Case 3:21-cv-06964 Document 1 Filed 03/26/21 Page 1 of 31 PageID: 1
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`
`
`
`
`Charles M. Lizza
`William C. Baton
`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.
`
`OF COUNSEL:
`
`Edgar H. Haug
`Nicholas F. Giove
`HAUG PARTNERS LLP
`745 Fifth Avenue
`New York, NY 10151
`
`UNITED STATES DISTRICT COURT
`DISTRICT OF NEW JERSEY
`
`SUPERNUS PHARMACEUTICALS,
`INC.,
`
`
`
`
`
`
`
`v.
`
`Plaintiff,
`
`AJANTA PHARMA LIMITED and
`AJANTA PHARMA USA INC.,
`
`
`
`Defendants.
`
`
`
`
`
`
`
`Civil Action No. ______________
`
`
`COMPLAINT FOR PATENT
`INFRINGEMENT
`
`(Filed Electronically)
`
`Plaintiff Supernus Pharmaceuticals, Inc. (“Supernus” or “Plaintiff”), by its undersigned
`
`attorneys, for its Complaint against Defendants Ajanta Pharma Limited and Ajanta Pharma USA
`
`Inc. (collectively, “Ajanta” or “Defendants”), alleges as follows:
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`NATURE OF THE ACTION
`
`1.
`
`This is a civil action for patent infringement arising under the patent laws of the
`
`United States, Title 35, United States Code, involving United States Patent Nos. 8,298,576 (“the
`
`’576 patent”), 8,298,580 (“the ’580 patent”), 8,663,683 (“the ’683 patent”), 8,877,248 (“the ’248
`
`patent”), 8,889,191 (“the ’191 patent”), 8,992,989 (“the ’989 patent”), 9,549,940 (“the ’940
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`

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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”).
`
`THE PARTIES
`
`2.
`
`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.
`
`3.
`
`Upon information and belief, Defendant Ajanta Pharma Limited (“Ajanta Ltd.”) is
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`a corporation operating and existing under the laws of India, with its principal place of business
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`at Ajanta House, Charkop, Kandivli West, Mumbai-400 067, Maharashtra, India.
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`4.
`
`According to Defendants’ website, “Ajanta Pharma is a specialty pharmaceutical
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`company engaged in development, manufacture and marketing of quality finished dosages in
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`domestic and international markets” with over 7,000 employees operating in more than 30
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`countries across 4 continents. Ajanta Website, http://www.ajantapharma.com/index.aspx
`
`(accessed March 26, 2021).
`
`5.
`
`Ajanta Ltd.’s Annual Report 2019-2020 states that it experienced “robust growth
`
`of 82% in the market” for FY 2020 in the United States. Ajanta Ltd.’s Annual Report 2019-2020
`
`at 3 and 9, http://www.ajantapharma.com/AdminData/AnnualReports/AnnualReportFY2019-
`
`20.pdf (accessed March 26, 2021). Ajanta Ltd.’s Annual Report 2019-2020 further states, “[t]his
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`growth was achieved on the back of 7 new product launches and market share gained by [Ajanta
`
`Ltd.] existing products. US has played key role in the resilience [Ajanta Ltd.] displayed amidst
`
`adversity.” Ajanta Ltd.’s Annual Report 2019-2020 at 9, http://www.ajantapharma.com/
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`AdminData/AnnualReports/AnnualReportFY2019-20.pdf (accessed March 26, 2021).
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`Additionally, Ajanta Ltd.’s Annual Report 2019-2020 indicates the company “[r]eceived
`
`approvals for 9 ANDAs which lead to a total of 40 approvals (including 1 tentative approval) . . .
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`.[and] 12 New ANDAs filled with USFDA.” Ajanta Ltd.’s Annual Report 2019-2020 at 39,
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`http://www.ajantapharma.com/AdminData/AnnualReports/AnnualReportFY2019-20.pdf
`
`(accessed March 26, 2021).
`
`6.
`
`Upon information and belief, Ajanta Ltd. is in the business of, inter alia: (i) the
`
`development and manufacture of generic pharmaceutical products for sale throughout the United
`
`States, including throughout the State of New Jersey, and importing generic pharmaceutical
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`products into the United States, including throughout the State of New Jersey; (ii) in concert with
`
`and/or through its various subsidiaries, including Defendant Ajanta Pharma USA Inc., the
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`preparation, submission, and filing of Abbreviated New Drug Applications (“ANDAs”) seeking
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`FDA approval to market generic drugs throughout the United States, including throughout the
`
`State of New Jersey; and (iii) in concert with and/or through its various subsidiaries, including
`
`Defendant Ajanta Pharma USA Inc., the distribution of generic pharmaceutical products for sale
`
`throughout the United States, including throughout the State of New Jersey.
`
`7.
`
`Upon information and belief, Defendant Ajanta Pharma USA Inc. (“Ajanta
`
`USA”) is a corporation operating and existing under the laws of the State of New Jersey, with its
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`principal place of business at One Grand Commons, 440 US Highway 22 East, Suite 150,
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`Bridgewater, NJ 08807. Upon information and belief, Ajanta USA is a wholly-owned subsidiary
`
`of Ajanta Ltd. Upon information and belief, Ajanta USA acts at the direction of, under the
`
`control of, and for the direct benefit of Ajanta Ltd. and is controlled and/or dominated by Ajanta
`
`Ltd.
`
`8.
`
`Upon information and belief, Ajanta USA is in the business of, inter alia: (i)
`
`developing, marketing, distributing, and/or selling generic pharmaceutical products throughout
`
`the United States, including throughout the State of New Jersey; (ii) in concert with and/or
`
`

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`through its parent, including Defendant Ajanta Ltd. and various subsidiaries, the preparation,
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`submission, and filing of ANDAs seeking FDA approval to market generic drugs throughout the
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`United States, including throughout the State of New Jersey; and (iii) alone or in concert with
`
`and/or through its parent, including Defendant Ajanta Ltd. and various subsidiaries, the
`
`distribution of generic pharmaceutical products for sale throughout the United States, including
`
`throughout the State of New Jersey.
`
`9.
`
`Upon information and belief, Ajanta Ltd. filed ANDA No. 215663 (“the Ajanta
`
`ANDA”) with FDA seeking approval to engage in the commercial manufacture, use, offer for
`
`sale, and/or sale in, and/or importation into, the United States of generic topiramate extended-
`
`release capsule, containing 25 mg, 50 mg, 100 mg, and 200 mg of topiramate (“the Ajanta
`
`Products”).
`
`10.
`
`Upon information and belief, Ajanta Ltd. and Ajanta USA collaborate to develop,
`
`manufacture, import, market, and distribute, and/or sell pharmaceutical products, including
`
`generic drug products (e.g., Risperidone Tablet (0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg);
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`Clomipramine Hydrochloride Capsules (25 mg, 50 mg, and 75 mg), and Aripiprazole Tablet (2
`
`mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg), and Tadalafil Tablet (2.5 mg, 5 mg, 10 mg, 20
`
`mg)) that will be manufactured and sold pursuant to an ANDA, throughout the United States,
`
`including throughout the State of New Jersey.
`
`11.
`
`Upon information and belief, Defendants and/or their affiliates manufacture
`
`and/or direct the manufacture of generic pharmaceutical products for which Ajanta Ltd. is the
`
`named ANDA applicant. Upon information and belief, Defendants each, directly or indirectly,
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`derive substantial revenue from the sales of such generic pharmaceutical products.
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`

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`JURISDICTION AND VENUE
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`12.
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`This Court has jurisdiction over the subject matter of this action pursuant to 28
`
`U.S.C. §§ 1331 and 1338(a).
`
`13.
`
`This Court has personal jurisdiction over Defendants under: (i) Fed. R. Civ. P.
`
`4(k)(1) and N.J. Ct. R. 4:4-4; and/or (ii) Fed. R. Civ. P. 4(k)(2).
`
`14.
`
`Upon information and belief, Defendants have purposefully availed themselves of
`
`the privilege of doing business in the State of New Jersey by continuously and systematically
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`placing goods in the stream of commerce for distribution and sale throughout the United States,
`
`including the State of New Jersey. For example, upon information and belief, Defendants state
`
`on their website that they are “gradually building a meaningful presence in the US market with
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`select product portfolio, which include complex technology products to get the competitive
`
`advantage in the market place. We expect US market to be our key growth driver in the coming
`
`years.” Ajanta Website, http://www.ajantapharma.com/overview.html (accessed March 26,
`
`2021). Defendants further state on their website “[o]ur products are already available on the
`
`shelf in US through our subsidiary, located in New Jersey, the hub of pharma industry in USA.”
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`Ajanta Website, http://www.ajantapharma.com/generics.html (accessed March 26, 2021). In
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`addition, Defendants’ website indicates that as of February 2021, Defendants had 42 products
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`approved by FDA with 18 additional products submitted and under approval with FDA. Ajanta
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`Website, http://www.ajantapharma.com/AdminData/InvesterPresentation/InvestorPresentation
`
`ofQ3FY2021.pdf (accessed March 26, 2021).
`
`15.
`
`This Court has personal jurisdiction over Ajanta USA at least because, upon
`
`information and belief: (i) Ajanta USA maintains a principal place of business in New Jersey
`
`located at One Grand Commons, 440 US Highway 22 East, Suite 150, Bridgewater, NJ 08807;
`
`(ii) Ajanta USA is doing business in New Jersey and maintains continuous and systematic
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`

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`contacts with this Judicial District; (iii) Ajanta USA, together with its parent Ajanta Ltd., is in
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`the business of developing and manufacturing generic pharmaceutical products for importation,
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`sale, and/or distribution in the State of New Jersey; (iv) Ajanta USA, together with its parent
`
`Ajanta Ltd., has committed, induced, and/or contributed to acts of patent infringement in New
`
`Jersey; and (v) Ajanta USA has previously submitted to the jurisdiction of this Court, has availed
`
`itself of New Jersey’s legal protections in prior litigations, and previously consented to personal
`
`jurisdiction and venue in this Judicial District.1
`
`16.
`
`Upon information and belief, Ajanta USA is registered with the State of New
`
`Jersey’s Division of Revenue and Enterprise Services as a business operating in New Jersey with
`
`Business Identification Number 0400533904. Upon information and belief, Ajanta USA is
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`registered with the State of New Jersey’s Department of Health as a drug & medical device
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`“manufacturer and wholesaler” and “wholesaler” with Registration Number 5004507. Ajanta
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`USA has, therefore, purposefully availed itself of the rights, benefits, and privileges of New
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`Jersey’s laws.
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`17.
`
`According to Defendants’ website, Ajanta USA is based in Bridgewater, New
`
`Jersey, and is a wholly-owned subsidiary of Ajanta Ltd. The website further states “[s]ince
`
`making the strategic decision to enter the US market, our Research and Development (R&D)
`
`team began developing a product portfolio of [ANDA] filings with a mix of Immediate-Release,
`
`
`
`1 This Court also has personal jurisdiction over Defendants because Ajanta Ltd. and Ajanta USA
`have previously submitted to the jurisdiction of this Court and have previously availed
`themselves of this Court by initiating lawsuits, consenting to this Court’s jurisdiction, and
`asserting counterclaims in other civil actions initiated in this jurisdiction. See, e.g., Horizon
`Medicines LLC, et al v. Ajanta Pharma Ltd., et al., Civil Action No. 19-18555 (BRM)(JAD)
`(D.N.J.) (Ajanta Ltd. and Ajanta USA filed a counterclaim and did not contest jurisdiction.) and
`Otsuka Pharmaceutical Co., Ltd. v. Ajanta Pharma Ltd., et al., Civil Action No. 14-05876
`(JBS)(KMW) (D.N.J.) (Ajanta Ltd. and Ajanta USA filed a counterclaim and did not contest
`jurisdiction.).
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`

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`Extended-Release, Delayed-Release, Orally Disintegrating Tablets and Powders.”
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`http://www.ajantapharmausa.com/overview.html (accessed March 26, 2021).
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`18.
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`This Court has personal jurisdiction over Ajanta Ltd. at least because, upon
`
`information and belief: (i) Ajanta Ltd. has purposefully directed its activities and the activities of
`
`Ajanta USA at residents and corporate entities within the State of New Jersey; (ii) the claims set
`
`forth herein against Ajanta Ltd. arise out of or relate to those activities; (iii) Ajanta Ltd.’s
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`contacts with the State of New Jersey (direct and indirect) are continuous and systematic; and
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`(iv) it is reasonable and fair for this Court to exercise personal jurisdiction over Ajanta Ltd.
`
`19.
`
`Upon information and belief, Ajanta Ltd.’s tortious acts of (i) preparing and filing
`
`ANDA No. 215663 with a paragraph IV certification to the patents in suit for the purpose of
`
`obtaining approval to engage in the commercial manufacture, use, offer to sell, and/or sale within
`
`the United States, and/or importation into the United States, of the Ajanta Products before the
`
`expiration of the patents in suit; and (ii) directing notice of its ANDA submission to Supernus,
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`are acts with real and injurious consequences giving rise to this infringement action, including
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`the present and/or anticipated commercial manufacture, use, and/or sale of the Ajanta Products
`
`by Defendants before the expiration of the patents in suit throughout the United States, including
`
`in this Judicial District. Because defending against an infringement lawsuit such as this one is an
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`inherent and expected part of a generic ANDA filer’s business, Ajanta Ltd. and Ajanta USA
`
`should reasonably anticipate being sued in New Jersey.
`
`20.
`
`This Court has personal jurisdiction over Defendants at least because, upon
`
`information and belief, if ANDA No. 215663 is approved, the Ajanta Products will be marketed
`
`and distributed by Ajanta USA, purportedly at the direction and control of Ajanta Ltd., in the
`
`State of New Jersey, prescribed by physicians practicing in the State of New Jersey, dispensed
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`

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`by pharmacies located within the State of New Jersey, and used by patients in the State of New
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`Jersey. Specifically, upon information and belief, Ajanta USA employs a salesforce that
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`includes personnel who regularly and continuously work in this Judicial District2 and, if Ajanta
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`Ltd. succeeds in obtaining FDA approval, Ajanta USA will use its salesforce to sell the Ajanta
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`Products in the State of New Jersey.
`
`21.
`
`Venue is proper for Ajanta USA under 28 U.S.C. §§ 1391 and/or 1400(b),
`
`because, inter alia Ajanta USA is subject to personal jurisdiction in this Judicial District, as set
`
`forth above, has committed and/or will commit further acts of infringement in this Judicial
`
`District, as set forth above, and/or does business in this Judicial District through a permanent and
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`continuous presence in the State of New Jersey, as set forth above.
`
`22.
`
`Venue is proper for Ajanta Ltd. under 28 U.S.C. §§ 1391 and/or 1400(b) because,
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`inter alia, Ajanta Ltd. is subject to personal jurisdiction in this Judicial District, as set forth
`
`above, has committed an act of infringement and will commit further acts of infringement in this
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`Judicial District, as set forth above, and/or continuously transacts business in this Judicial
`
`District, as set forth above.
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`23.
`
`Venue is proper in this Judicial District under 28 U.S.C. §§ 1391(b), 1391(c), and
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`§ 1400(b).
`
`
`
`2 Defendants’ website states that its “journey into the US marketplace” includes “a dedicated
`front end sales and marketing team.” Ajanta USA Website,
`http://www.ajantapharmausa.com/business-development.html (accessed March 26, 2021).
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`FACTS AS TO ALL COUNTS
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`24.
`
`Supernus’s Trokendi XR® is sold and marketed under New Drug Application
`
`(“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.
`
`25.
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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
`
`age and older; (ii) as an adjunctive therapy for the treatment of partial-onset seizures, primary
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`generalized tonic-clonic seizures, and seizures associated with Lennox-Gastaut syndrome in
`
`patients 6 years of age and older; and (iii) for the preventive treatment of migraine in patients 12
`
`years of age and older.
`
`26.
`
`Trokendi XR®’s recommended dosage: (i) for monotherapy in adults and in
`
`pediatric patients 10 years of age and older is 400 mg orally once daily, and in patients 6 to 9
`
`years of age is based on weight; (ii) for adjunctive therapy in adults with partial-onset seizures or
`
`Lennox-Gastaut Syndrome is 200 mg to 400 mg orally once daily and with primary generalized
`
`tonic-clonic seizures is 400 mg orally once daily, and for adjunctive therapy for patients 6 to 16
`
`years of age with partial-onset seizures, primary generalized tonic-clonic seizures, or seizures
`
`associated with Lennox-Gastaut syndrome is approximately 5 mg/kg to 9 mg/kg orally once
`
`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.
`
`27.
`
`28.
`
`NDA No. 201635 pertains to Trokendi XR® 25 mg, 50 mg, 100 mg, and 200 mg.
`
`FDA’s publication titled, “Approved Drug Products with Therapeutic
`
`Equivalence Evaluations,” (commonly known as the “Orange Book”) lists ten (10) patents,
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`specifically the ’576, ’580, ’683, ’248, ’191, ’989, ’940, ’004, ’983, and ’790 patents, as
`
`

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`covering Supernus’s Trokendi XR®. Pursuant to 21 U.S.C. 355(b)(1) and 355(c)(2), these ten
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`(10) patents were submitted to FDA with or after the approval of NDA No. 201635. These ten
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`(10) patents are listed in the Orange Book as covering Trokendi XR®.
`
`29.
`
`The ’576 patent, entitled, “Sustained-Release Formulations of Topiramate,” was
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`duly and legally issued by the United States Patent and Trademark Office on October 30, 2012,
`
`to Supernus upon assignment from inventors Likan Liang, Hua Wang, Padmanabh P. Bhatt, and
`
`Michael L. Vieira. Supernus owns all rights, title, and interest in the ’576 patent.
`
`30.
`
`The ’580 patent, entitled, “Sustained-Release Formulations of Topiramate,” was
`
`duly and legally issued by the United States Patent and Trademark Office on October 30, 2012,
`
`to Supernus upon assignment from inventors Likan Liang, Hua Wang, Padmanabh P. Bhatt, and
`
`Michael L. Vieira. Supernus owns all rights, title, and interest in the ’580 patent.
`
`31.
`
`The ’683 patent, entitled, “Sustained-Release Formulations of Topiramate,” was
`
`duly and legally issued by the United States Patent and Trademark Office on March 4, 2014, to
`
`Supernus upon assignment from inventors Likan Liang, Hua Wang, Padmanabh P. Bhatt, and
`
`Michael L. Vieira. Supernus owns all rights, title, and interest in the ’683 patent.
`
`32.
`
`The ’248 patent, entitled, “Sustained-Release Formulations of Topiramate,” was
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`duly and legally issued by the United States Patent and Trademark Office on November 4, 2014,
`
`to Supernus upon assignment from inventors Likan Liang, Hua Wang, Padmanabh P. Bhatt, and
`
`Michael L. Vieira. Supernus owns all rights, title, and interest in the ’248 patent.
`
`33.
`
`The ’191 patent, entitled, “Sustained-Release Formulations of Topiramate,” was
`
`duly and legally issued by the United States Patent and Trademark Office on November 18,
`
`2014, to Supernus upon assignment from inventors Likan Liang, Hua Wang, Padmanabh P.
`
`Bhatt, and Michael L. Vieira. Supernus owns all rights, title, and interest in the ’191 patent.
`
`

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`34.
`
`The ’989 patent, entitled, “Sustained-Release Formulations of Topiramate,” was
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`duly and legally issued by the United States Patent and Trademark Office on March 31, 2015, to
`
`Supernus upon assignment from inventors Likan Liang, Hua Wang, Padmanabh P. Bhatt, and
`
`Michael L. Vieira. Supernus owns all rights, title, and interest in the ’989 patent.
`
`35.
`
`The ’940 patent, entitled, “Sustained-Release Formulations of Topiramate,” was
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`duly and legally issued by the United States Patent and Trademark Office on January 24, 2017,
`
`to Supernus upon assignment from inventors Likan Liang, Hua Wang, Padmanabh P. Bhatt, and
`
`Michael L. Vieira. Supernus owns all rights, title, and interest in the ’940 patent.
`
`36.
`
`The ’004 patent, entitled, “Sustained-Release Formulations of Topiramate,” was
`
`duly and legally issued by the United States Patent and Trademark Office on January 31, 2017,
`
`to Supernus upon assignment from inventors Likan Liang, Hua Wang, Padmanabh P. Bhatt, and
`
`Michael L. Vieira. Supernus owns all rights, title, and interest in the ’004 patent.
`
`37.
`
`The ’983 patent, entitled, “Sustained-Release Formulations of Topiramate,” was
`
`duly and legally issued by the United States Patent and Trademark Office on April 18, 2017, to
`
`Supernus upon assignment from inventors Likan Liang, Hua Wang, Padmanabh P. Bhatt, and
`
`Michael L. Vieira. Supernus owns all rights, title, and interest in the ’983 patent.
`
`38.
`
`The ’790 patent, entitled, “Sustained-Release Formulations of Topiramate,” was
`
`duly and legally issued by the United States Patent and Trademark Office on June 11, 2019, to
`
`Supernus upon assignment from inventors Likan Liang, Hua Wang, Padmanabh P. Bhatt, and
`
`Michael L. Vieira. Supernus owns all rights, title, and interest in the ’790 patent.
`
`39.
`
`On or about February 10, 2021, Ajanta sent a letter purportedly pursuant to
`
`§ 505(j)(2)(B)(iv)(II) of the FDCA and 21 C.F.R. §§ 314.94, 314.95 regarding the Ajanta
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`

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`Products and the ’576, ’580, ’683, ’248, ’191, ’989, ’940, ’004, ’983, and ’790 patents (the
`
`“February 10 Notice Letter”) to Supernus at 1550 East Gude Drive, Rockville, Maryland 20850.
`
`40.
`
`The February 10 Notice Letter was signed by Dennies Varughese, Esq.,
`
`Pharm.D., of Sterne, Kessler, Goldstein & Fox P.L.L.C.––counsel for Ajanta––and authorized
`
`such counsel to accept service of process for Ajanta Ltd.
`
`41.
`
`Upon information and belief, ANDA No. 215663 is based upon Trokendi XR®
`
`(topiramate extended-release capsule), 25 mg, 50 mg, 100 mg, and 200 mg., as its reference
`
`listed drug.
`
`42.
`
`Upon information and belief, the Ajanta Products are topiramate extended-release
`
`capsules, 25 mg, 50 mg, 100 mg, and 200 mg.
`
`43.
`
`Upon information and belief, the proposed prescribing information for the Ajanta
`
`Products includes a header titled, “Indications and Usage,” and states that Ajanta Products are
`
`indicated: (i) as an initial monotherapy for the treatment of partial-onset or primary generalized
`
`tonic-clonic seizures in patients 6 years of age and older; (ii) as an adjunctive therapy for the
`
`treatment of partial-onset seizures, primary generalized tonic-clonic seizures, and seizures
`
`associated with Lennox-Gastaut syndrome in patients 6 years of age and older; and (iii) for the
`
`preventive treatment of migraine in patients 12 years of age and older.
`
`44.
`
`Upon information and belief, the proposed prescribing information for the Ajanta
`
`Products includes a header titled, “Dosage and Administration,” and states that: (i) the
`
`recommended dose for monotherapy in adults and in pediatric patients 10 years of age and older
`
`is 400 mg orally once daily, and dosing in patients 6 to 9 years of age is based on weight; (ii) the
`
`recommended total daily dose as adjunctive therapy in adults with partial-onset seizures or
`
`Lennox-Gastaut Syndrome is 200 mg to 400 mg orally once daily and with primary generalized
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`

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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
`
`generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome is
`
`approximately 5 mg/kg to 9 mg/kg orally once daily; and (iii) the recommended total daily dose
`
`as treatment for the preventive treatment of migraine in patients 12 years of age and older is 100
`
`mg once daily.
`
`45.
`
`Upon information and belief, the proposed prescribing information for the Ajanta
`
`Products will also state under the header “Dosage and Administration” that the Ajanta Products
`
`can be taken without regard to meals, to swallow capsule whole and intact, and do not sprinkle
`
`on food, chew, or crush.
`
`46.
`
`Upon information and belief, the proposed prescribing information for the Ajanta
`
`Products includes a header titled, “Description,” and states that the Ajanta Products contain the
`
`following inactive ingredients: Sugar Spheres, NF Hypromellose (Type 2910), USP Mannitol,
`
`USP Docusate Sodium, USP Sodium Benzoate, NF Ethylcellulose, NF Oleic Acid, NF Medium
`
`Chain Triglycerides, NF Polyethylene Glycol, NF Polyvinyl Alcohol, USP Titanium Dioxide,
`
`USP Talc, USP Lecithin, NF Xanthan Gum, NF Glycerin, USP-NF.
`
`47.
`
`Upon information and belief, Ajanta Ltd. and Ajanta USA acted in concert to
`
`develop the Ajanta Products and to seek approval from FDA to sell the Ajanta Products
`
`throughout the United States, including within this Judicial District.
`
`48.
`
`Upon information and belief, both Ajanta Ltd. and Ajanta USA participated in the
`
`preparation and/or filing of ANDA No. 215663.
`
`49.
`
`21 U.S.C. § 355(j)(2)(B)(iv)(II) requires that a letter notifying a patent holder of
`
`the filing of an ANDA containing a paragraph IV certification “include a detailed statement of
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`

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`Case 3:21-cv-06964 Document 1 Filed 03/26/21 Page 14 of 31 PageID: 14
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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
`
`statement of the factual and legal basis of the applicant’s opinion that the patent is not valid,
`
`unenforceable, or will not be infringed.” The detailed statement must include “(i) [f]or each
`
`claim of a patent alleged not to be infringed, a full and detailed explanation of why the claim is
`
`not infringed” and “(ii) [f]or each claim of a patent alleged to be invalid or unenforceable, a full
`
`and detailed explanation of the grounds supporting the allegation.” 21 C.F.R. § 314.95(c)(7)(i)-
`
`(ii).
`
`50.
`
`Upon information and belief, as of the date of the February 10 Notice Letter,
`
`Ajanta Ltd. and Ajanta USA were aware of the statutory provisions and regulations set out in 21
`
`U.S.C. § 355(j)(2)(B)(iv)(II) and 21 C.F.R. § 314.95(c)(7).
`
`51.
`
`The February 10 Notice Letter does not include any non-infringement contentions
`
`unique to claims 2-18 and 20-30 of the ’576 patent, claims 2-16 and 18-31 of the ’580 patent,
`
`claims 2-24 of the ’683 patent, claims 2-13 and 15-20 of the ’248 patent, claims 2-24 of the ’191
`
`patent, claims 2-13, 16-17, and 19-20 of the ’989 patent, claims 2-13, 16-17, and 19-20 of the
`
`’940 patent, claims 2-12, 15-16, and 18-30 of the ’983 patent, claims 2-11 and 13-15 of the ’004
`
`patent, and claims 2-11 and 13-25 of the ’790 patent.
`
`52.
`
`The February 10 Notice Letter does not include any invalidity contentions to any
`
`claim of the ’576, ’580, ’683, ’191, ’004, and ’790 patents. Further, the February 10 Notice
`
`Letter does not include any invalidity contentions to claims 1-13 and 15-17 of the ’248 patent,
`
`claims 1-13 and 15-17 of the ’989 patent, claims 1-13 and 15-17 of the ’940 patent, claims 1-12,
`
`14-16, and 21 of the ’983 patent.
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`53.
`
`Supernus and Defendants did not reach agreement on mutually acceptable terms
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`for an Offer of Confidential Access pursuant to 21 U.S.C. § 355(j)(5)(C) and 21 C.F.R. §
`
`314.95(c)(8). As of the filing of this Complaint, Defendants have not produced the Ajanta
`
`ANDA to Supernus.
`
`FIRST COUNT
`(Defendants’ Infringement of the ’576 Patent)
`
`54.
`
`Supernus repeats and re-alleges each of the foregoing Paragraphs as if fully set
`
`forth herein.
`
`55.
`
`Upon information and belief, Ajanta Ltd. submission and filing of ANDA No.
`
`215663 with a paragraph IV certification to the ’576 patent to obtain approval to engage in the
`
`commercial manufacture, use, and/or sale in, and/or importation into, the United States of the
`
`Ajanta Products before the expiration of the ’576 patent is an act of infringement of the ’576
`
`patent by Ajanta Ltd. of one or more claims of the ’576 patent under 35 U.S.C. § 271(e)(2)(A).
`
`56.
`
`Upon information and belief, Ajanta Ltd. and Ajanta USA will commercially
`
`manufacture, use, offer to sell, and/or sell within the United States, and/or import into the United
`
`States, the Ajanta Products upon, or in anticipation of, FDA approval of ANDA No. 215663.
`
`57.
`
`Upon information and belief, Ajanta Ltd. and Ajanta USA’s commercial
`
`manufacture, use, offering to sell, and/or sale within the United States, and/or importation into
`
`the United States, of the Ajanta Products will infringe, directly and/or indirectly, one or more
`
`claims of the ’576 patent under 35 U.S.C. § 271.
`
`58.
`
`Upon information and belief, the commercial offering for sale and/or sale of the
`
`Ajanta Products by Ajanta USA, purportedly at the direction and control of Ajanta Ltd., will
`
`induce and/or contribute to third-party infringement of one or more claims of the ’576 patent
`
`under 35 U.S.C. § 271.
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`

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`59.
`
`Upon information and belief, the factual and legal bases in the February 10 Notice
`
`Letter regarding the ’576 patent do not establish good-faith bases to comply with the statutory
`
`provisions and regulations set out in 21 U.S.C. § 355(j)(2)(B)(iv)(II) and 21 C.F.R. §
`
`314.95(c)(7).
`
`60.
`
`Defendants acted without a reasonable basis for believing that they 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.
`
`61.
`
`The acts of infringement set forth above will cause Supernus irreparable harm for
`
`which there is no adequate remedy at law, unless Ajanta Ltd. and Ajanta USA are preliminarily
`
`and permanently enjoined by this Court.
`
`SECOND COUNT
`(Defendants’ Infringement of the ’580 Patent)
`
`62.
`
`Supernus repeats and re-alleges each of the foregoing Paragraphs as if fully set
`
`forth herein.
`
`63.
`
`Upon information and belief, Ajanta Ltd. submission and filing of ANDA No.
`
`215663 with a paragraph IV certification to the ’580 patent to obtain approval to engage in the
`
`commercial manufacture, use, and/or sale in, and/or importation into, the United States of the
`
`Ajanta Products before the expiration of the ’580 patent is an act of infringement of the ’580
`
`patent by Ajanta Ltd. of one or more claims of the ’580 patent under 35 U.S.C. § 271(e)(2)(A).
`
`64.
`
`Upon information and belief, Ajanta Ltd. and Ajanta USA will commercially
`
`manufacture, use, offer to sell, and/or sell within the United States, and/or import into the United
`
`States, the Ajanta Products upon, or in anticipation of, FDA approval of ANDA No. 215663.
`
`65.
`
`Upon information and belief, Ajanta Ltd. and Ajanta USA’s commercial
`
`manufacture, use, offering to sell, and/or sale within the United States, and/or importation into
`
`

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`Case 3:21-cv-06964 Document 1 Filed 03/26/21 Page 17 of 31 PageID: 17
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`the United States, of the Ajanta Products will infringe, directly and/or indirectly, one or more
`
`claims of the ’580 patent under 35 U.S.C. § 271.
`
`66.
`
`Upon information and belief, the commercial offering for sale and/or sale of the
`
`Ajanta Products by Ajanta USA, purportedly at the direction and control of Ajanta Ltd., will
`
`induce and/or contribute to third-party infringement of one or more claims of the ’580 patent
`
`under 35 U.S.C. § 271.
`
`67.
`
`Upon information and belief, the factual and legal bases in the February 10 Notice
`
`Letter regarding the ’580 patent do not establish good-faith bases to comply with the statutory
`
`provisi