`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE SOUTHERN DISTRICT OF NEW YORK
`
`Kowa Company, Ltd., et al.,
`
`Plaintiffs,
`
`v.
`
`Aurobindo Pharma Limited et al.,
`
`Defendants.
`
`Kowa Company, Ltd., et al.,
`
`Plaintiffs,
`
`v.
`
`Amneal Pharmaceuticals LLC,
`
`Defendant.
`
`Kowa Company, Ltd., et al.,
`
`Plaintiffs,
`
`v.
`
`Mylan Inc., et al.,
`
`Defendants.
`
`Kowa Company, Ltd., et al.,
`
`Plaintiffs,
`
`v.
`
`Orient Pharma Co., Ltd.,
`
`Defendant.
`
`Civil Action No. 14-CV-2497 (PAC)
`
`Civil Action No. 14-CV-2758 (PAC)
`
`Civil Action No. 14-CV-2647 (PAC)
`
`Civil Action No. 14-CV-2759 (PAC)
`
`
`
`Case 1:14-cv-02758-PAC Document 57 Filed 04/10/15 Page 2 of 8
`
`Kowa Company, Ltd., et al.,
`
`Plaintiffs,
`
`v.
`
`Zydus Pharmaceuticals (USA) Inc., et al.,
`
`Defendants.
`
`Kowa Company, Ltd., et al.,
`
`Plaintiffs,
`
`v.
`
`Sawai USA, Inc., et al.,
`
`Defendants.
`
`Civil Action No. 14-CV-2760 (PAC)
`
`Civil Action No. 14-CV-5575 (PAC)
`
`JOINT DISPUTED CLAIM TERMS CHART
`
`Pursuant to the Civil Case Management Plan and Scheduling Order entered by the Court
`
`on October 17, 2014, Plaintiffs Kowa Company, Ltd., Kowa Pharmaceuticals America, Inc. and
`
`Nissan Chemical
`
`Industries, Ltd.
`
`(collectively “Plaintiffs”) and Defendants/Counterclaim-
`
`Plaintiffs Amneal Pharmaceuticals LLC (“Amneal”), Apotex Inc. and Apotex Corp. (“Apotex”),
`
`Aurobindo Pharma Limited and Aurobindo Pharma USA Inc. (collectively, “Aurobindo”),
`
`Mylan Pharmaceuticals Inc. and Mylan Inc. (collectively, “Mylan”), Orient Pharma Co., Ltd.
`
`(“Orient”), Sawai USA,
`
`Inc. and Sawai Pharmaceutical Co., Ltd.
`
`(“Sawai”), Zydus
`
`Pharmaceuticals (USA)
`
`Inc. and Cadila Healthcare Ltd.
`
`(dba Zydus Cadila)
`
`(“Zydus”)
`
`(collectively, “Defendants”)1 hereby provide the Court with the below chart, which identifies the
`
`1 The Apotex case caption is not included in these papers because no Markman issues are in
`dispute in that case.
`
`- 2 -
`
`
`
`Case 1:14-cv-02758-PAC Document 57 Filed 04/10/15 Page 3 of 8
`
`parties’ proposed constructions of the disputed claim terms of U.S. Patent Nos. 5,856,336 and
`
`6,465,4772.3
`
`Plaintiffs’ Position
`
`Plaintiffs do not believe that Defendants have identified any claim terms as to which
`
`claim construction is necessary or appropriate at this time. To the extent the Court believes that
`
`claim construction as to those claim terms is necessary and appropriate at this time, Plaintiffs
`
`have included herein their view as to the more appropriate construction as to these terms.
`
`Plaintiffs reserve the right to supplement and/or amend these proposed constructions.
`
`Defendants’ Position
`
`Defendants have identified two claim terms from two of the three asserted patents they
`
`believe require construction. The first claim term is from the ’336 patent and the second claim
`
`term is from the ’477 patent. Defendants disagree with Plaintiffs that construction of these terms
`
`is unnecessary since Defendants believe construction of these terms will likely bear on their
`
`respective invalidity and/or non-infringement positions in the case. Thus, Defendants believe
`
`that construing these terms is necessary and appropriate at this time. Defendants reserve the
`
`right to supplement and/or amend their proposed constructions of all the potentially disputed
`
`claim terms as necessary and appropriate, including in response to any actual construction of the
`
`potentially disputed claim terms that Plaintiffs may decide to offer. Defendants further reserve
`
`2 U.S. Patent No. 6,465,477 (“the ’477 patent”) is not at issue in the related cases involving
`Amneal and Aurobindo. Thus, Amneal and Aurobindo take no position on potentially disputed
`claim terms with respect to the ’477 patent. Furthermore, the Defendants do not believe any
`terms of U.S. Patent No. 8,557,993 B2 require construction.
`3 Pursuant to the Order entered by the Court on October 17, 2014, that the Markman hearing will
`not include indefiniteness, Defendants reserve their rights to raise indefiniteness arguments with
`respect to the patents-in-suit during the course of this litigation.
`
`- 3 -
`
`
`
`Case 1:14-cv-02758-PAC Document 57 Filed 04/10/15 Page 4 of 8
`
`the right to object to Plaintiffs’ proposed constructions based on, inter alia, the timetable for
`
`submission of the same.
`
`U.S. Patent No. 5,856,336
`
`Claim Term
`[applicable claims]
`“A compound of the formula,
`
`Z=―CH(OH)―CH2―CH(OH)―
`CH2―COO.1/2Ca.”
`
`[claim 1]
`
`Defendants’ Proposed
`Construction
`“A genus including each optical
`isomer of the formula
`
`Z=―CH(OH)―CH2―CH(OH)
`―CH2―COO.1/2Ca.
`and all mixtures thereof.”
`
`Plaintiffs’ Position
`
`No construction
`necessary, but to the
`extent the Court finds
`any construction
`necessary:
`
`“A compound having
`the following structure:
`
`Z=―CH(OH)―CH2―
`CH(OH)―CH2―COO.
`1/2Ca.
`
`- 4 -
`
`
`
`Case 1:14-cv-02758-PAC Document 57 Filed 04/10/15 Page 5 of 8
`
`U.S. Patent No. 6,465,477
`
`Claim Term
`[applicable claims]
`“an aqueous solution or dispersion
`of the pharmaceutical composition
`has pH of from 6.8 to 7.8”
`
`[claim 1]
`
`a
`
`Defendants’ Proposed
`Construction
`solid
`“A unit dose of
`the
`preparation
`of
`pharmaceutical
`composition
`has pH from 6.8 to 7.8 when
`dissolved or dispersed in 1 to
`10 mL of pure water”
`
`Plaintiffs’ Position
`
`No construction
`necessary, but to the
`extent the Court finds
`any construction
`necessary, the term
`“pH” :
`
`‘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.” (See ‘477
`patent, Col. 2, ll 56-61)
`
`- 5 -
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`
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`Case 1:14-cv-02758-PAC Document 57 Filed 04/10/15 Page 6 of 8
`
`Dated: April 10, 2015
`
`MINTZ, LEVIN, COHN, FERRIS, GLOVSKY AND
`POPEO, P.C.
`
`s/David G. Conlin
`Jennifer L. Dereka
`(jldereka@mintz.com)
`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)
`One Financial Center
`Boston, MA 02111
`(617) 542-6000
`
`- 6 -
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`
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`Case 1:14-cv-02758-PAC Document 57 Filed 04/10/15 Page 7 of 8
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`RAKOCZY MOLINO MAZZOCHI SIWIK LLP
`
`ALSTON & BIRD LLP
`
`s/Arnold B. Calmann
`William A. Rakoczy
`(wrakoczy@rmmslegal.com)
`Deanne M. Mazzochi
`(dmazzochi@rmmslegal.com)
`Amy D. Brody (abrody@rmmslegal.com)
`Luke T. Shannon (lshannon@rmmslegal.com)
`6 West Hubbard Street, Suite 500
`Chicago, Illinois 60654
`(312) 222-6301 (telephone)
`
`s/Natalie C. Clayton
`Natalie C. Clayton
`(Natalie.Clayton@alston.com)
`Paki Banky (paki.banky@alston.com)
`90 Park Avenue, 15th Floor
`New York, New York 10016-1387
`(212) 210-9400 (telephone)
`
`Attorneys for Defendant
`Orient Pharma Co., Ltd.
`
`Arnold B. Calmann (abc@saiber.com)
`Jakob B. Halpern (jbh@saiber.com)
`SAIBER LLC
`One Gateway Center, Suite 1000
`Newark, New Jersey 07102
`(973) 622-3333 (telephone)
`
`Attorneys for Defendants
`Mylan Pharmaceuticals Inc. and Mylan Inc.
`
`STERNE, KESSLER, GOLDSTEIN & FOX PLLC
`
`BUDD LARNER, P.C.
`
`s/Paul A. Ainsworth
`H. Keeto Sabharwal (keetos@skgf.com)
`Paul A. Ainsworth (painsworth@skgf.com)
`Chandrika Vira (cvira@skgf.com)
`1100 New York Avenue
`Washington, D.C. 20005
`(202) 772-8511 (telephone)
`
`Attorneys for Defendants Aurobindo Pharma
`Ltd. and Aurobindo Pharma USA Inc.
`
`s/Constance S. Huttner
`Andrew J. Miller (amiller@buddlarner.com)
`Constance S. Huttner
`(chuttner@buddlarner.com)
`Caroline Sun (csun@buddlarner.com)
`150 John F. Kennedy Parkway
`Short Hills, New Jersey 07078-2703
`(973) 379-4800 (telephone)
`
`Attorneys for Defendant
`Amneal Pharmaceuticals LLC
`
`- 7 -
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`
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`Case 1:14-cv-02758-PAC Document 57 Filed 04/10/15 Page 8 of 8
`
`KELLEY DRYE & WARREN LLP
`
`SUGHRUE MION, PLLC
`
`s/Vincent P. Rao II
`Steven J. Moore (smoore@kelleydrye.com)
`Vincent P. Rao II (vrao@kelleydrye.com)
`Elizabeth W. Swedock
`(eswedock@kelleydrye.com)
`101 Park Avenue
`New York, New York 10178
`(212) 808-7800 (telephone)
`
`Attorneys for Defendants Zydus
`Pharmaceuticals (USA) Inc. and Cadila
`Healthcare Limited
`
`s/Azy S. Kokabi
`Chidambaram S. Iyer (ciyer@sughrue.com)
`Michael R. Dzwonczyk
`(mdzwonczyk@sughrue.com)
`Azy S. Kokabi (akokabi@sughrue.com)
`SUGHRUE MION, PLLC
`2100 Pennsylvania Avenue, NW
`Washington, D.C. 20037-3213
`(202) 293-7060 (telephone)
`
`Craig S. Kesch
`FLEMMING ZULACK WILLIAMSON
`ZAUDERER LLP
`One Liberty Plaza
`New York, NY 10006-1404
`(212) 412-9500
`ckesch@fzwz.com
`
`Attorneys for Defendants Sawai USA, Inc. and
`Sawai Pharmaceutical Co., Ltd.
`
`- 8 -
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`