John E. Flaheity
`Ravin R. Patel
`
`MCCARTER & ENGLISH LLP
`Four Gateway Center
`100 Mulberry Street
`Newark, New Jersey 07102
`(973) 622-4444
`
`Afton/zeysfor Plaintfls AsrraZeneca
`Pharmaceuticals LP, ASImZeneca UK Limited,
`and AsrraZeneca AB.
`
`OF COUNSEL:
`
`Lisa B. Pensabene, Esq.
`Filko Prugo, Esq.
`Will C. Autz, Esq.
`O’MELVENY & MYERS LLP
`7 Times Square
`New York, NY 10036
`
`(212) 326-2000
`
`IN THE UNITED STATES DISTRICT COURT
`
`FOR THE DISTRICT OF NEVV JERSEY
`
`ASTRAZENECA PHARMACEUTICALS LP,
`ASTRAIZENECA UK LIMITED, and
`
`ASTRAZENECA AB,
`
`Plaintiffs,
`
`V.
`
`INNOPHARMA LICENSING LLC,
`
`Defendant.
`
`
`
`Civil Action No.
`
`COMPLAINT FOR PATENT INFRINGEMENT
`
`Plaintiffs Astrazeneca Pharmaceuticals LP, Astrazeneca UK Limited, and Astrazeneca
`
`AB (collectively “Plaintiffs” or “AstraZeneca”) bring this action for patent infringement against
`
`InnoPl1arma Licensing LLC (“Defendant”).
`
`THE PARTIES
`
`1.
`
`Plaintiff AstraZeneca Pharmaceuticals LP is a limited partnership organized under
`
`the laws of the State of Delaware, with its principal place of business at 1800 Concord Pike,
`
`Wilmington, Delaware 19850, U.S.A.
`
`|nnoPharma Exhibit 1005.0001
`
`

`

`2.
`
`Plaintiff AstraZeneea UK Limited is a private limited company organized under
`
`the laws of England and Wales, with its registered office at 2 Kingdom St, London W2 6BD,
`
`United Kingdom.
`
`3.
`
`Plaintiff AstraZeneca AB is a public limited liability company organized under
`
`the laws of Sweden with its principal place of business at Karlebyhus, Astraallen, Sodertalje,
`
`S-151 85, Sweden.
`
`4.
`
`On
`
`information
`
`and
`
`belief, Defendant
`
`InnoPharma Licensing
`
`LLC
`
`(“InnoPharma”) is a company having its principal place of business at 10 Knightsbridge Road,
`
`Piscataway, New Jersey 08854.
`
`NATURE OF THE ACTION
`
`5.
`
`This is a civil action for patent infringement under the patent laws of the United
`
`States, Title 35, United States Code, arising out of the filing by InnoPharma of Abbreviated New
`
`Drug Application (“ANDA”) No. 208648 with the U.S. Food and Drug Administration (“FDA”)
`
`seeking approval to engage in the commercial manufacture, use and sale of fulvestrant injection,
`
`50 mg/mL (the “Proposed ANDA Product”), which is a generic version of AstraZeneca’s
`
`FASLODEX® (fulvestrant)
`
`intramuscular
`
`injection product, prior
`
`to the
`
`expiration of
`
`AstraZeneca’s U.S. Patent Nos. 6,774,122, 7,456,160, 8,329,680, and 8,466,139.
`
`JURISDICTION AND VENUE
`
`6.
`
`This Court has jurisdiction over the subject matter of this action, which arises
`
`under the patent laws of the United States, pursuant t.o 28 U.S.C. §§ 1331, 1338(a), 2201, and
`
`2202.
`
`|nnoPharma Exhibit 1005.0002
`
`

`

`7.
`
`This Court has personal jurisdiction over Defendant because, inter alia, it has
`
`maintained continuous and systematic contacts with the State of New Jersey and this District by,
`
`at least, maintaining its principal place of business in this State.
`
`8.
`
`By letter dated April 6, 2016 (the “Notice Letter”),
`
`InnoPharma notified
`
`AstraZeneca that
`
`it submitted to the FDA ANDA No. 208648 (see ll 18 below). Upon
`
`information and belief, Defendant intends to manufacture for distribution and distribute and sell
`
`generic equivalents of AstraZeneca’s FASLODEX® (fulvestrant) intramuscular injection product
`
`throughout the United States, including in the State of New Jersey and in this judicial district, at
`
`least by making and shipping into this judicial district, or by offering to sell or selling, or causing
`
`others to offer to sell or sell, generic pharmaceutical products. Defendant derives substantial
`
`revenue from goods used or consumed or services rendered in this judicial district.
`
`9.
`
`Venue is proper in this District pursuant to 28 U .S.C. §§ 139l(b), (C) and 1400(b).
`
`THE PATENTS—IN—SUIT
`
`10.
`
`United States Patent No. 6,774,122 (the “’122 Patent”), entitled “Formulation,”
`
`was duly and legally issued on August 10, 2004 and will expire 011 January 9, 2021, with an
`
`additional six months of pediatric exclusivity that will expire July 9, 2021. AstraZeneca AB is
`
`the legal owner of the ’122 Patent. Astrazeneca UK Limited is the beneficial owner of the ’122
`
`Patent. A copy of the ’122 Patent is attached as Appendix A.
`
`11.
`
`United States Patent No. 7,456,160 (the ‘"160 Patent”), entitled “Formulation,”
`
`was duly and legally issued on November 25, 2008 and will expire on January 9, 2021, with an
`
`additional six months of pediatric exclusivity that will expire July 9, 2021. Astrazeneca AB is
`
`|nnoPharma Exhibit 1005.0003
`
`

`

`the legal owner of the ’l60 Patent. Astrazeneca UK Limited is the beneficial owner of the ’160
`
`Patent. A copy of the ’160 Patent is attached as Appendix B.
`
`12.
`
`United States Patent No. 8,329,680 (the “’680 Patent"), entitled “Formulation,”
`
`was duly and legally issued on December 11, 2012 and will expire on January 9, 2021, with an
`
`additional six months of pediatric exclusivity that will expire July 9, 2021. Astrazeneca AB is
`
`the legal owner of the ’680 Patent. Astrazeneca UK Limited is the beneficial owner of the ’680
`
`Patent. A copy of the ’68O Patent is attached as Appendix C.
`
`13.
`
`United States Patent No. 8,466,139 (the “’139 Patent"), entitled “Formulation,”
`
`was duly and legally issued on June 18, 2013 and will expire on January 9, 2021, with an
`
`additional six months of pediatric exclusivity that will expire July 9, 2021. Astra.Zeneca AB is
`
`the legal owner of the ’139 Patent. Astrazeneca UK Limited is the beneficial owner of the ’ 139
`
`Patent. A copy of the ’139 Patent is attached as Appendix D.
`
`FACTUAL BACKGROUND
`
`FASL 0DEX® (fulvestrantz intramuscular injection
`
`14.
`
`FASLODEX® (fulvestrant)
`
`intramuscular
`
`injection is an estrogen receptor
`
`antagonist approved by the FDA for the treatment of hormone receptor positive metastatic breast
`
`cancer in postmenopausal women with disease progression following antiestrogen therapy.
`
`15.
`
`AstraZeneca UK Limited is the holder of approved New Drug Application
`
`(“NDA”) No. 21-344 for FASLODEX® (fulvestrant) intramuscular injection,
`
`in 50 mg/mL
`
`dosage forms. Astra.Zeneca Pharmaceuticals LP is the authorized agent for matters related to
`
`NDA No. 21-344 in the United States.
`
`|nnoPharma Exhibit 1005.0004
`
`

`

`16.
`
`The use of FASLODEX® (fulvestrant) intramuscular injection is covered by one
`
`or more Claims of the ’122, ’160, ’680, and ’139 Patents, and the ’122, ’160, ‘($80, and ’139
`
`Patents have been listed for NDA No. 21-344 in the FDA’s publication, Approved Drug
`
`Products with Therapeutic Equivalence Evaliiaiioris, which is referred to as the “Orange Book.”
`
`17.
`
`AstraZeneca Pharmaceuticals LP sells and distributes FASLODEX® (fulvestrant)
`
`intramuscular injection in the United States pursuant to NDA No. 21-344.
`
`DEFENDANT’S ANDA
`
`18.
`
`By letter dated April 6, 2016 (the “Notice Letter”), Defendant not.if1ed
`
`Astrazeneca that it submitted to the FDA ANDA No. 208648 seeking approval to engage in the
`
`commercial manufacture, use and sale of the Proposed ANDA Product prior to the expiration of
`
`the ’122, ’160, ’680, and ’139 Patents, and included Within ANDA No. 208648 a certification
`
`pursuant to 21 U.S.C. § 355(j)(2)(A)(Vii)(IV) (“Paragraph IV Certification”) that the ’122, ’160,
`
`’680, and ’139 Patents are invalid, unenforceable, and/or will not be infringed by the
`
`manufacture, use, importation, sale or offer for sale of the Proposed ANDA Product.
`
`19.
`
`On information and belief, Defendant was necessarily aware of the Patents-in-Suit
`
`when it filed ANDA No. 208648 with a Paragraph IV Certification.
`
`20.
`
`On information and belief, ANDA No. 208648 refers to and relies upon the
`
`FASLODEX® (fulvestrant) intramuscular injection NDA a11d contains data that, according to
`
`Defendant, demonstrate the bioequivalence of the Proposed ANDA Product and FASLODEX®
`
`(fulvestrant) intramuscular injection.
`
`21.
`
`On information and belief, the Proposed ANDA Product will have instructions for
`
`use that substantially copy the instructions for FASLODEX® (fulvestrant)
`
`intramuscular
`
`injection, including instructions for administering the Proposed ANDA Product by intrarnuscular
`
`5
`
`|nnoPharma Exhibit 1005.0005
`
`

`

`injection to treat breast cancer. The instructions accompanying the Proposed ANDA Product
`
`will induce others to use and/or contribute to others’ use of the Proposed ANDA Product in the
`
`manner set forth in the instructions.
`
`COUNT I: INFRINGEMENT OF U.S. PATENT NO. 6,774,122
`
`22.
`
`Plaintiffs hereby reallege and incorporate by reference the allegations of
`
`paragraphs 1 — 21 ofthis Complaint.
`
`23.
`
`The use of the Proposed ANDA Product is covered by one or more Claims of the
`
`’l22 Patent.
`
`24.
`
`Defendant’s submission of ANDA No. 208648 under 21 U.S.C. § 3550') for the
`
`purpose of obtaining approval to engage in the commercial manufacture, use, importation, sale
`
`and/or offer for sale of the Proposed ANDA Product before the expiration of the ’l22 Patent
`
`constitutes infringement of one or more Claims of the ’l22 Patent under 35 U.S.C. § 271(c)(2).
`
`25.
`
`On information and belief, Defendant plans to, intends to, and will engage in the
`
`commercial manufacture, use, importation, sale and/or offer for sale of the Proposed ANDA
`
`Product
`
`immediately upon approval of ANDA No. 208648 and Will direct physicians and
`
`patients on the use of the Proposed ANDA Product through product labeling.
`
`26.
`
`The Proposed ANDA Product, when offered for sale, sold, and/or imported, and
`
`when used as directed, will be used in a manner that would directly infringe at least one or more
`
`Claims ofthe ’ 122 Patent under 35 U.S.C. § 27l(a).
`
`27.
`
`Upon FDA approval of ANDA No. 208648, Defendant will infringe the ’122
`
`Patent by making, using, offering to sell, selling, and/or importing the Proposed ANDA Product
`
`|nnoPharma Exhibit 1005.0006
`
`

`

`in the United States, and by actively inducing and/or contributing to infringement by others
`
`under 35 U.S.C. § 271(b) andfor
`
`28.
`
`On information and belief, Defendant had knowledge of the ’122 Patent when it
`
`submitted ANDA No. 208648 to the FDA and Defendant knows or should know that it will aid
`
`and abet another’s direct infringement of at least one of the Claims of the ’ 122 Patent.
`
`29.
`
`The Notice Letter lacks any legal or factual basis for non-infringement of any
`
`Claims of the ’ 122 Patent.
`
`30.
`
`Defendant has knowledge of the ‘I22 Patent and is knowingly and willfully
`
`infringing the ’ 122 Patent.
`
`31.
`
`Plaintiffs will be substantially and irreparably harmed by the infringing activities
`
`described above unless those activities are precluded by this Court. Plaintiffs have no adequate
`
`remedy at law.
`
`32.
`
`On information and belief, Defendant lacked a good faith basis for alleging
`
`invalidity of the ’122 Patent when it filed its Paragraph IV Certification. Accordingly,
`
`Defendant’s Paragraph IV Certification was wholly unjustified, and this case is exceptional
`
`under 35 U.S.C. § 285.
`
`COUNT II: DECLARATORY JUDGMENT OF INFRINGEMENT OF
`
`U.S. PATENT NO. 6,774,122
`
`33.
`
`Plaintiffs hereby reallege and incorporate by reference the allegations of
`
`paragraphs 1 v— 32 of this Complaint.
`
`34.
`
`This count arises under the Declaratory Judgment Act, 28 U.S.C. §§ 2201 and
`
`2202.
`
`|nnoPharma Exhibit 1005.000?
`
`

`

`35.
`
`On information and belief, Defendant has taken and plans to, intends to, and will
`
`take active steps to induce, or contribute to, the infringement of the ’ 122 Patent under 35 U.S.C.
`
`§ 27l(b) and/or § 2710:), after ANDA No. 208648 is approved.
`
`COUNT III: INFRINGEMENT OF U.S. PATENT NO. 7,456,160
`
`36.
`
`Plaintiffs hereby reallege and incorporate by reference the allegations of
`
`paragraphs 1 — 35 ofthis Complaint.
`
`37.
`
`The use of the Proposed ANDA Product is covered by one or more Claims of the
`
`’160 Patent.
`
`38.
`
`Defendant’s submission of ANDA No. 208648 under 21 U.S.C. § 3550') for the
`
`purpose of obtaining approval to engage in the commercial manufacture, use, importation, sale
`
`and/or offer for sale of the Proposed ANDA Product before the expiration of the ’160 Patent
`
`constitutes infringement of one or more Claims of the 160 Patent under 35 U.S.C. § 271(e)(2).
`
`39.
`
`On information and belief, Defendant plans to, intends to, and will engage in the
`
`commercial manufacture, use, importation, sale and/or offer for sale of the Proposed ANDA
`
`Product
`
`immediately upon approval of ANDA No. 208648 and Will direct physicians and
`
`patients on the use of the Proposed ANDA Product through product labeling.
`
`40.
`
`On information and belief, the Proposed ANDA Product, when offered for sale,
`
`sold, and/or imported, and when used as directed, will be used in a manner that would directly
`
`infringe at least one or more Claims of the ’l60 Patent under 35 U.S.C. § 2'/1(a).
`
`41.
`
`Upon FDA approval of ANDA No. 208648, Defendant will infringe the ’160
`
`Patent by making, using, offering to sell, selling, and/or importing the Proposed ANDA Product
`
`|nnoPharma Exhibit 1005.0008
`
`

`

`in the United States, and by actively inducing and/or contributing to infringement by others
`
`under 35 U.S.C. § 271(b) andfor
`
`42.
`
`On information and belief, Defendant had knowledge of the ’160 Patent when it
`
`submitted ANDA No. 208648 to the FDA and Defendant knows or should know that it will aid
`
`and abet another’s direct infringement of at least one of the Claims of the ’ 160 Patent.
`
`43.
`
`Defendant has knowledge of the ‘I60 Patent and is knowingly and willfully
`
`infringing the ’160 Patent.
`
`44.
`
`Plaintiffs will be substantially and irreparably harmed by the infringing activities
`
`described above unless those activities are precluded by this Court. Plaintiffs have no adequate
`
`remedy at law.
`
`45.
`
`On information and belief, Defendant
`
`lacked a good faith basis for alleging
`
`invalidity of the ’]60 Patent when it filed its Paragraph IV Certification. Accordingly,
`
`Defendant’s Paragraph IV Certification was wholly unjustified, and this case is exceptional
`
`under 35 U.S.C. § 285.
`
`COUNT IV: DECLARATORY JUDGNIENT OF INFRINGEMENT OF
`
`U.S. PATENT N0. 7,456,160
`
`46.
`
`Plaintiffs hereby reallege and incorporate by reference the allegations of
`
`paragraphs 1 — 45 of this Complaint.
`
`47.
`
`This count arises under the Declaratory Judgment Act, 28 U.S.C. §§ 2201 and
`
`2202.
`
`48.
`
`On information and belief, Defendant has taken and plans to, intends to, and will
`
`take active steps to induce, or contribute to, the infringement of the ’160 Patent under 35 U.S.C.
`
`§ 271(b) andfor § 271(0), after ANDA No. 208648 is approved.
`
`9
`
`|nnoPharma Exhibit 1005.0009
`
`

`

`COUNT V: INFRINGEMENT OF U.S. PATENT N0. 8,329,680
`
`49.
`
`Plaintiffs hereby reallege and incorporate by reference the allegations of
`
`paragraphs 1 — 48 of this Complaint.
`
`50.
`
`The use of the Proposed ANDA Product is covered by one or more Claims of the
`
`’680 Patent.
`
`51.
`
`Defendant’s submission of ANDA No. 208648 under 21 U.S.C. § 355(j) for the
`
`purpose of obtaining approval to engage in the commercial manufacture, use, importation, sale
`
`and/or offer for sale of the Proposed ANDA Product before the expiration of the ’680 Patent
`
`constitutes infringement of one or more Claims of the ’680 Patent under 35 U.S.C. § 27l(_e)(2).
`
`52.
`
`011 information and belief, Defendant plans to, intends to, and will engage i11 the
`
`commercial manufacture, use, importation, sale and/or offer for sale of the Proposed ANDA
`
`Product immediately upon approval of ANDA No. 208648 and will direct physicians and
`
`patients on the use of the Proposed ANDA Product through product labeling.
`
`53.
`
`On information and belief, the Proposed ANDA Product, when offered for sale,
`
`sold, and/or imported, and when used as directed, will be used in a manner that would directly
`
`infringe at least one or more Claims of the ’680 Patent under 35 U.S.C. § 271(a).
`
`54.
`
`Upon FDA approval of ANDA No. 208648, Defendant will infringe the ’680
`
`Patent by making, using, offering to sell, selling, and/or importing the Proposed ANDA Product
`
`in the United States, and by actively inducing and/or contributing t.o infringement by others
`
`under 35 U.S.C. §27l(b) andfor (C).
`
`55.
`
`On information and belief, Defendant had knowledge of the ’680 Patent when
`
`Defendant submitted ANDA No. 208648 to the FDA and Defendant knows or should know that
`
`it will aid and abet another’s direct infringement of at least one of the Claims of the ’680 Patent.
`
`10
`
`|nnoPharma Exhibit 1005.001O
`
`

`

`56.
`
`Defendant has knowledge of the ’68O Patent and is knowingly and willfully
`
`infringing the ’68O Patent.
`
`57.
`
`Plaintiffs will be substantially and irreparably harmed by the infringing activities
`
`described above unless those activities are precluded by this Court. Plaintiffs have no adequate
`
`remedy at law.
`
`58.
`
`On information and belief, Defendant
`
`lacked a good faith basis for alleging
`
`invalidity of the ’680 Patent when it filed its Paragraph IV Certification. Accordingly,
`
`Defendant’s Paragraph IV Certification was wholly unjustified, and this case is exceptional
`
`under 35 U.S.C. § 285.
`
`COUNT VI: DECLARATORY JUDGMENT OF INFRINGEMENT OF
`
`U.S. PATENT NO. 8,329,680
`
`59.
`
`Plaintiffs hereby reallege and incorporate by reference the allegations of
`
`paragraphs 1 — 58 of this Complaint.
`
`60.
`
`This count arises under the Declaratory’ Judgment Act, 28 U.S.C. §§ 2201 and
`
`2202.
`
`61.
`
`On information and belief, Defendant has taken and plans to, intends to, and Will
`
`take active steps to induce, or contribute to, the infringement of the ’680 Patent under 35 U.S.C.
`
`§ 271(b) and/or § 271(c), after ANDA No. 208648 is approved.
`
`COUNT VII: INFRINGEIVIENT OF US. PATENT NO. 8 466 139
`
`62.
`
`Plaintiffs hereby reallege and incorporate by reference the allegations of
`
`paragraphs 1 — 61 of this Complaint.
`
`63.
`
`The use of the Proposed ANDA Product is covered by one or more Claims of the
`
`’l39 Patent.
`
`11
`
`|nnoPharma Exhibit 1005.0011
`
`

`

`64.
`
`Defendant’s submission of ANDA No. 208648 under 21 U.S.C. § 3550') for the
`
`purpose of obtaining approval to engage in the commercial manufacture, use, importation, sale
`
`and/or offer for sale of the Proposed ANDA Product before the expiration of the ’l39 Patent
`
`constitutes infringement of one or more Claims of the ’ 139 Patent under 35 U .S.C. § 271(e)(2).
`
`65.
`
`On information and belief, Defendant plans to, intends to, and will engage in the
`
`commercial manufacture, use, importation, sale and/or offer for sale of the Proposed ANDA
`
`Product
`
`immediately upon approval of ANDA No. 208648 and will direct physicians and
`
`patients on the use of the Proposed ANDA Product through product labeling.
`
`66.
`
`On information and belief, the Proposed ANDA Product, when offered for sale,
`
`sold, and/or imported, and when used as directed, will be used in a manner that would directly
`
`infringe at least one or more Claims of the ’139 Patent under 35 U.S.C. § 271(a).
`
`67.
`
`Upon FDA approval of ANDA No. 208648, Defendant will infringe the ’l39
`
`Patent by making, using, offering to sell, selling, and/or importing the Proposed ANDA Product
`
`in the United States, and by actively inducing and/or contributing to infringement by others
`
`under 35 U.S.C. § 27l(b) and/or (0).
`
`68.
`
`On information and belief, Defendant had knowledge of the ’139 Patent when it
`
`submitted ANDA No. 208648 to the FDA and Defendant knows or should know that it will aid
`
`and abet another’s direct infringement of at least one of the Claims of the ’139 Patent.
`
`69.
`
`Defendant has knowledge of the ’l39 Patent and is knowingly and willfully
`
`infringing the ’ 139 Patent.
`
`70.
`
`Plaintiffs will be substantially and irreparably harmed by the infringing activities
`
`described above unless those activities are precluded by this Court. Plaintiffs have no adequate
`
`remedy at law.
`
`12
`
`|nnoPharma Exhibit 1005.0012
`
`

`

`71.
`
`On information and belief, Defendant
`
`lacked a good faith basis for alleging
`
`invalidity of the ’l39 Patent when it filed its Paragraph IV Certification. Accordingly,
`
`Defendant’s Paragraph IV Certification was wholly unjustified, and this case is exceptional
`
`under 35 U.S.C. § 285.
`
`COUNT VIII: DECLARATORY JUDGNIENT OF INFRINGEMENT OF
`
`U.S. PATENT NO. 8,466,139
`
`72.
`
`Plaintiffs hereby reallege and incorporate by reference the allegations of
`
`paragraphs 1 — 71 of this Complaint.
`
`73.
`
`This count arises under the Declaratory Judgment Act, 28 U .S.C. §§ 2201 and
`
`2202.
`
`74.
`
`On information and belief, Defendant has taken and plans to, intends to, and will
`
`take active steps to induce, or contribute to, the infringement ofthe ’ 139 Patent under 35 U.S.C.
`
`§ 271(b) and/or § 271(0), after ANDA No. 208648 is approved.
`
`PRAYER FOR RELIEF
`
`WHEREFORE, Plaintiffs respectfully request that this Court grant the following relief:
`
`a)
`
`b)
`
`Judgment that the ’122, ’l60, ’680, and “I39 Patents are valid and enforceable;
`
`Judgment that Defendant’s submission of ANDA No. 208648 was an act of
`
`infringement of one or more Claims of the ’122_, ‘I60, ’680, and ‘I39 Patents under 35 U.S.C.
`
`§ 271(6)(2);
`
`c)
`
`Judgment that Defendant’s making, using, offering to sell, selling, or importing
`
`into the United States of the Proposed ANDA Product prior to the expiration of the ’ 122,
`
`’ 160,
`
`’680, and ’139 Patents, will infringe, will actively induce infringement, andfor will contribute to
`
`the infringement of one or more Claims of the ’122, ’l60, ’680, and/or ’l39 Patents;
`13
`
`|nnoPharma Exhibit 10050013
`
`

`

`d)
`
`An Order pursuant to 35 U.S.C. § 2'/1(e)(4)(A) providing that the effective date of
`
`any FDA approval of ANDA No. 208648 shall be a date that is not earlier than the expiration of
`
`the ‘I22,
`
`’l6CI, ’680, and ’ 139 Patents plus any other exclusivity’ to which Plaintiffs are or
`
`become entitled;
`
`e)
`
`An Order permanently enjoining Defendant, its affiliates and subsidiaries, each of
`
`its officers, agents, servants and employees, and any person acting in concert with Defendant,
`
`from making, using, offering to sell, selling, marketing, distributing, or importing into the United
`
`States the Proposed ANDA Product until after the expiration of the ’l22, ’l60, ’680, and ’l39
`
`Patents plus any other exclusivity to which Plaintiffs are or become entitled;
`
`f)
`
`Judgment declaring that infringement, inducement or contributory infringement of
`
`the ’l22, ‘I60, ’680, and/or ’ 139 Patents by Defendant is willful should Defendant commercially
`
`manufacture, use, offer to sell, sell, or import into the United States the Proposed ANDA
`
`Product;
`
`g)
`
`A declaration that this case is an exceptional case Within the meaning of 35
`
`U.S.C. § 285 and an award of reasonable attorneys’ fees, expenses, and disbursements of this
`
`action;
`
`h)
`
`i)
`
`Plaintiffs’ reasonable costs and expenses in this action; and
`
`Such further and other relief as this Court deems proper and just.
`
`14
`
`|nnoPharma Exhibit 1005.0014
`
`

`

`Dated: April 7, 2016
`
`Respectfully submitted,
`
`OF COUNSEL:
`
`Lisa B. Pensabene, Esq.
`Filko Prugo, Esq.
`Will C. Autz, Esq.
`O’MELVENY & MYERS LLP
`7 Times Square
`New York, New York 10036
`
`(212) 326-2000
`
`By: S/John E. Fla/‘aergz
`John E. Flaherty
`Ravin R. Patel
`MCCARTER & ENGLISH LLP
`
`Four Gateway Center
`100 Mulberry Street
`Newark, New Jersey 07102
`(973) 622-4444
`
`Attorneys F0rPZaint2fi3*,
`A sIraZeneca Pharrraaceuricais LP,
`/i.s‘traZeneca UKL1'mz‘Ieed, and
`
`AstraZeneca AB
`
`|nnoPharma Exhibit 1005.0015
`
`

`

`CERTIFICATION PURSUANT TO L. CIV. R. 11.2
`
`Pursuant to Local Civil Rule 11.2,
`
`I hereby certify that the matter in controversy is
`
`related to the subject matter ofthe following actions:
`
`o ASTRAZENECA PHARMACEUTICALS LP, ASTRAZENECA UIsf LIMITED,
`
`cmd ASTRAZENECA AB V. SANDOZ INC, and SANDOZ INTERNATIONAL
`
`GmbH, CA. No. 1:14-cv-03547-RMB-KMW (“AsIrc1Zenecc1 v. Samioz”)
`0 ASTRAZENECA PHARMACEUTICALS LP, ASTRAZENECA UK LIIVIITED,
`
`and ASTRAZENECA AB v. SAGENT PHARMACEUTICALS, INC., CA. No.
`
`1:14-CV-05539-RMB-KMW (‘243fraZeneca v. Sagem"’)
`o ASTRAZENECA PHARMACEUTICALS LP, ASTRAZENECA UK LIMITED,
`
`cma’ ASTRAZENECA AB v. GLENMARK PHARMACEUTICALS INC, USA,
`
`C.A. No. 1:15-cv-00615-RMB-KMW (“AstraZe‘r2eca V. GZenmar'k”)
`o ASTRAZENECA PHARMACEUTICALS LP, ASTRAZENECA UK LIMITED,
`
`cma’ ASTRAZENECA AB 17. AGILA SPECIALTIES INC. F/K’/A STRIDES
`II\IC., ONCO THERAPIES LIILIITED, ILIYLAN PHARMACEUTICALS INC,
`
`It/IYLAN IABORATORIES LIIVIITED, and MTLAN INC., CA. No.
`
`l:l5-cv-
`
`O6039-RMB-KMW (“AsIraZeneca V. Agila”)
`o ASTRAZENECA PHARMACEUTICALS LP, ASTRAZENECA UK LIMITED,
`
`and ASTRAZENECA AB v. IMYLAN PHARMACEUTICALS INC.,
`
`ILIYLAN
`
`LABORATORIES LIMITED, and I./IYLAN INC, CA. No. 1:15-cv-O7009-
`
`RMB-KMW (“A3traZeneca v. Mylcm”)
`o ASTRAZENECA PHARMACEUTICALS LP, ASTRAZENECA UK LII1/IITED,
`
`az/MASTRAZENECA AB v. TEVA PHARMACEUTICALS USA, INC., CA. No.
`
`1:15—cv-07889-RMB-KMW (“AstraZeneca v. Teva”)
`II ASTRAZENECA PHARMACEUTICALS LP, ASTRAZENECA UK LIMITED,
`
`and ASTRAZENECA AB v. INNOPHARMA, INC, C.A. N0. 1:16-cv-O0894-
`
`RMB-Kl\/IW (“AstmZeneca v. Irm0Pharma Inc.’’)
`
`The foregoing cases involve FASLODEX® (fulvestrant)
`
`intramuscular injection, a
`
`product marketed by AstraZeneca that contains a fulvestrant formulation. The FASLODEX®
`
`(fulvestrant) intramuscular injection cases have been assigned to Hon. Renee M. Bumb, U.S.D..T.
`
`On May 7, 2015,
`
`the AstraZeneca v. Sandoz, AsIraZerzeca V. Sagem‘, and AstraZe:1eca v.
`
`Gfenmark cases were consolidated by Judge Bumb as Consolidated Case. No. 1:14-cV-03547-
`
`RMB-KMVV. On December 7, 2015, the ASm:tZeneca v. Agile: and ASIraZeneca v. Mjzlan cases
`
`were consolidated by Judge Bumb as Consolidated Case. No. 1:15-cv-06039-RMB-KMW.
`
`16
`
`|nnoPharma Exhibit 10050016
`
`

`

`Plaintiffs respectfully request that this case likewise be assigned to Judge Bumb due to her
`
`familiarity with the subject matter.
`
`Dated: April 7, 2016
`
`Respectfully submitted,
`
`OF COUNSEL:
`
`Lisa B. Pensabene, Esq.
`
`Filko Prugo, Esq.
`Will C. Autz, Esq.
`O’MELVENY 8: MYERS LLP
`7 Times Square
`New York, New York 10036
`
`By:
`
`s/Joim E. Flaherg
`John E. Flaherty
`Ravin R. Patel
`
`MCCARTER & ENGLISH LLP
`
`Four Gateway Center
`100 Mulberry Street
`Newark, New Jersey 07102
`
`(973) 622-4444
`
`Attorneys F0rPlaintifi"S,
`Asi‘mZeiieca Pharmaceuticals LP,
`AsiraZeneca UK Limited, and
`
`(212) 326-2000
`
`/lsiraZeneca AB
`
`17
`
`|nnoPharma Exhibit 1005.001?
`
`