`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`MEDA PHARMACEUTICALS INC.,
`and CIPLA LTD.,
`
`Plaintiffs,
`
`v.
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`APOTEX INC. and APOTEX CORP.,
`
`Defendants.
`
`C.A. No. 14-1453-LPS
`
`Steven J. Balick, John G. Day, and Andrew C. Mayo, ASHBY & GEDDES, Wilmington, DE
`
`H. Keeto Sabharwal, Dennies Varughese, Uma N. Everett, Rami Bardenstein, Dallin G. Glenn,
`Josh I. Miller, and Josephine J. Kim, STERNE, KESSLER, GOLDSTEIN & FOX P.L.L.C.,
`Washington, DC
`
`Attorneys for Plaintiffs Meda Pharmaceuticals and Cipla Ltd.
`
`Richard L. Horwitz, David E. Moore, Bindu A. Palapura, and Stephanie E. O'Byrne, POTTER,
`ANDERSON & CORROON LLP, Wilmington, DE
`
`Tung-On Kong and David M. Hanna, WILSON SONSINI GOODRICH & ROSA TI, San
`Francisco, CA
`
`Nicole W. Stafford and Robert Delafield, II, WILSON SONSINI GOODRICH & ROSATI,
`Austin, TX
`
`Adam Burrowbridge, WILSON SONSINI GOODRICH & ROSATI, Washington, DC
`
`Attorneys for Defendants Apotex Inc. and Apotex Corp.
`
`MEMORANDUM OPINION
`
`May 12, 2016
`Wilmington, Delaware
`
`
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`Case 1:14-cv-01453-LPS Document 114 Filed 05/12/16 Page 2 of 10 PageID #: 2176
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`On December 2, 2014, Plaintiffs Meda Pharmaceuticals and Cipla Ltd. ("Plaintiffs") filed
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`suit against Defendants Apotex Inc. and Apotex. Corp ("Apotex" or "Defendants") alleging
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`infringement of U.S. Patent Nos. 8,163,723 (the "' 723 patent"), 8,168,620 (the '"620 patent"),
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`and 9,259,428 (the '"428 patent"). The patents are directed to a single-dosage formulation for
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`the simultaneous administration of two active pharmaceutical ingredients: azelastine (an
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`antihistamine) and fluticasone (a corticosteroid).
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`The parties submitted technology tutorials (D.I. 44 and 45) and claim construction briefs
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`(D.I. 46, 47, 61 , 63 , and 96). The Court held a claim construction hearing on April 29, 2016.
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`(See D.I. 113 ("Tr."))
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`I.
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`LEGAL ST AND ARDS
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`The ultimate question of the proper construction of a patent is a question oflaw. See Teva
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`Pharm. USA, Inc. v. Sandoz, Inc. , 135 S. Ct. 831, 837 (2015) (citingMarh.wan v. Westview
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`Instruments, Inc. , 517 U.S. 370, 388-91 (1996)) . "It is a bedrock principle of patent law that the
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`claims of a patent define the invention to which the patentee is entitled the right to exclude."
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`Phillips v. AWH Corp. , 415 F.3d 1303 , 1312 (Fed. Cir. 2005) (internal quotation marks omitted).
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`"[T]here is no magic formula or catechism for conducting claim construction." Id. at 1324.
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`Instead, the court is free to attach the appropriate weight to appropriate sources "in light of the
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`statutes and policies that inform patent law." Id.
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`"[T]he words of a claim are generally given their ordinary and customary meaning .. .
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`[which is] the meaning that the term would have to a person of ordinary skill in the art in
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`question at the time of the invention, i.e., as of the effective filing date of the patent application."
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`1
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`Case 1:14-cv-01453-LPS Document 114 Filed 05/12/16 Page 3 of 10 PageID #: 2177
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`Id. at 1312-13 (internal citations and quotation marks omitted). "[T]he ordinary meaning of a
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`claim term is its meaning to the ordinary artisan after reading the entire patent." Id. at 1321
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`(internal quotation marks omitted). The patent specification "is always highly relevant to the
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`claim construction analysis. Usually, it is dispositive; it is the single best guide to the meaning of
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`a disputed term." Vitronics Corp. v. Conceptronic, Inc. , 90 F.3d 1576, 1582 (Fed. Cir. 1996).
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`While "the claims themselves provide substantial guidance as to the meaning of particular
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`claim terms," the context of the surrounding words of the claim also must be considered.
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`Phillips, 415 F.3d at 1314. Furthermore, "[o]ther claims of the patent in question, both asserted
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`and unasserted, can also be valuable sources of enlightenment ... [b ]ecause claim terms are
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`normally used consistently throughout the patent ... . " Id. (internal citation omitted).
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`It is likewise true that "[d]ifferences among claims can also be a useful guide .... For
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`example, the presence of a dependent claim that adds a particular limitation gives rise to a
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`presumption that the limitation in question is not present in the independent claim." Id. at 1314-
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`15 (internal citation omitted). This "presumption is especially strong when the limitation in
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`dispute is the only meaningful difference between an independent and dependent claim, and one
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`party is urging that the limitation in the dependent claim should be read into the independent
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`claim." SunRace Roots Enter. Co. , Ltd. v. SRAM Corp. , 336 F.3d 1298, 1303 (Fed. Cir. 2003).
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`It is also possible that "the specification may reveal a special definition given to a claim
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`term by the patentee that differs from the meaning it would otherwise possess. In such cases, the
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`inventor' s lexicography governs." Phillips, 415 F .3d at 1316. It bears emphasis that"[ e ]ven
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`when the specification describes only a single embodiment, the claims of the patent will not be
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`read restrictively unless the patentee has demonstrated a clear intention to limit the claim scope
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`2
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`Case 1:14-cv-01453-LPS Document 114 Filed 05/12/16 Page 4 of 10 PageID #: 2178
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`using words or expressions of manifest exclusion or restriction." Hill-Rom Servs. , Inc. v. Stryker
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`Corp. , 755 F.3d 1367, 1372 (Fed. Cir. 2014) (quoting Liebel-Flarsheim Co. v. Medrad, Inc., 358
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`F.3d 898, 906 (Fed. Cir. 2004)) (internal quotation marks omitted).
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`In addition to the specification, a court "should also consider the patent's prosecution
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`history, if it is in evidence." Mar/,.wan v. Westview Instruments, Inc., 52 F.3d 967, 980 (Fed. Cir.
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`1995), aff'd, 517 U.S . 370 (1996). The prosecution history, which is "intrinsic evidence,"
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`"consists of the complete record of the proceedings before the PTO [Patent and Trademark
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`Office] and includes the prior art cited during the examination of the patent." Phillips, 415 F.3d
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`at 1317. "[T]he prosecution history can often inform the meaning of the claim language by
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`demonstrating how the inventor understood the invention and whether the inventor limited the
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`invention in the course of prosecution, making the claim scope narrower than it would otherwise
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`be." Id.
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`In some cases, "the district court will need to look beyond the patent' s intrinsic evidence
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`and to consult extrinsic evidence in order to understand, for example, the background science or
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`the meaning of a term in the relevant art during the relevant time period." Teva , 135 S. Ct. at
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`841. Extrinsic evidence "consists of all evidence external to the patent and prosecution history,
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`including expert and inventor testimony, dictionaries, and learned treatises." Markman , 52 F.3d
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`at 980. For instance, technical dictionaries can assist the court in determining the meaning of a
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`term to those of skill in the relevant art because such dictionaries "endeavor to collect the
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`accepted meanings of terms used in various fields of science and technology." Phillips, 415 F.3d
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`at 1318. In addition, expert testimony can be useful "to ensure that the court' s understanding of
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`the technical aspects of the patent is consistent with that of a person of skill in the art, or to
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`3
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`Case 1:14-cv-01453-LPS Document 114 Filed 05/12/16 Page 5 of 10 PageID #: 2179
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`establish that a particular term in the patent or the prior art has a particular meaning in the
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`pertinent field. " Id. Nonetheless, courts must not lose sight of the fact that "expert reports and
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`testimony [are] generated at the time of and for the purpose of litigation and thus can suffer from
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`bias that is not present in intrinsic evidence." Id. Overall, while extrinsic evidence "may be
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`useful" to the court, it is "less reliable" than intrinsic evidence, and its consideration "is unlikely
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`to result in a reliable interpretation of patent claim scope unless considered in the context of the
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`intrinsic evidence." Id. at 1318-19. Where the intrinsic record unambiguously describes the
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`scope of the patented invention, reliance on any extrinsic evidence is improper. See Pitney
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`Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1308 (Fed. Cir. 1999) (citing Vitronics, 90
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`F.3d at 1583).
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`Finally, "[t]he construction that stays true to the claim language and most naturally aligns
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`with the patent' s description of the invention will be, in the end, the correct construction."
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`Renishaw PLC v. Marposs Societa ' per Azioni, 158 F.3d 1243, 1250 (Fed. Cir. 1998). It follows
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`that "a claim interpretation that would exclude the inventor' s device is rarely the correct
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`interpretation." Osram GmbH v. Int '! Trade Comm 'n, 505 F.3d 1351 , 1358 (Fed. Cir. 2007)
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`(quoting Modine Mfg. Co. v. U S. Int'! Trade Comm 'n, 75 F.3d 1545, 1550 (Fed. Cir. 1996)).
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`4
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`Case 1:14-cv-01453-LPS Document 114 Filed 05/12/16 Page 6 of 10 PageID #: 2180
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`II.
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`CONSTRUCTION OF DISPUTED TERM 1
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`"conditions"2
`
`Plaintiffs
`"diseases or illnesses resulting in or causing allergic reaction(s)"
`
`Defendants
`Plain and ordinary meaning. To the extent the Court determines that this term requires
`construction, Apotex proposes the following construction: "disease(s) or illness( es)"
`
`Court
`"disease(s) or illness( es)"
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`A patent's claims "define and circumscribe" the scope of a patentee' s right to exclude.
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`Ariad Pharmaceuticals, Inc. v. Eli Lilly and Co. , 598 F.3d 1366, 1347 (Fed. Cir. 2010) (en bane).
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`The Court, thus, begins its claim construction analysis with the language of the claims
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`themselves.
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`The asserted patents here claim a method for treating a "condition for which
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`administration of one or more antihistamines and/or one or more steroids is indicated." See, e.g.
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`' 723 pat. col. 11 :52-53 ; ' 620 pat. col. 12:42-44. Given this context, the Court finds that the plain
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`and ordinary meaning of the term "condition," to a person of ordinary skill in the art ("POSA"),
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`is "disease or illness."3
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`Claim language must be construed in the context of the claim as a whole. See !GT v.
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`1The parties have agreed to certain constructions, all of which the Court has adopted or
`will adopt.
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`2 This term appears in claims 1-4, 7, 8, 10-18, and 20-28 of the ' 723 patent and claims 16,
`17, and 24 of the of the ' 620 patent.
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`3The parties do not dispute that what Defendants have proposed as their construction is, in
`fact, the plain and ordinary meaning of "conditions" to a POSA. (See Tr. at 25-26, 36-37)
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`5
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`Case 1:14-cv-01453-LPS Document 114 Filed 05/12/16 Page 7 of 10 PageID #: 2181
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`Bally Gaming Int '!, Inc., 659 F.3d 1109, 1117 (Fed. Cir. 2011). "Extracting a single word from a
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`claim divorced from the surrounding limitations can lead construction astray." Id. Here, to the
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`extent the claims of the patents-in-suit are concerned principally (or, for certain dependent
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`claims, exclusively) with allergic reactions, it is not the word "conditions" that narrows the claim
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`scope. Rather, it is the other limitations that establish the classes of disease or illnesses included
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`within the scope of the claims: i.e., those conditions for which administration of an antihistamine
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`or steroid is indicated.
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`For instance, independent claim 1 of the ' 723 patent is limited to methods relating to
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`conditions typically treated by "antihistamines and/or .. . steroids." Undoubtedly, a POSA
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`would understand that not every disease or illness can be treated in this manner. But just because
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`the overall scope of the claim does not reach every disease or illness does not mean that the claim
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`term "condition" is being used in a manner narrower than its full plain and ordinary meaning.4
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`Plaintiffs argue that a person of ordinary skill in the art, having read the patent
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`specification, would understand that "condition" is limited to conditions that "result in or cause
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`an allergic reaction." (D.I. 47 at 14) The "person of ordinary skill in the art is deemed to read
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`the claim term not only in the context of the particular claim in which the disputed term appears,
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`but in the context of the entire patent, including the specification." Phillips, 415 F.3d at 1314.
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`Therefore, "[t]he customary meaning of a claim term is not determined in a vacuum and should
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`be harmonized, to the extent possible, with the intrinsic record, as understood in the field of the
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`invention." Lexion Med. , LLC v. Northgate Techs., Inc., 641 F.3d 1352, 1356 (Fed. Cir. 2011) .
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`4Thus, Plaintiffs' concern that Defendants' construction would encompass methods of
`treating anything from snake bites to cancer is unfounded. The claims would encompass these
`conditions if, but only if, these conditions meet the other claim limitations.
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`6
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`Case 1:14-cv-01453-LPS Document 114 Filed 05/12/16 Page 8 of 10 PageID #: 2182
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`Neither the intrinsic nor extrinsic evidence supports a narrower construction of
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`"conditions." A court may depart from the ordinary meaning of a claim term in only two
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`circumstances. See Pacing Techs. , LLC v. Garmin Int'!, Inc. , 778 F.3d 1021 , 1024 (Fed. Cir.
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`2015). First, a patentee may "act as a lexicographer" by assigning his own definition to a patent
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`claim term. Id. Second, a patentee may intentionally disclaim, or "disavow," claim scope. Id.
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`A disclaimer or disavowal requires either "words or expressions of manifest exclusion or
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`restriction," Hill-Rom Services, Inc. v. Stryker Corp. , 755 F.3d 1367, 1372 (Fed. Cir. 2014), cert.
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`denied, 135 S. Ct. 719, 190 L. Ed. 2d 463 (2014) (internal quotation marks omitted), or an
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`implicit definition "so clear that it equates to an explicit one," Thorner, 669 F.3d at 1368.
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`The intrinsic evidence Plaintiffs cite does not meet this exacting standard. Plaintiffs
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`suggest that the patentees "defined" their invention as a method "useful for preventing or
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`minimizing allergic reactions." (D.I. 47 at 13) (citing ' 723 pat. col. 1:20-22; '620 pat. col. 1:11-
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`13) Plaintiffs further note that the specification states that "the present invention relates [to
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`treatments for] allergic reactions," that the treatment of allergy symptoms was the purpose of the
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`invention, and that the prosecution history shows the patentee and examiner were focused on the
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`treatment of allergies. (D.I. 4 7 at 13-15) (citing ' 723 pat. col. 1:20-22; '620 pat. col. 1: 11-13)
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`While this evidence is probative of the "problem to be solved" by the invention, it is insufficient
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`here to limit the scope of the claim term "condition." See, e.g., E-Pass Technologies, Inc. v.
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`3Com Corp. , 343 F.3d 1364, 1370 (Fed. Cir. 2003). Rather, a disclaimer or disavowal is
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`typically justified only if the text of the disputed patent requires the conclusion that the patentee
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`disavowed claim scope, because to conclude otherwise would be inconsistent with its
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`specification or claims. This is especially true here, where: (i) the specification does not include
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`7
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`Case 1:14-cv-01453-LPS Document 114 Filed 05/12/16 Page 9 of 10 PageID #: 2183
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`explicitly narrowing language such as "the present invention requires," "the present invention is,"
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`or "all embodiments of the present invention are," Hill-Rom , 755 F.3d at 1372; (ii) the
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`specification contains at least six broader phrases that include "the present invention" (see, e.g. ,
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`' 723 pat. col. 4:41-53 , 5:47-58, 6:46-57, 7:19-27, 7:35-41 , 7:42-48), including one use that tracks
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`the broad language of claim 1 (see ' 723 patent 7:28 -34 ("The present invention also provides a
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`method for the prophylaxis or treatment in a mammal, such as a human, of conditions for which
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`administration of one or more antihistamine and/or one or more steroid is indicated .. . . "));5 and
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`(iii) the patent contains claims depending from independent claim 1 that are expressly limited to
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`"allergic rhinitis" (' 723 patent claim 8) or "allergic conjunctivitis" ('723 patent claim 9), which
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`Defendant concedes are preferred embodiments. 6
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`Other problems plague Plaintiffs' proposed construction. First, Plaintiffs rely on a
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`specification "definition" of "allergic reactions" that is not clearly a definition. (See Tr. at 32-36;
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`D.I. 4 7 at 4 (citing ' 723 patent 1 :26-28) ("Such allergic reactions commonly comprise the
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`allergy-related and vasomotor-related symptoms and the rhinovirus-related symptoms."))
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`Second, the purported "definition" would confusingly include within "allergic reactions"
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`conditions that Plaintiffs admit can be non-allergic. (See Tr. 35-36; D.I. 46 at 18 (citing D.I. 43-
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`5See also Absolute Software v. Stealth Signal, 659 F.3d 1121 , 1136 (Fed. Cir. 2011 )
`("[W]e have found that use of the phrase 'present invention' or 'this invention' is not always ...
`limiting, such as where the references to a certain limitation as being the ' invention' are not
`uniform, or where other portions of the intrinsic evidence do not support applying the limitation
`to the entire patent.").
`
`6See Liebel-Flarsheim v. Medrad, 358 F.3d 898, 913 (Fed. Cir. 2004) (" [I]t is improper to
`read limitations from a preferred embodiment described in the specification - even if it is !he
`only embodiment - into the claims absent a clear indication in the intrinsic record that the
`patentee intended the claims to be so limited.").
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`8
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`
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`Case 1:14-cv-01453-LPS Document 114 Filed 05/12/16 Page 10 of 10 PageID #: 2184
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`10 at 5)) Third, relatedly, the prosecution history includes references to non-allergic conditions,
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`such as types of asthma. (See D .I. 46 at 19)
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`Because Plaintiffs have not shown that a person of ordinary skill in the art would
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`understand "conditions" to be limited to conditions causing allergic reactions, nor demonstrated
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`that the patent itself so defined the term, the Court adopts Defendants' construction.
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`III. CONCLUSION
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`The Court will construe the disputed term as described above. An appropriate Order
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`follows.
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`9