`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`)))))
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`)))))))))))
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`
`IN RE: OZEMPIC (SEMAGLUTIDE)
`PATENT LITIGATION
`
`NOVO NORDISK INC. and
`NOVO NORDISK A/S,
`
`Plaintiffs,
`
`v.
`
`RIO BIOPHARMACEUTICALS INC.,
`et al.,
`
`Defendants.
`NOVO NORDISK INC. and
`NOVO NORDISK A/S,
`
`Plaintiffs,
`
`v.
`
`MYLAN PHARMACEUTICALS INC.
`
`MDL NO. 22-MD-3038 (CFC)
`ANDA CASE
`
`C.A. No. 22-294 (CFC)
`CONSOLIDATED
`ANDA CASE
`
`C.A. No. 22-1040 (CFC)
`ANDA CASE
`
`Defendant.
`AMENDED JOINT CLAIM CONSTRUCTION CHART
`Pursuant to Section 21 of the Scheduling Order governing this Action (see
`
`D.I. 22; see also D.I. 53 in C.A. No. 22-1040-CFC, adopting the Scheduling
`
`Order entered in C.A. No. 22-294-CFC as D.I. 22), the parties respectfully submit
`
`the attached Amended Joint Claim Construction Chart, addressing the claim
`
`Novo Nordisk Exhibit 2003
`Mylan Pharms. Inc.v. Novo Nordisk A/S
`IPR2023-00724
`Page 00001
`
`
`
`Case 1:22-cv-01040-CFC Document 101 Filed 05/23/23 Page 30 of 37 PageID #: 3414
`
`component
`having a thread
`or spline for
`engaging the
`limiter, and that
`during dose
`setting transfers
`rotational torque
`from one
`component to
`another
`component.”
`
`Term
`No.
`
`Term or Phrase for
`Construction
`
`CLAIM TERMS AT ISSUE IN THE ’462 PATENT
`Claim(s)
`Novo Nordisk’s
`Novo Nordisk’s
`Proposed
`Intrinsic Evidence
`Construction
`Citations
`
`Defendants’
`Proposed
`Construction
`
`14
`
`“A method for
`treating type 2
`diabetes”
`
`1
`
`The phrase is an
`express
`limitation of
`claims 1-10, and
`it carries its plain
`and ordinary
`meaning.
`
`Original
`Proposal: “a
`
`’462 Patent
`Specification:
`- Abstract
`- Figs. 1-3
`- Col.1, ll.17-18
`- Col.1, ll.31-36
`- Col.1, ll.45-50
`- Col.1, ll.56-62
`- Col.2, ll.6-33
`- Col.2, l.51 -
`
`The preambles
`are non-limiting.
`
`To the extent the
`term is a
`limitation, the
`term means
`administering
`semaglutide to
`alleviate the
`
`30
`
`Defendants’
`Intrinsic
`Evidence
`Citations
`’462 patent at
`1:31-2:2;
`5:16-31
`
`1:29-32; 1:45-
`49; 1:56-60;
`2:51-55; 2:63-
`66; 3:3-18;
`4:7-16; 4:25-
`34; 5:16-17;
`
`Novo Nordisk Exhibit 2003
`Mylan Pharms. Inc.v. Novo Nordisk A/S
`IPR2023-00724
`Page 00002
`
`
`
`Case 1:22-cv-01040-CFC Document 101 Filed 05/23/23 Page 31 of 37 PageID #: 3415
`
`Term
`No.
`
`Term or Phrase for
`Construction
`
`CLAIM TERMS AT ISSUE IN THE ’462 PATENT
`Claim(s)
`Novo Nordisk’s
`Novo Nordisk’s
`Proposed
`Intrinsic Evidence
`Construction
`Citations
`
`Defendants’
`Proposed
`Construction
`
`method of caring
`for or managing
`the care of a
`patient so as to
`combat type 2
`diabetes”
`
`Compromise
`Proposal
`Offered During
`Meet and
`Confer Process:
`“A method for
`treating type 2
`diabetes” is a
`limitation, and
`the preamble
`means “the
`claimed
`administration is
`for the care or
`management of a
`patient with type
`
`Col.3, l.5
`- Col.3, ll.4-5
`- Col.3, ll.8-18
`- Col.3, ll. 19-28
`- Col.4, ll.7-14
`- Col.4, ll.25-32
`- Col.4, l.62-
`Col.5, l.49
`- Col.6, ll.2-16
`- Col.6, ll.17-19
`- Col.6, ll.24-28
`- Col.6, ll.29-36
`- Col.6, ll.51-60
`- Col.6, ll.65-66
`- Col.7, ll.27-30
`- Col.8, ll.57-59
`- Col.9, ll.40-42
`- Col.9, ll.52-55
`- Col.10, ll.9-11
`- Col.15, ll.13-14
`- Col.16, ll.58-64
`- Col.17, ll.4-6
`- Col.20, ll.17-22
`
`symptoms and
`complications,
`and/or to cure or
`eliminate or
`prevent, and/or to
`prevent the onset
`of symptoms
`associated with
`type 2 diabetes.
`
`Compromise
`Proposal
`Offered During
`Meet and
`Confer Process:
`“A method for
`treating type 2
`diabetes” is a
`limitation only as
`to the stated
`purpose of the
`claim, and
`imparts no
`
`31
`
`Defendants’
`Intrinsic
`Evidence
`Citations
`6:1-16; 6:29-
`36; 16:56-64;
`17:4-6; 20:17-
`22; 20:31-37;
`20:55-23:26;
`23:26-28:36;
`35:40-36:53
`
`See generally
`’462 patent
`specification
`
`Prosecution
`history of the
`’462 patent at
`specification
`and claims as
`filed, on
`7/21/2017;
`Office action
`of 7/23/2018,
`at 3-8; Office
`action
`
`Novo Nordisk Exhibit 2003
`Mylan Pharms. Inc.v. Novo Nordisk A/S
`IPR2023-00724
`Page 00003
`
`
`
`Case 1:22-cv-01040-CFC Document 101 Filed 05/23/23 Page 32 of 37 PageID #: 3416
`
`Term
`No.
`
`Term or Phrase for
`Construction
`
`CLAIM TERMS AT ISSUE IN THE ’462 PATENT
`Claim(s)
`Novo Nordisk’s
`Novo Nordisk’s
`Proposed
`Intrinsic Evidence
`Construction
`Citations
`
`Defendants’
`Proposed
`Construction
`
`2 diabetes”9
`
`- Col.20, ll.31-37
`- Col.20, ll.49-51
`- Col.20, l.62 –
`Col.21, l.5
`- Col.21, ll.20-29
`- Col.21, ll.31-33
`- Col.22, ll.2-26
`- Table 1
`- Col.23, ll.18-26
`- Col.25, ll.37-42
`
`efficacy. The
`preamble means
`that ‘the claimed
`administration is
`intended as part
`of the care or
`management of a
`patient with type
`2 diabetes but
`does not require
`that the
`administration be
`efficacious in the
`treatment of such
`patient’s type 2
`diabetes.’”10
`
`Defendants’
`Intrinsic
`Evidence
`Citations
`response dated
`1/23/2019, at
`2-4; Notice of
`allowance
`dated
`3/6/2019, at 4-
`5.
`
`9 In advocating for their compromise proposal on this term, Defendants misstate Plaintiffs’ position on this term. In
`Reply, Plaintiffs stated that “Novo Nordisk’s proposed construction [of the preamble] does not include an efficacy
`requirement as Defendants incorrectly argue.” Jt. Br. (D.I. 136) at 24-25 (emphasis added).
`10 Defendants’ proposed construction of the preamble of the ’462 patent adopts Plaintiffs’ position that the preamble
`“does not impart an efficacy requirement.” Jt. Brief (D.I. 119) at 25.
`
`32
`
`Novo Nordisk Exhibit 2003
`Mylan Pharms. Inc.v. Novo Nordisk A/S
`IPR2023-00724
`Page 00004
`
`