Case 1:22-cv-01040-CFC Document 113 Filed 07/25/23 Page 1 of 8 PagelD #: 3743
`Case 1:22-cv-01040-CFC Document 113 Filed 07/25/23 Page 1 of 8 PageID #: 3743
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`IN RE: OZEMPIC (SEMAGLUTIDE)
`PATENT LITIGATION
`
`NOVO NORDISK INC. and
`NOVO NORDISKA/S,
`
`Plaintiffs,
`
`v.
`
`RIO BIOPHARMACEUTICALS INC.,
`et al.,
`
`Defendants.
`
`NOVO NORDISK INC. and
`NOVO NORDISKA/S,
`
`Plaintiffs,
`
`Vv.
`
`MYLAN PHARMACEUTICALSINC.
`
`Defendant.
`
`NeeeeeeeeNeNeeeeeeNNeeeeee
`
`MDLNO. 22-MD-3038 (CFC)
`ANDA CASE
`
`C.A. No. 22-294 (CFC)
`CONSOLIDATED
`ANDA CASE
`
`C.A. No. 22-1040 (CFC)
`ANDA CASE
`
`[PROPOSED] CLAIM CONSTRUCTION ORDER
`
`After having considered the submissions of the parties and hearing oral
`
`argument on the matter, and in accordance with the reasoning set forth on the record
`
`during oral argument, IT IS HEREBY ORDEREDthatthe following termsin the
`
`claims of the patents set forth below are construed as follows:
`
`Novo Nordisk Exhibit 2008
`Dr. Reddy's Laboratories v. Novo Nordisk A/S
`IPR2024-00009
`Page 00001
`
`
`Case 1:22-cv-01040-CFC Document 113 Filed 07/25/23 Page 1 of 8 PageID #: 3743
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`IN RE: OZEMPIC (SEMAGLUTIDE)
`PATENT LITIGATION
`
`NOVO NORDISK INC. and
`NOVO NORDISKA/S,
`
`Plaintiffs,
`
`v.
`
`RIO BIOPHARMACEUTICALS INC.,
`et al.,
`
`Defendants.
`
`NOVO NORDISK INC. and
`NOVO NORDISKA/S,
`
`Plaintiffs,
`
`Vv.
`
`MYLAN PHARMACEUTICALSINC.
`
`Defendant.
`
`NeeeeeeeeNeNeeeeeeNNeeeeee
`
`MDLNO. 22-MD-3038 (CFC)
`ANDA CASE
`
`C.A. No. 22-294 (CFC)
`CONSOLIDATED
`ANDA CASE
`
`C.A. No. 22-1040 (CFC)
`ANDA CASE
`
`[PROPOSED] CLAIM CONSTRUCTION ORDER
`
`After having considered the submissions of the parties and hearing oral
`
`argument on the matter, and in accordance with the reasoning set forth on the record
`
`during oral argument, IT IS HEREBY ORDEREDthatthe following termsin the
`
`claims of the patents set forth below are construed as follows:
`
`Novo Nordisk Exhibit 2008
`Dr. Reddy's Laboratories v. Novo Nordisk A/S
`IPR2024-00009
`Page 00001
`
`
`
`Case 1:22-cv-01040-CFC Document 113 Filed 07/25/23 Page 2 of 8 PagelD #: 3744
`Case 1:22-cv-01040-CFC Document 113 Filed 07/25/23 Page 2 of 8 PageID #: 3744
`
`U.S. Patent No. 8,920,383
`
`Plain and ordinary meaning, whichis
`
`
`“piston rod” (Claims 1, 2, 3, and 8)
`“shaft that causes the piston to be
`moved.”
`
`
`
`Plain and ordinary meaning, with no
`further construction necessary.'
`
`
`
`
`
`
`
`“housing” (Claims 2, 3, 6, 10, and 11)
`
`
`
`
` Noconstruction necessary.
`
`
`“defining a passage” (Claim 1)
`
`
`(Claim 1)
`
`U.S. Patent No. 9,775,953
`
`“piston rod” (Claim 1)
`
`Plain and ordinary meaning, whichis
`“shaft that causes the piston to be
`moved.”
`
`
`“housing” (Claims 1, 2, 8, 9, 19, 21, and| Plain and ordinary meaning, with no
`24)
`further construction necessary.’
`
`
`“defining a passage” (Claim 1)
`
`No construction necessary.
`
`U.S. Patent No. 10,335,462
`
`“A method for treating type 2 diabetes”
`
`The preamble termis an express
`limitation of claims 1-10, and it means
`that “the claimed administration is for
`rpose of care and managementof
`
`' As stated during the July 13, 2023 hearing, if the parties need a synonym for
`“housing,” they could use “enclosure.” Tr. 48:16-19.
`° As stated during the July 13, 2023 hearing, if the parties need a synonym for
`“housing,” they could use “enclosure.” Tr. 48:16-19.
`
`2
`
`Novo Nordisk Exhibit 2008
`Dr. Reddy's Laboratories v. Novo Nordisk A/S
`IPR2024-00009
`Page 00002
`
`
`
`Case 1:22-cv-01040-CFC Document 113 Filed 07/25/23 Page 3 of 8 PagelD #: 3745
`Case 1:22-cv-01040-CFC Document 113 Filed 07/25/23 Page 3 of 8 PageID #: 3745
`
`:
`
`U.S. Patent No. 10,335,462
`
`ies a patient with Type 2 diabetes” or“the
`
`claimed administration is intended to
`care for and manage a patient with Type
`2 diabetes.”
`
`IT IS FURTHER ORDEREDthat the Court will defer any ruling on claim
`
`construction of the following terms of U.S. Patent Nos. 8,920,383 and 9,775,953
`
`until after additional extrinsic evidence, including in the form of expert testimony,
`
`is presented for the Court’s consideration. The parties shall meet and confer to
`
`discuss an appropriate time for the Court to consider such additional extrinsic
`
`evidence and present their proposal to the Court by August 4, 2023.
`
`U.S. Patent No. 8,920,383 _
`
`Peers
`
`“limiter”
`
`1,5, and 8
`
`
`
`
`“driver”
`
`1,5, and 10
`
`
`
`
`
`
`
`
`
`
`Novo Nordisk Exhibit 2008
`Dr. Reddy's Laboratories v. Novo Nordisk A/S
`IPR2024-00009
`Page 00003
`
`
`
`Case 1:22-cv-01040-CFC Document 113 Filed 07/25/23 Page 4 of 8 PagelD #: 3746
`Case 1:22-cv-01040-CFC Document 113 Filed 07/25/23 Page 4 of 8 PageID #: 3746
`
`1, 8, 9, 19, 21, and 24
`
`U.S. Patent No. 9,775,953
`
`
`
`IT IS FURTHER ORDERED that the Court herein adopts the parties’
`
`agreed-to constructions set forth in the Amended Joint Claim Construction Chart
`
`(D.I. 145) and discussed on the record at
`
`the July 13, 2023 hearing. These
`
`constructions are set forth below:
`
`CLAIM TERMS AGREED UPONIN U.S. PATENT NO.8,114,833
`
`
`Construction
`Claim(s)
`
`
`Whenusedin connection with pH,
`}
`“about” 1,7, 16, and 22|“[plus] or [minus] 0.1 pH units from
`[the stated number]”
`
`
`
`
`“A method for
`reducing deposits on
`production
`equipment during
`production of a GLP
`1 agonist
`formulation”
`
`23
`
`The phraseis an expresslimitation of
`claim 23 andit carries its plain and
`ordinary meaning.
`
`
` reducing the
`agonist formulation”
`
`“A method for
`reducing deposits in
`the final product
`during production of
`a GLP-1 agonist
`formulation”
`
`
`26
`
`““A method for
`
`clogging of injection| 29
`devices by a GLP-1
`
`The phrase is an express limitation of
`claim 26 andit carries its plain and
`ordinary meaning.
`
`The phrase is an express limitation of
`claim 29 andit carries its plain and
`ordinary meaning.
`
`Novo Nordisk Exhibit 2008
`Dr. Reddy's Laboratories v. Novo Nordisk A/S
`IPR2024-00009
`Page 00004
`
`
`
`Case 1:22-cv-01040-CFC Document 113 Filed 07/25/23 Page 5 of 8 PagelD #: 3747
`Case 1:22-cv-01040-CFC Document 113 Filed 07/25/23 Page 5 of 8 PageID #: 3747
`
`CLAIM TERMS AGREED UPONIN U.S. PATENT NO.8,114,833
`
`
`
`“dose setting
`member”
`
`Plain and ordinary meaning, whichis
`‘the memberused to set the dose”
`
`
`
`
`
`“replacing the
`“Having a first formulation that utilized
`
`isotonicity agent
`an isotonicity agent other than propylene
`
`previously utilized in
`glycol and having a second formulation
`
`
`
`23, 26, and 29
`said formulation
`whereinthe isotonicity agent used in the
`
`
`
`
`with propylene
`first formulation is substituted or
`
`
`glycol”
`replaced with propylene glycol”
`
`
`
`
`“Having a first formulation that utilized
`
`
`an isotonicity agent other than propylene
`“the isotonicity
`glycol and having a second formulation
`agent to be replaced
`
`
`25, 28, and 31
`by propylene
`wherein the isotonicity agent used in the
`
`
`
`
`
`
`glycol”
`first formulation is substituted or
`
`
`
`replaced with propylene glycol”
`
`
`
` CLAIM TERMS AGREED UPONIN U.S. PATENT NO.8,920,383
`
`
`
`
`
` i+ “medicament”
`
`Plain and ordinary meaning, whichis
`“medication”
`
`
`
`
`
`Plain and ordinary meaning, whichts “a
`componentthat contains the medication,
` “reservoir”
`
`which componentis included only once
`in the injection device”
`
`
`“The piston rod rotates relative to the
`
`
`outermost housing of the injection
`
`
`|
`device and moves axially toward the
`
`
`needle end that expels the medicament”
`
`
`
`
`
`
`“the piston rod
`rotates and translates|
`axially forward”
`
`
`
`
`
`Novo Nordisk Exhibit 2008
`Dr. Reddy's Laboratories v. Novo Nordisk A/S
`IPR2024-00009
`Page 00005
`
`
`
`Case 1:22-cv-01040-CFC Document 113 Filed 07/25/23 Page 6 of 8 PagelD #: 3748
`Case 1:22-cv-01040-CFC Document 113 Filed 07/25/23 Page 6 of 8 PageID #: 3748
`
`CLAIM TERMS AGREED UPONIN U.S. PATENT NO.8,920,383
`
`3
`
`5, 8, and 9
`
`10
`
`Plain and ordinary meaning, whichis “‘a
`mechanism that allowslinearorrotary
`motionin only one direction while
`preventing motion in the opposite
`direction”
`
`“ratchet mechanism’
`
`
`
`
`
`
`
`
`Plain and ordinary meaning, whichis “‘a
`“locking means”
`
`mechanism for locking the piston rod
`
`against rotation in at least one direction”
`
`
`
`
`
`
`Plain and ordinary meaning, whichis “a
`“engaging surface”
`surface adapted to engage a
`
`corresponding surface”
`
`
`
`
`
`
`
`
`
`
`
`Plain and ordinary meaning, whichis
`
`
`“running lengthwise”
`
`
`
`
`
`member”
`
` Plain and ordinary meaning, whichis
` Plain and ordinary meaning, whichis
`
`“medication”
`
`
`
`
`
`
`
`3
`
`
`
`
`
`CLAIM TERMS AGREED UPONIN U.S. PATENT NO.9,775,953
`
`Construction
`
`son"
`direction”
`
`“dose setting
`
`ee
`
`=
`medicament
`
`33
`
`
`
`
`“the member used to set the dose”
`
`l
`
`.
`
`ace
`
`
` “reservoir”
`
`
`
`
`Plain and ordinary meaning, whichis “a
`component that contains the medication,
`which componentis included only once
`in the injection device”
`
`Novo Nordisk Exhibit 2008
`Dr. Reddy's Laboratories v. Novo Nordisk A/S
`IPR2024-00009
`Page 00006
`
`
`
`Case 1:22-cv-01040-CFC Document 113 Filed 07/25/23 Page 7 of 8 PagelD #: 3749
`Case 1:22-cv-01040-CFC Document 113 Filed 07/25/23 Page 7 of 8 PageID #: 3749
`
`
`
`Construction
`
`
` CLAIM TERMS AGREED UPON IN US. PATENT NO.9,775,a.
`
`“causes the piston
`
`
`rod to be displaced
`Plain and ordinary meaning, whichis
`
`
`“causes the piston rod to move, relative
`relative to the
`
`
`
`
`1,2; 7, and 17
`housing in a
`to the housing, in the longitudinal
`
`
`
`
`longitudinal
`direction”
`direction”
`
`
`
`
`Plain and ordinary meaning, whichis “a
`
`“engaging surface”|4,7, and 17
`surface adapted to engage a
`
`corresponding surface”
`
`
`
`Plain and ordinary meaning, whichis “‘a
`
`mechanismthat allowslinear or rotary
`
`8, 9, 19, 21, and
`
`“ratchet mechanism” 5A
`motion in only one direction while
`
`
`
`preventing motion inthe opposite
`direction”
`
`
`
`Plain and ordinary meaning, which is
`
`“adapted to be
`“adapted such that movement can be
`locked”
`
`
`restricted”
`
`
`
`
`CLAIM TERMS AGREED UPONIN U.S. PATENT NO.8,129,343
`
`ees
`
`Plain and ordinary meaning, whichis
`* N-€26-[2-(2-[2-(2-
`“the compound correspondingto the
`[2-(2-[4-(17-
`chemical name N-¢26-[2-(2-[2-(2-[2-(2-
`Carboxyheptadecano
`[4-(17-Carboxyheptadecanoylamino)-
`ylamino)-4(S)-
`
`carboxybutyrylamin|4 and 5 4(S)-carboxybutyrylamino]
`0]
`ethoxy)ethoxy]acetylamino)
`ethoxyethoxyJacety]
`ethoxyethoxy) acetyl] [Aib8,Arg34]
`amino)
`GLP-1-(7-37) peptide, which is also
`ethoxyethoxy)
`called ‘semaglutide’”
`[Aib8,Arg34]|
`acetyl]
`
`
`
`
`
`Novo Nordisk Exhibit 2008
`Dr. Reddy's Laboratories v. Novo Nordisk A/S
`IPR2024-00009
`Page 00007
`
`
`
`Case 1:22-cv-01040-CFC Document 113 Filed 07/25/23 Page 8 of 8 PagelD #: 3750
`Case 1:22-cv-01040-CFC Document 113 Filed 07/25/23 Page 8 of 8 PageID #: 3750
`
`CLAIM TERMS AGREED UPONIN U.S. PATENT NO.8,129,343
`
`
`
`GLP-1-(7-37)
`peptide”
`
`
`
`
`
`Plain and ordinary meaning, whichis “a
`compoundcorresponding to the claimed
`
`The chemical
`structure, whichis also called
`
`
`structure identified|1 and 2
`‘semaglutide’”
`in claims | and 2
`
`CLAIM TERMS AGREED UPONIN U.S. PATENT NO. 10,335,462 —
`
`written as NaH2PO,4”
`
`“once weekly in an
`amountof 1.0 mg”
`
`
`“solution”
`
`3, 4,5, 7, and 9
`
`“sodium dihydrogen
`phosphate”
`
`Plain and ordinary meaning, whichis
`“one administration per week in an
`amountof 1.0 mg”
`
`Plain and ordinary meaning whichis “a
`solution comprising semaglutide”
`
`Plain and ordinary meaning, whichis
`“sodium dihydrogen phosphate, the
`molecular formula for which may be
`
`SO ORDEREDthis 2
`
`day of July, 2023.
`
`CHIEF, Atfhae JUDGE
`
`Novo Nordisk Exhibit 2008
`Dr. Reddy's Laboratories v. Novo Nordisk A/S
`IPR2024-00009
`Page 00008
`
`
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