Case 1:14-cv-01453-LPS Document 61 Filed 12/23/15 Page 1 of 15 PageID #: 1803
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
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`MEDA PHARMACEUTICALS INC. and
`CIPLA LTD.,
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`C.A. No. 14-1453-LPS
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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 RESPONSIVE
`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
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`Attorneys for Plaintiffs
`Meda Pharmaceuticals Inc. and Cipla Ltd.
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`Of Counsel:
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`H. Keeto Sabharwal
`Dennies Varughese
`Uma N. Everett
`Rami Bardenstein
`Dallin G. Glenn
`Joshua I. Miller
`Josephine J. Kim
`STERNE, KESSLER, GOLDSTEIN &
` FOX P.L.L.C.
`1100 New York Ave., N.W., Suite 800
`Washington, DC 20005-3934
`(202) 371-2600
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`Dated: December 23, 2015
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`Case 1:14-cv-01453-LPS Document 61 Filed 12/23/15 Page 2 of 15 PageID #: 1804
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`TABLE OF CONTENTS
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`INTRODUCTION .............................................................................................................. 1 
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`ARGUMENT ...................................................................................................................... 2 
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`I. 
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`“[C]ondition(s)” Means “disease(s) or illness(es) resulting in or causing allergic
`reaction(s)” .............................................................................................................. 2 
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`A. 
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`B. 
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`Apotex’s Proposed Construction Disregards the Specification’s
`Description of the Invention ....................................................................... 2 
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`Apotex’s Construction Incorrectly Expands the Scope of the Claims to
`Include Myriad Diseases Outside of the Patent .......................................... 4 
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`II. 
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`“[A]dministration” should be given its plain and ordinary meaning ...................... 6 
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`A. 
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`B. 
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`The Claims of the ’620 and ’723 Patents are Limited to Single
`Formulation for Simultaneous Administration ........................................... 7 
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`The Prosecution History Prohibits Apotex’s Overly Broad Interpretation
`of the Scope of the Claims of the ’620 and ’723 Patents ............................ 9 
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`CONCLUSION ................................................................................................................. 11 
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`Case 1:14-cv-01453-LPS Document 61 Filed 12/23/15 Page 3 of 15 PageID #: 1805
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`TABLE OF AUTHORITIES
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`Cases
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` Page(s)
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`Acumed LLC v. Stryker Corp.,
`483 F.3d 800 (Fed. Cir. 2007)................................................................................................. 10
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`Chimie v. PPG Indus., Inc.,
`402 F.3d 1371 (Fed. Cir. 2005)............................................................................................... 10
`
`In re Paulsen,
`30 F.3d 1475 (Fed. Cir. 1994)................................................................................................... 8
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`Novo Nordisk of N. Am. v. Genentech, Inc.,
`77 F.3d 1364 (Fed. Cir. 1996)................................................................................................... 8
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`Nystrom v. Trex Co., Inc.,
`424 F.3d 1136 (Fed. Cir. 2005)................................................................................................. 3
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`Thorner v. Sony Computer Entm’t Am. LLC,
`669 F.3d 1362 (Fed. Cir. 2012)................................................................................................. 9
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`Trading Techs. Int’l Inc. v. eSpeed, Inc.,
`595 F.3d 1340 (Fed. Cir. 2010)................................................................................................. 9
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`Verizon Servs. Corp. v. Vonage Holdings Corp.,
`503 F.3d 1295 (Fed. Cir. 2007)................................................................................................. 2
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` ii
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`Case 1:14-cv-01453-LPS Document 61 Filed 12/23/15 Page 4 of 15 PageID #: 1806
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`INTRODUCTION
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`In their opening Brief (“Pl. Br.”), Plaintiffs demonstrated that their constructions of
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`condition(s) and administration follow the terms’ plain and ordinary meaning, according to the
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`context of the patents-in-suit, U.S. Patent Nos. 8,163,723 and 8,168,620. Plaintiffs established
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`that “condition(s)” means “disease(s) or illness(es) resulting in or causing allergic reaction(s),”
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`relying on the specification’s consistent description. The main purpose of the patents-in-suit and
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`scope of the invention is to prevent or minimize “[a]llergic reactions.” And for “administration,”
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`Plaintiffs established that the term should be accorded its plain and ordinary meaning, which is
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`“application” or “to apply,” because nothing in the intrinsic record modifies the governing plain
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`and ordinary meaning.
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`Apotex has not refuted Plaintiffs’ positions. Instead, Apotex’s opening brief (“Ap. Br.”)
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`is no more than attorney argument that ignores both the patents’ express teachings and the
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`amendments the patentees made during the prosecution of these patents. Apotex’s construction
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`of “condition(s)” includes many diseases that are unrelated to allergic reactions, such as “motion
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`sickness, ulcerative stomatitis, bee stings, snake bites, rheumatoid arthritis, lupus,” and many
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`more unrelated diseases. (Ap. Br. at 3-4.) These “other” diseases have nothing to do with the
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`patents—or with its teachings pertaining to nasal administration. And Apotex’s construction of
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`“administration” is equally flawed. It seeks to import into the claims limitations (separate and
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`sequential use) that were expressly removed from the scope of the issued claims of the patents-
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`in-suit during prosecution.
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`As mentioned in Plaintiffs’ opening Brief, Apotex’s motive is transparent: under the
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`guise of “claim construction,” Apotex seeks to expand the overall scope of the claimed
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`inventions to bolster their non-infringement and invalidity strategies. But the time for that is at
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`Case 1:14-cv-01453-LPS Document 61 Filed 12/23/15 Page 5 of 15 PageID #: 1807
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`trial, not by advancing unsupported claim constructions for terms that are clear on their face and
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`readily understood.
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`ARGUMENT
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`I.
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`“[C]ondition(s)” means “disease(s) or illness(es) resulting in or causing allergic
`reaction(s)”
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`Term
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`Plaintiffs’ Construction
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`Apotex’s Construction
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`condition(s)
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`disease(s) or illness(es) resulting
`in or causing allergic reaction(s)
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`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).”
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`A.
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`Apotex’s Proposed Construction Disregards the Specification’s Description
`of the Invention
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`Plaintiffs’ opening Brief established, and Apotex has not refuted, that the patents’
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`specification explicitly defines the invention consistent with Plaintiffs’ construction: “the present
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`invention relates to pharmaceutical products and formulations useful for preventing or
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`minimising [sic] allergic reactions.” (Pl. Br. at 9.) And this description is dispositive: “[w]hen a
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`patent thus describes the features of the ‘present invention’ as a whole, this description limits the
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`scope of the invention.” Verizon Servs. Corp. v. Vonage Holdings Corp., 503 F.3d 1295, 1308
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`(Fed. Cir. 2007) (emphasis added). Plaintiffs’ opening Brief confirmed that this description,
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`coupled with the contextual use of “condition(s)” in the claims, limits the scope of the invention
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`to allergic reactions, and does not extend to other diseases or illnesses. (Pl. Br. at 9-11.)
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`Apotex’s interpretation of “condition(s)” noticeably retreats from the specification’s
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`teachings and, indeed, fails to even acknowledge the portions of the specification which recite
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`this present invention. Remarkably, however, Apotex acknowledges “[t]he patentee … ‘is not
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`entitled to a claim construction divorced from the context of the written description and
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`Case 1:14-cv-01453-LPS Document 61 Filed 12/23/15 Page 6 of 15 PageID #: 1808
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`prosecution history’” (Ap. Br. at 12 (quoting Nystrom v. Trex Co., Inc., 424 F.3d 1136, 1144-45
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`(Fed. Cir. 2005)), but then violates this prohibition. Similarly, Apotex attacks Plaintiffs’
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`construction of the other term in dispute (“administration,” discussed below) stating “[p]laintiffs’
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`proposed construction … ignores the clear description of the term throughout the prosecution
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`history and specification.” (Ap. Br. at 12.) Yet, this is precisely what Apotex’s proposed
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`construction of “condition(s)” does—it ignores, indeed disregards, the dispositive intrinsic
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`evidence limiting the diseases to which the invention applies, and not to other random unrelated
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`conditions such as “snake bites,” “rheumatoid arthritis,” and many others that Apotex suggests as
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`discussed in the next section.
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`Apotex’s attempts to undermine Plaintiffs’ construction are unavailing. Apotex argues
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`that Sujeet Rajan—who submitted a declaration on behalf of the patentee during prosecution—
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`stated that the invention includes “management of symptoms of … non-allergic vasomotor
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`rhinitis.” (Ap. Br. at 15 (emphasis added).) Apotex also states that “rhinitis may be caused by
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`allergic, non-allergic, infectious, hormonal, occupational, and other factors.” (Id. at 16.) But each
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`of these conditions are covered by the patents.
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`Indeed, the patents’ specification expressly includes these condition(s) in its definition of
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`allergic reactions. The patent states, “allergic reactions commonly comprise the allergy-
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`related and vasomotor-related symptoms and the rhinovirus-related symptoms.” ’723 patent,
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`1:26-28 (emphases added). Thus, the specification defines “allergic reactions” as a function of
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`common symptoms that would have been familiar to a person of ordinary skill in the art,1
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`whether those symptoms arise from an allergy-related etiology (e.g., allergic rhinitis) or non-
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`1 Plaintiffs note that Apotex’s opening Brief does not include any discussion of
`the relevant level of skill in the art.
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`Case 1:14-cv-01453-LPS Document 61 Filed 12/23/15 Page 7 of 15 PageID #: 1809
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`allergy-related etiology (e.g., vasomotor or rhinovirus infection). Dr. Rajan’s statement explicitly
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`related to symptoms. And Plaintiffs’ construction is wholly consistent with the patents’ teaching:
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`disease(s) or illness(es) resulting in (which would include non-allergic etiology) or causing
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`(allergic etiology) allergic reactions (the symptoms). Asthma—another condition that Apotex
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`asserts is “non-allergic”—may fall under either allergic or non-allergic etiologies, but its
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`symptoms are allergic reactions. (See Ap. Br. at 16 (“inflammatory conditions of the nose, throat,
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`lungs such as asthma (including allergen-induced asthmatic reactions)” (emphasis added).)
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`And, in any event, Apotex has not explained how these closely related condition(s) that
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`result in common allergic reactions (or “symptoms”) justifies Apotex’s attempt to include other
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`entirely different condition(s) into the claims, such as rheumatoid arthritis and lupus.
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`B.
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`Apotex’s Construction Incorrectly Expands the Scope of the Claims to
`Include Myriad Diseases Outside of the Patent
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`The parties appear to agree on the general understanding of the word “condition(s)” as
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`being “disease(s) or illness(es),” as that phrase appears in both Plaintiffs’ and Apotex’s proposed
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`constructions. There’s no dispute, it seems, that “condition(s)” is synonymous with “disease(s).”
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`The real dispute, however, is over which specific diseases or illnesses are properly included
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`within the scope of the claims at issue in this case. As discussed above, Plaintiffs submit that the
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`patented invention relates only to those diseases or illnesses resulting in or causing allergic
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`reactions. Those conditions are what the inventors sought to treat, and they are the only ailments
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`that the inventions are intended to cover.
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`Apotex’s position that the ’620 and ’723 patent claims include various other diseases or
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`illnesses unrelated to those resulting in or causing allergic reactions is belied by the specification
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`and prosecution history. For example, Apotex suggests that bee stings, snake bites, ulcerative
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`stomatitis, rheumatoid arthritis, and lupus (just to name a few) are all diseases or illnesses that
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`Case 1:14-cv-01453-LPS Document 61 Filed 12/23/15 Page 8 of 15 PageID #: 1810
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`fall within the scope of Apotex’s construction of “condition(s).” (Ap. Br. at 3-4.) But treatment
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`of these other diseases or illnesses is not even mentioned, let alone described, by the patents’
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`written description or prosecution history. And Apotex’s own struggle to support and reconcile
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`this unworkable construction is readily apparent in its Brief. For example, at pages 13-14 of its
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`Brief, Apotex provides a page-long list of nearly a dozen third party literature references,
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`purportedly from the “intrinsic record,” to demonstrate that the term condition(s) is synonymous
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`with illness(es) and disease(s), but each one expressly relates to allergic rhinitis as the condition,
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`not any other disease.2
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`Apotex appears to scour the intrinsic record trying to find any evidence to show that the
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`patent covers conditions beside “allergic reactions.” Review of Apotex’s evidence, however,
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`2 Ap. Br. at 13-14 (“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 (‘Allergic rhinitis is a common disease...’); Nielsen, et al., ‘Intranasal
`corticosteroids for allergic rhinitis: superior relief?’ Drugs, 2001, vol. 61, No. 11, pp. 1563-
`1579, JCC Ex. 56, D.I. 43-16 (‘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. 453-463, ADIS
`International Ltd., JCC Ex. 39, D.I. 43-13 (‘Allergic rhinitis (AR) is currently the most common
`of all chronic conditions in children. The disease can be classified as seasonal or perennial,
`depending on when the child appears to have symptoms most predominantly.’) see also, Baena-
`Cagnani, C., ‘Safety and Tolerability of Treatments for Allergic Rhinitis in Children,’ Drug
`Safety 2004, vol. 27, No. 12, pp. 883-898, ADIS Data Information BV, JCC Ex. 40, D.I. 43-13;
`Gawchik, et al., ‘Comparison of intranasal triamcinolone acetonide with oral loratadine in the
`treatment of seasonal ragweed-induced allergic rhinitis,’ Am. J. Man. Care, 1997, vol. 3, No. 7,
`pp. 1052-1058, JCC Ex. 42, D.I. 43-14; Database Medline Online! US National Library of
`Medicine (NLM), Bethesda, MD, US: 2000 Portmann D et al: Acceptability of local treatment of
`allergic rhinitis with a combination of a corticoid (beclomethasone) and an antihistaminic
`(azelastine); vol. 121, No. 4, 2000, pp. 273-279, Abstract. JCC Ex. 29, D.I. 43-11; and Salib
`Rami Jean, et al., ‘Safety and Tolerability Profiles of Intranasal Antihistamines and Intranasal
`Corticosteroids in the Treatment of Allergic Rhinitis,’ Drug Safety 2003, vol. 26, No. 12, pp.
`863-893, ADIS Data Information BV, JCC Ex. 57, D.I. 43-16.”) (internal Bates numbering
`omitted).
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`Case 1:14-cv-01453-LPS Document 61 Filed 12/23/15 Page 9 of 15 PageID #: 1811
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`reveals not only that their argument fails, but also that Apotex’s alleged “support” actually
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`supports Plaintiffs’ position. Apotex says the specification states that steroids “will suppress
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`nasal and ocular inflammatory conditions” which are not necessarily related to “allergic
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`conditions.” (Ap. Br. at 15). However, Apotex was careful to omit the immediately preceding
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`sentence, which confirms that the patents are confined to addressing “allergic reactions”:
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`It is known to use antihistamines in nasal sprays and eye drops to treat allergy-
`related conditions. Thus, for example, it is known to use the antihistamine
`azelastine (usually as the hydrochloride salt) as a nasal spray against seasonal or
`perennial allergic rhinitis, or as eye drops against seasonal and perennial allergic
`conjunctivitis. It is also known to treat these conditions using a corticosteroid,
`which will suppress nasal and ocular inflammatory conditions.
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`’620 patent, 1:20-27 (emphases added).
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`Finally, Apotex’s opening Brief acknowledges, as it must, that “[t]he ’620 patent claims
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`drug product formulations for nasal administration” and “[t]he ’723 patent claims methods of
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`administering drug product formulations via intranasal administration.” (Ap. Br. at 2-3
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`(emphases added).) But then Apotex proceeds to shoehorn various unrelated other diseases into
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`its construction of “condition(s),” none of which have been shown or explained in the patents to
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`be responsive to treatment via nasal administration. This alone warrants rejecting Apotex’s
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`construction.
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`II.
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` “[A]dministration” should be given its plain and ordinary meaning
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`Term
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`Plaintiffs’ Construction
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`Apotex’s Construction
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`To administer simultaneously, either in
`the same or different pharmaceutical
`formulations, or separately or
`sequentially.
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`administration 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.”)
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`Case 1:14-cv-01453-LPS Document 61 Filed 12/23/15 Page 10 of 15 PageID #: 1812
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`A.
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`The Claims of the ’620 and ’723 Patents are Limited to Single Formulation
`for Simultaneous Administration
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`Neither the specification nor the prosecution history suggests departure from the plain
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`and ordinary meaning of the term “administration.” Therefore, it requires no construction. (Pl.
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`Br. at 12-14.) Nowhere in the specification is there any “special” definition for the term
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`“administration,” as Apotex contends; and the patentees did not act as their own lexicographer to
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`redefine this term from its ordinary usage. To the extent that the Court would find it helpful,
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`Plaintiffs submit that the ordinary meaning of “administration,” as it relates to pharmaceuticals,
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`is “application” or “to apply.”3
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`Ostensibly, there is no dispute between the parties as to the meaning of “administration”
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`in general. Instead, as confirmed by Apotex’s opening Brief, the actual dispute is whether the
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`claims of the patents-in-suit are limited to a single formulation containing both azelastine and
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`fluticasone for simultaneous administration, as Plaintiffs maintain and the intrinsic record
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`compels, or whether they extend to cover separate formulations that can be administered
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`separately or sequentially, as Apotex incorrectly contends. Apotex seeks construction of
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`“administration” for no reason other than as a means to advance its overly broad reading of the
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`claims. Apotex’s tactic should be rejected.
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`3 Plaintiffs proffered “application” or “to apply” only to adhere to this Court’s preference
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`that parties offer some explanation of disputed claim terms beyond simply asserting “plain and
`ordinary meaning,” and not as a formal proposed construction. See Honorable Leonard P. Stark,
`District of Delaware, REVISED PROCEDURES FOR MANAGING PATENT CASES (June 18, 2014) at 8,
`available at http://www.ded.uscourts.gov/sites/default/files/Chambers/LPS/PatentProcs/LPS-
`PatentProcedures.pdf. Moreover, this reflects the dictionary definition of “administration.” See
`Agfa Corp. v. Creo Products, Inc., 451 F.3d 1366, 1376 (Fed. Cir. 2006) (finding dictionary
`definitions appropriate when claim construction involves “little more than the application of
`widely accepted meaning of commonly understood words.”).
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`Case 1:14-cv-01453-LPS Document 61 Filed 12/23/15 Page 11 of 15 PageID #: 1813
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`Apotex asserts that its construction is a “definition [that] comes directly out of the
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`specifications,” and that “the patentees acted as their own lexicographers.” (Ap. Br. at 1.) Each
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`of these statements are demonstrably false. Apotex’s construction and arguments hinge on the
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`following passage from the specification:
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`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 formulation, or separately or
`sequentially.
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`See, e.g., ’723 patent, 4:61-64. But this is not a definition of “administration.” Rather, it is a
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`written description of the full features of the invention, which the inventors could have sought to
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`claim. But as explained in Plaintiffs’ opening brief (Pl. Br. at 14-18) and in the next section
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`below, the inventors during prosecution narrowed the scope of the subject matter that was
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`eventually claimed, and they chose to claim less than what is reflected in the written description.
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`And doing so is a common practice in patent prosecution, as patent applicants can—and often
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`do—claim less subject matter in a given patent than was initially disclosed in the written
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`description of the application. See Novo Nordisk of N. Am. v. Genentech, Inc., 77 F.3d 1364,
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`1369 (Fed. Cir. 1996) (“While claims are to be interpreted in light of the specification, all that
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`appears in the specification is not necessarily within the scope of the claims and thus entitled to
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`protection.”).
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`Apotex’s contention that the patentees, acting as lexicographers, redefined
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`“administration” to mean something other than its plain and ordinary meaning, is also false.
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`Lexicography requires “clarity, deliberateness, and precision” and, if done, must “set out [any]
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`uncommon definition in some manner within the patent disclosure so as to give one of ordinary
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`skill in the art notice of the change” in meaning. See In re Paulsen, 30 F.3d 1475, 1480, (Fed.
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`Cir. 1994) (emphasis added) (internal quotations omitted). The patents-in-suit here do not set
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`Case 1:14-cv-01453-LPS Document 61 Filed 12/23/15 Page 12 of 15 PageID #: 1814
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`forth an “uncommon definition,” or any definition for that matter, for the term “administration.”
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`The passage from the specification Apotex relies on is not lexicography or a definition of
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`“administration.” It was a description of the full embodiments of the invention when the
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`application was filed, which is broader than the issued claims in the present patents. “It is not
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`enough for a patentee to simply disclose a single embodiment or use a word in the same manner
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`in all embodiments, the patentee must clearly express an intent to redefine the term.” Thorner v.
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`Sony Computer Entm’t Am. LLC, 669 F.3d 1362, 1365 (Fed. Cir. 2012). That has not happened
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`here.
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`Indeed, the passage Apotex cites no more sets forth a definition of “administer,” than it
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`would a definition for “respective therapeutic agents,” which also appears in the passage Apotex
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`cites. Mere inclusion in the specification or in a description of embodiments doesn’t mean the
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`passage defines the term “administration.”
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`B.
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`The Prosecution History Prohibits Apotex’s Overly Broad Interpretation of
`the Scope of the Claims of the ’620 and ’723 Patents
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`Conspicuously, Apotex’s opening Brief relies almost exclusively on the descriptive
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`passage and originally submitted claim set from the original applications for the patents, and
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`ignores the important prosecution history where the patentees amended and narrowed what they
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`ultimately claimed in the ’620 and ’723 patents from that original disclosure, which is common
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`patent practice. See Trading Techs. Int’l Inc. v. eSpeed, Inc., 595 F.3d 1340, 1352 (Fed. Cir.
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`2010) (finding prosecution history “demonstrate[s] how the inventor understood the invention
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`and whether the inventor limited the invention in the course of prosecution, making the claim
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`scope narrower than it would otherwise be.”). “The purpose of consulting the prosecution history
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`in construing a claim is to exclude any interpretation that was disclaimed during prosecution.”
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`Case 1:14-cv-01453-LPS Document 61 Filed 12/23/15 Page 13 of 15 PageID #: 1815
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`Chimie v. PPG Indus., Inc., 402 F.3d 1371, 1384 (Fed. Cir. 2005). This is precisely what
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`happened here. (See Pl. Br. at 14-18.)
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`Nowhere in its Brief does Apotex contend with, or even mention, that the patentees
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`cancelled the “separate” and “sequential” limitations from the claims (Pl. Br. at 14-18), much
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`less explain how its construction is viable in light of the cancellation. The important prosecution
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`history that is omitted in Apotex’s opening Brief is dispositive, and defeats Apotex’s proposed
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`construction and its attempt to expand the claims. While separate dosage forms are disclosed in
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`the specification (as originally filed) as potential embodiments, during prosecution of the ’620
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`and ’723 patents, however, the patentees expressly removed these separate dosage forms before
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`obtaining issuance of the claims. (Pl. Br. at 14-18.) The remaining claims which issued and are
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`the asserted claims in this case are limited to a single formulation suitable for simultaneous
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`administration. (Pl. Br. at 16-17.) As such, Apotex’s construction fails because it hinges entirely
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`on a description of unclaimed alternative embodiments in the specification, as originally filed.
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`Finally, instead of contending with the actual prosecution history, Apotex’s opening Brief
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`resorts to expending three pages citing and discussing so-called “Other Intrinsic Evidence.” (Ap.
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`Br. at 9-11.) However, as Apotex admits, this material consists of nothing more than “other
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`patent applications and publications invented by others.” (Ap. Br. at 9 (emphases added).) They
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`are not the patentees’ statements, so they cannot be attributed to Plaintiffs as admissions about
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`the scope of the claimed inventions. At most, they are third-party information that, according to
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`the Federal Circuit, carry significantly less weight in claim construction determinations because
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`they are not the patentee’s statements regarding the invention. See Acumed LLC v. Stryker Corp.,
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`483 F.3d 800, 809 (Fed. Cir. 2007) (prior art references cited during prosecution are “not created
`
`by the patentee in attempting to explain and obtain the patent,” so they “merit[] less weight than
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`{01073185;v1 }
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`

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`Case 1:14-cv-01453-LPS Document 61 Filed 12/23/15 Page 14 of 15 PageID #: 1816
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`the evidence of the patentee’s own words”) (internal citations omitted). Even if the Court were to
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`entertain them, there is nothing in these references to support Apotex’s argument that the term
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`“administration” has a special meaning in the patents-in-suit. Moreover, Apotex cites these
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`references for the same language and proposition as the originally-filed written description
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`discussed above. That passage, as discussed, is nullified in view of the narrowing amendments
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`and arguments made during prosecution which resulted in the narrower claims of the ’620
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`and ’723 patents.
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`CONCLUSION
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`For the foregoing reasons, Plaintiffs respectfully request that the Court adopt Plaintiffs’
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`proposed constructions for the disputed terms: condition(s) and administration.
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`{01073185;v1 }
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`Case 1:14-cv-01453-LPS Document 61 Filed 12/23/15 Page 15 of 15 PageID #: 1817
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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.
`
`
`
`
`
`Of Counsel:
`
`H. Keeto Sabharwal
`Dennies Varughese
`Uma N. Everett
`Rami Bardenstein
`Dallin G. Glenn
`Joshua I. Miller
`Josephine J. Kim
`STERNE, KESSLER, GOLDSTEIN &
` FOX P.L.L.C.
`1100 New York Ave., N.W., Suite 800
`Washington, DC 20005-3934
`(202) 371-2600
`
`Dated: December 23, 2015
`
`
`{01073185;v1 }
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