Case 1:14-cv-01453-LPS Document 63 Filed 12/23/15 Page 1 of 19 PageID #: 1832
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`C.A. No. 14-1453-LPS
`
`))))))))))
`
`MEDA PHARMACEUTICALS INC. and
`CIPLA LTD.,
`
`Plaintiffs,
`
`v.
`
`APOTEX INC. and APOTEX CORP.,
`
`Defendants.
`
`APOTEX’S ANSWERING CLAIM CONSTRUCTION BRIEF
`
`Richard L. Horwitz (#2246)
`David E. Moore (#3983)
`Bindu A. Palapura (#5370)
`Stephanie E. O’Byrne (#4446)
`POTTER ANDERSON & CORROON LLP
`Hercules Plaza, 6th Floor
`1313 N. Market Street
`Wilmington, DE 19801
`Tel: (302) 984-6000
`rhorwitz@potteranderson.com
`dmoore@potteranderson.com
`bpalapura@potteranderson.com
`sobyrne@potteranderson.com
`
`Attorneys for Defendants Apotex Inc. and
`Apotex Corp.
`
`OF COUNSEL:
`
`Tung-On Kong
`David M. Hanna
`WILSON SONSINI GOODRICH & ROSATI
`Professional Corporation
`One Market Street
`Spear Tower Suite 3300
`San Francisco, California 94105
`Tel: (415) 947-2000
`
`Nicole W. Stafford
`Robert A. Delafield, II
`WILSON SONSINI GOODRICH & ROSATI
`Professional Corporation
`900 S. Capital of Texas Highway
`Las Cimas IV, Fifth Floor
`Austin, Texas 78746-5546
`Tel: (512) 338-5400
`
`Adam Burrowbridge
`WILSON SONSINI GOODRICH & ROSATI
`1700 K Street, NW, Fifth Floor
`Washington, DC 20006
`Tel: (202) 973-8992
`
`Dated: December 23, 2015
`1212673 / 42112
`
`

`
`Case 1:14-cv-01453-LPS Document 63 Filed 12/23/15 Page 2 of 19 PageID #: 1833
`
`TABLE OF CONTENTS
`
`Page
`
`I.
`
`II.
`
`INTRODUCTION ...............................................................................................................1
`
`DISPUTED CLAIM TERMS..............................................................................................2
`
`A.
`
`“Condition(s)”..........................................................................................................2
`
`1.
`
`2.
`
`3.
`
`“Condition(s)” Should Be Construed Consistently With Its Plain
`and Ordinary Meaning .................................................................................2
`
`Plaintiffs’ Construction Is Not Supported By the Specification..................3
`
`The Terms Must Be Construed In the Context Of the Claim Phrase
`As a Whole...................................................................................................6
`
`B.
`
`“Administration”......................................................................................................7
`
`1.
`
`2.
`
`3.
`
`Apotex’s Construction Most Naturally Aligns With the Patent’s
`Description Of the Invention .......................................................................7
`
`Plaintiffs Improperly Attempt To Import Limitations Based On
`Extrinsic Evidence Including Irrelevant Commercial Embodiments ........10
`
`Plaintiffs’ Did Not Disavow the Scope of the Term
`“Administration”........................................................................................12
`
`III.
`
`CONCLUSION..................................................................................................................14
`
`-i-
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`

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`Case 1:14-cv-01453-LPS Document 63 Filed 12/23/15 Page 3 of 19 PageID #: 1834
`
`TABLE OF CITATIONS
`
`CASES
`
`Page(s)
`
`Absolute Software, Inc. v. Stealth Signal, Inc.,
`659 F.3d 1121 (Fed. Cir. 2011)............................................................................................5
`
`Akeva, L.L.C. v. Adidas Am., Inc.,
`385 F. Supp. 2d 559 (M.D.N.C. 2005), aff’d, 208 Fed. Appx. 861
`(Fed. Cir. 2006)....................................................................................................................9
`
`Ballard Med. Prods. v. Allegiance Healthcare Corp.,
`268 F.3d 1352 (Fed. Cir. 2001)............................................................................................7
`
`Bayer Pharma AG v. Watson Labs., Inc.,
`C.A. No. 12-1726-LPS, 2014 WL 4954617 (D. Del. Sept. 30, 2014)...........................9, 10
`
`Bicon, Inc. v. Straumann Co.,
`441 F.3d 945 (Fed. Cir. 2006)..............................................................................................3
`
`Edwards Lifesciences v. Cook Inc.,
`582 F.3d 1322 (Fed. Cir. 2009)..........................................................................................13
`
`Gillette Co. v. Energizer Holdings, Inc.,
`405 F.3d 1367 (Fed. Cir. 2005)............................................................................................4
`
`Grober v. Mako Prods.,
`686 F.3d 1335 (Fed. Cir. 2012)..........................................................................................13
`
`Kyocera Wireless Corp. v. Int’l Trade Comm’n,
`545 F.3d 1340 (Fed. Cir. 2008)............................................................................................7
`
`Liebel-Flarsheim Co. v. Medrad, Inc.,
`358 F.3d 898 (Fed. Cir. 2004)..............................................................................................3
`
`Medtronic Inc. v. Boston Sci. Corp.,
`695 F.3d 1266 (Fed. Cir. 2012)............................................................................................5
`
`Merck & Co. v. Teva Pharms. USA, Inc.,
`347 F.3d 1367 (Fed. Cir. 2003)............................................................................................3
`
`O2 Micro Int’l Ltd. v. Beyond Innovation Tech. Co.,
`521 F.3d 1351 (Fed. Cir. 2008)............................................................................................8
`
`Phillips v. AWH Corp.,
`415 F.3d 1303 (Fed. Cir. 2005) (en banc).................................................................. passim
`
`-ii-
`
`

`
`Case 1:14-cv-01453-LPS Document 63 Filed 12/23/15 Page 4 of 19 PageID #: 1835
`
`Renishaw PLC v. Marposs Societa’ per Azioni,
`158 F.3d 1243 (Fed. Cir. 1998)..........................................................................................11
`
`Rosco, Inc. v. Velvac Inc.,
`C.A. No. 11-117-LPS, 2012 WL 6028239 (D. Del. Dec. 4, 2012)......................................8
`
`SciMed Life Sys., Inc. v. Advanced Cardiovascular Sys., Inc.,
`242 F.3d 1337 (Fed. Cir. 2001)..........................................................................................13
`
`Scriptgen Pharm., Inc. v. 3-Dimensional Pharm., Inc.,
`79 F. Supp. 2d 409 (D. Del. 1999).....................................................................................13
`
`Virgin Atlantic Airways Ltd. v. Delta Airlines, Inc.,
`C.A. No. 11-61-LPS-CJB, 2012 WL 1636147 (D. Del. Apr. 26, 2012)..............................7
`
`Vitronics Corp. v. Conceptronic, Inc.,
`90 F.3d 1576 (Fed. Cir. 1996)..............................................................................................9
`
`-iii-
`
`

`
`Case 1:14-cv-01453-LPS Document 63 Filed 12/23/15 Page 5 of 19 PageID #: 1836
`
`Plaintiffs
`
`Defendants
`
`Delafield Ex. __
`
`Pl. Op. Brief
`
`Def. Op Brief.
`
`’723 patent
`
`’620 patent
`
`TABLE OF ABBREVIATIONS
`
`Plaintiffs Meda Pharmaceuticals Inc. and Cipla Ltd.
`
`Defendant Apotex Inc. and Apotex Corp.
`
`The corresponding exhibit to the Declaration of Robert Delafield
`in Support of Apotex’s Answering Claim Construction Brief, filed
`concurrently herewith
`
`Plaintiffs’ Opening Markman Brief, filed Nov 23, 2015 (D.I.)
`
`Defendants’ Opening Markman Brief, filed Nov 23, 2015 (D.I.)
`
`U.S. Patent No. 8,163,723 (D.I. 43-1)
`
`U.S. Patent No. 8,168,620 (D.I. 43-2)
`
`Note: emphasis is added throughout unless otherwise indicated
`
`-iv-
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`

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`Case 1:14-cv-01453-LPS Document 63 Filed 12/23/15 Page 6 of 19 PageID #: 1837
`
`I.
`
`INTRODUCTION
`
`It is telling that Plaintiffs’ opening claim construction brief begins with an extended
`
`discussion of the extrinsic evidence in an attempt to redefine the claimed invention, even
`
`pointing to the commercial embodiment to argue the scope of the claims. Such tactics highlight
`
`the lack of merit of Plaintiffs’ proposed constructions and the Court should give them no weight.
`
`As Apotex proposed in their opening claim construction briefing and repeats herein, the intrinsic
`
`evidence is clear. The applicants used precise language in the patent and made clear that,
`
`“conditions” means “illnesses or diseases” and “administration” encompasses a combined
`
`preparation for simultaneous, separate, or sequential use. Only after Defendants served their
`
`invalidity contentions on the ’723 and ’620 patents, which identified the consequences of
`
`Plaintiffs’ word choices, did Plaintiffs disclaim certain claim scope in an effort to avoid those
`
`consequences.
`
`However, Plaintiffs efforts to avoid those consequences are untimely and their litigation
`
`derived constructions only highlight the fact that their proposed constructions run contrary to
`
`claim construction principles. Plaintiffs are asking the Court to limit the claims far short of their
`
`plain meaning, which is contrary to the law, the text of the claims, the intrinsic record, and even
`
`the extrinsic evidence. The claim term “administration” is explicitly defined as uses where the
`
`formulation is given: “simultaneously, either in the same or different pharmaceutical
`
`formulations, or separately or sequentially.” Similarly “conditions” has a self-evident meaning of
`
`disease(s) or illness(es) which Plaintiffs do not deny.
`
`For each of these two claim terms, Defendants’ proposed constructions are firmly rooted
`
`in the intrinsic evidence, which was fixed at the time the patents in suit issued. Plaintiffs must
`
`now be held to the patentee’s unambiguous statements about the scope of the claim terms.
`
`

`
`Case 1:14-cv-01453-LPS Document 63 Filed 12/23/15 Page 7 of 19 PageID #: 1838
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`Litigation should not provide Plaintiffs an opportunity to disavow the record and obtain patent
`
`coverage different than what is described and claimed in the patent.
`
`II.
`
`DISPUTED CLAIM TERMS
`
`A.
`
`“Condition(s)”
`
`Defendants’ proposal
`Plain and ordinary meaning.
`
`To the extent that the Court determines
`that this term requires construction,
`Apotex proposes the following
`construction: “disease(s) or
`illness(es).”
`
`Plaintiffs’ (revised) proposal
`disease(s) or illness(es) resulting in or
`causing allergic reaction(s)
`
`1.
`
`“Condition(s)” Should Be Construed Consistently With Its
`Plain and Ordinary Meaning
`
`The words of a claim “are generally given their ordinary and customary meaning” as they
`
`would be understood “in the context of the entire patent, including the specification.” Phillips v.
`
`AWH Corp., 415 F.3d 1303, 1312-13 (Fed. Cir. 2005) (en banc). The plain and ordinary meaning
`
`of “condition(s)” is broad, and is generally understood to include any “diseases or illnesses.” In
`
`contrast, Plaintiffs’ proposed construction limits the term “condition(s)” to only those diseases or
`
`illnesses “resulting in or causing allergic reaction(s).” While allergic reactions are one type of a
`
`disease or illness, it does not necessarily define the outer scope of the claims. As an initial
`
`matter, the express language of the claim makes clear that the relevant “condition(s)” in the
`
`context of the invention are not limited to only those related to allergic reactions. ’620 patent,
`
`12:40-44. Indeed, the claim language expressly states that the relevant “condition(s)” are
`
`“conditions for which administration of one or more anti-histamines and/or one or more steroid
`
`is indicated.” ’620 patent at claim 16. Accordingly, the claim expressly allows for any “diseases
`
`or illnesses” for which administration of an antihistamine and/or steroid is indicated, and
`
`-2-
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`

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`Case 1:14-cv-01453-LPS Document 63 Filed 12/23/15 Page 8 of 19 PageID #: 1839
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`Plaintiffs’ proposed construction to require that the disease or illness be limited to those resulting
`
`in or causing allergic reactions would improperly limit the scope of the claims. See Bicon, Inc. v.
`
`Straumann Co., 441 F.3d 945, 950-51 (Fed. Cir. 2006) (“[C]laims are interpreted with an eye
`
`toward giving effect to all terms in the claim.”).
`
`The Federal Circuit has stated that “it is improper to read limitations from a preferred
`
`embodiment described in the specification—even if it is the only embodiment—into the claims
`
`absent a clear indication in the intrinsic record that the patentee intended the claims to be so
`
`limited.” Liebel-Flarsheim Co. v. Medrad, Inc., 358 F.3d 898, 913 (Fed. Cir. 2004).
`
`Accordingly, Plaintiffs’ proposed construction, which purports to inject such limitations into the
`
`claims are improper because it would improperly restrict the breadth of the claim.
`
`2.
`
`Plaintiffs’ Construction Is Not Supported By the Specification
`
`Nor does Plaintiffs’ proposed construction have any basis in the patent specification.
`
`Claims are to be interpreted in view of the intrinsic evidence, which includes the claim language,
`
`the specification, and the prosecution history. Phillips, 415 F.3d at 1312-17 (citation omitted).
`
`The specification is usually “dispositive; it is the single best guide to the meaning of a disputed
`
`term.” Id. at 1315 (citation omitted). The “claims must be construed so as to be consistent with
`
`the specification, of which they are a part.” Merck & Co. v. Teva Pharms. USA, Inc., 347 F.3d
`
`1367, 1371 (Fed. Cir. 2003). The specification never once describes the invention as limited to
`
`treatment of “conditions” that result in or are caused by allergic reactions. Rather, the
`
`specification consistently and repeatedly teaches that the claimed invention can be used to treat
`
`any “condition” for which “administration of one or more anti-histamines and/or one or more
`
`steroid is indicated.”
`
`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 anti-histamine and/or one or more steroid is indicated, which method
`
`-3-
`
`

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`Case 1:14-cv-01453-LPS Document 63 Filed 12/23/15 Page 9 of 19 PageID #: 1840
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`comprises administration of a therapeutically effective amount of a
`pharmaceutical formulation substantially as hereinbefore described.
`
`’620 patent, 7:28-34.
`
`It will be appreciated, therefore, that the present invention further provides a
`pharmaceutical product ... for simultaneous, separate or sequential use in the
`treatment of conditions for which administration of one or more anti-histamine
`and/or one or more steroid is indicated.
`
`’620 patent, 4:52-53.
`
`There is also provided by the present invention a method for the prophylaxis or
`treatment in a mammal, such as a human, of conditions for which administration
`of one or more anti-histamine and/or one or more steroid is indicated, which
`method comprises administration of a therapeutically effective amount of a
`pharmaceutical product substantially as hereinbefore described ...
`
`’620 patent, 7:19-22.
`
`There is also provided by the present invention for use in the manufacture of a
`medicament for the prophylaxis or treatment in a mammal, such as a human, of
`conditions for which administration of one or more anti-histamine and/or one
`or more steroid is indicated ...
`
`’620 patent, 7:35-39.
`
`Construing “condition(s)” to mean “a disease(s) or illness(es) resulting in or causing
`
`allergic reaction(s)”, would render the claim language nonsensical. “In construing claims, the
`
`analytical focus must begin and remain centered on the language of the claims themselves, for it
`
`is that language that the patentee chose to use to particularly point out and distinctly claim the
`
`subject matter which the patentee regards as his invention.” Gillette Co. v. Energizer Holdings,
`
`Inc., 405 F.3d 1367, 1370 (Fed. Cir. 2005).
`
`Plaintiffs do not appear to dispute that a POSA would consider the term “condition”
`
`equivalent to “diseases or illnesses,” but rather, Plaintiffs rely on a preferred embodiment in the
`
`specification and argue that statement describing the “present invention” limited the scope of
`
`“conditions” to those “resulting in or causing allergic reactions.” See Pl. Op. Brief at 3 (“[T]he
`
`-4-
`
`

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`Case 1:14-cv-01453-LPS Document 63 Filed 12/23/15 Page 10 of 19 PageID #: 1841
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`patents expressly describe the “present invention” as being directed to treatment of “allergic
`
`reactions.”’). The phrase “present limitation” (or similarly, “this invention”) may not be used to
`
`import a limitation from a specific embodiment into a claim if the references to that 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.” Absolute Software, Inc. v. Stealth Signal,
`
`Inc., 659 F.3d 1121, 1136 (Fed. Cir. 2011). Medtronic Inc. v. Boston Sci. Corp., 695 F.3d 1266,
`
`1276 (Fed. Cir. 2012) (concluding “that the district court erred by restricting the claimed
`
`invention to the treatment of congestive heart failure”) (reversed and remanded on other
`
`grounds). In Medtronic, the Federal Circuit reversed the district court’s claim construction
`
`because “the district court did nothing more than append the limitation for the treatment of
`
`congestive heart failure, onto the ends of the disputed claim terms.” Id.at 1275. The Court
`
`further held that “this unquestionably added a limitation. This would only have been proper if the
`
`patentee specifically defined the terms to include that limitation, or disavowed their otherwise
`
`broad scope.” Id. The Court noted that while the specification explains the use of the invention to
`
`treat congestive heart failure, it also discloses the invention’s value in treating other diseases.”
`
`Id.
`
`Here, there is no statement in the specification, let alone the requisite clear and express
`
`statement, indicating that the inventors intended to depart from the plain and ordinary meaning
`
`and restrict “condition” in the manner Plaintiffs contend. The one passage to which Plaintiffs cite
`
`refers to examples of “conditions” to which that the invention is directed. Plaintiffs then seek to
`
`limit the definition of “condition” to those specific examples. Pl. Op. Brief at 9. That is one of
`
`the “cardinal sins” of claim construction. See Phillips, 415 F.3d at 1320.
`
`-5-
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`

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`Case 1:14-cv-01453-LPS Document 63 Filed 12/23/15 Page 11 of 19 PageID #: 1842
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`Moreover, other portions of the specification make clear that the “present invention” is
`
`much broader than Plaintiffs proposed construction and covers any disease or illness for “which
`
`administration of one or more anti-histamine and/or one or more steroid is indicated.” See e.g.,
`
`’620 patent, 7:19-22. Accordingly, the specification confirms that Apotex’s construction aligns
`
`with a POSA’s ordinary understanding and use of the term.
`
`3.
`
`The Terms Must Be Construed In the Context Of the Claim
`Phrase As a Whole
`
`The Federal Circuit has recognized that “the use of a term within the claim provides a
`
`firm basis for construing the term.” Phillips, 415 F. 3d at 1314. Plaintiffs assert that Apotex’s
`
`proposed construction does not align with the teachings of the patent and present the straw man
`
`argument that it could theoretically allow for diseases or illnesses such as “cancer.” Pl. Op. Brief
`
`at 1, 9, and 11. Plaintiffs’ contention is wrong and simply misstates Apotex’s proposal.1
`
`The relevant portion of the claim recites:
`
`The pharmaceutical formulation of claim 1, wherein said formulation is used in
`the treatment of conditions for which administration of one or more anti-
`histamine and/or one or more steroid is indicated.
`
`See, e.g.,’620 patent, Claim 16. Accordingly, the claims themselves make clear that the claimed
`
`“conditions” must be those for which administration of one or more anti-histamine and/or one
`
`or more steroid is indicated. Apotex’s proposed construction of “conditions” aligns with the
`
`surrounding claim language. Contrary to Plaintiffs’ arguments, “cancer” does not fall within the
`
`scope of the claims when they are considered, as they must be, contextually as a whole. Further,
`
`1 Apotex has never maintained that the invention is directed to the treatment of cancer.
`Plaintiffs’ repeated reference to cancer is a red herring that ignores the rest of the claim language
`clarifying that the claimed condition is one “for which administration of one or more anti-
`histamine and/or one or more steroid is indicated” in an effort to improperly narrow the plain
`meaning of the word “condition(s).”
`
`-6-
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`

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`Case 1:14-cv-01453-LPS Document 63 Filed 12/23/15 Page 12 of 19 PageID #: 1843
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`Plaintiffs’ proposed construction would arguably exclude diseases or illnesses that not even
`
`Plaintiffs would dispute as being “conditions for which administration of one or more anti-
`
`histamines and/or one or more steroid is indicated.” For example, Plaintiffs’ proposed
`
`construction would effectively exclude all indications for anti-histamines not related to allergic
`
`reactions, such as the treatment/prevention of motion sickness or use of antihistamine as a
`
`sedative. Accordingly, Plaintiffs criticism of Apotex’s proposed construction is misguided. See
`
`Kyocera Wireless Corp. v. Int’l Trade Comm’n, 545 F.3d 1340, 1347 (Fed. Cir. 2008) (“[T]his
`
`court does not interpret claim terms in a vacuum, devoid of the context of the claim as a
`
`whole.”); Phillips, 415 F.3d at 1314 (“[T]he context of the surrounding words of the claim also
`
`must be considered in determining the ordinary and customary meaning of those terms...”)
`
`(internal quotation and citation omitted); see also Virgin Atlantic Airways Ltd. v. Delta Airlines,
`
`Inc., No. 11-61-LPS-CJB, 2012 WL 1636147, at *6 (D. Del. Apr. 26, 2012) (noting “abstract
`
`possibilit[ies]” regarding claim scope are not relevant to claim construction).
`
`B.
`
`“Administration”
`
`Defendants’ proposal
`“to administer simultaneously, either
`in the same or different
`pharmaceutical formulations, or
`separately or sequentially”
`
`Plaintiffs’ proposal
`Plain and ordinary meaning.
`To the extent that the Court requires
`further explanation of the plain and
`ordinary meaning of “administration,”
`Plaintiffs propose that the plain and
`ordinary meaning of “administration”
`is “application.”
`
`1.
`
`Apotex’s Construction Most Naturally Aligns With the
`Patent’s Description Of the Invention
`
`The patents in suit describe what “administration” is and what it is not. The patentee may
`
`use the specification “to define what his invention is and what it is not.” Ballard Med. Prods. v.
`
`Allegiance Healthcare Corp., 268 F.3d 1352, 1359 (Fed. Cir. 2001). The patentee clearly and
`
`-7-
`
`

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`Case 1:14-cv-01453-LPS Document 63 Filed 12/23/15 Page 13 of 19 PageID #: 1844
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`repeatedly explained in the patent specification that the invention does not need to be in a single
`
`formulation nor given contemporaneously. This is not a case where any nuance or interpretation
`
`is required to understand what the patentee was attempting to include. The patent specification
`
`clearly, repeatedly, and unmistakably states:
`
`“The present invention further provides, therefore, a pharmaceutical product
`comprising (i) azelastine, or a pharmaceutically acceptable salt thereof, and (ii) at
`least one steroid selected from the group consisting of beclomethasone,
`fluticasone, mometasone and pharmaceutically acceptable esters thereof, as a
`combined preparation for simultaneous, separate, or sequential use in the
`treatment of conditions for which administration of one or more anti-histamine
`and/or one or more steroid is indicated.”
`
`’723 patent 6:46-54; ’620 patent 6:46-54.
`
`The construction that “most naturally aligns with the patent’s description of the
`
`invention” is the correct one. Phillips, 415 F.3d at 1316. Here, a construction of “administration”
`
`that includes either, “simultaneous, separate or sequential use” most naturally follows from the
`
`written description of the patents-in suit. Plaintiffs, by contrast, urge the Court to assign an open-
`
`ended “ordinary meaning” definition or alternatively define the term as “application.” Such an
`
`approach is an invitation to legal error. Without a meaningful construction, expert witnesses will
`
`be engaging in claim construction when they opine on whether the accused products have a so-
`
`called “ordinary meaning” administration. Thus, a construction merely stating that a term has its
`
`“ordinary meaning” is inadequate when it fails to resolve the parties’ dispute. O2 Micro Int’l Ltd.
`
`v. Beyond Innovation Tech. Co., 521 F.3d 1351, 1361 (Fed. Cir. 2008). Plaintiffs’ alternative
`
`construction is not supported by the intrinsic record. Nowhere in the specification or prosecution
`
`history is “administration” defined as “application.” Further, the alternative construction
`
`proposed by Plaintiffs does nothing to explain or define the term “administration” or resolve the
`
`dispute. See, Rosco, Inc. v. Velvac Inc., C.A. No. 11-117-LPS, 2012 WL 6028239, at *8 (D. Del.
`
`-8-
`
`

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`Case 1:14-cv-01453-LPS Document 63 Filed 12/23/15 Page 14 of 19 PageID #: 1845
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`Dec. 4, 2012) (stating that “claim construction should not become an obligatory exercise in
`
`redundancy” (internal quotations omitted)). Plaintiffs’ proposed construction is nothing but a
`
`circular argument and ignores the clear description of the term throughout the prosecution
`
`history and specification.
`
`Although Plaintiffs propose no meaningful construction for “administration,” they devote
`
`their brief to the argument “that the inventions as claimed only encompass simultaneous
`
`administration in a single dosage form” while providing no evidence that the plain and ordinary
`
`meaning is so limited. Pl. Op. Brief at 13. In the patent specification, the patentee told both the
`
`Patent Office and the public at large that “[i]t will be appreciated from the above, that the
`
`respective therapeutic agents of the combined preparation can be administered simultaneously,
`
`either in the same or different ... formulations, or separately or sequentially.” ’620 patent
`
`5:60-63. The public is entitled to rely on statements made by the patentee in the intrinsic record.
`
`Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996) (“The specification
`
`acts as a dictionary when it expressly defines terms used in the claims or when it defines terms
`
`by implication.”); Akeva, L.L.C. v. Adidas Am., Inc., 385 F. Supp. 2d 559, 564 (M.D.N.C. 2005)
`
`(“If Plaintiff wished for certain language in the specification to be considered inapplicable to the
`
`claims, it should have left that language out of the specification. Because it remains in the patent,
`
`the court must consider it.”), aff’d, 208 Fed. Appx. 861 (Fed. Cir. 2006) (not published).
`
`Furthermore, as demonstrated in Defendants’ Opening Brief, many other publications
`
`cited in the prosecution histories of the asserted patents also refer to administration of a
`
`combination product in a consistent way. See Def. Op. Brief at 9-11. “The Federal Circuit has
`
`explained that ‘prior art cited in a patent or cited in the prosecution history of the patent
`
`constitutes intrinsic evidence’ that may be considered during claim construction.” Bayer Pharma
`
`-9-
`
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`Case 1:14-cv-01453-LPS Document 63 Filed 12/23/15 Page 15 of 19 PageID #: 1846
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`AG v. Watson Labs., Inc., C.A. No. 12-1726-LPS, 2014 WL 4954617, at *9 (D. Del. Sept. 30,
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`2014) (internal quotation marks and citations omitted). Accordingly, as used throughout the
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`prosecution history by both the patentees and by the cited references, the term administration
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`should be construed as encompassing uses occurring “simultaneously, either in the same or
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`different pharmaceutical formulations, or separately or sequentially.”
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`2.
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`Plaintiffs Improperly Attempt To Import Limitations Based
`On Extrinsic Evidence Including Irrelevant Commercial
`Embodiments
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`Plaintiffs brazenly assert that the patents in suit are “directed to a single-dosage
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`formulation for the simultaneous administration of two active pharmaceutical ingredients:
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`azelastine and fluticasone.” Pl. Op. Brief at 1; see also id. at 12. However, that is demonstrably
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`incorrect. The patents in suit repeatedly make clear that “administration” can be “either in the
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`same or different pharmaceutical formulations, or separately or sequentially.” Despite the clear
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`language in the patent specification which Plaintiffs previously embraced to obtain the broadest
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`possible coverage, Plaintiffs nevertheless now urge a different construction of “administration”
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`in order to avoid invalidity references from the prior art. Plaintiffs resort to the extrinsic
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`“dictionary definitions” to further advocate for their “single dosage form” “simultaneous”
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`administration theory. Pl. Op. Brief at 14. Notably, Plaintiffs point to nothing in the intrinsic
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`record that suggests that “administration” must be simultaneous as Plaintiffs now contend. Pl.
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`Op. Brief at 1. Rather, Plaintiffs rely on the extrinsic commercial embodiment Dymista® in order
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`to seek a narrower construction. See id. Extrinsic evidence is “less significant than the intrinsic
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`record in determining the legally operative meaning of claim language.” Phillips, 415 F.3d at
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`1312-13. (citation and quotation marks omitted). A long standing rule of claim construction
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`prohibits importing limitations from the embodiments into the claims. See Phillips, 415 F.3d at
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`-10-
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`Case 1:14-cv-01453-LPS Document 63 Filed 12/23/15 Page 16 of 19 PageID #: 1847
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`1320. Accordingly, Plaintiffs’ attempt to import limitations based on a purported commercial
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`embodiment should be given no weight.
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`This is not a situation where the patentee used broad language to preserve their ability to
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`cover unforeseeable developments in technology. The patentee was well aware of all of the
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`conditions that are treated with antihistamines and steroids, and carefully and deliberately chose
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`to broadly claim a treatment for all such conditions and administrations and not just limit the
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`claim scope to “a single-dosage formulation for the simultaneous administration of two active
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`pharmaceutical ingredients” as they now claim. Pl. Op. Brief at 1, 4, 5, 7, 12.
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`Finally, Plaintiffs repeatedly conflate claim construction of the term “administration”
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`with other terms in the claim, and point to the commercial embodiment Dymista as supportive
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`evidence for their distorted reading of the specification. The Federal Circuit has stated that claim
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`construction “begins and ends in all cases with the actual words of the claim.” Renishaw PLC v.
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`Marposs Societa’ per Azioni, 158 F.3d 1243, 1248 (Fed. Cir. 1998). In particular, a party must
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`tie proposed definitions to specific terms in the claim. Renishaw PLC, 158 F.3d at 1248 (“Thus, a
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`party wishing to use statements in the written description to confine or otherwise affect a patent’s
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`scope must, at the very least, point to a term or terms in the claim with which to draw in those
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`statements. Without any claim term that is susceptible of clarification by the written description,
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`there is no legitimate way to narrow the property right.”). Here, plaintiffs are unable to otherwise
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`limit the scope of their claims through any particular claim term and instead erroneously claim
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`that the term “administration” should somehow limit the scope of the invention to a “single
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`dosage form” based on the extrinsic commercial embodiment. Those tactics highlight the lack of
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`merit of Plaintiffs’ proposed construction and the Court should give them no weight.
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`Case 1:14-cv-01453-LPS Document 63 Filed 12/23/15 Page 17 of 19 PageID #: 1848
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`3.
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`Plaintiffs’ Did Not Disavow the Scope of the Term
`“Administration”
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`It is telling that Plaintiffs cannot support their contention that the scope of the term
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`“administration” was somehow limited during prosecution with even a single citation to the
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`intrinsic record or any portion of the prosecution history where they ever used such a word to
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`limit the scope of the claims. Instead, Plaintiffs cherry pick certain evidence – either intrinsic or
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`extrinsic – and disregard the rest entirely. Plaintiffs also take inconsistent positions with respect
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`to the prosecution history, arguing in one portion of the brief that “the patentees disavowed claim
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`scope” and in the next breath seek the “plain and ordinary meaning” because they claim “the
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`patentees[did not] engage in any disavowal specifically regarding the term “administration.”’
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`See. Pl. Op. Brief at 14.
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`Plaintiffs’ conclusory argument regarding applicants’ disavowal of claim scope further
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`highlights the fact that plain and ordinary meaning of the term “administration” is not limited in
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`scope as Plaintiffs now claim. See Pl. Op. Brief at 15. In fact, Plaintiffs’ own arguments on this
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`point are inconsistent. On the one hand, Plaintiffs point out that the applicants’ amendments
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`during prosecution deleted all reference to “simultaneous” along with the terms “sequential” and
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`“separate” administration in the prior claim sets. See Pl. Op. Brief at 15. Yet, Plaintiffs claim that
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`“simultaneous” administration is somehow still required by the claims and only “sequential” and
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`“separate” are disavowed. The fact of the matter is that nothing in the prosecution