Case 2:11-cv-02523-ES-MAH Document 1 Filed 05/02/11 Page 1 of 33 PagelD: 1
`
`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
`
`Attorneys for Plainlifl
`Jazz Pharmaceuticals, Inc.
`
`UNITED STATES DISTRICT COURT
`DISTRICT OF NEW JERSEY
`
`
`JAZZ PHARMACEUTICALS, INC.,
`
`
`
`Plaintiff:
`
`V.
`
`ROXANE LABORATORIES, INC,
`Defendant.
`
`Civil Action No.
`
`COMPLAINT FOR
`PATENT INFRINGEMENT
`
`(Filed Electronically)
`
`Plaintiff Jazz Pharmaceuticals, Inc. (“Jazz Pharmaceuticals”), by its undersigned
`
`attorneys, for its Complaint against defendant Roxane Laboratories, Inc. (“Roxane”), alleges as
`
`follows:
`
`Nature of the Action
`
`1.
`
`This is an action for patent infringement under the patent laws of the United
`
`States, 35 U.S.C. §100, et seq, arising from Roxane’s filing of an Abbreviated New Drug
`
`Application (“ANDA”) with the United States Food and Drug Administration (“FDA”) seeking
`
`
`approval to commercially market a generic version of Jazz Pharmaceuticals’ XYR3M® drug
`
`product prior to the expiration of United States Patent No. 7,895,059 (the “’059 patent”) owned
`
`by Jazz Pharmaceuticals.
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`The Parties
`
`2.
`
`Plaintiff Jazz Pharmaceuticals is a corporation organized and existing under the
`
`laws of the State of Delaware, having a principal place of business at 3180 Porter Drive, Palo
`
`Alto, California 94304.
`
`3.
`
`On information and belief, defendant Roxane is a corporation organized under
`
`the laws of Nevada, having a principal place of business at 1809 Wilson Road, Columbus,
`
`Ohio 43228.
`
`4.
`
`On information and belief, Roxane is registered to do business in the State of
`
`New Jersey, and maintains a registered agent for service of process in New Jersey. On
`
`information and belief, Roxane regularly transacts business within this judicial district.
`
`Further, on information and belief, Roxane develops numerous generic drugs for sale and use
`
`throughout the United States, including in this judicial district. On information and belief,
`
`Roxane has litigated patent cases in this district in the past without contesting personal
`
`jurisdiction, and, in at least some of those actions, Roxane has asserted counterclaims.
`
`Jurisdiction and Venue
`
`5.
`
`This Court has jurisdiction over the subject matter of this action pursuant to 28
`
`U.S.C. §§ 1331, 1338(a), 2201, and 2202.
`
`6.
`
`This Court has personal jurisdiction over Roxane by Virtue of, inter alia, its
`
`systematic and continuous contacts with the State of New Jersey. On information and belief,
`
`Roxane has purposefully availed itself of this forum by, among other things, making, shipping,
`
`using, offering to sell or selling, or causing others to use, offer to sell, or sell, pharmaceutical
`
`products in the State of New Jersey and deriving revenue from such activities. Further, on
`
`information and belief, Roxane has customers in the State of New Jersey.
`
`7.
`
`Venue is proper in this district pursuant to 28 U.S.C. §§ 1391 and 1400(b).
`
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`The Patent-in-Suit
`
`8.
`
`On February 22, 2011, the United States Patent and Trademark Office
`
`(“USPTO”) duly and lawfully issued the ’059 patent, entitled “Sensitive Drug Distribution
`
`System and Method” to inventors Dayton Reardan, Patti Engle and Bob Gagne. A copy of the
`
`’059 patent is attached hereto as Exhibit A.
`
`The XYREM® Drug Product
`
`9.
`
`Jazz Pharmaceuticals holds an approved New Drug Application (“NDA”) under
`
`Section 505(a) of the Federal Food Drug and Cosmetic Act (“FFDCA”), 21 U.S.C. § 355(a),
`
`for sodium oxybate oral solution (NDA No. 21-196), which it sells under the trade name
`
`XYREM®. The claims of the ”059 patent cover, inter alia, methods of use and administration of
`
`sodium oxybate or pharmaceutical compositions containing sodium oxybate. Jazz
`
`Pharmaceuticals owns the ’059 patent.
`
`10.
`
`Pursuant to 21 U.S.C. § 355(b)(1) and attendant FDA regulations, ’059 patent is
`
`listed in the FDA publication, “Approved Drug Products with Therapeutic Equivalence
`
`Evaluations” (the “Orange Book”), with respect to XYREM®.
`
`Acts Giving Rise to this Suit
`
`11.
`
`Pursuant to Section 505 of the FFDCA, Roxane filed ANDA No. 202—090
`
`(“Roxane’s ANDA”) seeking approval to engage in the commercial use, manufacture, sale,
`
`offer for sale or importation of 500 mg/ml sodium oxybate oral solution (“Roxane’ s Proposed
`
`Product”), before the ’059 patent expires.
`
`12.
`
`In connection with the filing of its ANDA as described in the preceding
`
`paragraph, Roxane has provided a written certification to the FDA, as called for by Section 505
`
`of the FFDCA, alleging that the claims of the ’059 patent are invalid, unenforceable, and/or
`
`will not be infringed by the activities descfibed in Roxane’s ANDA.
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`13.
`
`No earlier than March 22, 2011, Roxane sent written notice of its ANDA
`
`certification to Jazz Pharmaceuticals (“Roxane”s Notice Letter”). Roxane’s Notice Letter
`
`alleged that the claims of the ”059 patent are invalid, unenforceable, and/or will not be
`
`infringed by the activities described in Roxane”s ANDA. Roxane”s Notice Letter also
`
`informed Jazz Pharmaceuticals that Roxane seeks approval to market Roxane”s Proposed
`
`Product before the ”059 patent expires.
`
`Count for Infringement of the ’059 Patent
`
`14.
`
`Plaintiff repeats and realleges the allegations of paragraphs 1—13 as though fully
`
`set forth herein.
`
`15.
`
`Roxane”s submission of its ANDA to obtain approval to engage in the
`
`commercial use, manufacture, sale, offer for sale, or importation of sodium oxybate oral
`
`solution, plior to the expiration of the ”059 patent, constitutes infringement of one or more of
`
`the claims of that patent under 35 U. SC. § 27l(e)(2)(A).
`
`16.
`
`There is a justiciable controversy between the parties hereto as to the
`
`infringement of the ”059 patent.
`
`17.
`
`Unless enjoined by this Court, upon FDA approval of Roxane” s ANDA, Roxane
`
`will infringe the ”059 patent under 35 U.S.C. § 271(a) by making, using, offering to sell,
`
`importing, and/or selling Roxane”s Proposed Product in the United States.
`
`18.
`
`Unless enjoined by this Court, upon FDA approval of Roxane’ s ANDA, Roxane
`
`will induce infringement of the ”059 patent under 35 U.S.C. § 271(b) by making, using,
`
`offering to sell, importing, and/or selling Roxane” 5 Proposed Product in the United States. On
`
`information and belief, upon FDA approval of Roxane”s ANDA, Roxane will intentionally
`
`encourage acts of direct infringement with knowledge of the ”059 patent and knowledge that its
`
`acts are encouraging infringement.
`
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`19.
`
`Unless enjoined by this Court, upon FDA approval of Roxane’ s ANDA, Roxane
`
`will contributorily infringe the ’059 patent under 35 U.S.C. § 271(c) by making, using, offering
`
`to sell, importing, and/or selling Roxane’s Proposed Product in the United States. On
`
`information and belief, Roxane has had and continues to have knowledge that Roxane’s
`
`Proposed Product is especially adapted for a use that infringes the ’059 patent and that there is
`
`no substantial non-infringing use for Roxane’s Proposed Product.
`
`20.
`
`Jazz Pharmaceuticals will be substantially and irreparably damaged and harmed
`
`if Roxane’s infringement of the ”059 patent is not enjoined.
`
`21.
`
`Jazz Pharmaceuticals does not have an adequate remedy at law.
`
`22.
`
`This case is an exceptional one, and Jazz Pharmaceuticals is entitled to an award
`
`of its reasonable attorneys’ fees under 35 U.S.C. § 285.
`
`PRAYER FOR RELIEF
`
`WHEREFORE, Plaintiff Jazz Pharmaceuticals respectfully requests the following relief:
`
`(A)
`
`A Judgment be entered that Roxane has infringed the ’059 patent by submitting
`
`ANDA No. 202-090,
`
`(B)
`
`A Judgment be entered that Roxane has infringed, and that Roxane’s making,
`
`using, selling, offering to sell, or importing Roxane’s Proposed Product will infringe one or more
`
`claims of the ’059 patent,
`
`(C)
`
`An Order that the effective date of FDA approval of ANDA No. 202-090 be a
`
`date which is not earlier than the later of the expiration of the ’059 patent, or any later expiration
`
`of exclusivity to which Plaintiff is or becomes entitled;
`
`(D)
`
`Preliminary and permanent injunctions enjoining Roxane and its officers, agents,
`
`attorneys and employees, and those acting in privity or concert with them, from making, using,
`
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`selling, offering to sell, or importing Roxane’s Proposed Product until after the expiration of the
`
`’059 patent, or any later expiration of exclusivity to which Plaintiff is or becomes entitled;
`
`(E)
`
`A permanent injunction be issued, pursuant to 35 U.S.C. § 271(e)(4)(B),
`
`restraining and enjoining Roxane, its officers, agents, attorneys and employees, and those acting
`
`in privity or concert with them, from practicing any methods as claimed in the ’059 patent, or
`
`from actively inducing or contributing to the infringement of any claim of the ’059 patent, until
`
`after the expiration of the ’059 patent, or any later expiration of exclusivity to which Plaintiff is
`
`or becomes entitled;
`
`(F)
`
`A Declaration that the commercial manufacture, use, importation into the United
`
`States, sale, or offer for sale of Roxane’ s Proposed Product will directly infringe, induce and/or
`
`contribute to infringement of the ’059 patent;
`
`(G)
`
`To the extent that Roxane has committed any acts with respect to the methods
`
`claimed in the ’059 patent, other than those acts expressly exempted by 35 U.S.C. § 27 1(e)(1),
`
`that Plaintiff Jazz Pharmaceuticals be awarded damages for such acts;
`
`(H)
`
`If Roxane engages in the commercial manufacture, use, importation into the
`
`United States, sale, or offer for sale of Roxane’s Proposed Product prior to the expiration of the
`
`’059 patent, a Judgment awarding damages to Plaintiff Jazz Pharmaceuticals resulting from such
`
`infringement, together with interest;
`
`(I)
`
`(J)
`
`Attorneys’ fees in this action as an exceptional case pursuant to 35 U.S.C. § 285;
`
`Costs and expenses in this action; and
`
`(K)
`
`Such further and other relief as this Court may deem just and proper.
`
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`
`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
`c1izza@saul . com
`
`Attorneys for Plainlifl
`Jazz Pharmaceuticals, Inc.
`
`Dated: May 2, 2011
`
`0: Counsel:
`
`F. Dominic Cerrito
`
`Daniel L. Malone
`
`JONES DAY
`222 East 4lst Street
`
`New York, New York 10017-6702
`(212) 326-3939
`
`Richard G. Greco
`RICHARD G. GRECO PC
`
`90 State Street, Suite 700
`
`Albany, New York 12207
`(212) 203-7625
`
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`CERTIFICATION PURSUANT TO L. CIV. R. 11.2
`
`I hereby certify that the matters captioned, Jazz Pharmaceuticals, Inc. v. Roxane
`
`Laboratories, Inc, Civil Action No. 10-6108 (SDW)(MCA) and Jazz Pharmaceuticals, Inc. v.
`
`Roxane Laboratories, Inc., Civil Action No. 11-660 (SDW)(MCA), are related to the matter in
`
`controversy because the matter in controversy involves the same plaintiff, the same defendant,
`
`and in both cases, the defendant is seeking FDA approval to market a generic version of the same
`
`sodium oxybate drug product.
`
`I further certify that, to the best of my knowledge, the matter in controversy is not the
`
`subject of any other action pending in any court, or of any pending arbitration or administrative
`
`
`By: 5/ 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
`
`Attorneys for Plaintifl
`Jazz Pharmaceuticals, Inc.
`
`proceeding.
`
`Dated: May 2, 2011
`
`Of Counsel:
`
`F. Dominic Cerrito
`Daniel L. Malone
`
`JONES DAY
`222 East 41st Street
`
`New York, New York 10017-6702
`(212) 326-3939
`
`Richard G. Greco
`RICHARD G. GRECO PC
`
`90 State Street, Suite 700
`Albany, New York 12207
`(212) 203-7625
`
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`EXHIBIT A
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`Case 2:“‘CV'02523'ES'MAH D"C”memll||||’lllllllllfllllllllll|||||lllllllillllIIlll‘lllllllllllllllllfillll0
`USOO7895059B2
`
`(12) United States Patent
`(10) Patent N0.:
`US 7,895,059 B2
`
`Reardan et al.
`(45) Date of Patent:
`*Feb. 22, 2011
`
`(75)
`
`(54) SENSITIVE DRUG DISTRIBUTION SYSTEM
`AND METHOD
`Inventors: Dayton T. Reardan, Shorewood, MN
`(US); Patti A. Engel, Eagan, MN (US);
`Bob Gagne St. Paul
`lVlN (US)
`’
`’
`Jazz Pharmaceuticals, Inc., Palo Alto,
`CA (US)
`.
`.
`.
`.
`suthetCFtO artiy (311531511111? thte germgftigg
`paen 1sexene oraJuse uner
`U.S.C. 154(1)) by 0 days.
`
`(73) Assignee:
`
`_
`( * ) Nome:
`
`This patent is subject to a terminal dis-
`claimer.
`(21) App1~N0~z 12/704,097
`
`6,021,392 A
`6,045,501 A
`6,055,507 A
`6 112 182 A
`’
`’
`6,315,720 B1
`6,347,329 131
`6,561,977 B2
`6,564,121 B1
`6,755,784 B2
`6,952,681 B2
`7,058,584 B2
`
`2/2000 Lester et 31.
`4/2000 Elsayed et a1,
`4/2000 C
`'
`8/2000 A::::fh;m
`_
`_
`'
`11/2001 Williams et al.
`2/2002 Evans
`5/2003 Williams et all
`5/2003 Wallace et a1,
`6/2004 Williams et a1,
`10/2005 McQuade et a1.
`.
`.
`6/2006 Kosmski et al.
`
`(Continued)
`OTHER PUBLICATIONS
`
`(22) Filed:
`
`Feb. 11, 2010
`
`“”, NASCSA National Conference, (Nov. 2000), 8 pages,
`
`(65)
`
`Prior Publication Data
`US 2010/0138237 A1
`Jun. 3, 2010
`
`Related US. Application Data
`(63) Continuation of application No. 10/322,348, filed on
`Dec. 17, 2002, now Pat. No. 7,668,730.
`Int. Cl.
`G06Q 10/00
`(52) U.S. Cl.
`(58)
`aa a‘a'aaa'a'agaaaa'a‘aa‘agh
`
`(51)
`
`(Continued)
`Primary Examinerilerry O’Connor
`Assistant ExamineriLena Naj arian
`(74) Attorney, Agent, or Firmischwegman, Lundberg &
`Woessner, P’A'
`(57)
`
`ABSTRACT
`
`.
`.
`.
`.
`.
`(2006.01)
`A drug distribution system and method utllizes a central
`705/2. 705/3. 600/300
`,
`,
`,m aaaaaaay aaa aaaaaaaa a aaaa an
`aa a
`W705/3'...600/300
`tive drug. Information is kept in the database regarding all
`lication file for com lete search histo
`physicians allowed to prescribe the sensitive drug, and all
`p
`patients receiving the drug. Abuses are identified by monitor-
`References Cited
`ing data in the database for prescription patterns by physi-
`cians and prescriptions obtained by patients. Further verifi-
`U.S. PATENT DOCUMENTS
`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.
`
`See a
`
`pp
`
`(56)
`
`ry.
`
`3,556,342 A
`4,847,764 A
`4,976,351 A
`5,737,539 A
`5,845,255 A
`5,924,074 A
`
`1/1971 Guarr
`7/1989 Halvorson
`12/1990 Manginietal.
`4/1998 Edelson et a1.
`12/1998 Mayaud
`7/1999 Evans
`
`16 Claims, 16 Drawing Sheets
`
`
`
`
`
`
`
`
`
`FMMWWE
`WMMDRG’HMILS
`MFIDIODTKSMUITIE
`WWW
`
`WHEMNIHNE
`
`27“ mmsr mums THE no.3
`
`TilMWWS‘IVEIFIS
`WW
`
`
`IDSUIDDIWSM “'mnml mn
`mumumn
`
`
`284 27a
`Mmmsum
`
`
`fiumlm2136
`
`
`MEIDBWMA
`MFMU‘IEIW mnumm
`mmnmi
`MNDII'SHNIKN
`
`mammm
`mm
`
`i
`252
`i
`2521
`mtmmsnmsn: “[01”me
`mmumm BINIIDWTDTNEHI
`Amtmm mmtmm
`mun-u:
`mmwmwmm
`W'ulpmu290
`-A _l__ALEITDHSSMID'IIE
`PII'DHIWWI'IIE
`EWKWI
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`WHWEMW
`
`
`
`
`
`
`
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`US 7,895,059 B2
`
`Page 2
`
`U.S. PATENT DOCUMENTS
`
`2/2010 Reardon et a1.
`7/2010 Reardan et al.
`7/2010 Reardan et al.
`9/2010 Reardan et al.
`5/2001 Kapp
`11/2001 Fletcher et a1.
`11/2001 Keresman, III et al.
`1/2002 Waddington et al.
`3/2002 Reitberg
`3/2002 Feeney, Jr. et a1.
`4/2002 Mayaud
`4/2002 McQuade et a1.
`5/2002 Kobylevsky et al.
`10/2002 Subich
`11/2002 Melker et a1.
`2/2003 Califano et a1.
`3/2003 Gogolak
`3/2003 Jay et al.
`5/2003 Lilly et a1.
`6/2003 Clementi
`7/2003 Jones
`7/2003 Kosinski et a1.
`8/2003 Andreasson et a1.
`10/2003 Kusterbeck
`12/2003 Eidex et al.
`12/2003 Cardenas et al.
`1/2004 Carrender et al.
`1/2004 Herceg et a1.
`1/2004 Moradi et al.
`4/2004 Kaafarani et al.
`6/2004 Denny
`6/2004 Fetterman et al.
`6/2004 Hill, Sr. et al.
`6/2004 Hill, Sr. et al.
`8/2004 Ericsson et a1.
`9/2004 Lilly et a1.
`4/2005 Reardan et al.
`9/2005 Reardan et al.
`10/2005 Reardan et al.
`
`OTHER PUBLICATIONS
`
`“An Interview with Orphan Medical about Xyrem”, http://www.
`talkaboutsleep.com/sleepdisorders/archives/
`Narcolepsyixyremiinterviewhtm, (Feb. 12, 2001), 3 pgs.
`“L .S. Appl. No. 10/322,348, Non Final Office Action mailed Jun. 17,
`2005”, 26 pgs.
`“LS. Appl. No. 10/322,348, Advisory Action mailed Feb. 5, 2007”,
`3 pgs.
`“LS. Appl. No. 10/322,348, Appeal Brief filed May 21, 2007”, 32
`Pg5~
`“LS. Appl. No. 10/322,348, Examiner Interview Summary mailed
`Oct. 21, 2009”, 3 pgs.
`“LS, Appl. No. 10/322,348, Final Office Action mailed Oct. 18,
`2006”, 14 pgs.
`“LS, Appl. No. 10/322,348, Final Office Action mailed Dec. 29,
`2005”, 11 pgs.
`“L .8, Appl. No. 10/322,348, Non Final Office Action mailed Jun. 19,
`2006”, 18 pgs.
`“L .8, Appl. No. 10/322,348, Non Final Office Action mailed Jun. 29,
`2005”, 12 pgs.
`“LS, Appl. No. 10/322,348, Notice of Allowance mailed Dec. 31,
`2009”, 16 pgs.
`“LS, Appl. No. 10/322,348, Preliminary Amendment mailed Sep.
`30, 2004”, 11 pgs.
`“L .8. Appl. No. 10/322,348, Reply Brief filed Dec. 3, 2007”, 4 pgs.
`“L.S. Appl. No. 10/322,348, Response filed Jan. 17, 2007 to Final
`Office Action mailed Oct. 18, 2006”, 17 pgs.
`
`7,668,730 B2
`7,765,106 B2
`7,765,107 B2
`7,797,171 B2
`2001/0001144 A1
`1/0042050 A1
`001/0047281 A1
`2/0010661 A1
`2/0032581 A1
`2/0032582 A1
`2/0042725 A1
`2/0042762 A1
`2/0052762 A1
`2/0161607 A1
`2/0177232 A1
`3/0033168 A1
`3/0046110 A1
`3/0050802 A1
`3/0093295 A1
`3/0110060 A1
`003/0127508 Al
`3/0144876 A1
`003/0160698 A1
`3/0197366 A1
`003/0229519 A1
`003/0233256 A1
`004/0008123 Al
`4/0019567 A1
`004/0019794 A1
`4/0078237 A1
`004/0107117 Al
`4/0117126 A1
`4/0122712 A1
`4/0122713 A1
`4/0162740 A1
`4/0176985 A1
`5/0090425 A1
`5/0216309 A1
`5/0222874 A1
`
`
`
`
`
`NNNNNNNNNNMNNNNNNNNNNNNNNNNNNNNNNN
`
`
`
`
`
`
`“L.S. Appl. No. 10/322,348, Response filed Mar. 29, 2006 to Final
`Office Action mailed Dec. 29, 2005", 11 pgs.
`“L.S. Appl. No. 10/322,348, Response filed Aug. 8, 2006 to Non
`Final Office Action mailed Jun. 19, 2006”, 10 pgs.
`“U.S. Appl. No. 10/322,348, Response filed Sep. 29, 2005 to Non
`Final Office Action mailed Jun. 29, 2005”, 19 pgs.
`“L .8. Appl. No. 10/731,915 Non Final Office Action mailed Oct. 5,
`2004”, 21 pgs.
`“L .S.Appl. No. 10/731,915,Non Final OfficeAction mailedAug. 12,
`2005", 22 pgs.
`“L.S. Appl. No. 10/731,915, Non Final Office Action Response
`mailed Feb. 2, 2005", 17 pgs.
`“L.S. Appl. No. 10/979,665, Non-Final Office Action mailed Nov.
`17, 2009", 19 pgs.
`“L.S. Appl. No. 10/979,665, Notice of Allowance mailed Apr. 30,
`2010", 8.
`“L .8. Appl. No. 10/979,665, Preliminary Amendment filed Jun. 22,
`2006”, 7 pgs.
`“L .8. Appl. No. 10/979,665, PreliminaryAmendment mailedNov. 2,
`2004”, 3 pgs.
`“L.S. App . No. 10/979,665, Response filed Mar. 11, 2010 to Non
`Final Office Action mailed Nov. 17, 2009”, 13 pgs.
`“L .8. Appl. No. 10/979,665, Response filed Jul. 14, 2009 to Restric-
`tion Requirement mailed Jun. 25, 2009”, 8 pgs.
`“L.S. App . No. 10/979,665, Restriction Requirement mailed Jun.
`25, 2009”, 7 pgs.
`“L .S. Appl. No. 11/097,651 ,Non-Final Office Action mailed Mar. 3,
`2010”, 19 )gs.
`“L.S. Appl. No. 11/097,651 Notice of Allowance mailed Jul. 23,
`2010”, 9 pgs.
`“LS. App . No. 11/097,651, Final Oflice Action mailed Nov. 12,
`2009”, 14 pgs.
`“U.S. App . No. 11/097,651, Non-Final Office Action mailed May
`29, 2009”, 21 pgs.
`“L .8. Appl. No. 11/097,651, Preliminary Amendment mailedApr. 1,
`2005”, 6 pgs.
`“L.S. App . No. 11/097,651, Response filed Feb. 9, 2010 to Final
`Office Action mailed Nov. 12, 2009", 11 pgs.
`“L .S.Appl. No. 11/097,65 1 , Response filed Jun. 3, 2010 to Non Final
`Office Action mailed Mar. 3, 2010”, 12 pgs.
`“L.S. App . No. 11/097,651, Response filed Sep. 17, 2009 to Non
`Final Office Action mailed May 29, 2009”, 10 pgs.
`“LS. Appl. No. 11/097,985 Supplemental Notice of Allowability
`Mailed Jun. 29, 2010”, 3 pgs.
`“L .5. Appl. No. l 1/097,985, Non Final OfficeAction mailed Sep. 14,
`2009”, 22 pgs.
`“U.S. Appl. No. 11/097,985, Preliminary Amendment mailedApr. 1,
`2005”, 7 pgs.
`“L.S. Appl. No. 11/097,985, Response filed Nov. 3, 2009 to Non
`Final Office Action mailed Sep. 14, 2009”, 15 pgs.
`“L .8. Appl. No. 11/097,985 , Notice ofAllowance mailed Mar. 10,
`2010”, 11 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.
`“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, filedApr. 12, 2005, (Jun. 17, 2005), 3 pgs.
`“System for Thalidomide Education and Prescribing Safety (S.T.E.
`PS.) Starter Kit”, Celgene Corporation, (2001), 103 pgs.
`Ukens, C., “Specialty Pharmacy”, Drug Topics, 144, (Jun. 5, 2000),
`40-47.
`
`PAR1025
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`Case 2:11-cv-02523-ES-MAH Document 1 Filed 05/02/11 Page 12 of 33 PagelD: 12
`
`U.S. Patent
`
`Feb. 22, 2011
`
`Sheet 1 of 16
`
`Us 7,895,059 B2
`
`100
`
`STORAGE
`
`O1 4
`
`FIG.
`
`1
`
`PAR1025
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`CBM of U.S. Patent No. 7,668,730
`Page 12 of 33
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`Page 12 of 33
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`

`

`Case 2:11-cv-02523-ES-MAH Document 1 Filed 05/02/11 Page 13 of 33 PagelD: 13
`
`U.S. Patent
`
`Feb. 22, 2011
`
`Sheet 2 of 16
`
`Us 7,895,059 B2
`
`MO MAILS/FAXES IN Rx/ENROLLMENT FORM
`
`202
`
`204
`
`AN MIME/REIMBURSEMENT SPECIAUST MAKE A COPY OF
`THE Rx/ENROLLMFJFI FORM (THE COPY Is STAMPEO
`“com AND THE ORIGINAL FAx IS THEN FORWARDED
`TOTHERNRMNNTHM
`
`
`
`ND MAILS/FAXES IN Rx/ENRONMENT FORM
`
`206
`
`2Io
`
`THE INTAKE/REIMBURSEMBII SPECIAUST ENTERS TI-IE
`PATTRIT AND PHYSICIAN INFO INTO Cl-iPS
`
`21 2
`
`IS
`THE M
`COMM?
`
`Rs
`
`NO
`
`220
`
`THE INTAKE/REIMBURSEMENT SPECIAUST CONTACTS MD
`TO VERIFY RECEIPT & ACCURACY OF THE PARENTS Rx
`dc THIS CONTACT IS RECORIID IN CHIPS
`
`222
`
`THE INTAKE/REIMBURSEMENT SPECIAUST SENDS CONSENT
`FORM AND A COVER LEITER TO THE PATIflIT
`224
`
`THE INTAKE/REIMBURSEMENT SPECIAUST FAXES A
`STATEMBIT OF MEDICAL NECESSNY TO THE
`MD T0 COMPLETE
`
`226
`
`THE INTAKE/REIMBURSEMENT SPECIAUST CONTACTS
`THE PATTBIIT'S INSURANCE PROVIDER TO VERIFY
`COVERAGE & BENEFITS
`
`3
`
`21 4-
`AN INTAKE REPRESENTATIVE WILL MAKE I ATTEMPT TO
`REACH NIE MD To OBTAIN THE MISSING INFORMATION
`216
`
`THE MISSING INFORMATION HAS NOT BEEN OBTAINED
`WITHIN 24 HOURS, THE RAT/ENROLLMENT FORM IS FAXED
`BACK TO THE MD WITH A REJECTTON EXPLANATION LEITER
`218
`
`A NOTE IS ENTERED IN CHIPS THAT THE
`APPUCATTON WAS REJECTED
`
`232
`
`SE NORD PROCESS FOR PATIENTS
`WHO ARE UNINSURED OR UNDERINSURED
`
`
`
`"0 230
`
`
`
`YES
`
`234
`
`INTAKE/REIMBURSEMENT SUBMTIS A COVERAGE
`APPROVAL FORM (STAPLE) TO THE "COPY" OF THE Rx
`ENROLLMENT FORM) TO THE PHARMACY TEAM AS
`NOTIFICATION TO PROCESS THE PATIENTS Rx
`
`PAR1025
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`Page 13 of 33
`
`
`
`
`THE PATIENT IS INFORMED OF THE COST OF THE
`PRODUCT AND IS GWEN PAYMENT OPTIONS
`
`2
`
`56
`
`INTAKE/REIMBURSEMENT
`ONCE PAYMENT IS RECEIVED,
`SUBMIIS A COVERAGE APPROVAL FORM (STAPLED TO
`THE "COPY' OF THE Rx/ENROLLMENT FORM) TO THE
`PHARMACY TEAM AS NOTIFICATION T0 PROCESS
`THE PATIENTS Rx
`
`
`
`Page 13 of 33
`
`

`

`Case 2:11-cv-02523-ES-MAH Document 1 Filed 05/02/11 Page 14 of 33 PagelD: 14
`
`U.S. Patent
`
`Feb. 22, 2011
`
`Sheet 3 of 16
`
`Us 7,895,059 B2
`
`208
`
`PHARMACY WORK FLOW
`
`268
`
`THE PATIENT IS SHIPPED
`A XYREM SUCCESS
`PACKET VIA 2—DAY USPS
`
`THE pmcm HOLDS mg
`PAHENI’s Rx UNTIL RECEMNC
`A COVERAGE APPROVAL FORM
`
`
` YES
`
`274
`
`NO
`
`THE PHARMACIST VERIHES
`THE MD.'S CREDENTIALS AND
`ENTERS ALL FINDINGS IN CHIPS
`
`276
`ARE THE
`
`
`MD.’S CREDENTIALS
`
`
`APPROVE)?
`
`280
`THE PHYSICIAN IS INDICAIHI
`AS APPROVED IN THE
`PHYSICIAN SCREEN IN CHIPS
`
`IF ANY DISCIPUNARY ACTIONS ARE
`IDENTIFIED, THE DR. OF PHARM.
`IS
`NOTIFIED AND TAKES ONE OF THE
`FOLLOWING ACTIONS:
`- Rx IS PROHED AND THE
`PHARMACIST MONITORS THE MD.'S
`PROGRAM ACTMIY
`— Rx IS NOT PROCESSBJ AND
`THE MD IS NOTED AS UNAPPROVED
`
`284 278
`
`N0
`
`THE PHYSICIAN IS INDICATE)
`AS UNAPPROVED IN CHIPS
`286
`THE MD IS CONTACTED BYA
`PHARNACISI & INFORMED TIIAT
`IHE PAIIENI’S Rx CANNOI
`BE PROCESSED
`
`
`
`CONTACT HIS HER PHYSICIAN
`
`282
`
`288
`
`THE PHARMACIST HOLDS THE
`PAITEMFS Rx UNTIL RECEIVING
`A COJERAGE APPROVAL FORM
`FROM INTAKE B'MBURSEMENT
`
`E RX AND ENROLLMENT FOR
`IS MAILED BACK TO TIIE MD
`ALONG WITH A COVER LEITER
`REITERAIING THAT THE Rx
`CANNOT BE PROCESSED
`
`290
`
`A LEITER IS SENT TO TTIE
`PATIENT INDICATINC THAT THE
`Rx CANNOT BE PROCESSED &
`THE PAITBIT IS INSTRUCTED TO
`
`FIG. 23
`
`PAR1025
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`

`Case 2:11-cv-02523-ES-MAH Document 1 Filed 05/02/11 Page 15 of 33 PagelD: 15
`
`U.S. Patent
`
`Feb. 22, 2011
`
`Sheet 4 of 16
`
`Us 7,895,059 B2
`
`240
`
`UPON RECEIPT OF THE COVERAGE APPROVAL FORM FROM
`INTAKE/REIMBURSEMENT THE PHARMACY TECHNICIAN
`CONTACTS THE PATTENT T0 COMPLETE THE "TECHNICIAN"
`SPECIFIDJ SECTIONS OF THE PATIENT
`
`COUNSEIJNG CHECKIJST
` 246
`
`
`AFTER COMPLEDNG TT'IE SPECIFIED SECTIONS OF THE
`CHECKLIST WITH THE PATIENT THE PHARMACY TECHNICIAN
`TRANSFERS THE CAIJ.ER TO THE PHARMACIST WHO
`REVIEWS THE ENTIRE CHECKLIST AND COMPLETES THE
`RBMINING "PHARMACIST" SPECIFIHJ SECTIONS
`248
`
`THE PHARMACIST INDICATES IN CHIPS THAT THE PATIENT
`COUNSEIJNG CHECKLIST WAS SUCCESSFULLY COMPLETED
`INCLUDING THE DATE COMPLETED
`
`250
`
`.
`E PHARMACIST SCHHJULE THE PATTBIT'S SHIPMENT F0
`THE NEXT BUSINESS DAY OR THE NEXT BUSINESS DAY
`THE PATTEIIT IS AVAILABLE TO SIGN FOR THE PACKAGE
`254
`
`TT'IE PHARMACIST ENTERS TT'IE Rx ORDER
`
`IN CHiPS, CREATING AN ORDER NUMBER
`
`256
`
`THE PHARMACIST VERIFES THE Rx AND ATTACHES THE
`VERIFICATION LABI-l TO THE HARD COPY Rx
`
`258
`
`A PICK TICKET IS GENERATED FOR THE ORDER & THE
`IRDER IS FORWARDED T0 TT-E PHARMACY FOR FULFILLMI
`260
`
`THE SHIPMENT IS CIINHRMEI)
`
`IN CHiPS
`
`262
`
`THE ORIGINAL RI IS HLED NNH THE PHARMACY
`Rx’S IN NUMERICAL. ORDER
`
`264
`THE ORDER IS SHIPPIJJ BY USPS EXPRESS MAIL
`
`244
`
`THE RECEIPT OF THE MATERIALS IS CONFIRMED AND
`ANOTHER CALI. IS SCHI-JJULED T0 COINSEL THE
`PATTEIIT BEFORE THE XYRDA IS SHIPPED
`
`252
`
`THE SHIPMENT MUST BE SENT TO THE PARENTS HOME
`ADDRESS UNIESS THE PATIENT IS TRAVEIJNG 0R HAS
`MOVED,
`IN WHICH CASE THE PHARMACIST WILL DETERMINE
`IF AN EXCEPTION WILL BE MADE. THE PATIBIT OR THE
`PATTENT'S DESIGNEE MUST SIGN FOR THE PACKAGE
`
`UPON DELNERY
`
`256
`INVENTORY Is CYCLE COUNTED AND
`ALL XYRHI
`RECONCILED WITH THE CHPS SYSTEM QUANITITES
`BEFORE HIE DAYS SHIPMENTS ARE SENT OUT
`
`“ FIG. 20
`
`PAR1025
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`Page 15 of 33
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`

`

`Case 2:11-cv-02523-ES-MAH Document 1 Filed 05/02/11 Page 16 of 33 PagelD: 16
`
`U.S. Patent
`
`Feb. 22, 2011
`
`Sheet 5 0f 16
`
`US 7,895,059 B2
`
`310
`
`PHYSICIAN SUCCESS
`
`PROGRAM MATERIALS
`
`REQUEST
`
`MD CALLS XYREM SUCCESS
`
`PROGRAM AT 1-856-XYREM88
`
`TO REQUEST PROGRAM
`
`MATERIALS
`
`AT MAIPRAFULFILLMENTCOM
`
`MD DEMOGRAPHICS. DEA#
`AND DATE OF REQUEST ARE
`
`ENTERED INTO CHiPS
`
`SDS REQUESTS MATERIALS TO
`
`BE SHIPPED TO THE MD VIA
`
`THE OMI FULFIIJ.MENT WEBSITE
`
`PAR1025
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`Page 16 of 33
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`

`Case 2:11-cv-02523-ES-MAH Document 1 Filed 05/02/11 Page 17 of 33 PagelD: 17
`
`U.S. Patent
`
`Feb. 22, 2011
`
`Sheet 6 of 16
`
`Us 7,895,059 B2
`
`402
`
`2 POSSIBLE REFILL
`
`REQUEST PROCESSES
`
`404
`
`EACH WEK A REFILL REPORT IS GENERATED OF
`PATIENTS WITH 10 DAYS OF PRODUCT REMAINING
`408
`
`A COPY OF THE REFILL REPORT IS PROVIDE)
`TO INTAKE/REIMBURSEMENT
`
`410
`
`N0 SOONER THAN 8 DAYS BEFORE MEDICATION
`
`DEPLENON, A PHARMACY TECHNICIAN CONTACTS THE
`PATIENT TO COMPLETE THE PRE—DEUVERY CHECKLIST
`
`412
`
`IS
`THE PATIENT
`
`REACHED?
`
`YES
`
`N0
`
`418
`
`THE PHARMACY TECHNICIAN SCHEDULES THE PATTENT'S
`SHIPMENT FOR THE NEXT BUSINESS DAY OR THE NEXT
`BUSINESS DAY TT'IE PATTENT IS AVAILABLE TO
`
`SIGN FOR THE PACKAGE
`
`THE PHARMACIST ENTERS THE Rx ORDER
`
`IN CHiPS, CREATING AN ORDER NUMBER
`
`420
`
`422
`
`THE PHARMACIST VERIHES TT-IE Rx AND ATTACHES TT-IE
`VERIFICATION LABEL TO THE HARD COPY Rx
`
`THE SHIPMENT IS CONHRMED N CHiPS
`
`424
`
`428
`
`A PICK TICKET IS GBIERATED FOR THE ORDER 8: THE
`RDER IS FORWARDI-JJ TO THE PHARMACY FOR FULFILLMI
`
`6
`
`A MESSAGE IS LEFT ONLY MENTIONING
`303 a A RETURN NUMBER
`
`414
`
`416
`
`A NOTE IS ENTERED IN THE CHiPS INDICATTNG TT-IE
`DATE TT-IE MESSAGE WAS LEFT FOR THE PATIENT
`
`426
`
`ALL XYREM INVENTORY IS CYCLE COIINTED AND
`
`RECONCILED WITH THE CHiPS SYSTDA OUANTNTES
`BI-IORE THE DAYS SHIPMENTS ARE SENT OUT
`
`.11- 430
`
`FIG. 4A
`
`PAR1025
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`Page 17 of 33
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`Page 17 of 33
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`

`Case 2:11-cv-02523-ES-MAH Document 1 Filed 05/02/11 Page 18 of 33 PagelD: 18
`
`U.S. Patent
`
`Feb. 22, 2011
`
`Sheet 7 of 16
`
`Us 7,895,059 B2
`
`406
`
`THE PARENT CALLS To REQUEST AN EARLY RBTLL
`432
`A NOTE CODE IS ENTERED IN CHIPS ON THE PATIENT
`SCREEN INDICAIIAC THE EARLY REFILL REQUEST
`436
`
`THE PHARMACIST EVALUATES THE PATENT'S
`COMPLIANCE WITH THERAPY AND/OR POSSIBLE PRODUCT
`DIVERSION, MISUSE 0R OVERUSE
`
`438
`
`THE PHARMAC'SI CONTACTS “IE PRESCR'B'NG
`PHYSICMN TO ALERT OF THE SRUARON AND CONHRM
`IF RE PHYSICIAN APPROVES 0F RIE EARLY REFILL
`
`434
`A XYRRA PROBLEM IDENRRCARON & MANAGEMENT RISK
`DIVERSION REPORT IS COMPLEIED & DOCUMENTI-J)
`IN
`CHPS. THE REPORT IS THEN FAXED TO OMI & NE
`
`ORIGINAL IS FILED IN A MONTHLY BATCH FILE
`
`442
`RIE PARENT MUST NAR UNRL RIE NEXT SCHEDULED
`Rm DATE To RECENE mnmom PRODUCT
`
`440
`
`N0
`
`DOES
`THE PHYSICIAN
`PROVE?
`
`m 444
`
`460
`
`YES
`
`446
`
`THE PANENT MUST WAIT UNNL THE NEXT SCHEDULED
`RI-J-"ll DATE T0 RECENE ADDIIIONAL PRODUCT
`
`THE PHARMACIST EIITERS A NOTE IN CHIPS
`
`IN THE PARENT SCREEN THAT THE PHYSICMN
`APPROVES THE REQUEST
`
`448
`THE PHARMACIST NORHES AN INTMAE/RBHBURSEMENT
`SPECMHST TO CONTACT THE PARENTS NSURANCE
`PROVIDER TO VERIFY COVERAGE FOR THE EARLY REHLL
`450
`
`
`
`N0
`
`_
`
`NO
`458
`IS THE
`PARENT MILL To
`
`
`PAY?
`
`462
`YES
`THE PAW IS INFORMED OF M COST OF M
`PRODUCT AND IS GIVEII PAYMENT OPRONS
`
`464
`
`ONCE PAYMENT IS RECEIVED THE 0an IS RllEASI-J)
`
`YES
`
`452
`
`466
`
`INTNIE/REIMBURSEMENT SUBMRS A COVERAGE APPROVAL
`FORM TO RIE PHARMACY TEAM AS NORRCARON RIAT
`THE PARENTS REHLL REQUEST CAN BE PROCESSED
`454
`
`INTAKE/IIMBURSDIEIR SUBMRS A COVERAGE APPROVAL
`FORM TO THE PHARMACY TEAM AS NORRCARON RIAT
`RE PARENT'S REFILL REQUEST CAN BE PROCISED
`468
`
`THE PHARMACY TECHNICMN CONTACTS THE PARENT To
`SCHEDUIE SHIPMENT OF THE PRODUCT FOR THE NEXT
`BUSINESS DAY 0R RIE NEXI BUSINESS DAY THE PARRR
`IS AVAILABLE TO SIGN TOR RIE PACKAGE
`
`
`
`RIE PHARMACY TECHNICMN CONTACTS II-IE PAREIR To
`SCHEDULE SHIPMEIR OF THE PRODUCT FOR THE NDR
`BUSINESS DAY OR THE NEXT BUSINESS DAY RIE PARENT
`IS AVAILABLE To SIGN FOR RIE PACKAGE
`
`CONTINUE
`
`456
`
`mm: 470
`
`FIG. 4B
`
`PAR1025
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`Page 18 of 33
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`Page 18 of 33
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`

`Case 2:11-cv-02523-ES-MAH Document 1 Filed 05/02/11 Page 19 of 33 PagelD: 19
`
`U.S. Patent
`
`Feb. 22, 2011
`
`Sheet 8 of 16
`
`Us 7,895,059 B2
`
`510
`
`UPON DETERMINING THAT A PATIENT IS UNINSURED OR
`
`
`
`UNDERINSURED. A REIMBURSEMENT SPECIALIST EXPLANS
`THE NORD PROGRAM TO THE PATIENT AND FAXES AN
`
`APPIJCATTON REQUEST FORM TO NORD FOR THE PATIBIT
`515
`
`THE INTAKE/REMBURSEMENT SPECIAIJST DOCUMBTIS
`IN CHiPS IT-IAT AN APPUCATION HAS BEBI REQUESTED
`THROUGH NORD
`
`520
`
`NORD NAILS A PAP APPucAIION TO THE
`
`PATIENT WITHIN I BUSINESS DAV
`
`525
`
`IS
`THE PATIENT
`
`APPROVE)?
`
`YES
`
`NO
`
`NORD SENDS A DENIAL LEITER TO DIE PARENT
`
`530
`
`545
`
`540
`
`NORD SENDS AN AccHPTANCE LEITER TO THE
`PATIENT AND FAXES A VOUCHER TO SDS INDICAIING THE
`PAIIEIITS APPROVAL FOR THE PROGRAM
`
`550
`
`SDS DOOUIIENIS IN OHPS THAT
`THE PATIEIIT WAS DENIED DV NORD
`
`AN INTAKE/REIMBURSEMENT SPECIAIJST SUBMIIS A
`COVERAGE APPROVAL FORM TO THE PHARMACY TEAM AS
`
`FOR COVERAGE THROUGH NORD
`
`NOTIFICATION THAT THE PATIENT HAS BEEN APPROVED
`
`PAR1025
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`Page 19 of 33
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`Page 19 of 33
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`Case 2:11-cv-02523-E