Case 1:14-cv-01453-LPS Document 96 Filed 04/01/16 Page 1 of 12 PageID #: 2053
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
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`C.A. No. 14-1453-LPS
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`MEDA PHARMACEUTICALS INC. and
`CIPLA LTD.,
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`Plaintiffs,
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`v.
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`APOTEX INC. and APOTEX CORP.,
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`Defendants.
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`PLAINTIFFS MEDA AND CIPLA’S SUPPLEMENTAL
`CLAIM CONSTRUCTION BRIEF
`
`Steven J. Balick (#2114)
`John G. Day (#2403)
`Andrew C. Mayo (#5207)
`ASHBY & GEDDES
`500 Delaware Ave., 8th Floor
`P.O. Box 1150
`Wilmington, DE 19899
`(302) 654-1888
`sbalick@ashby-geddes.com
`jday@ashby-geddes.com
`amayo@ashby-geddes.com
`
`Attorneys for Plaintiffs Meda Pharmaceuticals
`Inc. and Cipla Ltd.
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`Of Counsel:
`
`Dennies Varughese
`Uma N. Everett
`Rami Bardenstein
`Dallin G. Glenn
`Josephine J. Kim
`Joshua I. Miller
`STERNE, KESSLER, GOLDSTEIN & FOX
`PLLC
`1100 New York Ave., N.W., Suite 800
`Washington, DC 20005-3934
`(202) 371-2600
`
`Dated: April 1, 2016
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`{01103663;v1 }
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`Case 1:14-cv-01453-LPS Document 96 Filed 04/01/16 Page 2 of 12 PageID #: 2054
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`I.
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`II.
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`TABLE OF CONTENTS
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`INTRODUCTION .............................................................................................................. 1
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`THE COURT SHOULD ADOPT PLAINTIFFS’ CONSTRUCTION OF
`“ADMINISTRATION” FOR ALL THREE PATENTS-IN-SUIT ..................................... 2
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`A.
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`B.
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`The claims of the ’428 patent include both azelastine and fluticasone as active
`ingredients in a single formulation ......................................................................... 3
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`The claims of the ’428 patent and the prosecution history of the ’620 patent
`support Plaintiffs’ construction ............................................................................... 4
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`C.
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`The claims of the ’428 patent prove that Apotex’s construction is wrong ............. 5
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`1.
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`2.
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`Apotex’s construction ignores the explicit language in the ’428 patent’s
`claims .......................................................................................................... 5
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`The ’428 patent claims show that Apotex misplaces its reliance on the
`specifications’ description of embodiments................................................ 7
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`D.
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`Plaintiffs’ construction for “administration” also applies to the ’723 and ’620
`patents ..................................................................................................................... 8
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`III.
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`CONCLUSION ................................................................................................................... 8
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`Case 1:14-cv-01453-LPS Document 96 Filed 04/01/16 Page 3 of 12 PageID #: 2055
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`
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`Cases
`
`TABLE OF AUTHORITIES
`
`ACTV, Inc. v. Walt Disney Co.,
`346 F.3d 1082 (Fed. Cir. 2003)..................................................................................................6
`
`Acumed LLC v. Stryker Corp.,
`483 F.3d 800 (Fed. Cir. 2007)....................................................................................................7
`
`In re Katz Interactive Call Processing Patent Litig.,
`639 F.3d 1303 (Fed. Cir. 2011)..................................................................................................8
`
`In re Paulsen,
`30 F.3d 1475 (Fed. Cir. 1994)....................................................................................................8
`
`Laryngeal Mask Co. Ltd. v. Ambu,
`618 F.3d 1367 (Fed. Cir. 2010)..................................................................................................6
`
`Liebel-Flarsheim Co. v. Medrad, Inc.,
`358 F.3d 898 (Fed. Cir. 2004)....................................................................................................7
`
`NTP, Inc. v. Research in Motion, Ltd.,
`418 F.3d 1282 (Fed. Cir. 2005)..................................................................................................2
`
`Phillips v. AWH Corp.,
`415 F.3d 1303 (Fed. Cir. 2005)..............................................................................................3, 6
`
`SightSound Techs., LLC v. Apple Inc.,
`809 F.3d 1307 (Fed. Cir. 2015)..............................................................................................2, 8
`
`Source Vagabond Sys. Ltd. v. Hydrapak, Inc.,
`753 F.3d 1291 (Fed. Cir. 2014)..................................................................................................2
`
`
`
`
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`Case 1:14-cv-01453-LPS Document 96 Filed 04/01/16 Page 4 of 12 PageID #: 2056
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`I.
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`INTRODUCTION
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`The parties previously submitted claim construction briefs regarding U.S. Patent Nos.
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`8,163,723 and 8,168,620, two of the patents-in-suit, and the Court has set a Markman Hearing
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`for April 29, 2016. Plaintiffs’ Opening and Responsive briefs argued, among other things, that
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`the Court should adopt the plain and ordinary meaning for the term “administration”—as
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`meaning “application” or “to apply” a single formulation with two active ingredients— based on
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`the intrinsic record of both the ’620 and ’723 patents. Defendant Apotex disagreed, arguing that
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`the term “administration” means “to administer simultaneously, either in the same or different
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`pharmaceutical formulations, or separately or sequentially.” (D.I. 43, Exh. A at 9.) But Apotex’s
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`argument ran counter to the intrinsic evidence. With the recent addition of U.S. Patent No.
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`9,259,428 (the “’428 patent”) to this action,1 the Court invited supplemental claim construction
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`briefing on new terms or claim construction issues arising from the issuance of the ’428 patent.
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`(D.I. 82.)
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`In this brief, Plaintiffs address a single new claim construction issue: the ’428 patent’s
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`claims support Plaintiffs’ previously asserted construction of the term “administration” while at
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`the same time controverting Apotex’s tortured construction of this simple word. The Court
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`should adopt Plaintiffs’ construction of “administration” and apply that construction to all three
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`patents-in-suit. First, each claim of the ’428 patent recites the disputed term, and each claim
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`further specifically recites a single formulation that includes both azelastine and fluticasone (the
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`“active ingredients”). Second, the claims of the ’428 patent support the prosecution history
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`1 The ’428 patent was added to this action (D.I. 90) because it issued from the same parent
`application and is in the same family as the two patents asserted in the original Complaint, the
`’723 patent and the ’620 patent. All three patents share a largely identical specification, and a
`copy of the ‘428 patent is attached hereto as Exhibit A.
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`Case 1:14-cv-01453-LPS Document 96 Filed 04/01/16 Page 5 of 12 PageID #: 2057
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`arguments that Plaintiffs raised in their opening brief. Third, the claims of the ’428 patent refute
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`both Apotex’s proposed construction itself and Apotex’s reliance on embodiments disclosed in
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`the specification. Fourth, the Court should adopt Plaintiffs’ construction for “administration”
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`across the patents-in-suit because of the significant overlap in the intrinsic record for each patent.
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`II.
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`THE COURT SHOULD ADOPT PLAINTIFFS’ CONSTRUCTION FOR
`“ADMINISTRATION” FOR ALL THREE PATENTS-IN-SUIT
`
`The well-settled principles of claim construction support Plaintiffs’ construction. Claim
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`construction begins with the language of the claims. See Source Vagabond Sys. Ltd. v. Hydrapak,
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`Inc., 753 F.3d 1291, 1299 (Fed. Cir. 2014). Equally well-settled, where different patents “derive
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`from the same parent application and share many common terms, [courts] must interpret the
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`claims consistently across all asserted patents.” SightSound Techs., LLC v. Apple Inc., 809 F.3d
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`1307, 1316 (Fed. Cir. 2015) (quoting NTP, Inc. v. Research in Motion, Ltd., 418 F.3d 1282, 1293
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`(Fed. Cir. 2005)) (emphasis added). In their earlier briefs, when the case only involved the ’723
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`and the ’620 patents, Plaintiffs established that the intrinsic evidence of each patent supported
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`Plaintiffs’ construction. Further, while Apotex argued that the patentees acted as their own
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`lexicographers, Plaintiffs explained that the patentees neither acted as lexicographers nor did
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`they give the term “administration” any special meaning. Here, the ’428 patent’s claims further
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`confirm the correctness of Plaintiffs’ earlier plain-meaning construction of “administration”
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`based on the intrinsic record of the ’620 and ’723 patents: “application” of, or “to apply,” a
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`single formulation.
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`The claims of the ’428 patent explicitly recite that the two active ingredients are
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`contained in one formulation, conclusively demonstrating that Plaintiffs’ proposed construction
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`is the correct construction. As further evidence that Plaintiffs’ construction is correct, the claims
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`of the ’428 patent comport with the amendments to the claims that the inventors made during
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`Case 1:14-cv-01453-LPS Document 96 Filed 04/01/16 Page 6 of 12 PageID #: 2058
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`prosecution of the ’620 patent. These claims also show that the patentees did not redefine
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`“administration” in the specification, as Apotex contends, but that they instead disclaimed
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`disclosed embodiments.
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`A.
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`The claims of the ’428 patent include both azelastine and fluticasone as active
`ingredients in a single formulation
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`Each claim of the ’428 patent is directed to a single formulation that contains, among
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`other things, specific amounts of both azelastine hydrochloride and fluticasone propionate as
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`dual active ingredients. Every claim includes the term “administration,” and each claim further
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`requires a single formulation. The explicit claim language, present in every claim, should guide
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`the Court’s claim construction analysis. See Phillips v. AWH Corp., 415 F.3d 1303, 1314 (Fed.
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`Cir. 2005) (“Other claims of the patent in question, both asserted and unasserted, can also be
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`valuable sources of enlightenment as to the meaning of a claim term.”).
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`Claim 1 is representative and reads:
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`A method for the treatment of seasonal allergic rhinitis, comprising
`1.
`administration of a therapeutically effective amount of a nasal spray formulation
`comprising:
`from 0.001% (weight/weight) to 1% (weight/weight) of azelastine
`hydrochloride;
`from 0.0357% (weight/weight) to 1.5% (weight/weight) of fluticasone
`propionate;
`one or more preservatives;
`one or more thickening agents;
`one or more surfactants; and
`one or more isotonization agents.
`
`See ’428 patent, col. 11, ll. 51-61.
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`Claim 1 recites administration of a nasal spray formulation that includes all of the listed
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`ingredients, including both active ingredients. The claim does not recite administration of a first
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`nasal spray formulation comprising azelastine (and other ingredients) followed by the
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`Case 1:14-cv-01453-LPS Document 96 Filed 04/01/16 Page 7 of 12 PageID #: 2059
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`administration of a second nasal spray formulation comprising fluticasone (and other
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`ingredients), as Apotex’s construction suggests.
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`The claims that depend from claim 1 also refer only to a single formulation. Claim 2
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`further recites that the formulation of claim 1 “has a pH of 4.5 to about 6.5.” ’428 patent, col. 11,
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`ll. 62-63. The entire formulation—which includes both active ingredients—has a single pH.
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`Claim 3 further recites the formulation in “an aqueous suspension.” Id. at ll. 64-65. Thus,
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`dependent claim 3 describes only a single formulation in the form of an aqueous suspension.
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`Dependent claims 4, 7, 8, 10 and 11 recite specific percentages of the various ingredients—and
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`again, express each percentage in terms of a weight/weight percentage of a single whole. See id.
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`at col. 11, l. 66-col. 12, l. 3; id. at col. 12, ll. 9-14; id. at ll. 20-45. Dependent claim 12 recites
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`“[t]he method of claim 1, wherein one or more isotonization agents is present in an amount that a
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`reduction in the freezing point from 0.50° C. to 0.56° C. is attained in comparison to pure water.”
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`’428 patent, col. 12, ll. 46-50. This claim describes the effect that one ingredient has on the entire
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`nasal spray formulation. (See Parties’ Stipulated Construction, D.I. 95 at 1.)
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`All of these claims support Plaintiffs’ proposed construction. Each claim uses the term
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`“administration” in its plain and ordinary way: each claim recites the step of administering or
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`applying a single nasal spray formulation that includes both active ingredients. The ’428 patents’
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`claims do not support, indeed they negate, Apotex’s attempt to use “administration” as a means
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`to expand the scope of the invention.
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`B.
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`The claims of the ’428 patent and the prosecution history of the ’620 patent
`support Plaintiffs’ construction
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`Plaintiffs’ opening Markman brief explained that the patentees disclaimed certain claim
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`scope during the prosecution of the ’620 patent that directly refuted Apotex’s proposed
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`construction. (See D.I. 47 at 14-18.) The prosecution history of the ’620 patent shows that the
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`Case 1:14-cv-01453-LPS Document 96 Filed 04/01/16 Page 8 of 12 PageID #: 2060
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`words “separate” or “sequential” appeared in 11 different proposed claims to describe the use of
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`the active ingredients, (see e.g. id. at 16), but those limitations did not survive prosecution and
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`never issued in any claim. In fact, the patentees deliberately amended the claims to remove these
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`peripheral terms. In doing so, the patentees limited the scope of the claims to cover only the heart
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`of their invention: a novel combination of the two active ingredients in a single formulation.
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`The ’428 patent’s claims further confirm and capture the patentees’ view of the heart of
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`this invention as disclosed by the amendments made during prosecution. No claim in the ’428
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`patent contemplates the “separate” or “sequential” administration of the active ingredients. To
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`the contrary, the claims are clear: each claim recites a method wherein a single formulation with
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`both active ingredients is administered (or applied).
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`C.
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`The claims of the ’428 patent prove that Apotex’s construction is wrong
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`Not only do the claims of the ’428 patent support Plaintiffs’ construction, but they
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`undermine both the outcome of, and reasoning behind, Apotex’s construction. As explained
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`above, the claims of the ’428 patent are explicitly directed to single, dual-active ingredient
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`formulations. But Apotex’s construction suggests that in these same claims, the two active
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`ingredients can be split into separate formulations. The reason for Apotex’s error is clear: it
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`improperly relies on embodiments disclosed in the specification.
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`1.
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`Apotex’s construction ignores the explicit language in the ’428
`patent’s claims
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`The claims of the ’428 patent demonstrate that the claimed invention is directed to one
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`nasal spray. Apotex’s proposed construction of “administration” ignores the plain and ordinary
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`meaning of the claim language. Apotex suggests that the azelastine and fluticasone limitations
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`can be separated into different formulations. But that argument ignores the plain language of the
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`claims, which requires that the same formulation contains both active ingredients.
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`Case 1:14-cv-01453-LPS Document 96 Filed 04/01/16 Page 9 of 12 PageID #: 2061
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`Specifically, Apotex contends that “administration” means “to administer [azelastine and
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`fluticasone] simultaneously, either in the same or different pharmaceutical formulations, or
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`separately or sequentially.” (D.I. 43, Exh. A at 9). This construction offers four alternative modes
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`for the administration of the recited azelastine and fluticasone:
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`1. simultaneously, “in the same [] pharmaceutical formulation[]”;
`2. simultaneously, “in [] different pharmaceutical formulations”;
`3. “separately”; or
`4. “sequentially.”
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`Three of Apotex’s alternatives require the two APIs to be administered in different
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`formulations. These options do not accord with the explicit claim language. While the file history
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`of the ’620 patent shows that the inventors initially may have included two of these alternatives
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`(“separately” and “sequentially”) in the proposed claim language, the inventors eventually
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`removed this language from all of the issued claims of the ’620 patent. (See D.I. 47 at 14-18.)
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`Apotex’s proposed construction improperly ignores the actual words of the claim and,
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`therefore, is not correct. The “words of a claim are generally given their ordinary and customary
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`meaning.” Laryngeal Mask Co. Ltd. v. Ambu, 618 F.3d 1367, 1370 (Fed. Cir. 2010). “[T]he
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`claims themselves provide substantial guidance as to the meaning of particular claim terms.”
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`Phillips, 415 F.3d at 1314; see also ACTV, Inc. v. Walt Disney Co., 346 F.3d 1082, 1088 (Fed.
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`Cir. 2003) (“the context of the surrounding words of the claim also must be considered in
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`determining the ordinary and customary meaning of those terms”). Here, Apotex ignores the
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`plain, unambiguous language of the claims of the ’428 patent that require both active ingredients
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`to be present in the same formulation, not different formulations.
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`Case 1:14-cv-01453-LPS Document 96 Filed 04/01/16 Page 10 of 12 PageID #: 2062
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`2.
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`The ’428 patent claims show that Apotex misplaces its reliance on the
`specifications’ description of embodiments
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`In its opening brief on the ’620 and ’723 patents, Apotex relied almost exclusively on the
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`common specification of the patents-in-suit to support its construction.2 Apotex seems to suggest
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`that the patentees somehow “redefined” the term “administration” via their description of certain
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`embodiments in the specification of those patents. Plaintiffs demonstrated in their Opening and
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`Responsive briefs the fatal flaws in Apotex’s reasoning. Those flaws are further apparent in light
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`of the ’428 patent.
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`The ’428 patent shares a common specification with the ’620 and ’723 patents. Like
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`those two patents, the ’428 patent’s specification discloses the embodiments upon which
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`Apotex’s construction relies. Despite the statements that Apotex points to as lexicography, the
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`patentees used the term “administration” in its plain and ordinary manner in the claims of the
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`’428 patent. Had the patentees actually redefined “administration” in the manner proposed by
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`Apotex, they would not have used that term in claims explicitly directed to a single, dual-
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`ingredient formulation.
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`This unworkable result is rooted in Apotex’s improper reliance on embodiments, and not
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`actual definitions in the specification. See Liebel-Flarsheim Co. v. Medrad, Inc., 358 F.3d 898,
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`913 (Fed. Cir. 2004) (“it is improper to read limitations from a preferred embodiment … into the
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`claims absent a clear indication in the intrinsic record that the patentee intended the claims to be
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`so limited.”). As Plaintiffs have already explained, lexicography requires “clarity, deliberateness,
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`
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`2 Apotex also relied upon prior art references included in the prosecution history. Plaintiffs have
`already explained that these references are irrelevant here because they are entitled to less weight
`than the patentees’ own statements. (See D.I. 47 at 8, n.5 (citing Acumed LLC v. Stryker Corp.,
`483 F.3d 800, 809 (Fed. Cir. 2007)).)
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`Case 1:14-cv-01453-LPS Document 96 Filed 04/01/16 Page 11 of 12 PageID #: 2063
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`and precision,” and, if done, must “set out [any] uncommon definition in some manner within the
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`patent disclosure so as to give one or ordinary skill in the art notice of the change” in meaning.
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`(D.I. 61 at 8 (quoting In re Paulsen, 30 F.3d 1475, 1480 (Fed. Cir. 1994)).) The patentees did not
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`set out any “uncommon definition”; rather they used the term “administration” in its ordinary
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`way. As shown by the claims of the ’428 patent, the passages in the specification that Apotex
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`relies upon describe disclaimed embodiments; they do not redefine the term “administration.”
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`D.
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`Plaintiffs’ construction for “administration” also applies to the ’723 and ’620
`patents
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`Plaintiffs’ opening and responsive briefs explain in detail how the intrinsic evidence of
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`the ’723 and ’620 patents fully support Plaintiffs’ construction and refute Apotex’s. The claims
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`of the ’428 patent provide additional corroboration for Plaintiffs’ analysis of the intrinsic
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`evidence for the ’723 and ’620 patents.
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`The term “administration” should be construed consistently across the patents-in-suit:
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`where different patents “derive from the same parent application and share many common terms,
`
`[courts] must interpret the claims consistently across all asserted patents.” SightSound Techs.,
`
`809 F.3d at 1316 (internal quotations and citations omitted); see also In re Katz Interactive Call
`
`Processing Patent Litig., 639 F.3d 1303, 1325 (Fed. Cir. 2011) (courts “ordinarily interpret
`
`claims consistently across patents having the same specification.”). Here, each of the patents-in-
`
`suit claims priority to the same application, U.S. Application No. 10/518,016, and share a largely
`
`identical specification. See ’620 patent; ’723 patent, col. 1, ll. 7-15; ’428 patent, col. 1, ll. 18-20.
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`III. CONCLUSION
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`Plaintiffs have shown that their proposed construction of “administration”—
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`“application” or “to apply”—is correct. And the claimed inventions are directed to a single
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`formulation that simultaneously administers azelastine and fluticasone. The claim language of
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`Case 1:14-cv-01453-LPS Document 96 Filed 04/01/16 Page 12 of 12 PageID #: 2064
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`the ’428 patent supports that construction as does the intrinsic evidence that Plaintiffs previously
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`presented in their earlier claim construction briefs. Plaintiffs respectfully request that the Court
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`adopt Plaintiffs’ proposed construction for the term “administration” and reject Apotex’s
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`
`
`ASHBY & GEDDES
`
`/s/ Andrew C. Mayo
`
`
`Steven J. Balick (#2114)
`John G. Day (#2403)
`Andrew C. Mayo (#5207)
`500 Delaware Ave., 8th Floor
`P.O. Box 1150
`Wilmington, DE 19899
`(302) 654-1888
`sbalick@ashby-geddes.com
`jday@ashby-geddes.com
`amayo@ashby-geddes.com
`
`Attorneys for Plaintiffs Meda Pharmaceuticals Inc.
`and Cipla Ltd.
`
`
`proposed construction.
`
`
`
`
`
`Of Counsel:
`
`Dennies Varughese
`Uma N. Everett
`Rami Bardenstein
`Dallin G. Glenn
`Josephine J. Kim
`Joshua I. Miller
`STERNE, KESSLER, GOLDSTEIN & FOX
`PLLC
`1100 New York Ave., N.W., Suite 800
`Washington, DC 20005-3934
`(202) 371-2600
`
`Dated: April 1, 2016
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