Case 1:14-cv-02758-PAC Document 66 Filed 06/10/15 Page 1 of 14
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE SOUTHERN DISTRICT OF NEW YORK
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`Kowa Company, Ltd. et al.,
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`Plaintiffs,
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`v.
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`Aurobindo Pharma Limited et al.,
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`Defendants.
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`Kowa Company, Ltd. et al.,
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`Plaintiffs,
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`v.
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`Amneal Pharmaceuticals LLC,
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`Defendant.
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`Kowa Company, Ltd. et al.,
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`Plaintiffs,
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`v.
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`Mylan Inc. et al.,
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`Defendants.
`
`Kowa Company, Ltd. et al.,
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`Plaintiffs,
`
`v.
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`Orient Pharma Co., Ltd.,
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`Defendant.
`
`Civil Action No. 14-CV-2497 (PAC)
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`Civil Action No. 14-CV-2758 (PAC)
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`Civil Action No. 14-CV-2647 (PAC)
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`Civil Action No. 14-CV-2759 (PAC)
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`

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`Case 1:14-cv-02758-PAC Document 66 Filed 06/10/15 Page 2 of 14
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`Kowa Company, Ltd. et al.,
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`Plaintiffs,
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`v.
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`Zydus Pharmaceuticals (USA) Inc. et al.,
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`Defendants.
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`Kowa Company, Ltd. et al.,
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`Plaintiffs,
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`v.
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`Sawai USA, Inc. et al.,
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`Defendants.
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`Civil Action No. 14-CV-2760 (PAC)
`
`Civil Action No. 14-CV-5575 (PAC)
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`PLAINTIFFS’ RESPONSIVE CLAIM CONSTRUCTION BRIEF
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`Case 1:14-cv-02758-PAC Document 66 Filed 06/10/15 Page 3 of 14
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`TABLE OF CONTENTS
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`PAGE
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`I.
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`II.
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`SUMMARY.............................................................................................................1
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`ARGUMENT...........................................................................................................3
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`A.
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`B.
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`C.
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`Claim construction would constitute an advisory opinion...........................3
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`The ‘336 Patent............................................................................................4
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`The ‘477 Patent............................................................................................6
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`III.
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`CONCLUSION........................................................................................................9
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`i
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`Case 1:14-cv-02758-PAC Document 66 Filed 06/10/15 Page 4 of 14
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`Pursuant to the Civil Case Management Plan and Scheduling Order entered by the Court
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`on October 17, 2014, Plaintiffs Kowa Company, Ltd., Kowa Pharmaceuticals America, Inc.
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`(“Kowa”) and Nissan Chemical Industries, Ltd. (“Nissan”) (collectively “Plaintiffs”) hereby
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`submit their Responsive Claim Construction Brief.
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`I.
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`SUMMARY
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`In their Opening Brief, Defendants assert that “the parties have key disagreements
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`regarding claim scope that may impact noninfringement and/or invalidity, rendering it necessary
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`to construe the respective terms.” Defendants’ Joint Opening Claim Construction Brief
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`(“D.Br.”) at 2. Plaintiffs respectfully disagree. As pointed out in Plaintiffs’ Opening Brief,
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`“there is not much in dispute.” Plaintiffs’ Opening Claim Construction Brief (“P.Br.”) at 1.
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`The parties’ opening briefs reflect that, for the most part, the parties actually agree on the
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`meaning of the claim language at issue. For example, the parties agree that claim 1 of the ‘336
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`Patent encompasses optical isomers. See P.Br. at 13; D.Br. at 15-16. Similarly, for the ‘477
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`Patent, both parties agree that pH should be measured as described in the specification. See P.Br.
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`at 19; D.Br. at 21-22. The dispute between the parties with respect to claim construction thus
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`results from a disagreement over how to express what the claims say. All of this, however, stems
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`from Defendants’ efforts to construe claim language that does not need to be construed in the
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`first place.
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`It has been and remains Plaintiffs’ position that the claim language at issue does not need
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`to be construed. Nonetheless, in an effort to compromise with Defendants and avoid burdening
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`the Court, Plaintiffs proposed alternative claim constructions to try to resolve these issues. In
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`their Opening Brief, Defendants ascribe these alternative constructions to a purported intent to
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`change the meaning of the claims. In point of fact, nothing in Plaintiffs’ proposed alternative
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`1
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`Case 1:14-cv-02758-PAC Document 66 Filed 06/10/15 Page 5 of 14
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`constructions suggests that they have the meaning Defendants ascribe to them. For instance,
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`contrary to Defendants’ suggestion, there is nothing in Plaintiffs’ alternative construction for the
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`‘336 Patent that would exclude optical isomers from the scope of claim 1. See D.Br. at 19.
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`Similarly, nothing in Plaintiffs’ alternative construction would read the 6.8 to 7.8 pH range out of
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`claim 1 of the ‘477 Patent. See D.Br. at 20-21. Likewise, nothing in Plaintiffs’ alternative
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`construction would require one to derive the referenced pH from just the active pharmaceutical
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`ingredient (“API”) rather than from the “pharmaceutical composition” (which would include the
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`API plus inert ingredients (“excipients”)). See D.Br. at 22-23.1 In any event, much of
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`Defendants’ Opening Brief is devoted to tilting at windmills, attacking these unsupported
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`interpretations of Plaintiffs’ proposed alternative constructions.
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`As discussed in Plaintiffs’ Opening Brief, the claims that Defendants have asked the
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`Court to construe do not warrant construction, because construction is not necessary to
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`adjudicate any disputed issues with respect to validity or infringement. Jang v. Boston Scientific
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`Corp., 532 F. 3d 1330, 1337 (Fed. Cir. 2008) (warning against providing advisory opinions by
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`construing claim terms that do not impact the ultimate issue of infringement). In the event that
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`the Court construes the claims, however, Plaintiffs respectfully request that the Court reject
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`Defendants’ proposed claim constructions. Defendants’ proposed construction for the language
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`at issue in the ‘336 Patent requires the Court to redefine the term “compound” as a “genus,”
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`which is improper because there is nothing in the claim language, the specification, or the
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`prosecution history that supports Defendants’ re-definition. Cf. Endo Pharmaceuticals Inc. v.
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`Mylan Pharmaceuticals Inc., 11-717, 2013 LEXIS 111004 (D. Del. Aug. 7, 2013) (rejecting a
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`1 Had Defendants not declined to substantively confer on the parties’ proposed constructions, the
`foregoing could have been clear at the outset.
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`2
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`Case 1:14-cv-02758-PAC Document 66 Filed 06/10/15 Page 6 of 14
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`similar argument).2 Defendants’ proposed construction for the claim language at issue in the
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`‘477 Patent changes the identity of the substance that has the claimed pH from an “aqueous
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`solution or dispersion…” to “a unit dose of a solid preparation of the pharmaceutical
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`composition.” This changes the meaning of the claim. Plaintiffs’ proposed constructions avoid
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`these pitfalls, are consistent with the specification, and stay true to the language of the claims.
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`Defendants acknowledge in their Opening Brief that claim construction is “not an exercise in
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`rewriting claims….” D.Br. at 10. Defendants’ proposed claim constructions do exactly that.
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`Should the Court construe the claims, Plaintiffs respectfully submit that the Court should adopt
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`Plaintiffs’ proposed alternative constructions.
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`II.
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`ARGUMENT
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`A.
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`Claim construction would constitute an advisory opinion
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`Despite filing a 25-page Markman brief accompanied by a 16-page expert declaration,3
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`and despite being asked repeatedly by Plaintiffs what claim construction would accomplish and
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`why claim construction was necessary, Defendants have yet to articulate any substantive issue
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`that would turn on whether and/or how the Court construes the claim terms at issue. For the
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`reasons discussed in Plaintiffs’ Opening Brief, Defendants’ request that the Court construe the
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`claim language at issue invites the Court to render an improper advisory opinion. See P.Br. at 7-
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`9, 12-13, 18. In the absence of any substantive reason to engage in claim construction, a court
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`2 Defendants do not acknowledge the Endo v. Mylan case in their Opening Brief, despite the
`similarity of issues and the fact that the defendant in that 2013 case is a party to the instant
`litigation.
`3 Defendants’ expert declaration is not necessary for consideration of the Markman issues
`presented. Similarly, while Defendants recite the purported characteristics of a person of
`ordinary skill in the art (with which Plaintiffs do not agree), the level of ordinary skill in the art is
`not necessary for consideration of the Markman issues presented, as Defendants concede: “The
`parties have not identified a claim dispute that turns on resolving the specific level of ordinary
`skill.…”). See D.Br. at 13 n.8.
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`3
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`Case 1:14-cv-02758-PAC Document 66 Filed 06/10/15 Page 7 of 14
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`lacks authority to construe the claims. See, e.g., Jang, 532 F.3d at 1337; Superior Indus. v.
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`Masaba, Inc., 553 Fed. Appx. 986, 987 (Fed. Cir. 2014); Vivid Techs., Inc. v. American Science
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`& Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999); Westvaco Corp. v. Viva Magnetics Ltd., No.
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`00-9399, 2002 U.S Dist. LEXIS 17177, at *8-9 (S.D.N.Y. Sept. 17, 2002); Best Mgmt. Prods. v.
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`New England Fiberglass, L.L.C., No. 07-151, 2008 U.S. Dist. LEXIS 39462, at *8 n.5 (D.N.H.
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`May 12, 2008); Probatter Sports, LLC v. Sports Tutor, Inc., 2014 U.S. Dist. LEXIS 43124, No.
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`05-01975, at *3 (D. Conn. Mar. 31, 2014).
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`B.
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`The ‘336 Patent
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`Defendants mistakenly characterize the dispute regarding claim construction for the ‘336
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`Patent as a dispute over whether the claim language encompasses the below depicted optical
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`isomers of the compound recited in claim 1.
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`D.Br. at 19 (“Plaintiffs’ proposed construction, by refusing to agree with Defendants’, appears to
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`be designed to exclude one or more optical isomers and mixtures thereof.”). Plaintiffs agree,
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`4
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`Case 1:14-cv-02758-PAC Document 66 Filed 06/10/15 Page 8 of 14
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`however, that nothing in the claim excludes these optical isomers. See P. Br. at 13 (“Plaintiffs’
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`construction permits optical isomers having structure consistent with that depicted in claim 1.”).
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`Defendants argue that their construction “clarifies that the molecules the drawing
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`includes (all optical isomers and mixtures) [sic] to give full effect to the meaning of the term.”
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`D.Br at 12. This makes little sense. There is nothing in the claim to clarify. SmithKline
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`Beecham Corp. v. Apotex Corp., 403 F.3d 1331, 1339 (Fed. Cir. 2005) (holding that a claim to a
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`specific compound covers that compound “without further limitation”). Defendants’ own expert
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`concedes this point. See Declaration of David H. Sherman, Ph.D. in Support of Defendants’
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`Joint Opening Claim Construction Brief, at ¶ 34.
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`Defendants further argue that “[c]onstruing the stereochemical limitation of this term will
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`aid the Court and the parties in conducting infringement and invalidity analyses concerning the
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`‘336 Patent.” D.Br. at 12. This argument is difficult to credit given that Defendants have yet to
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`identify any issue regarding infringement or validity that could be affected by construction of
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`this claim language.
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`If the Court nonetheless elects to construe this claim language, Plaintiffs respectfully
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`submit that it should adopt Plaintiffs’ proposed construction. Including the word “structure” in
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`the proposed claim language is consistent with what the claim provides, and indicates that the
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`claimed compound comprises compounds having the structure depicted in the claim. Plaintiffs’
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`construction thus permits optical isomers whose structure is consistent with that depicted in
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`claim 1.
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`Defendants’ construction transforms claim 1 from a claim that permits optical isomers
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`that are consistent with the claimed structure to one in which each and every optical isomer is
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`separately claimed as a member of a genus and additionally claimed as part of a mixture of
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`Case 1:14-cv-02758-PAC Document 66 Filed 06/10/15 Page 9 of 14
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`isomers. This is improper. Indeed, as discussed in Plaintiffs’ Opening Brief, a similar argument
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`recently was rejected in Endo Pharmaceuticals Inc. v. Mylan Pharmaceuticals Inc., No. 11-717,
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`2013 U.S. Dist. LEXIS 111004 (D. Del. Aug. 7, 2013). See P.Br. at 15-16. Moreover,
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`Defendants’ construction distorts the meaning of the claim. A “compound” is not a genus of
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`species and mixtures of species. It is a chemical substance. In the case of claim 1, it is any
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`substance that has the structure recited in the claim. Defendants’ construction redefines the word
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`“compound” in a way not supported by the specification, the prosecution history, or the claim
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`language itself. Simply put, there is nothing in the intrinsic record that even suggests that the
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`patentee “clearly set forth a definition of the disputed claim term other than its plain and ordinary
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`meaning,” as would be required to redefine the term “compound” here. See Thorner v. Sony
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`Computer Entm’t Am. LLC, 669 F.3d 1362, 1365 (Fed. Cir. 2012). Accordingly, the Court
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`should reject Defendants’ proposed construction.
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`C.
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`The ‘477 Patent
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`As with the ‘336 Patent, Defendants mischaracterize the nature of the dispute between the
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`parties regarding how the ‘477 Patent claim language at issue should be construed. Contrary to
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`Defendants’ characterizations, this is not a dispute about whether the recited pH range (“6.8 to
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`7.8”) can be read out of the claims. It also is not a dispute about whether the substance having a
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`pH within that pH range is an aqueous solution or dispersion of just the API (i.e., Active
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`Pharmaceutical Ingredient) or of the “pharmaceutical composition” (which would include both
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`the API and any excipients). Rather, to the extent there is a dispute regarding claim construction,
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`it is over how to restate what is already clear from the language of the claim itself.
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`As discussed in Plaintiffs’ Opening Brief (and in Defendants’ Opening Brief), the
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`specification includes an express definition of the term “pH”:
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`Case 1:14-cv-02758-PAC Document 66 Filed 06/10/15 Page 10 of 14
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`The pH as referred to herein indicates the pH value to be determined in
`such a manner that a unit dose of a solid preparation comprising NK-104
`or its salt or ester is sampled and dissolved or dispersed in from 1 to 10 ml
`of pure water, and the pH of the resulting aqueous solution or dispersion is
`measured.
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`‘477 Patent, at 2:56-61. See P.Br. at 19; see also D.Br. at 21-22. The parties agree that this
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`portion of the specification describes the method by which the pH recited in the claims is to be
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`measured. See D.Br. at 21 (“the parties agree that the specification provides exact guidance as to
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`how the pH is to be determined…”) (emphasis in original); see also P.Br. at 19.
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`Plaintiffs propose that if construction is necessary, it should be limited to the term that is
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`purportedly in dispute, but which in fact is specifically defined in the patent specification –
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`“pH”. Defining just “pH” makes clear that pH is to be measured by dissolving or dispersing a
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`unit dose of the claimed pharmaceutical composition in from 1 to 10 ml of pure water. This
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`construction specifies how pH is to be measured, thus resolving the one issue Defendants
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`contend claim construction is necessary to address. See D.Br. at 20 (“Since the precise manner
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`in which pH is measured is not recited in the claim language, it is clear that construction of the
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`pH term, and the language that surrounds it, is required.”).
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`Defendants take Plaintiffs’ proposed alternative construction, which is drawn word-for-
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`word from the specification, and suggest that Plaintiffs are trying to read the recited pH range out
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`of the claims, which makes no sense. D.Br. at 20-21 (“[C]laim 1 specifically recites a pH of
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`from 6.8 to 7.8, a feature found nowhere in Plaintiffs’ proposed construction. To the extent
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`Plaintiffs seek to exclude the claimed pH range from their construction, such a construction is
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`plainly incorrect as it disregards an explicit claim limitation.”). In the box at D.Br. 23,
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`Defendants purport to depict “Plaintiffs’ construction of claim 1” by omitting the pH
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`requirement recited in the claim, and inserting the definition from the specification, despite the
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`Case 1:14-cv-02758-PAC Document 66 Filed 06/10/15 Page 11 of 14
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`fact that the pH requirement has been dropped from the claim. This is not only misleading, it is
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`nonsense.
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`It is not clear why Defendants believe Plaintiffs’ alternative construction may support this
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`bizarre interpretation. Defendants appear to believe that to construe a claim means to rewrite the
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`claim. That is not the case. It is the meaning of the claim terms that is construed, not a rewritten
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`claim omitting or changing terms. What would be the point of specifying how pH was to be
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`measured, if the claim no longer called for a pH value?
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`Plaintiffs are not changing the claim language at all, just applying the definition of pH
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`that everyone agrees should be applied. That understanding does not mean that claim terms
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`should be disregarded.
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`Defendants also suggest that Plaintiffs’ construction may limit the substance from which
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`the pH is derived to just the API. D.Br. at 23. (“To the extent Plaintiffs are suggesting that the
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`pH measurement should evaluate a mere component, and not the pharmaceutical composition as
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`a whole, Plaintiffs construction would be improper…”). Defendants have not identified a basis
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`for this speculation. This interpretation of Plaintiffs’ alternative construction ignores the fact that
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`Plaintiffs’ construction is limited to one word of the claim – “pH.” The remaining language of
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`the claim makes clear that it is an “aqueous solution or dispersion of the pharmaceutical
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`composition” that has the referenced pH. The claim also makes clear that this “pharmaceutical
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`composition” comprises the API “and a pharmaceutically acceptable carrier.” Construing just
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`the term “pH” makes clear how the pH measurement is to be taken. It does not, as Defendants
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`contend, change the rest of the claim language.
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`In fact, it is Defendants’ proposed construction that changes the claim language. The
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`claim specifies that it is an “aqueous solution or dispersion of the pharmaceutical composition”
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`8
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`Case 1:14-cv-02758-PAC Document 66 Filed 06/10/15 Page 12 of 14
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`that has a pH in the range referenced in the claim. Defendants’ construction changes the claim
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`language to provide instead that it is “a unit dose of a solid preparation of the pharmaceutical
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`composition” which has the pH. Defendants’ construction fosters confusion, as a matter of both
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`science and the English language. Moreover, Defendants’ proposed construction is inconsistent
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`with their own argument throughout their Opening Brief. As Defendants themselves state:
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`“…[T]he entirety of the claim language in context, as well as disclosures in the specification, …
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`all make clear the requirement that “an aqueous solution or dispersion of the pharmaceutical
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`composition has pH of from 6.8 to 7.8.” D.Br. at 22.4
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`The Court can avoid such confusion by declining to engage in claim construction and
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`instead relying on the already clear language of the claims, interpreted in the light of the
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`specification which contains the definition of pH. Alternatively, the Court can avoid confusion
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`by construing only the term “pH” and using the express definition recited in the specification.
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`III.
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`CONCLUSION
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`For the reasons set forth herein and in Plaintiffs’ Opening Brief, it is unnecessary to
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`formally construe the claims, and the Court should not assume that burden. Plaintiffs
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`respectfully submit that the Court should especially not construe the claim language Defendants
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`have identified for construction in accordance with Defendants’ proposed constructions.
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`4 See also, e.g., D.Br. at 4 (“Defendants’ construction confirms that the measured pH result taken
`from testing an aqueous solution of the pharmaceutical composition must fit within the pH range
`claimed.”) (underlining emphasis added); 6 (“The specification makes clear that the pH of an
`aqueous solution of the pharmaceutical composition, not anything else, is what requires
`measurement.”) (underlining emphasis added, other emphasis in original); 22 (“The claim
`language, however, makes clear that the pH measurements must be performed on ‘an aqueous
`solution or dispersion of the pharmaceutical composition.’”) (underlining emphasis added, other
`emphasis in original); (“… [N]umerous references in the specification make clear that the pH of
`an aqueous solution of the pharmaceutical composition … is what is being measured.”)
`(underlining emphasis added).
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`Case 1:14-cv-02758-PAC Document 66 Filed 06/10/15 Page 13 of 14
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`Alternatively, if the Court determines that it should construe the claims, Plaintiffs respectfully
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`request that the Court adopt Plaintiffs’ proposed alternative constructions.
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`Dated: June 10, 2015
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`Respectfully submitted,
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`Kowa Company, Ltd.,
`Kowa Pharmaceuticals America, Inc., and
`Nissan Chemical Industries, Ltd.,
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`By their attorneys,
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`s/Kathleen B. Carr
`Jennifer L. Dereka
`JLDereka@mintz.com
`MINTZ, LEVIN, COHN, FERRIS,
`GLOVSKY AND POPEO, P.C.,
`Chrysler Center
`666 Third Avenue
`New York, NY 10017
`(212) 692-6754
`
`David Conlin (admitted pro hac vice)
`DGConlin@mintz.com
`Kathleen B. Carr (admitted pro hac vice)
`KBCarr@mintz.com
`Adam P. Samansky
`APSamansky@mintz.com
`MINTZ, LEVIN, COHN, FERRIS,
`GLOVSKY AND POPEO, P.C.
`One Financial Center
`Boston, MA 02111
`(617) 542-6000
`
`10
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`Case 1:14-cv-02758-PAC Document 66 Filed 06/10/15 Page 14 of 14
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`CERTIFICATE OF SERVICE
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`I, Kathleen B. Carr, hereby certify that on June 10, 2015, a true and correct copy of the
`foregoing was filed pursuant to the Electronic Case Filing (ECF) system with service to be
`completed by Notification of Electronic Filing (NEF) on counsel of record for all parties from
`the Court.
`
`s/Kathleen B. Carr
`Kathleen B. Carr
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`11
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