Case: 1:22-cv-03511 Document #: 1 Filed: 07/06/22 Page 1 of 27 PageID #:1
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE NORTHERN DISTRICT OF ILLINOIS
`EASTERN DIVISION
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`SUPERNUS PHARMACEUTICALS, INC.,
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`v.
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`Plaintiff,
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`ALKEM LABORATORIES LTD.,
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`Defendant.
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`Civil Action No. ______
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`COMPLAINT FOR PATENT INFRINGEMENT
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`Plaintiff Supernus Pharmaceuticals, Inc. (“Supernus” or “Plaintiff”), by its undersigned
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`attorneys, for its Complaint against Defendant Alkem Laboratories Ltd. (“Alkem” or
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`“Defendant”), 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 Nos. 8,298,576 (“the
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`’576 patent”), 8,298,580 (“the ’580 patent”), 8,663,683 (“the ’683 patent”), 8,877,248 (“the ’248
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`patent”), 8,889,191 (“the ’191 patent”), 8,992,989 (“the ’989 patent”), 9,549,940 (“the ’940
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`patent”), 9,555,004 (“the ’004 patent”), 9,622,983 (“the ’983 patent”), and 10,314,790 (“the ’790
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`patent”) attached hereto as Exhibits A–J (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, Alkem is a corporation operating and existing under
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`the laws of India, with its principal place of business at Alkem House, Devashish, Senapati Bapat
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`Marg, Lower Parel (W), Mumbai – 400 013, Maharashtra, India.
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`4.
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`Upon information and belief, Alkem filed an Abbreviated New Drug Application
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`(“ANDA”) No. 217248 (“the Alkem ANDA”) with the U.S. Food and Drug Administration
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`(“FDA”) seeking approval to engage in the commercial manufacture, use, offer for sale, and/or
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`sale in, and/or importation into, the United States of generic topiramate extended-release
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`capsules, containing 25 mg, 50 mg, 100 mg, and 200 mg of topiramate (“the Alkem ANDA
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`Products”).
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`5.
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`On or about May 25, 2022, Alkem sent a letter purportedly pursuant to
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`subsections 505(j)(2)(B) and 505(j)(2)(B)(iv) of the Federal Food, Drug, and Cosmetic Act
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`(“FDCA”) and 21 C.F.R. § 314.95 stating that it had submitted Abbreviated New Drug
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`Application (ANDA) No. 217248 to FDA seeking approval to market the Alkem ANDA
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`Products, and containing a paragraph IV certification under 35 U.S.C. § 355(j)(2)(B)(iv)
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`concerning the ’576, ’580, ’683, ’248, ’191, ’989, ’940, ’004, ’983, and ’790 patents (the “May
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`25 Notice Letter”).
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`JURISDICTION AND VENUE
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`6.
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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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`7.
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`Alkem is subject to personal jurisdiction in the State of Illinois and this Judicial
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`District because the May 25 Notice Letter identified an attorney located within this district as its
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`agent for service with respect to this matter, stating that Manish K. Mehta, E-mail:
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`mmehta@beneschlaw.com, Benesch Friedlander Coplan & Aronoff, 71 South Wacker Drive,
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`Suite 1600, Chicago, Illinois 60606, “is authorized to accept service of process on behalf of
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`Alkem.”
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`8.
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`Alkem is also subject to personal jurisdiction in the State of Illinois and this
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`Judicial District because, among other reasons, Alkem, itself and through its affiliates, has
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`purposefully availed itself of the benefits and protections of Illinois’s laws such that it should
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`reasonably anticipate being sued here. On information and belief, Alkem, itself and through its
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`affiliates, develops, manufactures, imports, markets, offers to sell, and/or sells generic drugs
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`throughout the United States, including in the State of Illinois and this Judicial District, and
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`therefore transacts business within the State of Illinois and this Judicial District, and/or has
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`engaged in systematic and continuous business contacts within the State of Illinois and this
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`Judicial District.
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`9.
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`Upon information and belief, Alkem is in the business of manufacturing and
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`selling generic pharmaceutical products that are distributed throughout the United States,
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`including in the State of Illinois and this Judicial District. Upon information and belief, Alkem
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`directly or through its affiliates and agents, formulates, manufactures, packages, markets, and/or
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`sells pharmaceutical products throughout the United States, including in the State of Illinois and
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`this Judicial District. Indeed, Alkem’s website states that the “United States is the focal point of
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`international operations. In this stride, we have cumulatively filed more than 125 ANDAs with
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`the US FDA.” Alkem Website, https://www.alkemlabs.com/overview.php (last visited July 6,
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`2022). Alkem’s website further states that “we manufacture and supply a wide-range of generics
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`and branded formulations in the United States,” and “[o]ur products are available at major
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`pharmacy chains, wholesalers, managed care companies, distributors and pharmaceutical
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`retailers.” Alkem Website, https://www.alkemlabs.com/us.php (last visited July 6, 2022).
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`10.
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`Upon information and belief, upon approval of the Alkem ANDA, Defendant
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`and/or its affiliates or agents will distribute, market, and sell the Alkem ANDA Products in the
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`State of Illinois and this Judicial District, and also throughout the United States, and Alkem will
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`derive substantial revenue therefrom.
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`11.
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`Upon information and belief, upon approval of Alkem’s ANDA, Defendant
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`and/or its affiliates or agents will place the Alkem ANDA Products into the stream of commerce
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`with the reasonable expectation or knowledge and the intent that such products will ultimately be
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`purchased and used by consumers in the State of Illinois and this Judicial District.
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`12.
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`Upon information and belief, Defendant derives substantial revenue from directly
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`or indirectly selling generic pharmaceutical products and/or active pharmaceutical ingredients
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`used in generic pharmaceutical products sold throughout the United States, including in the State
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`of Illinois and this Judicial District.
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`13.
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`Defendant has taken the significant step of applying to FDA for approval to
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`engage in future activities—including the marketing of its generic drugs—which, upon
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`information and belief, will be purposefully directed at the State of Illinois and this Judicial
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`District and elsewhere throughout the United States. Upon information and belief, Defendant
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`intends to direct sales of its generic drugs in the State of Illinois and this Judicial District, among
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`other places, once Defendant receives the requested FDA approval to market its generic
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`products. Upon information and belief, Defendant will engage in marketing its proposed Alkem
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`ANDA Products in the State of Illinois and this Judicial District if FDA approves the Alkem
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`ANDA.
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`14.
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`Defendant’s tortious acts of (i) preparing and filing the Alkem ANDA 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, offer to sell, and/or sale within the United States, and/or
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`importation into the United States, of the Alkem ANDA Products before the expiration of the
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`patents in suit, and (ii) directing notice of its ANDA submission to Supernus, are acts with real
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`and injurious consequences giving rise to this infringement action, including the present and/or
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`anticipated commercial manufacture, use, offer to sell, and/or sale of the Alkem ANDA Products
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`by Defendant before the expiration of the patents in suit throughout the United States, including
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`in the State of Illinois and this Judicial District. Because defending against an infringement
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`lawsuit such as this one is an inherent and expected part of a generic ANDA filer’s business,
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`Defendant should reasonably anticipate being sued in the State of Illinois and this Judicial
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`District.
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`15.
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`Upon information and belief, Defendant intends to benefit directly if the Alkem
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`ANDA is approved by participating in the manufacture, importation, distribution, and/or sale of
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`the generic drug products that are the subject of the Alkem ANDA.
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`16.
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`This Court also has personal jurisdiction over Alkem because, among other
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`reasons, Alkem has previously consented to personal jurisdiction in this Judicial District.1
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`17.
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`This Court has personal jurisdiction over Alkem under Federal Rule of Civil
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`Procedure 4(k)(2) because, among other reasons, Alkem is organized under the laws of India.
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`1 This Court also has personal jurisdiction over Alkem because it has previously submitted to the
`jurisdiction of this Court and has previously availed itself of this Court by asserting
`claims/counterclaims in other civil actions initiated in this jurisdiction. See, e.g., Janssen
`Pharm., Inc. et al. v. Alkem Labs. Ltd., No. 13-9227 (N.D. Ill.), Dkt. 14; Forest Labs., Inc. et al.
`v. Indchemie Health Specialties Pvt. Ltd. et al., No. 12-1855 (N.D. Ill.), Dkt. 22; Shire Canada
`Inc., et al. v. Alkem Labs., Ltd., No. 11-206 (N.D. Ill.), Dkt. 11.
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`18.
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`Venue is proper in this Judicial District pursuant to 28 U.S.C. § 1391(c)(3) and/or
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`28 U.S.C. § 1400(b) because, upon information and belief, Alkem is not a resident of the United
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`States and may thus be sued in any Judicial District.2
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`19.
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`Venue is proper in this Judicial District pursuant to 28 U.S.C. §§ 1391(b) and (c)
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`and/or § 1400(b) because Alkem has previously consented to venue in this Judicial District.
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`20.
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`Venue is proper in this Judicial District because Alkem’s U.S. agent is located in
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`this Judicial District.3 The May 25 Notice Letter was signed by Mr. Mehta, E-mail:
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`mmehta@beneschlaw.com, 71 South Wacker Drive, Suite 1600, Chicago, Illinois 60606 of
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`Benesch Friedlander Coplan & Aronoff on behalf of Alkem, and states that Mr. Mehta is
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`Alkem’s authorized U.S. agent authorized to accept service of process on behalf of Alkem.
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`FACTS AS TO ALL COUNTS
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`21.
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`Supernus’s Trokendi XR® is sold and marketed under New Drug Application
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`(“NDA”) No. 201635, which was approved by FDA for the manufacture and sale of topiramate
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`extended-release capsules, 25 mg, 50 mg, 100 mg, and 200 mg.
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`22.
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`Trokendi XR® is an antiepileptic drug indicated: (i) as an initial monotherapy for
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`the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 6 years of
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`age and older; (ii) as an adjunctive therapy for the treatment of partial-onset seizures, primary
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`
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`2 In re HTC Corp., 889 F.3d 1349, 1354, 1357 (Fed. Cir. 2018) (explaining that a foreign
`corporation is subject to suit in any judicial district) (citing Brunette Machine Works, Ltd. v.
`Kockum Industries, Inc., 406 U.S. 706, 706, 713-14 (1972) and § 1391(c)(3)).
`3 See, e.g., Janssen Pharm., Inc. et al v. Alkem Labs. Ltd., No. 13-9227 (N.D. Ill.), Dkt. 14;
`Alkem Labs. Ltd. v. NPS Pharm., Inc., No. 13-6487 (N.D. Ill.), Dkt. 1 (Alkem stated that
`“[v]enue is also proper because the subject matter of this litigation stems from the notice letters
`sent by Alkem to NPS, with such notice letters identifying counsel located in this District as the
`registered agent for communications with Alkem, an entity of the country of India.”); Forest
`Labs., Inc. et al v. Indchemie Health Specialties Pvt. Ltd. et al, No. 12-1855 (N.D. Ill.), Dkt. 22;
`Shire Canada Inc., et al v. Alkem Labs., Ltd., No. 11-206 (N.D. Ill.), Dkt. 11.
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`generalized tonic-clonic seizures, and seizures associated with Lennox-Gastaut syndrome in
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`patients 6 years of age and older; and (iii) for the preventive treatment of migraine in patients 12
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`years of age and older.
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`23.
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`Trokendi XR®’s recommended dosage: (i) for monotherapy in adults and in
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`pediatric patients 10 years of age and older is 400 mg orally once daily, and in patients 6 to 9
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`years of age is based on weight; (ii) for adjunctive therapy in adults with partial-onset seizures or
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`Lennox-Gastaut Syndrome is 200 mg to 400 mg orally once daily and with primary generalized
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`tonic-clonic seizures is 400 mg orally once daily, and for adjunctive therapy for patients 6 to 16
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`years of age with partial-onset seizures, primary generalized tonic-clonic seizures, or seizures
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`associated with Lennox-Gastaut syndrome is approximately 5 mg/kg to 9 mg/kg orally once
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`daily; and (iii) for the preventive treatment of migraine in patients 12 years of age and older is
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`100 mg once daily.
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`24.
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`FDA’s publication titled “Approved Drug Products with Therapeutic Equivalence
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`Evaluations” (commonly known as the “Orange Book”) lists ten (10) patents, specifically the
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`’576, ’580, ’683, ’248, ’191, ’989, ’940, ’004, ’983, and ’790 patents, as covering Supernus’s
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`Trokendi XR®. Pursuant to 21 U.S.C. §§ 355(b)(1) and 355(c)(2), these ten (10) patents were
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`submitted to FDA with or after the approval of NDA No. 201635. These ten (10) patents are
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`listed in the Orange Book as covering Trokendi XR®.
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`25.
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`The ’576 patent, titled “Sustained-Release Formulations of Topiramate,” was duly
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`and legally issued by the United States Patent and Trademark Office on October 30, 2012, to
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`Supernus upon assignment from inventors Likan Liang, Hua Wang, Padmanabh P. Bhatt, and
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`Michael L. Vieira. Supernus owns all rights, title, and interest in the ’576 patent.
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`26.
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`The ’580 patent, titled “Sustained-Release Formulations of Topiramate,” was duly
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`and legally issued by the United States Patent and Trademark Office on October 30, 2012, to
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`Supernus upon assignment from inventors Likan Liang, Hua Wang, Padmanabh P. Bhatt, and
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`Michael L. Vieira. Supernus owns all rights, title, and interest in the ’580 patent.
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`27.
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`The ’683 patent, titled “Sustained-Release Formulations of Topiramate,” was duly
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`and legally issued by the United States Patent and Trademark Office on March 4, 2014, to
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`Supernus upon assignment from inventors Likan Liang, Hua Wang, Padmanabh P. Bhatt, and
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`Michael L. Vieira. Supernus owns all rights, title, and interest in the ’683 patent.
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`28.
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`The ’248 patent, titled “Sustained-Release Formulations of Topiramate,” was duly
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`and legally issued by the United States Patent and Trademark Office on November 4, 2014, to
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`Supernus upon assignment from inventors Likan Liang, Hua Wang, Padmanabh P. Bhatt, and
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`Michael L. Vieira. Supernus owns all rights, title, and interest in the ’248 patent.
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`29.
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`The ’191 patent, titled “Sustained-Release Formulations of Topiramate,” was duly
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`and legally issued by the United States Patent and Trademark Office on November 18, 2014, to
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`Supernus upon assignment from inventors Likan Liang, Hua Wang, Padmanabh P. Bhatt, and
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`Michael L. Vieira. Supernus owns all rights, title, and interest in the ’191 patent.
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`30.
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`The ’989 patent, titled “Sustained-Release Formulations of Topiramate,” was duly
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`and legally issued by the United States Patent and Trademark Office on March 31, 2015, to
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`Supernus upon assignment from inventors Likan Liang, Hua Wang, Padmanabh P. Bhatt, and
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`Michael L. Vieira. Supernus owns all rights, title, and interest in the ’989 patent.
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`31.
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`The ’940 patent, titled “Sustained-Release Formulations of Topiramate,” was duly
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`and legally issued by the United States Patent and Trademark Office on January 24, 2017, to
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`Supernus upon assignment from inventors Likan Liang, Hua Wang, Padmanabh P. Bhatt, and
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`Michael L. Vieira. Supernus owns all rights, title, and interest in the ’940 patent.
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`32.
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`The ’004 patent, titled “Sustained-Release Formulations of Topiramate,” was duly
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`and legally issued by the United States Patent and Trademark Office on January 31, 2017, to
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`Supernus upon assignment from inventors Likan Liang, Hua Wang, Padmanabh P. Bhatt, and
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`Michael L. Vieira. Supernus owns all rights, title, and interest in the ’004 patent.
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`33.
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`The ’983 patent, titled “Sustained-Release Formulations of Topiramate,” was duly
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`and legally issued by the United States Patent and Trademark Office on April 18, 2017, to
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`Supernus upon assignment from inventors Likan Liang, Hua Wang, Padmanabh P. Bhatt, and
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`Michael L. Vieira. Supernus owns all rights, title, and interest in the ’983 patent.
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`34.
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`The ’790 patent, titled “Sustained-Release Formulations of Topiramate,” was duly
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`and legally issued by the United States Patent and Trademark Office on June 11, 2019, to
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`Supernus upon assignment from inventors Likan Liang, Hua Wang, Padmanabh P. Bhatt, and
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`Michael L. Vieira. Supernus owns all rights, title, and interest in the ’790 patent.
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`35.
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`Upon information and belief, the Alkem ANDA is based upon Trokendi XR®
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`(topiramate extended-release capsules), 25 mg, 50 mg, 100 mg, and 200 mg, as its reference
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`listed drug.
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`36.
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`Upon information and belief, the Alkem ANDA Products are topiramate
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`extended-release capsules, 25 mg, 50 mg, 100 mg, and 200 mg.
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`37.
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`Upon information and belief, the proposed prescribing information for the Alkem
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`ANDA Products includes a header titled “Indications and Usage” and states that the Alkem
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`ANDA Products are indicated: (i) as an initial monotherapy for the treatment of partial-onset or
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`primary generalized tonic-clonic seizures in patients 6 years of age and older; (ii) as an
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`adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic
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`seizures, and seizures associated with Lennox-Gastaut syndrome in patients 6 years of age and
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`older; and (iii) for the preventive treatment of migraine in patients 12 years of age and older.
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`38.
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`Upon information and belief, the proposed prescribing information for the Alkem
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`ANDA Products includes a header titled “Dosage and Administration” and states that: (i) the
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`recommended dose for monotherapy in adults and in pediatric patients 10 years of age and older
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`is 400 mg orally once daily, and dosing in patients 6 to 9 years of age is based on weight; (ii) the
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`recommended total daily dose as adjunctive therapy in adults with partial-onset seizures or
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`Lennox-Gastaut Syndrome is 200 mg to 400 mg orally once daily and with primary generalized
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`tonic-clonic seizures is 400 mg orally once daily, and the recommended total daily dose as
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`adjunctive therapy for patients 6 to 16 years of age with partial-onset seizures, primary
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`generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome is
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`approximately 5 mg/kg to 9 mg/kg orally once daily; and (iii) the recommended total daily dose
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`as treatment for the preventive treatment of migraine in patients 12 years of age and older is 100
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`mg once daily.
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`39.
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`Upon information and belief, the proposed prescribing information for the Alkem
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`ANDA Products also states under the header “Dosage and Administration” that the Alkem
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`ANDA Products can be taken without regard to meals, to swallow capsule whole and intact, and
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`do not sprinkle on food, chew, or crush.
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`40.
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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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`41.
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`Upon information and belief, as of the date of the May 25 Notice Letter, Alkem
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`was aware of the provisions of 21 U.S.C. § 355(j)(2)(B)(iv)(II) and 21 C.F.R. § 314.95(c)(7).
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`42.
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`The May 25 Notice Letter does not include any noninfringement contentions
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`unique to claims 5, 7-10, 12-13, 15-18, 23, 25, and 27-30 of the ’576 patent, claims 3-8, 10-11,
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`13-16, 19-26, and 28-31 of the ’580 patent, claims 2, 4, 6-12, 14, 17-20, and 23-24 of the ’683
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`patent, claims 2, 4-9, 11-12, and 15-20 of the ’248 patent, claims 2-11, 13-16, and 22-24 of the
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`’191 patent, claims 2, 4-9, 11-12, 16-17, and 19-20 of the ’989 patent, claims 2, 4-9, 11-12, 16-
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`17, and 19-20 of the ’940 patent, claims 2-7, 9-10, and 13-15 of the ’004 patent, claims 2, 4-8,
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`10-11, 15-16, 18-20, 22-26, and 28-29 of the ’983 patent, and claims 2-7, 9-10, 13-21, and 23-24
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`of the ’790 patent.
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`43.
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`The May 25 Notice Letter does not include any invalidity contentions for any
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`claim of any of the patents in suit.
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`44.
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`The May 25 Notice Letter does not include any unenforceability contentions for
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`any claim of any of the patents in suit.
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`45.
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`As of the filing of this Complaint, Supernus and Alkem did not reach agreement
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`on mutually acceptable terms for an Offer of Confidential Access pursuant to 21 U.S.C.
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`§ 355(j)(5)(C) and 21 C.F.R. § 314.95(c)(8). As of the filing of this Complaint, Alkem has not
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`produced the Alkem ANDA to Supernus.
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`FIRST COUNT
`(Defendant’s Infringement of the ’576 Patent)
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`46.
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`Supernus repeats and re-alleges each of the foregoing Paragraphs as if fully set
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`forth herein.
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`47.
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`Upon information and belief, Defendant’s submission and filing of the Alkem
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`ANDA with a paragraph IV certification to the ’576 patent to obtain approval to engage in the
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`commercial manufacture, use, offer for sale, and/or sale in, and/or importation into, the United
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`States of the Alkem ANDA Products before the expiration of the ’576 patent is an act of
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`infringement of the ’576 patent by Defendant of one or more claims of the ’576 patent under 35
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`U.S.C. § 271(e)(2)(A).
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`48.
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`Upon information and belief, Defendant will commercially manufacture, use,
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`offer to sell, and/or sell within the United States, and/or import into the United States, the Alkem
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`ANDA Products upon, or in anticipation of, FDA approval of the Alkem ANDA.
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`49.
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`Upon information and belief, Defendant’s commercial manufacture, use, offering
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`to sell, and/or sale within the United States, and/or importation into the United States, of the
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`Alkem ANDA Products will infringe, directly and/or indirectly, one or more claims of the ’576
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`patent under 35 U.S.C. § 271.
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`50.
`
`Upon information and belief, the commercial offering for sale and/or sale of the
`
`Alkem ANDA Products by Defendant will induce and/or contribute to third-party infringement
`
`of one or more claims of the ’576 patent under 35 U.S.C. § 271.
`
`12
`
`

`

`Case: 1:22-cv-03511 Document #: 1 Filed: 07/06/22 Page 13 of 27 PageID #:13
`
`
`
`51.
`
`Upon information and belief, the factual and legal bases in the May 25 Notice
`
`Letter regarding the ’576 patent do not comply with the provisions of 21 U.S.C.
`
`§ 355(j)(2)(B)(iv)(II) and 21 C.F.R. § 314.95(c)(7).
`
`52.
`
`Defendant acted without a reasonable basis for believing that it would not be
`
`liable for infringement of the ’576 patent, thus rendering this case “exceptional” under 35 U.S.C.
`
`§ 285 and entitling Supernus to an award of reasonable attorneys’ fees under 35 U.S.C. § 285.
`
`53.
`
`The acts of infringement set forth above will cause Supernus irreparable harm for
`
`which there is no adequate remedy at law, unless Defendant is preliminarily and permanently
`
`enjoined by this Court.
`
`SECOND COUNT
`(Defendant’s Infringement of the ’580 Patent)
`
`54.
`
`Supernus repeats and re-alleges each of the foregoing Paragraphs as if fully set
`
`forth herein.
`
`55.
`
`Upon information and belief, Defendant’s submission and filing of the Alkem
`
`ANDA with a paragraph IV certification to the ’580 patent to obtain approval to engage in the
`
`commercial manufacture, use, offer for sale, and/or sale in, and/or importation into, the United
`
`States of the Alkem ANDA Products before the expiration of the ’580 patent is an act of
`
`infringement of the ’580 patent by Defendant of one or more claims of the ’580 patent under 35
`
`U.S.C. § 271(e)(2)(A).
`
`56.
`
`Upon information and belief, Defendant will commercially manufacture, use,
`
`offer to sell, and/or sell within the United States, and/or import into the United States, the Alkem
`
`ANDA Products upon, or in anticipation of, FDA approval of the Alkem ANDA.
`
`57.
`
`Upon information and belief, Defendant’s commercial manufacture, use, offering
`
`to sell, and/or sale within the United States, and/or importation into the United States, of the
`
`13
`
`

`

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`
`
`
`Alkem ANDA Products will infringe, directly and/or indirectly, one or more claims of the ’580
`
`patent under 35 U.S.C. § 271.
`
`58.
`
`Upon information and belief, the commercial offering for sale and/or sale of the
`
`Alkem ANDA Products by Defendant will induce and/or contribute to third-party infringement
`
`of one or more claims of the ’580 patent under 35 U.S.C. § 271.
`
`59.
`
`Upon information and belief, the factual and legal bases in the May 25 Notice
`
`Letter regarding the ’580 patent do not comply with the provisions of 21 U.S.C.
`
`§ 355(j)(2)(B)(iv)(II) and 21 C.F.R. § 314.95(c)(7).
`
`60.
`
`Defendant acted without a reasonable basis for believing that it would not be
`
`liable for infringement of the ’580 patent, thus rendering this case “exceptional” under 35 U.S.C.
`
`§ 285 and entitling Supernus to an award of reasonable attorneys’ fees under 35 U.S.C. § 285.
`
`61.
`
`The acts of infringement set forth above will cause Supernus irreparable harm for
`
`which there is no adequate remedy at law, unless Defendant is preliminarily and permanently
`
`enjoined by this Court.
`
`THIRD COUNT
`(Defendant’s Infringement of the ’683 Patent)
`
`62.
`
`Supernus repeats and re-alleges each of the foregoing Paragraphs as if fully set
`
`forth herein.
`
`63.
`
`Upon information and belief, Defendant’s submission and filing of the Alkem
`
`ANDA with a paragraph IV certification to the ’683 patent to obtain approval to engage in the
`
`commercial manufacture, use, offer for sale, and/or sale in, and/or importation into, the United
`
`States of the Alkem ANDA Products before the expiration of the ’683 patent is an act of
`
`infringement of the ’683 patent by Defendant of one or more claims of the ’683 patent under 35
`
`U.S.C. § 271(e)(2)(A).
`
`14
`
`

`

`Case: 1:22-cv-03511 Document #: 1 Filed: 07/06/22 Page 15 of 27 PageID #:15
`
`
`
`64.
`
`Upon information and belief, Defendant will commercially manufacture, use,
`
`offer to sell, and/or sell within the United States, and/or import into the United States, the Alkem
`
`ANDA Products upon, or in anticipation of, FDA approval of the Alkem ANDA.
`
`65.
`
`Upon information and belief, Defendant’s commercial manufacture, use, offering
`
`to sell, and/or sale within the United States, and/or importation into the United States, of the
`
`Alkem ANDA Products will infringe, directly and/or indirectly, one or more claims of the ’683
`
`patent under 35 U.S.C. § 271.
`
`66.
`
`Upon information and belief, the commercial offering for sale and/or sale of the
`
`Alkem ANDA Products by Defendant will induce and/or contribute to third-party infringement
`
`of one or more claims of the ’683 patent under 35 U.S.C. § 271.
`
`67.
`
`Upon information and belief, the factual and legal bases in the May 25 Notice
`
`Letter regarding the ’683 patent do not comply with the provisions of 21 U.S.C.
`
`§ 355(j)(2)(B)(iv)(II) and 21 C.F.R. § 314.95(c)(7).
`
`68.
`
`Defendant acted without a reasonable basis for believing that it would not be
`
`liable for infringement of the ’683 patent, thus rendering this case “exceptional” under 35 U.S.C.
`
`§ 285 and entitling Supernus to an award of reasonable attorneys’ fees under 35 U.S.C. § 285.
`
`69.
`
`The acts of infringement set forth above will cause Supernus irreparable harm for
`
`which there is no adequate remedy at law, unless Defendant is preliminarily and permanently
`
`enjoined by this Court.
`
`FOURTH COUNT
`(Defendant’s Infringement of the ’248 Patent)
`
`70.
`
`Supernus repeats and re-alleges each of the foregoing Paragraphs as if fully set
`
`forth herein.
`
`15
`
`

`

`Case: 1:22-cv-03511 Document #: 1 Filed: 07/06/22 Page 16 of 27 PageID #:16
`
`
`
`71.
`
`Upon information and belief, Defendant’s submission and filing of the Alkem
`
`ANDA with a paragraph IV certification to the ’248 patent to obtain approval to engage in the
`
`commercial manufacture, use, offer for sale, and/or sale in, and/or importation into, the United
`
`States of the Alkem ANDA Products before the expiration of the ’248 patent is an act of
`
`infringement of the ’248 patent by Defendant of one or more claims of the ’248 patent under 35
`
`U.S.C. § 271(e)(2)(A).
`
`72.
`
`Upon information and belief, Defendant will commercially manufacture, use,
`
`offer to sell, and/or sell within the United States, and/or import into the United States, the Alkem
`
`ANDA Products upon, or in anticipation of, FDA approval of the Alkem ANDA.
`
`73.
`
`Upon information and belief, Defendant’s commercial manufacture, use, offering
`
`to sell, and/or sale within the United States, and/or importation into the United States, of the
`
`Alkem ANDA Products will infringe, directly and/or indirectly, one or more claims of the ’248
`
`patent under 35 U.S.C. § 271.
`
`74.
`
`Upon information and belief, the commercial offering for sale and/or sale of the
`
`Alkem ANDA Products by Defendant will induce and/or contribute to third-party infringement
`
`of one or more claims of the ’248 patent under 35 U.S.C. § 271.
`
`75.
`
`Upon information and belief, the factual and legal bases in the May 25 Notice
`
`Letter regarding the ’248 patent do not comply with the provisions of 21 U.S.C.
`
`§ 355(j)(2)(B)(iv)(II) and 21 C.F.R. § 314.95(c)(7).
`
`76.
`
`Defendant acted without a reasonable basis for believing that it would not be
`
`liable for infringement of the ’248 patent, thus rendering this case “exceptional” under 35 U.S.C.
`
`§ 285 and entitling Supernus to an award of reasonable attorneys’ fees under 35 U.S.C. § 285.
`
`16
`
`

`

`Case: 1:22-cv-03511 Document #: 1 Filed: 07/06/22 Page 17 of 27 PageID #:17
`
`
`
`77.
`
`The acts of infringement set forth above will cause Supernus irreparable harm for
`
`which there is no adequate remedy at law, unless Defendant is preliminarily and permanently
`
`enjoined by this Court.
`
`FIFTH COUNT
`(Defendant’s Infringement of the ’191 Patent)
`
`78.
`
`Supernus repeats and re-alleges each of the foregoing Paragraphs as if fully set
`
`forth herein.
`
`79.
`
`Upon information and belief, Defendant’s submission and filing of the Alkem
`
`ANDA with a paragraph IV certification to the ’191 patent to obtain approval to engage in the
`
`commercial manufacture, use, offer for sale, and/or sale in, and/or importation into, the United
`
`States of the Alkem ANDA Products before the expiration of the ’191 patent is an act of
`
`infringement of the ’191 patent by Defendant of one or more claims of the ’191 patent under 35
`
`U.S.C. § 271(e)(2)(A).
`
`80.
`
`Upon information and belief, Defendant will commercially manufacture, use,
`
`offer to sell, and/or sell within the United States, and/or import into the United States, the Alkem
`
`ANDA Products upon, or in anticipation of, FDA approval of the Alkem ANDA.
`
`81.
`
`Upon information and belief, Defendant’s commercial manufacture, use, offering
`
`to sell, and/or sale within the United States, and/or importation into the United States, of the
`
`Alkem ANDA Products will infringe, directly and/