Case 1:18-cv-00052-RGA Document 1 Filed 01/03/18 Page 1 of 14 PageID #: 1
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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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`PURDUE PHARMA L.P., and PURDUE
`PHARMACEUTICALS L.P.,
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`
`Plaintiffs,
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`v.
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`
`KASHIV PHARMA, LLC,
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`
`Defendant.
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`COMPLAINT
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`Plaintiffs, Purdue Pharma L.P. and Purdue Pharmaceuticals L.P. (collectively,
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`“Purdue” or “Plaintiffs”), for their Complaint against Defendant Kashiv Pharma, LLC
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`(“Kashiv”), aver as follows:
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`NATURE OF THE ACTION
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`1.
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`This is an action for patent infringement arising under the patent laws of
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`the United States, Title 35, United States Code, for infringement of United States Patent
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`Nos. 9,763,933 (the “Mannion ’933 patent”)1; 9,770,416 (the “’416 patent”); and 9,775,808 (the
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`“’808 patent”) (collectively, “the patents-in-suit”). This action relates to Abbreviated New Drug
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`Application (“ANDA”) No. 203235 as amended, submitted, upon information and belief, by
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`Amneal Pharmaceuticals, LLC (“Amneal’s Amended ANDA”) to the United States Food and
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`Drug Administration (“FDA”). Plaintiffs seek judgment that Kashiv has infringed the Mannion
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`’933, ’416 and ’808 patents. The Mannion ’933, ’416 and ’808 patents are listed in the FDA
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`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.
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`KASHIV1023
`IPR of Patent No. 9,492,392
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`

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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-
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`release pain medication. Kashiv alleges to have filed Amneal’s Amended ANDA and, if so,
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`Kashiv has infringed the patents-in-suit under 35 U.S.C. § 271(e)(2)(A). Amneal’s Amended
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`ANDA seeks approval to market a generic version of Purdue’s OxyContin®, which is the subject
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`of approved NDA No. 022272, in the 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, 60 mg and 80 mg
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`dosage strengths (“Amneal’s Amended ANDA Products”).
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`2.
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`On September 17, 2015, Purdue filed a related complaint against Amneal,
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`C.A. No. 15-831-RGA, for patent infringement of U.S. Patent Nos. 9,060,976 (the “’976 patent”)
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`and 9,034,376 (the “’376 patent”). The previous action was filed in connection with Amneal’s
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`ANDA No. 203235, which contained a “Paragraph IV” certification under 21 U.S.C.
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`§ 355(j)(2)(A)(vii)(IV) alleging that the ’976 patent, listed in the Orange Book as covering
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`OxyContin®, is “unenforceable, invalid, and/or not infringed, either literally or under the
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`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.”
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`3.
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`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
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`patent”); 7,674,800 (the “’800 patent”); 7,683,072 (the “’072 patent”); 8,114,383 (the “’383
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`patent”); 8,309,060 (the “’060 patent”); 8,337,888 (the “’888 patent”); 8,808,741 (the “’741
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`patent”); 8,894,987 (the “’987 patent”); 8,894,988 (the “’988 patent”); 9,060,976 (the “’976
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`patent”); 9,034,376 (the “’376 patent”); and 9,073,933 (the “Kupper ’933 patent”). The previous
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`action was filed in connection with Amneal’s Amended ANDA, which contained a
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`“Paragraph IV” certification under 21 U.S.C. § 355(j)(2)(A)(vii)(IV) alleging that, inter alia, the
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`KASHIV1023
`IPR of Patent No. 9,492,392
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`

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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
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`literally or under the doctrine of equivalents, by the manufacture, use, sale, offer for sale, and/or
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`importation of the drug product for which ANDA No. 203235 has been submitted by Amneal.”
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`4.
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`On March 1, 2017, Purdue filed a related complaint against Amneal, C.A.
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`No. 17-210-RGA, for patent infringement of United States Patent Nos. 9,492,392 (the “’392
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`patent”); 9,492,393 (the “’393 patent”); and 9,522,919 (the “’919 patent”). The previous action
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`was filed in connection with Amneal’s Amended ANDA, which contained a “Paragraph IV”
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`certification under 21 U.S.C. § 355(j)(2)(A)(vii)(IV) alleging that the ’392, ’393, and ’919
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`patents, listed in the Orange Book as covering OxyContin®, are “unenforceable, invalid, and/or
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`not infringed, either literally or under the doctrine of equivalents, by the manufacture, use, sale,
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`offer for sale, and/or importation of the drug product for which ANDA No. 203235 has been
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`submitted by Amneal.”
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`5.
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`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
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`“’886 patent”), the Mannion ’933 patent, and 9,675,610 (the “’610 patent”). The previous action
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`was filed in connection with Amneal’s Amended ANDA, which contained a “Paragraph IV”
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`certification under 21 U.S.C. § 355(j)(2)(A)(vii)(IV) alleging that the ’610 patent, listed in the
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`Orange Book as covering OxyContin®,2 is “unenforceable, invalid, and/or not infringed, either
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`literally or under the doctrine of equivalents, by the manufacture, use, sale, offer for sale, and/or
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`importation of the drug product for which ANDA No. 203235 has been submitted by Amneal.”
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`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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`KASHIV1023
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`6.
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`Purdue has also filed, concurrently with the filing of the present
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`Complaint, a related complaint against Amneal for patent infringement of the ’416 and ’808
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`patents (“the Concurrent Amneal Action”). The Concurrent Amneal Action is identical to the
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`present Complaint, except that in the Concurrent Amneal Action, (a) Amneal is the sole-named
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`Defendant and (b) there are no allegations of infringement with respect to the Mannion ’933
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`patent, which are included in the related C.A. No. 17-1421. On information and belief, Amneal
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`(not Kashiv) is the owner of Amneal’s Amended ANDA. Plaintiffs are filing the present
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`Complaint out of an abundance of caution should Kashiv demonstrate that it, in fact, is the owner
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`of Amneal’s Amended ANDA.
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`THE PARTIES
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`7.
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`Plaintiff Purdue Pharma L.P. (“Purdue Pharma”) is a limited partnership
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`organized and existing under the laws of the State of Delaware, having a place of business at One
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`Stamford Forum, 201 Tresser Boulevard, Stamford, Connecticut 06901-3431. Purdue Pharma is
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`an owner of the ’416 and ’808 patents. Purdue Pharma is also the holder of approved NDA
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`No. 022272 for OxyContin®, indicated for pain severe enough to require daily, around-the-
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`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.
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`8.
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`Plaintiff Purdue Pharmaceuticals L.P. (“Purdue Pharmaceuticals”) is a
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`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
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`of the ’416 and ’808 patents.
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`9.
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`On information and belief, Kashiv is a limited liability company organized
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`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.
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`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.
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`11.
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`This Court has subject matter jurisdiction pursuant to 28 U.S.C. §§ 1331
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`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,
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`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
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`submission of Amneal’s Amended ANDA, as set forth below.
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`14.
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`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
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`16.
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`On information and belief, Kashiv has availed itself of the rights, benefits,
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`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).
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`17.
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`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
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`THE PATENTS-IN-SUIT
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`19.
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`Purdue Pharma and Purdue Pharmaceuticals are the lawful owners of all
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`right, title and interest in the Mannion ’933 patent, titled “TAMPER RESISTANT DOSAGE
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`FORMS,” including the right to sue and to recover for past infringement thereof. The Mannion
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`’933 patent is listed in the Orange Book as covering OxyContin®, which is the subject of
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`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.
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`Mannion, Edward P. O’Donnell, and Haiyong H. Huang as the inventors.
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`THE ’416 PATENT
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`20.
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`Purdue Pharma and Purdue Pharmaceuticals are the lawful owners of all
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`right, title and interest in the ’416 patent, titled “TAMPER RESISTANT DOSAGE FORMS,”
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`including the right to sue and to recover for past infringement thereof. The ’416 patent is listed
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`in the Orange Book as covering OxyContin®, which is the subject of approved NDA
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`No. 022272. Attached as Exhibit B is a copy of the ’416 patent, which was duly and legally
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`issued on September 26, 2017, naming William H. McKenna, Richard O. Mannion, Edward P.
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`O’Donnell, and Haiyong H. Huang as the inventors.
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`THE ’808 PATENT
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`21.
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`Purdue Pharma and Purdue Pharmaceuticals are the lawful owners of all
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`right, title and interest in the ’808 patent, titled “TAMPER RESISTANT DOSAGE FORMS,”
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`including the right to sue and to recover for past infringement thereof. The ’808 patent is listed
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`in the Orange Book as covering OxyContin®, which is the subject of approved NDA
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`No. 022272. Attached as Exhibit C is a copy of the ’808 patent, which was duly and legally
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`issued on October 3, 2017, naming William H. McKenna, Richard O. Mannion, Edward P.
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`O’Donnell, and Haiyong H. Huang as the inventors.
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`AMNEAL’S AMENDED ANDA
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`22.
`
`On information and belief, on or before September 27, 2011, Amneal filed
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`Amneal’s ANDA No. 203235 under § 505(j) of the Federal Food, Drug, and Cosmetic Act
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`(21 U.S.C. § 355(j)), seeking approval to engage in the commercial manufacture, use, sale, offer
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`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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`KASHIV1023
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`23.
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`In a letter dated August 3, 2015, addressed to Plaintiffs and received by
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`Purdue Pharma on or about August 4, 2015, Amneal provided what purports to be a “Notice of
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`Paragraph IV Certification” with respect to Amneal’s ANDA and Amneal’s Amended ANDA
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`Products, and the Orange Book patents, under § 505(j)(2)(B)(iv) of the Federal Food, Drug, and
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`Cosmetic Act.
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`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
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`(21 U.S.C. § 355(j)), seeking approval to engage in the commercial manufacture, use, sale, offer
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`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.
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`25.
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`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
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`of Paragraph IV Certification” with respect to Amneal’s Amended ANDA and Amneal’s
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`Amended ANDA Products, and
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`the Mannion ’933, ’416 and ’808 patents, under
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`§ 505(j)(2)(B)(iv) of the Federal Food, Drug, and Cosmetic Act (“Notice Letter”). On
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`information and belief, Amneal is the owner of the Amneal Amended ANDA. However, in the
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`Notice Letter, Kashiv alleges that “it submitted” ANDA No. 203235 to the FDA, and that it is
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`the owner of Amneal’s Amended ANDA.
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`26.
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`Plaintiffs commenced this action within the 45-day period after receiving
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`the Notice Letter dated November 21, 2017, as described in 21 U.S.C. § 355(j)(5)(B)(iii).
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`FIRST CLAIM FOR RELIEF
`(PATENT INFRINGEMENT OF U.S. PATENT NO. 9,770,416)
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`27.
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`Purdue Pharma and Purdue Pharmaceuticals incorporate by reference and
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`reallege paragraphs 1 through 26 above as though fully restated herein.
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`28.
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`Pursuant to 35 U.S.C. § 271(e)(2), Kashiv’s alleged submission of ANDA
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`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.
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`29.
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`Amneal’s Amended ANDA Products, or use thereof, are covered by one
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`or more claims of the ’416 patent, including but not limited to independent claim 1, which
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`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
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`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
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`weight PEO is at least partially melted upon curing and comprises at least about 50% (by weight)
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`of the dosage form; (c) the active agent comprises at least about 1.3% (by weight) of the dosage
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`form; (d) the molecular weight of each PEO is based on rheological measurements; (e) the total
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`weight of the dosage form is calculated by excluding the combined weight of said film coatings;
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`and (f) the dosage form is expanded upon curing, as measured by a decrease in density of at least
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`about 1.5%, and the dosage form provides a hardness of at least about 439 N.
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`30.
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`If approved by the FDA, Kashiv’s commercial manufacture, use,
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`importation, sale, and/or offer for sale of Amneal’s Amended ANDA Products will infringe,
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`contribute to the infringement of, and/or induce the infringement of one or more claims of the
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`’808 patent under 35 U.S.C. § 271(a)-(c).
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`31.
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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 ’416 patent.
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`32.
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`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.
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`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.
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`SECOND CLAIM FOR RELIEF
`(PATENT INFRINGEMENT OF U.S. PATENT NO. 9,775,808)
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`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
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`recites, inter alia, a pharmaceutical composition comprising: at least one active agent comprising
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`oxycodone or a pharmaceutically acceptable salt thereof; and at least one high molecular weight
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`polyethylene oxide (PEO), having an approximate molecular weight of from 1 million to
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`15 million; at least one of an additive and a film coating; wherein (a) the active agent and high
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`molecular weight PEO are combined in a solid oral extended release dosage form that is
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`(i) compression shaped, (ii) air cured by heated air, without compression, for at least about
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`5 minutes at a temperature above the softening temperature of the high molecular weight PEO,
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`(iii) cooled, and (iv) hardened; (b) the high molecular weight PEO comprises at least about 30%
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`(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.
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`37.
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`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.
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`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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`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
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`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
`
`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
`
`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
`
`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.
`
`47.
`
`Unless Kashiv is enjoined by the Court, Purdue Pharma and Purdue
`
`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
`
`remedy at law.
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`PRAYER FOR RELIEF
`
`WHEREFORE, Plaintiffs pray for judgment as follows:
`
`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
`
`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;
`
`B.
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`Adjudging, pursuant to 35 U.S.C. § 271(e)(4)(A), the effective date of any
`
`approval of ANDA No. 203235 as amended and Amneal’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 Mannion ’933, ’416 and ’808 patents, plus any additional
`
`periods of extension or exclusivity attached thereto;
`
`C.
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`Preliminarily and permanently enjoining, pursuant
`
`to 35 U.S.C.
`
`§§ 271(e)(4)(B) and 283 and Rule 65, Fed. R. Civ. P., Kashiv, 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
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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;
`
`D.
`
`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.
`
`Awarding Plaintiffs such other and further relief as this Court may deem
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`just and proper.
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`
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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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`KASHIV1023
`IPR of Patent No. 9,492,392
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