Case 1:13-cv-01674-RGA Document 403 Filed 02/22/16 Page 1 of 461 PageID #: 13952
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`
`
`
`
`
`
`C.A. No. 13-1674-RGA
`Consolidated
`
`
`
`C.A. No. 14-0422-RGA
`
`
`
`
`
`
`
`
`
`RECKITT BENCKISER
`PHARMACEUTICALS INC., RB
`PHARMACEUTICALS LIMITED, and
`MONOSOL RX, LLC,
`
`
`
`
`
`
`
`
`
`v.
`
`
`
`
`
`WATSON LABORATORIES, INC. and
`ACTAVIS LABORATORIES UT, INC.,
`
`
`
`
`
`
`
`
`
`
`Plaintiffs,
`
`
`
`
`
`Defendant.
`
`
`
`RECKITT BENCKISER
`PHARMACEUTICALS INC., RB
`PHARMACEUTICALS LIMITED, and
`MONOSOL RX, LLC,
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Plaintiffs,
`
`
`
`
`
`Defendants.
`
`
`
`
`v.
`
`
`
`
`PAR PHARMACEUTICAL, INC., and
`INTELGENX TECHNOLOGIES CORP.,
`
`
`
`
`
`
`
`
`
`
`
`
`JOINT PROPOSED FINDINGS OF FACT
`
`
`
`
`
`REDACTED VERSION D.I. 395
`
`DRL - EXHIBIT 1029
`DRL001
`
`

`
`Case 1:13-cv-01674-RGA Document 403 Filed 02/22/16 Page 2 of 461 PageID #: 13953
`TABLE OF CONTENTS
`
`
`Page
`
`I.
`
`II.
`
`B.
`
`
`PLAINTIFFS’ INFRINGEMENT PROPOSED FINDINGS OF FACT AND
`DEFENDANTS’ RESPONSES ......................................................................................... 1
`JURISDICTION AND OWNERSHIP .............................................................................. 1
`A.
`The Parties ............................................................................................................. 1
`B.
`RBP’s NDA and Suboxone® Sublingual Film ...................................................... 2
`C.
`The Asserted Patents .............................................................................................. 4
`D.
`The Asserted Claims .............................................................................................. 5
`TRIAL WITNESSES ON INFRINGEMENT ................................................................... 8
`A.
`Plaintiffs’ Witnesses .............................................................................................. 8
`1.
`Martyn Davies, Ph.D.................................................................................. 8
`2.
`Lon Mathias, Ph.D ..................................................................................... 9
`3.
`Wallace Yau, Ph.D ................................................................................... 10
`4.
`Nadine Paiement ...................................................................................... 11
`Defendants’ Witnesses ......................................................................................... 11
`1.
`Jason McConville, Ph.D .......................................................................... 11
`2.
`Kinam Park, Ph.D .................................................................................... 13
`3.
`Bozena Michniak-Kohn, Ph.D ................................................................. 13
`4.
`Dean Toste, Ph.D ..................................................................................... 13
`5.
`Garry Myers ............................................................................................. 14
`III. WATSON’S PROPOSED ANDA PRODUCT INFRINGES CLAIMS 62, 64, 65,
`69, AND 73 OF THE ’514 PATENT .............................................................................. 15
`A.
`Claims 62, 64, 65, 69, and 73 of the ’514 Patent ................................................. 15
`B. Watson Concedes That Its Proposed ANDA Product Meets All But Three
`Elements of the Asserted Claims ......................................................................... 17
`a)
`Watson’s proposed ANDA product is a drug delivery
`composition .................................................................................. 18
`Watson’s proposed ANDA Product comprises one or more
`substantially water swellable or water soluble polymers
`(polyethylene oxide and hypromellose) ....................................... 18
`Watson’s proposed ANDA product contains a desired
`amount of at least one active (buprenorphine HCl and
`naloxone HCl) .............................................................................. 18
`Watson’s proposed ANDA product comprises a particulate
`active (buprenorphine HCl) substantially uniformly
`stationed in the matrix .................................................................. 18
`
`b)
`
`c)
`
`d)
`
`
`
`
`
`DRL - EXHIBIT 1029
`DRL002
`
`

`
`Case 1:13-cv-01674-RGA Document 403 Filed 02/22/16 Page 3 of 461 PageID #: 13954
`TABLE OF CONTENTS (cont’d)
`
`
`Page
`
`
`
`e)
`
`f)
`
`h)
`
`i)
`
`j)
`
`k)
`
`g)
`
`Watson’s proposed ANDA product comprises a flavor
`(lime flavor), and sweeteners (acesulfame potassium and
`maltitol) ........................................................................................ 18
`The particulate active in Watson’s proposed ANDA
`product (buprenorphine HCl) has a particle size of 200
`microns or less ............................................................................. 19
`The matrix in Watson’s proposed ANDA product is
`capable of being dried without loss of substantial
`uniformity in the stationing of the buprenorphine
`particulate active, as the individual unit doses of the final
`product do not vary by more than 10% of the desired
`amount of buprenorphine HCl ..................................................... 19
`Subsequent to casting and drying of the matrix,
`substantially equally sized individual unit doses do not vary
`by more than 10% of said desired amount of said at least
`one active ..................................................................................... 19
`The particulate active in Watson’s proposed ANDA
`product (buprenorphine HCl) has a particle size of 100
`microns or less, as required by dependent Claim 64 ................... 19
`The variation in the drug content of Watson’s proposed
`ANDA product is less than 5 percent by weight per film
`dosage unit, as required by dependent Claim 65 ......................... 19
`Watson’s proposed ANDA product contains the opiate
`active buprenorphine HCl, as required by dependent Claim
`73.................................................................................................. 19
`C. Watson’s Proposed ANDA Product Meets the Remaining Elements of the
`Asserted Claims ................................................................................................... 20
`1.
`Watson’s proposed ANDA Product contains a “taste-masking
`agent . . .................................................................................................... 20
`The taste-masking agents are present in the amount of about 0.1–
`30% by weight of the drug delivery composition, as required by
`dependent Claim 69 ................................................................................. 21
`Watson’s proposed ANDA product is “a cast film comprising a
`flowable water-soluble or water swellable film-forming matrix” ........... 22
`The matrix in Watson’s proposed ANDA product “has a viscosity
`sufficient to aid in substantially maintaining non-self-aggregating
`uniformity of the active in the matrix” .................................................... 27
`D. Watson’s Proposed ANDA Product Infringes Dependent Claims 64, 65,
`69, and 73 ............................................................................................................. 36
`
`2.
`
`3.
`
`4.
`
`ii
`
`DRL - EXHIBIT 1029
`DRL003
`
`

`
`Case 1:13-cv-01674-RGA Document 403 Filed 02/22/16 Page 4 of 461 PageID #: 13955
`TABLE OF CONTENTS (cont’d)
`
`
`Page
`
`
`IV.
`
`PAR’S PROPOSED ANDA PRODUCT INFRINGES CLAIMS 62, 64, 65, 69,
`AND 73 OF THE ’514 PATENT .................................................................................... 40
`A.
`Par Does Not Dispute That Its Proposed ANDA Product Meets All But
`Two Elements of the Asserted Claims ................................................................. 40
`1.
`Par does not dispute that its proposed ANDA product meets
`elements related to the active ingredients and particle size ..................... 41
`Par does not dispute its proposed ANDA product meets the taste-
`masking elements ..................................................................................... 43
`Par does not dispute its proposed ANDA product meets the
`uniformity elements ................................................................................. 45
`Par’s Proposed ANDA Product is “a cast film comprising a flowable
`water-soluble or water swellable film-forming matrix” ...................................... 47
`The matrix in Par’s proposed ANDA product “has a viscosity sufficient to
`aid in substantially maintaining non-self-aggregating uniformity of the
`active in the matrix” ............................................................................................. 52
`Par’s ANDA Product Infringes Dependent Claims 64, 65, 69, and 73 ............... 58
`D.
`V. WATSON’S PROPOSED ANDA PRODUCT INFRINGES CLAIMS 1, 3, 6,
`AND 15–19 OF THE ’832 PATENT .............................................................................. 61
`A.
`Claim 1 of the ’832 Patent ................................................................................... 63
`1.
`The local pH limitation ............................................................................ 65
`a)
`Local pH may be measured in vitro ............................................. 70
`b)
`Watson’s ANDA specifies a pH of 3.0 to 5.0 .............................. 79
`c)
`Watson’s “film pH” measurements rely on a volume
`greater than that in the mouth ...................................................... 81
`The sufficient to optimize limitation ........................................................ 87
`a)
`Watson’s higher dosage strengths (12 mg/3 mg & 8 mg/2
`mg) ............................................................................................... 89
`Watson’s lower dosage strengths (4 mg/1 mg & 2 mg/0.5
`mg) ............................................................................................... 94
`Claim 3 of the ’832 Patent ................................................................................... 97
`Claim 6 of the ’832 Patent ................................................................................... 98
`Claim 15 of the ’832 Patent ................................................................................. 99
`1.
`Watson’s higher dosage strengths (12 mg/3 mg & 8 mg/2 mg) ............ 100
`2.
`Watson’s lower dosage strengths (4 mg/1 mg & 2 mg/0.5 mg) ............ 104
`Claim 16-19 of the ’832 Patent .......................................................................... 107
`
`B.
`C.
`D.
`
`2.
`
`3.
`
`B.
`
`C.
`
`2.
`
`b)
`
`E.
`
`iii
`
`DRL - EXHIBIT 1029
`DRL004
`
`

`
`b)
`
`c)
`
`d)
`
`3.
`
`B.
`C.
`D.
`
`Case 1:13-cv-01674-RGA Document 403 Filed 02/22/16 Page 5 of 461 PageID #: 13956
`TABLE OF CONTENTS (cont’d)
`
`
`Page
`
`
`VI.
`
`PAR’S PROPOSED ANDA PRODUCT INFRINGES CLAIMS 1, 3, 6, AND 15–
`19 OF THE ’832 PATENT ............................................................................................ 115
`A.
`Claim 1 of the ’832 Patent ................................................................................. 115
`1.
`Par’s Proposed ANDA Product Meets the Buffer Limitation ............... 117
`2.
`Par’s Proposed ANDA Product Meets the Local pH Limitation ........... 120
`a)
`Par’s ANDA lists a target pH of 3.5 to 4.0 in simulated
`saliva .......................................................................................... 120
`Par’s pH measurements rely on a volume greater than that
`in the mouth ............................................................................... 121
`Par’s proposed ANDA product gave a measured pH of 3.5
`in saliva ...................................................................................... 123
`Dr. Toste’s calculations fail to include the alkaline earth
`metal component ........................................................................ 124
`The sufficient to optimize limitation ...................................................... 127
`a)
`Par’s higher dosage strengths (12 mg/3 mg & 8 mg/2 mg) ....... 128
`b)
`Par’s lower dosage strengths (4 mg/1 mg & 2 mg/0.5 mg) ....... 129
`Claim 3 of the ’832 Patent ................................................................................. 130
`Claim 6 of the ’832 Patent ................................................................................. 131
`Claim 15 of the ’832 Patent ............................................................................... 132
`1.
`Par’s higher dosage strengths (12 mg/3 mg & 8 mg/2 mg) ................... 133
`2.
`Par’s lower dosage strengths (4 mg/1 mg & 2 mg/0.5 mg) ................... 133
`Claims 16–19 of the ’832 Patent ........................................................................ 135
`E.
`VII. WATSON’S ANDA PRODUCT INFRINGES CLAIMS 1 AND 4 OF THE ’150
`PATENT ........................................................................................................................ 139
`A.
`Claims 1 and 4 of the ’150 Patent ...................................................................... 139
`B. Watson Concedes That Its Proposed ANDA Product Meets All But One
`Element of the Asserted Claims ......................................................................... 140
`C. Watson’s Proposed ANDA Product Meets the Remaining Element of the
`Asserted Claims ................................................................................................. 143
`PEO Used in Watson’s Proposed ANDA Product ............................................. 145
`PEO MW Determination.................................................................................... 148
`GPC Analysis of Polyox N80 ............................................................................ 149
`PEO Blends Have a Unimodal MW Distribution .............................................. 152
`Partitioning GPC Data ....................................................................................... 155
`
`D.
`E.
`F.
`G.
`H.
`
`iv
`
`DRL - EXHIBIT 1029
`DRL005
`
`

`
`
`
`I.
`
`J.
`
`C.
`
`2.
`
`3.
`
`Case 1:13-cv-01674-RGA Document 403 Filed 02/22/16 Page 6 of 461 PageID #: 13957
`TABLE OF CONTENTS (cont’d)
`
`
`Page
`
`The two discrete sets of PEO are present in Polyox N80, as required by
`Claim 1 ............................................................................................................... 158
`1.
`A POSA would understand the raw mathematical value of 95,895
`to be 100,000 and the raw mathematical value of 900,318 to be
`900,000................................................................................................... 161
`Low MW PEO is about 60% or more of polymer component, as required
`by Claim 1 .......................................................................................................... 166
`High MW PEO Fraction Not “Stray” ................................................................ 171
`K.
`Watson’s Proposed ANDA Product Infringes Dependent Claim 4 ................... 173
`L.
`M. Watson’s Non-Infringement Arguments ............................................................ 175
`VIII. PAR’S ANDA PRODUCT INFRINGES CLAIMS 10 AND 13 OF THE ’150
`PATENT ........................................................................................................................ 180
`A.
`The Asserted Claims 10 and 13 of the ’150 Patent ............................................ 180
`B.
`Par Does Not Dispute That Its Proposed ANDA Product Meets All But
`One Element of the Asserted Claims ................................................................. 181
`Par’s Proposed ANDA Product Meets the Remaining Element of the
`Asserted Claims ................................................................................................. 186
`1.
`The two discrete sets of PEO are present in Polyox N80, as
`required by Claim 10 ............................................................................. 187
`Par’s Proposed ANDA Product Also Meets the Average MW
`Limitations under the Doctrine of Equivalents ...................................... 189
`Low MW PEO is about 60% or more of polymer component, as
`required by Claim 10 ............................................................................. 192
`High MW PEO fraction not “stray” ....................................................... 196
`4.
`Par’s Non-Infringement Arguments .................................................................. 197
`D.
`Par’s Proposed ANDA Product Infringes Dependent Claim 13 ........................ 202
`E.
`WATSON’S COUNTERSTATEMENT OF FACTS REGARDING INFRINGEMENT ........ 203
`I.
`WATSON DOES NOT INFRINGE THE ’150 PATENT ............................................. 203
`A. Watson Does Not Infringe Because Watson’s ANDA Products Use Only
`One PEO ............................................................................................................ 203
`B. Watson Does Not Infringe Because Watson Merely Practices the Prior Art .... 204
`C.
`The Analysis Conducted by Dr. Mathias and Dr. Yau Is Artificial and
`Does Not Speak To Infringement, Regardless of the Precise Values ................ 205
`Even if the Analysis Conducted by Dr. Mathias and Dr. Yau were
`Relevant, the Calculated Values do not Show Infringement ............................. 206
`II. WATSON DOES NOT INFRINGE THE ’514 PATENT ............................................. 208
`
`D.
`
`v
`
`DRL - EXHIBIT 1029
`DRL006
`
`

`
`Case 1:13-cv-01674-RGA Document 403 Filed 02/22/16 Page 7 of 461 PageID #: 13958
`TABLE OF CONTENTS (cont’d)
`
`
`Page
`
`2.
`
`b)
`
`b)
`
`vi
`
`
`
`E.
`
`F.
`
`II.
`
`A. Watson does not infringe claim 62 .................................................................... 208
`B. Watson does not infringe claims 64, 65, 69, and 73 .......................................... 209
`III. WATSON DOES NOT INFRINGE THE ’832 PATENT ............................................. 209
`A. Watson does not infringe claim 1 ...................................................................... 209
`1.
`Watson’s ANDA products do not have a local pH from about 3 to
`about 3.5 ................................................................................................. 209
`a)
`Watson’s experimentally-determined pH values do not
`show the “local” pH of Watson’s ANDA products ................... 209
`Dr. Davies’ calculated “local pH” values, obtained using
`the “Buffer Maker” program, have no relationship to “local
`pH” of Watson’s ANDA products ............................................. 212
`Watson’s ANDA products do not have a buffer in an amount
`sufficient to optimize the absorption of said buprenorphine ................. 214
`a)
`A comparison of the data in Watson’s ANDA to the data in
`the patent .................................................................................... 215
`Watson’s ANDA products have never been compared to
`Suboxone® tablets in a proper bioequivalence study ................ 216
`B. Watson does not infringe claims 3 or 6 ............................................................. 217
`C. Watson does not infringe claim 15 .................................................................... 217
`D.
`Claims 16-19 ...................................................................................................... 217
`PAR’S COUNTERSTATEMENT OF FACTS REGARDING INFRINGEMENT ................. 218
`I.
`THE ’150 PATENT ....................................................................................................... 218
`A.
`Par Uses Only A Single PEO: Polyox N80 ....................................................... 218
`B.
`Plaintiffs’ Partitioning Analysis Is Fundamentally Flawed ............................... 220
`C.
`Even Under Plaintiffs’ Flawed Partitioning Analysis, The Calculated
`Values Are Not Literally Within the Claimed Ranges ...................................... 223
`Dr. Mathias Has Not Established Infringement Under the Doctrine of
`Equivalents ......................................................................................................... 225
`Even Under Plaintiffs’ Partitioning Analysis, Par’s Polyox N80 Contains
`No More Than “Stray Amounts” of High Molecular Weight PEO ................... 227
`Dr. Mathias’s “Stray Amounts” Analysis Is Inconsistent with His
`Equivalents Analysis .......................................................................................... 228
`THE ’832 PATENT ....................................................................................................... 230
`A.
`Plaintiffs Have Not Demonstrated that the “Local pH” of Par’s Proposed
`ANDA Product Is About 3 to About 3.5 ........................................................... 230
`
`D.
`
`DRL - EXHIBIT 1029
`DRL007
`
`

`
`Case 1:13-cv-01674-RGA Document 403 Filed 02/22/16 Page 8 of 461 PageID #: 13959
`TABLE OF CONTENTS (cont’d)
`
`
`Page
`
`
`
`III.
`
`B.
`
`Par’s Proposed ANDA Products Do Not Contain a Buffer in an Amount to
`Provide a Local pH of About 3 to about 3.5 ...................................................... 238
`THE ’514 PATENT ....................................................................................................... 241
`A.
`Par’s Proposed ANDA Product Does Not Contain a Flowable Film-
`Forming Matrix .................................................................................................. 241
`Par’s Proposed ANDA Product Does Not Contain a Viscosity Sufficient to
`Aid in Substantially Maintaining Non-Self Aggregating Uniformity of the
`Active in the Matrix ........................................................................................... 242
`
`B.
`
`vii
`
`DRL - EXHIBIT 1029
`DRL008
`
`

`
`Case 1:13-cv-01674-RGA Document 403 Filed 02/22/16 Page 9 of 461 PageID #: 13960
`TABLE OF CONTENTS (cont’d)
`
`
`Page
`
`
`I.
`
`C.
`
`II.
`
`B.
`
`DEFENDANTS’ INVALIDITY PROPOSED FINDINGS OF FACT AND
`PLAINTIFFS’ RESPONSES ......................................................................................... 246
`’150 PATENT INVALIDITY........................................................................................ 246
`A.
`The Claims of the ’150 Patent Are Indefinite .................................................... 246
`1.
`Introduction ............................................................................................ 246
`2.
`There Are Multiple Methods to Calculate or Determine the
`Molecular Weight of a Polymer ............................................................. 248
`The Claims of the ’150 Patent Are Entitled to a Priority Date of April 22,
`2008.................................................................................................................... 254
`The Claims of the ’150 Patent Would Have Been Obvious in View of
`Yang (JTX-178) ................................................................................................. 259
`’514 PATENT INVALIDITY........................................................................................ 262
`A.
`Background of the ’514 Patent .......................................................................... 262
`B.
`The Claims of the ’514 Patent Are Invalid for Obviousness ............................. 263
`1.
`Background of the Relevant Technology .............................................. 263
`2.
`Claim 62 Would Have Been Obvious In View of Chen, Bess, and
`the Knowledge of a Person of Ordinary Skill in the Art ........................ 269
`a.
`The Prior Art Taught a Cast Film Made from a Flowable
`Water-Soluble or Water Swellable Film-Forming Matrix
`Comprising One or More Substantially Water Soluble or
`Water Swellable Polymers and a Desired Amount of At
`Least One Active........................................................................ 269
`The Prior Art Taught the Use of Taste-Masking Agents
`Selected from the Group of Flavors, Sweeteners, Flavor
`Enhancers, and Combinations Thereof in Pharmaceutical
`Films .......................................................................................... 271
`A Person of Ordinary Skill in the Art Would have
`Achieved the Claimed Uniformity ............................................. 272
`The Prior Art Taught a Particulate Active with a Particle
`Size of 200 Microns or Less In Pharmaceutical Films .............. 288
`Claim 64 Is Obvious In View of Chen, Bess, and the Knowledge of
`a Person of Ordinary Skill in the Art ..................................................... 291
`Claim 65 Would Have Been Obvious In View of Chen, Bess, and
`the Knowledge of a Person of Ordinary Skill in the Art ........................ 293
`Claim 69 Would Have Been Obvious In View of Chen, Bess, and
`the Knowledge of a Person of Ordinary Skill in the Art ........................ 296
`
`b.
`
`c.
`
`d.
`
`3.
`
`4.
`
`5.
`
`viii
`
`DRL - EXHIBIT 1029
`DRL009
`
`

`
`Case 1:13-cv-01674-RGA Document 403 Filed 02/22/16 Page 10 of 461 PageID #: 13961
`TABLE OF CONTENTS (cont’d)
`
`Page
`
`
`
`III.
`
`b.
`
`c.
`
`d.
`
`e.
`
`6.
`
`7.
`
`3.
`
`4.
`
`Claim 73 Is Obvious In View of Chen, Bess, and the Knowledge of
`a Person of Ordinary Skill in the Art ..................................................... 297
`Secondary Considerations Do Not Render the Claims Non-
`Obvious .................................................................................................. 298
`a.
`Dr. Langer’s Post-Dated References Do Not Render the
`Asserted Claims Non-Obvious .................................................. 298
`Plaintiffs Have Not Established that Suboxone Film
`Satisfied a Long-Felt Need or Supports Any Secondary
`Considerations of Non-Obviousness.......................................... 305
`The Claims of the ’514 Patent Are Indefinite .................................................... 308
`C.
`’832 PATENT INVALIDITY........................................................................................ 309
`A.
`The Asserted Claims of the ’832 Patent Are Invalid for Obviousness .............. 309
`1.
`Introduction ............................................................................................ 309
`2.
`The Scope and Content of the Prior Art ................................................. 310
`a.
`Suboxone sublingual tablets effectively delivered
`buprenorphine, but not naloxone, transmucosally under
`acidic conditions ........................................................................ 310
`EuroCeltique instructs a skilled artisan to formulate a film
`bioequivalent to Suboxone sublingual tablets for the
`transmucosal delivery of buprenorphine .................................... 314
`LabTec instructs a skilled artisan to formulate a film
`bioequivalent to Suboxone sublingual tablets for the
`transmucosal delivery of buprenorphine .................................... 316
`Cassidy teaches buprenorphine absorbs transmucosally at
`acidic pH .................................................................................... 318
`Birch teaches buprenorphine absorbs transmucosally at
`acidic pH .................................................................................... 319
`A Person of Ordinary Skill in the Art Would Have Been Motivated
`to Make an Oral Film Bioequivalent to Suboxone Sublingual
`Tablets for the Transmucosal Delivery of Buprenorphine .................... 323
`A Person of Ordinary Skill in the Art Would Have Selected Acidic
`Conditions for a Film to Selectively Deliver Buprenorphine
`Transmucosally, Including a pH of About 3 to About 3.5..................... 324
`a.
`Although irrelevant, the internal Reckitt documents relied
`on by Dr. Davies demonstrate that a person of skill in the
`art would select acidic conditions in developing a film
`bioequivalent to Suboxone sublingual tablets ............................ 328
`
`b.
`
`ix
`
`DRL - EXHIBIT 1029
`DRL010
`
`

`
`Case 1:13-cv-01674-RGA Document 403 Filed 02/22/16 Page 11 of 461 PageID #: 13962
`TABLE OF CONTENTS (cont’d)
`
`
`
`Page
`
`5.
`
`b.
`
`c.
`d.
`
`A Person of Ordinary Skill in the Art Would Have Expected
`Buprenorphine to Absorb at Low pH Where It Would Be
`Predominantly Ionized ........................................................................... 330
`a.
`All available absorption data showed that buprenorphine
`absorbed when essentially all ionized ........................................ 330
`The primary factors affecting buprenorphine absorption are
`most favorable at low pH values ................................................ 331
`pH was known to be a result-effective variable ......................... 335
`Dr. Davies’ “teaching away” references do not support that
`buprenorphine would not have been expected to absorb at
`low pH ........................................................................................ 336
`A Person of Ordinary Skill in the Art Would Have Been Able to
`Make a Film Bioequivalent to the Suboxone Sublingual Tablets
`with a Reasonable Expectation of Success ............................................ 340
`Claims 1, 3, and 6 of the ’832 Patent Would Have Been Obvious
`Over the Suboxone Tablets and EuroCeltique or LabTec in View
`of Cassidy and Birch .............................................................................. 343
`Claims 15-19 of the ’832 Patent Are Anticipated by and/or Obvious Over
`EuroCeltique and LabTec .................................................................................. 347
`1.
`EuroCeltique and LabTec Described Each and Every Element of
`Claim 15 ................................................................................................. 348
`EuroCeltique and LabTec Described Each and Every Element of
`Claim 16 ................................................................................................. 351
`EuroCeltique and LabTec Described Each and Every Element of
`Claim 17 ................................................................................................. 351
`EuroCeltique and LabTec Described Each and Every Element of
`Claim 18 ................................................................................................. 352
`EuroCeltique and LabTec Described Each and Every Element of
`Claim 19 ................................................................................................. 353
`Secondary Considerations Do Not Render the Asserted Claims Non-
`Obvious .............................................................................................................. 353
`Claims 1, 3, and 6 of the ’832 Patent Are Indefinite ......................................... 356
`1.
`The Term “Local pH” Is Indefinite ........................................................ 356
`2.
`The Term “Sufficient to Optimize Absorption” Is Indefinite ................ 359
`PLAINTIFFS’ COUNTERSTATEMENT OF FACTS REGARDING VALIDITY ................ 363
`I.
`THE ASSERTED CLAIMS OF THE ’514 PATENT ARE VALID ............................ 363
`A.
`Trial Witnesses on Validity ............................................................................... 363
`
`6.
`
`7.
`
`2.
`
`3.
`
`4.
`
`5.
`
`B.
`
`C.
`
`D.
`
`x
`
`DRL - EXHIBIT 1029
`DRL011
`
`

`
`Case 1:13-cv-01674-RGA Document 403 Filed 02/22/16 Page 12 of 461 PageID #: 13963
`TABLE OF CONTENTS (cont’d)
`
`
`
`B.
`C.
`
`b.
`
`3.
`
`4.
`5.
`6.
`
`Page
`Defendants’ Expert ................................................................................ 363
`1.
`Plaintiffs’ Expert .................................................................................... 363
`2.
`The Asserted Claims of the ’514 Patent ............................................................ 364
`The asserted claims of the ’514 Patent are not obvious ..................................... 366
`1.
`The technology of the ’514 Patent ......................................................... 366
`2.
`The prior art does not disclose films that meet the 10% uniformity
`requirement of independent Claim 62 .................................................... 366
`a.
`Chen does not disclose “individual unit doses which do not
`vary by more than 10% of said desired amount of said at
`least one active” ......................................................................... 367
`Bess does not disclose “individual unit doses which do not
`vary by more than 10% of said desired amount of said at
`least one active” ......................................................................... 369
`The prior art does not disclose the 5 percent uniformity
`requirement of Claim 65 ........................................................................ 370
`There was no motivation to combine Chen and Bess ............................ 371
`No reasonable expectation of success .................................................... 372
`The scientific literature confirms