Case 2:13-cv-00391-ES-JAD Document 91 Filed 10/30/14 Page 1 of 59 PageID: 962
`Case 2:13-cv-00391-ES-JAD Document 91 Filed 10/30/14 Page 1 of 59 PageID: 962
`Charles M. Lizza
`
`
`
`
`
`VIA ECF & FEDEX
`
`The Honorable Joseph A. Dickson, U.S.M.J.
`United States District Court
`
`Martin Luther King, Jr. Federal Building
`50 Walnut Street, 2D
`Newark, New Jersey 07102
`
`Phone: (973) 286-6715
`
`Fax: (973) 286-6815
`
`c1izza@saul.com
`www.saul.com
`
`October 30, 2014
`
`_R_e:
`
`Jazz Pharmaceuticals, Inc. v. Amneal Pharmaceuticals LLC, et al.,
`Civil Action No. 13-391 (ES)(JAD)
`
`Dear Judge Dickson:
`
`This firm, together with Quinn Emanuel Urquhart & Sullivan, LLP and Richard G. Greco
`PC, represents plaintiff Jazz Pharmaceuticals, Inc. (“Jazz”) in the above-captioned action. We
`write in opposition to defendant Par Pharmaceutical, Inc.’s (“Par”) October 20, 2014 letter
`requesting consolidation of this matter with Jazz Pharmaceuticals, Inc. et al. v. Par
`Pharmaceutical, Inc., Civ. No. 14-6150 (ES)(JAD) (“the ’306 patent case”) and Jazz
`Pharmaceuticals, Inc. v. Par Pharmaceutical, Inc., Civ. No. 14-5139 (ES)(JAD) (“the ’963
`patent case”). D.I. 88.
`
`Par makes two arguments in favor of consolidation: (1) that there is “significant overlap”
`between the new patents and the patents in the present action and (2) that any prejudice to Jazz is
`outweighed by efficiency. As discussed below, there is no overlap, let alone significant overlap,
`between the patents, and consolidation would significantly prejudice Jazz. Moreover, multiple
`Markman hearings will not be avoided through consolidation. Neither the ’306 patent nor the
`’963 patent present any statutory bar to Par’s FDA approval, which is likely years away if at all.
`Par’s rush to consolidate exhibits nothing more than an attempt to avoid a fair adjudication of
`Jazz’s patent rights. Accordingly, Jazz respectfully requests that the Court deny Par’s request for
`consolidation.
`
`A.
`
`The ’306 and ’963 Patents Do Not Significantly
`Overlap With The Patent In The Present Action
`
`Federal Rule of Civil Procedure 42(a) permits the Court to consolidate actions involving
`“common questions of law or fact for trial or pretrial purposes if it will facilitate the
`administration ofjustice.” Bruno v. Borough ofSeaside Park, 2006 WL 2355489, at *2 (D.N.J.
`
`One Riverfront Plaza, Suite 1520 o Newark, NJ 07102-5426 o Phone: (973) 286-6700 0 Fax: (973)286-6800
`
`
`DELAWARE
`
`NEW YORK
`NEW JERSEY
`MARYLAND MASSACHUSETTS
`A DELAWARE LIMITED LIABILITY PARTNERSHIP
`
`PENNSYLVANIA WASHINGTON, DC
`
`
`
`
`
`
`
`t
`;
`
`
`
`

`

`Case 2:13-cv-00391-ES-JAD Document 91 Filed 10/30/14 Page 2 of 59 PageID: 963
`Case 2:13-cv-00391-ES-JAD Document 91 Filed 10/30/14 Page 2 of 59 PageID: 963
`
`Hon. Joseph A. Dickson, U.S.M.J.
`October 30, 2014
`
`Page 2
`
`Aug. 14, 2006); Fed.R.Civ.P. 42(a). The moving party bears the burden of demonstratingthat
`consolidation is appropriate. Landsman & Funk, P. C. v. Skinder-Strauss Assocs., 2012 WL
`2476371, at *2 (D.N.J. Jun. 27, 2012). “A common question of law or fact shared by all of the
`cases is a prerequisite for consolidation.” Id.
`
`1.
`
`The ’306 Patent Covers Methods Of
`
`Avoiding Drug Interactions With Valproate
`
`The ’306 patent does not present questions of law and fact common to the patents-in~suit.
`As Par itself sets forth in its letter-request, the other patents-in-suit fall into two categories: (1)
`patents covering chemically stable and microbiologically sound pharmaceutical formulations
`containing gamma-hydroxybutyrate (“GHB”) and narcolepsy treatments using those
`formulations (“the ’431 patent family”); and (2) patents covering methods of safely distributing
`GHB (“the ’730 patent family”)1. The ’306 patent is part of a new patent family, unrelated to the
`’431 and ’730 patent families, with a different inventor and a different specification. The 34
`separate claims of the ’306 patent relate to methods avoiding potential drug-drug interactions due
`to concomitant use of GHB and the drug valproate.
`
`Par argues that “the ’306 patent relates to methods of treating patients with sodium
`oxybate, as do some of the [’431 patent family].” DJ. 13 at 3. This is misleading at best. Some
`claims in the ‘431 patent family relate to methods of administering sodium oxybate to treat
`narcolepsy; a treatment that includes specific dosing regimens and means of administering the
`drug.
`(See, e. g., ’650 patent at col. 70, lns. 55-67, attached hereto as Exhibit A.) The focus of
`the ’306 patent, by contrast, is on methods of avoiding drug-drug interactions between GHB and
`valproate—a concept that is wholly absent from the other patents-in-suit. (See ’306 patent at col.
`24, lns. 29-39, attached hereto as Exhibit B.) Thus, infringement of the ’306 patent will be
`focused on the novel issue of whether Par induces doctors, other healthcare providers, and
`patients to avoid drug-drug interactions in accordance with the claims of the ’306 patent. That
`inquiry will not have any overlap with the other patents-in-suit.
`
`Par further argues that there will be overlap on invalidity because Xyrem and the package
`insert for Xyrem are allegedly prior art to both the ’306 patent and the other patents-in—suit. D.I.
`13 at 3. Again, Par’s argument is misleading. Par has cited 30 references in support of its
`invalidity contentions for the other patents-in-suit. (See Par’s invalidity contentions at 4-13 and
`14-24, attached hereto as Exhibit C.) Notably, neither Xyrem nor the Xyrem package insert
`appear among Par’s cited references. Moreover, none of the prior art references cited in Par’s
`notice letter to Jazz concerning the ’306 patent overlap with the prior art Par has cited concerning
`the ’431 and ’730 patent families.
`(See 8/5/14 letter from M. Bonomi—Huvala to Jazz at 17-20,
`attached hereto at Exhibit D.) This is because the claimed ’306 patent subject matter is distinct
`from the subject matter of the other patents-in-suit. Further, because it concerns different subject
`
`matter, the ’306 patent will require different experts than the ’431 and ’730 patent families.
`
`1 These patent families contain 13 patents, list 7 inventors, and contain 135 asserted
`claims. The “’431 patent family” refers to US. Patent Nos. 6,472,431, 6,780,889, 7,262,219,
`7,851,506, 8,263,650, and 8,324,275. The “’730 patent family” refers to US. Patent Nos.
`7,668,730, 7,765,106, 7,765,107, 7,895,059, 8,457,988, 8,589,182, and the ’963 patent.
`
`

`

`Case 2:13-cv-00391-ES-JAD Document 91 Filed 10/30/14 Page 3 of 59 PageID: 964
`Case 2:13-ov-00391-ES-JAD Document 91 Filed 10/30/14 Page 3 of 59 PageID: 964
`
`Hon. Joseph A. Dickson, U.S.M.J.
`October 30, 2014
`
`Page 3
`
`Injecting the ’306 patent into this case will unnecessarily complicate the issues and will
`result in an inefficient use ofjudicial resources. In this case, where there are “disparate factual
`analyses and sources of proof required by the claims,” consolidation is not appropriate. Durso v.
`.
`Samsung Electronics America, Inc., No. 12-5352, 2013 WL 3864006, at *4 (D.N.J. Jul. 24,
`“““‘“‘“_"YOT3)"(Dick‘s‘0‘n?:TT)“a "’d‘2‘0‘1‘4”WIT123233‘2‘(DTNiffMarT247261‘4F)‘;“see‘aisofibertyfincoin“““““““““““““““““““““"‘5‘
`Mercury, Inc. v. Ford Marketing Corp, 149 F.R.D. 65, 81-82 (D.N.J. 1993) (denying
`consolidation where the evidence in one case was not relevant to the issues in the other).
`Accordingly, the ’306 patent case should not be consolidated with this matter.
`
`2.
`
`The ’963 Patent Covers Methods of Identifying
`Potential Misuse of a Prescription Drug By Analyzing
`Information Stored in a Computer Database
`
`Par argues that the ’963 patent will overlap with the patents already in suit because they
`“both involve patents from the same family.” D.I. 13 at 3. While Jazz agrees that the ’963
`patent is part of the ’730 patent family, that fact alone is not dispositive. The inventions claimed
`in the ’963 patent are of a different character than the other patents in the ’730 family.
`Specifically, the ’963 patent claims “computer-implemented system[s]” relating to drug
`distribution that differ from the methods claimed in the other patents in the ’730 patent family.
`For example, the claims of the ’963 patent focus on the particular database schema of computer-
`implemented systems that contain various fields for storing information, database queries that
`process information contained in the fields, and using these queries to identify potential misuse
`of a prescription drug. (See ’963 patent at col. 8, In. 39 to col. 9 In. 13, attached hereto as Exhibit
`E.) Other patents in the ’730 patent family, on the other hand (including those in this suit),
`concern methods of distributing a prescription drug via an exclusive central pharmacy where
`various checks and controls such as physician enrollment, patient education, and confirming
`receipt by the patient are put into place to prevent abuse of the drug. (See ’059 patent at col. 8,
`lns. 37-67, attached hereto as Exhibit F.)
`
`These differences in claim coverage will translate to (1) different terms needing
`construction in Markman proceedings, including terms relating to database technology; (2)
`different fact discovery concerning the working of the data analysis underlying Par’s computer
`systems; and (3) different types of experts, i.e., computer science experts relating to the ’963
`patent and pharmaceutical risk management experts for the other patents in the ’730 patent
`family. Thus, contrary to Par’s arguments, there will not be any significant overlap of issues
`relating to the ’963 patent. Accordingly, the ’963 patent also should not be consolidated with the
`patents-in-suit.
`
`B.
`
`Par’s Proposed Consolidation Would Prejudice Jazz
`
`The risk of prejudice must be weighed in determining whether consolidation is
`appropriate. See In re Consolidated Parlodel Litigation, 182 F.R.D. 441, 444 (D.N.J. 1998). Par
`argues that Jazz would not be prejudiced by consolidation or alternatively that any prejudice
`would be outweighed by efficiency gains. D.I. 13 at 4. Par is incorrect. Jazz would be
`
`

`

`Case 2:13-cv-00391-ES-JAD Document 91 Filed 10/30/14 Page 4 of 59 PageID: 965
`Case 2:13-cv-00391-ES-JAD Document 91 Filed 10/30/14 Page 4 of 59 PageID: 965
`
`Hon. Joseph A. Dickson, U.S.M.J.
`October 30, 2014
`Page 4
`
`prejudiced by Par’s proposed consolidation schedule and, as discussed above, the limited overlap
`between the new cases and the patents-in-suit would produce minimal, if any, efficiency gains.2
`
`Jazz’s original action against Par was filed in December 2013. The parties were about to
`f“““““““““““““““"servepp‘eningMarkman“briefsbefore‘proce‘e‘dingsWere'adjourn‘edoto"addressconsol‘idationi‘""""""""""""""""""""""""
`Simply put, the new actions are 10 months behind the original action. Moreover, contrary to
`Par’s proposal, there is no easy way for the new actions to “catch-up” to the original action.
`Under the Local Patent Rules, there are a series of triggering events (pre-set due dates) that
`cannot be accelerated without substantial prejudice to Jazz. For example, Jazz must serve its
`asserted claims; Par needs to serve its noninfringement and invalidity contentions; Jazz needs to
`serve its infringement contentions and responses to Par’s invalidity contentions; the parties must
`also exchange proposed terms for construction, proposed claim constructions, claim construction
`opposition evidence, meet and confer on claim construction issues, file a joint claim construction
`and prehearing statement, and complete Markman discovery. See L. Pat. R. 3.6, 4.1(a)-4.4.
`These mandatory activities will take at least six months to complete following an initial
`scheduling conference that has yet to occur. Par’s proposed schedule, however, gives the parties
`a mere three months to catch up. See DJ. 88, Appendix A. This is unworkable from a practical
`standpoint and prejudicial to Jazz.
`
`V
`
`Par’s interest in seeing these matters consolidated does not justify the prejudice that Jazz
`would suffer if the Local Patent Rules were short-circuited to the extent suggested by Par.3
`Margolis v. Hydroxatone, LLC, No. 11-4355, 2013 WL 875987, at *3 (D.N.J. Mar. 6, 2013)
`(finding consolidation unwarranted where it would result in prejudice to one of the parties). For
`example, under Par’s proposed schedule, Jazz would have only 28 days to respond to Par’s
`invalidity contentions concerning two patents totaling 62 claims. Even the 45 days allowed for
`patentees in Hatch-Waxman cases to normally respond falls far short of the months that Par has
`had to prepare since the ’963 and ’306 patents issued earlier this year. Par also seeks to shorten
`the time period designated for several other disclosures required under the Local Patent Rules in
`a manner that would hinder Jazz’s ability to consider and address Par’s positions on claim
`
`2 Par’s argument that any prejudice is of Jazz’s “own making” is similarly meritless.
`D.I. 13 at 4. There was no requirement that Jazz bring suit against Par within a set time period.
`As Par points out, Jazz brought its suits on both the ’306 and ’963 patents within 45 days as set
`forth by statute. Id.
`
`3 Par’s citation to the consolidation order in Jazz Pharmaceuticals, Inc. v. Roxane
`Laboratories, Inc, No. 10-6108 (D.N.J.) (“the Roxane matter”) is inapposite. Unlike here, that
`case concerned patents that were closely related to the patents that were already in-suit. See Jazz
`Pharms., Inc. v. Roxane Labs., Inc., No. 10-6108, 2013 WL 1596790, (D.N.J. Apr. 12, 2013)
`Also, the Court in that case did not truncate the time period allowed for the exchange of
`contentions as Par seeks to do in this case. Instead, the Court in the Roxane matter entered a
`schedule that included the full period allowed under the Local Patent Rules—rules that are
`designed to control a one patent case. (See Jazz Pharms., Inc. v. Roxane Labs., Inc. , No. 10-
`6108 (D.N.J.) (D1. 215 at 4.)). The schedule entered in the consolidated Roxane matter
`regarding closely related patents counsels strongly against consolidation and using a truncated
`schedule for an unrelated patent as Par advocates here.
`
`

`

`Case 2:13-cv-00391-ES-JAD Document 91 Filed 10/30/14 Page 5 of 59 PageID: 966
`Case 2:13-cv-00391-ES-JAD Document 91 Filed 10/30/14 Page 5 of 59 PageID: 966
`Hon. Joseph A. Dickson, U.S.M.J.
`October 30, 2014
`
`Page 5
`
`construction. See D.I. 88, Appendix A. Limiting the time period for Jazz to respond as Par
`proposes would significantly handicap Jazz’s ability to litigate the cases concerning the ’963 and
`’306 patents for little to no benefit with respect to judicial economy. Par’s request for
`consolidation should be denied for this additional reason.
`
`C.
`
`Any Gain In Judicial Economy for Par Would Be Negated by Other Matters
`Concerning the ’963 and ’306 Patents
`
`Here, judicial economy counsels against consolidating the ’963 and ’306 patents with this
`case. During the October 9, 2014 status conference, the Court suggested that consolidation of
`this case with the ’963 and ’306 patent cases could lessen the need for Judge Salas to conduct
`multiple Markmarz hearings for the cases concerning Jazz, Par, and Amneal. The mere
`consolidation of the ’963 and ’306 patent cases with this matter would not solve this potential
`issue. The ’963 and ’306 patents are also being asserted by Jazz against Ranbaxy in a separate
`matter.4 The parties would likely need to address Markmarz there separately and apart from the
`current matter. Also, Amneal has yet to submit any certifications concerning the ’963 and ’306
`patents to the FDA despite those patents’ having been listed in the Orange Book for several
`months. If Amneal files Paragraph IV certifications against those patents and provides Jazz with
`notice of such certifications, then Jazz will likely bring suit against Amneal for infringement of
`the ’963 and ’306 patents. This could create another instance where a Markmarz hearing will
`need to be conducted with respect to those patents.
`
`As explained above, claim construction issues regarding the ’963 and ’306 patents will be
`different from the issues concerning the patents-in-suit. Rather than rushing to consolidate the
`’963 and ’306 patents with the current matter, it would make more sense to consider moving
`forward separately and determining whether one Markmarz hearing concerning the ’963 and ’306
`patents can be scheduled to address claim construction issues relating to those patents in the Par,
`Ranbaxy, and potential Amneal matters. This would be a more efficient use ofj udicial resources
`than serially addressing claim construction issues surrounding the ’963 and ’306 patents as
`would likely occur if only the Par matters concerning the ’306 and ’963 patents were
`consolidated with this case. This additional factor weighs against consolidation.
`
`4 See Jazz Pharmaceuticals, Inc. v. Ranbaxy Laboratories Limited, et al., No. 14-4467
`(D.N.J.) (ES)(JAD) and Jazz Pharmaceuticals, Inc. v. Ranbaxy Laboratories Limited, et al., No.
`14-6151 (D.N.J.) (ES)(JAD).
`
`

`

`Case 2:13-cv-00391-ES-JAD Document 91 Filed 10/30/14 Page 6 of 59 PageID: 967
`Case 2:13-cv-0039l-ES-JAD Document 91 Filed 10/30/14 Page 6 of 59 PageID: 967
`Hon. Joseph A. Dickson, U.S.M.J.
`October 30, 2014
`
`Page 6
`
`***
`
`For the foregoing reasons, this Court should deny Par’s request to consolidate this matter
`with the ’963 and ’306 patent cases.
`
`
`
`Exhibits
`
`cc:
`
`All Counsel (Via e-mail)
`
`
`
`

`

`Case 2:13-cv-00391-ES-JAD Document 91 Filed 10/30/14 Page 7 of 59 PageID: 968
`Case 2:13-cv-00391-ES-JAD Document 91 Filed 10/30/14 Page 7 of 59 PageID: 968
`
`
`
`
`EXHIBIT A
`
`EXHIBIT A
`
`

`

`Case 2:13-cv-00391-ES-JAD Document 91 Filed 10/30/14 Page 8 of 59 PageID: 969
`111111
`1111111111111111111111111111111111111111111111111111111111111
`US008263650B2
`
`c12) United States Patent
`Cook et al.
`
`(10) Patent No.:
`(45) Date of Patent:
`
`US 8,263,650 B2
`*Sep.11,2012
`
`(54) MICROBIOLOGICALLY SOUND AND
`STABLE SOLUTIONS OF
`GAMMA-HYDROXYBUTYRATE SALT FOR
`THE TREATMENT OF NARCOLEPSY
`
`(75)
`
`Inventors: Harry Cook, Eden Prairie, MN (US);
`Martha Hamilton, St. Paul, MN (US);
`Douglas Danielson, Otsego, MI (US);
`Colette Goderstad, St. Paul, MN (US);
`Dayton T. Reardan, Shorewood, MN
`(US)
`
`(73) Assignee: Jazz Pharmaceuticals, Inc., Palo Alto,
`CA (US)
`
`( *) Notice:
`
`Subject to any disclaimer, the term of this
`patent is extended or adjusted under 35
`U.S.C. 154(b) by 0 days.
`
`This patent is subject to a terminal dis(cid:173)
`claimer.
`
`(21) Appl. No.: 13/446,940
`
`(22)
`
`Filed:
`
`Apr. 13, 2012
`
`(65)
`
`Prior Publication Data
`
`US 2012/0202880Al
`
`Aug. 9, 2012
`
`(60)
`
`Related U.S. Application Data
`
`Continuation of application No. 13/182,324, filed on
`Jul. 13, 2011, which is a continuation of application
`No. 12/913,644, filed on Oct. 27, 2010, which is a
`continuation of application No. 11/777,877, filed on
`Jul. 13, 2007, now Pat. No. 7,851,506, which is a
`division of application No. 10/841,709, filed on May 7,
`2004, now Pat. No. 7,262,219, which is a division of
`application No. 10/194,021, filed on Jul. 11,2002, now
`Pat. No. 6,780,889, which is a division of application
`No. 09/470,570, filed on Dec. 22, 1999, now Pat. No.
`6,472,431.
`
`(60)
`
`Provisional application No. 60/113,745, filed on Dec.
`23, 1998.
`
`(51)
`
`(52)
`(58)
`
`(56)
`
`Int. Cl.
`A61K 31134
`(2006.01)
`A61K 311215
`(2006.01)
`A61K 311185
`(2006.01)
`A61K 31119
`(2006.01)
`U.S. Cl. ......... 514/473; 514/529; 514/553; 514/557
`Field of Classification Search .................. 514/473,
`514/529, 553, 557
`See application file for complete search history.
`
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`
`(Continued)
`
`Primary Examiner- Raymond Henley, III
`(74) Attorney, Agent, or Firm- Schwegman, Lundberg &
`Woessner, P.A.
`
`ABSTRACT
`(57)
`Disclosed are formulations of gamma-hydroxybutyrate in an
`aqueous medium that are resistant to microbial growth. Also
`disclosed are formulations of gammahydroxybutyrate that
`are also resistant to the conversion into GBL. Disclosed are
`methods to treat sleep disorders, including narcolepsy, with
`these stable formulations ofGHB. The present invention also
`provides methods to treat alcohol and opiate withdrawal,
`reduced levels of growth hormone, increased intracranial
`pressure, and physical pain in a patient.
`
`18 Claims, 2 Drawing Sheets
`
`

`

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`The invention claimed is:
`1. A pharmaceutical composition, comprising an aqueous
`solution of about 500 mg/ml sodium gannna-hydroxybu-
`30 tyrate, wherein the composition has a pH of about 7.3 to about
`8.5, wherein the composition is chemically stable and resis(cid:173)
`tant to microbial growth, and wherein the composition is free
`of preservatives.
`2. The pharmaceutical composition of claim 1, wherein the
`35 composition has a pH of about 7.5.
`3. The pharmaceutical composition of claim 1, wherein the
`composition has a pH of about 8.0.
`4. The pharmaceutical composition of claim 1, wherein the
`composition has a pH of about 8.5.
`5. The pharmaceutical composition of claim 1, wherein the
`composition additionally comprises a pH adjusting or buff(cid:173)
`ering agent.
`6. The pharmaceutical composition of claim 5, wherein the
`pH adjusting or buffering agent is an acid.
`7. The pharmaceutical composition of claim 6, wherein the
`acid is an inorganic acid.
`8. The pharmaceutical composition of claim 6, wherein the
`acid is an organic acid.
`9. The pharmaceutical composition of claim 6, wherein the
`50 acid is selected from the group consisting of malic acid, citric
`acid, acetic acid, boric acid, lactic acid, hydrochloric acid,
`phosphoric acid, sulfuric acid, and nitric acid.
`10. The pharmaceutical composition of claim 6, wherein
`the acid is malic acid.
`11. A method of treating cataplexy or daytime sleepiness in
`a patient having narcolepsy comprising diluting the pharma(cid:173)
`ceutical composition of claim 1, and administering to the
`patient the diluted pharmaceutical composition.
`12. The method of claim 11, wherein the pharmaceutical
`composition is administered orally.
`13. The method of claim 12, wherein the pharmaceutical
`composition is administered orally as two consecutive single
`doses daily.
`14. The method of claim 13, wherein the first dose is
`administered prior to bedtime and the second dose is admin(cid:173)
`istered from about 2.5 to about 4.0 hours after administration
`of the first dose.
`
`

`

`Case 2:13-cv-00391-ES-JAD Document 91 Filed 10/30/14 Page 10 of 59 PageID: 971
`
`US 8,263,650 B2
`
`71
`15. A set comprising the pharmaceutical composition of
`claim 1 in one or more container means.
`16. The set of claim 15, 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.
`17. The set of claim 15, comprising a third container means
`capable of retaining a first container means, a second con-
`
`72
`tainer means, and one or more delivery vehicles capable of
`administering the pharmaceutical composition to the patient.
`18. The set of claim 17, wherein the first container means
`comprises the pharmaceutical composition, and the second
`container means comprises a diluent.
`
`* * * * *
`
`

`

`Case 2:13-cv-00391-ES-JAD Document 91 Filed 10/30/14 Page 11 of 59 PageID: 972
`Case 2:13-cv-00391-ES-JAD Document 91 Filed 10/30/14 Page 11 of 59 PageID: 972
`
`
`
`
`EXHIBIT B
`
`EXHIBIT B
`
`

`

`Case 2:13-cv-00391-ES-JAD Document 91 Filed 10/30/14 Page 12 of 59 PageID: 973
`111111
`1111111111111111111111111111111111111111111111111111111111111
`US008772306Bl
`
`c12) United States Patent
`Eller
`
`(10) Patent No.:
`(45) Date of Patent:
`
`US 8,772,306 Bl
`*Jul. 8, 2014
`
`(54) METHOD OF ADMINISTRATION OF
`GAMMA HYDROXYBUTYRATE WITH
`MONOCARBOXYLATE TRANSPORTERS
`
`(71) Applicant: Jazz Pharmaceuticals, Inc., Palo Alto,
`CA (US)
`
`(72)
`
`Inventor: Mark Eller, Redwood City, CA (US)
`
`(73) Assignee: Jazz Pharmaceuticals, Inc., Palo Alto,
`CA (US)
`
`( *) Notice:
`
`Subject to any disclaimer, the term of this
`patent is extended or adjusted under 35
`U.S.C. 154(b) by 0 days.
`
`This patent is subject to a terminal dis(cid:173)
`claimer.
`
`(21) Appl. No.: 13/872,997
`
`(22)
`
`Filed:
`
`Apr. 29, 2013
`
`Related U.S. Application Data
`
`(63)
`
`(60)
`
`Continuation of application No. 13/837,714, filed on
`Mar. 15, 2013.
`
`Provisional application No. 61/771,557, filed on Mar.
`1, 2013, provisional application No. 61/777,873, filed
`on Mar. 12, 2013.
`
`(51)
`
`(2006.01)
`(2006.01)
`(2006.01)
`
`Int. Cl.
`A61K 311505
`A61K 31133
`A61K 31155
`(52) U.S. Cl.
`USPC ....................... 514/275; 514/183; 514/214.03
`(58) Field of Classification Search
`USPC ..................................... 514/275, 183, 214.03
`See application file for complete search history.
`
`(56)
`
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