`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`C.A. No. 14-914 (GMS)
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`REDACTED -
`REDACTED -
`PUBLIC VERSION
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`)))))))))
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`CUBIST PHARMACEUTICALS, INC.,
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`v.
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`Plaintiff,
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`FRESENIUS KABI USA, LLC,
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`Defendant.
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`STIPULATION AND AGREEMENT TO NARROW ISSUES IN THE
`LITIGATION AND IPR PROCEEDINGS AND COVENANT NOT TO SUE
`
`MORRIS, NICHOLS, ARSHT & TUNNELL LLP
`Jack B. Blumenfeld (#1014)
`Maryellen Noreika (#3208)
`1201 N. Market Street, 16th Floor
`P.O. Box 1347
`Wilmington, DE 19899
`(302) 658-9200
`jblumenfeld@mnat.com
`mnoreika@mnat.com
`
`Attorneys for Plaintiff and Counterclaim
`Defendant Cubist Pharmaceuticals, Inc.
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`REDACTED -
`Original Filing Date: August 10, 2015
`Redacted Filing Date: August 17, 2015
`
`SHAW KELLER LLP
`Karen E. Keller (#4489)
`Jeffrey T. Castellano (#4837)
`300 Delaware Avenue, Suite 1120
`Wilmington, DE 19801
`(302) 298-0700
`kkeller@shawkeller.com
`jcastellano@shawkeller.com
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`Attorneys for Defendant and Counterclaim
`Plaintiff Fresenius Kabi USA, LLC
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`1 of 14
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`FRESENIUS-KABI, Exh. 1042
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`Case 1:14-cv-00914-GMS Document 77 Filed 08/17/15 Page 2 of 14 PageID #: 530
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`C.A. No. 14-914 (GMS)
`
`REDACTED -
`REDACTED -
`PUBLIC VERSION
`
`)))))))))
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`CUBIST PHARMACEUTICALS, INC.,
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`
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`
`
`
`
`v.
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`Plaintiff,
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`FRESENIUS KABI USA, LLC,
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`
`
`
`
`
`
`Defendant.
`
`STIPULATION AND AGREEMENT TO NARROW ISSUES IN THE
`LITIGATION AND IPR PROCEEDINGS AND COVENANT NOT TO SUE
`
`Plaintiff Cubist Pharmaceuticals, Inc. (“Plaintiff”) and Defendant Fresenius Kabi USA,
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`LLC (“Defendant”), by their undersigned counsel, stipulate and agree as follows:
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`WHEREAS Defendant submitted Abbreviated New Drug Application No. 206077
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`(together with any amendments or supplements thereto, “Defendant’s ANDA”) to obtain
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`approval from the FDA to engage in the commercial manufacture, use and/or sale of the generic
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`daptomycin injectable product described therein (“Defendant’s ANDA Product”);
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`WHEREAS Plaintiff represents that it owns Patent No. 6,468,967 (the “’967 Patent”),
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`Patent No. 6,852,689 (the “’689 Patent”), Patent No. 8,058,238 (the “’238 Patent”), and Patent
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`No. 8,129,342 (the “’342 Patent”);
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`WHEREAS Plaintiff represents that it holds approved New Drug Application No. 21572
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`for CUBICIN® injectable, IV (infusion), 500 mg/vial, which contains the active ingredient
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`daptomycin;
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`WHEREAS Plaintiff has asserted in Cubist Pharmaceuticals, Inc., v. Fresenius Kabi
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`USA, LLC, C.A. No. 14-914-GMS (D. Del.) (“this Litigation”) that the filing of Defendant’s
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`ANDA infringes (directly or indirectly) and/or the commercial manufacture, use, offer for sale,
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`2 of 14
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`Case 1:14-cv-00914-GMS Document 77 Filed 08/17/15 Page 3 of 14 PageID #: 531
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`sale and/or importation of Defendant’s ANDA Product would infringe (directly or indirectly) the
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`’967, ’689, ’238, and ’342 Patents;
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`WHEREAS at issue in this Litigation is whether the filing of Defendant’s ANDA
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`infringes (directly or indirectly) and/or the commercial manufacture, use, offer for sale, sale
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`and/or importation of Defendant’s ANDA Product would infringe (directly or indirectly) the
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`asserted claims of the ’967, ’689, ’238, and ’342 Patents;
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`WHEREAS at issue in this Litigation is whether the asserted claims of the ’967, ’689,
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`’238, and ’342 Patents are invalid;
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`WHEREAS Defendant filed inter partes review petitions with the U.S. Patent and
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`Trademark Office’s Patent Trial and Appeal Board (the “PTAB”) challenging the validity of
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`certain claims of the ’967, ’689, ’238, and ’342 Patents, the inter partes review petitions filed by
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`Defendant are as follows (referred to hereinafter as the “IPR Petitions”):
`
`(cid:120)
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`(cid:120)
`
`(cid:120)
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`(cid:120)
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`(cid:120)
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`(cid:120)
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`IPR2015-00227: challenging the validity of claims 1-7, 12-28, and 32-45
`of the ’967 Patent;
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`IPR2015-00223: challenging the validity of claims 1-5 and 10-57 of the
`’689 Patent;
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`IPR2015- 01566: challenging the validity of claims 1-54 of the ’342
`Patent;
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`IPR2015-01570: challenging the validity of claims 3-7, 21-25, 27-33, 35-
`44, 48-52, 61-63, 66, 85, 87-89, 92-109, 113, 115-121, 123-151, 153-159,
`161-162, 164-167, 175-184, and 189-190 of the ’238 Patent;
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`IPR2015-01571: challenging the validity of claims 1-19, 21-44, 48-51, 53,
`92-107, 112-146, 151-167, 176-177, 179, and 183-189 of the ’238 Patent;
`and
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`IPR2015-01572: challenging the validity of claims 20, 45-47, 49-52, 54-
`91, 108-111, 147-150, 168-175, 182-183, and 190-192 of the ’238 Patent;
`and
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`Case 1:14-cv-00914-GMS Document 77 Filed 08/17/15 Page 4 of 14 PageID #: 532
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`WHEREAS Plaintiff and Defendant seek to narrow the issues in dispute in this Litigation
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`and before the PTAB and thereby reduce the effort and judicial resources expended by the
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`Delaware District Court and the PTAB and reduce the time and expense consumed by Plaintiff
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`and Defendant;
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`Now, THEREFORE, Plaintiff and Defendant, by their undersigned counsel, subject to the
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`approval of the Court, hereby provide as follows:
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`Case 1:14-cv-00914-GMS Document 77 Filed 08/17/15 Page 5 of 14 PageID #: 533
`Case 1:14—cv—OO914—GMS Document 77 Filed 08/17/15 Page 5 of 14 Page|D #: 533
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`Case 1:14-cv-00914-GMS Document 77 Filed 08/17/15 Page 6 of 14 PageID #: 534
`Case 1:14—cv—OO914—GMS Document 77 Filed 08/17/15 Page 6 of 14 Page|D #: 534
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`Case 1:14-cv-00914-GMS Document 77 Filed 08/17/15 Page 7 of 14 PageID #: 535
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`MORRIS, NICHOLS, ARSHT & TUNNELL LLP
`
`SHAW KELLER LLP
`
`/s/ Maryellen Noreika
`
`Jack B. Blumenfeld (#1014)
`Maryellen Noreika (#3208)
`1201 North Market Street
`P.O. Box 1347
`Wilmington, DE 19899
`(302) 658-9200
`jblumenfeld@mnat.com
`mnoreika@mnat.com
`
`Attorneys for Plaintiff Cubist
`Pharmaceuticals, Inc.
`
`OF COUNSEL:
`
`William F. Lee
`Lisa J. Pirozzolo
`Emily R. Whelan
`Sean K. Thompson
`Ryann M. Muir
`WILMER CUTLER PICKERING HALE
` AND DORR LLP
`60 State Street
`Boston, MA 02109
`(617) 526-6000
`
`/s/ Jeffrey T. Castellano
`
`Karen E. Keller (#4489)
`Jeffrey T. Castellano (#4837)
`300 Delaware Avenue, Suite 1120
`Wilmington, DE 19802
`(302) 298-0700
`kkeller@shawkeller.com
`jcastellano@shawkeller.com
`
`Attorneys for Defendant Fresenius Kabi USA,
`LLC
`
`OF COUNSEL:
`
`Elizabeth J. Holland
`Robert V. Cerwinski
`Daniel P. Margolis
`Linnea P. Cipriano
`Aviv Zalcenstein
`GOODWIN PROCTER LLP
`The New York Times Building
`620 Eighth Avenue
`New York, NY 10018
`(212) 813-8800
`
`IT IS SO ORDERED this
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`
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` day of August 2015.
`
`United States District Judge
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`6
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`Case 1:14-cv-00914-GMS Document 77 Filed 08/17/15 Page 8 of 14 PageID #: 536
`Case 1:14—cv—0O914—GMS Document 77 Filed 08/17/15 Page 8 of 14 Page|D #: 536
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`Case 1:14-cv-00914-GMS Document 77 Filed 08/17/15 Page 9 of 14 PageID #: 537
`Case 1:14—cv—0O914—GMS Document 77 Filed 08/17/15 Page 9 of 14 Page|D #: 537
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`Case 1:14-cv-00914-GMS Document 77 Filed 08/17/15 Page 10 of 14 PageID #: 538
`Case 1:14—cv—0O914—GMS Document 77 Filed 08/17/15 Page 10 of 14 Page|D #: 538
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`Case 1:14-cv-00914-GMS Document 77 Filed 08/17/15 Page 11 of 14 PageID #: 539
`Case 1:14—cv—0O914—GMS Document 77 Filed 08/17/15 Page 11 of 14 Page|D #: 539
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`Case 1:14—cv—0O914—GMS Document 77 Filed 08/17/15 Page 12 of 14 Page|D #: 540
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`Case 1:14-cv-00914-GMS Document 77 Filed 08/17/15 Page 13 of 14 PageID #: 541
`Case 1:14—cv—0O914—GMS Document 77 Filed 08/17/15 Page 13 of 14 Page|D #: 541
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`Case 1:14-cv-00914-GMS Document 77 Filed 08/17/15 Page 14 of 14 PageID #: 542
`Case 1:14—cv—0O914—GMS Document 77 Filed 08/17/15 Page 14 of 14 Page|D #: 542
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