Case 1:17-cv-00450-RGA Document 1 Filed 04/20/17 Page 1 of 18 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., THE P.F.
`LABORATORIES, INC., and RHODES
`TECHNOLOGIES,
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`Plaintiffs,
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`v.
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`ABHAI, LLC and KVK-TECH, INC.,
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`Defendants.
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`COMPLAINT
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`Plaintiffs Purdue Pharma L.P., Purdue Pharmaceuticals L.P., The P.F.
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`Laboratories, Inc. (collectively, “Purdue”), and Rhodes Technologies (“Rhodes”) (collectively,
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`“Plaintiffs”), for their Complaint against Defendants Abhai, LLC (“Abhai”) and KVK-TECH,
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`Inc. (“KVK”) (collectively, “Defendants”), 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. 9,492,389 (“the ’389 patent”); 9,492,391 (“the ’391 patent”); 9,492,392 (“the ’392 patent”);
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`9,492,393 (“the ’393 patent”) and 9,522,919 (“the ’919 patent”) (collectively, “the patents-in-
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`suit”). This action relates to Abbreviated New Drug Application (“ANDA”) No. 207493
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`(“Defendants’ ANDA”) submitted upon information and belief in the name of Defendants to the
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`United States Food and Drug Administration (“FDA”).
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`2.
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`Plaintiffs seek judgment that Defendants have infringed the ’389, ’391,
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`’392, ’393, and ’919 patents, which are listed in the FDA Approved Drug Products With
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`Therapeutic Equivalence Evaluations (“Orange Book”) as covering Purdue’s OxyContin®
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`(oxycodone hydrochloride) (“OxyContin®”), an extended-release pain medication. Defendants
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`have infringed the Orange Book patents under 35 U.S.C. § 271(e)(2)(A) by filing ANDA
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`No. 207493, submitted in the name of Defendants to the FDA. Defendants’ ANDA seeks
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`approval to market a generic version of Purdue’s OxyContin®, which is the subject of approved
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`New Drug Application (“NDA”) No. 022272, in the 10 mg, 15 mg, 20 mg, 30 mg, 40 mg,
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`60 mg, and 80 mg dosage strengths (“Defendants’ ANDA Products”).
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`THE PARTIES
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`3.
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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
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`One Stamford Forum, 201 Tresser Boulevard, Stamford, Connecticut 06901-3431. Purdue
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`Pharma is an owner of the ’389, ’391, ’392, ’393, and ’919 patents, identified in paragraphs 19-
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`23 below. Purdue Pharma is also the holder of approved NDA No. 022272 for OxyContin®,
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`indicated for pain severe enough to require daily, around-the-clock, long-term opioid treatment
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`and for which alternative treatment options are inadequate. Purdue Pharma sells OxyContin® in
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`the United States.
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`4.
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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 ’389, ’391, ’392, ’393, and ’919 patents, identified in paragraphs 19-23 below.
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`5.
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`Plaintiff The P.F. Laboratories, Inc. (“P.F. Labs”) is a corporation
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`organized and existing under the laws of the State of New Jersey, having a place of business at
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`One Stamford Forum, Stamford, CT 06901. P.F. Labs is an owner of the ’919 patent, identified
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`in paragraph 23 below.
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`6.
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`Plaintiff Rhodes Technologies (“Rhodes”) is a general partnership
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`organized and existing under the laws of the State of Delaware, having a place of business at
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`498 Washington Street, Coventry, RI 02816. Rhodes is an owner of the ’919 patent, identified in
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`paragraph 23 below, and is involved in the manufacture of the active pharmaceutical ingredient
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`(“API”) used in OxyContin®.
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`7.
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`On information and belief, Defendant Abhai is a limited liability company
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`organized and existing under the laws of the State of Florida, having a principal place of business
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`at 194 Inlet Drive, St. Augustine, FL 32080.
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`8.
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`On information and belief, Defendant KVK is a corporation organized and
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`existing under the laws of the Commonwealth of Pennsylvania, having a principal place of
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`business at 110 Terry Drive, Suite 200, Newtown, PA 18940.
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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(b), 1391(c),
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`and 1400(b), because Defendants have committed an act of patent infringement in this Judicial
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`District.
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`PERSONAL JURISDICTION
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`12.
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`This Court has personal jurisdiction over each of the Defendants by virtue
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`of, inter alia, their systematic and continuous contacts with Delaware and contacts with
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`Delaware in connection with the submission of Defendants’ ANDA, as set forth below.
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`13.
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`On information and belief, Defendant KVK 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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`14.
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`On information and belief, Defendants are in the business of preparing
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`generic pharmaceuticals that they distribute in the State of Delaware and throughout the United
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`States.
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`15.
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`On information and belief, if ANDA No. 207493 is approved, the
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`Defendants’ 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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`16.
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`On information and belief, Defendants have admitted to, consented to or
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`have not contested, the jurisdiction of this Court, and/or have availed themselves of the rights,
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`benefits, and privileges of this Court by asserting counterclaims in a pending District of
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`Delaware action, Purdue Pharma L.P. et al. v. Abhai, LLC et al., C.A. No. 16-25 (RGA) (SRF).
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`17.
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`This Court also has personal jurisdiction over Defendants by virtue of the
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`fact that they directed their “Notice of Paragraph IV Certification” to Plaintiffs, including
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`Plaintiffs Purdue Pharma and Purdue Pharmaceuticals, which are limited partnerships organized
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`and existing under the laws of the State of Delaware, and Plaintiff Rhodes, which is a general
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`partnership organized and existing under the laws of the State of Delaware.
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`18.
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`This Court further has personal jurisdiction over Defendants by virtue of
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`the fact that Defendants have committed, or aided, abetted, contributed to, and/or participated in
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`the commission of, the tortious act of patent infringement that has led to foreseeable harm and
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`injury to Plaintiffs, including Plaintiffs Purdue Pharma and Purdue Pharmaceuticals, which are
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`limited partnerships organized and existing under the laws of the State of Delaware, and Plaintiff
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`Rhodes, which is a general partnership organized and existing under the laws of the State of
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`Delaware.
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`THE ’389 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 ’389 patent, titled “TAMPER RESISTANT DOSAGE FORMS,”
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`including the right to sue and to recover for past infringement thereof. The ’389 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. A copy of the ’389 patent is attached hereto as Exhibit A, which was duly and
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`legally issued on November 15, 2016, naming William H. McKenna, Richard O. Mannion,
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`Edward P. O’Donnell, and Haiyong H. Huang as the inventors.
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`THE ’391 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 ’389 patent, titled “TAMPER RESISTANT DOSAGE FORMS,”
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`including the right to sue and to recover for past infringement thereof. The ’391 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. A copy of the ’391 patent is attached hereto as Exhibit B, which was duly and
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`legally issued on November 15, 2016, naming William H. McKenna, Richard O. Mannion,
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`Edward P. O’Donnell, and Haiyong H. Huang as the inventors.
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`THE ’392 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 ’392 patent, titled “TAMPER RESISTANT DOSAGE FORMS,”
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`including the right to sue and to recover for past infringement thereof. The ’392 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. A copy of the ’392 patent is attached hereto as Exhibit C, which was duly and
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`legally issued on November 15, 2016, naming William H. McKenna, Richard O. Mannion,
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`Edward P. O’Donnell, and Haiyong H. Huang as the inventors.
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`THE ’393 PATENT
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`22.
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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 ’393 patent, titled “TAMPER RESISTANT DOSAGE FORMS,”
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`including the right to sue and to recover for past infringement thereof. The ’393 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. A copy of the ’393 patent is attached hereto as Exhibit D, which was duly and
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`legally issued on November 15, 2016, naming William H. McKenna, Richard O. Mannion,
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`Edward P. O’Donnell, and Haiyong H. Huang as the inventors.
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`THE ’919 PATENT
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`23.
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`Purdue and Rhodes are the lawful owners of all right, title and interest in
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`the ’919 patent, entitled “OXYCODONE COMPOSITIONS,” including all right to sue and to
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`recover for past infringement thereof, which patent is listed in the FDA’s Orange Book as
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`covering OxyContin®, which is the subject of approved NDA No. 022272. A copy of the ’919
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`patent is attached hereto as Exhibit E , which was duly and legally issued on December 20,
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`2016, naming Robert Chapman, Lonn S. Rider, Qi Hong, Donald Kyle, and Robert Kupper as the
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`inventors.
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`DEFENDANTS’ ANDA
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`24.
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`On information and belief, on or before December 7, 2015, Defendants
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`filed Defendants’ ANDA in the name of Defendants with the FDA, under § 505(j) of the Federal
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`Food, Drug, and Cosmetic Act (21 U.S.C. § 355(j)), seeking approval to engage in the
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`commercial manufacture, use, sale, offer for sale, or importation of Defendants’ ANDA
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`Products, generic products based on the Reference Listed Drug OxyContin®, which is the
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`subject of approved NDA No. 022272.
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`25.
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`On information and belief, Defendants subsequently submitted in their
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`ANDA a “Paragraph IV” certification under 21 U.S.C. § 355(j)(2)(A)(vii)(IV) alleging that
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`certain patents, listed in the Orange Book as covering OxyContin®, which is the subject of
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`approved NDA No. 022272, are “invalid, unenforceable, and/or will not be infringed by the
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`commercial manufacture, use, offer for sale, sale or importation of” the drug products described
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`in Defendants’ ANDA.
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`26.
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`In a letter dated December 7, 2015, addressed to Plaintiffs and received by
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`Purdue Pharma on or about December 8, 2015, Defendants provided what purports to be a
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`“Notice of Paragraph IV Certification” with respect to Defendants’ ANDA and Defendants’
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`ANDA Products, and certain Orange Book patents, under § 505(j)(2)(B)(iv) of the Federal Food,
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`Drug, and Cosmetic Act (“Notice Letter”).
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`27.
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`Defendants’ submission of Defendants’ ANDA was an act of infringement
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`of said Orange Book patents under the United States Patent Law, 35 U.S.C. § 271(e)(2)(A).
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`28.
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`Plaintiffs commenced a patent infringement action within the 45-day
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`period after receiving the Notice Letter as described in 21 U.S.C. § 355(j)(5)(B)(iii), Purdue
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`Pharma L.P. et al. v. Abhai, LLC et al., C.A. No. 16-25 (RGA) (SRF) (D. Del.).
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`29. While the above-captioned action was pending, the patents-in-suit were
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`issued and listed in the Orange Book as covering OxyContin®.
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`30.
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`Defendants’ submission of Defendants’ ANDA was also an act of
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`infringement of the patents-in-suit under the United States Patent Law, 35 U.S.C. § 271(e)(2)(A).
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`See, e.g., Research Found. of State Univ. of N.Y. v. Mylan Pharm. Inc., C.A. No. 09-184-LPS,
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`2012 WL 1901267, at *1 (D. Del. May 25, 2012) (“A party may bring suit on patents listed in
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`the Orange Book after the filing date of an ANDA.”).
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`FIRST CLAIM FOR RELIEF
`(PATENT INFRINGEMENT OF U.S. PATENT NO. 9,492,389)
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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), Defendants’ submission of ANDA
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`No. 207493 to the FDA seeking approval of Defendants’ ANDA Products was an act of
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`infringement of the ’389 patent by Defendants.
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`33.
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`Defendants’ ANDA Products, or the use or manufacture thereof, are
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`covered by one or more claims of the ’389 patent, including but not limited to independent
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`claim 1, which recites, inter alia, a cured shaped pharmaceutical tablet comprising at least a first
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`compression shaped and then air cured matrix, wherein said curing is without compression, by
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`heated air having a temperature of at least about 62° C for a duration of at least about 5 minutes,
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`said matrix comprising oxycodone or a pharmaceutically acceptable salt thereof in combination
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`with at least one high molecular weight polyethylene oxide having an approximate molecular
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`weight selected from the group consisting of 4,000,000, 7,000,000, and a combination thereof,
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`and various claims dependent therefrom.
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`34.
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`If approved by the FDA, Defendants’ commercial manufacture, use,
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`importation, sale, and/or offer for sale of Defendants’ ANDA Products will infringe, contribute
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`to the infringement of, and/or induce the infringement of one or more claims of the ’389 patent
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`under 35 U.S.C. § 271(a)-(c).
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`35.
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`Defendants’ ANDA Products constitute a material part of the inventions
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`covered by the claims of the ’389 patent.
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`36.
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`Upon information and belief, Defendants have been aware of the existence
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`of the ’389 patent, and have no reasonable basis for believing that Defendants’ ANDA Products
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`will not infringe the ’389 patent, thus rendering the case “exceptional,” as that term is used in
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`35 U.S.C. § 285.
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`37.
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`Unless Defendants are enjoined by the Court, Purdue Pharma and Purdue
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`Pharmaceuticals will be substantially and irreparably harmed by Defendants’ infringement of the
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`’389 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. 9,492,391)
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`38.
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`Purdue Pharma and Purdue Pharmaceuticals incorporate by reference
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`and reallege paragraphs 1 through 30 above as though fully restated herein.
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`39.
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`Pursuant to 35 U.S.C. § 271(e)(2), Defendants’ submission of ANDA
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`No. 207493 to the FDA seeking approval of Defendants’ ANDA Products was an act of
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`infringement of the ’391 patent by Defendants.
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`40.
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`Defendants’ ANDA Products, or the use thereof, are covered by one or
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`more claims of the ’391 patent, including but not limited to independent claim 1, which recites
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`inter alia, a method of treating pain comprising administering to a patient in need thereof a
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`pharmaceutical tablet comprising at least a first compression shaped and then air cured matrix,
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`wherein said curing is without compression by heated air having a temperature of at least about
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`62° C for a duration of at least about 5 minutes, said matrix comprising oxycodone or a
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`pharmaceutically acceptable salt thereof in combination with at least one high molecular weight
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`polyethylene oxide having, based on rheological measurements, an approximate molecular
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`weight selected from the group consisting of 4,000,000, 7,000,000, and a combination thereof,
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`and various claims dependent therefrom.
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`41.
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`If approved by the FDA, Defendants’ commercial manufacture, use,
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`importation, sale, and/or offer for sale of Defendants’ ANDA Products will infringe, contribute
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`to the infringement of, and/or induce the infringement of one or more claims of the ’391 patent
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`under 35 U.S.C. § 271(a)-(c).
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`42.
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`Defendants’ ANDA Products constitute a material part of the inventions
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`covered by the claims of the ’391 patent.
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`43.
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`On information and belief, Defendants know that Defendants’ ANDA
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`Products are especially made or especially adapted for use in the infringement of one or more
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`claims of the ’391 patent.
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`44.
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`On information and belief, Defendants have had and continue to have
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`knowledge that there is no substantial non-infringing use for Defendants’ ANDA Products.
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`45.
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`The administration of Defendants’ ANDA Products by any Healthcare
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`Providers and patients, for the treatment of pain, will directly infringe one or more claims of the
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`’391 patent.
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`46.
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`Defendants’ proposed label for Defendants’ ANDA Products will
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`explicitly instruct Healthcare Providers and patients to use Defendants’ ANDA Products in a
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`manner that will directly infringe one or more claims of the ’391 patent, including but not limited
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`to independent claim 1, which recites inter alia, a method of treating pain comprising
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`administering to a patient in need thereof a pharmaceutical tablet comprising at least a first
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`compression shaped and then air cured matrix, wherein said curing is without compression by
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`heated air having a temperature of at least about 62° C for a duration of at least about 5 minutes,
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`said matrix comprising oxycodone or a pharmaceutically acceptable salt thereof in combination
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`with at least one high molecular weight polyethylene oxide having, based on rheological
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`measurements, an approximate molecular weight selected from the group consisting of
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`4,000,000, 7,000,000, and a combination thereof, and various claims dependent therefrom.
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`OxyContin® is indicated for the management of 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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`47.
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`If Defendants’ ANDA Products are approved by the FDA, Defendants will
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`actively induce others including, e.g., Healthcare Providers and patients, to directly infringe one
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`or more claims of the ’391 patent. Since at least the November 15, 2016, Defendants have acted
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`with knowledge, or at least with willful blindness of the fact, that the induced acts would
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`constitute infringement of the ’391 patent.
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`48.
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`Defendants intend to cause direct infringement by others, e.g., Healthcare
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`Providers and patients.
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`49.
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`If Defendants’ ANDA Products are approved by the FDA, Defendants will
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`take affirmative steps to induce infringement by, among other things, instructing Healthcare
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`Providers and patients, through Defendants’ proposed label, to use Defendants’ ANDA Products
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`in a manner that directly infringes one or more claims of the ’391 patent. Thus, Defendants will
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`aid, abet, urge, or encourage others including, e.g., Healthcare Providers and patients, to directly
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`infringe one or more claims of the ’391 patent, and Defendants will affirmatively and
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`specifically intend to cause direct infringement.
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`50.
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`Upon information and belief, Defendants have been aware of the existence
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`of the ’391 patent, and have no reasonable basis for believing that Defendants’ ANDA Products
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`will not infringe the ’391 patent, thus rendering the case “exceptional,” as that term is used in
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`35 U.S.C. § 285.
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`51.
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`Unless Defendants are enjoined by the Court, Purdue Pharma and Purdue
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`Pharmaceuticals will be substantially and irreparably harmed by Defendants’ infringement of the
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`’391 patent. Purdue Pharma and Purdue Pharmaceuticals do not have an adequate remedy at
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`law.
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`THIRD CLAIM FOR RELIEF
`(PATENT INFRINGEMENT OF U.S. PATENT NO. 9,492,392)
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`52.
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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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`53.
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`Pursuant to 35 U.S.C. § 271(e)(2), Defendants’ submission of ANDA
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`No. 207493 to the FDA seeking approval of Defendants’ ANDA Products was an act of
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`infringement of the ’392 patent by Defendants.
`
`54.
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`Defendants’ ANDA Products, or the use or manufacture thereof, are
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`covered by one or more claims of the ’389 patent, including but not limited to independent
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`claim 1, which recites, inter alia, a cured shaped pharmaceutical tablet comprising at least a first
`
`compression shaped and then air cured matrix, wherein said curing is without compression, by
`
`heated air having a temperature of at least about 62° C for a duration of at least about 5 minutes,
`
`said matrix comprising oxycodone or a pharmaceutically acceptable salt thereof in combination
`
`with at least one high molecular weight polyethylene oxide having an approximate molecular
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`weight selected from the group consisting of 4,000,000, 7,000,000, and a combination thereof,
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`and various claims dependent therefrom.
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`55.
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`If approved by the FDA, Defendants’ commercial manufacture, use,
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`importation, sale, and/or offer for sale of Defendants’ ANDA Products will infringe, contribute
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`to the infringement of, and/or induce the infringement of one or more claims of the ’392 patent
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`under 35 U.S.C. § 271(a)-(c).
`
`56.
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`Defendants’ ANDA Products constitute a material part of the inventions
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`covered by the claims of the ’392 patent.
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`57.
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`Upon information and belief, Defendants have been aware of the existence
`
`of the ’392 patent, and have no reasonable basis for believing that Defendants’ ANDA Products
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`will not infringe the ’392 patent, thus rendering the case “exceptional,” as that term is used in
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`35 U.S.C. § 285.
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`58.
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`Unless Defendants are enjoined by the Court, Purdue Pharma and Purdue
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`Pharmaceuticals will be substantially and irreparably harmed by Defendants’ infringement of the
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`’392 patent. Purdue Pharma and Purdue Pharmaceuticals do not have an adequate remedy at
`
`law.
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`FOURTH CLAIM FOR RELIEF
`(PATENT INFRINGEMENT OF U.S. PATENT NO. 9,492,393)
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`59.
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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.
`
`60.
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`Pursuant to 35 U.S.C. § 271(e)(2), Defendants’ submission of ANDA
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`No. 207493 to the FDA seeking approval of Defendants’ ANDA Products was an act of
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`infringement of the ’393 patent by Defendants.
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`61.
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`Defendants’ ANDA Products, or the use thereof, are covered by one or
`
`more claims of the ’393 patent, including but not limited to independent claim 1, which recites
`
`inter alia, a method of treating pain comprising administering to a patient in need thereof a
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`pharmaceutical tablet comprising at least a first compression shaped and then air cured matrix,
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`wherein said curing is without compression by heated air having a temperature of at least about
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`62° C for a duration of at least about 5 minutes, said matrix comprising oxycodone or a
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`pharmaceutically acceptable salt thereof in combination with at least one high molecular weight
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`polyethylene oxide having, based on rheological measurements, an approximate molecular
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`weight selected from the group consisting of 4,000,000, 7,000,000, and a combination thereof,
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`and various claims dependent therefrom.
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`62.
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`If approved by the FDA, Defendants’ commercial manufacture, use,
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`importation, sale, and/or offer for sale of Defendants’ ANDA Products will infringe, contribute
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`to the infringement of, and/or induce the infringement of one or more claims of the ’393 patent
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`under 35 U.S.C. § 271(a)-(c).
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`63.
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`Defendants’ ANDA Products constitute a material part of the inventions
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`covered by the claims of the ’393 patent.
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`64.
`
`On information and belief, Defendants know that Defendants’ ANDA
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`Products are especially made or especially adapted for use in the infringement of one or more
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`claims of the ’393 patent.
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`65.
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`On information and belief, Defendants have had and continue to have
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`knowledge that there is no substantial non-infringing use for Defendants’ ANDA Products.
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`66.
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`The administration of Defendants’ ANDA Products by any Healthcare
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`Providers and patients, for the treatment of pain, will directly infringe one or more claims of the
`
`’391 patent.
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`67.
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`Defendants’ proposed label for Defendants’ ANDA Products will
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`explicitly instruct Healthcare Providers and patients to use Defendants’ ANDA Products in a
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`manner that will directly infringe one or more claims of the ’391 patent, including but not limited
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`to independent claim 1, which recites inter alia, a method of treating pain comprising
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`administering to a patient in need thereof a pharmaceutical tablet comprising at least a first
`
`compression shaped and then air cured matrix, wherein said curing is without compression by
`
`heated air having a temperature of at least about 62° C for a duration of at least about 5 minutes,
`
`said matrix comprising oxycodone or a pharmaceutically acceptable salt thereof in combination
`
`with at least one high molecular weight polyethylene oxide having, based on rheological
`
`measurements, an approximate molecular weight selected from the group consisting of
`
`4,000,000, 7,000,000, and a combination thereof, and various claims dependent therefrom.
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`OxyContin® is indicated for the management of pain severe enough to require daily, around-the-
`
`clock, long-term opioid treatment and for which alternative treatment options are inadequate.
`
`68.
`
`If Defendants’ ANDA Products are approved by the FDA, Defendants will
`
`actively induce others including, e.g., Healthcare Providers and patients, to directly infringe one
`
`or more claims of the ’393 patent. Since at least the November 15, 2016, Defendants have acted
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`with knowledge, or at least with willful blindness of the fact, that the induced acts would
`
`constitute infringement of the ’393 patent.
`
`69.
`
`Defendants intend to cause direct infringement by others, e.g., Healthcare
`
`Providers and patients.
`
`70.
`
`If Defendants’ ANDA Products are approved by the FDA, Defendants will
`
`take affirmative steps to induce infringement by, among other things, instructing Healthcare
`
`Providers and patients, through Defendants’ proposed label, to use Defendants’ ANDA Products
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`in a manner that directly infringes one or more claims of the ’393 patent. Thus, Defendants will
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`aid, abet, urge, or encourage others including, e.g., Healthcare Providers and patients, to directly
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`infringe one or more claims of the ’393 patent, and Defendants will affirmatively and
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`specifically intend to cause direct infringement.
`
`71.
`
`Upon information and belief, Defendants have been aware of the existence
`
`of the ’393 patent, and have no reasonable basis for believing that Defendants’ ANDA Products
`
`will not infringe the ’391 patent, thus rendering the case “exceptional,” as that term is used in 35
`
`U.S.C. § 285.
`
`72.
`
`Unless Defendants are enjoined by the Court, Purdue Pharma and Purdue
`
`Pharmaceuticals will be substantially and irreparably harmed by Defendants’ infringement of the
`
`’393 patent. Purdue Pharma and Purdue Pharmaceuticals do not have an adequate remedy at
`
`law.
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`FIFTH CLAIM FOR RELIEF
`(PATENT INFRINGEMENT OF U.S. PATENT NO. 9,522,919)
`
`73.
`
`Purdue and Rhodes incorporate by reference and reallege paragraphs 1
`
`through 30 above as though fully restated herein.
`
`74.
`
`Pursuant to 35 U.S.C. § 271(e)(2), Defendants’ submission of ANDA
`
`No. 207493 to the FDA seeking approval of Defendants’ ANDA Products was an act of
`
`infringement of the ’393 patent by Defendants.
`
`75.
`
`Defendants’ ANDA Products, or the use or manufacture thereof, are
`
`covered by one or more claims of the ’919 patent, including but not limited to independent
`
`claims 1, 4, 12, and 18, which recite, inter alia, an oxycodone hydrochloride composition
`
`wherein the ratio of 8α,14-dihydroxy-7,8-dihydrocodeinone to oxycodone hydrochloride is
`
`0.04% or less as measured by HPLC, and various claims dependent therefrom.
`
`76.
`
`If approved by the FDA, Defendants’ commercial manufacture, use,
`
`importation, sale, and/or offer for sale of Defendants’ ANDA Products will infringe, contribute
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`to the infringement of, and/or induce the infringement of one or more claims of the ’919 patent
`
`under 35 U.S.C. § 271(a)-(c).
`
`77.
`
`Defendants’ ANDA Products constitute a material part of the inventions
`
`covered by the claims of the ’919 patent.
`
`78.
`
`Upon information and belief, Defendants have been aware of the existence
`
`of the ’919 patent, and have no reasonable basis for believing that Defendants’ ANDA Products
`
`will not infringe the ’919 patent, thus rendering the case “exceptional,” as that term is used in 35
`
`U.S.C. § 285.
`
`79.
`
`Unless Defendants are enjoined by the Court, Purdue and Rhodes will be
`
`substantially and irreparably harmed by Defendants’ infringement of the ’919 patent. Purdue
`
`and Rhodes do not have an adequate remedy at law.
`
`PRAYER FOR RELIEF
`
`WHEREFORE, Plaintiffs pray for judgment as follows:
`
`A.
`
`Adjudging that Defendants have infringed one or more claims of each of
`
`the ’389, ’391, ’392, ’393, and ’919 patents, and that the commercial sale, offer for sale, use,
`
`importation, and/or manufacture of Defendants’ ANDA Products would infringe, induce
`
`infringement of, and/or contribute to the infringement of one or more claims of each of the ’389,
`
`’391, ’392, ’393, and ’919 patents;
`
`B.
`
`Adjudging, pursuant to 35 U.S.C. § 271(e)(4)(A), the effective date of any
`
`approval of ANDA No. 207493 and Defendants’ 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 ’389, ’391, ’392, ’393, and ’919 patents, plus any additional 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.
`
`§§ 271(e)(4)(B) and 283 and Rule 65, Fed. R. Civ. P., Defendants, their 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. 207493, including Defendants’ ANDA Products or any other drug product
`
`that infringes the ’389, ’391, ’392, ’393, and ’919 patents;
`
`D.
`
`Declaring this an exceptional case and awarding Plaintiffs their attorneys’
`
`fees and costs, as provided by 35 U.S.C. §§ 271(e)(4) and 285; and
`
`E.
`
`Awarding Plaintiffs such other and further relief as this Court may deem
`
`just and proper.
`
`
`
`OF COUNSEL:
`
`John J. Normi