Case 1:14-cv-02647-PAC Document 102 Filed 11/04/15 Page 1 of 5
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`UNITED STATES DISTRICT COURT
`SOUTHERN DISTRICT OF NEW YORK
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`KOWA COMPANY, LTD., et al.,
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`AUROBINDO PHARMA LTD., et al.,
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`Defendants.
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`HONORABLE PAUL A. CROTTY, United States District Judge:
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`Plaintiffs Kowa Company, Ltd., Kowa Pharmaceuticals America, Inc., and Nissan
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`Chemical Industries, Ltd. bring patent infringement claims against seven sets of Defendants.1
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`Plaintiffs, manufacturers of the cholesterol-lowering drug Livalo, allege that Defendants are
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`infringing U.S. Patent Nos. 5,856,336 (“the ‘336 Patent”); 6,465,477 (“the ‘477 Patent”); and
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`8,557,993 (“the ‘993 Patent”). Defendants seek claim construction of the ‘336 Patent and the
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`‘477 Patent; Plaintiffs respond that construction is not necessary for either patent.2 After the
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`parties briefed the issue, the Court held a Markman hearing on October 16, 2015. The Court
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`finds that Defendants have failed to raise an actual dispute regarding the proper scope of either
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`1 Defendants are Aurobindo Pharma Ltd. and Aurobindo Pharma USA Inc. (collectively “Aurobindo”); Mylan
`Pharmaceuticals, Inc. and Mylan, Inc. (collectively “Mylan”); Amneal Pharmaceuticals, LLC (“Amneal”); Orient
`Pharma Co., Ltd. (“Orient”); Zydus Pharmaceuticals (USA) Inc. and Cadila Healthcare Ltd. (collectively “Zydus”);
`Sawai USA, Inc. and Sawai Pharmaceutical Co., Ltd. (collectively “Sawai”); and Apotex, Inc. and Apotex Corp.
`(collectively “Apotex”).
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`2 The ‘336 Patent is not at issue in the Apotex case. The ‘477 Patent is not at issue in the Amneal, Apotex, and
`Aurobindo cases. There are no construction issues as to the ‘993 Patent.
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`1
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`14 Civ. 2497
`14 Civ. 2647
`14 Civ. 2758
`14 Civ. 2759
`14 Civ. 2760
`14 Civ. 5575
`14 Civ. 7934 (PAC)
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`OPINION & ORDER
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`Plaintiffs,
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`-against-
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`Case 1:14-cv-02647-PAC Document 102 Filed 11/04/15 Page 2 of 5
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`patent claim; and accordingly construction is unnecessary.
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`I.
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`Applicable Law
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`Claim construction is a matter of law for the Court to decide. Markman v. Westview
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`Instruments, Inc., 517 U.S. 370, 391 (1996). “Claim construction is a matter of resolution of
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`disputed meanings and technical scope, to clarify and when necessary to explain what the
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`patentee covered by the claims, for use in the determination of infringement.” U.S. Surgical
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`Corp. v. Ethicon, Inc., 103 F.3d 1554, 1568 (Fed. Cir. 1997). “When the parties raise an actual
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`dispute regarding the proper scope of these claims, the court, not the jury, must resolve that
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`dispute.” O2 Micro Int’l Ltd. v. Beyond Innovation Tech. Co., 521 F.2d 1351, 1360 (Fed. Cir.
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`2008).
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`II.
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`The ‘336 Patent
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`The ‘336 Patent consists of two claims. Claim 1 describes a chemical compound and
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`Claim 2 states that the compound is used “for reducing hyperlipidemia, hyperlipoproteinemia or
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`atherosclerosis.” See Pl. Opening Brief (“Pl. Br.”), Dkt. 65, Ex. 1 at col. 32, ll. 21-38.
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`Defendants seek construction of Claim 1. As stated at the Markman hearing, “[a]ll the
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`defendants want here in their construction is confirmation that all four stereoisomers are
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`included, all mixtures of them are included, and that in no way shape, or form are any of them
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`excluded.” Transcript of Markman Hearing (“Tr.”) at 11. There is no dispute because Plaintiffs
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`agree that the claim covers all four stereoisomers of the compound depicted in Claim 1 and all
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`mixtures thereof. See Tr. 6 (“[O]ne of ordinary skill in the art looking at that claim would clearly
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`understand that . . . there are four optical isomers which have the depicted structure. Claim 1
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`covers each of those.”); Tr. 6 (“Where there are mixtures of stereoisomers, each of those
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`stereoisomers in the mixture is covered by claim 1. Clearly such mixtures would also be covered
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`2
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`Case 1:14-cv-02647-PAC Document 102 Filed 11/04/15 Page 3 of 5
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`within the scope of claim 1.”); Tr. 7 (“The compound of formula 1 includes all the optical
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`isomers and all the mixtures”); Tr. 7 (“Both parties agree that claim 1 as it’s written and as it was
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`allowed by the patent examiner calls the optical isomers and mixtures thereof”); Tr. 10
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`(“[C]ompound claims [such as this one] which don’t include stereochemical terminology or
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`symbols are interpreted as being without limitation as to stereochemical forms.”).
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`Defendants’ reliance on Infosint, S.A. v. H. Lundbeck A/S, 603 F. Supp. 2d 748 (S.D.N.Y.
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`2009) in arguing for construction is unavailing. In that case, one party argued that the claim term
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`in dispute covered only a single optical isomer, so construction was necessary to clarify that the
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`claim covered all optical isomers. Id. at 756. Here, the parties agree that the claim covers all
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`four optical isomers. Since Defendants have not “raise[d] an actual dispute regarding the proper
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`scope of these claims”, O2 Micro, 521 F.2d at 1360, claim construction is unnecessary.
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`III. The ‘477 Patent
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`The ‘477 Patent states that pitavastatin calcium (also known as NK-104), the active
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`ingredient in Livalo, is “unstable at low pH, and many difficulties have been encountered in
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`formulating it into preparations.” See Pl. Br., Ex. 2 at col. 1, ll. 63-65. The patent describes a
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`method to make a stable form of the compound in the pH range 6.8 to 7.8. Defendants seek
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`construction of Claim 1, which reads in full:
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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 aqueous solution or
`dispersion of the pharmaceutical composition has pH of from 6.8 to 7.8.
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`Id. at col. 10, ll. 58-63. Defendants seek construction to clarify the method by
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`which pH is measured. To answer this question, both Plaintiffs and Defendants point to
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`the same explanatory language in the specification:
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`Case 1:14-cv-02647-PAC Document 102 Filed 11/04/15 Page 4 of 5
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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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`Id. at 5. The parties agree that this language explains that pH is to be determined by
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`taking a solid preparation of the pharmaceutical composition (likely a tablet), dissolving the
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`tablet in 1 to 10 ml of pure water, and measuring the pH of the resulting solution. Compare Pl.
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`Resp. Br., Dkt. 66 at 7 (“pH is to be measured by dissolving or dispersing a unit dose of the
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`claimed pharmaceutical composition in from 1 to 10 ml of pure water”); and Tr. at 37 (Pl.
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`Counsel: “[Y]ou take a unit dose of the – the thing you are trying to test is the pharmaceutical
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`composition. You take a unit dose of that. You either disperse it or dissolve it in from 1 to 10
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`milliliters of pure water, and then you measure the pH of the resulting liquid.”); with Def. Resp.
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`Br., Dkt. 79 at 21 (“Defendants’ proposed construction involves taking the ‘unit dose of a solid
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`preparation of the pharmaceutical composition’; ‘dissolv[ing] or dispers[ing the unit dose] in 1 to
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`10 mL of pure water’; and then testing for pH”); and Tr. at 40-41 (Def. Counsel: “[Y]ou take a
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`tablet, you’re going to dissolve that tablet in 1 to 10 milliliters of pure water, and then a pH
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`monitor is going to measure what the pH of that solution is.”) Here too Defendants have not
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`“raise[d] an actual dispute regarding the proper scope of these claims”, O2 Micro, 521 F.2d at
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`1360; and claim construction is unnecessary.
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`Case 1:14-cv-02647-PAC Document 102 Filed 11/04/15 Page 5 of 5
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`CONCLUSION
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`The Court holds that claim construction is not necessary. The parties are directed to
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`proceed with expert discovery according to the timeline as set forth in the Scheduling Order. See
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`Dkt. 93.
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`Dated: New York, New York
`November 4, 2015
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`SO ORDERED
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`PAUL A. CROTTY
`United States District Judge
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