Case 1:14-cv-00213-GMS Document 126 Filed 10/30/15 Page 1 of 15 PageID #: 2109
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`)
`SALIX PHARMACEUTICALS, INC. and
`)
`DR. FALK PHARMA GmbH,
`)
`
`)
`Plaintiffs,
`) C.A. No. 14-213-GMS
`
`) (CONSOLIDATED)
`v.
`)
`
`
`)
`NOVEL LABORATORIES, INC.,
`REDACTED VERSION OF DI 122
`)
`
`
`)
`Defendant.
`)
`)
`
`PROPOSED PRETRIAL ORDER
`VOLUME 2 OF 3 (EXHIBIT 13)
`
`
`YOUNG CONAWAY STARGATT & TAYLOR, LLP
`Adam W. Poff (#3990)
`Pilar G. Kraman (#5199)
`Rodney Square
`1000 North King Street
`Wilmington, DE 19801
`(302) 571-6600
`
`Of Counsel:
`
`H. Keeto Sabharwal
`Paul A. Ainsworth
`Chandrika Vira
`Deirdre M. Wells
`Daniel J. Ritterbeck
`STERNE, KESSLER, GOLDSTEIN & FOX, PLLC
`1100 New York Avenue
`Washington, DC 20005
`
`
`
`Attorneys for Defendant Novel Laboratories,
`Inc.
`
`
`WOMBLE CARLYLE SANDRIDGE & RICE, LLP
`Mary W. Bourke (#2356)
`Kristen Healey Cramer (#4512)
`Dana K. Severance (#4869)
`Daniel M. Attaway (#5130)
`222 Delaware Avenue, Suite 1501
`Wilmington, DE 19801
`(302) 252-4333
`
`Of Counsel:
`
`Tryn T. Stimart
`WOMBLE CARLYLE SANDRIDGE & RICE, LLP
`8065 Leesburg Pike, 4th Floor
`Tysons Corner, VA 22182
`
`Attorneys for Plaintiffs Salix Pharmaceuticals, Inc.
`and Dr. Falk Pharma GmbH
`
`
`Dated: October 23, 2015
`
`GeneriCo, Flat Line Capital
`Exhibit 1057 Page 1
`
`

`
`Case 1:14-cv-00213-GMS Document 126 Filed 10/30/15 Page 2 of 15 PageID #: 2110
`
`
`
`This matter having come before the Court at a pretrial conference held pursuant to Fed.
`R. Civ. P. 16, Mary W. Bourke, Kristen Healey Cramer, Dana K. Severance, Daniel M. Attaway
`of Womble Carlyle Sandridge & Rice, LLP 222 Delaware Avenue, Suite 1501, Wilmington,
`Delaware 19801, (302) 252-4333, and Tryn T. Stimart of Womble Carlyle Sandridge & Rice,
`LLP, 8065 Leesburg Pike, 4th Floor, Tysons Corner, VA 22182, having appeared as counsel for
`Plaintiffs Salix Pharmaceuticals, Inc. and Dr. Falk Pharma GmbH (“Plaintiffs”) and Adam W.
`Poff and Pilar G. Kraman of Young Conaway Stargatt & Taylor, LLP, Rodney Square, 1000
`North King Street, Wilmington, DE 19801, (302) 571-6600 and H. Keeto Sabharwal, Paul A.
`Ainsworth, Chandrika Vira, Deirdre M. Wells, and Daniel J. Ritterbeck of Sterne, Kessler,
`Goldstein & Fox, PLLC, 1100 New York Avenue, Washington, DC 20005, having appeared as
`counsel for Defendant Novel Laboratories, Inc. (“Novel” or “Defendant”), the following actions
`were taken:
`I.
`JURISDICTION
`This is an action for patent infringement under the patent laws of the United States, Title 35,
`United States Code. Jurisdiction of the Court is invoked under 28 U.S.C. §§ 1331, 1338(a), 2201, and
`2202. Jurisdiction is not disputed.
`II.
`STIPULATION AND STATEMENT
`The following stipulations and statements were submitted and are attached to and made a part
`of this Order.
`A.
`1.
`2.
`record in the case.
`
`Statement of Uncontested Facts
`The parties’ statement of uncontested facts is attached as Exhibit 1.
`These uncontested facts require no proof at trial and are part of the evidentiary
`
`2
`
`GeneriCo, Flat Line Capital
`Exhibit 1057 Page 2
`
`

`
`Case 1:14-cv-00213-GMS Document 126 Filed 10/30/15 Page 12 of 15 PageID #: 2120
`
`
`
`The parties may not list new deposition designations or counter-designations, or
`15.
`provide new objections to listed designations or counter-designations, except for good cause shown
`or by agreement of the parties.
`16.
`If applicable, a party’s designation of a page and line from a particular transcript
`shall be automatically deemed to include any errata indicated for that page and line in the attached
`errata sheets.
`When deposition designations are introduced, all counter-designations will also
`17.
`be introduced in the sequence in which the testimony was originally given. All colloquy between
`counsel and objections shall be eliminated when the deposition is read or played at trial. When
`deposition designations are read or played at trial, each party will be charged for the time taken to
`read or play its designations, as measured by the proportion of lines of testimony for its designations
`to the total number of lines of testimony read or played.
`G.
`Special Damages
`18.
`This case does not involve any claims for special damages.
`H. Waivers of Claims and Defenses
`19.
`There has been no waiver of any claims or defenses as of the date of this pretrial
`
`order.
`
`I.
`20.
`Exhibit 13.
`21.
`Exhibit 14.
`J.
`22.
`
`Proposed Findings of Fact and Conclusions of Law
`Plaintiffs’ Proposed Findings of Fact and Conclusions of Law are attached as
`
`Novel’s Proposed Findings of Fact and Conclusions of Law are attached as
`
`Discovery
`All fact discovery in this action is complete.
`
`12
`
`GeneriCo, Flat Line Capital
`Exhibit 1057 Page 3
`
`

`
`Case 1:14-cv-00213-GMS Document 126 Filed 10/30/15 Page 15 of 15 PageID #: 2123
`
`YOUNG CONAWAY STARGATT & TAYLOR, LLP
`
`/s/ Adam W. Poff
`____________________________
`Adam W. Poff (#3990)
`Pilar G. Kraman (#5199)
`Rodney Square
`1000 North King Street
`Wilmington, DE 19801
`(302) 571-6600
`apoff@ycst.com
`pkraman@ycst.com
`
`
`
`Of Counsel:
`
`H. Keeto Sabharwal
`Paul A. Ainsworth
`Chandrika Vira
`Deirdre M. Wells
`Daniel J. Ritterbeck
`Sterne, Kessler, Goldstein & Fox, PLLC
`1100 New York Avenue
`Washington, DC 20005
`
`Attorneys for Defendant Novel Laboratories,
`Inc.
`
`
`
`
`
`
`
`
`
`WOMBLE CARLYLE SANDRIDGE & RICE, LLP
`
`/s/ Mary W. Bourke
`________________________
`Mary W. Bourke (#2356)
`Kristen Healey Cramer (#4512)
`Dana K. Severance (#4869)
`Daniel M. Attaway (#5130)
`222 Delaware Avenue, Suite 1501
`Wilmington, DE 19801
`(302) 252-4333
`MBourke@wcsr.com
`KCramer@wcsr.com
`DAttaway@wcsr.com
`DSeverance@wcsr.com
`
`Of Counsel:
`
`Tryn T. Stimart
`Womble Carlyle Sandridge & Rice, LLP
`8065 Leesburg Pike, 4th Floor
`Tysons Corner, VA 22182
`
`Attorneys for Plaintiffs Salix Pharmaceuticals, Inc.
`and Dr. Falk Pharma GmbH
`
`
`
`
`
`
`
`15
`
`GeneriCo, Flat Line Capital
`Exhibit 1057 Page 4
`
`

`
`Case 1:14-cv-00213-GMS Document 126-1 Filed 10/30/15 Page 1 of 207 PageID #: 2124
`
`EXHIBIT 13
`
`GeneriCo, Flat Line Capital
`Exhibit 1057 Page 5
`
`

`
`Case 1:14-cv-00213-GMS Document 126-1 Filed 10/30/15 Page 2 of 207 PageID #: 2125
`
`C.
`
`D.
`E.
`
`EXHIBIT 13
`PLAINTIFFS’ PROPOSED FINDINGS OF FACT AND CONCLUSIONS OF LAW
`FINDINGS OF FACT................................................................................................................... 2
`I.
`BACKGROUND OF THE CASE.................................................................................... 2
`A.
`The parties............................................................................................................. 2
`B.
`The patents in suit and asserted claims............................................................... 3
`The Otterbeck patents ................................................................................. 3
`1.
`a)
`The ’620 patent ............................................................................... 3
`b)
`The ’886 patent ............................................................................... 4
`c)
`The ’965 patent ............................................................................... 5
`2.
`The ’688 patent ........................................................................................... 6
`The Court’s claim construction........................................................................... 7
`The Otterbeck patents ................................................................................. 7
`1.
`The ’688 patent ........................................................................................... 8
`2.
`Salix’s NDA No. 22-301 and Apriso® .................................................................. 9
`Novel’s ANDA No. 205841 and Novel’s ANDA product................................. 10
`The qualitative and quantitative composition of Novel’s ANDA
`1.
`product...................................................................................................... 11
`2.
`.................................................. 13
`OVERVIEW OF IBD INCLUDING ULCERATIVE COLITIS AND ITS
`TREATMENT WITH MESALAMINE ....................................................................... 17
`A.
`The gastrointestinal tract ................................................................................... 17
`B.
`Ulcerative colitis.................................................................................................. 18
`C.
`Treating and maintaining the remission of ulcerative colitis ......................... 19
`D.
`Use of mesalamine to treat and maintain the remission of ulcerative
`colitis..................................................................................................................... 20
`TECHNICAL OVERVIEW RELEVANT TO THE OTTERBECK
`PATENTS........................................................................................................................ 21
`A.
`Overview of polymers......................................................................................... 21
`B.
`Release of active pharmaceutical excipients in dosage forms......................... 23
`Dissolution is necessary for an API to be therapeutically effective ......... 23
`1.
`
`II.
`
`III.
`
`CONFIDENTIAL
`
`i
`
`Pretrial Order Ex. 13
`
`GeneriCo, Flat Line Capital
`Exhibit 1057 Page 6
`
`

`
`Case 1:14-cv-00213-GMS Document 126-1 Filed 10/30/15 Page 3 of 207 PageID #: 2126
`
`IV.
`
`C.
`D.
`
`2.
`Resistance to mass transport will affect the rate of drug release............. 24
`Overview of dissolution technology................................................................... 25
`Falk’s research and development of a delayed and extended release
`mesalamine formulation..................................................................................... 27
`NOVEL’S ANDA PRODUCT INFRINGES THE ASSERTED CLAIMS OF
`THE OTTERBECK PATENTS .................................................................................... 28
`A.
`The person of ordinary skill in the art.............................................................. 28
`B.
`Vivian Gray’s dissolution testing of
`....................................................................................... 29
`Materials tested and testing setup............................................................. 29
`Testing results........................................................................................... 30
`
`1.
`2.
`
`contain a “non gel-forming polymer matrix” or “polymer matrix”
`formed from “matrix-forming polymers” ........................................................ 34
`1.
`are formed from
`“matrix-forming polymers”...................................................................... 34
`The “matrix-forming polymers”
`form a “non gel-forming polymer matrix” or
`“polymer matrix”...................................................................................... 35
`a)
`
`2.
`
`b)
`
`does not form a gel............................................................. 35
`are used to
`incorporate and control the release of mesalamine....................... 36
`as that term has been
`construed by the Court....................................................................................... 37
`1.
`
`C.
`
`D.
`
`control the release of mesalamine ............................................................ 37
`a)
`The dissolution profiles of
`show
`that they control the release of mesalamine.................................. 38
`
`b)
`
`2.
`
`.......................................................................... 39
`
`.................................................. 40
`
`CONFIDENTIAL
`
`ii
`
`Pretrial Order Ex. 13
`
`GeneriCo, Flat Line Capital
`Exhibit 1057 Page 7
`
`

`
`Case 1:14-cv-00213-GMS Document 126-1 Filed 10/30/15 Page 4 of 207 PageID #: 2127
`
`a)
`
`b)
`
`b)
`
`c)
`
`d)
`
`e)
`
`f)
`
`g)
`
`At high enough concentrations in an
`will leach from the coating, which is further evidence of a
`continuous pore network............................................................... 43
`The
`will become structurally
`compromised................................................................................. 45
`Novel’s ANDA product meets each and every element of the asserted
`claims of the ’620 patent..................................................................................... 48
`Novel’s ANDA product meets each and every element of
`1.
`unasserted claim 1 of the ’620 patent....................................................... 48
`a)
`Element i: “[a]n orally administrable pharmaceutical pellet
`formulation having a controlled release profile for the
`treatment of the intestinal tract”.................................................... 49
`Element ii: “which comprises a core and an enteric coating
`and optionally pharmaceutically tolerable additives”................... 50
`Element iii: “the core including, as a pharmaceutically
`active compound, aminosalicylic acid or a
`pharmaceutically acceptable salt”................................................. 51
`Element iv: “wherein the active compound is present in the
`core in a non gel-forming polymer matrix”.................................. 52
`Element v: “which is essentially insoluble in the intestinal
`tract and permeable to intestinal fluids and the active
`compound”.................................................................................... 52
`Element vi: “the matrix-forming polymer making up at
`least 1% by weight of the total weight of the core”...................... 53
`Element vii: “and wherein the matrix-forming polymer is
`selected from the group consisting of poly(ethyl acrylate,
`methyl methacrylate) and poly(ethyl acrylate, methyl
`methacrylate, trimethylammonioethyl methacrylate
`chloride)” ...................................................................................... 53
`Novel’s ANDA product meets each and every element of asserted
`claim 4 of the ’620 patent ......................................................................... 54
`a)
`Element i: “[t]he pellet formulation as claimed in claim 1”......... 55
`b)
`Element ii: “wherein the active compound is 5-
`aminosalicylic acid”...................................................................... 55
`Novel’s ANDA product meets each and every element of asserted
`claim 5 of the ’620 patent ......................................................................... 55
`a)
`Element i: “[t]he pellet formulation as claimed in claim 1”......... 55
`
`E.
`
`2.
`
`3.
`
`CONFIDENTIAL
`
`iii
`
`Pretrial Order Ex. 13
`
`GeneriCo, Flat Line Capital
`Exhibit 1057 Page 8
`
`

`
`Case 1:14-cv-00213-GMS Document 126-1 Filed 10/30/15 Page 5 of 207 PageID #: 2128
`
`b)
`
`b)
`
`c)
`d)
`
`e)
`
`b)
`
`b)
`
`c)
`
`F.
`
`G.
`
`2.
`
`Element ii: “wherein the enteric coating comprises a
`methacrylic acid copolymer or methylhydroxypropyl-
`cellulose phthalate”....................................................................... 56
`Novel’s ANDA product meets each and every element of the asserted
`claim of the ’886 patent ...................................................................................... 56
`Novel’s ANDA product meets each and every element of
`1.
`unasserted claim 1 of the ’886 patent....................................................... 56
`a)
`Element i: “[a] controlled release pellet formulation for the
`treatment of the intestinal tract”.................................................... 57
`Element ii: “said formulation comprising a core
`comprising: 1) a homogenously dispersed pharmaceutically
`active compound in a non gel-forming polymer matrix”.............. 58
`Element iii: “and 2) an enteric coating”........................................ 59
`Element iv: “wherein the non gel-forming polymer matrix
`is essentially insoluble in the intestinal tract and permeable
`to intestinal fluid” ......................................................................... 60
`Element v: “made by the process comprising: mixing the
`pharmaceutically active compound and the non gel-forming
`polymer matrix; scattering in a pharmaceutically tolerable
`additive; and extruding a moist mass of the matrix-forming
`polymer and the active compound” .............................................. 61
`Novel’s ANDA product meets each and every element of asserted
`claim 13 of the ’886 patent ....................................................................... 62
`a)
`Element i: “[t]he controlled release pellet formulation of
`claim 1........................................................................................... 62
`Element ii: “wherein the pharmaceutically active
`compound comprises 5-aminosalicylic acid, balsalazide,
`sulfasalazine or a pharmaceutically acceptable salt thereof”........ 62
`Novel’s ANDA product meets each and every element of the asserted
`claims of the ’965 patent..................................................................................... 63
`Novel’s ANDA product meets each and every element of asserted
`1.
`claim 24 of the ’965 patent ....................................................................... 63
`a)
`Element i: “[a] controlled release pellet formulation
`comprising”................................................................................... 64
`Element ii: “1) 5-aminosalicylic acid in a core comprising a
`polymer matrix”............................................................................ 65
`Element iii: “wherein the polymer matrix is essentially
`insoluble in the intestinal tract and permeable to intestinal
`fluid”............................................................................................. 66
`
`CONFIDENTIAL
`
`iv
`
`Pretrial Order Ex. 13
`
`GeneriCo, Flat Line Capital
`Exhibit 1057 Page 9
`
`

`
`Case 1:14-cv-00213-GMS Document 126-1 Filed 10/30/15 Page 6 of 207 PageID #: 2129
`
`V.
`
`VI.
`
`2.
`
`2.
`
`d)
`
`e)
`f)
`
`b)
`
`Element iv: “and wherein the polymer matrix comprises at
`least 1% by weight of the total weight of the core”...................... 66
`Element v: “and 2) an enteric coating”......................................... 67
`Element vi: “wherein the pellets have a particle size of 0.1
`mm to 3 mm.................................................................................. 67
`Novel’s ANDA product meets each and every element of asserted
`claim 26 of the ’965 patent ....................................................................... 67
`a)
`Element i: “[t]he controlled release pellet formulation of
`claim 24”....................................................................................... 68
`Element ii: “wherein the pellets have a particle size of
`about 1 mm”.................................................................................. 68
`OVERVIEW OF INFORMATION RELEVANT TO THE ’688 PATENT.............. 68
`A.
`The state of the art of oral mesalamine formulations in 2007 ........................ 69
`B.
`Salix’s research and development of a method of maintaining
`ulcerative colitis with a once daily, low dose of a granulated
`mesalamine formulation without food .............................................................. 70
`MPPK 1001............................................................................................... 70
`1.
`MPUC 3003 and MPUC 3004.................................................................. 70
`2.
`MPPK 1002............................................................................................... 72
`3.
`MPPK 1003............................................................................................... 73
`4.
`NOVEL WILL INDUCE INFRINGEMENT OF THE ASSERTED CLAIMS
`OF THE ’688 PATENT.................................................................................................. 73
`A.
`A physician, pharmacist, other healthcare provider, or patient
`administering Novel’s ANDA product in accordance with Novel’s
`proposed package insert will directly infringe claim 1 of the ’688
`patent, either literally or under the doctrine of equivalents........................... 73
`First element: “A method of maintaining the remission of
`1.
`ulcerative colitis in a subject”.................................................................. 74
`Second element: “administering to the subject a granulated
`mesalamine formulation comprising four capsules each comprising
`0.375 g of granulated mesalamine once per day in the morning,
`without food” ............................................................................................ 74
`a)
`“administering”............................................................................. 74
`b)
`“to the subject”.............................................................................. 75
`c)
`“a granulated mesalamine formulation” ....................................... 75
`
`CONFIDENTIAL
`
`v
`
`Pretrial Order Ex. 13
`
`GeneriCo, Flat Line Capital
`Exhibit 1057 Page 10
`
`

`
`Case 1:14-cv-00213-GMS Document 126-1 Filed 10/30/15 Page 7 of 207 PageID #: 2130
`
`d)
`
`b)
`
`b)
`
`c)
`
`3.
`
`4.
`
`5.
`
`6.
`
`B.
`
`C.
`
`“comprising four capsules each comprising 0.375 g of
`granulated mesalamine once per day in the morning”.................. 76
`“without food” .............................................................................. 76
`e)
`Third element: “said method maintains remission of ulcerative
`colitis in a subject for a period of at least 6 months of treatment” .......... 80
`Fourth element: “remission is defined as a DAI score of 0 or 1”............ 81
`a)
`Revised construction of “remission is defined as a DAI of 0
`or 1”—“remission is defined as a rectal bleeding subscore
`of 0 and a mucosal appearance subscore of less than 2” .............. 82
`Original construction of “remission is defined as a DAI of 0
`or 1”—“remission is a DAI score of 0 or 1 as calculated by
`the sum of the four subscores based on stool frequency,
`bleeding, mucosal appearance on endoscopy, and
`physician’s rating of disease activity” .......................................... 84
`Fifth element: “the granulated mesalamine formulation is not
`administered with antacids”..................................................................... 87
`Sixth element: “and wherein 85% to 90% of the mesalamine
`reaches the terminal ileum and colon”..................................................... 87
`A physician, pharmacist, other healthcare provider, or patient
`administering Novel’s ANDA product will directly infringe claim 2 of
`the ’688 patent, either literally or under the doctrine of equivalents ............ 95
`First element: “The method of claim 1”................................................... 96
`1.
`Second element: “wherein the granulated mesalamine formulation
`2.
`is a delayed and extended release formulation”....................................... 96
`Novel intentionally encourages others to practice the methods of the
`asserted claims of the ’688 patent...................................................................... 97
`“without food”.......................................................................................... 98
`1.
`“said method maintains remission of ulcerative colitis in a subject
`2.
`for a period of at least 6 months of treatment; remission is defined
`as a DAI score of 0 or 1”.......................................................................... 98
`a)
`“said method maintains remission of ulcerative colitis in a
`subject for a period of at least 6 months of treatment”................. 99
`Revised construction of “remission is defined as a DAI of 0
`or 1”—“remission is defined as a rectal bleeding subscore
`of 0 and a mucosal appearance subscore of less than 2” .............. 99
`Original construction of “remission is defined as a DAI of 0
`or 1”—“remission is a DAI score of 0 or 1 as calculated by
`the sum of the four subscores based on stool frequency,
`
`CONFIDENTIAL
`
`vi
`
`Pretrial Order Ex. 13
`
`GeneriCo, Flat Line Capital
`Exhibit 1057 Page 11
`
`

`
`Case 1:14-cv-00213-GMS Document 126-1 Filed 10/30/15 Page 8 of 207 PageID #: 2131
`
`3.
`
`bleeding, mucosal appearance on endoscopy, and
`physician’s rating of disease activity” ........................................ 101
`“wherein 85% to 90% of the mesalamine reaches the terminal
`ileum and colon”..................................................................................... 102
`Novel was aware of the ’688 patent and knew the actions of others
`would constitute infringement ......................................................................... 104
`VII. THE ’688 PATENT IS NOT INVALID...................................................................... 105
`A.
`
`D.
`
`B.
`C.
`D.
`
`............................................................................................... 105
`The priority date of the ’688 patent ................................................................ 106
`The person(s) of ordinary skill in the art........................................................ 106
`The asserted claims of the ’688 patent would not have been obvious at
`the time of the invention................................................................................... 107
`Combination 1: Marakhouski, the Salix Press Release, and the
`1.
`Granu-Stix® SPC do not render the asserted claims of the ’688
`patent obvious......................................................................................... 109
`a)
`Granu-Stix® SPC......................................................................... 109
`b)
`Marakhouski ............................................................................... 111
`c)
`Salix Press Release ..................................................................... 114
`d)
`Additional references cited in conjunction with
`Combination 1............................................................................. 115
`(1)
`Salix Conference Call ..................................................... 115
`(2)
`Cooney............................................................................ 116
`(3)
`Brouwers......................................................................... 117
`There is no motivation to combine the references cited by
`Novel in Combination 1 to achieve the claimed invention
`and no reasonable expectation of success of doing so................ 117
`Combination 2: The Falk Brochure, Brunner, Baumgart, and
`Sandborn do not render the asserted claims of the ’688 patent
`obvious.................................................................................................... 118
`a)
`Falk Brochure.............................................................................. 119
`b)
`Brunner ....................................................................................... 121
`c)
`Baumgart..................................................................................... 123
`d)
`Sandborn ..................................................................................... 124
`
`e)
`
`2.
`
`CONFIDENTIAL
`
`vii
`
`Pretrial Order Ex. 13
`
`GeneriCo, Flat Line Capital
`Exhibit 1057 Page 12
`
`

`
`Case 1:14-cv-00213-GMS Document 126-1 Filed 10/30/15 Page 9 of 207 PageID #: 2132
`
`e)
`
`f)
`
`3.
`
`4.
`
`Additional references cited in conjunction with
`Combination 2............................................................................. 125
`(1)
`Salix Conference Call ..................................................... 125
`(2)
`Cooney............................................................................ 125
`(3)
`Rutgeerts......................................................................... 126
`There is no motivation to combine the references cited in
`Combination 2 to achieve the claimed invention and no
`reasonable expectation of success of doing so............................ 128
`Combination 3: Kruis DDW, Kruis 2007, Kamm, and the Granu-
`Stix® SPC do not render the asserted claims of the ’688 patent
`obvious.................................................................................................... 129
`a)
`There is no motivation to combine the Granu-Stix® SPC
`with general knowledge in the field of ulcerative colitis
`related to 5-ASA formulations to achieve the claimed
`invention and no reasonable expectation of success of
`doing so....................................................................................... 131
`Combination 4: AJG 2008 and the Granu-Stix® SPC do not render
`the asserted claims of the ’688 patent obvious....................................... 131
`a)
`There is no motivation to combine the Granu-Stix® SPC
`with general knowledge in the field of ulcerative colitis
`related to 5-ASA formulations to achieve the claimed
`invention and no reasonable expectation of success of
`doing so....................................................................................... 132
`The objective indicia of non-obviousness support a finding of non-
`obviousness of the asserted claims of the ’688 patent.................................... 133
`The failure of others to demonstrate the non-inferiority of a low,
`1.
`once daily dose of mesalamine for the maintenance of remission of
`ulcerative colitis...................................................................................... 133
`The failure of others to demonstrate that granulated mesalamine
`could be administered without food........................................................ 134
`The unexpected result that granulated mesalamine could be
`administered without food....................................................................... 136
`Long felt but unmet need for a low, once-daily dose of granulated
`mesalamine for the maintenance of remission of ulcerative colitis........ 137
`Skepticism by those in the field that a once daily, low dose of
`granulated mesalamine administered without food could maintain
`the remission of ulcerative colitis ........................................................... 138
`VIII. PLAINTIFFS ARE ENTITLED TO A PERMANENT INJUNCTION.................. 138
`
`E.
`
`2.
`
`3.
`
`4.
`
`5.
`
`CONFIDENTIAL
`
`viii
`
`Pretrial Order Ex. 13
`
`GeneriCo, Flat Line Capital
`Exhibit 1057 Page 13
`
`

`
`Case 1:14-cv-00213-GMS Document 126-1 Filed 10/30/15 Page 10 of 207 PageID #: 2133
`
`A.
`B.
`
`C.
`D.
`
`Plaintiffs have suffered an irreparable injury................................................ 139
`The remedies available at law are inadequate to compensate for the
`injury.................................................................................................................. 140
`A balance of the hardships warrants a remedy in equity.............................. 140
`The public interest would not be disserved by a permanent injunction...... 140
`
`CONFIDENTIAL
`
`ix
`
`Pretrial Order Ex. 13
`
`GeneriCo, Flat Line Capital
`Exhibit 1057 Page 14
`
`

`
`Case 1:14-cv-00213-GMS Document 126-1 Filed 10/30/15 Page 11 of 207 PageID #: 2134
`
`2.
`3.
`
`B.
`
`C.
`
`CONCLUSIONS OF LAW...................................................................................................... 142
`I.
`JURISDICTION AND VENUE................................................................................... 142
`II.
`CONTROLLING AUTHORITY ................................................................................ 142
`III.
`INFRINGEMENT......................................................................................................... 142
`A.
`Novel’s submission of ANDA No. 205841 was an act of infringement of
`the asserted claims of the ’620, ’886, ’965, and ’688 patents ........................ 142
`The infringement analysis: construing claim terms and comparing
`1.
`claims to the accused product................................................................. 142
`Legal standard for infringement under 35 U.S.C. § 271(e)(2)(A).......... 144
`Novel’s submission of ANDA No. 205841 was an act of
`infringement of the asserted claims of the ’620, ’886,’965, and
`’688 patents............................................................................................. 146
`The asserted claims of the ’620, ’886, ’965 patents will be directly
`infringed under 35 U.S.C. § 271(a), either literally or under the
`doctrine of equivalents...................................................................................... 146
`Legal standard for infringement under 35 U.S.C. § 271(a).................... 146
`1.
`Novel’s ANDA product will directly infringe asserted claims 4 and
`2.
`5 of the ’620 patent, asserted claim 13 of the ’886 patent, and
`asserted claims 24 and 26 of the ’965 patent under 35 U.S.C. §
`271(a)...................................................................................................... 149
`Novel will induce infringement of the asserted claims of the ’688
`patent under 35 U.S.C. § 271(b)....................................................................... 149
`Legal standard for infringement under 35 U.S.C. § 271(b).................... 149
`1.
`Novel will induce infringement of asserted claims 1 and 2 of the
`2.
`’688 patent .............................................................................................. 155
`a)
`Physicians, pharmacists, other healthcare provider