Case 1:23-cv-00101-CFC Document 126 Filed 03/25/24 Page 1 of 8 PageID #: 1899
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELA WARE
`
`NOVO NORDISK INC. and
`NOVO NORDISK A/S,
`
`Plaintiffs,
`
`V.
`
`•
`
`Civ. No. 23-cv-00101-CFC
`ANDA CASE
`
`MYLAN PHARMACEUTICALS
`INC.,
`
`Defendant.
`
`MEMORANDUM ORDER
`
`Plaintiffs Novo Nordisk Inc. and Novo Nordisk A/S ( collectively Novo
`
`Nordisk) market Wegovy®, a drug product approved by the U.S. Food and Drug
`
`Administration (FDA) to treat obesity and the reference product for the abbreviated
`
`new drug application filed by Defendant Mylan Pharmaceuticals, Inc. that led to
`
`this patent infringement litigation. Pending before me is the construction of two
`
`terms in claim 1 of the asserted U.S. Patent No. 9,764,003 (the #003 patent).
`
`The active ingredient in Wegovy® is a GLP-1 receptor agonist called
`
`semaglutide. Claim 1 of the #003 patent reads:
`
`A method for reducing body weight, comprising
`administering semaglutide once weekly in an amount of
`at least 0. 7 mg and up to 1.6 mg to a subject in need
`thereof, wherein said semaglutide is administered without
`another therapeutic agent.
`
`MPI EXHIBIT 1127 PAGE 1
`
`
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELA WARE
`
`NOVO NORDISK INC. and
`NOVO NORDISK A/S,
`
`Plaintiffs,
`
`V.
`
`•
`
`Civ. No. 23-cv-00101-CFC
`ANDA CASE
`
`MYLAN PHARMACEUTICALS
`INC.,
`
`Defendant.
`
`MEMORANDUM ORDER
`
`Plaintiffs Novo Nordisk Inc. and Novo Nordisk A/S ( collectively Novo
`
`Nordisk) market Wegovy®, a drug product approved by the U.S. Food and Drug
`
`Administration (FDA) to treat obesity and the reference product for the abbreviated
`
`new drug application filed by Defendant Mylan Pharmaceuticals, Inc. that led to
`
`this patent infringement litigation. Pending before me is the construction of two
`
`terms in claim 1 of the asserted U.S. Patent No. 9,764,003 (the #003 patent).
`
`The active ingredient in Wegovy® is a GLP-1 receptor agonist called
`
`semaglutide. Claim 1 of the #003 patent reads:
`
`A method for reducing body weight, comprising
`administering semaglutide once weekly in an amount of
`at least 0. 7 mg and up to 1.6 mg to a subject in need
`thereof, wherein said semaglutide is administered without
`another therapeutic agent.
`
`MPI EXHIBIT 1127 PAGE 1
`
`
`
`Case 1:23-cv-00101-CFC Document 126 Filed 03/25/24 Page 2 of 8 PageID #: 1900
`
`#003 patent at 3 5 :31-3 5 ( emphasis added).
`
`The first disputed term is "in an amount of at least 0. 7 mg and up to 1.6 mg."
`
`Both parties ask me to give the term its plain and ordinary meaning. They dispute,
`
`however what that meaning is. Novo Nordisk proposes that I construe the term to
`
`mean "in doses greater than or equal to 0. 7 mg and less than or equal to 1.6 mg,"
`
`D.I. 63 at 41, and argues that under this construction the claimed method allows for
`
`administrations of semaglutide in amounts less than 0. 7 mg and above 1.6 mg.
`
`Mylan argues that the claimed method does not allow for administrations of
`
`semaglutide in doses less than 0. 7 mg or above 1.6 mg, and its asks that I construe
`
`the term to mean "only in doses greater than or equal to 0. 7 mg and less than or
`
`equal to 1.6 mg." D.I. 63 at 41.
`
`Novo Nordisk argues that "[i]t is black letter law that '[t]he transition
`
`"comprising" in a method claim indicates that the claim is open-ended and allows
`
`for additional steps,' even where such steps are unclaimed." D.I. 63 at 42 (quoting
`
`Invitrogen Corp. v. Biocrest Mfg. L.P., 327 F.3d 1364, 1368 (Fed. Cir. 2003)
`
`(second alteration in the original)). Novo Nordisk "is correct that, generally, the
`
`use of the transitional phrase 'comprising' does not exclude additional, unrecited
`
`steps." Bd. of Regents of the Univ. of Texas Sys. v. BENQ Am. Corp., 533 F.3d
`
`1362, 1372 (Fed. Cir. 2008) (citing Dippin' Dots, Inc. v. Mosey, 476 F.3d 1337,
`
`2
`
`MPI EXHIBIT 1127 PAGE 2
`
`
`
`Case 1:23-cv-00101-CFC Document 126 Filed 03/25/24 Page 3 of 8 PageID #: 1901
`
`1343 (Fed. Cir. 2007)). But "[t]he presumption raised by the term 'comprising'
`
`does not reach into each of the [] steps to render every word and phrase therein
`
`open-ended-especially where ... the patentee has narrowly defined the claim
`
`term it[] seeks to have broadened." Dippin' Dots, 476 F.3d at 1343. Thus, a
`
`patentee "cannot rely on the word 'comprising' to broaden the scope of a claim
`
`phrase that was limited during prosecution so as to gain allowance of the patent."
`
`Univ. of Texas, 533. F.3d at 1373.
`
`In this case, during its prosecution of the #003 patent, Novo Nordisk
`
`expressly capped the dosage of the method in claim 1 at 1.6 mg in order to obtain
`
`the patent. On September 22, 2016, the United States Patent & Trademark Office
`
`(PTO) rejected Novo Nordisk's app~ication for a previous version of claim 1 (at the
`
`time designated claim 13) as indefinite because the proposed claim did not have an
`
`upper dosage limit:
`
`Claims 13, 16, 20, 21, 23, 28, and 29 are rejected under
`35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA), second
`paragraph, as being indefinite for failing to particularly
`point out and distinctly claim the subject matter which
`the inventor or a joint inventor, or for pre-AIA the
`applicant regards as the invention. This is a new
`rejection necessitated upon further consideration the
`claims and potential claim scope.
`
`Claim 13 (and dependent claims 16, 20, 21, 23, 28, and
`29) are drawn to a method for treating obesity,
`comprising administering semaglutide once weekly in an
`
`3
`
`MPI EXHIBIT 1127 PAGE 3
`
`
`
`Case 1:23-cv-00101-CFC Document 126 Filed 03/25/24 Page 4 of 8 PageID #: 1902
`
`amount of at least 0. 7 mg to a subject in need thereof,
`wherein said semaglutide is administered alone or in
`combination with an antiobesity agent.
`
`The metes and bounds of the claim are deemed to be
`indefinite because there is no upper limit in the claims.
`Accordingly, the claim is interpreted as a method of
`administering semaglutide once weekly in an amount of
`at least 0.7 mg which without an upper limit, further
`includes an amount that is broadly interpreted as up to an
`infinite amount (0. 7 mg - infinite amount). Claim
`clarification is required~
`
`D.I. 64-7 at 4 (bold and italicized font in the original). In response to this
`
`rejection, Novo Nordisk added the words "and up to 1.6 mg" to then-claim 13.
`
`D.I. 64-8 at 2. Based on that change (and others), the PTO issued claim 13 as
`
`claim 1 of the #003 patent.
`
`Having narrowed claim 1 with an upper dosage limit to gain allowance of
`
`the claim, Novo Nordisk cannot rely on the word "comprising" to broaden the
`
`scope of the claim to recapture what it expressly and unambiguously relinquished.
`
`Univ. of Texas, 533. F.3d at 1373. Thus, I agree with Mylan that claim 1 does not
`
`allow for administrations of semaglutide in doses greater than 1.6 mg. Mylan,
`
`however, does not identify anything in the prosecution history of the #003 patent
`
`that suggests, let alone clearly shows, that Novo Nordisk disclaimed dosage
`
`amounts below O. 7 mg to obtain issuance of claim 1. For that reason, I cannot
`
`agree that claim 1 does not allow for dosage amounts below 0.7 mg.
`
`4
`
`MPI EXHIBIT 1127 PAGE 4
`
`
`
`Case 1:23-cv-00101-CFC Document 126 Filed 03/25/24 Page 5 of 8 PageID #: 1903
`
`Accordingly, I will construe "in an amount of at least 0.7 mg and up to 1.6
`
`mg" to mean "in doses greater than or equal to 0. 7 mg and never to exceed 1.6
`
`mg." This construction is also consistent with the fact that the patent's written
`
`description discloses a dosage amount of less than 0. 7 mg, see, e.g., #003 patent at
`
`21 :15-17; 22:12-55, but does not disclose any dosage amount above 1.6 mg.
`
`The second disputed term is "administered without another therapeutic
`
`agent." Here again, both parties say I should give the term its plain and ordinary
`
`meaning but they disagree about what that meaning is. "Therapeutic agent" is not
`
`defined in the patent, and neither claim 1 nor any other claim makes clear what is
`
`the universe of therapeutic agents covered by "another therapeutic agent" in
`
`claim 1. Novo Nordisk asks me to construe "administered without another
`
`therapeutic agent" to mean "without coadministration of another medicament
`
`intended to reduce body weight." Mylan originally sought the construction
`
`"without coadministration of another medicament," but at the December 13, 2023
`
`claim construction hearing, it said that it was not seeking to exclude the
`
`coadministration of all other medicaments but only those medicaments implicated
`
`by the patent's written description and the discussion of the Madsbad et al.
`
`reference in the #003 patent's prosecution history. See D.I. 76 at 27:10-15.
`
`Having become convinced during oral argument that the term "additional
`
`5
`
`MPI EXHIBIT 1127 PAGE 5
`
`
`
`Case 1:23-cv-00101-CFC Document 126 Filed 03/25/24 Page 6 of 8 PageID #: 1904
`
`therapeutic agents" contemplated only additional agents that treat a specific subset
`
`of conditions, I asked the parties for additional briefing to help me determine those
`
`conditions. The parties filed supplemental letters on December 15, 2023. D.I. 77;
`
`D.I. 78.
`
`Having considered the parties' positions and studied the patent and its
`
`prosecution history, I will construe the term "administered without another
`
`therapeutic agent" to mean "administered without another therapeutic agent as part
`
`of the method for reducing body weight, or for treating the conditions of diabetes
`
`or hypertension." I will do so for two reasons.
`
`First, the patent's written description provides that:
`
`[i]n one embodiment the GLP-1 agonist is administered
`with another therapeutic agent. Administration with
`another therapeutic agent may be carried out as
`administration of the GLP-1 agonist and the other
`therapeutic agent within the same therapeutic window
`( e.g. within a period of two weeks, a period of one week,
`or in a 96, 72, or 48 hour period, etc.). The treatment
`with a GLP-1 agonist according to the present invention
`may be combined with one or more additional
`therapeutic agents, e.g. selected from antidiabetic agents,
`anti obesity agents, appetite regulating agents,
`antihypertensive agents, agents for the treatment and/or
`prevention of complications resulting from or associated
`with diabetes and agents for the treatment and/or
`prevention of complications and disorders resulting from
`or associated with obesity; examples of these therapeutic
`agents are: sulphonylureas, thiazolidinediones,
`biguanides, meglitinides, glucosidase inhibitors,
`
`6
`
`MPI EXHIBIT 1127 PAGE 6
`
`
`
`Case 1:23-cv-00101-CFC Document 126 Filed 03/25/24 Page 7 of 8 PageID #: 1905
`
`glucagon antagonists, and OPP-IV (dipeptidyl peptidase(cid:173)
`IV) inhibitors.
`
`#003 Patent at 4:35-52 ( emphasis added). It is clear from this passage that Novo
`
`Nordisk understood when it applied for the #003 patent that "another therapeutic
`
`agent" included at a minimum agents used to treat diabetes, obesity, and
`
`hypertension.
`
`Second, during the prosecution of the patent, Novo Nordisk added
`
`"administered without another therapeutic agent" to overcome the patent
`
`examiner's rejection of the then-pending claim 13 (now claim 1) as unpatentable
`
`on obviousness grounds because of an article authored by Madsbad and others.
`
`The examiner had stated in her rejection that "Madsbad teaches the advantages of
`
`using a combination of a GLP-1 receptor and metformin for not only treating type
`
`2 diabetes, but also treating the obesity that is associated with type 2 diabetes .... "
`
`D.I. 64-7 at 9. In its response to the rejection, Novo Nordisk added "administered
`
`without another therapeutic agent" and stated:
`
`Although Madsbad discusses GLP-1 receptor agonists,
`such discussion is focused on using such agonists in
`combination with metformin. Indeed, the Office Action
`specifically cites Madsbad for teaching that "because of
`the complementary effects of metformin and a GLP-1
`receptor agonist on weight and the low risk of
`hypoglycaemia with this combination, the most optimal
`approach for GLP-1 receptor agonist treatment may be in
`combination with metformin as agent number 2 in the
`7
`
`MPI EXHIBIT 1127 PAGE 7
`
`
`
`Case 1:23-cv-00101-CFC Document 126 Filed 03/25/24 Page 8 of 8 PageID #: 1906
`
`treatment algorithm." Office Action at page 11
`( emphasis added). Thus, Madsbad does not teach or
`suggest, as presently claimed, methods for treating
`obesity by administering semaglutide without another
`therapeutic agent.
`
`D.I. 64-8 at 4 ( underline and italicized font in the original). This statement makes
`
`clear that Novo Nordisk intended "another therapeutic agent" to cover at the very
`
`least agents used to treat diabetes and obesity.
`
`NOW THEREFORE, at Wilmington on this Twenty-fifth day of March in
`
`2024, it is HEREBY ORDERED that the Court adopts the following claim
`
`construction with respect to the asserted claims of U.S. Patent No. 9,764,003:
`
`"in an amount of at least 0. 7 mg and up
`to 1.6 m " Claims 1, 2, 5, and 6
`"administered without another
`therapeutic agent" (Claims 1, 2, 5, and
`6)
`
`"in doses greater than or equal to
`0.7 m and never to exceed 1.6 m "
`"administered without another
`therapeutic agent as part of the method
`for reducing body weight, or for
`treating the conditions of diabetes or
`h ertension."
`
`8
`
`1 .
`
`MPI EXHIBIT 1127 PAGE 8
`
`
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