Case 2:13-cv-00391-ES-JAD Document 49 Filed 03/17/14 Page 1 of 17 PageID: 614
`
`
`
`Charles M. Lizza
`William C. Baton
`Saul Ewing LLP
`The Legal Center
`One Riverfront Plaza, Suite 1520
`Newark, NJ 07102-5426
`(973) 286-6700
`clizza@saul.com
`
`Attorneys for Plaintiff
`Jazz Pharmaceuticals, Inc.
`
`Paul H. Kochanksi
`Lerner, David, Littenberg,
`Krumholz & Mentlik, LLP
`600 South Avenue West
`Westfield, NJ 07090
`(908) 654-5000
`pkochanski@ldlkm.com
`
`Attorneys for Defendant
`Amneal Pharmaceuticals, LLC
`
`
`
`UNITED STATES DISTRICT COURT
`DISTRICT OF NEW JERSEY
`
`
`Civil Action No. 13-391 (ES)(JAD)
`(Consolidated)
`
`
`
`(Filed Electronically)
`
`JAZZ PHARMACEUTICALS, INC.,
`
`
`
`
`
`
`
`v.
`
`Plaintiff,
`
`AMNEAL PHARMACEUTICALS, LLC,
`
`
`
`Defendant.
`
`JOINT CLAIM CONSTRUCTION AND PREHEARING STATEMENT
`
`
`
`
`
`
`
`
`

`

`Case 2:13-cv-00391-ES-JAD Document 49 Filed 03/17/14 Page 2 of 17 PageID: 615
`
`
`
`
`Plaintiff Jazz Pharmaceuticals, Inc. ((cid:147)Jazz(cid:148)) and Defendant Amneal Pharmaceuticals,
`
`LLC ((cid:147)Amneal(cid:148)) hereby submit their Joint Claim Construction and Prehearing Statement in
`
`accordance with Local Patent Rule 4.3.
`
`I.
`
`
`
`BACKGROUND
`
`This case arises out of Amneal(cid:146)s filing of ANDA No. 203631 with the U.S. Food and
`
`Drug Administration ((cid:147)FDA(cid:148)), which seeks approval to market a generic version of Jazz(cid:146)s
`
`XYREMfi product. The active ingredient in XYREMfi is sodium oxybate. Jazz alleges, among
`
`other things, that Amneal(cid:146)s submission of ANDA No. 203631 to the FDA constitutes
`
`infringement of certain claims of United States Patent Nos. 6,472,431 ((cid:147)the (cid:145)431 patent(cid:148)),
`
`6,780,889 ((cid:147)the (cid:145)889 patent(cid:148)), 7,262,219 ((cid:147)the (cid:145)219 patent(cid:148)), 7,851,506 ((cid:147)the (cid:145)506 patent(cid:148)),
`
`8,263,650 ((cid:147)the (cid:145)650 patent(cid:148)), 8,324,275 ((cid:147)the (cid:145)275 patent(cid:148)), and 8,461,203 ((cid:147)the (cid:145)203 patent(cid:148))
`
`(collectively, (cid:147)the (cid:145)431 patent family(cid:148)), and 7,895,059 ((cid:147)the (cid:145)059 patent(cid:148)), and 8,457,988 ((cid:147)the
`
`(cid:145)988 patent(cid:148)) (collectively, (cid:147)the (cid:145)059 patent family(cid:148)) owned by Jazz (collectively, (cid:147)the patents-
`
`in-suit(cid:148)) under 35 U.S.C. §271(e)(2). Amneal alleges, among other things, that the asserted
`
`claims are invalid and not infringed.
`
`
`
`Pursuant to Local Patent Rules 4.2(a)-(b), on February 14, 2014, the parties exchanged
`
`preliminary claim constructions and identified intrinsic as well as extrinsic evidence in support
`
`of their proposed preliminary constructions. Pursuant to Local Patent Rule 4.2(c), on February
`
`28, 2014, the parties exchanged intrinsic and extrinsic evidence opposing the other party’s
`
`proposed construction. Pursuant to Local Patent Rule 4.2(d), on March 6, 2014, counsel for the
`
`parties met and conferred for the purposes of narrowing the issues and preparation of the Joint
`
`Claim Construction and Prehearing Statement.
`
`
`
`
`2
`
`

`

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`
`
`II.
`
`CONSTRUCTION OF PATENT TERMS
`
`A.
`
`Agreed Upon Claim Constructions
`
`Pursuant to Local Patent Rule 4.3(a), the parties identify the following claim terms and
`
`constructions upon which Plaintiff and Amneal agree:
`
`Claim Term, Phrase, Clause
`"chemically stable"
`(’431 patent claims 1-7; ’889 patent claim 1;
`’219 patent claims 1-4; ’650 patent claims 1-18;
`’203 patent claims 1-18)
`"first container means"
`(’650 patent claims 17, 18)
`"second container means"
`(’650 patent claims 17, 18)
`"delivery vehicles"
`(’650 patent claims 17, 18)
`
`"another pharmacy"
`(’059 patent claims 7, 8, 10, 11, 15, 16;
`’988 patent claims 3, 11)
`
`
`B.
`
`Disputed Claim Terms
`
`Agreed Construction
`Resistant to degradation of GHB into its
`known or unknown decomposition elements.
`
`A container distinct from a second and third
`container.
`A container distinct from a first and third
`container.
`An instrument for assisting with the
`administration of the sodium
`gammahydroxybutyrate composition to a
`patient.
`A pharmacy different than the exclusive central
`pharmacy.1
`
`Pursuant to Local Patent Rule 4.3(b), attached hereto as Exhibit A is a series of claim
`
`charts identifying the claim terms and phrases in dispute and the parties(cid:146) proposed constructions.
`
`Additionally, attached hereto as Exhibit B is a series of claim charts providing the evidence,
`
`including intrinsic and extrinsic evidence, that each party intends to rely upon either to support
`
`its proposed construction or to oppose the other party(cid:146)s proposed construction.
`
`
`1 The parties dispute the construction of "exclusive central pharmacy" but agree on the
`construction of "another."
`
`
`
`
`3
`
`

`

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`
`
`C.
`
`Claim Terms Whose Construction Will Be Most Significant
`
`Pursuant to Local Patent Rule 4.3(c), the parties were unable to agree as to which terms
`
`(cid:147)whose construction will be most significant to the resolution of the case.(cid:148) Likewise, the parties
`
`were unable to agree as to which terms (cid:147)whose construction will be case or claim dispositive or
`
`substantially conducive to promoting settlement.(cid:148)
`
`1.
`
`By Jazz:
`
`None of the claims terms identified by Amneal below will likely be dispositive to the
`
`outcome of this case.
`
`Jazz agrees the Court(cid:146)s ruling regarding the claim term (cid:147)exclusive(cid:148) from the matter Jazz
`
`Pharmaceuticals, Inc. v. Roxane Laboratories, Inc., Civ. No. 10-6108 (D.N.J.) (ES)(MAH) ((cid:147)the
`
`Roxane matter(cid:148)) should apply to this case. Jazz reserves its right, however, to appeal the Court(cid:146)s
`
`construction of the claim term (cid:147)exclusive(cid:148) in both this matter and in the Roxane matter.
`
`Jazz disagrees with Amneal(cid:146)s contention that the claim term (cid:147)third container means(cid:148)
`
`should be subject to (cid:147)means-plus-function(cid:148) requirements of 35 U.S.C. § 112, ¶ 6. This claim
`
`term does not contain the language associated with means-plus-function claims and the Patent
`
`Office did not interpret this claim term as being subject to § 112, ¶ 6. Jazz further disagrees with
`
`Roxane(cid:146)s contention that this claim term is indefinite.2
`
`2.
`
`By Amneal:
`
`Local Patent Rule 4.3(c) requires the Parties to identify whether any disputed terms will
`
`be significant to the resolution of the case, case or claim dispositive, and/or substantially
`
`
`2 Jazz also disagrees with Amneal(cid:146)s assertion that the claim term (cid:147)wherein the one or
`more container means are selected from the group consisting of a drinking cup, a dosing cup, a
`syringe, a pipette, a vial, an ampule, a test tube, a flask, a bottle, and a pouch syringe(cid:148) does not
`require construction. Amneal fails to identify why its proposed non-construction of this term
`will be significant to the resolution of this case.
`
`
`
`
`4
`
`

`

`Case 2:13-cv-00391-ES-JAD Document 49 Filed 03/17/14 Page 5 of 17 PageID: 618
`
`
`conducive to promoting settlement. Despite the Parties’ best efforts to reach agreement on all
`
`terms, there are still four claim construction issues in dispute.
`
`Three of the claim terms in dispute may be dispositive of Plaintiff’s allegation that
`
`Amneal infringes one or more claims of one or more patents-in-suit. And one of the disputed
`
`terms may be dispositive of one basis for Amneal’s counterclaim of invalidity of claims 17 and
`
`18 of the ’650 patent-in-suit.
`
`First, the claim term "an aqueous composition comprising a first dose(cid:133) and an aqueous
`
`composition comprising a second dose" may be dispositive of Plaintiff’s allegation that Amneal
`
`infringes the claims of the ’506 patent.
`
`Second, "exclusive central pharmacy" may be dispositive of Plaintiff’s allegation that
`
`Amneal infringes the claims of the ’059 and ’988 patents. The parties agree to the construction of
`
`"exclusive" as "single or sole," consistent with the Markman order in Jazz Pharmaceuticals, Inc.
`
`v. Roxane Laboratories, Inc., 2:10-cv-06108-ES-SCM (consolidated) (D.N.J. Nov. 22, 2010),
`
`D.I. 151, at pp. 33-34. However, the remaining "central pharmacy" portion of the claim term
`
`remains in dispute. Also, construction of "exclusive central pharmacy" will aid in the
`
`construction of "another pharmacy."
`
`Lastly, the claim term "third container means" may be dispositive of Amneal’s
`
`counterclaim of invalidity of claims 17 and 18 of the ’650 patent for lacking a corresponding
`
`structure. And Amneal cannot infringe an invalid claim. As detailed in Exhibit A, Amneal
`
`contends that this is a means-plus-function limitation without sufficient disclosure of
`
`corresponding structure in the specification.
`
`
`
`
`5
`
`

`

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`In addition, Amneal contends that the Court need not construe the phrase "wherein the
`
`one or more container means are selected from the group consisting of a drinking cup, a dosing
`
`cup, a syringe, a pipette, a vial, an ampule, a test tube, a flask, a bottle, and a pouch syringe."
`
`This phrase is clear on its face and would be readily understood by those of ordinary skill in the
`
`art.
`
`Amneal reserves the right to edit or modify the proposed constructions and identification
`
`of disputed and agreed-upon terms identified herein.
`
`D.
`
`Anticipated Length of Time Necessary for the Claim Construction Hearing
`
`Pursuant to Local Patent Rule 4.3(d), the parties anticipate that the Court will be able to
`
`conduct a hearing on the meaning of the disputed terms in less than one day.
`
`E.
`
`Identification of Witnesses for the Claim Construction Hearing
`
`Pursuant to Local Patent Rule 4.3(e), the parties do not currently plan to call any
`
`witnesses at the claim construction hearing.
`
`
`
`
`
`
`6
`
`

`

`Case 2:13-cv-00391-ES-JAD Document 49 Filed 03/17/14 Page 7 of 17 PageID: 620
`
`
`
`
`Respectfully submitted,
`
`By: s/ Paul H. Kochanski
`
`Paul H. Kochanski
`LERNER, DAVID, LITTENBERG,
` KRUMHOLZ & MENTLIK, LLP
`600 South Avenue West
`Westfield, New Jersey 07090
`(908) 654-5000
`pkochanski@ldlkm.com
`
`OF COUNSEL:
`
`H. Keeto Sabharwal
`Dennies Varughese
`Deborah Sterling
`Joshua N. Mitchell
`STERNE, KESSLER, GOLDSTEIN
` & FOX PLLC
`1100 New York Ave., N.W.
`Suite 800
`Washington, DC 20005-3934
`(202) 371-2600
`
`Attorneys for Defendant
`Amneal Pharmaceuticals, LLC
`
`
`
`
`
`
`Dated: March 17, 2014
`
`Respectfully submitted,
`
`
`
`By: s/ Charles M. Lizza
`
`Charles M. Lizza
`William C. Baton
`SAUL EWING LLP
`One Riverfront Plaza, Suite 1520
`Newark, New Jersey 07102-5426
`(973) 286-6700
`clizza@saul.com
`
`OF COUNSEL:
`
`F. Dominic Cerrito
`Eric C. Stops
`Gabriel P. Brier
`QUINN EMANUEL URQUHART
` & SULLIVAN LLP
`51 Madison Avenue
`22nd Floor
`New York, New York 10010
`(212) 849-7000
`
`Richard G. Greco
`RICHARD G. GRECO PC
`90 State Street, Suite 700
`Albany, New York 12207
`(212) 203-7625
`
`Attorneys for Plaintiff
`Jazz Pharmaceuticals, Inc.
`
`
`
`
`
`
`
`7
`
`

`

`Case 2:13-cv-00391-ES-JAD Document 49 Filed 03/17/14 Page 8 of 17 PageID: 621
`Case 2:13-cv—00391-ES-JAD Document 49 Filed 03/17/14 Page 8 of 17 PageID: 621
`
`
`
`EXHIBIT A
`EXHIBIT A
`
`
`
`
`
`
`

`

`Case 2:13-cv-00391-ES-JAD Document 49 Filed 03/17/14 Page 9 of 17 PageID: 622
`
`
`Term
`(Patent Claims)
`(cid:147)wherein the one or more
`container means are selected
`from the group consisting of a
`drinking cup, a dosing cup, a
`syringe, a pipette, a vial, an
`ampule, a test tube, a flask, a
`bottle, and a pouch syringe(cid:148)
`
`((cid:145)650 patent claim 16)
`
`(cid:147)third container means(cid:148)
`
`((cid:145)650 patent claims 17, 18)
`
`Exhibit A
`
`Disputed Claim Terms
`
`‘431 PATENT FAMILY
`
`Jazz(cid:146)s Proposed Definition
`
`Amneal(cid:146)s Proposed Definition
`
`At least one container means
`is a drinking cup, a dosing
`cup, a syringe, a pipette, a
`vial, an ampule, a test tube, a
`flask, a bottle, or a pouch
`syringe.
`
`A container distinct from a
`first and second container.
`
`plain and ordinary meaning
`
`Amneal contends that the term
`(cid:147)third container means(cid:148) is a
`means-plus-function claim
`within the scope of 35 U.S.C.
`§ 112, ¶6.
`
`Function: (cid:147)third container
`means capable of retaining a
`first container means, a
`second container means, and
`one or more delivery vehicles
`capable of administering the
`pharmaceutical composition to
`the patient(cid:148)
`
`Amneal contends that the term
`(cid:147)third container means(cid:148)
`should be construed as a
`means-plus-function term
`within the scope of 35 U.S.C.
`§ 112, ¶6. See Altiris, Inc. v.
`Symantec Corp., 318 F.3d
`1363, 1375 (Fed. Cir. 2003);
`Biomedino, LLC v. Waters
`Technologies Corp., 490 F.3d
`946, 950 (Fed. Cir. 2007).
`This claim requires that the
`third container means has a
`function, but gives the means
`
`
`
`1
`
`

`

`Case 2:13-cv-00391-ES-JAD Document 49 Filed 03/17/14 Page 10 of 17 PageID: 623
`
`
`no structure: (cid:147)third container
`means capable of retaining a
`first container means, a
`second container means, and
`one or more delivery vehicles
`capable of administering the
`pharmaceutical composition to
`the patient.(cid:148) The specification
`fails to provide sufficient
`disclosure of a structure for
`the (cid:147)third container means(cid:148)
`making this term, and any
`claim in which it appears,
`indefinite: a lack of sufficient
`disclosure of structure under
`35 U.S.C. § 112, ¶6, renders a
`claim indefinite, and thus not
`amenable to construction. See
`In re Aoyama, 656 F.3d 1293,
`1298 (Fed. Cir. 2011) (quoting
`Enzo Biochem, Inc. v. Applera
`Corp., 599 F.3d 1325, 1332
`(Fed. Cir. 2010) ((cid:147)If a claim is
`indefinite, the claim, by
`definition, cannot be
`construed.(cid:148))).
`
`(cid:147)an aqueous composition
`orally administered to the
`patient as a first dose(cid:133) and an
`aqueous composition orally
`administered to the patient as
`a second dose(cid:148)
`
`(cid:147)an aqueous composition
`comprising a first dose . . . and
`an aqueous composition
`comprising a second dose(cid:148)
`
`((cid:145)506 patent claims 1-3)
`
`
`
`
`
`
`
`
`No construction necessary.
`
`
`
`2
`
`

`

`Case 2:13-cv-00391-ES-JAD Document 49 Filed 03/17/14 Page 11 of 17 PageID: 624
`
`
`Exhibit A
`
`Disputed Claim Terms
`
`‘059 PATENT FAMILY
`
`Jazz(cid:146)s Proposed Definition
`
`Amneal(cid:146)s Proposed Definition
`
`No construction necessary.
`
`(cid:147)the single or sole location
`where the approved
`prescription is filled and
`dispensed(cid:148)
`
`
`
`3
`
`Term
`(Patent Claims)
`(cid:147)exclusive central pharmacy(cid:148)
`
`((cid:145)059 patent claims 1-16;
`(cid:145)988 patent claims 1-15)
`
`
`
`
`

`

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`Case 2:13-cv—00391-ES-JAD Document 49 Filed 03/17/14 Page 12 of 17 PageID: 625
`
`
`
`EXHIBIT B
`EXHIBIT B
`
`
`
`
`
`

`

`Case 2:13-cv-00391-ES-JAD Document 49 Filed 03/17/14 Page 13 of 17 PageID: 626
`
`
`
`Evidence Supporting / Opposing Proposed Constructions for Disputed Terms
`
`Exhibit B
`
`‘431 PATENT FAMILY
`
`Jazz(cid:146)s Evidence
`
`Amneal(cid:146)s Evidence
`
`(cid:145)650 patent at col. 9:65 to col.
`10:42; col. 15:62 to col.
`16:37; col. 28:9-14.
`
`(cid:145)650 patent file history.
`
`Intrinsic Evidence
`
`The ’650 patent, col. 9, line 65,
`to col. 10, line 42; col. 15, line
`62, to col. 16, line 37; col. 18,
`ll. 3-5; col. 17, ll. 25-30; col.
`20, ll. 40-44; col. 22, ll. 40-67;
`col. 23, line 63, to col. 24, line
`16; col. 28, ll. 4-25; col. 36,
`line 66, to col. 37, line 6; col.
`71, ll. 3-6
`(AMNXYR_000006947-
`AMNXYR_000006986)
`
`Extrinsic Evidence
`
`Remington: The Science and
`Practice of Pharmacy, 19th Ed.
`(1995): (cid:147)A pharmaceutical
`container has been defined as a
`device which holds the drug
`and is, or may be, in direct
`contact with the preparation.
`The immediate container is
`described as that which is in
`direct contact with the drug at
`all times.(cid:148)
`(AMNXYR_000007747-
`AMNXYR_000007757)
`
`35 U.S.C. § 112, ¶6.
`
`Intrinsic Evidence
`
`The ’650 patent, col. 9, line 65,
`to col. 10, line 42; col. 15, line
`62, to col. 16, line 37; col. 17,
`ll. 25-30; col. 18, ll. 3-5; col.
`20, ll. 40-44; col. 22, ll. 40-67;
`
`Term
`(Patent Claims)
`(cid:147)wherein the one or more
`container means are selected
`from the group consisting of a
`drinking cup, a dosing cup, a
`syringe, a pipette, a vial, an
`ampule, a test tube, a flask, a
`bottle, and a pouch syringe(cid:148)
`
`((cid:145)650 patent claim 16)
`
`(cid:147)third container means(cid:148)
`
`((cid:145)650 patent claims 17, 18)
`
`(cid:145)650 patent at col. 9:65 to col.
`10:42; col. 15:62 to col.
`16:37; col. 28:9-14.
`
`(cid:145)650 patent file history.
`
`
`
`1
`
`

`

`Case 2:13-cv-00391-ES-JAD Document 49 Filed 03/17/14 Page 14 of 17 PageID: 627
`
`
`col. 23, line 63, to col. 24, line
`16; col. 28, ll. 4-25; col. 36,
`line 66, to col. 37, line 6; col.
`71, ll. 3-6
`(AMNXYR_000006947-
`AMNXYR_000006986)
`
`Extrinsic Evidence
`
`Remington: The Science and
`Practice of Pharmacy, 19th Ed.
`(1995): (cid:147)A pharmaceutical
`container has been defined as a
`device which holds the drug
`and is, or may be, in direct
`contact with the preparation.
`The immediate container is
`described as that which is in
`direct contact with the drug at
`all times.(cid:148)
`(AMNXYR_000007747-
`AMNXYR_000007757)
`
`Intrinsic Evidence
`
`The ’506 patent, col. 2, line 67,
`to col. 3, line 3; col. 8, line 65,
`to col. 9, line 19; col. 9, ll. 50-
`56, line 66 to col. 10, line 33;
`col. 12, ll. 53-65; col. 15, ll. 6-
`26, 51-66; col. 17, ll. 36-40;
`col. 18, ll. 29-67; col. 19, ll. 6-
`8; col. 25, ll. 48-51; col. 27, ll.
`31-32; col. 28, line 65, to col.
`29, line 7; col. 30, ll. 10-11;
`col. 72, ll. 19-33
`(AMNXYR_000006879-
`AMNXYR_000006920)
`
`The ’275 patent, col. 72, ll. 10-
`45 (AMNXYR_000006987-
`AMNXYR_000007027)
`
`Prosecution History of the ’506
`patent, claim 1 as filed, p. 101;
`Amendment and Response
`
`(cid:147)an aqueous composition
`comprising a first dose . . . and
`an aqueous composition
`comprising a second dose(cid:148)
`
`((cid:145)506 patent claims 1-3)
`
`(cid:145)506 patent at col. 9:22-34;
`25:45-52; 26:18-20.
`
`(cid:145)506 patent file history,
`including 4/2/2009 Response
`at 33-35; 1/11/2010 Response
`at 5-7.
`
`McGraw-Hill Dictionary of
`Scientific and Technical
`Terms (5th ed.) at 605.
`
`Merriam Webster(cid:146)s Collegiate
`Dictionary (10th ed.) at 346.
`
`Stedman(cid:146)s Medical Dictionary
`(26th Ed. 1995) at 517.
`
`
`
`
`2
`
`

`

`Case 2:13-cv-00391-ES-JAD Document 49 Filed 03/17/14 Page 15 of 17 PageID: 628
`
`
`filed April 6, 2009, in
`particular, pp. 29-30;
`Amendment and Response
`filed July 28, 2010, in
`particular, pp. 2 and 4; Notice
`of Allowance mailed October
`8, 2010, in particular, Notice of
`Allowability at p. 2
`(AMNXYR_000004406;
`AMNXYR_000004806-
`AMNXYR_000004841;
`AMNXYR_000004898-
`AMNXYR_000004904;
`AMNXYR_000004913-
`AMNXYR_000004919)
`
`Prosecution History of the ’275
`patent, Amendment and
`Response filed August 24,
`2012, in particular, pp. 5-6
`(AMNXYR_000013639-
`AMNXYR_000013651)
`
`Prosecution History of the ’431
`patent, claim 56 as filed, p. 111
`(AMNXYR_000018340)
`
`Prosecution History of U.S.
`Patent Application No.
`12/913,644, Preliminary
`Amendment dated January 10,
`2011, in particular, pp. 31-32
`(AMNXYR_000018685-
`AMNXYR_000018717)
`
`Extrinsic Evidence
`
`Webster’s Ninth New
`Collegiate Dictionary (1991)
`(AMNXYR_000018861-
`AMNXYR_000018866)
`
`
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`Case 2:13-cv-00391-ES-JAD Document 49 Filed 03/17/14 Page 16 of 17 PageID: 629
`
`
`Evidence Supporting / Opposing Proposed Constructions for Disputed Terms
`
`Exhibit B
`
`Term
`(Patent Claims)
`(cid:147)exclusive central pharmacy(cid:148)
`
`((cid:145)059 patent claims 1-16;
`(cid:145)988 patent claims 1-15)
`
`‘059 PATENT FAMILY
`
`Jazz(cid:146)s Evidence
`
`Amneal(cid:146)s Evidence
`
`(cid:145)059 patent at col. 2:16-21,
`3:40-51, 7:38-52, 7:65-8:3,
`Abstract, FIG. 7.
`
`(cid:145)730 patent file history,
`including 3/10/2005 Response
`at 16-17; 3/29/2006 Response
`at 5, 8; 1/17/2007 Response at
`13-14; 5/21/2007 Appeal
`Brief at 17, 22; 7/18/2007
`Substitute Appeal Brief at 22;
`12/3/2007 Reply Brief at 2-3;
`9/2/2009 BPAI Decision at 5,
`9; 11/2/2009 Response at 9-
`14; 12/31/2009 Notice of
`Allowance at 2-11.
`
`(cid:145)107 patent file history,
`including Petition to Make
`Special at 5-6; 11/3/2009
`Response at 6-12; 3/10/2010
`Notice of Allowance at 5-6.
`
`(cid:145)059 patent file history,
`including 12/21/2010 Notice
`of Allowance at 2-3.
`
`McGraw-Hill Dictionary of
`Scientific and Technical
`Terms (5th ed.) at 1484.
`
`Merriam Webster(cid:146)s Collegiate
`Dictionary (10th ed.) at 871.
`
`Stedman(cid:146)s Medical Dictionary
`(26th Ed. 1995) at 1341.
`
`
`Jazz Pharmaceuticals, Inc. v.
`Roxane Laboratories, Inc.,
`2:10-cv-06108-ES-SCM
`(consolidated) (D.N.J. Nov.
`22, 2010), D.I. 151 ((cid:147)Roxane
`Markman Order(cid:148)), at pp. 33-
`34
`
`Intrinsic Evidence
`
`The ’059 patent, col. 1, ll. 30-
`32; col. 3, ll. 46-48; col. 5, ll.
`12-14, 31-60, and 65-67; col.
`6, ll. 20-22, 27-31, 39-44, and
`48-55
`(AMNXYR_000006921-
`AMNXYR_000006946)
`
`The ’988 patent, col. 1, ll. 35-
`37; col. 3, ll. 50-52; col. 5, ll.
`16-18, 35-63; col. 6, ll. 1-3,
`23-25, 30-34, 42-47
`(AMNXYR_000007028-
`AMNXYR_000007051)
`
`Prosecution History of U.S.
`Patent No. 7,668,730 ((cid:147)the
`’730 patent(cid:148)), Amendment and
`Response filed January 17,
`2007, in particular, p. 10;
`Reply Brief filed December 3,
`2007, pp. 1-4; Amendment
`and Response filed November
`2, 2009, in particular, p. 9
`(AMNXYR-000003388-
`AMNXYR_000003403;
`AMNXYR_000003517-
`AMNXYR_000003520;
`AMNXYR_000003556-
`
`
`
`4
`
`

`

`Case 2:13-cv-00391-ES-JAD Document 49 Filed 03/17/14 Page 17 of 17 PageID: 630
`
`
`AMNXYR_000003571)
`
`Extrinsic Evidence
`
`Webster’s Ninth New
`Collegiate Dictionary (1991)
`(AMNXYR_000018861-
`AMNXYR_000018866)
`
`Dorland’s Illustrated Medical
`Dictionary (1994)
`(AMNXYR_000018858-
`AMNXYR_000018860)
`
`Jazz Pharmaceuticals, Inc., Q4
`2013 Earnings Conference
`Call, February 25, 2014
`(AMNXYR_000075234-
`AMNXYR_000075246)
`
`
`
`
`5
`
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`