references relied upon and relevant time period for
`
`the same. (See, e.g., Exhibit 2012 at 5:13-17, 5:22-6:5 (asking whether “prior to
`
`August, 2008, a POSA would not have expected the amount of conversion of PAA
`
`to PAGN in healthy subjects to be the same as that in a urea cycle disorder
`
`patient”), 10:17-11:2, 26:20-27:8, 28:9-18 (asking about what time period a POSA
`
`would have considered relevant for determining the rate of conversion). Moreover,
`
`the relevant time period for a POSA’s evaluation of the conversion of PAA to
`
`PAGN is implicit in Sondheimer’s definition of a POSA, which is recited in his
`
`declaration and refers to the alleged priority date for the ’012 patent. (See Exhibit
`
`1029 at ¶ 29.) Therefore, not only did Patent Owner first raise the topic it now
`
`seeks to exclude but it was also within the scope of Dr. Sondheimer’s declaration
`
`in support of the petition. To that end, Patent Owner’s request to exclude Dr.
`
`Sondheimer’s testimony should be rejected.
`
`III. CONCLUSION
`For the foregoing reasons, Petitioners respectfully request that the Board
`
`deny in its entirety Patent Owner’s Motion to Exclude.
`
`
`
`
`
`9
`
`
`
`IPR2015-01117
`Patent No. 8,642,012
`Petitioners’ Opp. to PO’s Motion to Exclude
`
`
`Respectfully Submitted,
`
`
`
`
`
`David H. Silverstein
`Registration No. 61,948
`Attorney for Petitioner
`Par Pharmaceutical, Inc.
`
`
`/Cynthia Lambert Hardman/
`Cynthia Lambert Hardman
`Registration No. 53,179
`Attorney for the Lupin
`Petitioners
`
`Date: June 30, 2016
`Axinn, Veltrop & Harkrider LLP
`950 F Street, N.W.
`Washington, DC 20004
`Tel: (202) 912-4700
`
`
`Goodwin Procter LLP
`The New York Times Building
`620 Eighth Avenue
`New York, NY 10018
`Tel: (212) 813-8800
`
`
`
`
`10
`
`
`
`CERTIFICATION OF SERVICE (37 C.F.R. §§ 42.6(e), 42.105(a))
`
` IPR2015-01117
`Patent No. 8,642,012
`Certificate of Service
`
`
`The undersigned hereby certifies that the above-captioned “Petitioners’
`
`Opposition to Patent Owner’s Motion to Exclude Evidence” was served in its
`
`entirety on June 30, 2016 through the Patent Review Processing System, and
`
`additionally upon the following parties via Electronic Mail:
`
`For Patent Owner:
`
`For Petitioner Lupin:
`
`Elizabeth J. Holland
`Cynthia Lambert Hardman
`GOODWIN PROCTER LLP
`eholland@goodwinproctor.com
`chardman@goodwinprocter.com
`
`Respectfully Submitted,
`
`
`
`
`
`David H. Silverstein
`Registration No. 61,948
`Attorney for Petitioner
`Par Pharmaceutical, Inc.
`
`Lauren Stevens:
`lstevens@horizonpharma.com
`Matthew C. Phillips:
`matthew.phillips@renaissanceiplaw.com
`Dennis Bennett:
`dennisbennett@globalpatentgroup.com
`
`Robert Green:
`rgreen@greengriffith.com
`Emer Simic: esimic@greengriffith.com
`Jessica Tyrus: jtyrus@greengriffith.com
`
`
`Date: June 30, 2016
`Axinn, Veltrop & Harkrider LLP
`950 F Street, N.W.
`Washington, DC 20004
`Tel: (202) 912-4700
`
`
`
`
`
`1