LUYE PHARMA GROUP LTD., LUYE PHARMA(USA) LTD., SHANDONG LUYE
`PHARMACEUTICAL CO., LTD., and NANJING LUYE PHARMACEUTICAL CO., LTD.
`Petitioners
`v.
`ALKERMES PHARMA IRELAND LTD and ALKERMES CONTROLLED
`THERAPEUTICS, INC.,
`Patent Owners
`
`
`IPR2016-01096
`U.S. Patent 6,667,061
`Petitioners’ Oral Argument
`August 28, 2017
`
`1
`
`
`PHARMACEUTICAL CO., LTD., and NANJING LUYE PHARMACEUTICAL CO., LTD.
`Petitioners
`v.
`ALKERMES PHARMA IRELAND LTD and ALKERMES CONTROLLED
`THERAPEUTICS, INC.,
`Patent Owners
`
`
`IPR2016-01096
`U.S. Patent 6,667,061
`Petitioners’ Oral Argument
`August 28, 2017
`
`1
`
`
`
`Institution of Trial for the ’061 Patent
`
`Ground 1
`
`Ground 2
`
`Paper 13 (Institution Decision) at 20, 31
`
`2 2
`2
`
`
`
`’061 Patent Claim 1
`
`The ’061 Patent,
`Ex.1001, Claim 1
`
`Paper 5, (Pet.) at 32-33, 49-50
`
`3 3
`3
`
`
`
`’061 Patent Claims 2-3
`
`The ’061 Patent,
`Ex.1001, Claims 2-3
`
`Paper 5 (Pet.) at 33-34, 50-51
`
`4 4
`4
`
`
`
`’061 Patent Claims 4-5, 10-11
`
`The ’061 Patent,
`Ex.1001, Claims 4-5
`
`The ’061 Patent,
`Ex.1001, Claims 10-11
`
`Paper 5 (Pet.) at 34-35
`
`5 5
`5
`
`
`
`’061 Patent Claims 6-7, 12-13
`
`The ’061 Patent,
`Ex.1001, Claims 6-7
`
`The ’061 Patent,
`Ex.1001, Claims 12-13
`
`Paper 5 (Pet.) at 34-35, 51-52
`
`6 6
`6
`
`
`
`’061 Patent Claims 8-9
`
`The ’061 Patent,
`Ex.1001, Claims 8-9
`
`Paper 5 (Pet.) at 34-35, 52
`
`7 7
`7
`
`
`
`’061 Patent Claims 17, 18, and 19
`
`The ’061 Patent,
`Ex.1001, Claims 17-19
`
`Paper 5 (Pet.) at 53
`
`8 8
`8
`
`
`
`’061 Patent Claims 20-21
`
`The ’061 Patent,
`Ex.1001, Claims 20-21
`
`Paper 5 (Pet.) at 53-54
`
`9 9
`9
`
`
`
`’061 Patent Claims 22-23
`
`The ’061 Patent,
`Ex.1001, Claims 22-23
`
`Paper 5 (Pet.) at 37-38, 54-56
`
`10 10
`10
`
`
`
`The Overriding Issue of Viscosity
`
`Petitioners have demonstrated that
`the injection vehicles in the Johnson
`and Gustafsson references have an
`inherent viscosity within the
`claimed range
`
`
`Paper 5, (Pet.) at 33, 50
`
`11 11
`11
`
`
`
`The ‘061 Patent Identifies A Vehicle With A Viscosity of
`19.7 cps
`
`The ’061 Patent,
`Ex.1001, col. 2, ll.34-37
`
`Paper 5 (Pet.) at 15
`
`12 12
`12
`
`
`
`The ‘061 Patent Disclaims An Injection Vehicle
`With 3% CMC
`
`The ’061 Patent,
`Ex.1001, col. 3, ll.3-8
`
`The ’061 Patent,
`Ex.1001, col. 3, ll.18-34
`
`Paper 5 (Pet.) at 15; Paper 40 (Reply) at 3, Ex.1024 paragraph 70
`
`
`13 13
`13
`
`
`
`Exemplary Viscosity Values Set Forth In the ‘061 Patent
`
`The ’061 Patent,
`Ex.1001, col.6, ll.9-20
`
`Paper 5 (Pet.) at 17-18; Paper 40 (Reply) at 16
`
`14 14
`14
`
`
`
`Exemplary Viscosity Values Set Forth In the ‘061 Patent
`
`The ’061 Patent,
`Ex.1001, col.9, ll.43-47
`
`The ’061 Patent,
`Ex.1001, col.10, ll.17-27
`
`Paper 5 (Pet.) at 24; Paper 40 (Reply) at 16
`
`15 15
`15
`
`
`
`Patent Office Requires Applicants To Show
`Unexpected Results
`
`4/9/03 Office Action,
`Ex.1016, p.4
`
`* * *
`
`Paper 5 (Pet.) at 16-18
`
`16 16
`16
`
`
`
`Tracy Declaration
`
`Tracy Decl., Ex.1018, p.1-2
`
`Paper 5 (Pet.) at 17-18; Paper 40 (Reply) at 9-10
`
`17 17
`17
`
`
`
`Tracy States “CMC is the viscosity-controlling
`component”
`
`Tracy Decl., Ex.1018, p.2
`
`Paper 5 (Pet.) at 17-18; Paper 40 (Reply) at 14
`
`18 18
`18
`
`
`
`Patent Owners Used Tracy to “Evidence” Viscosity To
`Overcome Prior Art
`
`05/14/03 Applicants’ Response,
`Ex.1017, p.3
`
`Paper 5 (Pet.) at 17-18
`
`19 19
`19
`
`
`
`Tracy Sufficient To Overcome the Cited Prior Art
`
`07/24/03 Notice of Allowance,
`Ex.1019, p.2
`
`Paper 5 (Pet.) at 18
`
`20 20
`20
`
`
`
`The Board Rejected Patent Owners’ Inherency
`Arguments
`
`Institution Decision, Paper 13, p.12
`
`Paper 13 (Institution Decision) at 12
`
`21 21
`21
`
`
`
`Based On Tracy, the Board Finds That Johnson Meets
`the Viscosity Limitation
`
`Institution Decision, Paper 13, p.14
`
`Paper 13 (Institution Decision) at 14
`
`22 22
`22
`
`
`
`Based On Tracy, the Board Finds That Gustafsson Meets
`the Viscosity Limitation
`
`Institution Decision,
`Paper 13, p.24-25
`
`Paper 13 (Institution Decision) at 24-25
`
`23 23
`23
`
`
`
`Johnson And Gustafsson Meet The Claimed
`Viscosity Limitation
`
`Institution Decision, Paper 13, p.32
`
`Paper 13 (Institution Decision) at 32
`
`24 24
`24
`
`
`
`The Other Limitations Are Known In The Prior Art
`
`25 25
`25
`
`
`
`Syringeabilty, Injectability, and Suspendability Are Well-Known
`Issues Considered By A POSA
`
`The ’061 Patent,
`Ex.1001, 1:17-22
`
`Paper 5, (Pet.) at 7; Ex.1002, paragraph 9
`
`26 26
`26
`
`
`
`The ‘061 Patent Admits Any Active or Microparticle
`Works
`
`The ’061 Patent,
`Ex.1001, col. 4, ll.25-30
`
`Paper 40 (Reply) at 6, 24-25
`
`27 27
`27
`
`
`
`The ‘061 Patent Defines Microparticles
`
`The ’061 Patent,
`Ex.1001, col. 5, ll.14-18
`
`Paper 5 (Pet.) at 20; Paper 40 (Reply) at 6
`
`28 28
`28
`
`
`
`Polymeric Binder
`
`The ’061 Patent,
`Ex.1001, col.14, ll.10-18
`
`*
`
`*
`
`*
`
`Paper 40 (Reply) at 7
`
`29 29
`29
`
`
`
`Prior Art For Instituted Grounds
`
`Ground 1
`Claims 1-13, 22, 23
`
`Ground 2
`Claims 1-3, 6-9, 12, 13, 17-23
`
`
`Gustafsson
`(Ex. 1011)
`International Publication
`No. WO 1997/014408
`
`
`Ramstack
`(Ex. 1005)
`International Publication
`No. WO 1995/013799
`
`
`
`Johnson
`(Ex.1009)
`U.S. Patent No. 5,654,010
`
`
`Kino
`(Ex. 1010)
`U.S. Patent No. 5,656,299
`
`
`
`PRIMARY
`
`SECONDARY
`
`Paper 13 (Institution Decision) at 20, 31
`
`30 30
`30
`
`
`
`Prior Art For Instituted Ground 1
`
`Ground 1
`Claims 1-13, 22, 23
`
`Ground 2
`Claims 1-3, 6-9, 12, 13, 17-23
`
`
`Gustafsson
`(Ex. 1011)
`International Publication
`No. WO 1997/014408
`
`
`Ramstack
`(Ex. 1005)
`International Publication
`No. WO 1995/013799
`
`
`
`Johnson
`(Ex.1009)
`U.S. Patent No. 5,654,010
`
`
`Kino
`(Ex. 1010)
`U.S. Patent No. 5,656,299
`
`
`
`PRIMARY
`
`SECONDARY
`
`Paper 13 (Institution Decision) at 20
`
`31 31
`31
`
`
`
`’061 Independent Claim
`
`The ’061 Patent,
`Ex.1001, Claim 1
`
`Paper 5 (Pet.) at 32-33, 49-50
`
`32 32
`32
`
`
`
`Johnson’s Prior Art Vehicles
`
`Johnson, Ex.1009, col.10, ll.17-21
`
`Johnson, Ex.1009, col.11, l.65-col.12, l.5
`
`Paper 5 (Pet.) at 24-26; Paper 40 (Reply) at 11
`
`33 33
`33
`
`
`
`Claim 1 Reads on Johnson’s Vehicle
`
`Johnson, Ex.1009, col.12, ll. 40-45
`
`Paper 5 (Pet.) at 24-26
`
`34 34
`34
`
`
`
`The Johnson Reference and The ‘061 Patent Have A
`Common Inventor
`
`Paper 5, (Pet.) at 9
`
`35 35
`35
`
`
`
`Patent Owner Admits That 0.75% CMC Has A Viscosity
`Of Approximately 7 cp
`
`Kino
`Vehicle
`
`Tracy Declaration
`
`Kino
`Vehicle
`
`0.5% CMC
`
`Viscosity < 7cp
`
`• CMC is viscosity
`controlling agent
`• 0.75% CMC has a
`viscosity of approx.
`7cp
`
`Paper 5 (Pet.) at 17-18; Ex.1002 paragraph 44
`
`36 36
`36
`
`
`
`Patent Owner Admits That 1.5% CMC Has A
`Viscosity of 27 cp
`
`Johnson
`Vehicle
`
`Tracy Declaration
`
`Johnson
`Vehicle
`
`3% CMC
`
`Viscosity > 27cp
`
`• CMC is viscosity
`controlling agent
`• 1.5% CMC has a
`viscosity of 27cp
`
`Paper 5 (Pet.) at 17-18, 33; Ex.1002 paragraph 44
`
`
`37 37
`37
`
`
`
`‘061 Patent vs. Johnson Prior Art
`
`The ‘061 Patent, Ex.1001, col.9, ll.43-47
`
`The ‘061 Patent, Ex.1001, col. 3, ll.3-8
`
`Johnson, Ex.1009, col.12, ll.39-45
`
`Paper 5 (Pet.) at 24-26; Paper 40 (Reply) at 16-17
`
`38 38
`38
`
`
`
`The ‘061 Patent And The Tracy Declaration Do Not
`Describe CMC Used Or Other Viscosity Factors
`
`Reply, Paper 40, p.13
`
`Reply, Paper 40, p.15
`
`Paper 40 (Reply) 13, 15
`
`39 39
`39
`
`
`
`Kino Teaches Wetting Agents And Density
`Enhancing Agents
`
`Kino, Ex.1010, col. 4, ll.38-60
`
`*
`
`*
`
`*
`
`Paper 5 (Pet.) at 26-27
`
`40 40
`40
`
`
`
`Motivation To Combine Johnson’s Formulation With
`Kino’s Filler To Arrive At Claims 4, 5, 10, 11
`
`DeLuca Supp. Decl.,
`Ex.1024, paragraph 76
`
`Paper 40 (Reply) at 17
`
`41 41
`41
`
`
`
`Prior Art Motivates A POSA To Increase the Viscosity To
`Prevent Sedementation
`
`USP23, Ex.1034, p. 1949
`
`Paper 40 (Reply) at 5
`
`42 42
`42
`
`
`
`Motivation To Combine Johnson’s Formulation With
`Kino’s Wetting Agent To Arrive At Claims 4,5, 10, 11
`
`DeLuca Supp. Decl.,
`Ex.1024, paragraph 76
`
`Paper 40 (Reply) at 17
`
`43 43
`43
`
`
`
`Prior Art For Instituted Ground 2
`
`Ground 1
`Claims 1-13, 22, 23
`
`Ground 2
`Claims 1-3, 6-9, 12, 13, 17-23
`
`
`Gustafsson
`(Ex. 1011)
`International Publication
`No. WO 1997/014408
`
`
`Ramstack
`(Ex. 1005)
`International Publication
`No. WO 1995/013799
`
`
`
`Johnson
`(Ex.1009)
`U.S. Patent No. 5,654,010
`
`
`Kino
`(Ex. 1010)
`U.S. Patent No. 5,656,299
`
`
`
`PRIMARY
`
`SECONDARY
`
`Paper 13 (Institution Decision) at 31
`
`44 44
`44
`
`
`
`Patent Owner Admits That 1.5% CMC Has A
`Viscosity of 27 cp
`
`Gustafsson
`Vehicle
`
`Tracy Declaration
`
`Gustafsson
`Vehicle
`
`3% CMC
`
`Viscosity > 27cp
`
`• CMC is viscosity
`controlling agent
`• 1.5% CMC has a
`viscosity of 27cp
`
`Paper 5 (Pet.) at 17-18, 50
`
`45 45
`45
`
`
`
`Gustafsson Teaches An Injection Vehicle Within The
`Claimed Viscosity Range
`
`Gustafson,
`Ex.1011, p.18, ll.21-24
`
`Gustafsson,
`Ex.1011, p.19, ll.21-24
`
`Paper 5 (Pet.) at 39; Paper 40 (Reply) at 18
`
`46 46
`46
`
`
`
`Gustafsson Teaches All Of The Components Of The
`Injection Vehicle Must Be Pharmaceutically Acceptable
`
`Gustafsson,
`Ex.1011, p.6, ll.29-33
`
`Ex.1024 paragraph 86; Paper 40 (Reply) at 18
`
`47 47
`47
`
`
`
`Gustafsson Teaches Use Of Polymers Including PLGA
`
`Gustafsson
`Ex.1011, p.6, ll.15-29
`
`Paper 40 (Reply) at 24; Ex.1024 paragraph 107
`
`48 48
`48
`
`
`
`Gustafsson’s Invention Is Applicable To Any Active
`Suitable For Parenteral Administration
`
`Gustafsson
`Ex.1011, p.6, ll.33-35
`
`Paper 5 (Pet.) at 39
`
`49 49
`49
`
`
`
`Gustafsson’s Microspheres And Injection Vehicle
`
`Gustafsson’s Microspheres
`With PLGA Coating
`
`Gustafsson’s Injection Vehicle
`
`PLGA Coating
`(Polymeric Binder)
`
`
`
`Microparticles
`
`Active
`
`Starch
`(Polymer)
`
`Physiological
`sodium chloride
`solution containing
`3%CMC
`
`Paper 5 (Pet.) at 49-52; Paper 40 (Reply) at 19-20
`
`50 50
`50
`
`
`
`Gustafsson Meets the Limitation of Microparticle
`
`Institution Decision, Paper 13, p.25-26
`
`Paper 13 (Institution Decision) at 25-26
`
`51 51
`51
`
`
`
`Gustafsson Teaches Microparticles Having A Size
`Within The Claimed Range
`
`Gustafsson,
`Ex.1011, p.7, ll.28-33
`
`Paper 5 (Pet.) at 47
`
`52 52
`52
`
`
`
`The ‘061 Patent Is Directed To A Composition Suitable
`For Injection and Not Any Specific Microparticle
`
`The ‘061 Patent,
`Ex.1001, col. 4, ll.25-30
`
`Paper 40 (Reply) at 6, 24-25
`
`53 53
`53
`
`
`
`Prior Art Teaches Parenterally Adminstratable
`Microparticles
`
`Gustafsson,
`Ex.1011, p.6, ll.33-35
`
`Paper 5 (Pet.) at 39
`
`54 54
`54
`
`
`
`Ramstack’s Microparticles And Gustafsson’s Injection
`Vehicle Are Combinable
`
`Ramstack’s Microspheres With
`Gustafsson’s PLGA Coating
`
`Gustafsson’s Injection Vehicle
`
`PLGA Coating
`(Polymeric Binder)
`
`PLGA
`(Polymer)
`
`Microparticles
`
`
`
`Risperidone
`
`Physiological
`sodium chloride
`solution containing
`3%CMC
`
`Paper 5 (Pet.) at 46-47, 54
`
`55 55
`55
`
`
`
`Ramstack Teaches Risperidone As An Active Agent
`
`Ramstack,
`Ex.1005, p.30, l.20
`
`Paper 5 (Pet.) at 46, 54
`
`56 56
`56
`
`
`
`Ramstack Teaches Macromolecular Bioactive Agents
`In Microparticles
`
`Ramstack,
`Ex.1005, p.32 ll.14-17
`
`DeLuca Supplemental Decl., Ex.1024 paragraph 107
`
`57 57
`57
`
`
`
`Ramstack Teaches Various Active Agents
`
`Institution Decision, Paper 13, p.22
`
`Paper 13 (Institution Decision) at 22
`
`58 58
`58
`
`
`
`Patent Owners Did Nothing More Than Combine Well-
`Known Elements
`
`Petition, Paper 5, p.23
`
`Paper 5 (Pet.) at 23
`
`59 59
`59
`
`
`
`Patent Owners Did Nothing More Than Combine Well-
`Known Elements
`
`Petition, Paper 5, p.6
`
`Paper 5 (Pet.) at 6
`
`60 60
`60
`
`
`
`Secondary Considerations
`
`61 61
`61
`
`
`
`Patent Owners Have Not Demonstrated
`Unexpected Results
`
`Reply, Paper 40, p.27
`
`Paper 40 (Reply) at 27
`
`62 62
`62
`
`
`
`Commercial Success Requires Nexus
`
`•
`
`•
`
`“[C]ommercial success alone is not sufficient to demonstrate
`nonobviousness of a claimed invention.” In re DBC, 545 F.3d 1373, 1384
`(Fed. Cir. 2008)
`
`“[T]he proponent must offer proof ‘that sales were a direct result of the
`unique characteristics of the claimed invention—as opposed to other
`economic and commercial factors unrelated to the quality of the
`patented subject matter.” In re DBC, 545 F.3d 1373, 1384 (Fed. Cir. 2008)
`(citation omitted)
`
`• Patent Owners must establish that any commercial success was based on
`patentable features not found in the prior art. See Asyst Techs., Inc. v.
`Emtrak, Inc., 544 F.3d 1310, 1316 (Fed. Cir. 2008); see also J.T. Eaton &
`Co. v. Atl. Paste & Glue Co., 106 F.3d 1563, 1571 (Fed. Cir. 1997).
`
`Paper 5 (Pet.) at 56; Paper 40 (Reply) at 28, 29
`
`63 63
`63
`
`
`
`Patent Owner Has Not Shown A Nexus Between the
`Alleged Commercial Success And the Patented Invention
`
`Reply, Paper 40, p.28
`
`Paper 5 (Pet.) at 57; Paper 40 (Reply) at 28
`
`64 64
`64
`
`
`
`The Handbook Teaches Low Viscosity Within The
`Claimed Range
`
`Handbook, Ex.1008, p.78
`
`Handbook, Ex.1008, p.79
`
`Paper 5 (Pet.) at 6,9, 25; Paper 40 (Reply) at 4
`
`65 65
`65
`
`
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