Case 1:13—cv—O2046—GMS Document 349 Filed 05/15/15 Page 1 of 11 Page|D #: 4457
`
`IN THE UNITED STATES DISTRICT COURT
`
`FOR THE DISTRICT OF DELAWARE
`
`IN RE BENDAl\/[USTINE CONSOLIDATED
`CASES
`
`C.A. No. 13-2046-GMS (consolidated)
`
`STIPULATION AND [PROPOSED] ORDER
`REGARDING AGREED-UPON CLAIM CONSTRUCTIONS
`
`Plaintiff and Defendants, by and through their respective undersigned counsel, hereby
`
`stipulate and agree as follows:
`
`WHEREAS, at the April 22, 2015 Markmcm hearing, the parties informed the Court that
`
`they have agreed upon constructions for the following claim terms:
`
`(1) “lyophilized
`
`composition” in the ‘524, ‘279 and ‘836 patents; (2) “lyophilized pharmaceutical composition”
`
`in the ‘l9O patent; and (3) “pharmaceutical composition that has been reconstituted” in the ‘27O
`
`patent; and that all parties except InnoPharrna have agreed upon constructions for the following
`
`claim terms:
`
`(4) “stable lyophilized preparation” in the ‘863 patent; and (5) “lyophilized
`
`preparation” / “lyophilized composition” in the ‘27O patent; and
`
`WHEREAS, at the conclusion of the Markmcm hearing, the Court instructed the parties to
`
`submit a stipulation setting forth the constructions upon which the parties have reached
`
`agreement.
`
`It is hereby STIPULATED and ORDERED, subject to the approval of the Court, that:
`
`1.
`
`All parties agree that the claim term “lyophilized composition” in the ‘524, ‘279
`
`and ‘836 patents should be construed to mean “freeze-dried composition,” with the
`
`understanding that this claim term covers only solid material.
`
`FRESENIUS KABI 1019-OOO1
`
`€€€€€€€€
`
`
`IN THE UNITED STATES DISTRICT COURT
`
`FOR THE DISTRICT OF DELAWARE
`
`IN RE BENDAl\/[USTINE CONSOLIDATED
`CASES
`
`C.A. No. 13-2046-GMS (consolidated)
`
`STIPULATION AND [PROPOSED] ORDER
`REGARDING AGREED-UPON CLAIM CONSTRUCTIONS
`
`Plaintiff and Defendants, by and through their respective undersigned counsel, hereby
`
`stipulate and agree as follows:
`
`WHEREAS, at the April 22, 2015 Markmcm hearing, the parties informed the Court that
`
`they have agreed upon constructions for the following claim terms:
`
`(1) “lyophilized
`
`composition” in the ‘524, ‘279 and ‘836 patents; (2) “lyophilized pharmaceutical composition”
`
`in the ‘l9O patent; and (3) “pharmaceutical composition that has been reconstituted” in the ‘27O
`
`patent; and that all parties except InnoPharrna have agreed upon constructions for the following
`
`claim terms:
`
`(4) “stable lyophilized preparation” in the ‘863 patent; and (5) “lyophilized
`
`preparation” / “lyophilized composition” in the ‘27O patent; and
`
`WHEREAS, at the conclusion of the Markmcm hearing, the Court instructed the parties to
`
`submit a stipulation setting forth the constructions upon which the parties have reached
`
`agreement.
`
`It is hereby STIPULATED and ORDERED, subject to the approval of the Court, that:
`
`1.
`
`All parties agree that the claim term “lyophilized composition” in the ‘524, ‘279
`
`and ‘836 patents should be construed to mean “freeze-dried composition,” with the
`
`understanding that this claim term covers only solid material.
`
`FRESENIUS KABI 1019-OOO1
`
`€€€€€€€€
`
`
`Case 1:13—cv—O2046—GMS Document 349 Filed 05/15/15 Page 2 of 11 Page|D #: 4458
`
`2.
`
`All parties agree that the claim term “lyophilized pharmaceutical composition” in
`
`the ‘l9O patent should be construed to mean “a freeze-dried composition that is made under
`
`conditions such that it is suitable for administration to humans upon reconstitution.”
`
`3.
`
`All parties agree that the claim term “pharmaceutical composition that has been
`
`reconstituted” in the ‘27O patent should be construed to mean “pharmaceutical composition that
`
`has been dissolved in a solvent and that is suitable for medical administration.”
`
`4.
`
`All parties except InnoPharrna agree that the claim term “stable lyophilized
`
`preparation” in the ‘863 patent should be construed to mean “solid material obtained by freeze-
`
`drying having sufficient stability to have utility as a pharmaceutical product,” with the
`
`understanding that this claim term covers only solid material1
`
`5.
`
`All parties except InnoPharrna agree that the claim term “lyophilized preparation”
`
`/ “lyophilized composition” in the ‘27O patent should be construed to mean “freeze-dried
`
`preparation” / “freeze-dried composition,” with the understanding that this claim term covers
`
`only solid material“
`
`InnoPharrna contends that this claim term means “the solid product of lyophilization that
`1
`has a detectable amount of TBA or an amount of TBA that materially alters the solubility of
`bendamustine in water, having sufficient stability to have utility as a pharmaceutical product.”
`
`InnoPharrna contends that this claim term means “the solid product of lyophilization, and
`2
`not the reconstituted product or the pre-lyophilization product, having an alcohol added that
`materially alters the solubility of bendamustine.”
`
`2
`
`FRESENIUS KABI 1019-OOO2
`
`
`
`Case 1:13—cv—O2046—GMS Document 349 Filed 05/15/15 Page 3 of 11 Page|D #: 4459
`
`SO AGREED AND STIPULATED:
`
`SHAW KELLER LLP
`
`BAYARD, P.A.
`
`/s/ John W. Shaw
`
`John W. Shaw (No. 3362)
`Karen E. Keller (No. 4489)
`300 Delaware Ave., Suite 1120
`Wilmington, DE 19801
`(302) 298-0700
`j shaw@ shawkeller. com
`kkeller@shawkeller.com
`
`OF COUNSEL:
`
`David M. Hashmall
`
`Calvin E. Wingfield Jr.
`Jonathan A. Auerbach
`
`Timothy J. Rousseau
`Joshua A. Whitehill
`
`GOODWIN PROCTER LLP
`
`The New York Times Building
`620 Eighth Avenue
`New York, NY 10018
`(212)813-8800
`
`Paul F. Ware
`
`Daryl L. Wiesen
`Emily L. Rapalino
`Nicholas K. Mitrokostas
`
`GOODWIN PROCTER LLP
`Exchange Place
`53 State Street
`
`Boston, MA 02109
`(617) 570-1000
`
`Counselfor Plaz'nZzflCephal0n, Inc. in C.A.
`Nos. 13-2046-GMS; 13-2082-GMS; 13-2094-
`
`/s/ Stephen B. Brauerrnan
`Stephen B. Brauerrnan (No. 4952)
`Vanessa R. Tiradentes (No. 5398)
`Sara E. Bussiere (No. 5725)
`222 Delaware Avenue, Suite 900
`Wilmington, DE 19801
`(302)655-5000
`sbrauerrnan@bayardlaw.com
`vtiradentes@bayardlaw.com
`sbussiere@bayardlaw.com
`
`OF COUNSEL:
`
`David M. Hashmall
`
`Calvin E. Wingfield Jr.
`Jonathan A. Auerbach
`
`Timothy J. Rousseau
`Joshua A. Whitehill
`
`GOODWIN PROCTER LLP
`
`The New York Times Building
`620 Eighth Avenue
`New York, NY 10018
`(212)813-8800
`
`Paul F. Ware
`
`Daryl L. Wiesen
`Emily L. Rapalino
`Nicholas K. Mitrokostas
`GOODWIN PROCTER LLP
`
`Exchange Place
`53 State Street
`Boston, MA 02109
`(617) 570-1000
`
`GMS; 14-122-GMS; 14-334-GMS; 14-335-
`GMS; 14-568-GMS, 14-671-GMS, 14-1116-
`
`Counselfor PlamZzflCephal0n, Inc. in C.A.
`Nos. 13-2080-GMS; 13-2081-GMS; 13-2095-
`
`GMS, 14-1241-GMS, 14-1242-GMS, and 14-
`
`GMS; 13-2104-GMS; 14-590-GMS, 14-1045-
`
`1332
`
`GMS, 14-123 7-GMS, 14-1238-GMS, and 14-
`1239-GMS
`
`FRESENIUS KABI 1019-OOO3
`
`
`
`Case 1:13—cv—O2046—GMS Document 349 Filed 05/15/15 Page 4 of 11 Page|D #: 4460
`
`SMITH KATZENSTEIN & JENKINS LLP
`
`ROSS ARONSTAM & MORITZ LLP
`
`/s/ Neal C. Belgam
`Neal C. Belgam (No. 2721)
`800 Delaware Avenue, Suite 1000
`P.O. BOX 410
`
`Wilmington, DE 19899
`(302) 504-1688
`nbelgam@skjlaw.com
`
`OF COUNSEL:
`
`Michael R. Dzwonczyk
`Sughrue Mion, PLLC
`2100 Pennsylvania Ave., N. W.
`Washington, DC 20037
`mdzwonczyk@sughrue.com
`
`Counselfor Accord Healthcare Inc.
`
`/s/ Benjamin J. Schladweiler
`Benjamin J. Schladweiler (No. 4601)
`100 S. West Street, Suite 400
`Wilmington, DE 19801
`(302) 576-1600
`bschladweiler@ramllp.com
`
`OF COUNSEL:
`
`Anthony J. Fitzpatrick
`Vincent L. Capuano
`Laura A. Vogel
`Carolyn A. Alenci
`Duane Morris LLP
`
`100 High Street, Suite 2400
`Boston, MA 02110-1724
`ajfitzpatrick@duanemorris.com
`vcapuano@duanemorris.com
`lavogel@duanemorris.com
`caalenci@duanemorris.com
`
`Counselfor Actavis LLC
`
`FRESENIUS KABI 1019-OOO4
`
`
`
`Case 1:13—cv—O2046—GMS Document 349 Filed 05/15/15 Page 5 of 11 Page|D #: 4461
`
`MORRIS JAl\/[ES LLP
`
`/s/ Mary B. Matterer
`Mary B. Matterer (No. 2696)
`500 Delaware Avenue, Suite 1500
`Wilmington, DE 19801
`(302) 888-6800
`mmatterer@morri sj ames. com
`
`OF COUNSEL:
`
`Nicole Stafford
`
`Anna Phillips
`Wilson, Sonsini, Goodrich & Rosati
`900 South Capital of Texas Highway
`Las Cimas IV, Fifth Floor
`
`Austin, TX 78746
`nstafford@wsgr.com
`anphillips@wsgr.com
`
`Joshua Mack
`
`Wilson, Sonsini, Goodrich & Rosati
`
`12235 El Camino Real, Suite 200
`San Diego, CA 92130
`(858)350-2300
`jmack@wsgr.com
`
`Counselfor Agila Specialties Inc., Onco
`Therapies Limited
`
`PINCKNEY, WEIDINGER, URBAN &
`JOYCE LLC
`
`/s/ Gregory T. Donilon
`Elizabeth Wilburn Joyce (No. 3666)
`Gregory T. Donilon (No. 4244)
`1220 N. Market Street, Suite 950
`Wilmington, DE 19801
`(302) 504-1497
`ewilburnjoyce@pwujlaw.com
`
`OF COUNSEL:
`
`Louis H. Weinstein
`
`James P. Barabas
`
`BUDD LARNER, P.C.
`50 John F. Kennedy Parkway
`Short Hills, NJ 07078
`(973) 379-4800
`lweinstein@buddlarner.com
`jbarabas@buddlarner.com
`
`Counselfor Dr. Reddy ’s Laboratories Ltd. and
`Dr. Reddy ’s Laboratories Inc.
`
`FRESENIUS KABI 1019-OOO5
`
`
`
`Case 1:13—cv—O2046—GMS Document 349 Filed 05/15/15 Page 6 of 11 Page|D #: 4462
`
`STAMOULIS & WEINBLATT LLC
`
`STAMOULIS & WEINBLATT LLC
`
`/s/ Stamatios Stamoulis
`
`/s/ Stamatios Stamoulis
`
`Stamatios Stamoulis (No. 4606)
`Richard C. Weinblatt (No. 5080)
`Two Fox Point Centre
`
`Stamatios Stamoulis (No. 4606)
`Richard C. Weinblatt (No. 5080)
`Two Fox Point Centre
`
`6 Denny Road, Suite 307
`Wilmington, DE 19809
`(302) 999-1540
`stamoulis@swdelaw.com
`weinblatt@swdelaw.com
`
`6 Denny Road, Suite 307
`Wilmington, DE 19809
`(302) 999-1540
`stamoulis@swdelaw.com
`weinblatt@swdelaw.com
`
`OF COUNSEL:
`
`OF COUNSEL:
`
`Barry S. White
`Steven M. Amundson
`Frommer Lawrence & Haug LLP
`745 Fifth Avenue
`New York, New York 10151
`(212) 588-0800
`bwhite@flhlaw.com
`
`Michael H. Baniak
`Vincent M. Smolczynski
`Seyfarth Shaw LLP
`131 South Dearborn Street, Suite 2400
`Chicago, IL 60603
`mbaniak@seyfath.com
`Vsmolczynski@seyfarth.com
`
`Counselfor Emcure Pharmaceuticals Ltd. and Nigamnarayan (Nigarn) Acharya
`Emcure Pharmaceuticals USA, Inc.
`SEYFARTH SHAW LLP
`
`1075 Peachtree Street, N.E., Suite 2500
`Atlanta, GA 30309
`nacharya@seyfarth.com
`
`Shashank Upadhye
`Joseph Cwik
`55 W. Monroe Street, Ste. 3400
`
`Chicago, IL 60603
`(312) 327-3326
`Inno-bendamustine@aminta1ati.com
`
`Counselfor Inn0Pharma, Inc.
`
`FRESENIUS KABI 1019-0006
`
`
`
`Case 1:13—cv—O2046—GMS Document 349 Filed 05/15/15 Page 7 of 11 Page|D #: 4463
`
`STAMOULIS & WEINBLATT LLC
`
`PROCTER HEYMAN LLP
`
`/s/ Stamatios Stamoulis
`
`/s/ Dominick Gattuso
`
`Stamatios Stamoulis (No. 4606)
`Richard C. Weinblatt (No. 5080)
`Two Fox Point Centre
`6 Denny Road, Suite 307
`Wilmington, DE 19809
`(302) 999-1540
`stamoulis@swdelaw.com
`weinblatt@swdelaw.com
`
`OF COUNSEL:
`
`Paul H. Berghoff
`Paul S. Tully, Ph.D.
`Erin R. Woelker
`
`MCDONNELL BOEHNEN HULBERT &
`BERGHOFF LLP
`300 S. Wacker Dr.
`Chicago, Illinois 60606
`(312)913-0001
`
`Counselfor Pharmascience, Inc.
`
`Dominick Gattuso (No. 3630)
`300 Delaware Ave., Suite 200
`Wilmington, DE 19801
`(302) 472-7300
`DGattuso@proctorheyman.com
`
`OF COUNSEL:
`
`David C. Doyle
`Eric M. Acker
`
`E. Cary Miller
`Stephen D. Keane
`Mary Prendergast
`MORRISON & FOERSTER LLP
`
`12531 High Bluff Drive, Suite 100
`San Diego, California 92130-2040
`Telephone: 858.720.5100
`DDoyle@mofo.com
`EAcker@mofo.com
`EMiller@mofo.com
`SKeane@mofo.com
`l\/[Prendergast@mofo.com
`
`Counselfor Scmdoz Inc.
`
`FRESENIUS KABI 1019-OOO7
`
`
`
`Case 1:13—cv—O2046—GMS Document 349 Filed 05/15/15 Page 8 of 11 Page|D #: 4464
`
`ABRAMS & BAYLIS S, LLP
`
`/s/
`
`John M. Seaman (No. 3868)
`20 Montchanin Road, Suite 200
`Wilmington, DE 19807
`(302) 778-1000
`seaman@abramsbayliss.com
`
`OF COUNSEL:
`
`Neal Seth
`
`Karin Hessler
`
`Wiley Rein LLP
`1776 K St NW
`
`Washington DC 20006
`nseth@wileyrein.com
`
`Counselfor Hetero Labs Ltd. and Hetero USA,
`Inc.
`
`YOUNG CONAWAY STARGATT &
`TAYLOR LLP
`
`/s/ Samantha G. Wilson
`Melanie K. Sharp (No. 2501)
`Monte T. Squire (No. 4764)
`Samantha G. Wilson (No. 5816)
`1000 North King Street
`Wilmington, DE 19801
`(302) 571-6881
`msharp@ycst.com
`
`JENNER & BLOCK LLP
`
`Bradford P. Lyerla
`Sara Tonnies Horton
`
`Yusuf Esat
`353 N. Clark St.
`Chicago, IL 60654 -3456
`(312) 222-9350
`
`Counselfor Hospira, Inc.
`
`FRESENIUS KABI 1019-OOO8
`
`
`
`Case 1:13—cv—O2046—GMS Document 349 Filed 05/15/15 Page 9 of 11 Page|D #: 4465
`
`FLASTER/GREENBERG P.C.
`
`POLSINELLI PC
`
`/s/ William Burnett
`William J. Burnett (#4078)
`1000 N. West Street
`Suite 1200
`Wilmington, DE 19801
`302.351.1910
`william.bumett@flastergreenberg.com
`
`Attorneysfor Defendants Eurohealth
`International Sarl and West-Ward
`Pharmaceutical Corp.
`
`/s/ R. Montgomery Donaldson
`R. Montgomery Donaldson (DE Bar No. 4367)
`Shanti M. Katona (DE Bar No. 5352)
`222 Delaware Avenue, Suite 1101
`Wilmington, Delaware 19801
`Phone:
`(302) 252-0920
`Fax:
`(3 02) 252-0921
`rrndonaldson@polsinelli.com
`skatona@polsinelli.com
`
`OF COUNSEL;
`
`Ronald M. Daignault
`Tedd W. Van Buskirk
`
`POLSINELLI PC
`
`900 Third Avenue
`
`21“ Floor
`
`New York, NY 10022
`Phone: (212)684-0199
`Fax: (212) 684-0197
`rdaignault@polsinelli.com
`
`Counselfor Defendant Sagent
`Pharmaceuticals, Inc.
`
`FRESENIUS KABI 1019-0009
`
`
`
`Case 1:13—cv—O2046—GMS Document 349 Filed 05/15/15 Page 10 of 11 Page|D #: 4466
`
`RICHARDS, LAYTON & FINGER, P.A.
`
`BIFFERATO, LLC
`
`/s/ Kelly E. Farnan
`Kelly E. Faman (#4395)
`One Rodney Square
`P.O. Box 551
`Wilmington, DE 19899
`(302) 651-7700
`Faman@rlf.com
`
`OF COUNSEL:
`Robert Vroom
`
`Breckenridge Pharmaceutical Inc.
`60 E. 42”“ Street, Suite 5210
`New York, New York 10165
`
`/s/
`Thomas F. Driscoll III (#4703)
`800 N. King Street, Plaza Legal
`Wilmington, DE 19801
`Tel : (302)254-7600
`tdriscoll@bifferato.com
`
`OF COUNSEL:
`
`Jay R. Deshmukh
`William R. Zimmerman
`
`KNOBBE, MARTENS, OLSON & BEAR,
`LLP
`1717 Pennsylvania Avenue N.W., Suite 900
`Washington, DC 20006
`Tel: 202-640-6400
`
`Attorneysfor Defendants Breckenridge
`Pharmaceutical, Inc. and Natco Pharma
`Limited
`
`Thomas P. Krzeminski
`William O. Adams
`
`Karen M. Cassidy
`KNOBBE, MARTENS, OLSON & BEAR,
`LLP
`
`2040 Main Street, 14th Floor
`
`Irvine, CA 92614
`Tel: 949-760-0404
`
`Attorneysfor Defendants Wockhardt Bio AG,
`Wockhardt Ltd, and Wockhardt USA, LLC
`
`Dated: May 15, 2015
`
`10
`
`FRESENIUS KABI 1019-0010
`
`
`
`Case 1:13—cv—O2046—GMS Document 349 Filed 05/15/15 Page 11 of 11 Page|D #: 4467
`
`IT IS SO ORDERED this
`
`day of
`
`2015
`
`United States District Judge
`
`11
`
`FRESENIUS KABI 1019-0011
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