`
`
`
`
`
`
`
`
`
`v.
`
`Plaintiffs,
`
`C.A. No. 23-101 (CFC)
`ANDA CASE
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`
`)
`NOVO NORDISK INC. and
`
`)
`NOVO NORDISK A/S,
`
`)
`
`
`)
`
`)
`
`)
`
`)
`
`)
`MYLAN PHARMACEUTICALS INC.,
`)
`
`)
`
`
`
`
`Defendant.
`
`[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 ORDERED that the following terms in the
`
`asserted claims of the patents set forth below are construed as follows:
`
`U.S. Patent No. 9,764,003 (“’003 Patent”)
`Term
`Court’s Construction
`The preamble is limiting. It requires that
`the method be employed for the purpose of
`reducing the patient’s body weight, and it
`does not require a showing of efficacy.
`(Claim Construction Hr’g Tr. at 21:20–24.)
`
`“A method for reducing body
`weight” (Claims 1, 2, 5, and 6)
`
`
`
`
`U.S. Patent No. 10,888,605 (“’605 Patent”)
`Term
`Court’s Construction
`“A liquid pharmaceutical
`Plain and ordinary meaning; the
`composition comprising semaglutide
`composition comprises semaglutide and
`and phenol . . . wherein the phenol is
`phenol wherein the phenol is no more than
`no more than 0.1 mg/ml” (Claims 6,
`0.1 mg/ml. (Claim Construction Hr’g Tr.
`8, 10, 12, and 14)
`at 100:14–18.)
`
`
`
`MPI EXHIBIT 1128 PAGE 1
`
`
`
`
`where the amino acid sequence is that
`of SEQ ID NO: 7.”
`(Claims 1 and 2)
`“N-ε26-[2-(2-[2-(2-[2-(2-[4-(17-
`Carboxyheptadecanoylamino)-4(S)-
`carboxybutyrylamino]ethoxy)ethoxy]
`acetylamino)ethoxy]ethoxy)acetyl]
`[Aib8,Arg34]GLP-1-(7-37)peptide”
`(Claims 4 and 5)
`
`Plain and ordinary meaning, which is
`“the compound corresponding to the
`chemical N-ε26-[2-(2-[2-(2-[2-(2-[4-(17-
`Carboxyheptadecanoylamino)-4(S)-
`carboxybutyrylamino]ethoxy)ethoxy]
`acetylamino)ethoxy]ethoxy)acetyl]
`[Aib8,Arg34]GLP-1-(7-37)peptide,
`which is also called ‘semaglutide’”
`
`Case 1:23-cv-00101-CFC Document 79 Filed 12/15/23 Page 2 of 3 PageID #: 1458
`
`
`
`IT IS FURTHER ORDERED that the Court herein adopts the parties’
`
`agreed upon constructions set forth in the Amended Joint Claim Construction Chart
`
`(D.I. 67) and the letters submitted to the Court pursuant to the December 11, 2023
`
`Oral Order, (D.I. 74, 75).
`
`Claim Terms Agreed Upon in U.S. Patent No. 8,129,343
`Term
`Agreed Upon Construction
`“A compound of the structure
`Plain and ordinary meaning, which is “a
`compound corresponding to the claimed
`structure, which is also called
`‘semaglutide’”
`
`
`
`
`
`Claim Term Agreed Upon in the ’605 Patent
`Term
`Agreed Upon Construction
`“therapeutically effective amount”
`Plain and ordinary meaning, which is
`(Claim 14)
`“an amount intended to have a
`beneficial effect on obesity”
`
`Claim Terms Agreed Upon in U.S. Patent No. 11,318,191
`Term
`Agreed Upon Construction
`“0[.0]% (w/w) to 0.1% (w/w) phenol”
`Plain and ordinary meaning, which is
`(Claims 2, 10, 11, 14, 15, 18, 21, 22,
`“0[.0]% (none) to 0.1% (w/w) phenol”
`24, and 26)
`“therapeutically effective amount”
`(Claims 15, 22, and 26)
`
`Plain and ordinary meaning, which is
`“an amount intended to have a
`beneficial effect on the disease”
`
`2
`
`MPI EXHIBIT 1128 PAGE 2
`
`
`
`Case 1:23-cv-00101-CFC Document 79 Filed 12/15/23 Page 3 of 3 PageID #: 1459
`
`
`
`
`
`
`
`
`Claim Terms Agreed Upon in U.S. Patent No. 11,318,191
`Term
`Agreed Upon Construction
`“optionally one or more agents for
`Plain and ordinary meaning, which is
`adjusting pH”
`“one or more agents for adjusting pH
`(Claims 16 and 23)
`can be, but need not be, present”
`“optionally histidine”
`Plain and ordinary meaning, which is
`(Claim 16)
`“histidine can be, but need not be,
`present”
`Plain and ordinary meaning, which is “a
`compound having the formula Na2HPO4
`in the dihydrate form”
`
`“disodium hydrogen phosphate
`dihydrate”
`(Claim 11)
`
`Claim Term Agreed Upon in the ’003 Patent
`Term
`Agreed Upon Construction
`“at least 0.8 mg”
`Plain and ordinary meaning, which is, in
`(Claim 2)
`conjunction with the limitations of
`claim 1 from which claim 2 depends, “at
`least 0.8 mg and up to 1.6 mg of
`semaglutide”
`
`The Court has taken under advisement the constructions of “without another
`
`therapeutic agent” and “once weekly in an amount of at least 0.7 mg and up to 1.6
`
`mg” from asserted claims 1, 2, 5, and 6 of the ’003 Patent and will issue a separate
`
`order regarding those terms in due course.
`
`
`
`
`
`
`
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`SO ORDERED this ____ day of December, 2023.
`
`The Honorable Colm F. Connolly
`Chief, United States District Judge
`
`3
`
`MPI EXHIBIT 1128 PAGE 3
`
`
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