Case 3:21-cv-12133 Document 1 Filed 06/03/21 Page 1 of 25 PageID: 1
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`William C. Baton
`Charles M. Lizza
`Sarah A. Sullivan
`SAUL EWING ARNSTEIN & LEHR LLP
`One Riverfront Plaza
`1037 Raymond Blvd., Suite 1520
`Newark, NJ 07102
`wbaton@saul.com
`
`Attorneys for Plaintiff
`Supernus Pharmaceuticals, Inc.
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`OF COUNSEL:
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`Edgar H. Haug
`Nicholas F. Giove
`Gregory Sephton
`Andrew S. Roper
`Jason A. Kanter
`HAUG PARTNERS LLP
`745 Fifth Avenue
`New York, NY 10151
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`UNITED STATES DISTRICT COURT
`DISTRICT OF NEW JERSEY
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`SUPERNUS PHARMACEUTICALS, INC.,
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`Plaintiff,
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`Civil Action No. _____________
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`COMPLAINT FOR PATENT
`INFRINGEMENT
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`(Filed Electronically)
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`v.
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`RICONPHARMA LLC and INGENUS
`PHARMACEUTICALS, LLC,
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`Defendants.
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`Plaintiff Supernus Pharmaceuticals, Inc. (“Supernus” or “Plaintiff”), by its undersigned
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`attorneys, for its Complaint against Defendants RiconPharma LLC (“Ricon”) and Ingenus
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`Pharmaceuticals, LLC (“Ingenus”) (collectively, “Defendants”), alleges as follows:
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`NATURE OF THE ACTION
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`1.
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`This is a civil action for patent infringement arising under the patent laws of the
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`United States, Title 35, United States Code, involving United States Patent No. 7,722,898 (“the
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`’898 patent”), United States Patent No. 7,910,131 (“the ’131 patent”), United States Patent No.
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`8,617,600 (“the ’600 patent”), United States Patent No. 8,821,930 (“the ’930 patent”), United
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`States Patent No. 9,119,791 (“the ’791 patent”), United States Patent No. 9,351,975 (“the ’975
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`patent”), United States Patent No. 9,370,525 (“the ’525 patent”), United States Patent No.
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`9,855,278 (“the ’278 patent”), and United States Patent No. 10,220,042 (“the ’042 patent”),
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`attached hereto as Exhibits A–I (collectively, “the patents in suit”).
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`THE PARTIES
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`2.
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`Plaintiff Supernus is a corporation organized and existing under the laws of
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`Delaware, having its principal place of business at 9715 Key West Avenue, Rockville, Maryland
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`20850.
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`3.
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`Upon information and belief, RiconPharma LLC (“Ricon”) is a New Jersey
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`limited liability company, having its principal place of business at 100 Ford Road, Suite 9,
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`Denville, New Jersey 07834.
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`4.
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`Upon information and belief, Ricon is in the business of, inter alia, developing,
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`manufacturing, marketing, distributing, and directly and/or indirectly selling generic
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`pharmaceutical products throughout the United States (including in the State of New Jersey), and
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`importing generic pharmaceutical products into the United States (including into the State of
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`New Jersey).
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`5.
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`Upon information and belief, Ricon either directly or through one or more of its
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`affiliates and/or agents, develops, manufactures, distributes, markets, offers to sell, and sells
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`generic pharmaceutical products, including in the State of New Jersey.
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`6.
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`On information and belief, Defendant Ingenus Pharmaceuticals, LLC (“Ingenus”)
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`is a corporation organized and existing under the laws of Delaware, having its principal place of
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`business at 4190 Millenia Road, Orlando, Florida 32839. On information and belief, Ingenus
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`also has facilities at 140 New Dutch Lane, Fairfield, New Jersey 07004 and, like Ricon, at 100
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`Ford Road, Suite 9, Denville, New Jersey 07834.
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`7.
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`Upon information and belief, Ricon and Ingenus work together for the direct
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`benefit of each other.
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`8.
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`Upon information and belief, Ingenus states on its webpage that it entered into a
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`merger agreement with Ricon on August 8, 2014, and that the combined entity has filed multiple
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`ANDAs. Ingenus website, https://www.ingenus.com/riconpharma%C2%ADingenus-merger-7/
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`(visited May 24, 2021).
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`9.
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`Upon information and belief, Ingenus is in the business of, inter alia, developing,
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`manufacturing, marketing, distributing, and/or selling generic pharmaceutical products
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`throughout the United States (including in the State of New Jersey), and importing generic
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`pharmaceutical products into the United States (including into the State of New Jersey).
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`10.
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`Upon information and belief, Ingenus is registered as a wholesale drug distributor
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`in the State of New Jersey under Registration No. 5004116. Upon information and belief, Ricon,
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`with the assistance of Ingenus, prepared, and filed Abbreviated New Drug Application
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`(“ANDA”) No. 215796 (“the Ricon ANDA”) with FDA seeking approval to engage in the
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`commercial manufacture, use, sale, offer for sale, and/or importation into the United States of
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`generic oxcarbazepine extended-release tablets, containing 150 mg, 300 mg, and 600 mg of
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`oxcarbazepine (“the Ricon Product”).
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`JURISDICTION AND VENUE
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`11.
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`This Court has jurisdiction over the subject matter of this action pursuant to 28
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`U.S.C. §§ 1331 and 1338(a).
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`12.
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`This Court has personal jurisdiction over Defendants under: (i) Fed. R. Civ. P.
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`4(k)(1); and (ii) N.J. Ct. R. 4:4-4.
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`13.
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`Upon information and belief, Defendants maintain a regular and established place
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`of business in New Jersey and have purposefully availed themselves of the privilege of doing
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`business in the State of New Jersey by continuously and systematically placing goods in the
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`stream of commerce for distribution and sale throughout the United States, including the State of
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`New Jersey. For example, upon information and belief, Ingenus states on its website that
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`“Ingenus’ New Jersey-based research & development facility specializes in the development of
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`solid orals (IR, MR, SL, and Films), topicals (ointments, creams, lotions, gels, powders, foams,
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`and sprays), transdermal patches (Hydrogel & Matrix), injectables (solutions, lyophilized, and
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`suspensions), and nasal sprays” and that “Ingenus today is poised to file 25 ANDAs a year.”
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`Ingenus website, https://www.ingenus.com/manufacturing/ (visited May 9, 2021).
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`14.
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`Upon information and belief, Defendants maintain a broad distributorship
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`network within the State of New Jersey and enjoy substantial income from sales of their generic
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`pharmaceutical products in the State of New Jersey.
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`15.
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`Upon information and belief, Ingenus is registered as a wholesale drug distributor
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`in the State of New Jersey under the Registration No. 5004116. Ingenus has, therefore,
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`purposefully availed itself of the rights, benefits, and privileges of New Jersey’s laws.
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`16.
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`On information and belief, Ricon and Ingenus have been, and continue to be, joint
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`and primary actors in the drafting, submission, approval, and maintenance of the Ricon ANDA.
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`17.
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`This Court has personal jurisdiction over Defendants because, inter alia:
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`(i) Ricon, together with Ingenus, has committed, induced, or contributed to acts of patent
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`infringement in New Jersey, including, but not limited to, the preparation of materials related to
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`the Ricon ANDA submission; (ii) Defendants are doing business in New Jersey and maintain
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`continuous and systematic contacts with this Judicial District, including by having a regular and
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`established place of business in New Jersey; (iii) Defendants directly or indirectly through agents
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`regularly do or solicit business in New Jersey and/or derive substantial revenue from services or
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`things used or consumed in New Jersey; (iv) Defendants transact business, perform work, and
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`contract to supply services or products in New Jersey; and (v) Ingenus is registered as a
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`wholesale drug distributor in the State of New Jersey under Registration No. 5004116. For
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`example, the FDA requires ANDA filers to prepare test batches of the proposed generic product.
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`See, e.g., https://www.fda.gov/media/107325/download. Upon information and belief, the only
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`Ingenus manufacturing facility identified on Ingenus’ website for non-oncology products and
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`treatments—such as those claimed in the patents in suit—is located in New Jersey. Ingenus
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`website, https://www.ingenus.com/manufacturing/ (visited May 9, 2021).
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`18.
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`Ricon’s tortious acts of (i) preparing and filing ANDA No. 215796 with a
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`paragraph IV certification to the patents in suit for the purpose of obtaining approval to engage in
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`the commercial manufacture, use, sale, offer for sale, and/or importation into the United States of
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`the Ricon Product before the expiration of the patents in suit; and (ii) directing notice of its
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`ANDA submission to Plaintiff Supernus, are acts with real and injurious consequences giving
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`rise to this infringement action, including the present and/or anticipated commercial
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`manufacture, use, and/or sale of Ricon’s ANDA Product before the expiration of the patents in
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`suit throughout the United States, including in this Judicial District. On information and belief,
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`Ingenus participated with Ricon in the above-mentioned tortious acts. Because defending
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`against an infringement lawsuit such as this one is an inherent and expected part of a generic
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`ANDA filer’s business, Ricon and Ingenus should reasonably anticipate being sued in New
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`Jersey.
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`19.
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`Upon information and belief, if ANDA No. 215796 is approved, Ricon’s ANDA
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`Product will be marketed and distributed by Defendants in the State of New Jersey, prescribed by
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`physicians practicing in the State of New Jersey, dispensed by pharmacies located within the
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`State of New Jersey, and used by patients in the State of New Jersey.
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`20.
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`Venue is proper in this judicial district under 28 U.S.C. §§ 1391(b) and 1391(c),
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`and § 1400(b).
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`21.
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`Venue is proper for Ricon under 28 U.S.C. §§ 1391 and/or 1400(b), because, inter
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`alia, Ricon is incorporated in New Jersey, maintains a regular and established place of business
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`in New Jersey, is subject to personal jurisdiction in this Judicial District, has committed acts of
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`infringement and will commit further acts of infringement in this Judicial District, and/or
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`continuously transacts business in this Judicial District. In addition, Ricon does business in this
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`Judicial District through a permanent and continuous presence in the State of New Jersey. Upon
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`information and belief, Ricon employs a salesforce that includes personnel who regularly and
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`continuously work in this Judicial District and, if Ricon succeeds in obtaining FDA approval,
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`Ricon will use its salesforce to sell the Ricon ANDA Product in the State of New Jersey.
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`22.
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`Venue is proper for Ingenus under 28 U.S.C. §§ 1391 and/or 1400(b), because,
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`inter alia, Ingenus maintains a regular and established place of business in New Jersey, is subject
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`to personal jurisdiction in this Judicial District, and, based on information and belief, has
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`committed an act of infringement and will commit further acts of infringement in this Judicial
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`District, as set forth above, and/or continuously transacts business in this Judicial District, as set
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`forth above. Upon information and belief, Ingenus employs a salesforce that includes personnel
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`who regularly and continuously work in this Judicial District. In addition, Ingenus is registered
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`to do business in New Jersey, designating an in-state agent to receive service of process in New
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`Jersey and, in fact, does business in this Judicial District through a permanent and continuous
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`presence in the State of New Jersey. For example, Ingenus is registered with the State of New
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`Jersey’s Department of Health as a drug wholesaler under Registration No. 5004116 and
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`continuously sells its products in this Judicial District.
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`FACTS AS TO ALL COUNTS
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`23.
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`Supernus owns New Drug Application (“NDA”) No. 202810, which was
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`approved by FDA for the manufacture and sale of oxcarbazepine extended-release tablets, 150
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`mg, 300 mg, and 600 mg, which Supernus markets under the name Oxtellar XR®.
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`24.
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`Oxtellar XR® is an antiepileptic drug indicated for: (i) adjunctive therapy in the
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`treatment of partial seizures in adults; and (ii) adjunctive therapy in the treatment of partial
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`seizures in children 6 to 17 years of age.
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`25.
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`The ’898 patent, entitled, “Modified-Release Preparations Containing
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`Oxcarbazepine and Derivatives Thereof” was duly and legally issued by the United States Patent
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`and Trademark Office on May 25, 2010, to Supernus upon assignment from inventors
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`Padmanabh P. Bhatt, Argaw Kidane, and Kevin Edwards. Supernus owns all rights, title, and
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`interest in the ’898 patent.
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`26.
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`The ’131 patent, entitled, “Method of Treating Seizures Using Modified Release
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`Formulations of Oxcarbazepine” was duly and legally issued by the United States Patent and
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`Trademark Office on March 22, 2011, to Supernus upon assignment from inventors Padmanabh
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`P. Bhatt, Argaw Kidane, and Kevin Edwards. Supernus owns all rights, title, and interest in the
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`’131 patent.
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`27.
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`The ’600 patent, entitled, “Modified Release Preparations Containing
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`Oxcarbazepine and Derivatives Thereof” was duly and legally issued by the United States Patent
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`and Trademark Office on December 31, 2013, to Supernus upon assignment from inventors
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`Padmanabh P. Bhatt, Argaw Kidane, and Kevin Edwards. Supernus owns all rights, title, and
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`interest in the ’600 patent.
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`28.
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`The ’930 patent, entitled, “Modified Release Preparations Containing
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`Oxcarbazepine and Derivatives Thereof” was duly and legally issued by the United States Patent
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`and Trademark Office on September 2, 2014, to Supernus upon assignment from inventors
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`Padmanabh P. Bhatt, Argaw Kidane, and Kevin Edwards. Supernus owns all rights, title, and
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`interest in the ’930 patent.
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`29.
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`The ’791 patent, entitled, “Modified Release Preparations Containing
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`Oxcarbazepine and Derivatives Thereof” was duly and legally issued by the United States Patent
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`and Trademark Office on September 1, 2015, to Supernus upon assignment from inventors
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`Padmanabh P. Bhatt, Argaw Kidane, and Kevin Edwards. Supernus owns all rights, title, and
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`interest in the ’791 patent.
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`30.
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`The ’975 patent, entitled, “Modified Release Preparations Containing
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`Oxcarbazepine and Derivatives Thereof” was duly and legally issued by the United States Patent
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`and Trademark Office on May 31, 2016, to Supernus upon assignment from inventors
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`Padmanabh P. Bhatt, Argaw Kidane, and Kevin Edwards. Supernus owns all rights, title, and
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`interest in the ’975 patent.
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`31.
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`The ’525 patent, entitled, “Modified Release Preparations Containing
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`Oxcarbazepine and Derivatives Thereof” was duly and legally issued by the United States Patent
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`and Trademark Office on June 21, 2016, to Supernus upon assignment from inventors
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`Padmanabh P. Bhatt, Argaw Kidane, and Kevin Edwards. Supernus owns all rights, title, and
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`interest in the ’525 patent.
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`32.
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`The ’278 patent, entitled, “Modified Release Preparations Containing
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`Oxcarbazepine and Derivatives Thereof” was duly and legally issued by the United States Patent
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`and Trademark Office on January 2, 2018, to Supernus upon assignment from inventors
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`Padmanabh P. Bhatt, Argaw Kidane, and Kevin Edwards. Supernus owns all rights, title, and
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`interest in the ’278 patent.
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`33.
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`The ’042 patent, entitled, “Modified Release Preparations Containing
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`Oxcarbazepine and Derivatives Thereof” was duly and legally issued by the United States Patent
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`and Trademark Office on March 5, 2019, to Supernus upon assignment from inventors
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`Padmanabh P. Bhatt, Argaw Kidane, and Kevin Edwards. Supernus owns all rights, title, and
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`interest in the ’042 patent.
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`34.
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`Pursuant to 21 U.S.C. § 355(b)(1), the patents in suit are listed in FDA’s
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`publication titled, “Approved Drug Products with Therapeutic Equivalence Evaluations”
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`(commonly known as the “Orange Book”) in connection with Oxtellar XR®. Supernus
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`submitted the patents in suit to FDA to be listed in the Orange Book for NDA No. 202810.
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`35.
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`Upon information and belief, Defendants prepared and filed the Ricon ANDA
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`with FDA under § 505(j) of the Federal Food, Drug, and Cosmetic Act (“FDCA”) (codified at 21
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`U.S.C. § 355(j)), seeking approval to engage in the commercial manufacture, use, sale, offer for
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`sale, and/or importation of the Ricon Product and included a “paragraph IV” certification seeking
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`approval before the expiration of patents in suit.
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`36.
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`21 U.S.C. § 355(j)(2)(B)(iv)(II) requires that a letter notifying a patent holder of
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`the filing of an ANDA containing a paragraph IV certification “include a detailed statement of
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`the factual and legal basis of the opinion of the applicant that the patent is invalid or will not be
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`infringed.” Likewise, 21 C.F.R. § 314.95(c)(7) requires that such a letter include “[a] detailed
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`statement of the factual and legal basis of the applicant’s opinion that the patent is not valid,
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`unenforceable, or will not be infringed.” The detailed statement must include “(i) [f]or each
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`claim of a patent alleged not to be infringed, a full and detailed explanation of why the claim is
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`not infringed” and “(ii) [f]or each claim of a patent alleged to be invalid or unenforceable, a full
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`and detailed explanation of the grounds supporting the allegation.” 21 C.F.R. § 314.95(c)(7)(i)-
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`(ii).
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`37.
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`On or about April 20, 2021, Ricon sent a letter purportedly pursuant to
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`§ 505(j)(2)(B)(iv) of the FDCA and 21 C.F.R. §§ 314.94, 314.95 regarding the Ricon Product
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`and the ’898 patent, the ’131 patent, the ’600 patent, the ’930 patent, the ’791 patent, the ’975
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`patent, the ’525 patent, the ’278 patent, and the ’042 patent (the “April 20 Notice Letter”).
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`38.
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`The April 20 Notice Letter contends that the Ricon Product does not infringe
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`independent claim 1 of each of the patents in suit. The April 20 Notice Letter does not include
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`any non-infringement contentions unique to claims 2-20 of the ’898 patent, claims 2–24 of the
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`’131 patent, claims 2–22 of the ’600 patent, claims 2-20 of the ’930 patent, claims 2-24 of the
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`’791 patent, claims 2-20 of the ’975 patent, claims 2-21 of the ’525 patent, claims 2-21 of the
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`’278 patent, and claims 2-27 of the ’042 patent.
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`39.
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`The April 20 Notice Letter does not include any detailed statement of the factual
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`and legal basis for Defendants’ opinion that the patents in suit are unenforceable.
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`40.
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`The April 20 Notice Letter does not contend that the patents in suit are invalid as
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`anticipated, obvious, or invalid for lack of enablement and/or written description. In fact, the
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`April 20 Notice Letter does not include any prior-art based invalidity contentions based on 35
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`U.S.C. § 102 or 35 U.S.C. § 103.
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`41.
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`The April 20 Notice Letter does not include any description of the composition,
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`formulation, ingredients, development, manufacture, or testing of the Ricon Product beyond a
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`vague and unsupported statement that the Ricon Product does not include a “‘homogenous
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`matrix’ or any one of the polymers having pH dependent solubility” required by certain claims of
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`the patent in suit. Plaintiff and Defendants did not reach agreement on mutually acceptable
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`terms for an Offer of Confidential Access pursuant to 21 U.S.C. § 355(j)(5)(C) and 21 C.F.R. §
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`314.95(c)(8). As of the filing of this Complaint, Defendants have not produced the Ricon
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`ANDA to Plaintiff.
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`FIRST COUNT
`(Defendants’ Infringement of the ’898 Patent)
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`42.
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`Plaintiff repeats and re-alleges each of the foregoing Paragraphs as if fully set
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`forth herein.
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`43.
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`Upon information and belief, Defendants seek FDA approval for the manufacture,
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`use, marketing, sale, and/or distribution of the Ricon Product.
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`44.
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`Upon information and belief, Defendants included a paragraph IV certification to
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`the ’898 patent to obtain approval to engage in the commercial manufacture, use, sale, offer for
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`sale, and/or importation of the Ricon Product before the expiration of the ’898 patent.
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`45.
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`Upon information and belief, Defendants will commercially manufacture, use,
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`sell, offer for sale, and/or import the Ricon Product upon, or in anticipation of, FDA approval.
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`46.
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`The submission and filing of ANDA No. 215796 with a paragraph IV certification
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`to the ’898 patent for the purpose of obtaining approval to engage in the commercial
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`manufacture, use, sale, offer for sale, and/or importation into the United States of the Ricon
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`Product before the expiration of the ’898 patent is an act of infringement by Defendants of one or
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`more claims of the ’898 patent under 35 U.S.C. § 271 et seq., including under 35 U.S.C.
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`§271(e)(2)(A).
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`47.
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`Defendants’ commercial manufacture, use, sale, offer for sale, and/or importation
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`into the United States of the Ricon Product that is the subject of ANDA No. 215796 will
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`infringe, directly and/or indirectly, one or more claims of the ’898 patent under 35 U.S.C. § 271
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`et seq., including under 35 U.S.C. § 271(a), 35 U.S.C. § 271(b), and/or 35 U.S.C. § 271(c).
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`48.
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`Upon information and belief, Defendants’ offering for sale and/or sale of the
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`Ricon Product will induce and/or contribute to third-party infringement of one or more claims of
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`the ’898 patent under 35 U.S.C. § 271.
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`49.
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`Defendants’ infringement of the ’898 patent has caused and will cause Supernus
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`to suffer irreparable harm. Defendants’ infringement will continue unless enjoined by the Court.
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`Supernus has no adequate remedy at law and thus preliminary and permanent injunctions are
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`appropriate to prohibit Defendants from infringing the ’898 patent.
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`50.
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`As of the date of the April 20 Notice Letter, Defendants were aware of the
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`existence of the ’898 patent—as well as the statutory provisions and regulations set forth in 21
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`U.S.C. § 355 and 21 C.F.R. § 314.95—and acted without a reasonable basis for believing that
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`they would not be liable for infringement of the ’898 patent, thus rendering this case
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`“exceptional” under 35 U.S.C. § 285.
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`SECOND COUNT
`(Defendants’ Infringement of the ’131 Patent)
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`51.
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`Plaintiff repeats and re-alleges each of the foregoing Paragraphs as if fully set
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`forth herein.
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`52.
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`Upon information and belief, Defendants included a paragraph IV certification to
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`the ’131 patent to obtain approval to engage in the commercial manufacture, use, sale, offer for
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`sale, and/or importation of the Ricon Product before the expiration of the ’131 patent.
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`53.
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`The submission and filing of ANDA No. 215796 with a paragraph IV certification
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`to the ’131 patent for the purpose of obtaining approval to engage in the commercial
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`manufacture, use, sale, offer for sale, and/or importation into the United States of the Ricon
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`Product before the expiration of the ’131 patent is an act of infringement by Defendants of one or
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`more claims of the ’131 patent under 35 U.S.C. § 271 et seq., including under 35 U.S.C.
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`§271(e)(2)(A).
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`54.
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`Defendants’ commercial manufacture, use, sale, offer for sale, and/or importation
`
`into the United States of the Ricon Product that is the subject of ANDA No. 215796 will
`
`infringe, directly or indirectly, one or more claims of the ’131 patent under 35 U.S.C. § 271 et
`
`seq., including under 35 U.S.C. § 271(a), 35 U.S.C. § 271(b), and/or 35 U.S.C. § 271(c).
`
`55.
`
`Upon information and belief, Defendants’ offering for sale and/or sale of the
`
`Ricon Product will induce and/or contribute to third-party infringement of one or more claims of
`
`the ’131 patent under 35 U.S.C. § 271.
`
`56.
`
`Defendants’ infringement of the ’131 patent has caused and will cause Supernus
`
`to suffer irreparable harm. Defendants’ infringement will continue unless enjoined by the Court.
`
`Supernus has no adequate remedy at law and thus preliminary and permanent injunctions are
`
`appropriate to prohibit Defendants from infringing the ’131 patent.
`
`57.
`
`As of the date of the April 20 Notice Letter, Defendants were aware of the
`
`existence of the ’131 patent—as well as the statutory provisions and regulations set forth in
`
`21U.S.C. § 355 and 21 C.F.R. § 314.95—and acted without a reasonable basis for believing that
`
`they would not be liable for infringement of the ’131 patent, thus rendering this case
`
`“exceptional” under 35 U.S.C. § 285.
`
`THIRD COUNT
`(Defendants’ Infringement of the ’600 Patent)
`
`58.
`
`Plaintiff repeats and re-alleges each of the foregoing Paragraphs as if fully set
`
`forth herein.
`
`
`
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`
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`59.
`
`Upon information and belief, Defendants included a paragraph IV certification to
`
`the ’600 patent to obtain approval to engage in the commercial manufacture, use, sale, offer for
`
`sale, and/or importation of the Ricon Product before the expiration of the ’600 patent.
`
`60.
`
`The submission and filing of ANDA No. 215796 with a paragraph IV certification
`
`to the ’600 patent for the purpose of obtaining approval to engage in the commercial
`
`manufacture, use, sale, offer for sale, and/or importation into the United States of the Ricon
`
`Product before the expiration of the ’600 patent is an act of infringement by Defendants of one or
`
`more claims of the ’600 patent under 35 U.S.C. § 271 et seq., including under 35 U.S.C.
`
`§271(e)(2)(A).
`
`61.
`
`Defendants’ commercial manufacture, use, sale, offer for sale, and/or importation
`
`into the United States of the Ricon Product that is the subject of ANDA No. 215796 will
`
`infringe, directly or indirectly, one or more claims of the ’600 patent under 35 U.S.C. § 271 et
`
`seq., including under 35 U.S.C. § 271(a), 35 U.S.C. § 271(b), and/or 35 U.S.C. § 271(c).
`
`62.
`
`Upon information and belief, Defendants’ offering for sale and/or sale of the
`
`Ricon Product will induce and/or contribute to third-party infringement of one or more claims of
`
`the ’600 patent under 35 U.S.C. § 271.
`
`63.
`
` Defendants’ infringement of the ’600 patent has caused and will cause Supernus
`
`to suffer irreparable harm. Defendants’ infringement will continue unless enjoined by the Court.
`
`Supernus has no adequate remedy at law and thus preliminary and permanent injunctions are
`
`appropriate to prohibit Defendants from infringing the ’600 patent.
`
`64.
`
`As of the date of the April 20 Notice Letter, Defendants were aware of the
`
`existence of the ’600 patent—as well as the statutory provisions and regulations set forth in 21
`
`U.S.C. § 355 and 21 C.F.R. § 314.95—and acted without a reasonable basis for believing that
`
`
`
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`
`
`they would not be liable for infringement of the ’600 patent, thus rendering this case
`
`“exceptional” under 35 U.S.C. § 285.
`
`FOURTH COUNT
`(Defendants’ Infringement of the ’930 Patent)
`
`65.
`
`Plaintiff repeats and re-alleges each of the foregoing Paragraphs as if fully set
`
`forth herein.
`
`66.
`
`Upon information and belief, Defendants included a paragraph IV certification to
`
`the ’930 patent to obtain approval to engage in the commercial manufacture, use, sale, offer for
`
`sale, and/or importation of the Ricon Product before the expiration of the ’930 patent.
`
`67.
`
`The submission and filing of ANDA No. 215796 with a paragraph IV certification
`
`to the ’930 patent for the purpose of obtaining approval to engage in the commercial
`
`manufacture, use, sale, offer for sale, and/or importation into the United States of the Ricon
`
`Product before the expiration of the ’930 patent is an act of infringement by Defendants of one or
`
`more claims of the ’930 patent under 35 U.S.C. § 271 et seq., including under 35 U.S.C. §
`
`271(e)(2)(A).
`
`68.
`
` Defendants’ commercial manufacture, use, sale, offer for sale, and/or importation
`
`into the United States of the Ricon Product that is the subject of ANDA No. 215796 will
`
`infringe, directly or indirectly, one or more claims of the ’930 patent under 35 U.S.C. § 271 et
`
`seq., including under 35 U.S.C. § 271(a), 35 U.S.C. § 271(b), and/or 35 U.S.C. § 271(c).
`
`69.
`
`Upon information and belief, Defendants’ offering for sale and/or sale of the
`
`Ricon Product will induce and/or contribute to third-party infringement of one or more claims of
`
`the ’930 patent under 35 U.S.C. § 271.
`
`70.
`
`Defendants’ infringement of the ’930 patent has caused and will cause Supernus
`
`to suffer irreparable harm. Defendants’ infringement will continue unless enjoined by the Court.
`
`
`
`15
`
`
`
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`

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`
`
`
`Supernus has no adequate remedy at law and thus preliminary and permanent injunctions are
`
`appropriate to prohibit Defendants from infringing the ’930 patent.
`
`71.
`
`As of the date of the April 20 Notice Letter, Defendants were aware of the
`
`existence of the ’930 patent—as well as the statutory provisions and regulations set forth in 21
`
`U.S.C. § 355 and 21 C.F.R. § 314.95—and acted without a reasonable basis for believing that
`
`they would not be liable for infringement of the ’930 patent, thus rendering this case
`
`“exceptional” under 35 U.S.C. § 285.
`
`FIFTH COUNT
`(Defendants’ Infringement of the ’791 Patent)
`
`72.
`
`Plaintiff repeats and re-alleges each of the foregoing Paragraphs as if fully set
`
`forth herein.
`
`73.
`
`Upon information and belief, Defendants included a paragraph IV certification to
`
`the ’791 patent to obtain approval to engage in the commercial manufacture, use, sale, offer for
`
`sale, and/or importation of the Ricon Product before the expiration of the ’791 patent.
`
`74.
`
`The submission and filing of ANDA No. 215796 with a paragraph IV certification
`
`to the ’791 patent for the purpose of obtaining approval to engage in the commercial
`
`manufacture, use, sale, offer for sale, and/or importation into the United States of the Ricon
`
`Product before the expiration of the ’791 patent is an act of infringement by Defendants of one or
`
`more claims of the ’791 patent under 35 U.S.C. § 271 et seq., including under 35 U.S.C. §
`
`271(e)(2)(A).
`
`75.
`
` Defendants’ commercial manufacture, use, sale, offer for sale, and/or
`
`importation into the United States of the Ricon Product that is the subject of ANDA No. 215796
`
`will infringe, directly or indirectly, one or more claims of the ’791 patent under 35 U.S.C. § 271
`
`et seq., including under 35 U.S.C. § 271(a), 35 U.S.C. § 271(b), and/or 35 U.S.C. § 271(c).
`
`
`
`16
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`
`
`
`

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`Case 3:21-cv-12133 Document 1 Filed 06/03/21 Page 17 of 25 PageID: 17
`
`
`
`76.
`
`Upon information and belief, Defendants’ offering for sale and/or sale of the
`
`Ricon Product will induce and/or contribute to third-party infringement of one or more claims of
`
`the ’791 patent under 35 U.S.C. § 271.
`
`77.
`
`Defendants’ infringement of the ’791 patent has caused and will cause Supernus
`
`to suffer irreparable harm. Defendants’ infringement will continue unless enjoined by the Court.
`
`Supernus has no adequate remedy at law and thus preliminary and permanent injunctions are
`
`appropriate to prohibit Defendants from infringing the ’791 patent.
`
`78.
`
`As of the date of the April 20 Notice Letter, Defendants were aware of the
`
`existence of the ’791 patent—as well as the statutory provisions and regulations set forth in 21
`
`U.S.C. § 355 and 21 C.F.R. § 314.95—and acted without a reasonable basis for believing that
`
`they would not be liable for infringement of the ’791 patent, thus rendering this case
`
`“exceptional” under 35 U.S.C. § 285.
`
`SIXTH COUNT
`(Defendants’ Infringement of the ’975 Patent)
`
`79.
`
`Plaintiff repeats and re-alleges each of the foregoing Paragraphs as if fully set
`
`forth herein.
`
`80.
`
`Upon information and belief, Defendants included a paragraph IV certification to
`
`the ’975 patent to obtain approval to engage in the commercial manufacture, use, sale, offer for
`
`sale, and/or imp