Case 1:14-cv-01453-LPS Document 46 Filed 11/23/15 Page 1 of 20 PageID #: 1559
`
`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 INC.’S AND APOTEX CORP.’S
`OPENING 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: November 23, 2015
`1210091 / 42112
`
`

`
`Case 1:14-cv-01453-LPS Document 46 Filed 11/23/15 Page 2 of 20 PageID #: 1560
`
`TABLE OF CONTENTS
`
`Page
`
`I.
`
`II.
`
`III.
`
`IV.
`
`INTRODUCTION .............................................................................................................1
`
`THE PATENTS-IN-SUIT AND RELEVANT TECHNOLOGY BACKGROUND ........2
`
`LEGAL STANDARD........................................................................................................5
`
`ARGUMENT.....................................................................................................................6
`
`A.
`
`“Administration”....................................................................................................6
`
`1.
`
`2.
`
`3.
`
`The Patentee Explicitly Stated that the Purported Invention Can Be
`“Administered Simultaneously, Either in the Same or Different
`Pharmaceutical Formulations, or Separately or Sequentially” ..................6
`
`Other Intrinsic Evidence Supports Apotex’s Construction of
`“Administration”........................................................................................9
`
`Plaintiffs’ Construction Is Inconsistent With the Intrinsic Evidence.......11
`
`B.
`
`“Condition”..........................................................................................................12
`
`1.
`
`2.
`
`3.
`
`“Condition” Requires No Construction ...................................................12
`
`Apotex’s Construction Should Apply If the Court Opts to Construe
`“Condition”..............................................................................................13
`
`Plaintiffs Improperly Imports Limitations Into the Claims .....................15
`
`V.
`
`CONCLUSION................................................................................................................17
`
`i
`
`

`
`Case 1:14-cv-01453-LPS Document 46 Filed 11/23/15 Page 3 of 20 PageID #: 1561
`
`TABLE OF AUTHORITIES
`
`Page(s)
`
`CASES
`Advanced Cardiovascular Sys., Inc. v. Medtronic, Inc.,
`265 F.3d 1294 (Fed. Cir. 2001)..........................................................................................8
`
`Bayer Pharma AG v. Watson Labs., Inc.,
`C.A. No. 12-1726-LPS, 2014 WL 4954617 (D. Del. Sept. 30, 2014)............................5-6
`
`Bristol-Myers Squibb Co. v. Mylan Pharms. Inc.,
`C.A. No. 09-651-LPS, 2012 WL 1753670 (D. Del. May 16, 2012)..............................5, 6
`
`HarrisCorp. v. IXYS Corp.,
`114 F.3d 1149 (Fed. Cir. 1997)........................................................................................13
`
`Hastings v. United States,
`78 Fed. Cl. 729 (Fed. Cl. 2007) .......................................................................................13
`
`Interactive Gift Exp., Inc. v. Compuserve Inc.,
`256 F.3d 1323 (Fed. Cir. 2001)..........................................................................................6
`
`Markman v. Westview Instruments, Inc.,
`517 U.S. 370 (1996).......................................................................................................5, 6
`
`Nystrom v. Trex Co., Inc.,
`424 F.3d 1136 (Fed. Cir. 2005)........................................................................................12
`
`Phillips v. AWH Corp.,
`415 F.3d 1303 (Fed. Cir. 2005)......................................................................................5, 6
`
`Rosco, Inc. v. Velvac Inc.,
`C.A. No. 11-117-LPS, 2012 WL 6028239 (D. Del. Dec. 4, 2012)..................................12
`
`SmithKline Beecham Corp. v. Apotex Corp.,
`403 F.3d 1331 (Fed. Cir. 2005)..........................................................................................5
`
`V–Formation, Inc. v. Benetton Grp. SpA,
`401 F.3d 1307 (Fed. Cir. 2005)..........................................................................................6
`
`Vitrionics, Corp. v. Conceptronic, Inc.,
`90 F.3d 1576 (Fed. Cir. 1996)............................................................................................5
`
`ii
`
`

`
`Case 1:14-cv-01453-LPS Document 46 Filed 11/23/15 Page 4 of 20 PageID #: 1562
`
`I.
`
`INTRODUCTION
`
`Pursuant to the Scheduling Order entered by the Court on April 13, 2015 (D.I. 18),
`
`Defendants Apotex Inc. and Apotex Corp. (“Apotex”) submit this claim construction brief to
`
`address the proper construction of the disputed terms of the patents-in-suit. There are only two
`
`claim terms in dispute – “administration” and “condition.”
`
`Apotex’s construction of the term “administration” is “to administer simultaneously,
`
`either in the same or different pharmaceutical formulations, or separately or sequentially.” This
`
`definition comes directly out of the specifications of both of the patents-in-suit. Indeed, the
`
`patentees use this construction to describe how the alleged invention is to be administered
`
`throughout the specifications and prosecution histories of each of the patents. Because the
`
`patentees acted as their own lexicographers by explicitly providing a description of how the
`
`invention is to be administered, “administration” requires construction. Moreover, Apotex’s
`
`construction is also consistent with how many additional third party references contained in the
`
`prosecution histories of both patents use the term administration to describe the administration of
`
`similar combination treatments.
`
`Plaintiffs, however, propose no construction for this term or alternatively that
`
`“administration” means “application.” Neither of Plaintiffs’ proposals provide any definition or
`
`explanation of the term, nor do they allow for the unambiguous description of “administration”
`
`given by the patentees in the specifications of the patents-in-suit. Instead, Plaintiffs’
`
`construction constitutes an improper circular description of the claim term and finds no adequate
`
`support in the intrinsic evidence.
`
`Unlike the term “administration”, the term “condition” does not need to be construed.
`
`The plain language of the claims themselves separately identify what conditions are at issue by
`
`

`
`Case 1:14-cv-01453-LPS Document 46 Filed 11/23/15 Page 5 of 20 PageID #: 1563
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`referencing conditions for which administration of one or more antihistamines and/or one or
`
`more steroids is indicated. The term “condition” also does not require construction because it is
`
`readily understandable. Apotex therefore proposes this claim term should be given its plain and
`
`ordinary meaning. If the Court is inclined to enter a specific claim construction for this term,
`
`Apotex’s proposed alternative construction for the term “condition(s)” of “disease(s) or
`
`illness(es)” is consistent with both the intrinsic and extrinsic evidence.
`
`Plaintiffs ask the Court to construe “condition” in an attempt to impermissibly amend the
`
`claims to add in the unsupported limitation of “resulting in or causing allergic reactions.” The
`
`plain fact is that the claims themselves specify what specific “conditions” are to be treated by
`
`identifying what indications the claims are to be used for. Plaintiffs’ own construction itself does
`
`not define condition, per se, but only improperly narrows the scope of the term to only certain
`
`specific conditions.
`
`For the reasons set forth below, Apotex respectfully requests that the Court enter
`
`Apotex’s proposed constructions and reject Plaintiffs’ proposed constructions.
`
`II.
`
`THE PATENTS-IN-SUIT AND RELEVANT TECHNOLOGY BACKGROUND
`
`This is a Hatch-Waxman case. There are two asserted patents: United States Patent Nos.
`
`8,163,723 (“the ’723 patent”) and 8,168,620 (“the ’620 patent”) (collectively, “the patents-in-
`
`suit”) JCC Ex.1 1 (D.I. 43-1); JCC Ex. 5 (D.I. 43-2).
`
`The asserted patents are related2 and on their face purport to share a common priority
`
`date – June 14, 2002 (the filing date of Great Britain patent application). The ’620 patent claims
`
`1 “JCC Ex. __” refers to the exhibits attached to the Joint Claim Construction Chart filed with
`the Court on October 22, 2015 (D.I. 43).
`
`2
`
`

`
`Case 1:14-cv-01453-LPS Document 46 Filed 11/23/15 Page 6 of 20 PageID #: 1564
`
`drug product formulations for nasal administration. It, generally speaking, is directed to
`
`formulations that are suitable for the administration of two active ingredients: azelastine (an
`
`antihistamine); and fluticasone (a corticosteroid). The ’723 patent claims methods of
`
`administering drug product formulations via intranasal administration. It, generally speaking, is
`
`directed to methods of administration of the same two active ingredients, azelastine and
`
`fluticasone.
`
`Antihistamines as a class of compounds have long been used to help with a variety of
`
`conditions such as allergic rhinitis, asthma, urticaria, atopic dermatitis, and serum sickness and
`
`have also been used for motion sickness, Meniere’s Disease, nausea and vomiting due to
`
`pregnancy, ulcerative stomatitis, bee stings, and snake bites. See, e.g., Ex.3 A (Sherman, W. B.,
`
`The Uses and Abuses of Antihistamine Drugs, pp. 315, 321-22 (1951)). As described in the
`
`specification, the antihistamine at issue in the asserted claims – azelastine (including salt forms
`
`of azelastine) – was known in the prior art and used to treat a number of conditions, including
`
`allergy-related conditions. ’723 patent col. 1 ln. 29-34,’620 patent col. 1 ln. 20-25.
`
`Administration of azelastine was known to be accomplished via nasal sprays and eye drops. Id.
`
`Azelastine was also known to have a rapid onset of action starting to work within fifteen
`
`minutes. See, Ex. B (Horak, Friedrich; et al. (2009) “Azelastine nasal spray for the treatment of
`
`allergic and nonallergic rhinitis” Expert Review of Clinical Immunology 5 (6): 660-662).
`
`(...continued from previous page)
`2 The ’620 patent issued from U.S. Ser. No. 10/518,016 (“the ’016 application”), filed July
`6, 2005 which is a national phase filing of App. No. PCT/GB03/02557, filed June 13, 2003
`which claims priority to UK Patent App. No. GB 0213739.6, filed June 14, 2002. The ’723
`patent issued from U.S. Ser. No. 12/879,515 (“the ’515 application”), filed September 10, 2010
`as a divisional of the ’016 application.
`
`3 “Ex. __” refers to exhibits attached to the Declaration of Robert Delafield in support of this
`brief and filed concurrently herewith.
`
`3
`
`

`
`Case 1:14-cv-01453-LPS Document 46 Filed 11/23/15 Page 7 of 20 PageID #: 1565
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`Azelastine works as a histamine blocker by exhibiting histamine H1-receptor antagonist activity.
`
`See, Ex. C, Label for Astelin® Nasal Spray, APOTEX_AZFL0059491. After azelastine is
`
`metabolized in the body, the major metabolite desmethylazelastine also possesses H1-receptor
`
`antagonist activity. Id. In 1996, Plaintiffs marketed an azelastine nasal spray under the trade
`
`name Astelin®. Id. at APOTEX_AZFL0059484.
`
`Steroids have also long been known to help with a variety of conditions such as
`
`Addison’s Disease, rheumatoid arthritis and many inflammatory diseases of the skin, allergy,
`
`asthma and certain systematic diseases such as disseminated lupus and erythematosus. See, e.g.,
`
`Ex. D (Di Cyan, E., “Steroid Hormones and Other Steroidal Synthetics,” CRC Handbook of
`
`Chemistry and Physics, 68th Ed., pp. C-682-98, 1987). As described in the specification,
`
`fluticasone is the corticosteroid at issue in the asserted claims and was also known for many
`
`years in the prior art to treat a number of conditions, including the suppression of nasal and
`
`ocular inflammatory conditions such as allergy-related conditions. ’723 patent col. 1 ln. 35-42,
`
`’620 patent col. 1 ln. 26-33. Fluticasone provides anti-inflammatory activity and its
`
`effectiveness depends on its regular use as it has a variable time to onset for different patients.
`
`See Ex. G, Label for Flonase® Nasal Spray, APOTEX_AZFL0130286 and 0130292-293. Thus,
`
`Flonase® takes slightly longer to take effect than azelastine. Administration of fluticasone was
`
`also known to be accomplished via nasal sprays. Id. In 1994, the FDA approved a fluticasone
`
`nasal spray under the trade name Flonase. Id at APOTEX_AZFL0130284.
`
`The claimed inventions, generally speaking, purport to combine two known active
`
`ingredients for the treatment of conditions that each active ingredient individually was already
`
`known to treat. The specifications of each of the asserted patents identifies a number of ways to
`
`accomplish nasal administration including nasal sprays, nasal drops, and insufflation powders.
`
`4
`
`

`
`Case 1:14-cv-01453-LPS Document 46 Filed 11/23/15 Page 8 of 20 PageID #: 1566
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`’723 patent col. 2 ln. 16 – 18; ’620 patent col 2 ln. 15 – 17 (same). The specifications also
`
`clarify that “the respective therapeutic agents of the combined preparation can be administered
`
`simultaneously, either in the same of different pharmaceutical formulations, or separately or
`
`sequentially.” ’723 patent col. 4 ln. 61 – col. 5 ln. 4.; ’620 patent col 4 ln. 61 – col. 5 ln. 4
`
`(same).
`
`III.
`
`LEGAL STANDARD
`
`The claims of a patent define the scope of the invention. Markman v. Westview
`
`Instruments, Inc., 517 U.S. 370, 373 (1996). The interpretation of claim language is a question
`
`of law for the court to decide. Id. at 391. Claims are to be interpreted in view of the intrinsic
`
`evidence, which includes the claim language, the specification, and the prosecution history. See
`
`Phillips v. AWH Corp., 415 F.3d 1303, 1312-17 (Fed. Cir. 2005) (en banc). The specification is
`
`usually “dispositive; it is the single best guide to the meaning of a disputed term.” Id. at 1315
`
`(citation omitted). Claim terms “are generally given their ordinary and customary meaning
`
`which is the meaning that term would have to a person of ordinary skill in the art in question at
`
`the time of the invention.” Bristol-Myers Squibb Co. v. Mylan Pharms. Inc., C.A. No. 09-651-
`
`LPS, 2012 WL 1753670, at *1 (D. Del. May 16, 2012) (quoting Phillips v. AWH Corp., 415 F.3d
`
`1303, 1312-13 (Fed. Cir. 2005) (internal quotations omitted).
`
`The intrinsic evidence—the patent itself, including the claims and the specification, as
`
`well as the prosecution history—“is the most significant source of the legally operative meaning
`
`of disputed claim language.” SmithKline Beecham Corp. v. Apotex Corp., 403 F.3d 1331, 1338
`
`(Fed. Cir. 2005) (quoting Vitrionics, Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir.
`
`1996). “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
`
`5
`
`

`
`Case 1:14-cv-01453-LPS Document 46 Filed 11/23/15 Page 9 of 20 PageID #: 1567
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`claim construction.” Bayer Pharma AG v. Watson Labs., Inc., C.A. No. 12-1726-LPS, 2014 WL
`
`4954617, at *9 (D. Del. Sept. 30, 2014) quoting V–Formation, Inc. v. Benetton Grp. SpA, 401
`
`F.3d 1307, 1311 (Fed. Cir. 2005) (internal quotation marks and citations omitted).
`
`Where useful, the Court “also may rely on extrinsic evidence, which consists of all
`
`evidence external to the patent and prosecution history, including expert and inventor testimony,
`
`dictionaries, and learned treatises.” BMS, 2012 WL 1753670, at *2 (quoting Markman, 52 F.3d
`
`at 980) (internal quotations omitted); Phillips v. AWH Corp., 415 F.3d 1303, 1317 (Fed. Cir.
`
`2005) (citations omitted). “Extrinsic evidence may always be consulted, however, to assist in
`
`understanding the underlying technology.” Interactive Gift Exp., Inc. v. Compuserve Inc., 256
`
`F.3d 1323, 1332 (Fed. Cir. 2001).
`
`IV.
`
`ARGUMENT
`
`A.
`
`“Administration”
`
`Plaintiffs’ Proposed Construction
`
`Apotex’s Proposed Construction
`
`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.”
`
`“to administer simultaneously, either in
`the same or different pharmaceutical
`formulations, or separately or
`sequentially”
`
`The claim term “administration” should be construed to mean “to administer
`
`simultaneously, either in the same or different pharmaceutical formulations, or separately or
`
`sequentially.” That construction is taken directly from the specification of the patents in suit.
`
`The Patentee Explicitly Stated that the Purported Invention Can Be
`1.
`“Administered Simultaneously, Either in the Same or Different
`Pharmaceutical Formulations, or Separately or Sequentially”
`
`6
`
`

`
`Case 1:14-cv-01453-LPS Document 46 Filed 11/23/15 Page 10 of 20 PageID #: 1568
`
`The intrinsic evidence shows unambiguously that the patentees acted as their own
`
`lexicographers for the term “administration” by specifically describing different ways to
`
`accomplish administration in accordance with the invention. The term “administration” means
`
`administer “simultaneously, either in the same or different pharmaceutical formulations, or
`
`separately or sequentially.” Because the patentee provided their own definition throughout the
`
`prosecution history and specification, the term “administration” needs to be construed and not
`
`simply given its plain and ordinary meaning as Plaintiffs propose. The specification makes clear
`
`that the purported invention can be administered in a variety of ways. The following excerpt is
`
`from the section of the specification entitled “Detailed Description of the Invention”:
`
`It will also be appreciated from the above, that the respective therapeutic agents
`of the combined preparation can be administered simultaneously, either in
`the same or different pharmaceutical formulations, or separately or
`sequentially. If there is separate or sequential administration, it will also be
`appreciated that the subsequently administered therapeutic agents should be
`administered to a patient within a time scale so as to achieve, or more particularly
`optimise, the above referred to advantageous synergistic therapeutic effect of a
`combined preparation as present in a pharmaceutical product according to the
`present invention.
`
`’723 patent col. 4 ln. 61 – col. 5 ln. 4.; ’620 patent col 4 ln. 61 – col. 5 ln. 4 (same).
`
`The specification is replete with reiterations of that same description of the purported
`
`invention. The following excerpts are also from the section of the specification entitled
`
`“Detailed Description of the Invention”:
`
`
`
`“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 col. 6 ln. 46-54; ’620 patent col. 6 ln. 46-54 (same)
`
`
`
`“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
`
`7
`
`

`
`Case 1:14-cv-01453-LPS Document 46 Filed 11/23/15 Page 11 of 20 PageID #: 1569
`
`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 hereinfore described, as a combined preparation for simultaneous,
`separate or sequential use in the treatment of such conditions.” ’723 patent col 7 ln. 19-
`27; ’620 patent col. 7 ln. 19-27 (same).
`
`The prosecution history of both patents is consistent with the specifications in that the
`
`patentees made clear that administration can be accomplished in a variety of ways. In the U.S.
`
`patent application to which both patents claim priority -- U.S. Patent Application No. 10/518,016
`
`filed as PCT No. PCT/GB03/02557 (WO 03/105856) (“the ’016 application”) -- the patentee
`
`stated “the respective therapeutic agents of the combined preparation can be administered
`
`simultaneously, either in the same or different pharmaceutical formulations, or separately or
`
`sequentially.” Id. at pp. 1-2, 5-6; see also pp. 7-10; JCC Ex. 6, D.I. 43-3 (MED_DYM_0000020-
`
`43). Similarly, in the original application of the ‘723 patent, which is a division of the ‘016
`
`applications, the same language appears. U.S. Patent Application No. 12/879,515; Original
`
`Application (“the ‘515 application”), pp. 2, 8, 10-13, JCC Ex. 74, D.I. 43-17 (MED_DYM
`
`00009277-9302).
`
`Patentees used the exact same language in foreign counterpart patent applications, which
`
`are part of the intrinsic evidence. See, e.g., EP 1 519 731 B1, pp.1-11, JCC Ex. 31, D.I. 43-12
`
`(MED_DYM_00000348-358); EP 2 072 051 A1, pp. 1-8, JCC Ex. 32, D.I. 43-12 (MED_DYM_
`
`00000362-369). Advanced Cardiovascular Sys., Inc. v. Medtronic, Inc., 265 F.3d 1294, 1305
`
`(Fed. Cir. 2001) (“The prosecution history of a related patent can be relevant if, for example, it
`
`addresses a limitation in common with the patent in suit.”).
`
`With reference to the claim language, any of those administration techniques fall within
`
`the scope of “administration” as that term is used in the claims. Specifically, the ’723 patent
`
`consists entirely of method claims, and each of the claimed methods requires the step of
`
`8
`
`

`
`Case 1:14-cv-01453-LPS Document 46 Filed 11/23/15 Page 12 of 20 PageID #: 1570
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`“intranasal administration” of a pharmaceutical composition, and the ‘620 patent claims
`
`pharmaceutical formulations that are “suitable for nasal administration.” In accordance with the
`
`intrinsic record, “intranasal administration” and “nasal administration” can be accomplished
`
`simultaneously, either in the same or different pharmaceutical formulations, or separately or
`
`sequentially.
`
`2.
`
`Other Intrinsic Evidence Supports Apotex’s Construction of
`“Administration”
`
`In addition to the patentees’ own description of administration, many other patent
`
`applications and publications invented by others in the field of nasally administered
`
`pharmaceutical products that were referenced in the prosecution histories of the asserted patents
`
`also refer to administration in a consistent way. Specifically, these other intrinsic references
`
`about similar combination products also refer to administration as encompassing not only the
`
`simultaneous use of the combination in the same product, but also separate or sequential use in
`
`different pharmaceutical formulations. Thus, it was common in the field of nasally administered
`
`pharmaceutical formulations to recognize that “administration” includes more than one possible
`
`way for the two drug substances to be used together. For example, each of the following
`
`references cited during prosecution of the patents-in-suit specifically refer to administration as
`
`follows: “The individual compounds of such combinations may be administered either
`
`sequentially or simultaneously in separate or combined pharmaceutical formulations.”
`
`WO/2002/076933, p. 21, JCC Ex. 49, D.I. 43-15 (MED_DYM_00004438), WO/2002/012266, p.
`
`17, JCC Ex. 59, D.I. 43-16 (MED_DYM_00006215) and WO/2002/100879, p. 17, JCC Ex. 71,
`
`D.I. 43-17 (MED_DYM_00008700). Other references cited during prosecution also consistently
`
`specify that “[i]t will be appreciated that the compounds of the combination may be administered
`
`simultaneously, either in the same or different pharmaceutical formulations or sequentially.”
`
`9
`
`

`
`Case 1:14-cv-01453-LPS Document 46 Filed 11/23/15 Page 13 of 20 PageID #: 1571
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`WO/2001/078736, pp. 1-4, JCC Ex. 61, D.I. 43-16 (MED_DYM_00006587-6591),
`
`WO/2001/078741, p. 1, JCC Ex. 65, D.I. 43-16 (MED_DYM_00007776), WO/2001/078745, p
`
`1, JCC Ex. 67, D.I. 43-17 (MED_DYM_00008004), and WO/2001/078739, p. 1, JCC Ex. 66,
`
`D.I. 43-17 (MED_DYM_00007792).
`
`Many other foreign patent applications and publications cited during prosecution of the
`
`asserted patents also specify the use of simultaneous, separate or sequential administration,
`
`which is consistent with the way patentees described administration throughout the
`
`specifications. See, e.g., PCT application PCT/GB02i04602 (WO/2003/033000) (Published
`
`4/24/03), p. 5, JCC Ex. 43, D.I. 43-14 (MED_DYM_00003853) (“It will be appreciated that the
`
`compounds of the salmeterol and fluticasone propionate combination may be administered
`
`simultaneously, either in the same or different pharmaceutical formulations, or sequentially.”);
`
`WO/2003/066656, pp. 14-15, JCC Ex. 45, D.I. 43-14 (MED_DYM_00004224-4225);
`
`WO/2003/042229, p. 9, JCC Ex. 51, D.I. 43-15 (MED_DYM_00004621); and
`
`WO/2002/100879, pp. 17, JCC Ex. 71, D.I. 43-7 (MED_DYM_00008683-8700) (Referring to
`
`aerosol formulations that may be provided, “optionally in combination with another therapeutic
`
`active ingredient. Administration may be once daily or several times daily, for example 2, 3, 4 or
`
`8 times, giving for example 1, 2 or 3 doses each time.”); WO/2003/066033, p. 19, JCC Ex. 52,
`
`D.I. 43-15 (MED_DYM_00004690) and WO/2003/066036, p. 15, JCC Ex. 53, D.I. 43-15
`
`(MED_DYM_00004758) (“The individual compounds of such combinations may be
`
`administered either sequentially in separate pharmaceutical compositions as well as
`
`simultaneously in combined pharmaceutical formulations.”); WO/2004/019955, p. 3, JCC Ex.
`
`54, D.I. 43-15 (MED_DYM_00004833) (“It will be appreciated that the compounds of the
`
`combination may be administered simultaneously, either in the same pharmaceutical formulation
`
`10
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`Case 1:14-cv-01453-LPS Document 46 Filed 11/23/15 Page 14 of 20 PageID #: 1572
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`(hereinafter also referred to as fixed combination) or in different pharmaceutical formulations
`
`(hereinafter also referred to as free combination) or sequentially in any order.”); EP0416951, pp.
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`2-3, JCC Ex. 60, D.I. 43-16 (MED_DYM_00006264-6265) (“Thus according to one aspect of
`
`the invention there are provided pharmaceutical compositions comprising effective amounts of
`
`salmeterol (and/or a pharmaceutically acceptable salt thereof) and fluticasone propionate as
`
`combined preparations for simultaneous, sequential or separate administration of salmeterol and
`
`fluticasone propionate by inhalation in the treatment of respiratory disorders.”); see also
`
`WO/2000/049993, pp. 28, JCC Ex. 73, D.I. 43-17 (MED_DYM_00008890); WO/2002/085296,
`
`pp.17, JCC Ex. 77, D.I. 43-18 (MED_DYM_00011420); WO/1992/014472, pp. 4, JCC Ex. 78,
`
`D.I. 43-18 (MED_DYM_00011727); WO/2003/033000, pp. 5, JCC Ex. 80, D.I. 43-18
`
`(MED_DYM_00012082); and WO/2004/019955, pp. 3, JCC Ex. 82, D.I. 43-18 (MED DYM
`
`00012951); Australian Patent Application AU 2003244799 B2, pp. 5- 10, JCC Ex. 38, D.I. 43-13
`
`(MED_DYM_00002083-088); Proposed Claim Amendment to Korean Patent Application No.
`
`2004-7020819, pp. 4-5, JCC Ex. 41, D.I. 43-14 (MED DYM 00002253-254); WO/2000/066522,
`
`pp. 96, JCC Ex. 58, D.I. 43-16 (MED_DYM_00006008); and U.S. Patent Application
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`Publication No. U.S. 2004/0235807 A1, p. 12, JCC Ex. 76, D.I. 43-18 (MED_DYM_00011186).
`
`As used throughout the prosecution histories by both the patentees and by others, the term
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`administration should be construed as “to administer simultaneously, either in the same or
`
`different pharmaceutical formulations, or separately or sequentially.”
`
`3.
`
`Plaintiffs’ Construction Is Inconsistent With the Intrinsic Evidence
`
`Plaintiffs propose “administration” should be given its plain and ordinary meaning, or
`
`alternatively, be construed as “application.” Neither of Plaintiffs’ alternatives is supported by
`
`the intrinsic record. Nowhere in the specification or prosecution history is “administration”
`
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`

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`Case 1:14-cv-01453-LPS Document 46 Filed 11/23/15 Page 15 of 20 PageID #: 1573
`
`defined as “application.” Further, the construction “application” that Plaintiffs propose does
`
`nothing to explain or define the term “administration.” See, Rosco, Inc. v. Velvac Inc., C.A. No.
`
`11-117-LPS, 2012 WL 6028239, at *8 (D. Del. 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. The patentee,
`
`however, “is not entitled to a claim construction divorced from the context of the written
`
`description and prosecution history.” Nystrom v. Trex Co., Inc., 424 F.3d 1136, 1144-45 (Fed.
`
`Cir. 2005). Thus, Plaintiffs’ proposed construction constitutes an improper redundant
`
`description of the claim term and finds no adequate support in the intrinsic evidence.
`
`B.
`
`“Condition”
`
`Plaintiffs’ Proposed Construction
`
`Apotex’s Proposed Construction
`
`“condition(s) resulting in or causing
`allergic reaction(s)”
`
`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).”
`
`1.
`
`“Condition” Requires No Construction
`
`The claim term “condition” is understood without need for construction, and nothing in
`
`the specification directs or even suggests a construction for the term “condition” beyond its plain
`
`and ordinary meaning. The plain language of the claims themselves provide context for the
`
`“condition” at issue in the claims. Specifically, each claim of the patents-in-suit that uses the
`
`term “condition” further specifies exactly what range of diseases or illnesses are to be treated.
`
`See e.g., Claim 1, the ‘723 patent (“A method for the prophylaxis or treatment in a mammal of a
`
`condition for which administration of one or more antihistamines and/or one or more steroids is
`
`12
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`

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`Case 1:14-cv-01453-LPS Document 46 Filed 11/23/15 Page 16 of 20 PageID #: 1574
`
`indicated...”); see also, the ‘620 patent claims 16 and 24. That language is unambiguous and
`
`clear on its face. No construction is required. Hastings v. United States, 78 Fed. Cl. 729, 733
`
`(Fed. Cl. 2007) (“The Federal Circuit has held that where the claim term’s meaning is apparent
`
`on its face, the court need not venture far from the claim language itself, long admonishing
`
`courts not to make constructions that ‘contribute nothing but meaningless verbiage to the
`
`definition of the claimed invention.’”) (quoting HarrisCorp. v. IXYS Corp., 114 F.3d 1149, 1152
`
`(Fed. Cir. 1997)).
`
`2.
`
`Apotex’s Construction Should Apply If the Court Opts to Construe
`“Condition”
`
`To the extent the Court determines that the term “condition” requires construction, it
`
`should be construed to mean “disease(s)” or “illness(es).” The intrinsic record shows that the
`
`term “condition” is synonymous with “disease(s)” or “illness(es).” For example, “condition” and
`
`“disease” are used synonymously to describe the same thing. See, the ‘723 patent claim 8
`
`(“wherein said condition is allergic rhinitis”); see also Schmidt, M. W., “The new topical steroid
`
`ciclesonide is effective in the treatment of allergic rhinitis,” Journal of Clinical Pharmacology,
`
`1999, vol. 39, pp. 1062-1069, JCC Ex. 36, D.I. 43-13 (MED_DYM_00000726-733 at 726)
`
`(“Allergic rhinitis is a common disease...”); Nielsen, et al., “Intranasal corticosteroids for allergic
`
`rhinitis: superior relief?” Drugs, 2001, vol. 61, No. 11, pp. 1563-1573, JCC Ex. 56, D.I. 43-16
`
`(MED_DYM_00005344-5354 at 5345) (“Allergic rhinitis is a common condition...Although
`
`allergic rhinitis is not a life-threatening disease, it can severely impact on quality of life...”);
`
`Galant, S., et al., “Clinical Prescribing of Allergic Rhinitis Medication in the Preschool and
`
`Young School-Age Child, What are the Options?,” BioDrugs2001, vol. 15, No. 7, pp. 453-46