`
`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
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`Plaintiffs Novo Nordisk Inc. and Novo Nordisk A/S ( collectively Novo
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`Nordisk) market Wegovy®, a drug product approved by the U.S. Food and Drug
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`Administration (FDA) to treat obesity and the reference product for the abbreviated
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`new drug application filed by Defendant Mylan Pharmaceuticals, Inc. that led to
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`this patent infringement litigation. Pending before me is the construction of two
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`terms in claim 1 of the asserted U.S. Patent No. 9,764,003 (the #003 patent).
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`The active ingredient in Wegovy® is a GLP-1 receptor agonist called
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`semaglutide. Claim 1 of the #003 patent reads:
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`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.
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`MPI EXHIBIT 1127 PAGE 1
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`Case 1:23-cv-00101-CFC Document 126 Filed 03/25/24 Page 2 of 8 PageID #: 1900
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`#003 patent at 3 5 :31-3 5 ( emphasis added).
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`The first disputed term is "in an amount of at least 0. 7 mg and up to 1.6 mg."
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`Both parties ask me to give the term its plain and ordinary meaning. They dispute,
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`however what that meaning is. Novo Nordisk proposes that I construe the term to
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`mean "in doses greater than or equal to 0. 7 mg and less than or equal to 1.6 mg,"
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`D.I. 63 at 41, and argues that under this construction the claimed method allows for
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`administrations of semaglutide in amounts less than 0. 7 mg and above 1.6 mg.
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`Mylan argues that the claimed method does not allow for administrations of
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`semaglutide in doses less than 0. 7 mg or above 1.6 mg, and its asks that I construe
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`the term to mean "only in doses greater than or equal to 0. 7 mg and less than or
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`equal to 1.6 mg." D.I. 63 at 41.
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`Novo Nordisk argues that "[i]t is black letter law that '[t]he transition
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`"comprising" in a method claim indicates that the claim is open-ended and allows
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`for additional steps,' even where such steps are unclaimed." D.I. 63 at 42 (quoting
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`Invitrogen Corp. v. Biocrest Mfg. L.P., 327 F.3d 1364, 1368 (Fed. Cir. 2003)
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`(second alteration in the original)). Novo Nordisk "is correct that, generally, the
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`use of the transitional phrase 'comprising' does not exclude additional, unrecited
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`steps." Bd. of Regents of the Univ. of Texas Sys. v. BENQ Am. Corp., 533 F.3d
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`1362, 1372 (Fed. Cir. 2008) (citing Dippin' Dots, Inc. v. Mosey, 476 F.3d 1337,
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`2
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`MPI EXHIBIT 1127 PAGE 2
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`
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`Case 1:23-cv-00101-CFC Document 126 Filed 03/25/24 Page 3 of 8 PageID #: 1901
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`1343 (Fed. Cir. 2007)). But "[t]he presumption raised by the term 'comprising'
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`does not reach into each of the [] steps to render every word and phrase therein
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`open-ended-especially where ... the patentee has narrowly defined the claim
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`term it[] seeks to have broadened." Dippin' Dots, 476 F.3d at 1343. Thus, a
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`patentee "cannot rely on the word 'comprising' to broaden the scope of a claim
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`phrase that was limited during prosecution so as to gain allowance of the patent."
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`Univ. of Texas, 533. F.3d at 1373.
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`In this case, during its prosecution of the #003 patent, Novo Nordisk
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`expressly capped the dosage of the method in claim 1 at 1.6 mg in order to obtain
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`the patent. On September 22, 2016, the United States Patent & Trademark Office
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`(PTO) rejected Novo Nordisk's app~ication for a previous version of claim 1 (at the
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`time designated claim 13) as indefinite because the proposed claim did not have an
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`upper dosage limit:
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`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.
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`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
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`3
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`MPI EXHIBIT 1127 PAGE 3
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`
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`Case 1:23-cv-00101-CFC Document 126 Filed 03/25/24 Page 4 of 8 PageID #: 1902
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`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.
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`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~
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`D.I. 64-7 at 4 (bold and italicized font in the original). In response to this
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`rejection, Novo Nordisk added the words "and up to 1.6 mg" to then-claim 13.
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`D.I. 64-8 at 2. Based on that change (and others), the PTO issued claim 13 as
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`claim 1 of the #003 patent.
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`Having narrowed claim 1 with an upper dosage limit to gain allowance of
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`the claim, Novo Nordisk cannot rely on the word "comprising" to broaden the
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`scope of the claim to recapture what it expressly and unambiguously relinquished.
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`Univ. of Texas, 533. F.3d at 1373. Thus, I agree with Mylan that claim 1 does not
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`allow for administrations of semaglutide in doses greater than 1.6 mg. Mylan,
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`however, does not identify anything in the prosecution history of the #003 patent
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`that suggests, let alone clearly shows, that Novo Nordisk disclaimed dosage
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`amounts below O. 7 mg to obtain issuance of claim 1. For that reason, I cannot
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`agree that claim 1 does not allow for dosage amounts below 0.7 mg.
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`4
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`MPI EXHIBIT 1127 PAGE 4
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`
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`Case 1:23-cv-00101-CFC Document 126 Filed 03/25/24 Page 5 of 8 PageID #: 1903
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`Accordingly, I will construe "in an amount of at least 0.7 mg and up to 1.6
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`mg" to mean "in doses greater than or equal to 0. 7 mg and never to exceed 1.6
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`mg." This construction is also consistent with the fact that the patent's written
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`description discloses a dosage amount of less than 0. 7 mg, see, e.g., #003 patent at
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`21 :15-17; 22:12-55, but does not disclose any dosage amount above 1.6 mg.
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`The second disputed term is "administered without another therapeutic
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`agent." Here again, both parties say I should give the term its plain and ordinary
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`meaning but they disagree about what that meaning is. "Therapeutic agent" is not
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`defined in the patent, and neither claim 1 nor any other claim makes clear what is
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`the universe of therapeutic agents covered by "another therapeutic agent" in
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`claim 1. Novo Nordisk asks me to construe "administered without another
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`therapeutic agent" to mean "without coadministration of another medicament
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`intended to reduce body weight." Mylan originally sought the construction
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`"without coadministration of another medicament," but at the December 13, 2023
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`claim construction hearing, it said that it was not seeking to exclude the
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`coadministration of all other medicaments but only those medicaments implicated
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`by the patent's written description and the discussion of the Madsbad et al.
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`reference in the #003 patent's prosecution history. See D.I. 76 at 27:10-15.
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`Having become convinced during oral argument that the term "additional
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`5
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`MPI EXHIBIT 1127 PAGE 5
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`
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`Case 1:23-cv-00101-CFC Document 126 Filed 03/25/24 Page 6 of 8 PageID #: 1904
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`therapeutic agents" contemplated only additional agents that treat a specific subset
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`of conditions, I asked the parties for additional briefing to help me determine those
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`conditions. The parties filed supplemental letters on December 15, 2023. D.I. 77;
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`D.I. 78.
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`Having considered the parties' positions and studied the patent and its
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`prosecution history, I will construe the term "administered without another
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`therapeutic agent" to mean "administered without another therapeutic agent as part
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`of the method for reducing body weight, or for treating the conditions of diabetes
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`or hypertension." I will do so for two reasons.
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`First, the patent's written description provides that:
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`[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
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`MPI EXHIBIT 1127 PAGE 6
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`
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`Case 1:23-cv-00101-CFC Document 126 Filed 03/25/24 Page 7 of 8 PageID #: 1905
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`glucagon antagonists, and OPP-IV (dipeptidyl peptidase(cid:173)
`IV) inhibitors.
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`#003 Patent at 4:35-52 ( emphasis added). It is clear from this passage that Novo
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`Nordisk understood when it applied for the #003 patent that "another therapeutic
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`agent" included at a minimum agents used to treat diabetes, obesity, and
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`hypertension.
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`Second, during the prosecution of the patent, Novo Nordisk added
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`"administered without another therapeutic agent" to overcome the patent
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`examiner's rejection of the then-pending claim 13 (now claim 1) as unpatentable
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`on obviousness grounds because of an article authored by Madsbad and others.
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`The examiner had stated in her rejection that "Madsbad teaches the advantages of
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`using a combination of a GLP-1 receptor and metformin for not only treating type
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`2 diabetes, but also treating the obesity that is associated with type 2 diabetes .... "
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`D.I. 64-7 at 9. In its response to the rejection, Novo Nordisk added "administered
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`without another therapeutic agent" and stated:
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`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
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`MPI EXHIBIT 1127 PAGE 7
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`
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`Case 1:23-cv-00101-CFC Document 126 Filed 03/25/24 Page 8 of 8 PageID #: 1906
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`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.
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`D.I. 64-8 at 4 ( underline and italicized font in the original). This statement makes
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`clear that Novo Nordisk intended "another therapeutic agent" to cover at the very
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`least agents used to treat diabetes and obesity.
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`NOW THEREFORE, at Wilmington on this Twenty-fifth day of March in
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`2024, it is HEREBY ORDERED that the Court adopts the following claim
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`construction with respect to the asserted claims of U.S. Patent No. 9,764,003:
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`"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."
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`8
`
`1 .
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`MPI EXHIBIT 1127 PAGE 8
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`