(12) United States Patent
`Reardan et al.
`
`(10) Patent N0.:
`(45) Date of Patent:
`
`US 8,731,963 B1
`*May 20, 2014
`
`USOO8731963B1
`
`(54) SENSITIVE DRUG DISTRIBUTION SYSTEM
`AND METHOD
`
`(75) Inventors: Dayton T-lReardan, ShoreWOOd, MN
`(Us); PattlA- Engel, Eagan, MN (Us);
`Bob Gagne, St. Paul, MN (US)
`
`(73) Assignee: Jazz Pharmaceuticals, Inc., Palo Alto,
`CA S
`(U )
`
`( * ) 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-
`claimer.
`
`(21) APP1-N0-I 13/592,202
`
`(22) Filed:
`
`Aug. 22, 2012
`
`Related US. Application Data
`(63) Continuation of application No. 13/013,680, ?led on
`Jan. 25, 2011, now abandoned, which is a continuation
`Ofapplication NO- 12/704,097, ?led on Feb- 11, 2010,
`now Pat. No. 7,895,059, which is a continuation of
`application No. 10/322,348, ?led on Dec. 17, 2002,
`now Pat. No. 7,668,730.
`
`(51) Int. Cl.
`
`(2012.01)
`
`G06Q 10/00
`52 U 5 Cl
`705/2_ 705/3_ 707/803
`(
`) U'SI;C '
`’
`’
`_
`""""" "_' """ "_ """"""" "
`_
`(58) Fleld 0f ClaSSI?catlon SearCh
`USPC .... ., ................................. .. 707/803, 705/2, 3
`See apphcanon ?le for Complete SearCh hlswry'
`References Cited
`
`(56)
`
`U.S. PATENT DOCUMENTS
`
`3,556,342 A
`4,847,764 A
`
`1/ 1971 Guarr
`7/ 1989 Halvorson
`
`4,976,351 A 12/1990 Mangini et a1.
`5,737,539 A
`4/1998 Edelson et a1.
`5,845,255 A 12/1998 Mayaud
`5,924,074 A
`7/1999 Evans
`5,963,919 A * 10/1999 Brinkley et 31‘ “““““““ H 705/28
`6,021,392 A
`2/2000 Lester et a1.
`6,045,501 A
`4/2000 Elsayed et a1.
`6,055,507 A
`4/2000 Cunningham
`6,112,182 A
`8/2000 Akers et 31'
`6,315,720 B1
`11/2001 Williams et al.
`6,347,329 B1
`2/2002 Evans
`6,564,121 B1
`5/2003 Wallace et al.
`6,687,676 B 1
`2/2004 Denny
`(Continued)
`
`FOREIGN PATENT DOCUMENTS
`
`EP
`
`0527027 A1
`2/1993
`OTHER PUBLICATIONS
`
`“Advisory Committee Video on Xyrem, Oral Solution”, (May 29,
`2001), 9 minutes, 8 seconds.
`d)
`(C t_
`on 1nue
`
`Primary Examiner * Lena Naj arian
`(74) Attorney, Agent, or Firm * Schwegman Lundberg &
`Woessner, RA
`
`ABSTRACT
`(57)
`A drug distribution system and method utilizes a central
`.
`.
`.
`pharmacy and database to track all prescnptlons for a sen51
`.
`.
`.
`.
`.
`t1ve drug. Informatlon IS kept 1n the database regardlng all
`physicians allowed to prescribe the sensitive drug, and all
`patients receiving the drug. Abuses are identi?ed by monitor
`ing data in the database for prescription patterns by physi
`Cians and prescriptions Obtained by patients_ Further veri?_
`cation is made that the physician is eligible to prescribe the
`drug by consulting a separate database, and optionally
`whether any actions are taken against the physician. Multiple
`controls beyond those for normal drugs are imposed on the
`distribution depending on the sensitivity of the drug.
`
`28 Claims, 16 Drawing Sheets
`
`1? W W ACTIJNS ARE
`1586050, 1% ML 0"
`IS
`WWII) MD WES CHE UT Tll
`
`“ Ex 15 Pmtassm mi 1111
`11mm mums we we
`Panama mm
`
`1
`
`] 11+: names; was me
`wants a um. mm
`| A contact mm mm
`[_ mm mm:
`Milli
`lej.........l'.
`
`mm THAT F155 k
`FNMT BE WESSZD
`JG
`
`PAR1001
`IPR of U.S. Patent No. 8,731,963
`Page 1 of 26
`
`

`
`US 8,731,963 B1
`Page 2
`
`(56)
`
`References Cited
`
`U.S. PATENT DOCUMENTS
`
`6/2004 Williams et al.
`6,755,784 B2
`6,952,681 B2 10/2005 McQuade et al.
`7,058,584 B2
`6/2006 Kosinski et al.
`7,668,730 B2
`2/2010 Reardan et al.
`7,765,106 B2
`7/2010 Reardan et al.
`7,765,107 B2
`7/2010 Reardan et al.
`7,797,171 B2
`9/2010 Reardan et al.
`7,895,059 B2
`2/2011 Reardan et al.
`8,457,988 B1
`6/2013 Reardan et al.
`8,589,182 B1
`11/2013 Reardan et al.
`5/2001 Kapp
`2001/0001144 A1
`2001/0042050 A1
`11/2001 Fletcher et al.
`2001/0047281 A1
`11/2001 Keresman, III et al.
`1/ 2002 Waddington et al.
`2002/0010661 A1
`3/ 2002 Reitberg
`2002/0032581 A1
`3/2002 Feeney, Jr. et al.
`2002/0032582 A1
`4/2002 Mayaud
`2002/0042725 A1
`2002/0042762 A1
`4/ 2002 McQuade et al.
`5/ 2002 Kobylevsky et al.
`2002/0052762 A1
`10/ 2002 Subich
`2002/0161607 A1
`2002/0177232 A1
`11/2002 Melker et al.
`2003/0033168 A1
`2/ 2003 Califano et al.
`3/ 2003 Gogolak
`2003/0046110 A1
`2003/0050731 A1*
`3/2003 Rosenblum ................. .. 700/232
`3/2003 Jay et al.
`2003/0050802 A1
`2003/0074225 A1
`4/ 2003 Borsand et al.
`5/2003 Lilly et al.
`2003/0093295 A1
`6/ 2003 Clementi
`2003/0110060 A1
`2003/0127508 A1
`7/ 2003 Jones
`2003/0144876 A1
`7/ 2003 Kosinski et al.
`2003/0160698 A1
`8/ 2003 Andreasson et al.
`10/ 2003 Kusterbeck
`2003/0197366 A1
`2003/0229519 A1
`12/2003 EideX et al.
`2003/0233256 A1
`12/ 2003 Cardenas et al.
`2004/0008123 A1
`1/ 2004 Carrender et al.
`1/2004 Herceg et al.
`2004/0019567 A1
`2004/0019794 A1
`1/ 2004 Moradi et al.
`2004/0078237 A1
`4/ 2004 Kaafarani et al.
`6/ 2004 Denny
`2004/0107117 A1
`2004/0117126 A1
`6/ 2004 Fetterman et al.
`2004/0122712 A1
`6/2004 Hill, Sr. et al.
`2004/0122713 A1
`6/2004 Hill, Sr. et al.
`2004/0162740 A1
`8/ 2004 Ericsson et al.
`9/ 2004 Lilly et al.
`2004/0176985 A1
`2005/0090425 A1
`4/2005 Reardan et al.
`2005/0216309 A1
`9/2005 Reardan et al.
`2005/0222874 A1
`10/2005 Reardan et al.
`2010/0138237 A1
`6/2010 Reardan et al.
`2011/0119085 A1
`5/2011 Reardan et al.
`2012/0209623 A1
`8/2012 Reardan et al.
`
`OTHER PUBLICATIONS
`
`“An Interview with Orphan Medical about Xyrem”, http://www.
`talkaboutsleep. com/ sleepdisorders/ archive s/N arcolepsyixyremi
`interview.htm, (Feb. 12, 2001), 3 pgs.
`“US. Appl. No. 10/322,348, Advisory Action mailed Feb. 5, 2007”,
`3 pgs.
`“US. Appl. No. 10/322,348, Appeal Brief ?led May 21, 2007”, 32
`pgs.
`“US. Appl. No. 10/322,348, Examiner Interview Summary mailed
`Oct. 21, 2009”, 3 pgs.
`“US. Appl. No. 10/322,348, Final Of?ce Action mailed Oct. 18,
`2006”, 14 pgs.
`“US. Appl. No. 10/322,348, Final Of?ce Action mailed Dec. 29,
`2005”, 11 pgs.
`“US. Appl. No. 10/322,348, Non Final Of?ce Action mailed Jun. 17,
`2005”, 26 pgs.
`“US. Appl. No. 10/322,348, Non Final Of?ce Action mailed Jun. 19,
`2006”, 18 pgs.
`“US. Appl. No. 10/322,348, Non Final Of?ce Action mailed Jun. 29,
`2005”, 12 pgs.
`“US. Appl. No. 10/322,348, Notice of Allowance mailed Dec. 31,
`2009”, 16 pgs.
`
`“US. Appl. No. 10/322,348, Preliminary Amendment mailed Sep.
`30, 2004”, 11 pgs.
`“US. Appl. No. 10/322,348, Reply Brief ?led Dec. 3, 2007”, 4 pgs.
`“US. Appl. No. 10/322,348, Response ?led Jan. 17, 2007 to Final
`Of?ce Action mailed Oct. 18, 2006”, 17 pgs.
`“US. Appl. No. 10/322,348, Response ?led Mar. 29, 2006 to Final
`Of?ce Action mailed Dec. 29, 2005”, 11 pgs.
`“US. Appl. No. 10/322,348, Response ?led Aug. 8, 2006 to Non
`Final Of?ce Action mailed Jun. 19, 2006”, 10 pgs.
`“US. Appl. No. 10/322,348, Response ?led Sep. 29, 2005 to Non
`Final Of?ce Action mailed Jun. 29, 2005”, 19 pgs.
`“U.S.Appl. No. 10/731,915, Non Final Of?ceAction mailed Sug. 12,
`2005”, 22 pgs.
`“US. Appl. No. 10/731,915, Non Final Of?ce Action mailed Oct. 5,
`2004”, 21 pgs.
`“US. Appl. No. 10/731,915, Non Final Of?ce Action Response
`mailed Feb. 2, 2005”, 17 pgs.
`“US. Appl. No. 10/979,665, Non-Final Of?ce Action mailed Nov.
`17, 2009”, 19 pgs.
`“US. Appl. No. 10/979,665, Notice of Allowance mailed Apr. 30,
`2010”, 8 pgs.
`“US. Appl. No. 10/979,665, Preliminary Amendment ?led Jun. 22,
`2006”, 7 pgs.
`“US. Appl. No. 10/979,665, PreliminaryAmendment mailed Nov. 2,
`2004”, 3 pgs.
`“US. Appl. No. 10/979,665, Response ?led Mar. 11, 2010 to Non
`Final Of?ce Action mailed Nov. 17, 2009”, 13 pgs.
`“US. Appl. No. 10/979,665, Response ?led Jul. 14, 2009 to Restric
`tion Requirement mailed Jun. 25, 2009”, 8 pgs.
`“US. Appl. No. 10/979,665, Restriction Requirement mailed Jun.
`25, 2009”, 7 pgs.
`“US. Appl. No. 11/097,651, Examiner Interview Summary mailed
`May 27, 2010”, 3 pgs.
`“US. Appl. No. 11/097,651, Final Of?ce Action mailed Nov. 12,
`2009”, 14 pgs.
`“US. Appl. No. 11/097,651, Non-Final Of?ce Action mailed Mar. 3,
`2010”, 19 pgs.
`“US. Appl. No. 11/097,651, Non-Final Of?ce Action mailed May
`27, 2009”, 21 pgs.
`“US. Appl. No. 11/097,651, Notice of Allowance mailed Jul. 23,
`2010”, 9 pgs.
`“U.S.Appl. No. 11/097,651, PreliminaryAmendment mailedApr. 1,
`2005”, 6 pgs.
`“US. Appl. No. 11/097,651, Response ?led Feb. 9, 2010 to Final
`Of?ce Action mailed Nov. 12, 2009”, 11 pgs.
`“U.S.Appl. No. 11/097,65 1, Response ?led Jun. 3, 2010 to Non Final
`Of?ce Action mailed Mar. 3, 2010”, 12 pgs.
`“US. Appl. No. 11/097,651, Response ?led Sep. 17, 2009 to Non
`Final Of?ce Action mailed May 29, 2009”, 10 pgs.
`“US. Appl. No. 11/097,985, Non Final Of?ceAction mailed Sep. 14,
`2009”, 22 pgs.
`“US. Appl. No. 11/097,985, Notice of Allowance mailed Mar. 10,
`2010”, 11 pgs.
`“U.S.Appl. No. 11/097,985, PreliminaryAmendment mailedApr. 1,
`2005”, 7 pgs.
`“US. Appl. No. 11/097,985, Response ?led Nov. 3, 2009 to Non
`Final Of?ce Action mailed Sep. 14, 2009”, 15 pgs.
`“US. Appl. No. 11/097,985, Supplemental Notice of Allowability
`mailed Jun. 29, 2010”, 3 pgs.
`“U.S.Appl. No. 12/704,097, Non-Final Of?ceAction mailed Sep. 24,
`2010”, 5 pgs.
`“US. Appl. No. 12/704,097, Notice of Allowance mailed Dec. 21,
`2010”, 8 pgs.
`“US. Appl. No. 12/704,097, Response ?led Nov. 4, 2010 to Non
`Final Of?ce Action mailed Sep. 24, 2010”, 12 pgs.
`“US. Appl. No. 13/013,680, Response ?led Jun. 12, 2012 to Restric
`tion Requirement mailed Dec. 14, 2011”, 9 pgs.
`“US. Appl. No. 13/013,680, Restriction Requirement mailed Dec.
`14, 2011”, 7 pgs.
`“US. Appl. No. 13/013,680, Preliminary Amendment ?led Jun. 13,
`2012”, 4 pgs.
`
`PAR1001
`IPR of U.S. Patent No. 8,731,963
`Page 2 of 26
`
`

`
`US 8,731,963 B1
`Page 3
`
`(56)
`
`References Cited
`
`OTHER PUBLICATIONS
`
`“Civil Docket”, Jazz Pharmaceuticals, Inc. v. Roxane Laboratories,
`Inc., (United States District Court, District of New Jersey Civil
`Action No. 2:10-CV-06108-ES-CLW), (Nov. 22, 2010), 15 pgs.
`“Complaint for Patent Infringement”, Jazz Pharmaceuticals, Inc. v.
`Roxane Laboratories, Inc., (United States District Court, District of
`New Jersey Civil Action No. 10-6108 (ES) (CLW)), (Nov. 22, 2010),
`14 pgs.
`“Diversion Prevention Through Responsible Distribution”, NADDI
`Regional Training, (May 2001), 12 pages.
`“Diversion Prevention Through Responsible Distribution”, NADDI
`Regional Training Tennessee, (Jun. 2001), 14 Pages.
`“Diversion Prevention Through Responsible Distribution”, NADDI
`National Conference, (Nov. 2001), 15 pages.
`“JaZZ Pharmaceuticals, Inc.’s Opening Markman Brief’, Jazz Phar
`maceuticals, Inc. v. RoxaneLaboratories, Inc., United States District
`Court, District of New Jersey Civil Action No. 10-6108 (ES) (CLW),
`(Dec. 5, 2011), 34 pgs.
`“JaZZ Pharmaceuticals, Inc.’s Responsive Markman Brief’, Jazz
`Pharmaceuticals, Inc. v. Roxane Laboratories, Inc., (United States
`District Court, District of New Jersey Civil Action No. 10-6108 (ES)
`(CLW)), (Feb. 21, 2012), 41 pgs.
`“Joint Claim Construction and Prehearing Statement”, Jazz Pharma
`ceuticals, Inc. v. Roxane Laboratories, Inc., (United States District
`Court, District of New Jersey Civil Action No. 10-6108 (ES) (CLW)),
`(Oct. 21, 2011), 31 pgs.
`“Letter dated Oct. 14, 2010 from Randall S. Wilson (Roxane Labs) to
`Bruce C. Cozadd (JaZZ Pharmaceuticals)”, Re: Patent Notice Pursu
`ant to Section 505(b)(3)(B) [21 USC Sec. 355(b)(3)(B)], (Oct. 14,
`2010), 11 pgs.
`“Letter from Theodora McCormick to Magistrate Judge Cathy L.
`Weldor”, (w/ Exhibits), (Feb. 27, 2012), 60 pgs.
`“Letter from Theodora McCormick to Magistrate Judge Cathy L.
`Weldor”, (w/ Exhibits), (Mar. 19, 2012), 104 pgs.
`“Letter from Theodora McCormick to Magistrate Judge Cathy L.
`Weldor”, (Mar. 29, 2012), 4 pgs.
`“NASCSA National Conference”, Orphan Medical, Inc., (Nov.
`2000), 8 pgs.
`“Peripheral and Central Nervous System Drugs Advisory Commit
`tee”, Department of Health and Human Services Food and Drug
`Administration Center for Drug Evaluation and Research, Holiday
`Inn, Bethesda, Maryland, (Jun. 6, 2001), 7 pages.
`“Preliminary Amendment pursuant to 37 CFR Sec. 1.115”, U.S.
`Appl. No. 11/104,013, ?led Apr. 12, 2005, 3 pgs.
`“Reply to Counterclaims”, Jazz Pharmaceuticals, Inc. v. Roxane
`Laboratories, Inc., (United States District Court, District of New
`Jersey Civil Action No. 10-6108 (SDW) (MCA), (Feb. 7, 2011), 37
`pgs~
`“Reply to Counterclaims”, Jazz Pharmaceuticals, Inc. v. Roxane
`Laboratories, Inc., (United States District Court, District of New
`Jersey Civil Action No. 11-660 (SDW) (MCA) Lead Action CV-10
`6108), (Apr. 18, 2011), 6 pgs.
`“Roxane Laboratories, Inc.’s Answer, Af?rmative Defenses and
`Counterclaims to Plaintiffs Complaint”, Jazz Pharmaceuticals, Inc.
`v. Roxane Laboratories, Inc., (United States District Court, District
`of New Jersey Civil Action No. 10-6108 (ES) (CLW), (Dec. 29,
`2010), 21 pgs.
`“Roxane Laboratories, Inc.’s Initial Invalidity and Noninfringement
`Contentions Pursuant to Local Patent Rule 3.6”, Jazz Pharmaceuti
`cals, Inc. v. RoxaneLaboratories, Inc., (United States District Court,
`District of New Jersey Civil Action No. 2: 10-cv-06108 (SDW)
`(MCA)), (Apr. 14, 2011), 317 pgs.
`“Roxane Laboratories, Inc.’s Opening Markman Brief in Support of
`Its Claim Constructions”, Jazz Pharmaceuticals, Inc. v. Roxane
`Laboratories, Inc., (United States District Court, District of New
`Jersey Civil Action No. 2.10-cv-06108 (ES) (CLW)), (Dec. 5, 2011),
`37 pgs.
`“Roxane Laboratories, Inc.’s Responsive Markman Brief in Support
`of Its Claim Constructions”, Jazz Pharmaceuticals, Inc. v. Roxane
`
`Laboratories, Inc., (United States District Court, District of New
`Jersey Civil Action No. 2: 10-cv-06108 (ES) (CLW)), (Feb. 21, 2012),
`27 pgs.
`“System for Thalidomide Education and Prescribing Safety (S.T.E.
`P.S.) Starter Kit”, Celgene Corporation, (2001), 103 pgs.
`Ukens, C., “Specialty Pharmacy”, Drug Topics, 144, (Jun. 5, 2000),
`40-47.
`“U.S. Appl. No. 13/595,757, Non Final Of?ce Action mailed Jan. 17,
`2013”, 6 pgs.
`“Markman Opinion, ?led Sep. 14, 2012, in the case ofJazz Pharma
`ceuticals, Inc., Plaintiff, v. Roxane Laboratories, Inc., Defendant
`(United States District Court for the District of New Jersey, Civil
`10-6108 ES)”, 43 pgs.
`“Roxane Laboratories, Inc.’s Answer and Af?rmative Defenses to
`Plaintiffs Complaint”, (Jan. 4, 2013), 8 pgs.
`“Roxane Laboratories, Inc.’s Answer, Af?rmative Defenses and
`Counterclaims to Plaintiff s Complaint”, (Mar. 9, 2011), 13 pgs.
`“Roxane Laboratories, Inc.’s Answer, Af?rmative Defenses and
`Counterclaims to Plaintiff s Complaint”, (Jun. 1, 2011), 12 pgs.
`“Roxane Laboratories, Inc.’s Answer, Af?rmative Defenses and
`Counterclaims to Plaintiff s Complaint”, (Nov. 9, 2012), 18 pgs.
`“Brie?ng Booklet for the Peripheral and Central Nervous System
`Drugs Advisory Committee Meeting”, Orphan Medical, Inc., (Jun. 6,
`2001), 353 pgs.
`“Civil Cover Sheet”, Jazz Pharmaceuticals, Inc. v. Amneal Pharma
`ceuticals, LLC, (United States District Court, District of New Jersey,
`(Jan. 18, 2013), 2 pgs.
`“Complaint for Patent Infringement”, Jazz Pharmaceuticals, Inc. v.
`Amneal Pharmaceuticals, LLC, (United States District Court, Dis
`trict ofNew Jersey, (Jan. 18,2013), 17 pgs.
`“Controlled Substances Act”, Drugs of Abuse, US. Department of
`Justice, Drug Enforcement Administration, (1997), 9 pgs.
`“Detailed Factual and Legal Basis of Non-Infringement and/ or Inval
`idity”, Amneal Pharmaceuticals, LLC, (Dec. 12, 2012), 3 pgs.
`“Detailed Factual and Legal Basis of Non-Infringement and/ or Inval
`idity”, Amneal Pharmaceuticals, LLC, (Dec. 7, 2012), 6 pgs.
`“Exhibits A-D”, Jazz Pharmaceuticals v Amneal Pharmaceuticals,
`LLC, (Jan. 18,2013), 151 pgs.
`“Exhibits D-G”, Jazz Pharmaceuticals v Amneal Pharmaceuticals,
`LLC, (Jan. 18,2013), 123 pgs.
`“Fed. R. Civ. P. Rule 7.1 Disclosure Statement”, (Jan. 18, 2013), 2
`pgs~
`“Making Good in Your Own Mail-Order Business”, Changing
`TimesiThe Kiplinger Magazine, (Oct. 1980), 66-68.
`“Notice of Electronic Filing: Civil Inital Pleadings (Attorney/Credit
`Card) Use Case 33-1”, US District Court, District of new Jersey
`[LIVE], (Jan. 18,2013), 2 pgs.
`“Notice of Paragraph IV Certi?cation Concerning ANDA 203631 for
`Sodiium Oxybate Oral Solution, 500 mg/mL”, Amneal Pharmaceu
`ticals, LLC, (Dec. 7, 2012), 4 pgs.
`“Notice of Paragraph IV Certi?cation Concerning ANDA 203631 for
`Sodiium Oxybate Oral Solution. 500 mg/mL”, Amneal Pharmaceu
`ticals, LLC, (Dec. 12, 2012), 4 pgs.
`“Peripheral and Central Nervous System Drugs Advisory Commit
`teeiTranscript”, Department of Health and Human Services Food
`and Drug Administration Center for Drug Evaluation and Research,
`Holiday Inn, Bethesda, Maryland, (Jun. 6, 2001), 381 pgs.
`“Xyrem Prescription and Distribution Process-Video Script”, (Feb.
`2, 2001), 10 pgs.
`Deutsch, Sheryl, “The Veri?cation and Information-Gathering Pro
`cess”, The Credentialing Handbook, Aspen Publishers, Inc., (1999),
`231-275.
`Mani, Ranjit, “Preliminary Clinical Safety Review of NDA No.
`21196”, Orphan Medical, Inc., (May 3,2001), 122 pgs.
`“U.S. Appl. No. 13/595,676, Notice of Allowance mailed Sep. 17,
`2013”, 8 pgs.
`“Civil Cover Sheet”, Jazz Pharmaceuticals, Inc. v. Amneal Pharma
`ceuticals, LL C, (United States District Court, District of New Jersey),
`(Sep. 12,2013), 2 pgs.
`“Complaint for Patent Infringement with Exhibit A”, Jazz Pharma
`ceuticals, Inc. v. Amneal Pharmaceuticals, LLC, (United States Dis
`trict Court, District ofNew Jersey), (Sep. 12, 2013), 76 pgs.
`
`PAR1001
`IPR of U.S. Patent No. 8,731,963
`Page 3 of 26
`
`

`
`US 8,731,963 B1
`Page 4
`
`(56)
`
`References Cited
`
`OTHER PUBLICATIONS
`
`“Fed. R. Civ. P. Rule 7.1 Disclosure Statement”, Jazz Pharmaceuti
`cals, Inc. v. Amneal Pharmaceuticals, LLC, (United States District
`Court, District of New Jersey), (Sep. 12, 2013), 2 pgs.
`“Notice of Electronic Filing: Civil Inital Pleadings (Attorney/Credit
`Card) Use Case 33- 1)”, Jazz Pharmaceuticals, Inc. v. Amneal Phar
`maceuticals, LLC, (United States District Court, District of New
`Jersey [LIVE]), (Sep. 12, 2013), 1 pg.
`“U.S. Appl. No. 13/595,676 , Response ?led May 31, 2013 to Non
`Final Of?ce Action mailed Mar. 21, 2013”, 14 pgs.
`“U.S. Appl. No. 13/595,676, Examiner Interview Summary mailed
`May 30, 2013”, 3 pgs.
`“Notice of Paragraph IV Certi?cation”, Detailed Statement of the
`Factual and Legal Bases for Pars Paragraph IV Patent Certi?cation
`and Offer of Con?dential Access, (Nov. 20, 2013), 190 pgs.
`Oxtoby, David W, et al., “”, Principles of Modern Chemistry, Fort
`Worth : Saunders College Pub., (1996), 52-56.
`“Civil Action No. 2:13-cv-00391-ES-SCM (consolidated)”, Defen
`dant Amneal Pharmaceuticals, LLC’ s Preliminary Invalidity Conten
`tions (United States District Court of New Jersey), 182 pgs.
`“Civil Cover Sheet”, Jazz Pharmaceuticals, Inc. v. Par Pharmaceu
`ticals, Inc., (United States District Court, District of New Jersey),
`(Dec. 27, 2013), 1 pg.
`“Complaint for Patent Infringement”, Jazz Pharmaceuticals, Inc. v.
`Par Pharmaceuticals, Inc, (United States District Court, District of
`New Jersey), (Dec. 27, 2013), 26 pgs.
`“Fed. R. Civ. P. Rule 7.1 Disclosure Statement”, Jazz Pharmaceuti
`cals, Inc. v. Par Pharmaceuticals, Inc., (United States District Court,
`District ofNew Jersey), (Dec. 27, 2013), 2 pgs.
`“Final Minutes: Peripheral and Central Nervous System Drugs Advi
`sory Committee”, [Online]. Retrieved from the Internet: <URL:
`http://www.fda.gov/ohrms/dockets/ac/01/minutes/3754m1.htm>,
`(Jun. 6, 2001), 6 pgs.
`“Notice of Paragraph IV Certi?cation”, Detailed Statement of the
`Factual and Legal Bases for Pars Paragraph IV Patent Certi?cation
`and Offer of Con?dential Access, (Dec. 20, 2013), 190 pgs.
`“Orphan Medical Slides: Xyrem (sodium oxybate) oral solution”,
`Peripheral and Central Nervous System Drugs Advisory Committee
`Meeting, [Online]. Retrieved from the Internet: <URL: http://www.
`
`fda. gov/ ohrms/ dockets/ ac/ 0 1/ slides/ 3754s 1i0 liorphanmedical/
`index.htm>, (Jun. 6, 2001), 167 pgs.
`“Report on the Filing or Determination of an Action Regarding a
`Patent or Trademark”, Jazz Pharmaceuticals, Inc. v. Par Pharmaceu
`ticals, Inc., United States District Court, District of New Jersey Case
`No. 2:13-cv-07884-ES-JAD, (Dec. 27, 2013), 1 pg.
`“Slides: Pediatric Subcommittee of the Peripheral and Central Ner
`vous system Drugs Advisory Committee”, [Online]. Retrieved from
`the Internet: <URL: http://www.fda.gov/ohrms/dockets/ac/ 01/
`slides/3754s1.htm>, (Jun. 6, 2001), 86 pgs.
`“Summons in a Civil Case”, Jazz Pharmaceuticals, Inc. v. Par Phar
`maceuticals, Inc. , United States District Court, District of New Jersey
`Case No. 213-CV-07884-ES-JAD, (Dec. 31, 2013), 2 pgs.
`Oxtoby, David W, et al., Principles of Modern Chemistry, Fort Worth:
`Saunders College Pub., (1996), 52-56.
`U.S. Appl. No. 13/595,676, Non Final Of?ce Action mailed Mar. 21,
`2013, 16 pgs.
`U.S. Appl. No. 13/595,757, Examiner Interview Summary mailed
`Mar. 12, 2013, 3 pgs.
`U.S. Appl. No. 13/595,757, Notice of Allowance mailed Mar. 21,
`2013, 68 pgs.
`U.S. Appl. No. 13/595,757, Response ?led Mar. 7, 2013 to Non Final
`Of?ce Action mailed Jan. 17, 2013, 8 pgs.
`“Roxane Laboratories, Inc. ’s Amended Answer and Af?rmative
`Defenses to Plaintiffs Complaint Regarding US. Patent No.
`8,234,275”, Exhibit 2, (Apr. 26,2013), 15 pgs.
`“Roxane Laboratories, Inc.’s Amended Answer, Af?rmative
`Defenses and Counterclaims to Plaintiffs Complaint Regarding US.
`Patent No. 8,263,650”, Exhibit 1, (Apr. 26, 2013), 23 pgs.
`“Answer, Defenses, and Counterclaims”, Jazz Pharmaceuticals, Inc.
`v. Amneal Pharmaceuticals, LLC, (United States District Court, Dis
`trict of New Jersey Civil Action No. 13-391 ES-SCM, (Apr. 15,
`2013), 22 pgs.
`“Notice of Voluntary Dismissal of Counterclaims Pertaining to US.
`Patent Nos. 7,668,730; 7,765,106; and 7,765,107 (Contained in
`Counts I, II) Pursuant to Fed. R. Civ. P. 41(a), (c)”, Jazz Pharmaceu
`ticals, Inc. v. Amneal Pharmaceuticals, LLC, (United States District
`Court, District ofNew Jersey Civil Action No. 13-391 ES-SCM, (Jul.
`15, 2013), 2 pgs.
`
`* cited by examiner
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