Case 1:17-cv-00227-JFB-SRF Document 39 Filed 01/29/18 Page 1 of 11 PageID #: 383
`
`Plaintiffs,
`
`
`
`
`
`
`C.A. No. 17-227 (VAC) (MPT)
`
`
`
`
`
`
`
`v.
`
`NOVO NORDISK INC. and NOVO
`NORDISK A/S,
`
`
`
`
`
`TEVA PHARMACEUTICALS USA, INC.,
`
`
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`
`JOINT CLAIM CONSTRUCTION CHART
`
`Pursuant to paragraph 15 of the Scheduling Order (D.I. 17), as amended most recently on
`
`
`
`Defendant.
`
`January 26, 2018 (D.I. 38), the parties respectfully submit the attached Joint Claim Construction
`
`Chart.
`
`Copies of U.S. Patent Nos. 8,114,833 (the “’833 Patent”), 9,265,893 (the “’893 Patent”),
`
`and RE41,956 (the “RE ’956 Patent”) are attached hereto as Exhibits A, B, and C, respectively.
`
`Portions of the prosecution history of the ’893 Patent cited in the Joint Claim Chart are attached
`
`hereto as Exhibit D. Portions of the prosecution history of the RE ’956 Patent cited in the Joint
`
`Claim Chart are attached hereto as Exhibit E.
`
`
`
`
`
`MORRIS, NICHOLS, ARSHT & TUNNELL LLP
`
`/s/ Jack B. Blumenfeld
`Jack B. Blumenfeld (#1014)
`Maryellen Noreika (#3208)
`1201 North Market Street
`P.O. Box 1347
`Wilmington, DE 19899
`(302) 658-9200
`jblumenfeld@mnat.com
`mnoreika@mnat.com
`
`Attorneys for Plaintiffs
`
`
`
`
`
`
`
`SHAW KELLER LLP
`
`
`/s/ John W. Shaw
`John W. Shaw (#3362)
`Karen E. Keller (#4489)
`I.M. Pei Building
`1105 North Market Street
`12th Floor
`Wilmington, DE 19801
`jshaw@shawkeller.com
`kkeller@shawkeller.com
`
`Attorneys for Defendant
`
`
`
`
`
`
`
`
`
`

`

`Case 1:17-cv-00227-JFB-SRF Document 39 Filed 01/29/18 Page 2 of 11 PageID #: 384
`
`Jeffrey J. Oelke
`Alison Hanstead
`Ryan P. Johnson
`John Scheibeler
`Laura T. Moran
`WHITE & CASE LLP
`1221 Avenue of the Americas
`New York, NY 10020
`(212) 819-8200
`
`Of Counsel to Novo Nordisk Inc. and Novo
`Nordisk A/S
`
`
`
`Leora Ben-Ami
`Thomas F. Fleming
`Gregory Springsted
`Robert Hyberg
`KIRKLAND & ELLIS LLP
`601 Lexington Avenue
`New York, NY 10022
`(212) 446-5943
`
`
`Of Counsel to Teva Pharmaceuticals USA,
`Inc.
`
`2
`
`

`

`Case 1:17-cv-00227-JFB-SRF Document 39 Filed 01/29/18 Page 3 of 11 PageID #: 385
`
`Defendant’s Intrinsic Evidence
`
`
`
`‘833 Patent Specification
`
`col.1, ll.30-49
`col.1, ll.53-57
`col.2, ll.35-67
`col.3, ll.39-48
`col.13, ll.30-35
`
` -
`
`
`-
`-
`-
`-
`
`Novo Nordisk Inc. et al. v. Teva Pharmaceuticals USA, Inc.
`Civil Action No. 17-227-VAC-MPT
`Joint Claim Construction Chart
`
`CLAIM TERMS AT ISSUE IN U.S. PATENT NO. 8,114,833
`
`Term for
`Construction
`
`Claims
`
`“replacing the
`isotonicity
`agent
`previously
`utilized in said
`formulation
`with propylene
`glycol”
`
`
`23, 26,
`29
`
`Plaintiffs’
`Proposed
`Construction
`
`“utilizing
`propylene glycol
`in
`lieu
`of
`another
`isotonicity agent
`evaluated
`for
`use in a GLP-1
`agonist
`pharmaceutical
`
`Plaintiffs’ Intrinsic Evidence1
`
`
`
`’833 Patent Specification:
`
`-
`-
`-
`-
`-
`
`col.1, ll.30-49
`col.1, ll.53-57
`col.2, ll.35-67
`col.3, ll.39-48
`col.13, ll.30-35
`
`Defendant’s
`Proposed
`Construction
`
`Plain and
`Ordinary meaning,
`but if to be
`construed:
`
`Having a first
`formulation that
`utilized an
`isotonicity agent
`
`
`1 The parties reserve the right to rely on any intrinsic evidence on which the other relies, and any intrinsic evidence contradicting or otherwise rebutting any
`evidence on which the citing party relies. The parties reserve the right to rely on the prosecution history of related applications to the ’833 Patent. The parties
`also reserve the right to rely on extrinsic evidence and/or expert declaration or testimony in support of their proposed constructions or to rebut the other party’s
`arguments and/or any expert declaration or testimony submitted by the other party. For all asserted patents, Defendant’s position is that notwithstanding
`anything contained herein, certain claims and claims term remain indefinite under either party's construction. Unless the Court directs otherwise, Defendant
`agrees to postpone consideration of this issue until expert discovery. Plaintiffs’ position is that any claims or claim terms that Defendant may argue are indefinite
`should have been identified in Defendant’s invalidity or non-infringement contentions, both of which were served prior to filing of this claim chart with the
`Court, or in the course of the parties’ negotiations regarding claim terms needing construction.
`
`
`
`
`
`
`
`
`

`

`Case 1:17-cv-00227-JFB-SRF Document 39 Filed 01/29/18 Page 4 of 11 PageID #: 386
`
`24, 27,
`30
`
`formulation”
`
`-
`col.13, ll.43-47
`-
`col.14, ll.16-40
`-
`col.14, l.56 – col.15, l.13
`-
`col.15, ll.28-48
`-
`col.15, ll.57-60
`-
`col.15, l.61 – col.22, l.21
`- Figures 1-7
`
`25, 28,
`31
`
`-
`col.13, ll.43-47
`-
`col.14, ll.16-40
`-
`col.14, l.56 – col.15, l.13
`-
`col.15, ll.28-48
`-
`col.15, ll.57-60
`-
`col.15, l.61 – col.22, l.21
`- Figures 1-7
`
`other than
`propylene glycol
`and having a
`second
`formulation
`wherein the
`isotonicity agent
`used in the first
`formulation is
`substituted or
`replaced with
`propylene glycol.
`
`“the propylene
`glycol-
`containing
`formulation . . .
`[and] the
`formulation
`containing the
`previously
`utilized
`isotonicity
`agent”
`
`“isotonicity
`agent to be
`replaced by
`propylene
`glycol”
`
`CLAIM TERMS AGREED UPON
`
`Term for Construction
`
`Claims
`
`Parties’ Proposed Construction
`
`“about”
`
`1, 5, 6, 7, 16, 20, 21,
`22
`
`When used in connection with pH, “+ or – 0.1 pH units from [the stated number]”
`
`
`
`
`
`
`
`
`
`
`
`2
`
`
`
`
`
`
`
`

`

`Case 1:17-cv-00227-JFB-SRF Document 39 Filed 01/29/18 Page 5 of 11 PageID #: 387
`
`CLAIM TERMS AT ISSUE IN U.S. PATENT NO. 9,265,893
`
`Defendant’s Intrinsic Evidence
`
`‘893 Specification:
`
` -
`
`
`col.1, ll.46-50
`-
`col.2, ll.27-29
`-
`col.2, ll.50-54
`-
`col.3, ll.37-45
`-
`col.3, ll.46-51
`-
`col.3, ll.65-66
`-
`col.4, ll.6-7
`- Figure 1
`
`
`File History of the ’893 Patent:
`
`
`-
`
`-
`
`July 25, 2013 Appeal Brief
`at 11 (NNVICT00008893)
`July 25, 2013 Appeal Brief
`at 12 (NNVICT00008894)
`
`Defendant’s
`Proposed
`Construction
`
`“component
`a
`with
`that
`protrusion
`inserts into the
`push button that
`is
`used
`to
`transfer
`axial
`force from the
`push button to
`the injector”
`
`Plaintiffs’ Intrinsic Evidence2
`
`
`
`’893 Patent Specification:
`
`col.1, ll.24-34
`col.1, ll.46-50
`col.2, ll.50-54
`col.3, ll.37-45
`col.3, ll.46-51
`
`Jan. 16, 2014 Reply Brief
`at 3 (NNVICT00008974)
`July 25, 2013 Appeal Brief
`at 16 (NNVICT00008898)
`
`
`File History of the ’893 Patent:
`
`
`-
`-
`-
`-
`-
`
`-
`
`-
`
`
`
`Term for
`Construction
`
`Claims
`
`“driving part”
`
`1, 2, 5
`
`Plaintiffs’
`Proposed
`Construction
`
`plain meaning,
`which is “a part
`that
`transfers
`force from the
`push button”
`
`
`2 The parties reserve the right to rely on any intrinsic evidence on which the other relies, and any intrinsic evidence contradicting or otherwise rebutting any
`evidence on which the citing party relies. The parties reserve the right to rely on the prosecution history of related applications to the ’893 Patent. The parties
`also reserve the right to rely on extrinsic evidence and/or expert declaration or testimony in support of their proposed constructions or to rebut the other party’s
`arguments and/or any expert declaration or testimony submitted by the other party. For all asserted patents, Defendant’s position is that notwithstanding
`anything contained herein, certain claims and claims term remain indefinite under either party's construction. Unless the Court directs otherwise, Defendant
`agrees to postpone consideration of this issue until expert discovery. Plaintiffs’ position is that any claims or claim terms that Defendant may argue are indefinite
`should have been identified in Defendant’s invalidity or non-infringement contentions, both of which were served prior to filing of this claim chart with the
`Court, or in the course of the parties’ negotiations regarding claim terms needing construction.
`3
`
`
`
`
`
`
`
`

`

`Case 1:17-cv-00227-JFB-SRF Document 39 Filed 01/29/18 Page 6 of 11 PageID #: 388
`
`
`
`
`’893 Patent Specification:
`
`- Abstract
`-
`col.1, ll.46-52
`-
`col.1, ll. 53-56
`-
`col.2, ll.27-31
`-
`col.3, ll.61-64
`-
`col.4, ll.11-14
`-
`col.4, ll.23-32
`- Figures 1, 2
`
`
`File History of the ’893 Patent:
`
`
`Jan. 16, 2014 Reply Brief at
`3 (NNVICT00008974)
`July 25, 2013 Appeal Brief
`at 11(NNVICT00008893)
`July 25, 2013 Appeal Brief
`at 12(NNVICT00008894)
`July 25, 2013 Appeal Brief
`at 15(NNVICT00008897)
`
`
`-
`
`-
`
`-
`
`-
`
`
`
`
`
`“pivot bearing”
`
`1
`
`plain meaning,
`which
`is
`“a
`machine part in
`which
`another
`part turns, where
`friction
`along
`the
`axis
`of
`rotation
`is
`reduced at
`the
`contacting
`surfaces of the
`two parts”
`
`“a conical or
`spherical surface
`in contact with
`another surface
`to
`reduce
`friction between
`two parts
`that
`are subjected to
`axial thrust and
`rotation”
`
`
`
`’893 Patent Specification:
`
`- Abstract
`-
`col.1, ll.46-52
`-
`col.1, ll.53-56
`-
`col.2, ll.1-14
`-
`col.2, ll.27-31
`-
`col.3, ll.1-3
`-
`col.3, ll.24-29
`-
`col.3, ll.61-64
`-
`col.4, ll.11-14
`-
`col.4, ll.23-32
`-
`col.4, ll.34-37
`- Figure 2
`
`
`File History of the ’893 Patent:
`
`
`-
`
`-
`
`-
`
`Jan. 16, 2014 Reply Brief
`at 3 (NNVICT00008974)
`July 25, 2013 Appeal Brief
`at 12 (NNVICT00008894)
`July 25, 2013 Appeal Brief
`at 15 (NNVICT00008897)
`
`
`
`
`4
`
`
`
`
`
`

`

`Case 1:17-cv-00227-JFB-SRF Document 39 Filed 01/29/18 Page 7 of 11 PageID #: 389
`
`“radial bearing” 2
`
`plain meaning,
`which
`is
`“a
`machine part in
`which
`another
`part turns, where
`friction
`perpendicular to
`the
`axis
`of
`rotation
`is
`reduced at
`the
`contacting
`surfaces of the
`two parts”
`
`
`
`’893 Patent Specification:
`
`- Abstract
`-
`col.1, ll.57-61
`-
`col.1, ll.62-67
`-
`col.3, ll.1-3
`-
`col.3, ll.24-29
`-
`col.2, ll.1-14
`-
`col.4, ll.14-19
`-
`col.4, ll.23-32
`-
`col.4, ll.34-37
`- Figure 2
`
`
`File History of the ’893 Patent:
`
`
`“cylindrical
`raised area of
`contact
`to
`reduce
`friction
`between a shaft
`and bore
`that
`rotate relative to
`each other”
`
`
`
`’893 Patent Specification:
`
`- Abstract
`-
`col.1, ll.57-61
`-
`col.1, ll.62-67
`-
`col.2, ll.1-14
`-
`col.4, ll.14-19
`-
`col.4, ll.23-32
`- Figures 1, 2
`
`
`
`
`
`
`-
`
`Jan. 16, 2014 Reply Brief
`at 3 (NNVICT00008974)
`
`
`
`
`
`
`
`
`
`
`
`
`5
`
`
`
`
`
`

`

`Case 1:17-cv-00227-JFB-SRF Document 39 Filed 01/29/18 Page 8 of 11 PageID #: 390
`
`CLAIM TERMS AT ISSUE IN U.S. PATENT NO. RE 41,956
`
`Term for
`Construction
`
`Claims
`
`Plaintiffs’
`Proposed
`Construction
`
`Plaintiffs’ Intrinsic Evidence3
`
`Defendant’s
`Proposed
`Construction
`
`Defendant’s Intrinsic Evidence
`
`RE ’956 Patent Specification:
`
`col.2, ll.14-22
`col.2, ll.40-44
`col.2, ll.45-49
`col.3, ll.23-33
`col.3, ll.30-32
`col.3, ll.56-65
`col.4, ll.38-53
`
`-
`-
`-
`-
`-
`-
`-
`
`
`File History of the RE ’956 Patent:
`- Dec. 20, 2007 Amendment
`at 9 (NNVICT00010664)
`- Nov.
`21,
`2008
`Amendment at 9, n.2
`(NNVICT00011366)
`- Nov.
`2008
`21,
`Amendment at 10-11, n.4
`(NNVICT00011367-68)
`- Nov.
`21,
`2008
`
`“a disk-shaped
`or
`cylindrical
`component with
`a helical
`track
`on
`its
`outer
`surface”
`
`
`
`RE ’956 Patent Specification:
`
`
`col.2, ll.14-22
`col.2, ll.23-28
`col.2, ll.40-44
`col.2, ll.45-49
`col.2, ll.50-53
`col.3, l.66 – col.4, l.4
`col.4, ll.27-30
`
`-
`-
`-
`-
`-
`-
`-
`
`File History of the RE ’956 Patent:
`- Nov. 21, 2008 Amendment
`at 9 (NNVICT00011366)
`- Nov. 21, 2008 Amendment
`at 11 (NNVICT00011368)
`- Nov. 21, 2008 Amendment
`at 13 (NNVICT00011370)
`
`
`
`“driver”
`
`1, 2, 3,
`4
`
`plain meaning,
`which is “a part
`that
`transfers
`force from the
`injection button”
`
`
`3 The parties reserve the right to rely on any intrinsic evidence on which the other relies, and any intrinsic evidence contradicting or otherwise rebutting any
`evidence on which the citing party relies. The parties reserve the right to rely on the prosecution history of related applications to the ’956 Patent. The parties
`also reserve the right to rely on extrinsic evidence and/or expert declaration or testimony in support of their proposed constructions or to rebut the other party’s
`arguments and/or any expert declaration or testimony submitted by the other party. For all asserted patents, Defendant’s position is that notwithstanding
`anything contained herein, certain claims and claims term remain indefinite under either party's construction. Unless the Court directs otherwise, Defendant
`agrees to postpone consideration of this issue until expert discovery. Plaintiffs’ position is that any claims or claim terms that Defendant may argue are indefinite
`should have been identified in Defendant’s invalidity or non-infringement contentions, both of which were served prior to filing of this claim chart with the
`Court, or in the course of the parties’ negotiations regarding claim terms needing construction.
`6
`
`
`
`
`
`
`
`

`

`Case 1:17-cv-00227-JFB-SRF Document 39 Filed 01/29/18 Page 9 of 11 PageID #: 391
`
`
`
`RE ’956 Patent Specification:
`
`
`col.2, ll.23-28
`-
`col.2, ll.35-39
`-
`-
`col.2, ll.40-44
`-
`col.2, ll.45-49
`col.2, ll.50-56
`-
`col.3, l.66 – col.4, l.4
`-
`col.4, ll.27-30
`-
`- Figures 1, 2, 3
`
`File History of the RE ’956 Patent:
`
` -
`
` Nov. 21, 2008 Amendment
`at 11 (NNVICT00011368)
`- Nov. 21, 2008 Amendment
`at 13 (NNVICT00011370)
`
`
`
`
`
`helical
`“a
`groove on
`the
`outer surface of
`the driver”
`
`Amendment at 11, n.5
`(NNVICT00011368)
`
`
`
`RE ’956 Patent Specification:
`
`-
`-
`-
`-
`-
`-
`
`col.2, ll.23-28
`col.2, ll.35-39
`col.2, ll.50-54
`col.3, l.66 – col.4, l.4
`col.4, ll.17-24
`col.4, ll.27-30
`
`“track”
`
`1, 2, 4
`
`plain meaning,
`which is “a path
`along which a
`part moves”
`
`
`File History of the RE ’956 Patent:
`
`
`2008
`11
`
`- Nov.
`21,
`at
`Amendment
`(NNVICT00011368)
`- Dec. 20, 2007 Amendment
`at 9 (NNVICT00010664)
`- Nov.
`21,
`2008
`Amendment at 11, n.5
`(NNVICT00011368)
`
`
`
`
`
`7
`
`
`
`
`
`

`

`Case 1:17-cv-00227-JFB-SRF Document 39 Filed 01/29/18 Page 10 of 11 PageID #: 392
`
`
`
`
`
`RE ’956 Patent Specification:
`
`RE ’956 Patent Specification:
`
`- Abstract
`-
`col.2, ll.23-28
`-
`col.2, ll.28-32
`-
`col.2, ll.40-44
`-
`col.2, ll.45-49
`-
`col.2, ll.50-56
`-
`col.3, l.66 – col.4, l.10
`-
`col.4, ll.27-33
`-
`col.4, ll.34-38
`-
`col.4, ll.43-59
`
`
`File History of the RE ’956 Patent:
`
`
`- Nov. 21, 2008 Amendment
`at 11 (NNVICT00011368)
`
`
`
`“track
`follower”
`
`1, 2, 4
`
`plain meaning,
`which is “a part
`that
`moves
`along a path”
`
`-
`-
`-
`-
`-
`-
`-
`
`col.2, ll.23-28
`col.2, ll.28-32
`col.2, ll.48-53
`col.3, l.66 – col.4, l.10
`col.4, ll.30-33
`col.4, ll.34-38
`col.4, ll.43-55
`
`
`File History of the RE ’956 Patent:
`
`
`2008
`11
`
`- Nov.
`21,
`at
`Amendment
`(NNVICT00011368)
`- Dec. 20, 2007 Amendment
`at 9 (NNVICT00010664)
`- Nov.
`21,
`2008
`Amendment at 11, n.5
`(NNVICT00011368)
`
`
`lever
`“movable
`that
`follows a
`pre-defined path
`and is coupled
`to
`the
`dose
`setting member”
`
`
`
`8
`
`
`
`
`
`

`

`Case 1:17-cv-00227-JFB-SRF Document 39 Filed 01/29/18 Page 11 of 11 PageID #: 393
`
`
`
`RE ’956 Patent Specification:
`
`
`
`
`RE ’956 Patent Specification:
`
`-
`-
`-
`-
`-
`
`col.2, ll.23-26
`col.2, ll.35-39
`col.2, ll.55-57
`col.4, ll.10-16
`col.4, ll.53-59
`
`
`File History of the RE ’956 Patent:
`
`- Nov.
`2008
`21,
`11-12
`at
`Amendment
`(NNVICT00011368-69)
`- Nov.
`21,
`2008
`Amendment at 12, n.6
`(NNVICT00011369)
`
`
`
`and
`
`Plain
`ordinary
`meaning.
`
`- Abstract
`-
`col.2, ll.23-26
`-
`col.2, ll.35-39
`-
`col.2, ll.55-56
`-
`col.4, ll.10-16
`-
`col.4, ll.53-59
`
`
`File History of the RE ’956 Patent:
`
`- Nov. 21, 2008 Amendment
`at
`11-13
`(NNVICT00011368-70)
`
`
`“track having a
`length”
`
`1, 2
`
`length of
`“the
`the track that the
`track
`follower
`can move along”
`
`
`
`
`
`
`
`9
`
`
`
`
`
`