Case 1:14-cv-02758-PAC Document 63 Filed 05/08/15 Page 1 of 24
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE SOUTHERN DISTRICT OF NEW YORK
`
`Kowa Company, Ltd. et al.,
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`Plaintiffs,
`
`v.
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`Aurobindo Pharma Limited et al.,
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`Defendants.
`
`Kowa Company, Ltd. et al.,
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`Plaintiffs,
`
`v.
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`Amneal Pharmaceuticals LLC,
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`Defendant.
`
`Kowa Company, Ltd. et al.,
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`Plaintiffs,
`
`v.
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`Mylan Inc. et al.,
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`Defendants.
`
`Kowa Company, Ltd. et al.,
`
`Plaintiffs,
`
`v.
`
`Orient Pharma Co., Ltd.,
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`Defendant.
`
`Civil Action No. 14-CV-2497 (PAC)
`
`Civil Action No. 14-CV-2758 (PAC)
`
`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 63 Filed 05/08/15 Page 2 of 24
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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,
`
`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)
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`Civil Action No. 14-CV-5575 (PAC)
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`

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`Case 1:14-cv-02758-PAC Document 63 Filed 05/08/15 Page 3 of 24
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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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`III.
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`IV.
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`SUMMARY.............................................................................................................1
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`LIVALO®, THE SUBJECT OF THIS LITIGATION .............................................5
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`CLAIM CONSTRUCTION DISPUTE STATUS ...................................................6
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`APPLICABLE LEGAL PRINCIPLES....................................................................7
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`A.
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`B.
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`Authority and obligation to construe claims................................................7
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`Rules of claim construction .......................................................................10
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`V.
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`ARGUMENT.........................................................................................................10
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`A.
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`The ‘336 Patent..........................................................................................10
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`1.
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`2.
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`3.
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`The parties’ claim construction positions ......................................11
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`There is no need for the Court to construe this claim....................12
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`If the Court does construe the claim, it should adopt
`Plaintiffs’ proposed construction ...................................................13
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`B.
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`The ‘477 Patent..........................................................................................16
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`1.
`
`2.
`
`3.
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`The parties’ claim construction positions ......................................17
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`There is no need for the Court to construe this claim....................18
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`If the Court does construe the claims, it should adopt
`Plaintiffs’ proposed construction ...................................................18
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`VI.
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`CONCLUSION......................................................................................................20
`
`i
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`Case 1:14-cv-02758-PAC Document 63 Filed 05/08/15 Page 4 of 24
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`PLAINTIFFS’ OPENING CLAIM CONSTRUCTION BRIEF1
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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 (“October 17, 2014 Order”), Plaintiffs Kowa Company, Ltd., Kowa
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`Pharmaceuticals America, Inc. (“Kowa”) and Nissan Chemical Industries, Ltd. (“Nissan”)
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`(collectively, “Plaintiffs”) hereby submit their Opening Claim Construction Brief.
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`I.
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`SUMMARY
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`In accordance with the Court’s October 17, 2014 Order, the parties filed their Joint
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`Disputed Claim Terms Chart on April 10, 2015. As noted in that submission, Plaintiffs do not
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`believe that Defendants have identified any claim terms as to which claim construction is
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`necessary or appropriate at this time. In the event that the Court believes that claim construction
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`as to those terms is necessary and appropriate, Plaintiffs have proposed claim constructions that
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`are more appropriate for the terms that Defendants identified.
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`The parties’ claim construction submissions are directed to two claims, one claim from
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`U.S. Patent No. 5,856,336 (“the ‘336 Patent”) (Exhibit 1), and one claim from U.S. Patent No.
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`6,465,477 (“the ‘477 Patent”) (Exhibit 2). The parties agree that no construction is necessary
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`with respect to the terms of U.S. Patent No. 8,557,993 (“the ‘993 Patent).
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`Plaintiffs believe that there is not much in dispute with regard to the proposed claim
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`constructions. Defendants, however, have adopted a rather contorted approach with regard to
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`their attempts at defining the two terms they have identified for construction. Simply put,
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`Defendants’ attempts to define these terms are neither accurate nor consistent with the language
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`of the claims.
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`1 The Apotex case caption is not included among the captions for this brief because only U.S.
`Patent No. 8,557,993 is at issue in that case, and there were no claim construction issues raised
`with respect to that patent.
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`1
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`Claim 1 of the ‘336 Patent provides as follows:
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`The parties’ positions with regard to claim construction for this claim are as follows:
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`Defendants’ proposed construction improperly changes “compound” to “genus” and
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`inserts language relating to optical isomers and mixtures, rather than keeping consistent with
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`2
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`what the claim provides. Claim 1 defines a compound, by providing the compound’s structure.
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`Defendants proposed construction suggests that a claim directed to “a compound” having a
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`defined structure should be redefined by the Court as a claim to a “genus” including “each
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`optical isomer” of the specified formula “and all mixtures thereof.” Defendants appear to be
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`confusing what they say is covered by the claim with what the claim language means. The
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`interpretation of what types of things are covered by a structure-defined compound claim is
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`neither necessary nor appropriate for a claim construction proceeding. A compound claim
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`having a defined structure is simply that: a claim to a compound that has the structure specified
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`in the claim. See Endo Pharms. Inc. v. Mylan Pharm. Inc., No. 11-717, 2013 U.S. Dist. LEXIS
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`111004, at *8-11 (D. Del. Aug. 7, 2013) (rejecting defendant Mylan’s attempt to redefine the
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`term “compound” by inserting stereochemical language).
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`In the event that the Court believes that a Markman claim construction is appropriate for
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`this claim, Plaintiffs’ proposed construction more accurately reflects the language of the claim.
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`Defendants similarly have adopted a convoluted approach to proposing claim
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`construction for the ‘477 Patent. Claim 1 of that patent provides as follows:
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`A pharmaceutical composition comprising (E)-3,5-dihydroxy-7-[4’-4” –
`flurophenyl-2’-cyclopropyl-quinolin-3”-yl]-6-heptenoic acid, or its salt or
`ester, and a pharmaceutically acceptable carrier, of which an aqueous
`solution or dispersion of the pharmaceutical composition has a pH from
`6.8 to 7.8.
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`Defendants have inappropriately selected a lengthy portion of this claim as a claim
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`“term” for construction:
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`an aqueous solution or dispersion of the pharmaceutical composition has
`pH from 6.8 to 7.8.
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`The parties’ positions with regard to construction of this claim “term” (which actually is a
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`long phrase) are as follows:
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`3
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`Defendants’ construction inappropriately takes a sixteen-word phrase from Claim 1 and
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`attempts to define that complete phrase by unnecessarily rewording it and incorporating language
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`from the specification that specifically relates to the term “pH.” Defendants propose to change
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`“an aqueous solution or dispersion” into a “unit dose of a solid preparation….” The end result of
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`these contortions is a proposed definition that does not make sense.
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`The ‘477 Patent specification explains, “The pH as referred to herein indicates the pH
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`value to be determined in such a manner that a unit dose of a solid preparation comprising NK-
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`104 or its salt or ester is sampled and dissolved or dispersed in from 1 to 10 ml of pure water,
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`and the pH of the resulting aqueous solution or dispersion is measured.” See ‘477 Patent, col. 2,
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`ll. 56-61. While Plaintiffs do not believe that formal claim construction is necessary with regard
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`to the claim as proposed by the Defendants, in the event that the Court were to engage in claim
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`construction, the construction proposed by Plaintiffs comports, verbatim, with the specification.
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`4
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`Defendants’ proposed construction, on the other hand, inappropriately over-includes a
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`substantial portion of the claim rather than proposing a construction for a claim term, and
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`rearranges and rewrites the claim in a confusing way. In accordance with the Defendants’
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`proposed construction, the “resulting aqueous solution or dispersion” no longer is the thing being
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`measured as claimed and as referenced in the specification, but rather the “unit dose” is.
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`While Plaintiffs do not believe that construction is necessary, and so indicated during the
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`meet and confer process, in an effort to compromise and resolve any issues so as to avoid
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`unnecessarily burdening the Court, Plaintiffs considered Defendants’ proposals, and in good
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`faith offered the alternative proposals set forth herein in an effort to resolve potential issues
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`related to claim construction. Defendants to date have declined to consider Plaintiffs’ alternative
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`proposals or provide any basis for why those proposals do not resolve issues with regard to the
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`terms identified by Defendants.
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`II.
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`LIVALO®, THE SUBJECT OF THIS LITIGATION
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`The above-captioned actions relate to Livalo®, a drug approved for use to reduce high
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`cholesterol, as well as low density lipoproteins (LDL-C), triglycerides and apolipoprotein B, and
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`to increase high density lipoprotein cholesterol (HDL-C) in adults requiring such treatment.
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`Livalo® is a member of a class of drugs, called “statins,” that lower cholesterol by inhibiting
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`HMG CoA reductase, an enzyme involved in the production of cholesterol. Livalo® provides an
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`important treatment for high cholesterol. Livalo® has enjoyed very substantial success in the
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`marketplace, even in the face of competition from brand and generic versions of other
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`cholesterol-lowering drugs (including, e.g., generic Lipitor®). The success of Livalo® is
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`reflected in the fact that numerous generic pharmaceutical companies – including at least the
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`5
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`seven sets of defendants in these related cases (the “Litigation”)2 – have filed Abbreviated New
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`Drug Applications (ANDAs) with the FDA seeking permission to make and sell copies of
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`Livalo®.
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`III.
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`CLAIM CONSTRUCTION DISPUTE STATUS
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`The three patents-in-suit in the Litigation are U.S. Patents Nos. 5,856,336 (“the ‘336
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`Patent”), 6,465,477 (“the ‘477 Patent”), and 8,557,993 (“the ‘993 Patent”). As required by the
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`Court’s October 17, 2014 Order, the parties filed a Joint Disputed Claim Terms Chart on April
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`10, 2015. The parties agree that no construction is necessary with respect to the terms of the
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`‘993 Patent. The parties disagree, however, as to whether any claim construction is necessary
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`with respect to the ‘336 and ‘477 Patents. Defendants have proposed that the Court construe
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`claim language from each of these patents. Plaintiffs maintain that construction is not only
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`unnecessary because the plain and ordinary meanings of the claims are clear on their face, but
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`also because Defendants have not presented a real controversy about the meaning of the claims
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`or any context with respect to how the disputed claim constructions actually relate to the accused
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`products. See Jang v. Boston Scientific Corp., 532 F. 3d 1330, 1337 (Fed. Cir. 2008). Thus, for
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`example, it is impossible to discern whether either of the requested claim construction rulings
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`would actually affect any issue in the case. Id. at 1336. Plaintiffs have requested an explanation
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`from Defendants as to how the proposed construction rulings would relate to any actual issue in
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`the case, but Defendants have been unable or unwilling to disclose such information. Under
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`these circumstances, making the requested rulings would be improper, because it would result in
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`an advisory opinion. Id. at 1337-38.
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`2 Amneal, Apotex, Aurobindo, Mylan, Orient, Sawai and Zydus. The Apotex case caption is not
`included in these papers because no Markman issues are in dispute in that case.
`6
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`Each of the defendants in the Litigation served a “paragraph IV” notice letter on
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`Plaintiffs. As required by 21 U.S.C. § 355(b)(3)(D)(ii), each of these letters purports to provide
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`“a detailed statement of the factual and legal basis of the opinion of the applicant that the patent
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`is invalid or will not be infringed.” Nothing in any of Defendants’ detailed notice letters makes
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`clear why construction of the claim language Defendants have now asked the Court to construe
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`is necessary to adjudicate the validity or infringement issues presented in this case. Moreover,
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`one of the defendants in the Litigation, Mylan, recently filed a petition for Inter Partes Review
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`(“IPR Petition”) regarding the ‘336 Patent, which further corroborates that claim construction is
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`unnecessary, unequivocally stating: “no terms or phrases require construction for purposes of
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`this Petition.” IPR2015-01069, paper no. 2, at p. 15.3 Still further, when asked during the meet
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`and confer process why these limitations needed to be construed, Defendants were unable and/or
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`flatly refused to identify any arguments – whether related to validity or infringement – that
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`would turn on how either of these two claims were construed. As there is no indication that the
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`claim language Defendants have asked this Court to construe will impact either infringement or
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`validity, any claim construction at this time would be purely advisory.
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`IV.
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`APPLICABLE LEGAL PRINCIPLES
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`A.
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`Authority and obligation to construe claims
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`Article III of the United States Constitution does not authorize opinions deciding issues
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`as to which there is no concrete controversy between the parties. Coffman v. Breeze, 323 U.S.
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`316, 322-24 (1945). In the context of claim construction, it is not enough that the parties
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`disagree on the meaning of a particular claim term. Rather, the disagreement between the parties
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`must have an effect on an issue related to infringement or validity. Jang, 532 F. 3d at 1336-37
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`3 Notably, Mylan’s IPR Petition was filed after the parties submitted their Joint Claim Chart in
`this litigation.
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`(finding that even though the parties “extensively briefed” claim construction issues, the Court
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`could not review the district court’s opinion on claim construction without knowing whether its
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`construction “would actually affect the issue of infringement”).
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`A court is not required to construe every term recited in a patent claim, or even every
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`term the parties ask it to construe. O2 Micro Intern. v. Beyond Innovation Tech., 521 F.3d 1351,
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`1362 (Fed. Cir. 2008) (“We, however, recognize that district courts are not (and should not be)
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`required to construe every limitation present in a patent’s asserted claims.”); U.S. Surgical Corp.
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`v. Ethicon, Inc., 103 F.3d 1554, 1568 (Fed. Cir. 1997) (Claim construction “is not an obligatory
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`exercise in redundancy.”). Rather, a court is obligated to construe only claim terms as to which
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`there is an actual dispute affecting the scope of the claims. O2 Micro, 521 F.3d at 1360 (“When
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`the parties raise an actual dispute regarding the proper scope of these claims, the court, not the
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`jury, must resolve that dispute.”) (emphasis added).
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`Construction of a claim term that does not impact the infringement or invalidity analysis
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`is improper. The Federal Circuit has repeatedly held that it lacks jurisdiction for appellate
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`review of claim constructions that do not affect infringement or invalidity. For example, in Jang,
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`the Federal Circuit declined to review a district court’s claim construction after entry of a
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`stipulated judgment of infringement, explaining:
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`…[W]e cannot determine with certainty which of the claim construction
`disputes actually has an effect on the infringement issue.
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`If we did not require clarification of the stipulated judgment in this
`case, we would risk rendering an advisory opinion as to claim construction
`issues that do not actually affect the infringement controversy between the
`parties.
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`Jang, 532 F.3d at 1336; see also Superior Indus. v. Masaba, Inc., 553 Fed. Appx. 986, 990 (Fed.
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`Cir. 2014) (“If none of the accused products includes a support frame, then the multiple terms
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`Case 1:14-cv-02758-PAC Document 63 Filed 05/08/15 Page 12 of 24
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`relating to the support frame are irrelevant to the infringement analysis and our review of the
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`district court’s construction of these terms would be an impermissible advisory opinion.”). The
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`Federal Circuit has also expressly stated that claims should be construed only to the extent
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`necessary to resolve a controversy between the parties. Vivid Techs., Inc. v. American Sci. &
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`Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (agreeing with the patentee that “only those
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`terms need be construed that are in controversy, and only to the extent necessary to resolve the
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`controversy.”).
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`A number of district courts, including the Southern District of New York, have relied on
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`Vivid Technologies for the proposition that district courts should not construe claim terms where
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`such construction would not be relevant to the infringement or invalidity analyses. See, e.g.,
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`Westvaco Corp. v. Viva Magnetics Ltd., No. 00-9399, 2002 U.S. Dist. LEXIS 17177, at *8-9
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`(S.D.N.Y. Sept. 17, 2002) (“The Court construes claims objectively, without reference to the
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`accused product, but only terms that are actually in controversy with respect to infringement are
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`construed. The principle that a court should construe only disputed terms is intended to avoid
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`advisory opinions violative of Article III of the United States Constitution.”); Best Mgmt. Prods.
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`v. 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) (“Though the relationship between the claims and the allegedly infringing
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`products has no relevance to the claim construction inquiry itself, a court cannot legitimately
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`exercise its judicial power to undertake the inquiry without an actual controversy as to whether
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`the claims cover the products.”); Probatter Sports, LLC v. Sports Tutor, Inc., No. 05-01975,
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`2014 U.S. Dist. LEXIS 43124, at *3 (D. Conn. Mar. 31, 2014) (“Only those terms that are in
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`controversy need to be construed, and the construction only needs to be to the extent necessary to
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`resolve the controversy.”).
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`B.
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`Rules of claim construction
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`When Article III courts have jurisdiction to decide an actual controversy regarding the
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`meaning of a disputed claim term, certain well-settled canons apply. “It is a bedrock principle of
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`patent law that the claims of a patent define the invention to which the patentee is entitled the
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`right to exclude.” Phillips v. AWH Corp., 415 F.3d 1303, 1312 (Fed. Cir. 2005) (en banc)
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`(internal quotation marks and citations omitted). Thus, the claim construction analysis begins
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`with “the claims themselves,” which “provide substantial guidance as to the meaning of
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`particular claim terms.” Pfizer, Inc. v. Teva Pharm. USA, Inc., 429 F.3d 1364, 1373 (Fed. Cir.
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`2005) (quoting Phillips, 415 F.3d at 1314). The Federal Circuit applies a “heavy presumption
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`that a claim term carries its ordinary and customary meaning.” CCS Fitness, Inc. v. Brunswick
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`Corp., 288 F.3d 1359, 1366 (Fed. Cir. 2002) (internal quotation marks omitted); see Phillips, 415
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`F.3d at 1312 (quoting Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir.
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`1996)). Claims must also “be read in view of the specification, of which they are a part.”
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`Phillips, 415 F.3d at 1315 (quoting Markman v. Westview Instruments, Inc., 52 F.3d 967, 979
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`(Fed. Cir. 1995) (en banc), aff’d, 517 U.S. 370 (1996)).
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`V.
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`ARGUMENT
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`A.
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`The ‘336 Patent
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`The ‘336 Patent describes how, prior to the invention of the ‘336 Patent, only limited
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`information was available regarding synthetic derivatives of HMG-CoA reductase inhibitors.
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`‘336 Patent, at col. 1, ll. 24-30. The inventors of the ‘336 Patent discovered that
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`“mevalonolactone derivatives having a quinolone ring, the corresponding dihydroxy carboxylic
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`acids and salts and esters thereof have high inhibitory activities against cholesterol
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`biosynthesis….” Id. at col. 1, ll. 31-37. Claim 1 of the ‘336 Patent is directed to such a
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`compound. Claim 2 is directed to a method of reducing hyperlipidemia, hyperlipoproteinemia or
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`atherosclerosis by administering the compound of claim 1.
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`Claim 1 of the ‘336 Patent, the claim Defendants ask the Court to construe, provides as
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`follows:
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`1.
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`The parties’ claim construction positions
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`Defendants ask the Court to turn a simple claim directed to a single “compound” into a
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`confusing genus claim directed to optical isomers and mixtures thereof. Plaintiffs maintain that
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`no construction is necessary, but if the claim is construed, it should be construed to mean a
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`compound having the structure recited in the claim. The parties’ respective positions, as set forth
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`in the Joint Claim Chart, are provided below.
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`11
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`2.
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`There is no need for the Court to construe this claim.
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`Defendants, through their proposed claim construction, ask the Court to re-define into a
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`“genus” a compound claim that is expressed in accordance with its structure. It is not clear why
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`Defendants have asked the Court to make this determination. When asked in the meet and
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`confer between the parties why the language of claim 1 needed to be construed, Defendants
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`declined to provide any substantive answer. In their paragraph IV notice letters, none of the
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`Defendants purported to construe the language now at issue, and thus no defendant can point to
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`any argument in the paragraph IV notice letters that would be affected by the construction they
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`now seek. Even more notably, in Mylan’s IPR Petition directed at the ‘336 Patent, which was
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`filed after the parties submitted their Joint Claim Chart in this litigation, Mylan expressly stated
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`Case 1:14-cv-02758-PAC Document 63 Filed 05/08/15 Page 16 of 24
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`that “no terms or phrases require construction for purposes of this Petition.”4 IPR2015-01069,
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`paper no. 2 at 15. Thus, at least one Defendant has acknowledged that for § 102 and § 103
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`validity purposes, no construction of the ‘336 Patent claims is necessary. It makes no sense for
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`this Court to construe a claim that does not need construction.
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`Because construing claim 1 of the ‘336 Patent would not resolve any substantive issues in
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`this case, the Court lacks jurisdiction to construe it. Construction of this claim language would
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`be nothing more than an advisory opinion. See, e.g., Jang 532 F.3d at 1332, 1336-37; Vivid
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`Techs., 200 F.3d at 803.
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`3.
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`If the Court does construe the claim, it should adopt Plaintiffs’ proposed
`construction
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`To the extent the Court determines that it can and should construe this claim, it should
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`give the claim its ordinary and customary meaning: specifically, a compound having the
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`structure recited in the claim. This construction would encompass any compound that has the
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`structure depicted in the claim.
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`Plaintiffs’ construction permits optical isomers having structure consistent with that
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`depicted in claim 1. Defendants’ construction transforms claim 1 from a claim that permits
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`optical isomers that are consistent with the claimed structure to one in which the claim itself is
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`defined as a “genus” comprising multiple optical isomers and all mixtures thereof. Plaintiffs’
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`proposed construction is correct because it is consistent with the language of the claims and the
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`specification. Defendants’ proposal requires the Court to redefine the term “compound” as a
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`4 Plaintiffs note that Mylan made this admission with the caveat that it was in the context of the
`“broadest reasonable interpretation in light of the specification” under 37 C.F.R. §42.100(b), but
`that does not negate an admission that no terms or phrases of the ‘336 Patent require
`construction.
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`“genus,” which is improper because there is nothing in the specification or prosecution history
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`that supports that re-definition, nor is it supported by the claim itself.
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`Plaintiffs’ proposed alternative construction is consistent with the language of claim 1.
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`There are naming conventions that describe the stereochemistry of a compound. See, e.g.,
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`Sanofi-Synthelabo v. Apotex, Inc., 470 F.3d 1368, 1372 (Fed. Cir. 2006). When the term
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`“compound” is used, and none of these naming conventions is employed, it is understood to
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`mean a compound without limitation as to stereochemical form. Pfizer Inc. v. Teva Pharm. USA,
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`Inc., 555 Fed. Appx. 961, 965-66 (Fed. Cir. 2014); SmithKline Beecham Corp. v. Apotex Corp.,
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`403 F.3d 1331, 1339 (Fed. Cir. 2005) (holding that claim to a specific compound should be
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`construed to embrace that compound “without further limitation”). By construing the claim
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`without reference to stereochemical structure, Plaintiffs’ construction stays true to the language
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`of the claim.
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`Plaintiffs’ proposed construction also is consistent with the specification. In the
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`specification, the inventors expressly recognized that mevalonolactone derivatives – of which
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`pitavastatin calcium is one – may have optical isomers. Indeed, after identifying a number of
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`mevalonolactone derivatives, the specification states that these compounds:
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`… may have at least two to four optical isomers. The compounds of
`formula I include all of these optical isomers and all of the mixtures
`thereof.
`
`‘336 Patent, at col. 2, l.66 - col. 3, l.2 (emphasis added). This passage makes clear that the
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`mevalonolactone derivative compounds identified in the first two columns of the ‘336 Patent
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`may have optical isomers. Plaintiffs’ construction is consistent with the specification: it permits
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`optical isomers having structure consistent with the structure depicted in claim 1.
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`Case 1:14-cv-02758-PAC Document 63 Filed 05/08/15 Page 18 of 24
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`Defendants’ proposed construction requires the Court to depart from the plain and
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`ordinary meaning of “compound,” redefining the term to mean “a genus including each optical
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`isomer… and mixtures thereof.” In order to justify departing from the plain and ordinary
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`meaning, Defendants need to show that the patentee either: 1) disavowed the full scope of the
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`claim, or 2) acted as its own lexicographer. Thorner v. Sony Computer Entm’t Am. LLC, 669
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`F.3d 1362, 1365 (Fed. Cir. 2012). “To act as its own lexicographer, a patentee must ‘clearly set
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`forth a definition of the disputed claim term’ other than its plain and ordinary meaning” and must
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`“‘clearly express an intent’ to redefine the term.” Id. (quoting CCS Fitness, 288 F.3d at 1366;
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`Helmsderfer v. Bobrick Washroom Equip., Inc., 527 F.3d 1379, 1381 (Fed. Cir. 2008)).
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`Nothing in the intrinsic record suggests that the inventors intended to redefine the term
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`“compound” to mean “a genus including each optical isomer … and mixtures thereof.” Indeed,
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`as discussed above, the specification suggests exactly the opposite. By stating that certain
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`“compounds” “may” include optical isomers, the specification makes clear that the term
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`“compound” is being used in its ordinary manner to refer to a chemical substance, not to each
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`and every optical isomer of that substance, and mixtures thereof.
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`Defendants’ attempt in this case to redefine the term “compound” using stereochemical
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`language mirrors the unsuccessful attempt of defendant Mylan to do the same in Endo
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`Pharmaceuticals Inc. v. Mylan Pharmaceuticals Inc., No. 11-717, 2013 U.S. Dist. LEXIS
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`111004 (D. Del. Aug. 7, 2013). In that case, as here, the claim language was silent as to
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`stereochemistry, but defendant Mylan, like Defendants here, nonetheless tried to construe the
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`term “compound” to mean separately each enantiomer of the compound and mixtures thereof.
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`Id. at *8-9. In that case, as here, the specification included a statement that the compounds
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`disclosed “may contain” optical isomers and that “[t]he invention thus includes all such
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`Case 1:14-cv-02758-PAC Document 63 Filed 05/08/15 Page 19 of 24
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`enantiomers and mixtures.”5 Id. at *10. The Endo court concluded that given the absence of
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`stereochemical language in the claims, and clear intent not to impose stereochemical limitations
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`on the word “compound” in the specification, there was no reasonable basis to insert
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`stereochemical language into its construction of the word “compound.” Id. at *9-11. Plaintiffs
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`respectfully submit that this Court should do the same here.
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`B.
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`The ‘477 Patent6
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`The ‘477 Patent discloses that pitavastatin calcium is “unstable at low pH, and many
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`difficulties have been encountered in formulating it into preparations.” ‘477 Patent, at col. 1, ll.
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`63-65. The patent further describes how HMG-CoA reductase inhibitors, of which pitavastatin
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`calcium is one, have been “formulated into preparations with pH 8 or higher, desirably pH 9 or
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`higher” but pitavastatin (NK-104) has been found to be “unstable even within a high pH range.”
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`Id. at col. 1, l.65-col. 2, l.3. The invention of the ‘477 Patent relates to a stable composition of
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`pitavastatin that the inventors found to be “unexpectedly” “stable within a relatively low pH.” Id.
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`at col. 2, ll. 14-15.
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`The ‘477 Patent includes 15 claims, of which claim 1 is the only independent claim.
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`Claim 1 provides as follows:
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`A pharmaceutical composition comprising (E)-3,5-dihydroxy-7-[4’-4” –
`flurophenyl-2’-cyclopropyl-quinolin-3”-yl]-6-heptenoic acid, or its salt or
`ester, and a pharmaceutically acceptable carrier, of which an aqueous
`solution or dispersion of the pharmaceutical composition has a pH from
`6.8 to 7.8.
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`5The specification of the patent at issue in the Endo case stated in relevant part: “It will be
`appreciated that compounds of formula (I) may maintain one or more asymmetric centres, and
`such compounds will exist as optical isomers (enantiomers). The invention thus includes all
`such enantiomers and mixtures, including racemic mixtures, thereof.” 2013 U.S. Dist. LEXIS
`111004 at *10.
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`6 The ‘477 Patent is not at issue in the Amneal, Apotex, or Aurobindo cases.
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`Case 1:14-cv-02758-PAC Document 63 Filed 05/08/15 Page 20 of 24
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`Id. at col. 10, ll. 58-64.
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`1.
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`The parties’ claim construction positions
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`Defendants select an entire phrase from claim 1 – “an aqueous solution or dispersion of
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`the pharmaceutical composition has a pH from 6.8 to 7.8” – and ask the Court to construe it.
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`Plaintiffs respectfully submit that no construction is necessary, but that if the Court does engage
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`in claim construction, then a simpler and more logical approach should be taken. That is, claim
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`construction should be directed to the term “pH,” and should incorporate the definition of “pH”
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`provided in the specification. The parties’ respective positions, as set forth in the Joint Claim
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`Chart, are set forth below.
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`Case 1:14-cv-02758-PAC Document 63 Filed 05/08/15 Page 21 of 24
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`2.
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`There is no need for the Court to construe this claim language.
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`It does not appear that construction of this claim language will resolve any relevant issues
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`in the case. When asked in the meet and confer between the parties why this language needed to
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`be construed, Defendants responded that construction was necessary because one needs to
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`measure pH in order to apply the claims. Defendants, however, were unable to identify any
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`substantive issues relating to infringement or invalidity7 that turn on how this language is
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`construed.8
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`One reason that no substantive issues turn on construction is that the claim language is
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`clear on its face. Accordingly, there is no “actual dispute” between the parties as to the scope of
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`the claims sufficient to trigger the Court’s obligation to construe the claims. O2 Micro, 521
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`F.3d. at 1360. Not only is the Court not obligated to construe this claim language, because the
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`Court’s construction would not resolve any substantive issues in this case, an