Case 1:17-cv-01421-RGA Document 1 Filed 10/10/17 Page 1 of 16 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., PURDUE
`PHARMACEUTICALS L.P., and
`GRÜNENTHAL GMBH,
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`
`Plaintiffs,
`
`v.
`
`
`AMNEAL PHARMACEUTICALS, LLC,
`
`
`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”) and Grünenthal GmbH (“Grünenthal”) (collectively, “Plaintiffs”), for their Complaint
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`against Defendant Amneal Pharmaceuticals, LLC (“Amneal”), 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. 9,763,886 (the “’886 patent”), 9,763,933 (the “Mannion ’933 patent”),1 and 9,675,610 (the
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`“’610 patent”) (collectively, “the patents-in-suit”). This action relates to Abbreviated New Drug
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`Application (“ANDA”) No. 203235 as amended (“Amneal’s Amended ANDA”) submitted, upon
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`information and belief, in the name of Amneal to the United States Food and Drug
`
`Administration (“FDA”). Plaintiffs seek judgment that Amneal has infringed the ’886, Mannion
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`’933 and ’610 patents. The ’610 and Mannion ’933 patents are listed in the FDA Approved Drug
`
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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 in a related action pending in this Court, C.A. No. 1:15-cv-01152-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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`KASHIV1021
`IPR of Patent No. 9,492,392
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`

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`Products With Therapeutic Equivalence Evaluations (“Orange Book”) as covering Purdue’s
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`OxyContin® (oxycodone hydrochloride) (“OxyContin®”), an extended-release pain medication.
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`Amneal has infringed the patents-in-suit under 35 U.S.C. § 271(e)(2)(A) by filing ANDA
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`No. 203235 as amended, submitted upon information and belief in the name of Amneal to the
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`FDA. Amneal’s Amended ANDA seeks approval to market a generic version of Purdue’s
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`OxyContin®, which is the subject of approved NDA No. 022272, in the 10 mg, 15 mg, 20 mg,
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`30 mg, 40 mg, 60 mg and 80 mg 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, Plaintiffs filed a related Complaint against
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`Amneal, C.A. No. 15-1152-RGA, for patent infringement of U.S. Patent Nos. 7,674,799 (the
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`“’799 patent”); 7,674,800 (the “’800 patent”); 7,683,072 (the “’072 patent”); 8,114,383 (the
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`“’383 patent”); 8,309,060 (the “’060 patent”); 8,337,888 (the “’888 patent”); 8,808,741 (the
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`“’741 patent”); 8,894,987 (the “’987 patent”); 8,894,988 (the “’988 patent”); 9,060,976 (the
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`“’976 patent”); 9,034,376 (the “’376 patent”); and 9,073,933 (the “Kupper ’933 patent”). The
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`previous 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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`2
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`KASHIV1021
`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, ’376 and Kupper ’933 patents, listed in
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`the Orange Book as covering OxyContin®, are “unenforceable, invalid, and/or not infringed,
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`either literally or under the doctrine of equivalents, by the manufacture, use, sale, offer for sale,
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`and/or importation of the drug product for which ANDA No. 203235 has been submitted by
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`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 ANDA, which contained a “Paragraph IV” certification
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`under 21 U.S.C. § 355(j)(2)(A)(vii)(IV) alleging that the ’392, ’393, and ’919 patents, listed in
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`the Orange Book as covering OxyContin®, are “unenforceable, invalid, and/or not infringed,
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`either literally or under the doctrine of equivalents, by the manufacture, use, sale, offer for sale,
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`and/or importation of the drug product for which ANDA No. 203235 has been submitted by
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`Amneal.”
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`THE PARTIES
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`5.
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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 Mannion ’933 and ’886 patents. Purdue Pharma is also the holder of approved
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`NDA No. 022272 for OxyContin®, indicated for pain severe enough to require daily, around-
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`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.
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`3
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`KASHIV1021
`IPR of Patent No. 9,492,392
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`6.
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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 Mannion ’933 and ’886 patents.
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`7.
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`Plaintiff Grünenthal GmbH (“Grünenthal”) is a corporation organized and
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`existing under the laws of Germany, having an address at 52078 Aachen, Zieglerstrasse 6,
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`Germany. Grünenthal is the owner of the ’610 patent.
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`8.
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`On information and belief, Amneal is a limited liability company
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`organized and existing under the laws of the State of Delaware, having a principal place of
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`business at 400 Crossing Boulevard, 3rd floor, Bridgewater, NJ 08807.
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`SUBJECT MATTER JURISDICTION AND VENUE
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`9.
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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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`10.
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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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`11.
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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 Amneal resides in this judicial district.
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`PERSONAL JURISDICTION
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`12.
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`This Court has personal jurisdiction over Amneal by virtue of, inter alia,
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`the fact that Amneal is a Delaware limited liability company, Amneal’s systematic and
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`continuous contacts with Delaware, and Amneal’s contacts with Delaware in connection with the
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`submission of its ANDA, as set forth below.
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`4
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`KASHIV1021
`IPR of Patent No. 9,492,392
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`13.
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`On information and belief, Amneal is registered to conduct business
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`within the State of Delaware and maintains as a registered agent The Corporation Trust
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`Company, Corporation Trust Center, 1209 Orange St, Wilmington, Delaware 19801.
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`14.
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`On
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`information and belief, Amneal holds current and valid
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`“Distributor/Manufacturer CSR” and “Pharmacy-Wholesale” licenses from the Delaware Board
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`of Pharmacy.
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`15.
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`On information and belief, Amneal is in the business of preparing generic
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`pharmaceuticals that it distributes in the State of Delaware and throughout the United States.
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`16.
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`On information and belief, Amneal has admitted to, consented to or has
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`not contested, the jurisdiction of this Court, and/or has availed itself of the rights, benefits, and
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`privileges of this Court by asserting counterclaims in prior District of Delaware actions, e.g.,
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`Purdue Pharma L.P. et al. v. Amneal Pharmaceuticals LLC, C.A. No. 17-210; Purdue Pharma
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`L.P. et al. v. Amneal Pharmaceuticals LLC, C.A. No. 15-1152; Purdue Pharma L.P. et al. v.
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`Amneal Pharmaceuticals LLC, C.A. No. 15-831; Forest Laboratories, LLC v. Amneal
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`Pharmaceuticals LLC, C.A. No. 15-756; Hospira, Inc. v. Amneal Pharmaceuticals LLC, C.A.
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`No. 15-697; Forest Laboratories, LLC v. Amneal Pharmaceuticals LLC, C.A. No. 15-430;
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`Merck Sharpe & Dohme Corp. v. Amneal Pharmaceuticals LLC, C.A. No. 15-250; and Forest
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`Laboratories, Inc. v. Amneal Pharmaceuticals LLC, C.A. No. 14-508.
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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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`5
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`KASHIV1021
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`18.
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`This Court further has personal jurisdiction over Amneal by virtue of the
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`fact that Amneal has committed, or aided, abetted, contributed to, and/or participated in the
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`commission of, the tortious act of patent infringement that has led to foreseeable harm and injury
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`to Plaintiffs, including Plaintiffs Purdue Pharma and Purdue Pharmaceuticals, which are limited
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`partnerships organized and existing under the laws of the State of Delaware.
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`THE ’886 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 ’886 patent, titled “TAMPER RESISTANT DOSAGE FORMS,”
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`including the right to sue and to recover for past infringement thereof. A copy of the ’886 patent
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`is attached hereto as Exhibit A, which was duly and legally issued on September 19, 2017,
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`naming William H. McKenna, Richard O. Mannion, Edward P. O’Donnell, and Haiyong H.
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`Huang as the inventors.
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`THE MANNION ’933 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 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. A copy of the Mannion ’933 patent is attached hereto as Exhibit B,
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`which was duly and legally issued on September 19, 2017, naming William H. McKenna,
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`Richard O. Mannion, Edward P. O’Donnell, and Haiyong H. Huang as the inventors.
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`6
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`THE ’610 PATENT
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`21.
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`Grünenthal is the lawful owner of all right, title and interest in the ’610
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`patent, titled “ABUSE-PROOFED DOSAGE FORM,” including the right to sue and to recover
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`for past infringement thereof. The ’610 patent is listed in the Orange Book as covering
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`OxyContin®, which is the subject of approved NDA No. 022272. A copy of the ’610 patent is
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`attached hereto as Exhibit C, which was duly and legally issued on June 13, 2017, naming
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`Johannes Bartholomaeus and Heinrich Kugelmann as the inventors.
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`AMNEAL’S AMENDED ANDA
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`22.
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`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
`
`Listed Drug OxyContin®, which is the subject of approved NDA No. 022272. On information
`
`and belief, Amneal subsequently submitted in its ANDA a “Paragraph IV” certification under
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`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,
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`unenforceable, and/or not infringed by the commercial manufacture, use or sale of” the drug
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`products described in Amneal’s ANDA.
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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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`7
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`24.
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`On information and belief, on or before October 30, 2015, Amneal filed
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`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. On
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`information and belief, Amneal’s Amended ANDA contained a “Paragraph IV” certification
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`under 21 U.S.C. § 355(U)(2)(A)(vii)(IV) alleging that the ’799, ’800, ’072, ’383, ’060, ’888,
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`’741, ’987, ’988, ’976 and ’933 patents, listed in the Orange Book as covering OxyContin®,
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`which is the subject of approved NDA No. 022272, are “unenforceable, invalid, and/or not
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`infringed, either literally or under the doctrine of equivalents, by the manufacture, use, sale, offer for
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`sale, and/or importation” of the drug products described in Amneal’s Amended ANDA.
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`25.
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`In a letter dated October 30, 2015, addressed to Plaintiffs and received by
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`Purdue Pharma on or about November 2, 2015, Amneal provided what purports to be 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 the ’799, ’800, ’072, ’383, ’060, ’888, ’741, ’987, ’988, ’976 and
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`’933 patents, under § 505(j)(2)(B)(iv) of the Federal Food, Drug, and Cosmetic Act.
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`26.
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`On information and belief, on or before January 16, 2017, Amneal filed
`
`Amneal’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 Amneal’s Amended ANDA Products, generic products based on
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`the Reference Listed Drug OxyContin®, which is the subject of approved NDA No. 022272. On
`
`information and belief, Amneal’s Amended ANDA contained a “Paragraph IV” certification
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`under 21 U.S.C. § 355(U)(2)(A)(vii)(IV) alleging, inter alia, that the ’392, ’393 and ’919
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`patents, listed in the Orange Book as covering OxyContin®, which is the subject of approved
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`8
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`NDA No. 022272, are “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 products described in Amneal’s Amended ANDA.
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`27.
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`In a letter dated January 16, 2017, addressed to Purdue and received by
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`Purdue Pharma on or about January 17, 2017, Amneal provided what purports to be a “Notice of
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`Paragraph IV Certification” with respect to Amneal’s Amended ANDA and Amneal’s Amended
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`ANDA Products, and the Orange Book patents, under § 505(j)(2)(B)(iv) of the Federal Food,
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`Drug, and Cosmetic Act.
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`28.
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`On information and belief, on or before August 23, 2017, Amneal filed
`
`Amneal’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,
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`offer for sale, or importation of Amneal’s Amended ANDA Products, generic products based on
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`the Reference Listed Drug OxyContin®, which is the subject of approved NDA No. 022272. On
`
`information and belief, Amneal’s Amended ANDA contained a “Paragraph IV” certification
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`under 21 U.S.C. § 355(U)(2)(A)(vii)(IV) alleging, inter alia, that the ’610 patent, listed in the
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`Orange Book as covering OxyContin®, which is the subject of approved NDA No. 022272, are
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`“unenforceable, invalid, and/or not infringed, either literally or under the doctrine of equivalents,
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`by the manufacture, use, sale, offer for sale, and/or importation” of the drug products described
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`in Amneal’s Amended ANDA.
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`29.
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`In a letter dated August 23, 2017, addressed to Plaintiffs and received by
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`Purdue Pharma on or about August 24, 2017, Amneal provided what purports to be a “Notice of
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`Paragraph IV Certification” with respect to Amneal’s Amended ANDA and Amneal’s Amended
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`9
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`ANDA Products, and the ’610 patent, under § 505(j)(2)(B)(iv) of the Federal Food, Drug, and
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`Cosmetic Act (“Notice Letter”).
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`30.
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`Plaintiffs commenced this action within the 45-day period after receiving
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`the Notice Letter dated August 23, 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. 9,763,886)
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`31.
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`Purdue Pharma and Purdue Pharmaceuticals incorporate by reference and
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`reallege paragraphs 1 through 30 above as though fully restated herein.
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`32.
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`Pursuant to 35 U.S.C. § 271(e)(2), Amneal’s submission of ANDA
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`No. 203235, as amended, to the FDA seeking approval of Amneal’s Amended ANDA Products
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`was an act of infringement of the ’886 patent by Amneal.
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`33.
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`The manufacture of Amneal’s Amended ANDA Products, or the sale,
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`offer for sale, or use thereof, are covered by one or more claims of the ’886 patent, including but
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`not limited to independent claim 1, which recites, inter alia, a method of producing a plurality of
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`solid oral extended release pharmaceutical dosage forms comprising the steps of: mixing at least
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`one active agent, at least one high molecular weight polyethylene oxide (PEO) having an
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`approximate molecular weight of from 1 million to 15 million, to provide a PEO composition;
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`compressing the PEO composition to provide a plurality of shaped matrix compositions; curing
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`the shaped matrix compositions by exposure to heated air at a curing temperature that is at least
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`the softening temperature of the high molecular weight PEO for a curing time of at least about 5
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`minutes, to provide a plurality of cured matrix compositions; cooling the cured matrix
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`compositions; wherein (a) the molecular weight of each PEO is based on rheological
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`measurements; (b) the high molecular weight PEO comprises at least about 30% (by weight) of
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`each dosage form; (c) the total weight of each dosage form is calculated by excluding the
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`combined weight of said film coatings; and (d) each cured matrix composition comprises a solid
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`oral pharmaceutical dosage form that provides an extended release of at least one active agent.
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`34.
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`If approved by the FDA, Amneal will infringe the ’886 patent by making,
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`using, offering for sale, selling, and distributing products embodying the patented inventions in
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`violation of 35 U.S.C. § 271(a) or (g) and/or by inducing others to make, use, sell, or offer for
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`sale products and methods embodying the patented inventions in violation of 35 U.S.C. § 271(b).
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`35.
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`Amneal, through at least its labeling and manufacturing process, will
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`intentionally induce infringement of the ’886 patent by at least patients who will take Amneal’s
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`Amended ANDA Products, caregivers/healthcare providers who administer the products, and
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`any manufacturers other than Amneal who manufacture Amneal’s Amended ANDA Products.
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`36.
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`Upon information and belief, Amneal has been aware of the existence of
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`the ’886 patent and has no reasonable basis for believing that the manufacture, use, sale, or offer
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`for sale of Amneal’s Amended ANDA Products will not infringe the ’886 patent, thus rendering
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`the case “exceptional,” as that term is used in 35 U.S.C. § 285.
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`37.
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`Unless Amneal is enjoined by the Court, Purdue Pharma and Purdue
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`Pharmaceuticals will be substantially and irreparably harmed by Amneal’s infringement of the
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`’886 patent. Purdue Pharma and Purdue Pharmaceuticals do not have an adequate remedy at
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`law.
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`SECOND CLAIM FOR RELIEF
`(PATENT INFRINGEMENT OF U.S. PATENT NO. 9,763,933)
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`38.
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`Purdue Pharma and Purdue Pharmaceuticals incorporate by reference and
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`reallege paragraphs 1 through 37 above as though fully restated herein.
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`39.
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`Pursuant to 35 U.S.C. § 271(e)(2), Amneal’s submission of ANDA
`
`No. 203235 as amended to the FDA seeking approval of Amneal’s Amended ANDA Products
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`was an act of infringement of the Mannion ’933 patent by Amneal.
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`40.
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`Amneal’s Amended ANDA Products, or the use thereof, are covered by
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`one or more claims of the Mannion ’933 patent, including but not limited to independent claim 1,
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`which recites, inter alia, a pharmaceutical composition comprising: at least one active agent; at
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`least one high molecular weight polyethylene oxide (PEO) having an approximate molecular
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`weight of from 1 million to 15 million; wherein (a) the active agent and high molecular weight
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`PEO are combined in a solid oral extended release dosage form that is (i) compression shaped,
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`(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.
`
`41.
`
`If approved by the FDA, Amneal’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).
`
`42.
`
`Amneal’s ANDA Products constitute a material part of the inventions
`
`covered by the claims of the Mannion ’933 patent.
`
`43.
`
`Upon information and belief, Amneal 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 1:17-cv-01421-RGA Document 1 Filed 10/10/17 Page 13 of 16 PageID #: 13
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`ANDA Products will not infringe the Mannion ’933 patent, thus rendering the case
`
`“exceptional,” as that term is used in 35 U.S.C. § 285.
`
`44.
`
`Unless Amneal is enjoined by the Court, Purdue Pharma and Purdue
`
`Pharmaceuticals will be substantially and irreparably harmed by Amneal’s infringement of the
`
`Mannion ’933 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. 9,675,610)
`
`45.
`
`Plaintiffs incorporate by reference and reallege paragraphs 1 through 44
`
`above as though fully restated herein.
`
`46.
`
`Pursuant to 35 U.S.C. § 271(e)(2), Amneal’s submission of ANDA
`
`No. 203235 as amended to the FDA seeking approval of Amneal’s Amended ANDA Products
`
`was an act of infringement of the ’610 patent by Amneal.
`
`47.
`
`Amneal’s Amended ANDA Products, or the use or manufacture thereof,
`
`are covered by one or more claims of the ’610 patent, including but not limited to independent
`
`claim 1, which recites, inter alia, a solid dosage form for oral administration with reduced
`
`potential for parenteral abuse, said dosage form comprising: (a) one or more active ingredients
`
`having potential for abuse selected from the group consisting of (among others) oxycodone and a
`
`pharmaceutically acceptable salt thereof; and (b) one or more viscosity-increasing agents in a
`
`quantity such that an aqueous extract of a total content of the dosage form when comminuted and
`
`combined with 10 ml of water at 25° C forms a gel that can be drawn up into and injected back
`
`out of a hypodermic needle having a diameter of 0.9 mm, into a further quantity of water,
`
`wherein threads of the gel injected from said needle remain visible to the naked eye in said
`
`further quantity of water at 37° C.
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`48.
`
`If approved by the FDA, Amneal’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
`
`’610 patent under 35 U.S.C. § 271(a)-(c).
`
`49.
`
`Amneal’s Amended ANDA Products constitute a material part of the
`
`inventions covered by the claims of the ’610 patent.
`
`50.
`
`Upon information and belief, Amneal has been aware of the existence of
`
`the ’610 patent and has no reasonable basis for believing that Amneal’s Amended ANDA
`
`Products will not infringe the ’610 patent, thus rendering the case “exceptional,” as that term is
`
`used in 35 U.S.C. § 285.
`
`51.
`
`Unless Amneal is enjoined by the Court, Plaintiffs will be substantially
`
`and irreparably harmed by Amneal’s infringement of the ’610 patent. Plaintiffs do not have an
`
`adequate remedy at law.
`
`PRAYER FOR RELIEF
`
`WHEREFORE, Plaintiffs pray for judgment as follows:
`
`A.
`
`Adjudging that Amneal has infringed one or more claims of each of
`
`the ’886, Mannion ’933 and ’610 patents, and that the commercial sale, offer for sale, use,
`
`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 ’886,
`
`Mannion ’933 and ’610 patents;
`
`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 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
`
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`than the last date of expiration of the ’886, Mannion ’933, and ’610 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., Amneal, 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 Amneal’s Amended ANDA Products or any other
`
`drug product that infringes the ’886, Mannion ’933 and ’610 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.
`
`
`
`
`
`
`OF COUNSEL:
`
`John J. Normile
`Pablo Hendler
`Gasper J. LaRosa
`Kenneth S. Canfield
`Sarah A. Geers
`Lisamarie LoGiudice
`JONES DAY
`250 Vesey Street
`New York, NY 10281
`(212) 326-3939
`
`
`
`
`
`
`
`
`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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`Case 1:17-cv-01421-RGA Document 1 Filed 10/10/17 Page 16 of 16 PageID #: 16
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`Jason G. Winchester
`JONES DAY
`77 West Wacker Drive
`Chicago, IL 60601
`(312) 269-4373
`
`Attorneys for Plaintiffs Purdue Pharma L.P.
`and Purdue Pharmaceuticals L.P.
`
`Joann M. Neth
`Jennifer H. Roscetti
`Anthony C. Tridico
`Matthew J. Luneack
`Erin M. Sommers
`Krista E. Bianco
`FINNEGAN, HENDERSON, FARABOW,
`GARRETT & DUNNER, LLP
`901 New York Avenue, NW
`Washington, DC 20001-4413
`(202) 408-4000
`Attorneys for Plaintiff Grünenthal GmbH
`
`October 10, 2017
`
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