Case 1:14-cv-01453-LPS Document 114 Filed 05/12/16 Page 1 of 10 PageID #: 2175
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`MEDA PHARMACEUTICALS INC.,
`and CIPLA LTD.,
`
`Plaintiffs,
`
`v.
`
`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
`
`

`
`Case 1:14-cv-01453-LPS Document 114 Filed 05/12/16 Page 2 of 10 PageID #: 2176
`
`On December 2, 2014, Plaintiffs Meda Pharmaceuticals and Cipla Ltd. ("Plaintiffs") filed
`
`suit against Defendants Apotex Inc. and Apotex. Corp ("Apotex" or "Defendants") alleging
`
`infringement of U.S. Patent Nos. 8,163,723 (the "' 723 patent"), 8,168,620 (the '"620 patent"),
`
`and 9,259,428 (the '"428 patent"). The patents are directed to a single-dosage formulation for
`
`the simultaneous administration of two active pharmaceutical ingredients: azelastine (an
`
`antihistamine) and fluticasone (a corticosteroid).
`
`The parties submitted technology tutorials (D.I. 44 and 45) and claim construction briefs
`
`(D.I. 46, 47, 61 , 63 , and 96). The Court held a claim construction hearing on April 29, 2016.
`
`(See D.I. 113 ("Tr."))
`
`I.
`
`LEGAL ST AND ARDS
`
`The ultimate question of the proper construction of a patent is a question oflaw. See Teva
`
`Pharm. USA, Inc. v. Sandoz, Inc. , 135 S. Ct. 831, 837 (2015) (citingMarh.wan v. Westview
`
`Instruments, Inc. , 517 U.S. 370, 388-91 (1996)) . "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).
`
`"[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.
`
`"[T]he 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."
`
`1
`
`

`
`Case 1:14-cv-01453-LPS Document 114 Filed 05/12/16 Page 3 of 10 PageID #: 2177
`
`Id. at 1312-13 (internal citations and quotation marks omitted). "[T]he 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). The patent specification "is always highly relevant to the
`
`claim construction analysis. Usually, it is dispositive; it is the single best guide to the meaning of
`
`a disputed term." Vitronics Corp. v. Conceptronic, Inc. , 90 F.3d 1576, 1582 (Fed. Cir. 1996).
`
`While "the claims themselves provide substantial guidance as to the meaning of particular
`
`claim terms," the context of the surrounding words of the claim also must be considered.
`
`Phillips, 415 F.3d at 1314. Furthermore, "[o]ther claims of the patent in question, both asserted
`
`and unasserted, can also be valuable sources of enlightenment ... [b ]ecause claim terms are
`
`normally used consistently throughout the patent ... . " Id. (internal citation omitted).
`
`It is likewise true that "[d]ifferences among claims can also be a useful guide .... For
`
`example, the 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 (internal citation omitted). This "presumption is especially strong when 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. , Ltd. v. SRAM Corp. , 336 F.3d 1298, 1303 (Fed. Cir. 2003).
`
`It is also possible that "the 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. It bears emphasis that"[ e ]ven
`
`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
`
`2
`
`

`
`Case 1:14-cv-01453-LPS Document 114 Filed 05/12/16 Page 4 of 10 PageID #: 2178
`
`using words or expressions of manifest exclusion or restriction." Hill-Rom Servs. , Inc. v. Stryker
`
`Corp. , 755 F.3d 1367, 1372 (Fed. Cir. 2014) (quoting Liebel-Flarsheim Co. v. Medrad, Inc., 358
`
`F.3d 898, 906 (Fed. Cir. 2004)) (internal quotation marks omitted).
`
`In addition to the specification, a court "should also consider the patent's prosecution
`
`history, if it is in evidence." Mar/,.wan v. Westview Instruments, Inc., 52 F.3d 967, 980 (Fed. Cir.
`
`1995), aff'd, 517 U.S . 370 (1996). 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.
`
`In some cases, "the district court will need to look beyond the patent' s intrinsic evidence
`
`and to consult extrinsic evidence in order to understand, for example, the background science or
`
`the meaning of a term in the relevant art during the relevant time period." Teva , 135 S. Ct. at
`
`841. Extrinsic evidence "consists of all evidence external to the patent and prosecution history,
`
`including expert and inventor testimony, dictionaries, and learned treatises." Markman , 52 F.3d
`
`at 980. For instance, technical dictionaries can assist the court in determining the meaning of a
`
`term to those of skill in the relevant art because such dictionaries "endeavor to collect the
`
`accepted meanings of terms used in various fields of science and technology." Phillips, 415 F.3d
`
`at 1318. In addition, expert testimony can be useful "to ensure that the court' s understanding of
`
`the technical aspects of the patent is consistent with that of a person of skill in the art, or to
`
`3
`
`

`
`Case 1:14-cv-01453-LPS Document 114 Filed 05/12/16 Page 5 of 10 PageID #: 2179
`
`establish that a particular term in the patent or the prior art has a particular meaning in the
`
`pertinent field. " Id. Nonetheless, courts must not lose sight of the fact that "expert reports and
`
`testimony [are] generated at the time of and for the purpose of litigation and thus can suffer from
`
`bias that is not present in intrinsic evidence." Id. Overall, while extrinsic evidence "may be
`
`useful" to the court, it is "less reliable" than intrinsic evidence, and its consideration "is unlikely
`
`to result in a reliable interpretation of patent claim scope unless considered in the context of the
`
`intrinsic evidence." Id. at 1318-19. Where the intrinsic record unambiguously describes the
`
`scope of the patented invention, reliance on any extrinsic evidence is improper. See Pitney
`
`Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1308 (Fed. Cir. 1999) (citing Vitronics, 90
`
`F.3d at 1583).
`
`Finally, "[t]he 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 ' per Azioni, 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 '! Trade Comm 'n, 505 F.3d 1351 , 1358 (Fed. Cir. 2007)
`
`(quoting Modine Mfg. Co. v. U S. Int'! Trade Comm 'n, 75 F.3d 1545, 1550 (Fed. Cir. 1996)).
`
`4
`
`

`
`Case 1:14-cv-01453-LPS Document 114 Filed 05/12/16 Page 6 of 10 PageID #: 2180
`
`II.
`
`CONSTRUCTION OF DISPUTED TERM 1
`
`"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)"
`
`A patent's claims "define and circumscribe" the scope of a patentee' s right to exclude.
`
`Ariad Pharmaceuticals, Inc. v. Eli Lilly and Co. , 598 F.3d 1366, 1347 (Fed. Cir. 2010) (en bane).
`
`The Court, thus, begins its claim construction analysis with the language of the claims
`
`themselves.
`
`The asserted patents here claim a method for treating a "condition for which
`
`administration of one or more antihistamines and/or one or more steroids is indicated." See, e.g.
`
`' 723 pat. col. 11 :52-53 ; ' 620 pat. col. 12:42-44. Given this context, the Court finds that the plain
`
`and ordinary meaning of the term "condition," to a person of ordinary skill in the art ("POSA"),
`
`is "disease or illness."3
`
`Claim language must be construed in the context of the claim as a whole. See !GT v.
`
`1The parties have agreed to certain constructions, all of which the Court has adopted or
`will adopt.
`
`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.
`
`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)
`
`5
`
`

`
`Case 1:14-cv-01453-LPS Document 114 Filed 05/12/16 Page 7 of 10 PageID #: 2181
`
`Bally Gaming Int '!, Inc., 659 F.3d 1109, 1117 (Fed. Cir. 2011). "Extracting a single word from a
`
`claim divorced from the surrounding limitations can lead construction astray." Id. Here, to the
`
`extent the claims of the patents-in-suit are concerned principally (or, for certain dependent
`
`claims, exclusively) with allergic reactions, it is not the word "conditions" that narrows the claim
`
`scope. Rather, it is the other limitations that establish the classes of disease or illnesses included
`
`within the scope of the claims: i.e., those conditions for which administration of an antihistamine
`
`or steroid is indicated.
`
`For instance, independent claim 1 of the ' 723 patent is limited to methods relating to
`
`conditions typically treated by "antihistamines and/or .. . steroids." Undoubtedly, a POSA
`
`would understand that not every disease or illness can be treated in this manner. But just because
`
`the overall scope of the claim does not reach every disease or illness does not mean that the claim
`
`term "condition" is being used in a manner narrower than its full plain and ordinary meaning.4
`
`Plaintiffs argue that a person of ordinary skill in the art, having read the patent
`
`specification, would understand that "condition" is limited to conditions that "result in or cause
`
`an allergic reaction." (D.I. 47 at 14) The "person of ordinary skill in the art is deemed to read
`
`the claim term not only in the context of the particular claim in which the disputed term appears,
`
`but in the context of the entire patent, including the specification." Phillips, 415 F.3d at 1314.
`
`Therefore, "[t]he customary meaning of a claim term is not determined in a vacuum and should
`
`be harmonized, to the extent possible, with the intrinsic record, as understood in the field of the
`
`invention." Lexion Med. , LLC v. Northgate Techs., Inc., 641 F.3d 1352, 1356 (Fed. Cir. 2011) .
`
`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.
`
`6
`
`

`
`Case 1:14-cv-01453-LPS Document 114 Filed 05/12/16 Page 8 of 10 PageID #: 2182
`
`Neither the intrinsic nor extrinsic evidence supports a narrower construction of
`
`"conditions." A court may depart from the ordinary meaning of a claim term in only two
`
`circumstances. See Pacing Techs. , LLC v. Garmin Int'!, Inc. , 778 F.3d 1021 , 1024 (Fed. Cir.
`
`2015). First, a patentee may "act as a lexicographer" by assigning his own definition to a patent
`
`claim term. Id. Second, a patentee may intentionally disclaim, or "disavow," claim scope. Id.
`
`A disclaimer or disavowal requires either "words or expressions of manifest exclusion or
`
`restriction," Hill-Rom Services, Inc. v. Stryker Corp. , 755 F.3d 1367, 1372 (Fed. Cir. 2014), cert.
`
`denied, 135 S. Ct. 719, 190 L. Ed. 2d 463 (2014) (internal quotation marks omitted), or an
`
`implicit definition "so clear that it equates to an explicit one," Thorner, 669 F.3d at 1368.
`
`The intrinsic evidence Plaintiffs cite does not meet this exacting standard. Plaintiffs
`
`suggest that the patentees "defined" their invention as a method "useful for preventing or
`
`minimizing allergic reactions." (D.I. 47 at 13) (citing ' 723 pat. col. 1:20-22; '620 pat. col. 1:11-
`
`13) Plaintiffs further note that the specification states that "the present invention relates [to
`
`treatments for] allergic reactions," that the treatment of allergy symptoms was the purpose of the
`
`invention, and that the prosecution history shows the patentee and examiner were focused on the
`
`treatment of allergies. (D.I. 4 7 at 13-15) (citing ' 723 pat. col. 1:20-22; '620 pat. col. 1: 11-13)
`
`While this evidence is probative of the "problem to be solved" by the invention, it is insufficient
`
`here to limit the scope of the claim term "condition." See, e.g., E-Pass Technologies, Inc. v.
`
`3Com Corp. , 343 F.3d 1364, 1370 (Fed. Cir. 2003). Rather, a disclaimer or disavowal is
`
`typically justified only if the text of the disputed patent requires the conclusion that the patentee
`
`disavowed claim scope, because to conclude otherwise would be inconsistent with its
`
`specification or claims. This is especially true here, where: (i) the specification does not include
`
`7
`
`

`
`Case 1:14-cv-01453-LPS Document 114 Filed 05/12/16 Page 9 of 10 PageID #: 2183
`
`explicitly narrowing language such as "the present invention requires," "the present invention is,"
`
`or "all embodiments of the present invention are," Hill-Rom , 755 F.3d at 1372; (ii) the
`
`specification contains at least six broader phrases that include "the present invention" (see, e.g. ,
`
`' 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
`
`the broad language of claim 1 (see ' 723 patent 7:28 -34 ("The present invention also provides a
`
`method for the prophylaxis or treatment in a mammal, such as a human, of conditions for which
`
`administration of one or more antihistamine and/or one or more steroid is indicated .. . . "));5 and
`
`(iii) the patent contains claims depending from independent claim 1 that are expressly limited to
`
`"allergic rhinitis" (' 723 patent claim 8) or "allergic conjunctivitis" ('723 patent claim 9), which
`
`Defendant concedes are preferred embodiments. 6
`
`Other problems plague Plaintiffs' proposed construction. First, Plaintiffs rely on a
`
`specification "definition" of "allergic reactions" that is not clearly a definition. (See Tr. at 32-36;
`
`D.I. 4 7 at 4 (citing ' 723 patent 1 :26-28) ("Such allergic reactions commonly comprise the
`
`allergy-related and vasomotor-related symptoms and the rhinovirus-related symptoms."))
`
`Second, the purported "definition" would confusingly include within "allergic reactions"
`
`conditions that Plaintiffs admit can be non-allergic. (See Tr. 35-36; D.I. 46 at 18 (citing D.I. 43-
`
`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.").
`
`8
`
`

`
`Case 1:14-cv-01453-LPS Document 114 Filed 05/12/16 Page 10 of 10 PageID #: 2184
`
`10 at 5)) Third, relatedly, the prosecution history includes references to non-allergic conditions,
`
`such as types of asthma. (See D .I. 46 at 19)
`
`Because Plaintiffs have not shown that a person of ordinary skill in the art would
`
`understand "conditions" to be limited to conditions causing allergic reactions, nor demonstrated
`
`that the patent itself so defined the term, the Court adopts Defendants' construction.
`
`III. CONCLUSION
`
`The Court will construe the disputed term as described above. An appropriate Order
`
`follows.
`
`9