Case 1:17-cv-00210-RGA Document 1 Filed 03/01/17 Page 1 of 16 PageID #: 1
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`C.A. No. __________________
`
`)))))))))))))
`
`PURDUE PHARMA L.P., PURDUE
`PHARMACEUTICALS L.P., THE P.F.
`LABORATORIES, INC., and RHODES
`TECHNOLOGIES,
`
`Plaintiffs,
`
`v.
`
`AMNEAL PHARMACEUTICALS, LLC,
`
`Defendant.
`
`COMPLAINT
`
`Plaintiffs, Purdue Pharma L.P., Purdue Pharmaceuticals L.P., The P.F.
`
`Laboratories, Inc. (collectively, “Purdue”) and Rhodes Technologies (“Rhodes”) (collectively,
`
`“Plaintiffs”), for their Complaint against Defendant, Amneal Pharmaceuticals, LLC (“Amneal”
`
`or “Defendant”), aver as follows:
`
`NATURE OF THE ACTION
`
`1.
`
`This is an action for patent infringement arising under the patent laws of
`
`the United States, Title 35, United States Code, for infringement of United States Patent
`
`Nos. 9,492,392 (the ‘’392 patent”); 9,492,393 (the ‘’393 patent”); and 9,522,919 (the ‘’919
`
`patent”) (collectively, “the patents-in-suit”). This action relates to Abbreviated New Drug
`
`Application (“ANDA”) No. 203235 as amended (“Defendant’s Amended ANDA”) submitted,
`
`upon information and belief, in the name of Amneal to the United States Food and Drug
`
`Administration (“FDA”).
`
`2.
`
`Plaintiffs seek judgment that Defendant has infringed the ’392, ’393 and
`
`’919 patents (collectively, “the Orange Book patents”), which are listed in the FDA Approved
`
`KASHIV1018
`IPR of Patent No. 9,492,392
`
`

`

`Case 1:17-cv-00210-RGA Document 1 Filed 03/01/17 Page 2 of 16 PageID #: 2
`
`Drug Products With Therapeutic Equivalence Evaluations (“Orange Book”) as covering
`
`Purdue’s OxyContin® (oxycodone hydrochloride) (“OxyContin®”), an extended-release pain
`
`medication. Defendant has infringed the Orange Book patents under 35 U.S.C. § 271(e)(2)(A)
`
`by filing ANDA No. 203235 as amended, submitted upon information and belief in the name of
`
`Amneal to the FDA. Defendant’s Amended ANDA seeks approval to market a generic version
`
`of Purdue’s OxyContin®, which is the subject of approved NDA No. 022272, in the 10 mg,
`
`15 mg, 20 mg, 30 mg, 40 mg, 60 mg and 80 mg dosage strengths (“Defendant’s Amended
`
`ANDA Products”).
`
`3.
`
`On December 15, 2015, Purdue filed a related complaint against
`
`Defendant, C.A. No. 15-1152-RGA, for patent infringement of U.S. Patent Nos. 7,674,799 (the
`
`“’799 patent”); 7,674,800 (the “’800 patent”); 7,683,072 (the “’072 patent”); 8,337,888 (the
`
`“’888 patent”); 8,808,741 (the “’741 patent”); 8,894,987 (the “’987 patent”); 8,894,988 (the
`
`“’988 patent”); 9,060,976 (the “’976 patent”); 9,034,376 (the “’376 patent”); and 9,073,933 (the
`
`“’933 patent”). The previous action was filed in connection with Defendant’s Amended ANDA,
`
`which contained a “Paragraph IV” certification under 21 U.S.C. § 355(j)(2)(A)(vii)(IV) alleging
`
`that, inter alia, the ’799, ’800, ’072, ’888, ’741, ’987, ’988, ’976, ’376 and ’933 patents, listed in
`
`the Orange Book as covering OxyContin®, are “unenforceable, invalid, and/or not infringed,
`
`either literally or under the doctrine of equivalents, by the manufacture, use, sale, offer for sale,
`
`and/or importation of the drug product for which ANDA No. 203235 has been submitted by
`
`Amneal.”
`
`4.
`
`On September 17, 2015, Purdue filed a related complaint against
`
`Defendant, C.A. No. 15-831-RGA, for patent infringement of U.S. Patent Nos. 9,060,976 (the
`
`“’976 patent”) and 9,034,376 (the “’376 patent”). The previous action was filed in connection
`
`- 2 -
`
`KASHIV1018
`IPR of Patent No. 9,492,392
`
`

`

`Case 1:17-cv-00210-RGA Document 1 Filed 03/01/17 Page 3 of 16 PageID #: 3
`
`with Defendant’s ANDA, which contained a “Paragraph IV” certification under 21 U.S.C.
`
`§ 355(j)(2)(A)(vii)(IV) alleging that the ’976 patent, listed in the Orange Book as covering
`
`OxyContin®, is ““unenforceable, invalid, and/or not infringed, either literally or under the
`
`doctrine of equivalents, by the manufacture, use, sale, offer for sale, and/or importation of the
`
`drug product for which ANDA No. 203235 has been submitted by Amneal.”
`
`THE PARTIES
`
`5.
`
`Plaintiff Purdue Pharma L.P. (“Purdue Pharma”) is a limited partnership
`
`organized and existing under the laws of the State of Delaware, having a place of business at One
`
`Stamford Forum, 201 Tresser Boulevard, Stamford, CT 06901. Purdue Pharma is an owner of
`
`the ’392, ’393 and ’919 patents, identified in paragraphs 20-22 below. Purdue Pharma is also the
`
`holder of approved NDA No. 022272 for OxyContin®, indicated for pain severe enough to
`
`require daily, around-the-clock, long-term opioid treatment and for which alternative treatment
`
`options are inadequate. Purdue Pharma sells OxyContin® in the United States.
`
`6.
`
`Plaintiff Purdue Pharmaceuticals L.P. (“Purdue Pharmaceuticals”) is a
`
`limited partnership organized and existing under the laws of the State of Delaware, having a
`
`place of business at 4701 Purdue Drive, Wilson, NC 27893. Purdue Pharmaceuticals is an owner
`
`of the ’392, ’393 and ’919 patents, identified in paragraphs 20-22 below.
`
`7.
`
`Plaintiff The P.F. Laboratories, Inc. (“P.F. Labs”) is a corporation
`
`organized and existing under the laws of the State of New Jersey, having a place of business at
`
`One Stamford Forum, Stamford, CT 06901. P.F. Labs is an owner of the ’919 patent, identified
`
`in paragraphs 20-22 below.
`
`8.
`
`Plaintiff Rhodes Technologies (“Rhodes”) is a general partnership
`
`organized and existing under the laws of the State of Delaware, having a place of business at
`
`- 3 -
`
`KASHIV1018
`IPR of Patent No. 9,492,392
`
`

`

`Case 1:17-cv-00210-RGA Document 1 Filed 03/01/17 Page 4 of 16 PageID #: 4
`
`498 Washington Street, Coventry, RI 02816. Rhodes is an owner of the ’919 patent, identified in
`
`paragraph 22 below, and is involved in the manufacture of the active pharmaceutical ingredient
`
`(“API”) used in OxyContin®.
`
`9.
`
`On information and belief, Defendant is a limited liability company
`
`organized and existing under the laws of the State of Delaware, having a principal place of
`
`business at 400 Crossing Boulevard, 3rd floor, Bridgewater, NJ 08807.
`
`SUBJECT MATTER JURISDICTION AND VENUE
`
`10.
`
`This action arises under the patent laws of the United States, including
`
`35 U.S.C. § 271 and the Declaratory Judgment Act, 28 U.S.C. §§ 2201 and 2202.
`
`11.
`
`This Court has subject matter jurisdiction pursuant to 28 U.S.C. §§ 1331
`
`and 1338(a).
`
`and 1400(b).
`
`12.
`
`Venue is proper in this Court pursuant to 28 U.S.C. §§ 1391(b), 1391(c),
`
`PERSONAL JURISDICTION
`
`13.
`
`This Court has personal jurisdiction over the Defendant by virtue of, inter
`
`alia, the fact that Amneal is a Delaware limited liability company, Defendant’s systematic and
`
`continuous contacts with Delaware, and Defendant’s contacts with Delaware in connection with
`
`the submission of its ANDA, as set forth below.
`
`14.
`
`On information and belief, Amneal is registered to conduct business
`
`within the State of Delaware and maintains as a registered agent The Corporation Trust
`
`Company, Corporation Trust Center, 1209 Orange Street, Wilmington, Delaware 19801.
`
`- 4 -
`
`KASHIV1018
`IPR of Patent No. 9,492,392
`
`

`

`Case 1:17-cv-00210-RGA Document 1 Filed 03/01/17 Page 5 of 16 PageID #: 5
`
`15.
`
`On
`
`information and belief, Amneal holds current and valid
`
`“Distributor/Manufacturer CSR” and “Pharmacy-Wholesale” licenses from the Delaware Board
`
`of Pharmacy.
`
`16.
`
`On information and belief, Defendant is in the business of preparing
`
`generic pharmaceuticals that it distributes in the State of Delaware and throughout the United
`
`States.
`
`17.
`
`On information and belief, if ANDA No. 203235 as amended is approved,
`
`Defendant’s Amended ANDA Products would, among other things, be marketed and distributed
`
`in Delaware, and/or prescribed by physicians practicing and dispensed by pharmacies located
`
`within Delaware, all of which would have a substantial effect on Delaware.
`
`18.
`
`On information and belief, Defendant has admitted to, consented to or has
`
`not contested, the jurisdiction of this Court, and/or has availed itself of the rights, benefits, and
`
`privileges of this Court by asserting counterclaims in prior District of Delaware actions, e.g.,
`
`Purdue Pharma L.P. et al. v. Amneal Pharmaceuticals LLC, C.A. No. 15-1152; Purdue Pharma
`
`L.P. et al. v. Amneal Pharmaceuticals LLC, C.A. No. 15-831; Forest Laboratories, LLC v.
`
`Amneal Pharmaceuticals LLC, C.A. No. 15-756; Hospira, Inc. v. Amneal Pharmaceuticals LLC,
`
`C.A. No. 15-697; Forest Laboratories, LLC v. Amneal Pharmaceuticals LLC, C.A. No. 15-430;
`
`Merck Sharpe & Dohme Corp. v. Amneal Pharmaceuticals LLC, C.A. No. 15-250; and Forest
`
`Laboratories, Inc. v. Amneal Pharmaceuticals LLC, C.A. No. 14-508.
`
`19.
`
`This Court further has personal jurisdiction over Defendant by virtue of
`
`the fact that Defendant has committed, or aided, abetted, contributed to, and/or participated in the
`
`commission of, the tortious act of patent infringement that has led to foreseeable harm and injury
`
`to Plaintiffs, including Plaintiffs Purdue Pharma and Purdue Pharmaceuticals, which are limited
`
`- 5 -
`
`KASHIV1018
`IPR of Patent No. 9,492,392
`
`

`

`Case 1:17-cv-00210-RGA Document 1 Filed 03/01/17 Page 6 of 16 PageID #: 6
`
`partnerships organized and existing under the laws of the State of Delaware, and Plaintiff
`
`Rhodes, which is a general partnership organized and existing under the laws of the State of
`
`Delaware.
`
`THE ’392 PATENT
`
`THE PATENTS-IN-SUIT
`
`20.
`
`Purdue Pharma and Purdue Pharmaceuticals are the lawful owners of all
`
`right, title and interest in the ’392 patent, titled “TAMPER RESISTANT DOSAGE FORMS,”
`
`including the right to sue and to recover for past infringement thereof. The ’392 patent is listed
`
`in the Orange Book as covering OxyContin®, which is the subject of approved NDA
`
`No. 022272. A copy of the ’392 patent is attached hereto as Exhibit A, which was duly and
`
`legally issued on November 15, 2016, naming William H. McKenna, Richard O. Mannion,
`
`Edward P. O’Donnell, and Haiyong H. Huang as the inventors.
`
`THE ’393 PATENT
`
`21.
`
`Purdue Pharma and Purdue Pharmaceuticals are the lawful owners of all
`
`right, title and interest in the ’393 patent, titled “TAMPER RESISTANT DOSAGE FORMS,”
`
`including the right to sue and to recover for past infringement thereof. The ’393 patent is listed
`
`in the Orange Book as covering OxyContin®, which is the subject of approved NDA
`
`No. 022272. A copy of the ’393 patent is attached hereto as Exhibit B, which was duly and
`
`legally issued on November 15, 2016, naming William H. McKenna, Richard O. Mannion,
`
`Edward P. O’Donnell, and Haiyong H. Huang as the inventors.
`
`THE ’919 PATENT
`
`22.
`
`Purdue and Rhodes are the lawful owners of all right, title and interest in
`
`the ’919 patent, titled “OXYCODONE COMPOSITIONS,” including the right to sue and to
`
`- 6 -
`
`KASHIV1018
`IPR of Patent No. 9,492,392
`
`

`

`Case 1:17-cv-00210-RGA Document 1 Filed 03/01/17 Page 7 of 16 PageID #: 7
`
`recover for past infringement thereof. The ’919 patent is listed in the Orange Book as covering
`
`OxyContin®, which is the subject of approved NDA No. 022272. A copy of the ’919 patent is
`
`attached hereto as Exhibit C, which was duly and legally issued on December 20, 2016, naming
`
`Robert Chapman, Lonn S. Rider, Qi Hong, Donald Kyle, and Robert Kupper as the inventors.
`
`DEFENDANT’S AMENDED ANDA
`
`23.
`
`On information and belief, on or before September 27, 2011, Defendant
`
`filed Defendant’s ANDA No. 203235 under § 505(j) of the Federal Food, Drug, and Cosmetic
`
`Act (21 U.S.C. § 355(j)), seeking approval to engage in the commercial manufacture, use, sale,
`
`offer for sale, or importation of Defendant’s ANDA Products, generic products based on the
`
`Reference Listed Drug OxyContin®, which is the subject of approved NDA No. 022272. On
`
`information and belief, Defendant subsequently submitted in its ANDA a “Paragraph IV”
`
`certification under 21 U.S.C. § 355U)(2)(A)(vii)(IV) alleging that the ’976 patent, listed in the
`
`FDA’s Orange Book as covering the OxyContin®, which is the subject of approved NDA
`
`No. 022272, is “invalid, unenforceable, and/or not infringed by the commercial manufacture, use
`
`or sale of” the drug products described in Defendant’s ANDA.
`
`24.
`
`In a letter dated August 3, 2015, addressed to Plaintiffs and received by
`
`Purdue Pharma on or about August 4, 2015, Defendant provided what purports to be a “Notice of
`
`Paragraph IV Certification” with respect to Defendant’s ANDA and Defendant’s Amended
`
`ANDA Products, and the Orange Book patents, under § 505(j)(2)(B)(iv) of the Federal Food,
`
`Drug, and Cosmetic Act.
`
`25.
`
`On information and belief, on or before October 30, 2015, Defendant filed
`
`Defendant’s Amended ANDA under § 505(j) of the Federal Food, Drug, and Cosmetic Act (21
`
`U.S.C. § 355(j)), seeking approval to engage in the commercial manufacture, use, sale, offer for
`
`- 7 -
`
`KASHIV1018
`IPR of Patent No. 9,492,392
`
`

`

`Case 1:17-cv-00210-RGA Document 1 Filed 03/01/17 Page 8 of 16 PageID #: 8
`
`sale, or importation of Defendant’s Amended ANDA Products, generic products based on the
`
`Reference Listed Drug OxyContin®, which is the subject of approved NDA No. 022272. On
`
`information and belief, Defendant’s Amended ANDA contained a “Paragraph IV” certification
`
`under 21 U.S.C. § 355(U)(2)(A)(vii)(IV) alleging that the ’799, ’800, ’072, ’383, ’060, ’888,
`
`’741, ’987, ’988, ’976 and ’933 patents, listed in the Orange Book as covering OxyContin®,
`
`which is the subject of approved NDA No. 022272, are “unenforceable, invalid, and/or not
`
`infringed, either literally or under the doctrine of equivalents, by the manufacture, use, sale, offer for
`
`sale, and/or importation” of the drug products described in Defendant’s Amended ANDA.
`
`26.
`
`In a letter dated October 30, 2015, addressed to Plaintiffs and received by
`
`Purdue Pharma on or about November 2, 2015, Defendant provided what purports to be a
`
`“Notice of Paragraph IV Certification” with respect to Defendant’s Amended ANDA and
`
`Defendant’s Amended ANDA Products, and the ’799, ’800, ’072, ’383, ’060, ’888, ’741, ’987,
`
`’988, ’976 and ’933 patents, under § 505(j)(2)(B)(iv) of the Federal Food, Drug, and Cosmetic
`
`Act.
`
`27.
`
`On information and belief, on or before January 16, 2017, Defendant filed
`
`Defendant’s Amended ANDA No. 203235 under § 505(j) of the Federal Food, Drug, and
`
`Cosmetic Act (21 U.S.C. § 355(j)), seeking approval to engage in the commercial manufacture,
`
`use, sale, offer for sale, or importation of Defendant’s Amended ANDA Products, generic
`
`products based on the Reference Listed Drug OxyContin®, which is the subject of approved
`
`NDA No. 022272. On information and belief, Defendant’s Amended ANDA contained a
`
`“Paragraph IV” certification under 21 U.S.C. § 355(U)(2)(A)(vii)(IV) alleging, inter alia, that
`
`the ’392, ’393 and ’919 patents, listed in the Orange Book as covering OxyContin®, which is the
`
`subject of approved NDA No. 022272, are “unenforceable, invalid, and/or not infringed, either
`
`- 8 -
`
`KASHIV1018
`IPR of Patent No. 9,492,392
`
`

`

`Case 1:17-cv-00210-RGA Document 1 Filed 03/01/17 Page 9 of 16 PageID #: 9
`
`literally or under the doctrine of equivalents, by the manufacture, use, sale, offer for sale, and/or
`
`importation” of the drug products described in Defendant’s Amended ANDA.
`
`28.
`
`In a letter dated January 16, 2017, addressed to Plaintiffs and received by
`
`Purdue Pharma on or about January 17, 2017, Defendant provided what purports to be a “Notice
`
`of Paragraph IV Certification” with respect to Defendant’s Amended ANDA and Defendant’s
`
`Amended ANDA Products, and the Orange Book patents, under § 505(j)(2)(B)(iv) of the Federal
`
`Food, Drug, and Cosmetic Act (“Notice Letter”).
`
`29.
`
`Plaintiffs commenced this action within the 45-day period after receiving
`
`the Notice Letter as described in 21 U.S.C. § 355(j)(5)(B)(iii).
`
`FIRST CLAIM FOR RELIEF
`(PATENT INFRINGEMENT OF U.S. PATENT NO. 9,492,392)
`
`30.
`
`Purdue Pharma and Purdue Pharmaceuticals incorporate by reference and
`
`reallege paragraphs 1 through 29 above as though fully restated herein.
`
`31.
`
`Pursuant to 35 U.S.C. § 271(e)(2), Defendant’s submission of ANDA
`
`No. 203235 as amended to the FDA seeking approval of Defendant’s Amended ANDA Products
`
`was an act of infringement of the ’392 patent by Defendant.
`
`32.
`
`Defendant’s Amended ANDA Products, or the use thereof, are covered by
`
`one or more claims of the ’392 patent, including but not limited to independent claim 1, which
`
`recites inter alia, a cured shaped pharmaceutical tablet comprising at least a first compression
`
`shaped and then air cured matrix, wherein said curing is without compression, by heated air
`
`having a temperature of at least about 62° C for a duration of at least about 5 minutes, said
`
`matrix comprising oxycodone or a pharmaceutically acceptable salt thereof in combination with
`
`at least one high molecular weight polyethylene oxide having an approximate molecular weight
`
`- 9 -
`
`KASHIV1018
`IPR of Patent No. 9,492,392
`
`

`

`Case 1:17-cv-00210-RGA Document 1 Filed 03/01/17 Page 10 of 16 PageID #: 10
`
`selected from the group consisting of 4,000,000, 7,000,000, and a combination thereof, and
`
`various claims dependent therefrom.
`
`33.
`
`If approved by the FDA, Defendant’s commercial manufacture, use,
`
`importation, sale, and/or offer for sale of Defendant’s Amended ANDA Products will infringe,
`
`contribute to the infringement of, and/or induce the infringement of one or more claims of the
`
`’392 patent under 35 U.S.C. § 271(a)-(c).
`
`34.
`
`Defendant’s Amended ANDA Products constitute a material part of the
`
`inventions covered by the claims of the ’392 patent.
`
`35.
`
`Upon information and belief, Defendant has been aware of the existence
`
`of the ’392 patent, and has no reasonable basis for believing that Defendant’s Amended ANDA
`
`Products will not infringe the ’392 patent, thus rendering the case “exceptional,” as that term is
`
`used in 35 U.S.C. § 285.
`
`36.
`
`Unless Defendant is enjoined by the Court, Purdue Pharma and Purdue
`
`Pharmaceuticals will be substantially and irreparably harmed by Defendant’s infringement of the
`
`’392 patent. Purdue Pharma and Purdue Pharmaceuticals do not have an adequate remedy at
`
`law.
`
`SECOND CLAIM FOR RELIEF
`(PATENT INFRINGEMENT OF U.S. PATENT NO. 9,492,393)
`
`37.
`
`Purdue Pharma and Purdue Pharmaceuticals incorporate by reference and
`
`reallege paragraphs 1 through 29 above as though fully restated herein.
`
`38.
`
`Pursuant to 35 U.S.C. § 271(e)(2), Defendant’s submission of ANDA
`
`No. 203235 as amended to the FDA seeking approval of Defendant’s Amended ANDA Products
`
`was an act of infringement of the ’393 patent by Defendant.
`
`- 10 -
`
`KASHIV1018
`IPR of Patent No. 9,492,392
`
`

`

`Case 1:17-cv-00210-RGA Document 1 Filed 03/01/17 Page 11 of 16 PageID #: 11
`
`39.
`
`Defendant’s Amended ANDA Products, or the use thereof, are covered by
`
`one or more claims of the ’393 patent, including but not limited to independent claim 1, which
`
`recites inter alia, a method of treating pain comprising administering to a patient in need thereof
`
`a pharmaceutical tablet comprising at least a first compression shaped and then air cured matrix,
`
`wherein said curing is without compression by heated air having a temperature of at least about
`
`62° C for a duration of at least about 5 minutes, said matrix comprising oxycodone or a
`
`pharmaceutically acceptable salt thereof in combination with at least one high molecular weight
`
`polyethylene oxide having, based on rheological measurements, an approximate molecular
`
`weight selected from the group consisting of 4,000,000, 7,000,000, and a combination thereof,
`
`and various claims dependent therefrom. If approved by the FDA, Defendant’s commercial
`
`manufacture, use, importation, sale, and/or offer for sale of Defendant’s Amended ANDA
`
`Products will infringe, contribute to the infringement of, and/or induce the infringement of one or
`
`more claims of the ’393 patent under 35 U.S.C. § 271(a)-(c).
`
`40.
`
`Defendant’s Amended ANDA Products constitute a material part of the
`
`inventions covered by the claims of the ’393 patent.
`
`41.
`
`On information and belief, Defendant knows that Defendant’s Amended
`
`ANDA Products are especially made or especially adapted for use in the infringement of one or
`
`more claims of the ’393 patent.
`
`42.
`
`On information and belief, Defendant has had and continues to have
`
`knowledge that there is no substantial non-infringing use for Defendant’s Amended ANDA
`
`Products.
`
`- 11 -
`
`KASHIV1018
`IPR of Patent No. 9,492,392
`
`

`

`Case 1:17-cv-00210-RGA Document 1 Filed 03/01/17 Page 12 of 16 PageID #: 12
`
`43.
`
`The administration of Defendant’s Amended ANDA Products by any
`
`Healthcare Providers and patients, for the treatment of pain, will directly infringe one or more
`
`claims of the ’393 patent.
`
`44.
`
`Defendant’s proposed label for Defendant’s Amended ANDA Products
`
`will explicitly instruct Healthcare Providers and patients to use Defendant’s Amended ANDA
`
`Products in a manner that will directly infringe one or more claims of the ’393 patent, including
`
`but not limited to independent claim 1, which recites inter alia, a method of treating pain
`
`comprising administering to a patient in need thereof a pharmaceutical tablet comprising at least
`
`a first compression shaped and then air cured matrix, wherein said curing is without compression
`
`by heated air having a temperature of at least about 62° C for a duration of at least about
`
`5 minutes, said matrix comprising oxycodone or a pharmaceutically acceptable salt thereof in
`
`combination with at least one high molecular weight polyethylene oxide having, based on
`
`rheological measurements, an approximate molecular weight selected from the group consisting
`
`of 4,000,000, 7,000,000, and a combination thereof, and various claims dependent therefrom.
`
`OxyContin® is indicated for the management of pain severe enough to require daily, around-the-
`
`clock, long-term opioid treatment and for which alternative treatment options are inadequate.
`
`45.
`
`If Defendant’s Amended ANDA Products are approved by the FDA,
`
`Defendant will actively induce others including, e.g., Healthcare Providers and patients, to
`
`directly infringe one or more claims of the ’393 patent. Since at least the date of the Notice
`
`Letter, Defendant has acted with knowledge, or at least with willful blindness of the fact, that the
`
`induced acts would constitute infringement of the ’393 patent.
`
`46.
`
`Defendant intends to cause direct infringement by others, e.g., Healthcare
`
`Providers and patients.
`
`- 12 -
`
`KASHIV1018
`IPR of Patent No. 9,492,392
`
`

`

`Case 1:17-cv-00210-RGA Document 1 Filed 03/01/17 Page 13 of 16 PageID #: 13
`
`47.
`
`If Defendant’s Amended ANDA Products are approved by the FDA,
`
`Defendant will take affirmative steps to induce infringement by, among other things, instructing
`
`Healthcare Providers and patients, through Defendant’s proposed label, to use Defendant’s
`
`Amended ANDA Products in a manner that directly infringes one or more claims of the ’393
`
`patent. Thus, Defendant will aid, abet, urge, or encourage others including, e.g., Healthcare
`
`Providers and patients, to directly infringe one or more claims of the ’393 patent, and Defendant
`
`will affirmatively and specifically intend to cause direct infringement.
`
`48.
`
`Upon information and belief, Defendant has been aware of the existence
`
`of the ’393 patent, and has no reasonable basis for believing that Defendant’s Amended ANDA
`
`Products will not infringe the ’393 patent, thus rendering the case “exceptional,” as that term is
`
`used in 35 U.S.C. § 285.
`
`49.
`
`Unless Defendant is enjoined by the Court, Purdue Pharma and Purdue
`
`Pharmaceuticals will be substantially and irreparably harmed by Defendant’s infringement of the
`
`’393 patent. Purdue Pharma and Purdue Pharmaceuticals do not have an adequate remedy at
`
`law.
`
`THIRD CLAIM FOR RELIEF
`(PATENT INFRINGEMENT OF U.S. PATENT NO. 9,522,919)
`
`50.
`
`Purdue and Rhodes incorporate by reference and reallege paragraphs 1
`
`through 29 above as though fully restated herein.
`
`51.
`
`Pursuant to 35 U.S.C. § 271(e)(2), Defendant’s submission of ANDA
`
`No. 203235 as amended to the FDA seeking approval of Defendant’s Amended ANDA Products
`
`was an act of infringement of the ’919 patent by Defendant.
`
`52.
`
`Defendant’s Amended ANDA Products, or the use or manufacture thereof,
`
`are covered by one or more claims of the ’919 patent, including but not limited to independent
`
`- 13 -
`
`KASHIV1018
`IPR of Patent No. 9,492,392
`
`

`

`Case 1:17-cv-00210-RGA Document 1 Filed 03/01/17 Page 14 of 16 PageID #: 14
`
`claims 1, 4, 12 and 18, which recite, inter alia, an oxycodone hydrochloride composition
`
`wherein the ratio of 8α,14-dihydroxy-7,8-dihydrocodeinone to oxycodone hydrochloride is
`
`0.04% or less as measured by HPLC, and various claims dependent therefrom.
`
`53.
`
`If approved by the FDA, Defendant’s commercial manufacture, use,
`
`importation, sale, and/or offer for sale of Defendant’s Amended ANDA Products will infringe,
`
`contribute to the infringement of, and/or induce the infringement of one or more claims of the
`
`’919 patent under 35 U.S.C. § 271(a)-(c).
`
`54.
`
`Defendant’s Amended ANDA Products constitute a material part of the
`
`inventions covered by the claims of the ’919 patent.
`
`55.
`
`Upon information and belief, Defendant has been aware of the existence
`
`of the ’919 patent, and has no reasonable basis for believing that Defendant’s Amended ANDA
`
`Products will not infringe the ’919 patent, thus rendering the case “exceptional,” as that term is
`
`used in 35 U.S.C. § 285.
`
`56.
`
`Unless Defendant is enjoined by the Court, Purdue and Rhodes will be
`
`substantially and irreparably harmed by Defendant’s infringement of the ’919 patent. Purdue
`
`and Rhodes do not have an adequate remedy at law.
`
`PRAYER FOR RELIEF
`
`WHEREFORE, Plaintiffs pray for judgment as follows:
`
`A.
`
`Adjudging that Defendant has infringed one or more claims of each of the
`
`’392, ’393 and ’919 patents, and that the commercial sale, offer for sale, use, importation, and/or
`
`manufacture of Defendant’s Amended ANDA Products would infringe, induce infringement of,
`
`and/or contribute to the infringement of one or more claims of each of the ’392, ’393 and ’919
`
`patents;
`
`- 14 -
`
`KASHIV1018
`IPR of Patent No. 9,492,392
`
`

`

`Case 1:17-cv-00210-RGA Document 1 Filed 03/01/17 Page 15 of 16 PageID #: 15
`
`B.
`
`Adjudging, pursuant to 35 U.S.C. § 271(e)(4)(A), the effective date of any
`
`approval of ANDA No. 203235 as amended and Defendant’s Amended ANDA Products, under
`
`§ 505(j) of the Federal Food, Drug and Cosmetic Act (21 U.S.C. § 355(j)), to be a date not earlier
`
`than the last date of expiration of the ’392, ’393 and ’919 patents, plus any additional periods of
`
`extension or exclusivity attached thereto;
`
`C.
`
`Preliminarily and permanently enjoining, pursuant
`
`to 35 U.S.C.
`
`§§ 271(e)(4)(B) and 283 and Rule 65, Fed. R. Civ. P., Defendant, its officers, partners, agents,
`
`servants, employees, parents, subsidiaries, divisions, affiliate corporations, other related business
`
`entities, and all other persons acting in concert, participation, or in privity with them, and their
`
`successors and assigns, from any commercial manufacture, use, offer to sell, or sale within the
`
`United States, or importation into the United States, of any drug product that is the subject of
`
`ANDA No. 203235 as amended, including Defendant’s Amended ANDA Products or any other
`
`drug product that infringes the ’392, ’393 and ’919 patents;
`
`D.
`
`Declaring this an exceptional case and awarding Plaintiffs their attorneys’
`
`fees and costs, as provided by 35 U.S.C. §§ 271(e)(4) and 285; and
`
`E.
`
`Awarding Plaintiffs such other and further relief as this Court may deem
`
`just and proper.
`
`- 15 -
`
`KASHIV1018
`IPR of Patent No. 9,492,392
`
`

`

`Case 1:17-cv-00210-RGA Document 1 Filed 03/01/17 Page 16 of 16 PageID #: 16
`
`MORRIS, NICHOLS, ARSHT & TUNNELL LLP
`
`/s/ Rodger D. Smith II
`
`Jack B. Blumenfeld (#1014)
`Rodger D. Smith II (#3778)
`1201 North Market Street
`P.O. Box 1347
`Wilmington, DE 19899
`(302) 658-9200
`jblumenfeld@mnat.com
`rsmith@mnat.com
`
`Attorneys for Plaintiffs
`
`OF COUNSEL:
`
`John J. Normile
`Pablo D. Hendler
`Gasper J. LaRosa
`Kenneth S. Canfield
`Sarah A. Geers
`Lisamarie LoGiudice
`JONES DAY
`250 Vesey Street
`New York, NY 10281-1047
`(212) 326-3939
`
`Jason G. Winchester
`JONES DAY
`77 West Wacker Drive
`Chicago, IL 60601
`(312) 269-4373
`
`March 1, 2017
`
`- 16 -
`
`KASHIV1018
`IPR of Patent No. 9,492,392
`
`