Case 113-cv-01206-LPS
`
`Document 257-1
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`Filed 10/26/15
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`Page
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`of 590 Page ID
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`3553
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`1N THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
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`UCB 1NC UCB BIOPHARMA SPRL
`RESEARCH CORPORATION
`TECHNOLOGiES INC and
`HARRIS FRC CORPORATiON
`
`Plaintiffs
`
`ACCORD HEALTHCARE iNC et al
`
`Defendants
`
`C.A No 13-1206 LPS
`CONSOLIDATED
`
`EXHIBIT
`
`PLAINTIFFS AND DEFENDANTS
`JOINT STATEMENT OF UNCONTESTED FACTS
`
`Breckenridge Exhibit 1004
`Breckenridge v. Research Corporation Technologies, Inc.
`
`
`
`Document 257-1
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`Filed 10/26/15
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`Page
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`of 590 Page ID
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`3553
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`1N THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`UCB 1NC UCB BIOPHARMA SPRL
`RESEARCH CORPORATION
`TECHNOLOGiES INC and
`HARRIS FRC CORPORATiON
`
`Plaintiffs
`
`ACCORD HEALTHCARE iNC et al
`
`Defendants
`
`C.A No 13-1206 LPS
`CONSOLIDATED
`
`EXHIBIT
`
`PLAINTIFFS AND DEFENDANTS
`JOINT STATEMENT OF UNCONTESTED FACTS
`
`Breckenridge Exhibit 1004
`Breckenridge v. Research Corporation Technologies, Inc.
`
`
`
`Case 113-cv-01206-LPS
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`Document 257-1
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`Filed 10/26/15
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`of 590 Page ID
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`3554
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`EXHIBIT
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`PARTIES
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`UCBs VIMPAT
`
`PATENT-Th1-SUIT U.S Patent No RE38551
`
`DEFENDANTS ABBREVIATED NEW DRUG APPLICATIONS
`
`II
`
`III
`
`IV
`
`AccordsANDANo.205011
`
`Alembics ANDANo 204974
`
`Amneals ANDA No 204857 and 204839
`
`Aurobindos ANDANo 204994
`
`Breckenridge and Vennoots ANDANo 204921
`
`SunsANDANo 205031
`
`ActavissANDANo 204855
`
`Apotexs ANDA Nos 204986 and 206355
`
`Mylans ANDANo 205026
`
`Zyduss ANDANo 204947
`
`Th1FRTh1GEMENT
`
`Accord and Intas ANDA Products
`
`Alembics ANDA Products
`
`Amneal ANDA Products
`
`Aurobindos ANDA Products
`
`Breckenridge and Vennoot ANDA Products
`
`SunsANDAProducts
`
`Actaviss ANDA Products
`
`Apotexs ANDA Products
`
`Mylans ANDA Products
`
`10
`
`10
`
`11
`
`12
`
`12
`
`13
`
`13
`
`
`
`Case 113-cv-01206-LPS
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`Document 257-1
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`Zyduss ANDA Products
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`VI
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`AUTHENTICITY OF DOCUMENTS
`
`VII
`
`PRIOR ART
`
`Pharmacologic Therapy for Epilepsy
`
`Specific References
`
`14
`
`14
`
`15
`
`15
`
`15
`
`11
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`
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`Case 113-cv-01206-LPS
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`Document 257-1
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`Filed 10/26/15
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`3556
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`PLAINTIFFS AND DEFENDANTS
`JOINT STATEMENT OF UNCONTESTED FACTS
`
`PARTIES1
`
`Plaintiff UCB Inc is
`
`corporation organized and existing under the laws
`
`of Delaware having
`
`principal place of business at 1950 Lake Park Drive Smryna Georgia
`
`30080
`
`Plaintiff UCB BioPharma SPRL together with UCB Inc UCB is
`
`corporation organized and existing under the laws of Belgium having
`
`principal place of
`
`business at Allée de la Recherche 60 Brussels 1070 Belgium
`
`Plaintiff Research Corporation Technologies
`
`Inc RCT is
`
`corporation organized and existing under the laws of Delaware having
`
`principal place of
`
`business at 5210 East Williams Circle Suite 240 Tucson Arizona 85711-441
`
`Plaintiff Harris FRC Corporation Harris is
`
`corporation organized and
`
`existing under the laws of New Jersey having
`
`principal place of business at 2137 State
`
`Highway 35 Holmdel New Jersey 07733
`
`Defendant Accord Healthcare Inc Accord is
`
`corporation organized
`
`and existing under the laws of North Carolina having
`
`principal place of business at 1009 Slater
`
`Road Ste 210-B Durham North Carolina 27703
`
`Defendant
`
`Intas Pharmaceuticals Ltd Intas is
`
`corporation organized
`
`and existing under the laws of India having
`
`principal place of business at Chinubhai Centre
`
`off Nehru Bridge Ashram Road Ahmedabad 380009 Gujarat India
`
`Each individual defendant is stipulating only to facts relating to itself and not to facts relating to
`other defendants
`
`
`
`Case 113-cv-01206-LPS
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`Defendant Alembic Pharmaceuticals Ltd Alembic is
`
`corporation
`
`organized and existing under the laws of India having
`
`principal place of business at Alembic
`
`Road Vadodara-390 003 Gujarat India
`
`Defendant Amneal Pharmaceuticals LLC Amneal is
`
`corporation
`
`organized and existing under the laws of Delaware having
`
`principal place of business at 400
`
`Crossing Boulevard 3rd Floor Bridgewater New Jersey 08807
`
`Defendant Amneal Pharmaceuticals of New York LLC is
`
`corporation
`
`organized and existing under the laws of Delaware having
`
`principal place of business at 85
`
`Adams Avenue Hauppauge New York 11788
`
`10
`
`Defendant Aurobindo Pharma Ltd Aurobindo is
`
`corporation
`
`organized and existing under the laws of India having
`
`principal place of business at Plot
`
`Maitrivihar Ameerpet Hyderabad
`
`500038 Telagana India
`
`11
`
`Defendant Aurobindo Pharma USA Inc is
`
`corporation organized and
`
`existing under the laws of Delaware having
`
`principal place of business at Wheeling Road
`
`Dayton New Jersey 08810
`
`12
`
`Defendant Breckenridge Pharmaceutical
`
`Inc Breckenridge is
`
`corporation organized and existing under the laws of Florida having
`
`principal place of
`
`business at 6111 Broken Sound Parkway NW Suite 170 Boca Raton Florida 33487
`
`13
`
`Defendant Vennoot Pharmaceuticals LLC Vennoot is
`
`corporation
`
`organized and existing under the laws of Georgia having
`
`principal place of business at 11009
`
`Estates Circle Alpharetta Georgia 30022
`
`
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`Case 113-cv-01206-LPS
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`14
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`Defendant Sun Pharma Global FZE Sun is
`
`corporation organized and
`
`existing under the laws of United Arab Emirates having
`
`principal place of business at
`
`Executive Suite 43 Block
`
`SAlE-Zone P0 Box 122304 Sharjah U.A.E
`
`15
`
`Defendant Sun Pharmaceutical
`
`Industries Ltd is
`
`corporation organized
`
`and existing under the laws of India having
`
`principal place of business at SUN HOUSE CTS
`
`No 201 B/i Western Express Highway Goregaon
`
`Mumbai 400063 India
`
`16
`
`Defendant Watson Laboratories Inc
`
`Florida n/k/a Actavis Laboratories
`
`FL Inc Actavis is
`
`corporation organized and existing under the laws of Florida having
`
`principal place of business at 4955 Orange Drive Fort Lauderdale Florida 33314
`
`17
`
`Defendant Watson Pharma Inc n/k/a Actavis Pharma Inc is
`
`corporation organized and existing under the laws of Delaware having
`
`principal place of
`
`business at Morris Corporate Center III 400 Interpace Parkway Parsippany New Jersey 07054
`
`18
`
`Defendant Actavis Inc is
`
`corporation organized and existing under the
`
`laws of Nevada having
`
`principal place of business at Morris Corporate Center III 400
`
`Interpace Parkway Parsippany New Jersey 07054
`
`19
`
`Defendant Apotex Corp together with Apotex Inc Apotex is
`
`corporation organized and existing under the laws of Delaware having
`
`principal place of
`
`business at 2400 North Commerce Parkway Suite 400 Weston Florida 33326
`
`20
`
`Defendant Apotex Inc is
`
`corporation organized and existing under the
`
`laws of Canada having
`
`principal place of business at 150 Signet Drive Toronto Ontario
`
`Canada M9L
`
`T9
`
`
`
`Case 113-cv-01206-LPS
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`21
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`Defendant Mylan Pharmaceuticals Inc is
`
`corporation organized and
`
`existing under the laws of West Virginia having
`
`principal place of business at 781 Chestnut
`
`Ridge Road Morgantown West Virginia 26505
`
`22
`
`Defendant Mylan Inc is
`
`corporation organized and existing under the
`
`laws of Pennsylvania having
`
`principal place of business at 1500 Corporate Drive Canonsburg
`
`Pennsylvania 15317
`
`23
`
`Defendant Zydus Pharmaceuticals USA Inc is
`
`corporation organized
`
`and existing under the laws of New Jersey having
`
`principal place of business at 73 Route 31
`
`North Pennington New Jersey 08534
`
`24
`
`Defendant Cadila Healthcare Limited is
`
`corporation organized and
`
`existing under the laws of India having
`
`principal place of business at Zydus Tower Satellite
`
`Cross Roads Ahmedabad 380015 Gujarat India
`
`II
`
`UCBs VIMPAT
`UCB is the holder of New Drug Application NDA Nos 022-253 022-
`254 and 022-255 which cover an anti-epileptic drug known by the trade name VIMIPAT
`
`25
`
`26
`
`The active ingredient of VIMIPAT is
`
`compound called lacosamide
`
`27
`
`On October 28 2008 NDA Nos 022-253 022-254 were approved by the
`Food and Drug Administration FDA to authorize the commercial marketing of VIMIPAT
`
`tablets and injection as an adjunctive therapy in patients age 17 years or older for partial on-set
`
`seizures
`
`Injection is indicated as short term replacement when oral administration is not feasible
`
`in these patients
`
`28
`
`On April 20 2010 NDA No 022-25 was approved by the FDA to
`
`authorize the commercial marketing of VIMIPAT oral solution as an adjunctive therapy in
`
`patients age 17 years or older for partial on-set seizures
`
`
`
`Case 113-cv-01206-LPS
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`In August 2014 NDA Nos 022-253 022-254 and 022-254 were further
`
`approved as monotherapy in patients age 17 years or older for partial on-set seizures
`
`III
`
`PATENT-IN-SUIT U.S Patent No RL38551
`
`30
`
`The patent-in-suit is United States Patent No RE 38551 the 551
`
`Patent JTX-OO1 Harold Kohn is named as the inventor of the 551 Patent which was filed
`
`on January 28 2002 The 551 Patent
`
`is
`
`reissue of U.S Patent No 5773475 and claims
`
`priority to provisional patent application No 60/013522
`
`filed on March 15 1996 The 551
`
`Patent
`
`issued on July
`
`2004 The 551 Patent will expire no later than March 17 2022
`
`31
`
`RCT is the current owner of the 551 Patent Harris is the exclusive
`
`licensee of the 551 Patent UCB BioPharma SPRL is the exclusive sublicensee of the 551
`
`Patent
`
`for use in humans
`
`32
`
`In the FDAs Orange Book the 551 Patent
`
`is listed in the entries for
`
`VIMPAT
`
`IV
`
`DEFENDANTS ABBREVIATED NEW DRUG APPLICATIONS
`
`Accords ANDA No 205011
`
`Accord submitted to the FDA Abbreviated New Drug Application
`33
`ANDA No 205011 under the provisions of 21 U.S.C 355j seeking approval
`
`to engage in
`
`the commercial manufacture use offer for sale sale and/or
`
`importation of
`
`generic copy of
`
`UCBs VIMPAT products
`
`34
`
`Accords ANDA included
`
`certification under 21 U.S.C
`
`35 5j2AviiIV asserting that
`
`in their opinion the 551 Patent
`
`is invalid unenforceable
`
`or will not be infringed by the manufacture use offer for sale and/or
`
`importation of Accord and
`
`Intas ANDA Products
`
`
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`Case 113-cv-01206-LPS
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`Alembics ANDA No 204974
`
`35
`
`Alembic submitted to the FDA ANDA No 204974 under the provisions of
`
`21 U.S.C 355j seeking approval
`
`to engage in the commercial manufacture use or sale of
`
`lacosamide tablets
`
`36
`
`Alembics ANDA included
`
`certification under 21 U.s.c
`
`355j2AviiIV asserting that
`
`in its opinion the 551 Patent
`
`is invalid unenforceable or
`
`will not be infringed by the commercial manufacture use or sale of Alembics ANDA Products
`
`Amneals ANDA No 204857 and 204839
`
`37
`
`Amneal submitted to the FDA ANDA No 204857 and 204839 under the
`
`provisions of 21 U.S.C 355j seeking approval
`
`to engage in the commercial manufacture
`
`use offer for sale sale and/or
`
`importation of generic lacosamide tablets 50 mg 100 mg 150 mg
`
`and 200 mg and lacosamide oral solution 10 mg/mL
`
`38
`
`Amneals ANDA included
`
`certification under 21 U.S.C
`
`355j2AviiIV asserting that
`
`in its opinion the 551 Patent
`
`is invalid unenforceable or
`
`will not be infringed by the manufacture use offer for sale and/or
`
`importation of Amneals
`
`ANDA Products
`
`Aurobindos ANDA No 204994
`
`39
`
`Aurobindo submitted to the FDA ANDA No 204994 under the provisions
`
`of 21 U.S.C 355j seeking approval
`
`to engage in the commercial manufacture use offer for
`
`sale sale and/or
`
`importation of generic lacosamide tablets 50 mg 100 mg 150 mg and 200 mg
`
`40
`
`Aurobindos ANDA included
`
`certification under 21 U.S.C
`
`355j2AviiIV asserting that
`
`in its opinion the 551 Patent
`
`is invalid unenforceable or
`
`will not be infringed by the manufacture use offer for sale and/or
`
`importation of Aurobindo
`
`ANDA Products
`
`
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`Case 113-cv-01206-LPS
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`Document 257-1 Filed 10/26/15
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`Page 10 of 590 PagelD
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`3562
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`Breckenridge and Vennoots ANDA No 204921
`
`41
`
`Breckenridge and Vennoot submitted to the FDA ANDA No 204921
`
`under the provisions of 21 U.S.C 355j seeking approval
`
`to engage in the commercial
`
`manufacture use offer for sale sale and/or
`
`importation of generic lacosamide tablets 50 mg
`
`100 mg 150 mg and 200 mg
`
`42
`
`Breckenridge and Vennoots ANDA included
`
`certification under 21
`
`U.S.C 355j2AviiIV asserting that in their opinion the 551 Patent is invalid
`
`unenforceable or will not be infringed by the manufacture use offer for sale and/or
`
`importation
`
`of Breckenridge and Vennoots ANDA Products
`
`Suns ANDA No 205031
`
`43
`
`Sun submitted to the FDA ANDA No 205031 under the provisions of 21
`
`U.S.C 355j seeking approval
`
`to engage in the commercial manufacture use offer for sale
`
`sale and/or
`
`importation of lacosamide tablets 50 mg 100 mg 150 mg and 200 mg
`
`44
`
`Suns ANDA included
`
`certification under 21 U.S.C
`
`355j2AviiIV asserting that
`
`in its opinion the 551 Patent
`
`is invalid unenforceable or
`
`will not be infringed by the manufacture use offer for sale and/or
`
`importation of Suns ANDA
`
`Products
`
`Actaviss ANDA No 204855
`
`45
`
`Actavis submitted to the FDA ANDA No 204855 under the provisions of
`
`21 U.S.C 355j seeking approval
`
`to engage in the commercial manufacture use offer for
`
`sale sale and/or
`
`importation of generic lacosamide tablets 50 mg 100 mg 150 mg and 200 mg
`
`46
`
`Actaviss ANDA included
`
`certification under 21 U.S.C
`
`355j2AviiIV asserting that
`
`in its opinion the 551 Patent
`
`is invalid unenforceable or
`
`
`
`Case 113-cv-01206-LPS
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`Document 257-1 Filed 10/26/15
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`Page 11 of 590 PagelD
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`3563
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`will not be infringed by the manufacture use offer for sale and/or
`
`importation of Actaviss
`
`ANDA Products
`
`Apotexs ANDA Nos 204986 and 206355
`
`47
`
`Apotex submitted to the FDA ANDA Nos 204986 and 206355 under the
`
`provisions of 21 U.S.C 355j seeking approval
`
`to engage in the commercial manufacture use
`
`or sale of Apotex ANDA Products
`
`48
`
`Apotexs ANDA included
`
`certification under 21 U.s.c
`
`355j2AviiIV asserting that
`
`in its opinion the 551 Patent
`
`is invalid unenforceable
`
`and/or will not be infringed by the commercial manufacture use or sale of Apotexs ANDA
`
`Products
`
`Mylans ANDA No 205026
`
`49
`
`Mylan submitted to the FDA ANDA No 205026 under the provisions of
`
`21 U.S.C 355j seeking approval
`
`to engage in the commercial manufacture use offer for
`
`sale sale and/or
`
`importation of generic lacosamide tablets 50 mg 100 mg 150 mg and 200 mg
`
`Mylan ANDA Products
`
`50
`
`Mylans ANDA included
`
`certification under 21 U.S.C
`
`355j2AviiIV asserting that
`
`in its opinion the 551 Patent
`
`is invalid unenforceable or
`
`will not be infringed by the manufacture use offer for sale and/or
`
`importation of Mylans
`
`ANDA Products
`
`Zyduss ANDA No 204947
`
`51
`
`Zydus submitted to the FDA ANDA No 204947 under the provisions of
`
`21 U.S.C 355j seeking approval
`
`to engage in the commercial manufacture use offer for
`
`sale sale and/or
`
`importation of generic lacosamide tablets 50 mg 100 mg 150 mg and 200 mg
`
`
`
`Case 113-cv-01206-LPS
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`Document 257-1 Filed 10/26/15
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`Page 12 of 590 PagelD
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`3564
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`52
`
`Zyduss ANDA included
`
`certification under 21 U.s.c
`
`355j2AviiIV asserting that
`
`in its opinion the 551 Patent
`
`is invalid unenforceable or
`
`will not be infringed by the manufacture use offer for sale and/or
`
`importation of Zydus
`
`ANDA Products
`
`INFRINGEMENT
`
`Accord and Intass ANDA Products
`
`53
`
`The filing of Accord and Intass ANDANo 205011 meets all of the
`
`elements of asserted claims
`
`10 and 13 of the 551 Patent under 35 U.S.C 271e2 See DI
`
`208
`
`54
`
`Accord and Intas ANDA Products or the administration of Accord and
`
`Intass ANDA Products according to their indicated use will meet all of the elements of the
`
`asserted claims
`
`10 and 13 of the 551 Patent
`
`See DI 208
`
`55
`
`Upon final approval of Accord and Intass ANDA No 205011 the
`
`commercial manufacture use sale or offer for sale within the United States or importation into
`
`the United States of Accord and Intas ANDA Products and their administration according to
`
`their indicated use will meet all of the elements of the asserted claims
`
`10 and 13 of the 551
`
`Patent See DI 208
`
`Alembics ANDA Products
`
`56
`
`The filing of Alembics ANDA No 204974 meets all of the elements of
`
`asserted claims
`
`10 and 13 of the 551 Patent under 35 U.S.C 271e2 if those claims are
`
`not found to be invalid or unenforceable
`
`See DI 210
`
`57
`
`Alembics ANDA Products or the administration of Alembics ANDA
`
`Products according to their indicated use will meet all of the elements of the asserted claims
`
`
`
`Case 113-cv-01206-LPS
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`Document 257-1 Filed 10/26/15
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`Page 13 of 590 PagelD
`
`3565
`
`10 and 13 of the 551 Patent
`
`if those claims are not found to be invalid or unenforceable
`
`See
`
`DI 210
`
`58
`
`Upon final approval of Alembics ANDA No 204974 the commercial
`
`manufacture use sale or offer for sale within the United States or importation into the United
`
`States of Alembics ANDA Products and their administration according to their indicated use
`
`will meet all of the elements of the asserted claims
`
`10 and 13 of the 551 Patent
`
`if those
`
`claims are not found to be invalid or unenforceable
`
`See DI 210
`
`Amneals ANDA Products
`
`59
`
`The submission of Amneals ANDA Nos 204857 and 204839 to the FDA
`
`met all of the elements of asserted claims
`
`10 and 13 of the 551 Patent under 35 U.S.C
`
`271e2A if those claims are not found to be invalid or unenforceable
`
`See DI 199
`
`60
`
`Amneals ANDA Products or the administration of Amneals ANDA
`
`Products according to their indicated use will meet all of the elements of the asserted claims
`
`10 and 13 of the 551 Patent
`
`if those claims are not found to be invalid or unenforceable
`
`See
`
`DI 199
`
`61
`
`Upon final approval of Amneals ANDANos 204857 and 204839 the
`
`commercial manufacture use sale or offer for sale within the United States or importation into
`
`the United States of Amneals ANDA Products and their administration according to their
`
`indicated use will meet all of the elements of the asserted claims
`
`10 and 13 of the 551
`
`Patent
`
`if those claims are not found to be invalid or unenforceable
`
`See DI 199
`
`Aurobindos ANDA Products
`
`62
`
`The submission of Aurobindos ANDA No 204994 to the FDA met all of
`
`the elements of asserted claims
`
`10 and 13 of the 551 Patent under 35 U.S.C 271e2A
`
`if those claims are not found to be invalid or unenforceable
`
`See DI 203
`
`10
`
`
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`Case 113-cv-01206-LPS
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`Document 257-1 Filed 10/26/15
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`Page 14 of 590 PagelD
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`3566
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`63
`
`Aurobindos ANDA Products or the administration of Aurobindos
`
`ANDA Products according to their indicated use will meet all of the elements of the asserted
`
`claims
`
`10 and 13 of the 551 Patent
`
`if those claims are not found to be invalid or
`
`unenforceable
`
`See DI 203
`
`64
`
`Upon final approval of Aurobindos ANDANo 204994 the commercial
`
`manufacture use sale or offer for sale within the United States or importation into the United
`
`States of Aurobindo ANDA Products and their administration according to their indicated
`
`use will meet all of the elements of the asserted claims
`
`10 and 13 of the 551 Patent
`
`if those
`
`claims are not found to be invalid or unenforceable
`
`See DI 203
`
`Breckenridge and Vennoots ANDA Products
`
`65
`
`The submission of Breckenridge and Vennoots ANDA No 204921 to the
`
`FDA met all of the elements of asserted claims
`
`10 and 13 of the 551 Patent under 35 U.S.C
`
`271e2A if those claims are not found to be invalid or unenforceable
`
`See DI 202
`
`66
`
`Breckenridge and Vennoot ANDA Products or the administration of
`
`Breckenridge and Vennoot ANDA Products according to their indicated use will meet all of the
`
`elements of the asserted claims
`
`10 and 13 of the 551 Patent
`
`if those claims are not found to
`
`be invalid or unenforceable
`
`See DI 202
`
`67
`
`Upon final approval of Breckenridge and Vennoots ANDA No 204921
`
`the commercial manufacture use sale or offer for sale within the United States or importation
`
`into the United States of Breckenridge and Vennoots ANDA Products and their administration
`
`according to their indicated use will meet all of the elements of the asserted claims
`
`10 and 13
`
`of the 551 Patent
`
`if those claims are not found to be invalid or unenforceable
`
`See DI 202
`
`11
`
`
`
`Case 113-cv-01206-LPS
`
`Document 257-1 Filed 10/26/15
`
`Page 15 of 590 PagelD
`
`3567
`
`Sun
`
`ANDA Products
`
`68
`
`The submission of Suns ANDA No 20503 ito the FDA met all of the
`
`elements of asserted claims
`
`iO and i3 of the 55i Patent under 35 U.S.C 27ie2A if
`
`those claims are not found to be invalid or unenforceable
`
`See DI 20i
`
`69
`
`Suns ANDA Products or the administration of Suns ANDA Products
`
`according to their indicated use will meet all of the elements of the asserted claims
`
`iO and i3
`
`of the 55i Patent
`
`if those claims are not found to be invalid or unenforceable
`
`See DI 20i
`
`70
`
`Upon final approval of Suns ANDANo 20503i
`
`the commercial
`
`manufacture use sale or offer for sale within the United States or importation into the United
`
`States of Suns ANDA Products and their administration according to their indicated use will
`
`meet all of the elements of the asserted claims
`
`iO and i3 of the 55i Patent
`
`if those claims
`
`are not found to be invalid or unenforceable
`
`See DI 20i
`
`Actaviss ANDA Products
`
`7i
`
`The submission of Actaviss ANDANo 204855 to the FDA met all of the
`
`elements of asserted claims
`
`iO and i3 of the SSi Patent under 35 U.S.C 27ie2A if
`
`those claims are not found to be invalid or unenforceable
`
`See DI 200
`
`72
`
`Actaviss ANDA Products or the administration of Actaviss ANDA
`
`Products according to their indicated use will meet all of the elements of the asserted claims
`
`iO and i3 of the 55 Patent
`
`if those claims are not found to be invalid or unenforceable
`
`See
`
`DI 200
`
`73
`
`Upon final approval of Actaviss ANDA No 204855 the commercial
`
`manufacture use sale or offer for sale within the United States or importation into the United
`
`States of Actavis ANDA Products and their administration according to their indicated use
`
`i2
`
`
`
`Case 113-cv-01206-LPS
`
`Document 257-1 Filed 10/26/15
`
`Page 16 of 590 PagelD
`
`3568
`
`will meet all of the elements of the asserted claims
`
`10 and 13 of the 551 Patent
`
`if those
`
`claims are not found to be invalid or unenforceable
`
`See DI 200
`
`Apotexs ANDA Products
`
`74
`
`The filing of Apotexs ANDA Nos 204986 and 206355 meets all of the
`
`elements of asserted claims
`
`10 and 13 of the 551 Patent under 35 U.S.C 271e2 if those
`
`claims are not found to be invalid or unenforceable
`
`See Dkt 216
`
`75
`
`Apotexs ANDA Products or the administration of Apotexs ANDA
`
`Products according to their indicated use will meet all of the elements of the asserted claims
`
`10 and 13 of the 551 Patent if those claims are not found to be invalid or unenforceable
`
`See
`
`DI 216
`
`76
`
`Upon final approval of Apotexs ANDANos 204986 and 206355 the
`
`commercial manufacture use sale or offer for sale within the United States or importation into
`
`the United States of Apotexs ANDA Products and their administration according to their
`
`indicated use will meet all of the elements of the asserted claims
`
`10 and 13 of the 551 Patent
`
`if those claims are not found to be invalid or unenforceable
`
`See DI 216
`
`Mylans ANDA Products
`
`77
`
`The submission of Mylans ANDA No 204994 to the FDA infringed
`
`asserted claims
`
`10 and 13 of the 551 Patent under 35 U.S.C 271e if those claims are not
`
`found to be invalid or unenforceable
`
`See DI 211
`
`78
`
`Upon final approval of Mylans ANDANo 204994 the commercial
`
`manufacture use sale or offer for sale within the United States or importation into the United
`
`States of Mylans ANDA Products and their administration according to their indicated use
`
`would infringe asserted claims
`
`10 and 13 of the 551 Patent
`
`if those claims are not found to
`
`be invalid or unenforceable
`
`See DI 211
`
`13
`
`
`
`Case 113-cv-01206-LPS
`
`Document 257-1 Filed 10/26/15
`
`Page 17 of 590 PagelD
`
`3569
`
`Zyduss ANDA Products
`
`79
`
`The submission of Zyduss ANDANo 204947 meets all of the elements
`
`of asserted claims
`
`10 as it depends from claim and 13 as it depends from claims
`
`11 and
`
`12 of the 551 Patent under 35 U.S.C 271e2A if those claims are not found to be invalid
`
`or unenforceable
`
`See DI 215
`
`80
`
`Zyduss ANDA Products or the administration of Zyduss ANDA
`
`Products according to their indicated use will meet all of the elements of the asserted claims
`
`10 and 13 of the 551 Patent if those claims are not found to be invalid or unenforceable
`
`See
`
`DI 215
`
`81
`
`Upon final approval of Zydus ANDA No 204947 the commercial
`
`manufacture use sale or offer for sale within the United States or importation into the United
`
`States of Zyduss ANDA Products and their administration according to their indicated use will
`
`meet all of the elements of the asserted claims
`
`10 and 13 of the 551 Patent
`
`if those claims
`
`are not found to be invalid or unenforceable
`
`See DI 215
`
`VI
`
`AUTHENTICITY OF DOCUMENTS
`
`82
`
`The parties do not dispute the authenticity of documents produced with the
`
`following bates prefixes
`
`DEF
`KOHN VIM
`RCT-VIM
`UCB-VIM
`HAR VIM
`PLS VIM
`
`14
`
`
`
`Case 113-cv-01206-LPS
`
`Document 257-1 Filed 10/26/15
`
`Page 18 of 590 PagelD
`
`3570
`
`VII
`
`PRIOR ART
`
`Pharmacologic Therapy for Epilepsy
`Before the March 15 1996 more than 20 antiepileptic drugs AEDs
`
`83
`
`had been marketed to patients in the United States including phenobarbital mephobarbital
`
`phenytoin trimethadione mephenytoin paramethadione phenythenylate
`
`phenacemide
`
`metharbital benzchloropropionamide aminoglutethimide acetazolamide phensuximide
`
`primidone methsuximide ethotoin methazolamide ethosuximide diazepam carbamazepine
`
`clonazepam lorazepam valproic acid clorazepate felbamate gabapentin and lamotrigine
`
`84
`
`Lacosamide first
`
`launched on the U.S market in 2008 as adjunctive or
`
`add-on therapy for partial-onset seizures
`
`85
`
`Lacosamide had been formerly identified by or referred to as SPM 927
`
`ADD 234037 or harkoseride
`
`Specific References
`
`86
`
`For purposes of this litigation the following references are prior art to the
`
`551 patent under 35 U.S.C
`
`102 and 103
`
`U.S Patent No 5378729 to Kohn and Watson DTX-2012
`
`European Patent Application No
`
`194 464 DTX-2219
`
`European Patent Application No
`
`263 506 DTX-2221
`
`European Patent Application No
`
`400 440 DTX-2222
`
`Aldrich Handbook of Fine Chemicals Catalog 1994 DTX-2223
`
`New Route to the Synthesis of Amino Acids
`Amoroso et al
`Through the Mercury Cyclization of Chiral Amidals Org Chem
`571082-1087 1992 DTX-2224
`
`Basis For Sophisticated
`Ariens E.J Stereochemistry
`Nonsense In Pharmacokinetics And Clinical Pharmacology Eur
`Clin Pharmacol 26663-668 1984 DTX-2225
`
`15
`
`
`
`Case 113-cv-01206-LPS
`
`Document 257-1 Filed 10/26/15
`
`Page 19 of 590 PagelD
`
`3571
`
`Ethical And Regulatory
`Ariens E.J Racemic Therapeutics
`Aspects Eur Clin Pharmacol 4189-93 1991 DTX-2226
`
`Svante Axelsson et al Versatile Synthesis of Stereospecifically
`Chem Soc Perkin
`Labelled D-Amino Acids via Labelled Aziridines
`Trans 1807-815 1994 Axelsson 1994 DTX-2227
`
`Patrick Bardel et al Synthesis and Anticonvulsant Activities of cc
`Acetamido-N-Benzylacetamide Derivatives Containing an Electron-
`Deficient a-Heteroaromatic Substituent 37 Med Chem 4567-4571
`1994 Bardel 1994
`JTX-065
`
`Synthesis of Functionalized Amino Acids and Studies on
`Bardel
`Their Site and Mode of Action for the Control of Convulsants Disorders
`dissertation presented to the Faculty of the Department of Chemistry
`University of Houston May 1994 Bardel Thesis JTX-096
`
`M.N Cayen Racemic Mixtures And Single Stereoisomers Industrial
`Concerns And Issues In Drug Development Chirality Vol 394-98
`1991 Cayen 1991 DTX-2228
`
`Cerrini et al Serine-Containing lO-Membered Cyclodepsipeptides
`Peptide Protein Res 282 1993 Cerrini 1993 DTX-2229
`41 Intl
`
`Judith
`
`Potent New
`Conley Functionalized Amino Acid Derivatives
`and
`Agents for the Treatment of Epilepsy Synthesis and Spectroscopic
`Pharmacological Properties May 1986 Conley thesis JTX-006
`
`Harold Kohn Functionalized DL-Amino Acid
`Judith
`Conley
`Derivatives Potent New Agents for the Treatment of Epilepsy 30
`Med Chem 567-674 1987 Conley 1987 JTX-007
`
`Sergio Cortes et al Effect of Structural Modification of the Hydantoin
`Ring on Anticonvulsant Activity 28 Med Chem 60 1-606 1985
`Cortes JTX-057
`
`DeCamp The FDA Perspective On The Development Of
`Stereoisomers Chirality Vol 12-6 1989 DeCamp 1989 DTX
`2230
`
`FDA Guideline For Submitting Supporting Documentation In Drug
`Applications For The Manufacture Of Drug Substances February 1987
`FDA Guidelines 1987 DTX-223
`
`FDA Policy Statement For The Development Of New Stereoisomeric
`Drugs Chirality Vol 433 8-340 1992 FDA Policy 1992 DTX
`2232
`
`16
`
`
`
`Case 113-cv-01206-LPS
`
`Document 257-1 Filed 10/26/15
`
`Page 20 of 590 PagelD
`
`3572
`
`FDA Guideline for Industry Dose-Response
`Information to Support
`Drug Registration Nov 1994 FDA Dose-Response Guidance
`DTX-223
`
`C.N Hinko Anticonvulsant Activity of Novel Derivatives of 2- and 3-
`Piperidinecarboxylic Acid In Mice And Rats Neuropharmacology Vol
`351721-1735 1996 Hinko 1996 JTX-089
`
`Jaeger et al Enzymatic Resolution of O-Methyl-N-acetyl-DL-serine
`Amino Acids XXXII 28 Croat Chem Acta 1956 Jaeger 1956
`DTX-223
`
`Oliver Keil et al New Hydantoinases
`from Thermophilic
`Synthesis of Enantiomerically Pure D-Amino
`Microorganisms
`1257-1260 1995 Keil 1995
`AcidsTetrahedron Asymmetry
`DTX-223
`
`Harold Kohn et al Marked Stereospecificity in New Class of
`Anticonvulsants 457 Brain Res 371-375 1988 Kohn 1988 JTX
`010
`
`Conley New Antiepileptic Agents 24
`Harold Kohn
`Chemistry in Britain 231-234 March 1988 Kohn
`Conley 1988
`JTX-009
`
`Judith
`
`Harold Kohn et al Preparation and Anticonvulsant Activity of Series
`of Functionalized cc-Aromatic and cc-Heteroaromatic Amino Acids 33
`Med Chem 919-926 1990 Kohn 1990 JTX-011
`
`Harold Kohn et al Preparation and Anticonvulsant Activity of Series
`Amino Acids 34 Med
`of Functionalized cc-Heteroatom-Substituted
`Chem 2444-2452 1991 Kohn 1991 JTX-080
`
`Harold Kohn et al Synthesis and Anticonvulsant Activities of
`Heterocyclic a-Acetamido-N-Benzylacetamide Derivatives 36 Med
`Chem 3350-3360 1993 Kohn 1993 JTX-056
`
`Harold Kohn et al Anticonvulsant Properties of N-Substituted cccc
`Pharmaceutical Sci 689-69 May
`Diamino Acid Derivatives 83
`1994 Kohn 1994 JTX-067
`
`CS Kumkumian The Use Of Stereochemically Pure Pharmaceuticals
`in Drug Stereochemistry Analytical Methods and Pharmacology Ch
`Drayer Kumkumian 1988
`12 pp 299-3 10 1988 eds Wainer
`DTX-223
`
`aa
`
`bb
`
`cc
`
`dd
`
`17
`
`
`
`Case 113-cv-01206-LPS
`
`Document 257-1 Filed 10/26/15
`
`Page 21 of 590 PagelD
`
`3573
`
`Philippe LeGall 2-Substituted-2-acetamido-N-benzylacetamides
`and Anticonvulsant Properties Dec 1987
`Synthesis Spectroscopic
`LeGall thesis DTX-2019
`
`Phillipe LeGall et al Synthesis ofFunctionalizedNon-NaturalAmino
`Acid Derivatives via Amidoalky/ation Transformations 32 Tnt
`Peptide Protein Res 279-29 1988 LeGall 1988 JTX-008
`
`M.S Lennard Clinical Pharmacology Through The Looking Glass
`Reflections On The Racemate vs Enantiomer Debate Br Clin
`1623-625 1991 Lennard 1991 DTX-2278
`Pharmac Vol
`
`Schmidt Dose-Finding Studies in Clinical Drug Development 34
`Eur Clin Pharmacol 15-19 1988 Schmidt 1988 DTX-2237
`
`A.K Scott Stereoisomers And Drug Toxicity Drug Safety Vol 8149-
`159 1993 Scoff 1993 DTX-2238
`
`Silverman Drug Discovery Design and Development
`Richard
`The Organic Chemistry of Drug Design and Drug Action Ch
`4-50
`1992 Silverman 1992 JTX-069
`
`in
`
`Heathcock Introduction to Organic
`Streitwieser Jr and
`Chemistry 1985 DTX-2239
`
`Synge Experiments On Amino Acids IV The Methyl Ethers
`Of Some N-Acetyl-Hydroxyamino-Acids Biochem
`33193 1939
`Synge 1939 DTX-2240
`
`ee
`
`ff
`
`gg
`
`hh
`
`ii
`
`ii
`
`jj
`
`kk
`
`11
`
`Block J.H Physiochemical Properties in Relation to Biologic Action
`in Wilson
`Gisvolds Textbook of Organic Medicinal and
`Pharmaceutical Chemistry 9th Ed.Ch
`3-43 Delgado
`
`Remers eds
`
`1991 WG 1991 JTX-068
`mm Chen Yong-Jun et al Synthesis of new vitamin D3 analogues with
`decalin-type CD-ring Tetrahedron Letters Volume 37 Issue 52 Pages
`93619364 1996 DTX-2244
`
`nn
`
`oo
`
`pp
`
`Biologically-Active Fluorochemicals
`Filler
`Vol 33361-375 1986 DTX-2245
`
`Fluorine Chemistry
`
`Levin V.A Relationship Of Octanol/Water Partition Coefficient And
`Molecular Weight To Rat Brain Capillary Permeability Med Chem
`Vol 23682-684 1980 Levin 1980 JTX-092
`
`Strategies in antiepileptic drug development
`Schmidt
`Loscher
`is rational drug design superior to random screening and structural
`variation Epilepsy Res 172 95-134 1994 JTX-093
`
`18
`
`
`
`Case 113-cv-01206-LPS
`
`Document 257-1 Filed 10/26/15
`
`Page 22 of 590 PagelD
`
`3574
`
`
`rr
`
`ss
`
`Marron Thomas
`Roush William
`Diastereoselective synthesis of
`N-benzoyl mycalamine the fully elaborated trioxadecalin nucleus of
`Control of the key N-acyl aminal stereocenter via
`mycalamide
`carbamate acylation Tetrahedron Letters Volume 36 Issue 10 Pages
`15811584 1995 DTX-2246
`Rogawski MA Porter RJ Antiepileptic drugs pharmacological
`mechanisms and clinical efficacy with consideration of promising
`developmental stage compounds Pharmacol Rev
`223-86 1990
`JTX-094
`
`et al Studies on the reductive cleavage of canavanine and
`Takahara
`acid Archives of Biochemistry and Biophysics
`canavaninosuccinic
`Pages 8595 1971 JTX-095
`Volume 145 Issue
`
`87
`
`In particular for purposes of this litigation the LeGall thesis was publicly
`
`accessible more than one year before the earliest priority date for the 551 patent and constitutes
`
`printed publication within the meaning of 35 U.S.C
`
`102b
`
`88
`
`For purposes of this litigation claim 44 of U.S Patent No 5654301 the
`
`301 patent defines
`
`genus of compounds with methoxymethyl group at R3
`
`89
`
`Claim 46 of the 301 patent should read as follows An anti-convulsant
`
`composition comprising an anti-convulsant effective amount of
`
`compound from any one of
`
`claim 9-44 and
`
`pharmaceutic
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