Case 1:13-cv-01679-GMS Document 39 Filed 04/23/15 Page 1 of 5 PageID #: 360
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
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`CUBIST PHARMACEUTICALS, INC.,
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`Plaintiff,
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`v.
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`
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`STRIDES, INC. and AGILA SPECIALTIES
`PRIVATE LIMITED,
`
`
`
`
`
`
`C.A. No. 13-1679 (GMS)
`
`
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`))
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`
`
`
`
`Defendants.
`
`STIPULATION TO NARROW ISSUES IN THE LITIGATION,
`COVENANT NOT TO SUE, AND SETTLEMENT OF IPR PROCEEDINGS
`
`Plaintiff Cubist Pharmaceuticals, Inc. (“Plaintiff”) and Defendants Agila Specialties Inc.
`
`(f/k/a Strides, Inc.) and Agila Specialties Private Limited (collectively, “Defendants”), by their
`
`undersigned counsel, stipulate and agree as follows:
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`WHEREAS Defendants submitted Abbreviated New Drug Application No. 205037
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`(“Defendants’ ANDA”) to obtain approval from the FDA to engage in the commercial
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`manufacture, use and/or sale of generic daptomycin injectable, IV (infusion), 500 mg/vial
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`(“Defendants’ 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. 21-572
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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. Strides, Inc. et al,
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`C.A. No. 13-1679-GMS (D. Del) (“this Litigation”) that the filing of Defendants’ ANDA
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`PETITIONER - EXHIBIT 1040
`
`
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`)
`)
`)
`)
`)
`)
`)
`)
`
`CUBIST PHARMACEUTICALS, INC.,
`
`
`Plaintiff,
`
`
`
`
`
`
`v.
`
`
`
`STRIDES, INC. and AGILA SPECIALTIES
`PRIVATE LIMITED,
`
`
`
`
`
`
`C.A. No. 13-1679 (GMS)
`
`
`
`))
`
`
`
`
`
`Defendants.
`
`STIPULATION TO NARROW ISSUES IN THE LITIGATION,
`COVENANT NOT TO SUE, AND SETTLEMENT OF IPR PROCEEDINGS
`
`Plaintiff Cubist Pharmaceuticals, Inc. (“Plaintiff”) and Defendants Agila Specialties Inc.
`
`(f/k/a Strides, Inc.) and Agila Specialties Private Limited (collectively, “Defendants”), by their
`
`undersigned counsel, stipulate and agree as follows:
`
`WHEREAS Defendants submitted Abbreviated New Drug Application No. 205037
`
`(“Defendants’ ANDA”) to obtain approval from the FDA to engage in the commercial
`
`manufacture, use and/or sale of generic daptomycin injectable, IV (infusion), 500 mg/vial
`
`(“Defendants’ ANDA Product”);
`
`WHEREAS Plaintiff represents that it owns Patent No. 6,468,967 (the “’967 Patent”),
`
`Patent No. 6,852,689 (the “’689 Patent”), Patent No. 8,058,238 (the “’238 Patent”), and Patent
`
`No. 8,129,342 (the “’342 Patent”);
`
`WHEREAS Plaintiff represents that it holds approved New Drug Application No. 21-572
`
`for Cubicin® injectable, IV (infusion), 500 mg/vial, which contains the active ingredient
`
`daptomycin;
`
`WHEREAS Plaintiff has asserted in Cubist Pharmaceuticals Inc., v. Strides, Inc. et al,
`
`C.A. No. 13-1679-GMS (D. Del) (“this Litigation”) that the filing of Defendants’ ANDA
`
`PETITIONER - EXHIBIT 1040
`
`
`
`Case 1:13-cv-01679-GMS Document 39 Filed 04/23/15 Page 2 of 5 PageID #: 361
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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 Defendants’ 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 Defendants’ 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 Defendants’ ANDA Product would infringe (directly or indirectly) claims
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`1-45 of the ’967 Patent, claims 1-57 of the ’689 Patent, claims 1-192 of the ’238 Patent, or
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`claims 1-54 of the ’342 Patent;
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`WHEREAS at issue in this Litigation is whether claims 1-45 of the ’967 Patent, claims 1-
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`57 of the ’689 Patent, claims 1-192 of the ’238 Patent, or claims 1-54 of the ’342 Patent are
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`invalid;
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`WHEREAS Defendant Agila Specialties Inc. and Mylan Pharmaceuticals Inc. filed inter
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`partes review petitions with the U.S. Patent and Trademark Office’s Patent Trial and Appeal
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`Board (the “PTAB”) challenging the validity of certain claims of the ’967, ’689, ’238, and ’342
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`Patents, the inter partes review petitions filed by Defendant Agila Specialties Inc. and Mylan
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`Pharmaceuticals Inc. are as follows (referred to hereinafter as the “IPR Petitions”):
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`
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`IPR2015-00131: challenging the validity of claims 1-17 and 20-45 of the
`’967 Patent;
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`IPR2015-00132: challenging the validity of claims 1-12, 14-18, 21-30,
`32,33, and 36-57 of the ’689 Patent;
`
`IPR2015-00140: challenging the validity of claims 1-54 of the ’342
`Patent;
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`IPR2015-00141: challenging the validity of claims 1-7, 49, 52-65, 93,
`108-111, 125-138, and 147-150 of the ’238 Patent;
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`IPR2015-00142: challenging the validity of claims 8-9, 49-51, 85-92, 105-
`107, 113-124, 144-146, 151-162, and 164-175 of the ’238 Patent;
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`2
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`
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`Case 1:13-cv-01679-GMS Document 39 Filed 04/23/15 Page 3 of 5 PageID #: 362
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`
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`
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`IPR2015-00143: challenging the validity of claims 37-42, 48, 139-143;
`66-84, 94-104, 112, and 163 of the ’238 Patent; and
`
`IPR2015-00144: challenging the validity of claims 10-48, 139-143, and
`176-192 of the ’238 Patent;
`
`WHEREAS, for the sole purpose of this stipulation and agreement, hereinafter the term
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`“Defendants” includes Mylan Pharmaceuticals in its capacity as a co-petitioner with Agila
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`Specialties Inc. in the filing of the IPR Petitions; and
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`WHEREAS Plaintiff and Defendants seek to narrow the issues in dispute in this
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`Litigation and before the PTAB and thereby reduce the effort and judicial resources expended by
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`the Delaware District Court and the PTAB and reduce the time and expense consumed by
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`Plaintiff and Defendants;
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`Now, THEREFORE, Plaintiff and Defendants, by their undersigned counsel, hereby
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`provide as follows:
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`1.
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`Without prejudice to any claim or defense Defendants have in this
`
`Litigation, Defendants agree to request that the IPR Petitions be withdrawn or terminated by
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`contacting the PTAB within one (1) business day of execution of the present Stipulation to
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`request leave to file a motion to withdraw or terminate each IPR Petition and filing such motion
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`within two (2) business days of PTAB approval to file; and Defendants further stipulate and
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`agree not to file, maintain, join, or support another challenge to any claims of the ‘238, ‘342,
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`‘967, or ‘689 patents in the U.S. Patent Office;
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`2.
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`Plaintiff agrees to join or not oppose the request to withdraw/terminate the
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`IPR Petitions;
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`3.
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`Defendants stipulate and agree as follows:
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`3
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`
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`Case 1:13-cv-01679-GMS Document 39 Filed 04/23/15 Page 4 of 5 PageID #: 363
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`a.
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`Defendants consent to the entry of a judgment finding that the
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`commercial manufacture, use, sale, offer for sale, or importation of Defendants’ ANDA Product
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`would infringe claims 91, 98 and 187 of the ’238 Patent, claims 23 and 53 of the ’342 Patent,
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`claims 16-17 and 34-35 of the ’967 Patent, and claims 51-52 of the ’689 Patent to the extent that
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`such claims are not found to be unenforceable or invalid pursuant to a final and non-appealable
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`decision.
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`b.
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`Defendants consent to the entry of a judgment finding the
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`submission of Defendants’ ANDA to the FDA to have infringed claims 91, 98 and 187 of the
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`’238 Patent, claims 23 and 53 of the ’342 Patent, claims 16-17 and 34-35 of the ’967 Patent, and
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`claims 51-52 of the ’689 Patent to the extent that such claims are not found to be unenforceable
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`or invalid pursuant to a final and non-appealable decision.
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`4.
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`Plaintiff stipulates and agrees to limit the asserted claims against
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`Defendants (or their successors and/or assigns) in this Litigation to claims 91, 98 and 187 of the
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`’238 Patent, claims 23 and 53 of the ’342 Patent, claims 16-17 and 34-35 of the ’967 Patent, and
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`claims 51-52 of the ’689 Patent;
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`5.
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`Plaintiff covenants not to sue or otherwise hold Defendants (or their
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`successors and assigns) liable for infringement of claims 1-15, 18-33, and 36-45 of the ’967
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`Patent, claims 1-50 and 53-57 of the ’689 Patent, claims 1-90, 92-97, 99-186, and 188-192 of the
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`’238 Patent, and claims 1-22, 24-52, and 54 of the ’342 Patent (collectively the “Unasserted
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`Claims”) based on: (1) the filing of Defendants’ ANDA or (2) Defendants’ manufacture,
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`importation into the United States, sale, offer for sale and/or use of Defendants’ ANDA Product.
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`6.
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`Defendants stipulate and agree to dismiss from this Litigation and, with
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`respect to Defendants’ ANDA Product, not reassert in any action: (a) Defendants’ Affirmative
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`4
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`Case 1:13-cv-01679-GMS Document 39 Filed 04/23/15 Page 5 of 5 PageID #: 364
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`Defenses with respect to the Unasserted Claims; (b) Defendants’ Counterclaims directed to a
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`declaratory judgment of non-infringement relating to: (1) the filing of Defendants’ ANDA or (2)
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`Defendants’ manufacture, importation into the United States, sale, offer for sale and/or use of
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`Defendants’ ANDA Product; and (c) Defendants’ Counterclaims directed to a declaratory
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`judgment of invalidity of the Unasserted Claims.
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`7.
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`Plaintiff and Defendants agree that the claims or defenses not specifically
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`addressed herein are not prejudiced or otherwise affected by this stipulation and agreement.
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`8.
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`Plaintiff and Defendants agree that this stipulation and agreement is
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`binding on their respective successors and assigns.
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`MORRIS, NICHOLS, ARSHT & TUNNELL LLP
`
`/s/ Jack B. Blumenfeld
`
`Jack B. Blumenfeld (#1014)
`Maryellen Noreika (#3208)
`1201 North Market Street
`P.O. Box 1347
`Wilmington, DE 19899
`(302) 658-9200
`jblumenfeld@mnat.com
`mnoreiks@mnat.com
`
`
`
`Attorneys for Plaintiff and Patent Owner
`Cubist Pharmaceuticals, Inc.
`
`OF COUNSEL:
`
`William F. Lee
`Lisa J. Pirozzolo
`Emily Whelan
`Sean Thompson
`WILMER CUTLER PICKERING HALE
` AND DORR LLP
`60 State Street
`Boston, MA 02109
`(617) 526-6000
`
`
`5
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`POTTER ANDERSON & CORROON LLP
`
`/s/ Richard L. Horwitz
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`____________________________
`Richard L. Horwitz (#2246)
`David E. Moore (#3983)
`Bindu A. Palapura (#5370)
`Hercules Plaza
`P.O. Box 951
`Wilmington, DE 19899
`(302) 984-6000
`rhorwitz@potteranderson.com
`dmoores@potteranders.com
`bpalapura@potteranderson.com
`
`Attorneys for Defendants Agila Specialties Inc. and
`Agila Specialties Private Limited and for Mylan
`Pharmaceuticals Inc.
`
`OF COUNSEL:
`
`Nicole Stafford
`WILSON SONSINI GOODRICH & ROSATI
`900 South Capital of Texas Highway
`Las Cimas IV, Fifth Floor
`Austin, TX 78746
`(512) 338-5402
`
`
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