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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
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`C.A. No. __________________
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`)))))))))
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`
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`PURDUE PHARMA L.P., and PURDUE
`PHARMACEUTICALS L.P.,
`
`
`Plaintiffs,
`
`v.
`
`
`KASHIV PHARMA, LLC,
`
`
`Defendant.
`
`COMPLAINT
`
`Plaintiffs, Purdue Pharma L.P. and Purdue Pharmaceuticals L.P. (collectively,
`
`“Purdue” or “Plaintiffs”), for their Complaint against Defendant Kashiv Pharma, LLC
`
`(“Kashiv”), 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. 9,763,933 (the “Mannion ’933 patent”)1; 9,770,416 (the “’416 patent”); and 9,775,808 (the
`
`“’808 patent”) (collectively, “the patents-in-suit”). This action relates to Abbreviated New Drug
`
`Application (“ANDA”) No. 203235 as amended, submitted, upon information and belief, by
`
`Amneal Pharmaceuticals, LLC (“Amneal’s Amended ANDA”) to the United States Food and
`
`Drug Administration (“FDA”). Plaintiffs seek judgment that Kashiv has infringed the Mannion
`
`’933, ’416 and ’808 patents. The Mannion ’933, ’416 and ’808 patents are listed in the FDA
`
`1
`The Mannion ’933 patent is different from U.S. Patent No. 9,073,933, which is one of the
`patents-in-suit asserted against Amneal Pharmaceuticals, LLC, in related action C.A. No. 15-
`1152-RGA, and which has been referred to as the “’933 patent.” To avoid confusion, Plaintiffs
`refer to U.S. Patent No. 9,073,933 as the Kupper ’933 patent.
`
`KASHIV1023
`IPR of Patent No. 9,492,392
`
`
`
`Case 1:18-cv-00052-RGA Document 1 Filed 01/03/18 Page 2 of 14 PageID #: 2
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`Approved Drug Products With Therapeutic Equivalence Evaluations (“Orange Book”) as
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`covering Purdue’s OxyContin® (oxycodone hydrochloride) (“OxyContin®”), an extended-
`
`release pain medication. Kashiv alleges to have filed Amneal’s Amended ANDA and, if so,
`
`Kashiv has infringed the patents-in-suit under 35 U.S.C. § 271(e)(2)(A). Amneal’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 (“Amneal’s Amended ANDA Products”).
`
`2.
`
`On September 17, 2015, Purdue filed a related complaint against Amneal,
`
`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 with Amneal’s
`
`ANDA No. 203235, 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
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`drug product for which ANDA No. 203235 has been submitted by Amneal.”
`
`3.
`
`On December 15, 2015, Purdue filed a related complaint against Amneal,
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`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”); 8,114,383 (the “’383
`
`patent”); 8,309,060 (the “’060 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 “Kupper ’933 patent”). The previous
`
`action was filed in connection with Amneal’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
`
`- 2 -
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`KASHIV1023
`IPR of Patent No. 9,492,392
`
`
`
`Case 1:18-cv-00052-RGA Document 1 Filed 01/03/18 Page 3 of 14 PageID #: 3
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`’799, ’800, ’072, ’383, ’060, ’888, ’741, ’987, ’988, ’976, and Kupper ’933 patents, listed in the
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`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 March 1, 2017, Purdue filed a related complaint against Amneal, C.A.
`
`No. 17-210-RGA, for patent 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”). The previous action
`
`was filed in connection with Amneal’s Amended ANDA, which contained a “Paragraph IV”
`
`certification under 21 U.S.C. § 355(j)(2)(A)(vii)(IV) alleging that the ’392, ’393, and ’919
`
`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.”
`
`5.
`
`On October 10, 2017, Purdue filed a related complaint against Amneal,
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`C.A. No. 17-1421-RGA, for patent infringement of United States Patent Nos. 9,763,886 (the
`
`“’886 patent”), the Mannion ’933 patent, and 9,675,610 (the “’610 patent”). The previous action
`
`was filed in connection with Amneal’s Amended ANDA, which contained a “Paragraph IV”
`
`certification under 21 U.S.C. § 355(j)(2)(A)(vii)(IV) alleging that the ’610 patent, listed in the
`
`Orange Book as covering OxyContin®,2 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.”
`
`
`2
`The Mannion ’933 patent is also listed in the Orange Book as covering OxyContin®, but
`no “Paragraph IV” certification had been received as of the filing of the lawsuit.
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`- 3 -
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`KASHIV1023
`IPR of Patent No. 9,492,392
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`
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`Case 1:18-cv-00052-RGA Document 1 Filed 01/03/18 Page 4 of 14 PageID #: 4
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`6.
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`Purdue has also filed, concurrently with the filing of the present
`
`Complaint, a related complaint against Amneal for patent infringement of the ’416 and ’808
`
`patents (“the Concurrent Amneal Action”). The Concurrent Amneal Action is identical to the
`
`present Complaint, except that in the Concurrent Amneal Action, (a) Amneal is the sole-named
`
`Defendant and (b) there are no allegations of infringement with respect to the Mannion ’933
`
`patent, which are included in the related C.A. No. 17-1421. On information and belief, Amneal
`
`(not Kashiv) is the owner of Amneal’s Amended ANDA. Plaintiffs are filing the present
`
`Complaint out of an abundance of caution should Kashiv demonstrate that it, in fact, is the owner
`
`of Amneal’s Amended ANDA.
`
`THE PARTIES
`
`7.
`
`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, Connecticut 06901-3431. Purdue Pharma is
`
`an owner of the ’416 and ’808 patents. 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.
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`Purdue Pharma sells OxyContin® in the United States.
`
`8.
`
`Plaintiff Purdue Pharmaceuticals L.P. (“Purdue Pharmaceuticals”) is a
`
`limited partnership organized and existing under the laws of the State of Delaware, having a
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`place of business at 4701 Purdue Drive, Wilson, NC 27893. Purdue Pharmaceuticals is an owner
`
`of the ’416 and ’808 patents.
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`- 4 -
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`KASHIV1023
`IPR of Patent No. 9,492,392
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`
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`Case 1:18-cv-00052-RGA Document 1 Filed 01/03/18 Page 5 of 14 PageID #: 5
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`9.
`
`On information and belief, Kashiv is a limited liability company organized
`
`and existing under the laws of the State of Delaware, having a principal place of business at 995
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`US 202/206, Bridgewater, NJ 08807.
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`SUBJECT MATTER JURISDICTION AND VENUE
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`10.
`
`This action arises under the patent laws of the United States, including
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`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).
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`12.
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`Venue is proper in this Court pursuant to 28 U.S.C. §§ 1391 and 1400(b)
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`because Kashiv resides in this judicial district and because Kashiv has committed acts of
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`infringement in this judicial district.
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`PERSONAL JURISDICTION
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`13.
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`This Court has personal jurisdiction over Kashiv by virtue of, inter alia,
`
`the fact that Kashiv is a Delaware limited liability company, Kashiv’s systematic and continuous
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`contacts with Delaware, and Kashiv’s contacts with Delaware in connection with its alleged
`
`submission of Amneal’s Amended ANDA, as set forth below.
`
`14.
`
`On information and belief, Kashiv is registered to conduct business within
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`the State of Delaware and maintains as a registered agent Paracorp Inc., 2140 S Dupont Hwy,
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`Camden, Delaware 19934.
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`15.
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`On information and belief, Kashiv is in the business of preparing generic
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`pharmaceuticals that it or its agents distribute in the State of Delaware and throughout the United
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`States.
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`KASHIV1023
`IPR of Patent No. 9,492,392
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`Case 1:18-cv-00052-RGA Document 1 Filed 01/03/18 Page 6 of 14 PageID #: 6
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`16.
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`On information and belief, Kashiv has availed itself of the rights, benefits,
`
`and privileges of Delaware Courts by asserting claims in prior Delaware actions, e.g., Kashiv
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`Pharma, LLC v. Sanjeev K. Gupta, C.A. No. 2017-0340-JTL (Del. Ch. May 4, 2017).
`
`17.
`
`On information and belief, if ANDA No. 203235 as amended is approved,
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`Amneal’s Amended ANDA Products would, among other things, be marketed and distributed in
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`Delaware, and/or prescribed by physicians practicing and dispensed by pharmacies located
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`within Delaware, all of which would have a substantial effect on Delaware.
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`18.
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`This Court further has personal jurisdiction over Kashiv by virtue of the
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`fact that Kashiv has alleged to have filed Amneal’s Amended ANDA and, if so, Kashiv has
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`committed, or aided, abetted, contributed to, and/or participated in the commission of, the
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`tortious act of patent infringement that has led to foreseeable harm and injury to Plaintiffs Purdue
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`Pharma and Purdue Pharmaceuticals, which are limited partnerships organized and existing
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`under the laws of the State of Delaware.
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`THE MANNION ’933 PATENT
`
`THE PATENTS-IN-SUIT
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`19.
`
`Purdue Pharma and Purdue Pharmaceuticals are the lawful owners of all
`
`right, title and interest in the Mannion ’933 patent, titled “TAMPER RESISTANT DOSAGE
`
`FORMS,” including the right to sue and to recover for past infringement thereof. The Mannion
`
`’933 patent is listed in the Orange Book as covering OxyContin®, which is the subject of
`
`approved NDA No. 022272. Attached as Exhibit A is a copy of the Mannion ’933 patent, which
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`was duly and legally issued on September 19, 2017, naming William H. McKenna, Richard O.
`
`Mannion, Edward P. O’Donnell, and Haiyong H. Huang as the inventors.
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`- 6 -
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`KASHIV1023
`IPR of Patent No. 9,492,392
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`
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`Case 1:18-cv-00052-RGA Document 1 Filed 01/03/18 Page 7 of 14 PageID #: 7
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`THE ’416 PATENT
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`20.
`
`Purdue Pharma and Purdue Pharmaceuticals are the lawful owners of all
`
`right, title and interest in the ’416 patent, titled “TAMPER RESISTANT DOSAGE FORMS,”
`
`including the right to sue and to recover for past infringement thereof. The ’416 patent is listed
`
`in the Orange Book as covering OxyContin®, which is the subject of approved NDA
`
`No. 022272. Attached as Exhibit B is a copy of the ’416 patent, which was duly and legally
`
`issued on September 26, 2017, naming William H. McKenna, Richard O. Mannion, Edward P.
`
`O’Donnell, and Haiyong H. Huang as the inventors.
`
`THE ’808 PATENT
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`21.
`
`Purdue Pharma and Purdue Pharmaceuticals are the lawful owners of all
`
`right, title and interest in the ’808 patent, titled “TAMPER RESISTANT DOSAGE FORMS,”
`
`including the right to sue and to recover for past infringement thereof. The ’808 patent is listed
`
`in the Orange Book as covering OxyContin®, which is the subject of approved NDA
`
`No. 022272. Attached as Exhibit C is a copy of the ’808 patent, which was duly and legally
`
`issued on October 3, 2017, naming William H. McKenna, Richard O. Mannion, Edward P.
`
`O’Donnell, and Haiyong H. Huang as the inventors.
`
`AMNEAL’S AMENDED ANDA
`
`22.
`
`On information and belief, on or before September 27, 2011, Amneal filed
`
`Amneal’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 Amneal’s ANDA Products, generic products based on the Reference
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`Listed Drug OxyContin®, which is the subject of approved NDA No. 022272.
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`- 7 -
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`KASHIV1023
`IPR of Patent No. 9,492,392
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`
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`Case 1:18-cv-00052-RGA Document 1 Filed 01/03/18 Page 8 of 14 PageID #: 8
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`23.
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`In a letter dated August 3, 2015, addressed to Plaintiffs and received by
`
`Purdue Pharma on or about August 4, 2015, Amneal provided what purports to be a “Notice of
`
`Paragraph IV Certification” with respect to Amneal’s ANDA and Amneal’s Amended ANDA
`
`Products, and the Orange Book patents, under § 505(j)(2)(B)(iv) of the Federal Food, Drug, and
`
`Cosmetic Act.
`
`24.
`
`On information and belief, on or before October 30, 2015, Amneal filed
`
`Amneal’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 sale, or importation of Amneal’s Amended ANDA Products, generic products based on the
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`Reference Listed Drug OxyContin®, which is the subject of approved NDA No. 022272.
`
`25.
`
`In a letter dated November 21, 2017, addressed to Plaintiffs and received
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`by Purdue Pharma on or about November 22, 2017, Kashiv purports to have provided a “Notice
`
`of Paragraph IV Certification” with respect to Amneal’s Amended ANDA and Amneal’s
`
`Amended ANDA Products, and
`
`the Mannion ’933, ’416 and ’808 patents, under
`
`§ 505(j)(2)(B)(iv) of the Federal Food, Drug, and Cosmetic Act (“Notice Letter”). On
`
`information and belief, Amneal is the owner of the Amneal Amended ANDA. However, in the
`
`Notice Letter, Kashiv alleges that “it submitted” ANDA No. 203235 to the FDA, and that it is
`
`the owner of Amneal’s Amended ANDA.
`
`26.
`
`Plaintiffs commenced this action within the 45-day period after receiving
`
`the Notice Letter dated November 21, 2017, as described in 21 U.S.C. § 355(j)(5)(B)(iii).
`
`FIRST CLAIM FOR RELIEF
`(PATENT INFRINGEMENT OF U.S. PATENT NO. 9,770,416)
`
`27.
`
`Purdue Pharma and Purdue Pharmaceuticals incorporate by reference and
`
`reallege paragraphs 1 through 26 above as though fully restated herein.
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`KASHIV1023
`IPR of Patent No. 9,492,392
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`Case 1:18-cv-00052-RGA Document 1 Filed 01/03/18 Page 9 of 14 PageID #: 9
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`28.
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`Pursuant to 35 U.S.C. § 271(e)(2), Kashiv’s alleged submission of ANDA
`
`No. 203235, as amended, to the FDA seeking approval of Amneal’s Amended ANDA Products,
`
`if true, was an act of infringement of the ’416 patent by Kashiv.
`
`29.
`
`Amneal’s Amended ANDA Products, or use thereof, are covered by one
`
`or more claims of the ’416 patent, including but not limited to independent claim 1, which
`
`recites, inter alia, a pharmaceutical composition comprising: at least active agent comprising an
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`opioid or a pharmaceutically acceptable salt, and at least one high molecular weight polyethylene
`
`oxide (PEO), having an approximate molecular weight of from 1 million to 8 million; wherein
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`(a) the active agent and high molecular weight PEO are combined in a solid oral extended release
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`dosage form that is (i) compression shaped, (ii) air cured by heated air, without compression, for
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`a curing time of about 15 minutes to about 8 hours at a curing temperature of about 60 C to about
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`90 C, (iii) cooled, and (iv) hardened; (b) the high molecular weight; (b) the high molecular
`
`weight PEO is at least partially melted upon curing and comprises at least about 50% (by weight)
`
`of the dosage form; (c) the active agent comprises at least about 1.3% (by weight) of the dosage
`
`form; (d) the molecular weight of each PEO is based on rheological measurements; (e) the total
`
`weight of the dosage form is calculated by excluding the combined weight of said film coatings;
`
`and (f) the dosage form is expanded upon curing, as measured by a decrease in density of at least
`
`about 1.5%, and the dosage form provides a hardness of at least about 439 N.
`
`30.
`
`If approved by the FDA, Kashiv’s commercial manufacture, use,
`
`importation, sale, and/or offer for sale of Amneal’s Amended ANDA Products will infringe,
`
`contribute to the infringement of, and/or induce the infringement of one or more claims of the
`
`’808 patent under 35 U.S.C. § 271(a)-(c).
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`KASHIV1023
`IPR of Patent No. 9,492,392
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`Case 1:18-cv-00052-RGA Document 1 Filed 01/03/18 Page 10 of 14 PageID #: 10
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`31.
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`Amneal’s Amended ANDA Products constitute a material part of the
`
`inventions covered by the claims of the ’416 patent.
`
`32.
`
`Upon information and belief, Kashiv has been aware of the existence of
`
`the ’416 patent and has no reasonable basis for believing that the manufacture, use, sale, or offer
`
`for sale of Amneal’s Amended ANDA Products will not infringe the ’416 patent, thus rendering
`
`the case “exceptional,” as that term is used in 35 U.S.C. § 285.
`
`33.
`
`Unless Kashiv is enjoined by the Court, Purdue Pharma and Purdue
`
`Pharmaceuticals will be substantially and irreparably harmed by Kashiv’s infringement of the
`
`’416 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. 9,775,808)
`
`34.
`
`Purdue Pharma and Purdue Pharmaceuticals incorporate by reference and
`
`reallege paragraphs 1 through 26 above as though fully restated herein.
`
`35.
`
`Pursuant to 35 U.S.C. § 271(e)(2), Kashiv’s submission of ANDA
`
`No. 203235 as amended to the FDA seeking approval of Amneal’s Amended ANDA Products, if
`
`true, was an act of infringement of the ’808 patent by Kashiv.
`
`36.
`
`Amneal’s Amended ANDA Products, or the use thereof, are covered by
`
`one or more claims of the ’808 patent, including but not limited to independent claim 1, which
`
`recites, inter alia, a pharmaceutical composition comprising: at least one active agent comprising
`
`oxycodone or a pharmaceutically acceptable salt thereof; and at least one high molecular weight
`
`polyethylene oxide (PEO), having an approximate molecular weight of from 1 million to
`
`15 million; at least one of an additive and a film coating; wherein (a) the active agent and high
`
`molecular weight PEO are combined in a solid oral extended release dosage form that is
`
`- 10 -
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`KASHIV1023
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`Case 1:18-cv-00052-RGA Document 1 Filed 01/03/18 Page 11 of 14 PageID #: 11
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`(i) compression shaped, (ii) air cured by heated air, without compression, for at least about
`
`5 minutes at a temperature above the softening temperature of the high molecular weight PEO,
`
`(iii) cooled, and (iv) hardened; (b) the high molecular weight PEO comprises at least about 30%
`
`(by weight) of the dosage form; (c) the molecular weight of each PEO is based on rheological
`
`measurements; and (d) the total weight of the dosage form is calculated by excluding the
`
`combined weight of said film coatings.
`
`37.
`
`If approved by the FDA, Kashiv’s commercial manufacture, use,
`
`importation, sale, and/or offer for sale of Amneal’s Amended ANDA Products will infringe,
`
`contribute to the infringement of, and/or induce the infringement of one or more claims of the
`
`’808 patent under 35 U.S.C. § 271(a)-(c).
`
`38.
`
`Amneal’s Amended ANDA Products constitute a material part of the
`
`inventions covered by the claims of the ’808 patent.
`
`39.
`
`Upon information and belief, Kashiv has been aware of the existence of
`
`the ’808 patent and has no reasonable basis for believing that Amneal’s Amended ANDA
`
`Products will not infringe the ’808 patent, thus rendering the case “exceptional,” as that term is
`
`used in 35 U.S.C. § 285.
`
`40.
`
`Unless Kashiv is enjoined by the Court, Purdue Pharma and Purdue
`
`Pharmaceuticals will be substantially and irreparably harmed by Kashiv’s infringement of the
`
`’808 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. 9,763,933)
`
`41.
`
`Purdue Pharma and Purdue Pharmaceuticals incorporate by reference and
`
`reallege paragraphs 1 through 26 above as though fully restated herein.
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`Case 1:18-cv-00052-RGA Document 1 Filed 01/03/18 Page 12 of 14 PageID #: 12
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`42.
`
`Pursuant to 35 U.S.C. § 271(e)(2), Kashiv’s alleged submission of ANDA
`
`No. 203235 as amended to the FDA seeking approval of Amneal’s Amended ANDA Products, if
`
`true, was an act of infringement of the Mannion ’933 patent by Kashiv.
`
`43.
`
`Amneal’s Amended ANDA Products, or the use thereof, are covered by
`
`one or more claims of the Mannion ’933 patent, including but not limited to independent claim 1,
`
`which recites, inter alia, a pharmaceutical composition comprising: at least one active agent; at
`
`least one high molecular weight polyethylene oxide (PEO) having an approximate molecular
`
`weight of from 1 million to 15 million; wherein (a) the active agent and high molecular weight
`
`PEO are combined in a solid oral extended release dosage form that is (i) compression shaped,
`
`(ii) air cured by heated air, without compression, for at least about 5 minutes at a temperature
`
`above the softening temperature of the high molecular weight PEO, (iii) cooled, and
`
`(iv) hardened; (b) the high molecular weight PEO comprises at least about 30% (by weight) of
`
`the dosage form; (c) the molecular weight of each PEO is based on rheological measurements;
`
`and (d) the total weight of the dosage form is calculated by excluding the combined weight of
`
`said film coatings.
`
`44.
`
`If approved by the FDA, Kashiv’s commercial manufacture, use,
`
`importation, sale, and/or offer for sale of Amneal’s Amended ANDA Products will infringe,
`
`contribute to the infringement of, and/or induce the infringement of one or more claims of the
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`Mannion ’933 patent under 35 U.S.C. § 271(a)-(c).
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`45.
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`Amneal’s Amended ANDA Products constitute a material part of the
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`inventions covered by the claims of the Mannion ’933 patent.
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`46.
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`Upon information and belief, Kashiv has been aware of the existence of
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`the Mannion ’933 patent and has no reasonable basis for believing that Amneal’s Amended
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`Case 1:18-cv-00052-RGA Document 1 Filed 01/03/18 Page 13 of 14 PageID #: 13
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`ANDA Products will not infringe the Mannion ’933 patent, thus rendering the case
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`“exceptional,” as that term is used in 35 U.S.C. § 285.
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`47.
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`Unless Kashiv is enjoined by the Court, Purdue Pharma and Purdue
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`Pharmaceuticals will be substantially and irreparably harmed by Kashiv’s infringement of the
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`Mannion ’933 patent. Purdue Pharma and Purdue Pharmaceuticals do not have an adequate
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`remedy at law.
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`PRAYER FOR RELIEF
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`WHEREFORE, Plaintiffs pray for judgment as follows:
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`A.
`
`Adjudging that Kashiv has infringed one or more claims of each of the
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`Mannion ’933, ’416 and ’808 patents, and that the commercial sale, offer for sale, use,
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`importation, and/or manufacture of Amneal’s Amended ANDA Products would infringe, induce
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`infringement of, and/or contribute to the infringement of one or more claims of each of the
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`Mannion ’933, ’416 and ’808 patents;
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`B.
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`Adjudging, pursuant to 35 U.S.C. § 271(e)(4)(A), the effective date of any
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`approval of ANDA No. 203235 as amended and Amneal’s Amended ANDA Products, under
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`§ 505(j) of the Federal Food, Drug and Cosmetic Act (21 U.S.C. § 355(j)), to be a date not earlier
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`than the last date of expiration of the Mannion ’933, ’416 and ’808 patents, plus any additional
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`periods of extension or exclusivity attached thereto;
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`C.
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`Preliminarily and permanently enjoining, pursuant
`
`to 35 U.S.C.
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`§§ 271(e)(4)(B) and 283 and Rule 65, Fed. R. Civ. P., Kashiv, its officers, partners, agents,
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`servants, employees, parents, subsidiaries, divisions, affiliate corporations, other related business
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`entities, and all other persons acting in concert, participation, or in privity with them, and their
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`successors and assigns, from any commercial manufacture, use, offer to sell, or sale within the
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`Case 1:18-cv-00052-RGA Document 1 Filed 01/03/18 Page 14 of 14 PageID #: 14
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`United States, or importation into the United States, of any drug product that is the subject of
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`ANDA No. 203235 as amended, including Amneal’s Amended ANDA Products or any other
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`drug product that infringes the Mannion ’933, ’416 and ’808 patents;
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`D.
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`Declaring this an exceptional case and awarding Plaintiffs their attorneys’
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`fees and costs, as provided by 35 U.S.C. §§ 271(e)(4) and 285; and
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`E.
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`Awarding Plaintiffs such other and further relief as this Court may deem
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`just and proper.
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`
`
`OF COUNSEL:
`
`John J. Normile
`Pablo Hendler
`Gasper J. LaRosa
`Kenneth S. Canfield
`Sarah A. Geers
`JONES DAY
`250 Vesey Street
`New York, NY 10281
`(212) 326-3939
`
`January 3, 2018
`
`
`
`
`
`
`
`MORRIS, NICHOLS, ARSHT & TUNNELL LLP
`
`/s/ Rodger D. Smith II
`
`
`
`
`Jack B. Blumenfeld (#1014)
`Rodger D. Smith II (#3778)
`Megan E. Dellinger (#5739)
`1201 North Market Street
`P.O. Box 1347
`Wilmington, DE 19899
`(302) 658-9200
`jblumenfeld@mnat.com
`rsmith@mnat.com
`mdellinger@mnat.com
`
`Attorneys for Plaintiffs
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