`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE NORTHERN DISTRICT OF WEST VIRGINIA
`Clarksburg
`
`ASTRAZENECAAB and ASTRAZENECA
`PHARMACEUTICALS LP,
`
`Plaintiffs,
`
`v.
`
`MYLAN PHARMACEUTICALS, INC. and
`KINDEVA DRUG DELIVERY L.P.,
`
`Defendants.
`
`CIVIL ACTION NO. I :22-CV-35
`Judge Bailey
`
`MEMORANDUM OPINION AND ORDER
`
`This patent infringement case involves one (1) United States Patent issued to
`
`AstraZeneca AB and sold and distributed byAstraZeneca Pharmaceuticals LP (collectively,
`
`“AstraZeneca”). Specifically, the patent at issue is U.S. Patent No. 11,311,558 (“the
`
`patent-in-suit”).
`
`AstraZeneca uses the pharmaceutical corn positions and methods
`
`described in the patent to produce Symbicort®, a prescription drug approved for the
`
`treatment of inflammatory conditions/disorders, especially respiratory diseases such as
`
`asthma, chronic obstructive pulmonary disease (“COPD”), and rhinitis. The patent-in-suit
`
`shares a specification with U.S. Patent Nos. 7,759,328, 8,143,239, 8,575,137, and
`
`10,166,247 that were the subject of two prior trials before Judge Keeley, but their claims
`
`have different scopes.
`
`Pending before this Court is the parties’ proposed competing claim construction of
`
`four (4) terms:
`
`1
`
`
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`Case 1:22-cv-00035-JPB-RWT Document 204 Filed 11/23/22 Page 2 of 19 PageID #: 10563
`
`Claim Term
`
`AstraZeneca’s Proposed
`Construction
`
`Mylan’s Proposed
`Construction
`
`“pharmaceutical
`corn position”
`
`Indefinite.
`“suspension for
`therapeutic administration” Alternatively, “a
`formulation intended for
`therapeutic administration”
`
`“formoterol”
`
`“formoterol”
`
`“budesonide or an epimer
`thereof”
`
`“budesonide or an epimer
`thereof’
`
`“about 0.001 % w/w~~
`
`“approximately 0.001 %
`w/w~~
`
`“Formoterol, including its
`enantiomers, mixtures of
`its enantiomers, the free
`base, salt or solvate, or a
`solvate of a salt”
`
`“Budesonide, including
`epimers, esters, salts, and
`solvates thereof’
`
`“0.001 % ± 0.0002% w/w,
`i.e. within
`0.0008%—0.0012% w/w”
`
`I.
`
`Background
`
`According to AstraZeneca, 3M Company, through its 3M Drug Delivery Systems
`
`division, submitted Abbreviated New Drug Application (“ANDA”) No. 211699 to the United
`
`States Food and Drug Administration (“FDA”) under 21 U.S.C. § 355(j), in order to obtain
`
`approval
`
`to engage in the commercial manufacture, use or sale of budesonide and
`
`formoterol fumarate dihydrate inhalation aerosol, 80 mcgl4.5 mcg and 160 mcgl4.5 mcg
`
`(“Mylan’s ANDA Products”). See [Doc. 1 at 4]. On August 17, 2018, 3M transferred certain
`
`interests in ANDA No. 211699 to Mylan Pharmaceuticals Inc.
`
`[Id.]. Thereafter, on May 1,
`
`2020, 3M closed on a transaction whereby 3M sold substantially all of its drug delivery
`
`systems business to an affiliate of Altaris Capital Partners, LLC (“Altaris”).
`
`[Id.]. Following
`
`this transaction, Altaris launched Kindeva as an independent company, and all of 3M’s
`
`2
`
`
`
`Case 1:22-cv-00035-JPB-RWT Document 204 Filed 11/23/22 Page 3 of 19 PageID #: 10564
`
`activities relating to ANDA No. 21169 were transferred to Kindeva.
`
`[Id.]. Kindeva will
`
`manufacture Mylan’s ANDA Products.
`
`[Id. At 4—5]. ANDA No. 21169 was approved on
`
`March 16, 2022.
`
`In a letterdated August 30, 2018, Mylan notified AstraZeneca that it had filed ANDA
`
`No. 211699 seeking approval to market Mylan’s ANDA Products prior to the expiration of
`
`the patents listed in FDA’s Approved Drug Products with Therapeutic Equivalence
`
`Evaluations for Symbicort.
`
`[Id. at 5].
`
`In its letter, Mylan asserted that the ‘328, ‘239, and
`
`‘137 patents are invalid, unenforceable, and not infringed by the commercial manufacture,
`
`use, or sale of Mylan’s ANDA Products.
`
`[Id. at 6].
`
`In a second letter dated October 11, 2019, Mylan notified AstraZeneca that it had
`
`submitted a certification to the FDA to obtain approval
`
`to engage in the commercial
`
`manufacture, use, or sale of the product described in ANDA No. 211699 prior to the
`
`expiration of the ‘247 patent.
`
`[Id. at 5].
`
`In its second letter, Mylan also asserted that the
`
`‘247 patent was invalid, unenforceable, and not infringed by the commercial manufacture,
`
`use, or sale of Mylan’s ANDA Products.
`
`[Id. at 6].
`
`The parties proceeded to trial on the ‘328,
`
`‘239, and ‘137 patents (the “Trial
`
`Patents”) in October 2020.
`
`[Id.]. Prior to trial, Mylan stipulated to infringement of the
`
`asserted claims of the Trial Patents.
`
`[Id.]. After a five-day trial, Judge Keeley entered
`
`judgment of nonobviousness as to each asserted claim. See AstraZeneca AB v. Mylan
`
`Pharms. Inc., 522 F.Supp.3d 200 (N.D. W.Va. Mar. 2, 2021) (Keeley, J.). The Court held
`
`that a person of ordinary skill in the art (“POSA”) “would not have been motivated to select
`
`the specific formulation claimed by the patents-in-suit.” Id. at 219. The Court furtherfound
`
`3
`
`
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`Case 1:22-cv-00035-JPB-RWT Document 204 Filed 11/23/22 Page 4 of 19 PageID #: 10565
`
`that the prior art “teaches away and does not render the claims obvious” because it “cut
`
`against the very goal a POSA would have been trying to achieve—a stable product with a
`
`consistent dose.” Id. at 220. Judge Keeley likewise found that “a POSA would not have
`
`had a reasonable expectation of success in creating a stable budesonide pMDI using HFA
`
`227, PVP K25, and PEG-i 000, much less when these ingredients were combined with
`
`formoterol.” Id.
`
`Mylan appealed, and the Federal Circuit affirmed the Court’s judgment of
`
`nonobviousness. AstraZeneca AB v. Mylan Pharms. Inc., 19 F.4th 1325, 1337—38 (Fed.
`
`Cir. 2021).1
`
`In a letter dated March 8, 2022, AstraZeneca notified Mylan that the United States
`
`Patent and Trademark Office (“USPTO”) allowed the pending claims of U.S. Patent
`
`Application No. 16/832,590 (“the ‘590 application”), which issued as the ‘558 patent on
`
`April 26,2022.
`
`[Doc. 1 at 7].
`
`In its letter, AstraZeneca notified Mylan of two items: (1)that
`
`its proposed generic Symbicort products infringe every limitation of the allowed claims and
`
`(2) that the allowed claims were substantially identical to the invention claimed in the U.S.
`
`Patent Application Publication No. 2021/0069215 (“the ‘215 publication”).
`
`[Id.].
`
`II.
`
`Legal Standards
`
`The construction of patent claims is a matter of law governed by federal statutes
`
`and the decisions of the Supreme Court of the United States and the United States Court
`
`1 The Federal Circuit disagreed with the Court’s construction of a term not at issue
`in most claims of the patent-in-suit (0.001%). The Federal Circuit vacated for further
`proceedings. Judge Keeley issued a Memorandum Opinion and Order Following Bench
`Trial on November 9, 2022, holding Mylan carried its burden of proving that the asserted
`claims are invalid pursuant to 35 U.S.C. § 112 for lack of enablement and lack of written
`description. See Civ. Act. No. i:18-CV-193 [Doc. 606].
`
`4
`
`
`
`Case 1:22-cv-00035-JPB-RWT Document 204 Filed 11/23/22 Page 5 of 19 PageID #: 10566
`
`of Appeals for the Federal Circuit. See Markman v. Westviewlnstruments, Inc., 52 F.3d
`
`967, 979 (Fed. Cir. 1995). When interpreting the meaning of a claim, a court may consider
`
`the context, the specification, and the prosecution histories as intrinsic evidence.
`
`Id.
`
`(quoting Unique Concepts, Inc. v. Brown, 939 F.2d 1558, 1561 (Fed. Cir. 1991)). “It is
`
`a bedrock principle of patent law that the claims of a patent define the invention to which
`
`the patentee is entitled the right to exclude.” Phillips v. AWH Corp., 415 F.3d 1303, 1312
`
`(Fed. Cir. 2005) (internal quotation marks omitted). The description of an invention in the
`
`claims, therefore, limits the scope of the invention. Id. “[T]here is no magic formula or
`
`catechism for conducting claim construction.” Id. at 1324.
`
`Instead, the Court is free to
`
`attach the appropriate weight to appropriate sources “in light of the statutes and policies
`
`that inform patent law.” Id.
`
`“[Tjhe words of a claim are generally given their ordinary and customary meaning
`
`[which is] the meaning that the term would have to a person of ordinary skill
`
`in the art in
`
`question at the time of the invention,
`
`i.e., as of the effective filing date of the patent
`
`application.” Id. at 1312—13 (internal citations and quotation marks omitted). “[TIhe ordinary
`
`meaning of a claim term is its meaning to the ordinary artisan after reading the entire
`
`patent.” Id. at 1321 (internal quotation marks omitted).
`
`When construing patent claims, then, a court must considerthe context of the entire
`
`patent, including both asserted and unasserted claims. Id. Because a patent will ordinarily
`
`use patent terms consistently, “the usage of a term in one claim can often illuminate the
`
`meaning of the same term in other claims.” Id. Accordingly, “[d]ifferences among claims”
`
`can provide insight into “understanding the meaning of particular claim terms,” and “the
`
`5
`
`
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`Case 1:22-cv-00035-JPB-RWT Document 204 Filed 11/23/22 Page 6 of 19 PageID #: 10567
`
`presence of a dependent claim that adds a particular limitation gives rise to a presumption
`
`that the limitation in question is not present in the independent claim.” Id. at 1314—15
`
`(citing Liebel-Flarsheim Co. v. Medrad, Inc., 358 F.3d 898, 910 (Fed. Cir. 2004)).
`
`Pursuant to 35 U.S.C. § 112(a), an inventor must use the patent specification to
`
`describe the claimed invention in “full, clear, concise, and exact terms.” The patent
`
`specification therefore “is always highly relevantto the claim construction analysis. Usually,
`
`it is dispositive; it is the single best guide to the meaning of a disputed term.” Wtronics
`
`Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1992).
`
`“[T]he specification may reveal a special definition given to a claim term by the
`
`patentee that differs from the meaning it would otherwise possess.
`
`In such cases, the
`
`inventor’s lexicography governs.” Phillips, 415 F.3d at 1316. “Even when the specification
`
`describes only a single embodiment, the claims of the patent will not be read restrictively
`
`unless the patentee has demonstrated a clear intention to limit the claim scope using
`
`words or expressions of manifest exclusion or restriction.” Hil-Rom Servs., Inc. v. Stryker
`
`Corp., 755 F.3d 1367, 1372 (Fed. Cir. 2014) (quoting Liebel-Flarsheim, 358 F.3d at 906)
`
`(internal quotation marks omitted).
`
`Nevertheless, a court may not
`
`import a limitation into the claims from the
`
`specification. Phillips, 415 F.3d at 132. The Federal Circuit has “repeatedly warned”
`
`against limiting the claims to the embodiments specifically described in the specification.
`
`Id. In other words, a court should not construe the patent claims as being limited to a single
`
`embodiment simply because the patent describes only one embodiment.
`
`Id.
`
`(citing
`
`6
`
`
`
`Case 1:22-cv-00035-JPB-RWT Document 204 Filed 11/23/22 Page 7 of 19 PageID #: 10568
`
`Gemstar-TV Guide Int’l Inc. v. Int’l Trade Comm’n, 383 F.3d 1352, 1366 (Fed. Cir.
`
`2004)).
`
`A court “should also consider the patent’s prosecution history, if it is in evidence.”
`
`Markman, 52 F.3d at 980. The prosecution history, which is “intrinsic evidence,” “consists
`
`of the complete record of the proceedings before the PTO [Patent and Trademark Office]
`
`and includes the prior art cited during the examination of the patent.” Phillips, 415 F.3d
`
`at 1317. “[T]he prosecution history can often inform the meaning of the claim language by
`
`demonstrating how the inventor understood the invention and whether the inventor limited
`
`the invention in the course of prosecution, making the claim scope narrower than it would
`
`otherwise be.” Id.
`
`“The construction that stays true to the claim language and most naturally aligns
`
`with the patent’s description of the invention will be, in the end, the correct construction.”
`
`Renishaw PLC v. Marposs Societa’perAzioni, 158 F.3d 1243, 1250 (Fed. Cir. 1998).
`
`It follows that “a claim interpretation that would exclude the inventor’s device is rarely the
`
`correct interpretation.” Osram GmbH v. Int’l Trade Comm’n, 505 F.3d 1351, 1358 (Fed.
`
`Cir. 2007) (quoting Modine Mfg. Co. v. U.S. Int’l Trade Comm’n, 75 F.3d 1545, 1550
`
`(Fed. Cir. 1996)).
`
`Finally, while a court may consider extrinsic evidence such as expert testimony,
`
`dictionaries, and learned treatises in defining the “ordinary and customary meaning” of a
`
`term, such evidence carries less legal significance than the intrinsic record. Id. Reliable
`
`extrinsic evidence includes “those sources available to the public that show what a person
`
`of skill
`
`in the art would have understood disputed claim language to mean.” Id. at 1314
`
`7
`
`
`
`Case 1:22-cv-00035-JPB-RWT Document 204 Filed 11/23/22 Page 8 of 19 PageID #: 10569
`
`(quoting Innova/Pure Water~, Inc. v. Safari Water Filtration Systems, Inc., 381 F.3d
`
`1111, 1116 (Fed. Cir. 2004)). Extrinsic evidence “is to be used for the court’s
`
`understanding of the patent, not for the purpose of varying or contradicting the terms of the
`
`claims.” Markman, 52 F.3d at 981.
`
`The “ultimate issue of the proper construction of a claim” is a matter of law reviewed
`
`de novo, but a court’s resolution of subsidiary factual issues during claim construction is
`reviewed for clear error. Teva Pharma. USA, Inc. v. Sandoz, Inc., 574 u.s. 318 (2015).
`
`When a judge reviews only intrinsic evidence, her “determination will amount solely to a
`
`determination of law, and the Court of Appeals will review that construction de novo.” Id. at
`
`841. When a judge needs to “look beyond the patent’s intrinsic evidence” and consult
`
`extrinsic evidence to understand the background science, or the meaning of a term, she
`
`will “need to make subsidiary factual findings about that extrinsic evidence,” which will be
`
`reviewed for clear error. Id.
`
`Ill.
`
`The Claims
`
`The Court begins its analysis by looking to the “actual words of the claim,” Becton,
`
`Dickinson and Co. v. TycoHealthcare Group, LP, 616 F.3d 1249, 1254(Fed. Cir. 2010),
`
`as well as the context in which the disputed term appears. Phillips, 415 F.3d at 1314.
`
`Patent claims come in two general
`
`forms:
`
`independent and dependent.
`
`35 U.S.C.
`
`§ 112(c).
`
`Independent claims do not refer to any other claim of the patent and are read
`
`separately to determine their scope.
`
`Inamin, Ltd. v. Magnetar Tech. Corp., 623
`
`F.Supp.2d 1055, 1065 (C.D. Cal. 2009). Dependent claims, in contrast, refer to at least
`
`one other claim, include all of the limitations of the claim to which they refer, and specify
`
`8
`
`
`
`Case 1:22-cv-00035-JPB-RWT Document 204 Filed 11/23/22 Page 9 of 19 PageID #: 10570
`
`a further limitation on that claim. 30 U.S.C. § 112(d); see also Monsanto Co. v. Syngenta
`
`Seeds, Inc., 503 F.3d 1352, 1357 (Fed. cir. 2007).
`
`1.
`
`The ‘558 Patent
`
`Independent claim I reads:
`
`1. A pharmaceutical composition comprising formoterol, budesonide, or an
`
`epimer thereof, 1,1,1 -2,3,3,3-heptafluoropropane (HFA 227), about 0.0005
`
`to about 0.05% w/w polyvinyl pyrrolidone (PVP) K25, and about 0.05 to
`
`about 0.35% w/w polyethylene glycol (PEG) 1000 (PEG having an average
`
`molecular weight of 1000 Daltons).
`
`‘558 Patent, col. 8. Dependent claim 4 reads:
`
`4. The pharmaceutical composition according to claim I wherein the
`
`formoterol is in the form of fumarate dihydrate salt.
`
`Id. Dependent claim 7 reads:
`
`7. The pharmaceutical composition according to claim I, wherein the
`
`pharmaceutical composition is in the form of a suspension.
`
`Id. Dependent claim 12 reads:
`
`12. The pharmaceutical composition according to claim I wherein the PVP
`
`K25 is present in an amount of about 0.001% w/w.
`
`Id.
`
`IV.
`
`Claim Construction
`
`The task of the Court is to “define[ J the claim[s] with whatever specificity and
`
`precision is warranted by the language of the claim and the evidence bearing on the proper
`
`9
`
`
`
`Case 1:22-cv-00035-JPB-RWT Document 204 Filed 11/23/22 Page 10 of 19 PageID #:
`10571
`
`construction.” PPG Indus. v. Guardian Indus. Corp., 156 F.3d 1351, 1355 (Fed. Cir.
`
`1998).
`
`A.
`
`“pharmaceutical composition”
`
`Mylan’s “pharmaceutical composition” construction recites “a formulation intended
`
`for therapeutic administration.” AstraZeneca’s proposes a narrower construction,
`
`“a
`
`suspension for therapeutic administration.”
`
`“[CJlaim differentiation’ refers to the presumption that an independent claim should
`
`not be construed as requiring a limitation added by a dependent claim. See Nazomi
`
`Commc’ns, Inc. v. Arm Holdings, PLC., 403 F.3d 1364, 1370 (Fed. Cir. 2005) (‘[C]laim
`
`differentiation “normally means that limitations stated in dependent claims are not to be
`
`read into the independent claim from which they depend.” (quoting Karlin Tech., Inc. v.
`
`Surgical Dynamics, Inc., 177 F.3d 968, 971—72 (Fed. Cir. 1999))); see also Phillips, 415
`
`F.3d at 1314—15 (explaining the presumption without invoking the ‘claim differentiation’
`
`label).
`
`Thus,
`
`the claim differentiation tool works best
`
`in the relationship between
`
`independent and dependent claims. See Liebel-Flarsheim Co. v. Medrad, Inc., 358 F.3d
`
`898, 910 (Fed. Cir. 2004) (citing SunRace Roots Enter. Co. v. SRAM Corp., 336 F.3d
`
`1298, 1302—03 (Fed. Cir. 2003)).” Curtiss-Wright Flow Control Corp. v. Velan, Inc., 438
`
`F.3d 1374, 1380 (Fed. Cir. 2006).
`
`35 U.S.C. § 112 stresses that a dependent claim must add a limitation to those
`recited in the independent claim. See 35. U.S.C. § 112 (2000) (“[A] claim in dependent
`
`form shall contain a reference to a claim previously set forth and then specify a further
`
`limitation of the subject matter claimed.” (emphasis added)).
`
`“Thus,
`
`reading an
`
`10
`
`
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`Case 1:22-cv-00035-JPB-RWT Document 204 Filed 11/23/22 Page 11 of 19 PageID #:
`10572
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`additional limitation from a dependent claim into an independent claim would not only make
`
`the additional limitations superfluous, it might render the dependent claim invalid.”
`
`Id.
`
`1.
`
`Suspension
`
`The patent-in-suit includes independent claim I and dependent claims 2—13, which
`
`all depend from claim 1. Dependent claim 7 adds just a single limitation to independent
`
`claim 1: ii requires that the “pharmaceutical composition according to claim 1” must be “in
`
`the form of a suspension.”
`
`‘558 Patent, col. 8. Claims I and 7 of the patent-in-suit thus
`
`trigger a strong presumption that the “suspension” limitation of dependent claim 7 should
`
`not be imported into the broader “pharmaceutical composition” of claim 1. Were it
`
`otherwise, claim 7 would be rendered meaningless.
`
`The doctrine of claim differentiation is at
`
`its strongest in this case “where the
`
`limitation that is sought to be ‘read into’ an independent claim already appears in a
`
`dependent claim.”
`
`InterDigital Communications, LLC v. International Trade Com’n,
`
`690 F.3d 1318, 1324 (Fed. Cir. 2012) (quoting Liebel-Flarsheim Co., 358 F.3d at 910)).
`
`Although the doctrine of claim differentiation creates only a presumption, which can be
`
`overcome by strong contrary evidence such as definitional language in the patent or a clear
`
`disavowal of claim scope, neither type of contrary evidence is present here. To the
`
`contrary, the presumption is “especially strong” in this case because “the limitation in
`
`dispute is the only meaningful difference between an independent and dependent claim,
`
`and one party is urging that the limitation in the dependent claim should be read into the
`
`independent claim.” SunRace Roots Enter. Co., 336 F.3d at 1303.
`
`11
`
`
`
`Case 1:22-cv-00035-JPB-RWT Document 204 Filed 11/23/22 Page 12 of 19 PageID #:
`10573
`
`Here, if the term “pharmaceutical composition” means “a suspension for therapeutic
`
`administration,” then claim 7 would read: “A suspension for therapeutic administration
`
`according to claim 1, wherein a suspension for therapeutic administration is in the form of
`
`a suspension.” That would render claim 7 superfluous and redundant of claim 1. The term
`
`“pharmaceutical composition” must be construed as “a formulation for therapeutic
`
`composition,” which includes other forms of compositions as well,
`
`including at
`
`least
`
`solutions.
`
`2.
`
`Stability
`
`Mylan seeks to read a functional stability requirement
`
`into “pharmaceutical
`
`composition” whereas AstraZeneca argues “pharmaceutical composition” does not include
`
`a functional stability requirement.
`
`Because the claims—and not the specification—delineate the scope of exclusive
`
`rights, courts must not “improperly import[] a limitation from the specification into the
`
`claims.” Cont’l Circuits LLC v. Intel Corp., 915 F.3d 788, 796—97 (Fed. Cir. 2019)
`
`(quotation omitted). Where, as here, multiple patents “derive from the same parent
`
`application and share many common terms,”
`
`the court “must
`
`interpret
`
`the claims
`
`consistently across all asserted patents.” SightSound Techs., LLC v. Apple Inc., 809
`
`F.3d 1307, 1316 (Fed. Cir. 2015) (quoting NTP, Inc. v. Research in Motion, Ltd., 418
`
`F.3d 1282, 1293 (Fed. Cir. 2005)).
`
`The asserted claims of the patent-in-suit do not expressly recite a functional stability
`
`requirement. Reading a stability limitation into “pharmaceutical composition” violates the
`
`“well-established principle that a court may not
`
`import
`
`limitations from the written
`
`12
`
`
`
`Case 1:22-cv-00035-JPB-RWT Document 204 Filed 11/23/22 Page 13 of 19 PageID #:
`10574
`
`description into the claims.” Laitram Corp. v. NEC Corp., 163 F.3d 1342, 1347 (Fed. Cir.
`
`1998); Phillips, 415 F.3d at 1320, Cont’I Circuits, 915 F.3d at 796—97.
`
`An invention’s purpose or property is not a claim limitation, unless it
`
`is recited
`
`explicitly in the claim.
`
`“[N]ot every benefit flowing from an invention is a claim limitation.”
`
`i4i Ltd. P’ship v. Microsoft Corp., 598 F.3d 831, 843 (Fed. Cir. 2010). Even where a
`
`“claimed composition was designed to solve certain problems of the prior art” and “the
`
`patentee noted the functional import” in the specification, it “does not mean that we must
`
`attribute a function to [a] nonfunctional phrase.” Ecolab, Inc. v. Envirochem, Inc., 264
`
`F.3d 1358, 1367 (Fed. Cir. 2001). Simply put, “[w]here the function is not recited in the
`
`claim itself bythe patentee, we do not import such a limitation.” Id. The “excellent physical
`
`suspension stability” of the compositions in the patent-in-suit was an important benefit of
`
`the invention, but that characteristic, unrecited in the claims, does not turn the physical
`
`suspension stability into a claim limitation.
`
`“The fact that a patent asserts that an invention achieves several objectives does
`
`not require that each of the claims be construed as limited to structures that are capable
`
`of achieving all of the objectives.” Phillips, 415 F.3d at 1327. “An invention may possess
`
`a number of advantages or purposes, and there is no requirement that every claim directed
`
`to that invention be limited to encompass all of them.” E-Pass Techs., Inc. v. 3Com
`
`Corp., 343 F.3d 1364, 1370 (Fed. Cir. 2003). Thus, the Federal Circuit’s statement
`
`regarding the related patents that “the written description and prosecution history place
`
`considerable emphasis on the stability of the claimed formulations” does not support
`
`reading a stability limitation into the claims. AstraZeneca AB, 19 F.4th at 1330.
`
`13
`
`
`
`Case 1:22-cv-00035-JPB-RWT Document 204 Filed 11/23/22 Page 14 of 19 PageID #:
`10575
`
`“Even if
`
`‘all of the embodiments discussed in the patent’
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`included a specific
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`limitation, it would not be ‘properto import from the patent’s written descriptions limitations
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`that are not found in the claims themselves.” Cadence Pharms. Inc. v. Exela PharmSci
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`Inc., 780 F.3d 1364, 1369 (Fed. Cir. 2015) (quoting Flo Healthcare Solutions, Inc. v.
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`Kappos, 697 F.3d 1367, 1375 (Fed. Cir. 2012)).
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`The ‘247 patent claims recite a “stable pharmaceutical composition.” As Judge
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`Keeley’s decision following the trial of the ‘247 patent explained, the claims of the ‘247
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`patent “contain an important behavioral limitation, that the formulation be ‘stable.’ This is
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`a considerable change from the Previously Tried Claims which imposed even more specific
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`structural limitations upon the formulation by requiring particular grades or concentrations
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`of each of the five ingredients.” Civ. Act. No. 1:18-CV-193 [Doc. 606 at 23]. This confirms
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`that “pharmaceutical composition” does not require “stable” in the patent-in-suit. Importing
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`a stability requirement into “pharmaceutical composition” here would render the term
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`“stable” in the ‘247 patent superfluous. The Previously Tried Claims—i.e., the claims of the
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`‘328, ‘237, and ‘139 patents asserted at the 2020 trial—like the patent-in-suit here, do not
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`use the modifier “stable” with “pharmaceutical composition.” The term “stable” in the ‘247
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`patent added a requirement that “pharmaceutical composition” did not carry: “stable’
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`further requires the applicable type of stability to be present.” See [Doc. 158-25 at 22].
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`Because it is “highly disfavored to construe terms in a way that renders them void,
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`meaningless, or superfluous,” Wasica Fin. GMBH v. Cont’I Auto Sys., Inc., 853 F.3d
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`1272, 1288 n.10 (Fed. Cir. 2017), this Court declines to limit the term “pharmaceutical
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`composition” to stable compositions. This Court notes that claims must be construed
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`consistently across all asserted patents. However, the patent-in-suit added a claim
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`separate and distinct from other claims In the Previously Tried Patents. Thus, this Court
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`will adopt
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`“pharmaceutical composition’
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`to mean “a formulation for therapeutic
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`composition’ so as to not Include a functional stability requirement but also not render
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`meaningless claIm 7.
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`B.
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`“fonnoterol” and “b desonide or an eplmer thereof’
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`Although the parties In this case have litigated this patent family and specification
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`for several years, neither has previously sought a construction of lormoterol’ or
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`“budesonide or an epimer thereof.’
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`In an attempt to preempt a hypothetical argument of
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`its opponent, Mylan now asserts that construction of th~ese terms Is necessary.
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`Speclflcally~ it contends that AstraZeneca will
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`improperly attempt to limit the terms to
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`particularforms of the chemicals described in the patent’ See [Doc. 161 at 7]. But, as of
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`yet, AstraZeneca has done no such thing and there appears to be no real dispute between
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`thepartlesastothescopeoftheterms.
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`lnfact,AstraZenecaagreesthattheterms”do
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`not exclude the drug forms in Mylan’s construction’ and Mylan concedes that it infringes
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`these elements under either parties’ construction.
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`[Doc. 163 at 25].
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`‘The Markman decisions do not hold that the trial judge must repeat or restate
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`every claim term in order to comply with the ruling that claim construction Is for the court
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`Claim construction is a matter of resolution of disputed meanings and technical scope, to
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`clarify and when necessary to explain what the patentee covered by the claims, for use in
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`the determination of infringement.
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`it Is not an obligatory exercise in redundancy.’ U.S.
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`Surgical Corp. v. Ethlcon, Inc., 103 F.3d 1554,1568 (Fed. Cir. 1997).
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`15
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`Moreover, “although the claims are construed objectively and without reference to
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`the accused device, only those terms need to be construed that are in controversy, and
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`only to the extent necessary to resolve the controversy.” Wvid Techs., Inc. v. Am. Sd.
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`& Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999).
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`Because the preference is to avoid needless constructions, this Court declines to
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`construe “formoterol” and “bud esonide or an epimer thereof.” The parties have litigated
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`claims with these terms for years without any further construction. The parties have fully
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`participated in Markman proceedings both here and in Delaware, and have never
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`previously sought construction of these terms.
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`“The simple reason no party sought
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`construction is that
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`the meaning of
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`these terms is not disputed—’formoterol’ and
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`‘budesonide or an epimer thereof’ do not exclude the drug forms in Mylan’s construction.”
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`See [Doc. 163 at 25].
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`Thus, this Court will adopt “formoterol” and “budesonide or an epimer thereof” to
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`have their plain and ordinary meaning.
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`C.
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`“about 0.001% wlw”
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`The term “about” appears in Claim 12 of the patent-in-suit. Specifically, Claim 12
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`states:
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`12. The pharmaceutical composition according to claim I wherein the PVP
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`K25 is present in an amount of about 0.001% wlw.
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`‘558 Patent, col. 8. AstraZeneca argues that “about” should be interpreted to mean
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`“approximately.” Mylan, on the other hand, contends that about should be ascribed a
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`precise numerical range, i.e., “0.001 ± 0.0002% w/w, i.e. within 0.0008%-0.0012% wlw.”
`
`16
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`The claims and the specifications use the term “about” but never attempt to define
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`it numerically. The Federal Circuit has made it clear that “about” is to be given its plain and
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`ordinary meaning. See also Ferring B.V. v. Watson Labs., Inc.-FIa., 764 F.3d 1382,
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`1389 (Fed. Cir. 2014) (“We think that the district court did not err in giving the term ‘about’
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`its ordinary meaning and in refusing to give it a more specific construction.”); Merck & Co.,
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`Inc. v. Teva Pharms. USA, Inc., 395 F.3d 1364, 1372 (Fed. Cir. 2005) (“Because the
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`patentee did not clearly redefine ‘about’ in the specification, .
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`. [w]e thus hold that the term
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`.
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`‘about’ should be given its ordinary and accepted meaning of ‘approximately.”); Par
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`Pharm. Inc. v. Hospira, Inc., 835 Fed.App’x. 578, 584 (Fed. Cir. 2020) (“The district
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`court’s analysis is consistent with our precedents. The parties agreed that ‘about’ should
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`be construed to have its ‘plain and ordinary meaning’ of ‘approximately’.. . with no further
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`refinement as a claim-construction matter.”).
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`“When ‘about’
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`is used as part of a numeric range, ‘the use of the word “about[]”
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`avoids a strict numerical boundary to the specified parameter.
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`Its range must be
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`interpreted in its technologic and stylistic context.’ [Pall Corp., 66 F.3d at 1217].
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`In
`
`determining how far beyond the claimed range the term ‘about’ extends the claim, ‘[w]e
`
`must focus ... on the criticality of the [numerical limitation] to the invention.’ Ortho-McNeiI
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`Pharm., Inc. v. Caraco Pharm. Ltd., 476 F.3d 1321, 1327 (Fed. Cir. 2007).
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`In other
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`words, we must look to the purpose that the ‘about 30 pm’ limitation serves, to determine
`
`how much smaller than 30 pm the average particle diameter can be and still serve that
`
`purpose. To be clear, it is the purpose of the limitation in the claimed invention—not the
`
`17
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`purpose of the invention itself—that is relevant.” Cohesive Techs., Inc. v. Waters Corp.,
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`543 F.3d 1351, 1368 (fed. Cir. 2008) (emphasis in original).
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`Here, the parties dispute the meaning of “about” in the context of a claim limitation
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`that PVP K25 is present in an amount of “about 0.001 % w/w.” Mylan erroneously attempts
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`to turn a dispute about infringement into a dispute about claim construction. The question
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`of whether “about 0.001 %“ encompasses Mylan’s concentration of PVP K25 is “a question
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`of technologic fact whether an accused device meets a reasonable meaning of ‘about’ in
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`the particular circumstances.” Par Pharm., Inc. v. Hospira, Inc., 835 Fed .App’x 578, 584
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`(Fed. Cir. 2020). The “strict numerical boundary” Mylan currently seeks to engraft into the
`
`claim is the exact
`
`type of specificity for the claim term “about” the Federal Circuit
`
`proscribes. Cohesive Techs., Inc., 543 F.3d at 1368. Thus, this Court rules that “about”
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`means “approximately” and will wait to hear the evidence presented at trial to determine
`
`what the word “approximately” means based on the stylistic and technological context of
`
`the ‘558 patent.
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`“[A] district court may engage in claim construction during various phases of
`
`litigation, not just in a Markman order.” Conoco, Inc. v. Energy & Envtl Int’l, L.C., 460
`
`F.3d 1349, 1359 (Fed. Cir. 2006). This Court may “engage in rolling claim construction,
`
`in which the court
`
`revisits and alters its interpretation of
`
`the claim terms as its
`
`understanding of the technology evolves.”
`
`Id. (quoting Guttman,
`
`Inc. v. Kopykake
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`Enters., Inc., 302 F.3d 1352, 1361 (Fed. Cir. 2002)).
`
`18
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`V.
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`Conclusion
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`For the foregoing reasons, this Court CONSTRUES the following terms and phrases
`
`as follows:
`
`1.
`
`2.
`
`3.
`
`4.
`
`“pharmaceutical composition” means “a formulation for therapeutic
`
`administration”;
`
`“formoterol” means “formoterol”;
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`“budesonide or an epimer thereof” mean