Case 3:21-cv-14268 Document 1 Filed 07/28/21 Page 1 of 32 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
`clizza@saul.com
`wbaton@saul.com
`
`Attorneys for Plaintiff
`Supernus Pharmaceuticals, Inc.
`
`OF COUNSEL:
`
`Edgar H. Haug
`Nicholas F. Giove
`Richard F. Kurz
`HAUG PARTNERS LLP
`745 Fifth Avenue
`New York, NY 10151
`
`UNITED STATES DISTRICT COURT
`DISTRICT OF NEW JERSEY
`
`SUPERNUS PHARMACEUTICALS,
`INC.,
`
`
`
`
`
`
`
`v.
`
`Plaintiff,
`
`TORRENT PHARMACEUTICALS LTD.
`and TORRENT PHARMA 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 Torrent Pharmaceuticals Ltd. and Torrent
`
`Pharma Inc. (collectively, “Torrent” or “Defendants”), alleges as follows:
`
`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
`
`

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`Case 3:21-cv-14268 Document 1 Filed 07/28/21 Page 2 of 32 PageID: 2
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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
`
`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
`
`Delaware, having its principal place of business at 9715 Key West Avenue, Rockville, Maryland
`
`20850.
`
`3.
`
`Upon information and belief, Defendant Torrent Pharmaceuticals Ltd. is a
`
`corporation operating and existing under the laws of India, with its principal place of business at
`
`Torrent House, Off. Ashram Road, Ahmedabad, Gujarat, 380009, India.
`
`4.
`
`Upon information and belief, Torrent Pharmaceuticals 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 products into the United States, including throughout the State of New
`
`Jersey; (ii) in concert with and/or through its various subsidiaries, including Defendant Torrent
`
`Pharma Inc., the preparation, submission, and filing of Abbreviated New Drug Applications
`
`(“ANDAs”) seeking 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 Torrent Pharma Inc., the distribution of generic pharmaceutical
`
`products for sale throughout the United States, including throughout the State of New Jersey.
`
`5.
`
`According to Defendants’ website, Torrent Pharmaceuticals Ltd. “is one of the
`
`leading pharma companies of the Country,” “ranked amongst the leaders in therapeutic segment
`
`of cardiovascular (CV), central nervous system (CNS), gastro-intestinal (GI) and women
`
`healthcare (WHC),” “has significant presence in diabetology, pain management, gynaecology,
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`

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`oncology and anti-infective segments,” and has “a widespread global presence in over 40
`
`countries.” Torrent Website, https://torrentpharma.com/index.php/site/info/aboutUs (accessed
`
`July 28, 2021).
`
`6.
`
`Torrent Pharmaceuticals Ltd.’s Annual Report 2020-2021 states that “[r]evenues
`
`from the US business were ₹1261 crores (sales US$ 166 million) during 2020-21.” Torrent
`
`Pharmaceuticals Ltd.’s Annual Report 2020-2021 at 114,
`
`https://torrentpharma.com/pdf/download/AR-2020-21.pdf (accessed July 28, 2021).
`
`7.
`
`Torrent Pharmaceuticals Ltd.’s Annual Report 2020-2021 indicates that while
`
`new approvals for two of its facilities “were on hold pursuant to their negative classification by
`
`the USFDA,” the company expected that “[n]ew approvals from said facilities shall commence,
`
`post its re-inspection by USFDA.” Further, the company “has filled [sic] 12 ANDA’s during
`
`2020-21,” “has 103 ANDA approvals (including 6 tentative approvals) and its pipeline consists
`
`of 54 pending approvals (not including tentative or partnered filings) and more than 40 products
`
`under development to be filed over the next 3 years.” Torrent Pharmaceuticals Ltd.’s Annual
`
`Report 2020-2021 at 114, https://torrentpharma.com/pdf/download/AR-2020-21.pdf (accessed
`
`July 28, 2021).
`
`8.
`
`Upon information and belief, Defendant Torrent Pharma Inc. is a Delaware
`
`limited liability company having its principal place of business at 150 Allen Road, Suite 102,
`
`Basking Ridge, NJ 07920. Upon information and belief, Torrent Pharma Inc. is a wholly-owned
`
`subsidiary of Torrent Pharmaceuticals Ltd. Upon information and belief, Torrent Pharma Inc.
`
`acts at the direction of, under the control of, and for the direct benefit of Torrent Pharmaceuticals
`
`Ltd. and is controlled and/or dominated by Torrent Pharmaceuticals Ltd.
`
`

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`9.
`
`Upon information and belief, Torrent Pharma Inc. 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 through its parent, including Defendant Torrent Pharmaceuticals Ltd. and various
`
`subsidiaries, the preparation, submission, and filing of ANDAs seeking FDA approval to market
`
`generic drugs throughout the United States, including throughout the State of New Jersey; and
`
`(iii) alone or in concert with and/or through its parent, including Defendant Torrent
`
`Pharmaceuticals Ltd. and various subsidiaries, the distribution of generic pharmaceutical
`
`products for sale throughout the United States, including throughout the State of New Jersey.
`
`10.
`
`Upon information and belief, Torrent filed ANDA No. 215918 (“the Torrent
`
`ANDA”) with the 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 capsules, containing 25 mg, 50 mg, 100 mg, and 200 mg of topiramate (“the Torrent
`
`ANDA Products”).
`
`11.
`
`Upon information and belief, Torrent Pharmaceuticals Ltd. and Torrent Pharma
`
`Inc. are acting cooperatively with respect to the Torrent ANDA.
`
`12.
`
`Upon information and belief, Torrent Pharmaceuticals Ltd. and Torrent Pharma
`
`Inc. collaborate to develop, manufacture, import, market, and distribute, and/or sell
`
`pharmaceutical products, including generic drug products (e.g., Losartan Potassium Tablets (25
`
`mg, 50 mg, and 100 mg), Isosorbide Mononitrate Extended-Release Tablets (30 mg, 60 mg, and
`
`120 mg), Felodipine Extended-Release Tablets (2.5 mg, 5 mg, and 10 mg), and Zolpidem
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`Tartrate Tablets (5 mg and 10 mg)) that will be manufactured and sold pursuant to an ANDA,
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`throughout the United States, including throughout the State of New Jersey.
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`

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`13.
`
`Upon information and belief, Defendants and/or their affiliates manufacture
`
`and/or direct the manufacture of generic pharmaceutical products for which Torrent is the named
`
`ANDA applicant. Upon information and belief, Defendants each, directly or indirectly, derive
`
`substantial revenue from the sales of such generic pharmaceutical products.
`
`14.
`
`Upon information and belief, Torrent will market the Torrent ANDA Products
`
`throughout the United States, including in New Jersey, upon approval of the Torrent ANDA.
`
`JURISDICTION AND VENUE
`
`15.
`
`This Court has jurisdiction over the subject matter of this action pursuant to 28
`
`U.S.C. §§ 1331 and 1338(a).
`
`16.
`
`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).
`
`17.
`
`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
`
`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, Torrent states on
`
`its website that, as “[t]he world’s largest market for pharmaceuticals, USA has always been on
`
`Torrent Pharma’s strategic radar. Torrent Pharma Inc., our subsidiary, serves the growing need
`
`of our products in the market and today we are ranked 10th amongst the US generic Indian
`
`Companies.” Torrent Website, https://torrentpharma.com/index.php/site/info/business_usa
`
`(accessed July 28, 2021). Regarding its U.S. business, Torrent Pharmaceuticals Ltd.’s Annual
`
`Report 2020-2021 further states that “Torrent continued to strengthen its pipeline and has filed
`
`12 ANDAs (PY 12) during the year,” and that “3 products were launched during the year.”
`
`Torrent Pharmaceuticals Ltd.’s Annual Report 2020-2021 at 80,
`
`https://torrentpharma.com/pdf/download/AR-2020-21.pdf (accessed July 28, 2021). In addition,
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`Torrent’s website indicates its “aim to strengthen [their] position in the [U.S.] market by
`
`launching complex generics which include specialty oral solids (Oncology) and value added
`
`medicines 505(b)(2) in the coming times.” Torrent Website,
`
`https://torrentpharma.com/index.php/site/info/business_usa (accessed July 28, 2021).
`
`18.
`
`This Court has personal jurisdiction over Torrent Pharma Inc. at least because,
`
`upon information and belief: (i) Torrent Pharma Inc. maintains a principal place of business in
`
`New Jersey located at 150 Allen Road, Suite 102, Basking Ridge, NJ 07920; (ii) Torrent Pharma
`
`Inc. is doing business in New Jersey and maintains continuous and systematic contacts with this
`
`Judicial District; (iii) Torrent Pharma Inc., together with its parent Torrent Pharmaceuticals Ltd.,
`
`is in the business of developing and manufacturing generic pharmaceutical products for
`
`importation, sale, and/or distribution in the State of New Jersey; (iv) Torrent Pharma Inc.,
`
`together with its parent Torrent Pharmaceuticals Ltd., has committed, induced, and/or
`
`contributed to acts of patent infringement in New Jersey; and (v) Torrent Pharma Inc. 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
`
`19.
`
`Upon information and belief, Torrent Pharma Inc. is registered with the State of
`
`New Jersey’s Division of Revenue and Enterprise Services as a business operating in New Jersey
`
`
`
`1 This Court also has personal jurisdiction over Defendants because Torrent Pharmaceuticals
`Ltd. and Torrent Pharma Inc. 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., Allergan Sales, LLC v. Torrent Pharm. Ltd., No. 19-21709 (ES)(SCM) (D.N.J.), ECF No.
`21 (showing that Torrent Pharmaceuticals Ltd. and Torrent Pharma Inc. filed a counterclaim and
`did not contest jurisdiction); Takeda Pharm. Co. v. Torrent Pharm. Ltd., No. 17-3186
`(SRC)(CLW) (D.N.J.), ECF No. 12 (same); Otsuka Pharm. Co. v. Torrent Pharm. Ltd., No. 14-
`1078 (JBS)(KMW) (D.N.J.), ECF No. 11 (same).
`
`

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`with Business Identification Number 0400474439. New Jersey’s Division of Revenue and
`
`Enterprise Services Website,
`
`https://www.njportal.com/DOR/BusinessNameSearch/Search/BusinessName (accessed July 28,
`
`2021). Upon information and belief, Torrent Pharma Inc. is registered with the State of New
`
`Jersey’s Department of Health as a drug and medical device “manufacturer and wholesale[r]”
`
`with Registration Number 5003857. New Jersey Department of Health Website,
`
`https://healthapps.state.nj.us/fooddrug/fdList.aspx (accessed July 28, 2021). Torrent Pharma Inc.
`
`has, therefore, purposefully availed itself of the rights, benefits, and privileges of New Jersey’s
`
`laws.
`
`20.
`
`According to Torrent’s website, Torrent Pharma Inc. is based in Basking Ridge,
`
`New Jersey, and is a wholly-owned subsidiary of Torrent Pharmaceuticals Ltd. Torrent Website,
`
`https://torrentpharma.com/index.php/site/info/international (accessed on July, 28, 2021);
`
`https://torrentpharma.com/index.php/site/info/businessAreas (accessed on July 28, 2021).
`
`21.
`
`Upon information and belief, Torrent Pharmaceuticals Ltd. derives substantial
`
`revenue from directly or indirectly selling generic pharmaceutical products and/or active
`
`pharmaceutical ingredient(s) used in generic pharmaceutical products sold throughout the United
`
`States, including in this Judicial District.
`
`22.
`
`Upon information and belief, Torrent Pharma Inc. derives substantial revenue
`
`from directly or indirectly selling generic pharmaceutical products and/or active pharmaceutical
`
`ingredient(s) used in generic pharmaceutical products sold throughout the United States,
`
`including in this Judicial District.
`
`23.
`
`This Court has personal jurisdiction over Torrent Pharmaceuticals Ltd. at least
`
`because, upon information and belief: (i) Torrent Pharmaceuticals Ltd. has purposefully directed
`
`

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`its activities and the activities of Torrent Pharma Inc. at residents and corporate entities within
`
`the State of New Jersey; (ii) the claims set forth herein against Torrent Pharmaceuticals Ltd. arise
`
`out of or relate to those activities; (iii) Torrent Pharmaceuticals Ltd.’s contacts with the State of
`
`New Jersey (direct and indirect) are continuous and systematic; and (iv) it is reasonable and fair
`
`for this Court to exercise personal jurisdiction over Torrent Pharmaceuticals Ltd.
`
`24.
`
`Upon information and belief, Torrent’s tortious acts of (i) preparing and filing the
`
`Torrent ANDA 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 Torrent ANDA Products
`
`before the expiration of the patents in suit, and (ii) directing notice of its ANDA submission to
`
`Supernus, are acts with real and injurious consequences giving rise to this infringement action,
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`including the present and/or anticipated commercial manufacture, use, offer to sell, and/or sale of
`
`the Torrent ANDA 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 inherent and expected part of a generic ANDA filer’s business,
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`Torrent should reasonably anticipate being sued in New Jersey.
`
`25.
`
`This Court has personal jurisdiction over Torrent at least because, upon
`
`information and belief, if the Torrent ANDA is approved, the Torrent ANDA Products will be
`
`marketed and distributed by Torrent Pharma Inc., purportedly at the direction and control of
`
`Torrent Pharmaceuticals Ltd., in the State of New Jersey, prescribed by physicians practicing in
`
`the State of New Jersey, dispensed by pharmacies located within the State of New Jersey, and
`
`used by patients in the State of New Jersey. Specifically, upon information and belief, if Torrent
`
`succeeds in obtaining FDA approval, Torrent will sell the Torrent ANDA Products in the State of
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`New Jersey. Torrent has previously admitted to marketing and selling drug products in the State
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`of New Jersey and throughout the United States, directly and through its affiliates.2
`
`26.
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`Upon information and belief, Torrent Pharmaceuticals Ltd. intends to benefit
`
`directly if the Torrent ANDA is approved by participating in the manufacture, importation,
`
`distribution, and/or sale of the generic drug products that are the subject of the Torrent ANDA.
`
`27.
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`Upon information and belief, Torrent Pharma Inc. intends to benefit directly if the
`
`Torrent ANDA is approved by participating in the manufacture, importation, distribution, and/or
`
`sale of the generic drug products that are the subject of the Torrent ANDA.
`
`28.
`
`Upon information and belief, Torrent Pharma Inc. acts at the direction, and for the
`
`benefit, of Torrent Pharmaceuticals Ltd. and is controlled and/or dominated by Torrent
`
`Pharmaceuticals Ltd.
`
`29.
`
`Upon information and belief, Torrent Pharma Inc. and Torrent Pharmaceuticals
`
`Ltd. act, operate, and/or hold themselves out to the public as a single integrated business.
`
`30.
`
`Venue is proper under 28 U.S.C. §§ 1391(b) and (c) and/or § 1400(b) because,
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`upon information and belief, Torrent Pharma Inc. has a principal place of business in New Jersey
`
`and has and will continue to engage in infringing activities in New Jersey.
`
`31.
`
`Venue is proper under 28 U.S.C. §§ 1391(b) and (c) and/or § 1400(b) because,
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`upon information and belief, Torrent Pharmaceuticals Ltd. is incorporated in India and may be
`
`sued in any judicial district in the United States in which the Defendant is subject to the court’s
`
`personal jurisdiction.
`
`
`
`2 See, e.g., Allergan Sales, LLC v. Torrent Pharm. Ltd., No. 19-21709 (ES)(SCM) (D.N.J.), ECF
`No. 21 at 3-4 (showing that Torrent Pharmaceuticals Ltd. and Torrent Pharma Inc. filed a
`counterclaim and admitted to marketing and selling drug products in the State of New Jersey).
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`

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`32.
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`Venue is proper under 28 U.S.C. §§ 1391(b) and (c) and/or § 1400(b). Torrent
`
`has previously consented to venue in this Judicial District.3
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`FACTS AS TO ALL COUNTS
`
`33.
`
`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
`
`extended-release capsules, 25 mg, 50 mg, 100 mg, and 200 mg.
`
`34.
`
`Trokendi XR® is an antiepileptic drug 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.
`
`35.
`
`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
`
`
`
`3 See, e.g., Allergan Sales, LLC v. Torrent Pharm. Ltd., No. 19-21709 (ES)(SCM) (D.N.J.), ECF
`No. 21 (showing that Torrent Pharmaceuticals Ltd. and Torrent Pharma Inc. filed a
`counterclaim and did not contest jurisdiction); Takeda Pharm. Co. v. Torrent Pharm. Ltd., No.
`17-3186 (SRC)(CLW) (D.N.J.), ECF No. 12 (same); Otsuka Pharm. Co. v. Torrent Pharm.
`Ltd., No. 14-1078 (JBS)(KMW) (D.N.J.), ECF No. 11 (same).
`
`

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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.
`
`36.
`
`FDA’s publication titled “Approved Drug Products with Therapeutic Equivalence
`
`Evaluations” (commonly known as the “Orange Book”) lists ten (10) patents, specifically the
`
`’576, ’580, ’683, ’248, ’191, ’989, ’940, ’004, ’983, and ’790 patents, as covering Supernus’s
`
`Trokendi XR®. Pursuant to 21 U.S.C. §§ 355(b)(1) and 355(c)(2), these ten (10) patents were
`
`submitted to FDA with or after the approval of NDA No. 201635. These ten (10) patents are
`
`listed in the Orange Book as covering Trokendi XR®.
`
`37.
`
`The ’576 patent, titled “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 ’576 patent.
`
`38.
`
`The ’580 patent, titled “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.
`
`39.
`
`The ’683 patent, titled “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.
`
`40.
`
`The ’248 patent, titled “Sustained-Release Formulations of Topiramate,” was duly
`
`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
`
`Michael L. Vieira. Supernus owns all rights, title, and interest in the ’248 patent.
`
`41.
`
`The ’191 patent, titled “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.
`
`42.
`
`The ’989 patent, titled “Sustained-Release Formulations of Topiramate,” was 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.
`
`43.
`
`The ’940 patent, titled “Sustained-Release Formulations of Topiramate,” was 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.
`
`44.
`
`The ’004 patent, titled “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.
`
`45.
`
`The ’983 patent, titled “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.
`
`

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`46.
`
`The ’790 patent, titled “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.
`
`47.
`
`On or about June 15, 2021, Torrent sent a letter purportedly pursuant to 21 U.S.C.
`
`§ 355(j)(2)(B) and 21 C.F.R. § 314.95 regarding the Torrent ANDA Products and the ’576, ’580,
`
`’683, ’248, ’191, ’989, ’940, ’004, ’983, and ’790 patents (the “June 15 Notice Letter”) to
`
`Supernus at 9715 Key West Ave., Rockville, Maryland 20850.
`
`48.
`
`The June 15 Notice Letter was signed by A. Neal Seth of Wiley Rein LLP,
`
`Torrent’s authorized representative.
`
`49.
`
`Upon information and belief, the Torrent ANDA is based upon Trokendi XR®
`
`(topiramate extended-release capsules), 25 mg, 50 mg, 100 mg, and 200 mg, as its reference
`
`listed drug.
`
`50.
`
`Upon information and belief, the Torrent ANDA Products are topiramate
`
`extended-release capsules, 25 mg, 50 mg, 100 mg, and 200 mg.
`
`51.
`
`Upon information and belief, the proposed prescribing information for the Torrent
`
`ANDA Products includes a header titled “Indications and Usage” and states that Torrent ANDA
`
`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.
`
`

`

`Case 3:21-cv-14268 Document 1 Filed 07/28/21 Page 14 of 32 PageID: 14
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`52.
`
`Upon information and belief, the proposed prescribing information for the Torrent
`
`ANDA 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
`
`tonic-clonic seizures is 400 mg orally once daily, and the recommended total daily dose as
`
`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.
`
`53.
`
`Upon information and belief, the proposed prescribing information for the Torrent
`
`ANDA Products will also state under the header “Dosage and Administration” that the Torrent
`
`ANDA Products can be taken without regard to meals, to swallow capsule whole and intact, and
`
`do not sprinkle on food, chew, or crush.
`
`54.
`
`Upon information and belief, Torrent Pharmaceuticals Ltd. and Torrent Pharma
`
`Inc. acted in concert to develop the Torrent ANDA Products and/or seek approval from the FDA
`
`to sell the Torrent ANDA Products throughout the United States, including within this Judicial
`
`District.
`
`55.
`
`Upon information and belief, both Torrent Pharmaceuticals Ltd. and Torrent
`
`Pharma Inc. participated in the preparation and/or filing of the Torrent ANDA.
`
`

`

`Case 3:21-cv-14268 Document 1 Filed 07/28/21 Page 15 of 32 PageID: 15
`
`56.
`
`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
`
`the factual and legal basis of the opinion of the applicant that the patent is invalid or will not be
`
`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).
`
`57.
`
`Upon information and belief, as of the date of the June 15 Notice Letter, Torrent
`
`was 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).
`
`58.
`
`The June 15 Notice Letter does not include any noninfringement contentions
`
`unique to claims 2-3, 5-18, 22-25, and 27-30 of the ’576 patent, claims 3-8, 10-11, 13-16, 18-28,
`
`and 29-31 of the ’580 patent, claims 6-16, 18-20, and 23-24 of the ’683 patent, claims 2-9, 11-
`
`12, and 15-20 of the ’248 patent, claims 2-20, and 22-24 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 2-11 and
`
`13-15 of the ’004 patent, claims 2-12, 15-16, and 18-30 of the ’983 patent, and claims 2-10 and
`
`13-24 of the ’790 patent.
`
`59.
`
`The June 15 Notice Letter does not include any invalidity contentions to any
`
`claim of the ’576, ’580, ’683, ’248, ’191, ’989, ’940, ’004, ’983, and ’790 patents.
`
`

`

`Case 3:21-cv-14268 Document 1 Filed 07/28/21 Page 16 of 32 PageID: 16
`
`60.
`
`Supernus and Torrent did not reach agreement on mutually acceptable terms 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, Torrent has not produced the Torrent ANDA
`
`to Supernus.
`
`FIRST COUNT
`(Defendants’ Infringement of the ’576 Patent)
`
`61.
`
`Supernus repeats and re-alleges each of the foregoing Paragraphs as if fully set
`
`forth herein.
`
`62.
`
`Upon information and belief, Torrent’s submission and filing of the Torrent
`
`ANDA with a paragraph IV certification to the ’576 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 Torrent ANDA Products before the expiration of the ’576 patent is an act of
`
`infringement of the ’576 patent by Torrent of one or more claims of the ’576 patent under 35
`
`U.S.C. § 271(e)(2)(A).
`
`63.
`
`Upon information and belief, Torrent will commercially manufacture, use, offer
`
`to sell, and/or sell within the United States, and/or import into the United States, the Torrent
`
`ANDA Products upon, or in anticipation of, FDA approval of the Torrent ANDA.
`
`64.
`
`Upon information and belief, Torrent’s commercial manufacture, use, offering to
`
`sell, and/or sale within the United States, and/or importation into the United States, of the
`
`Torrent ANDA Products will infringe, directly and/or indirectly, one or more claims of the ’576
`
`patent under 35 U.S.C. § 271.
`
`65.
`
`Upon information and belief, the commercial offering for sale and/or sale of the
`
`Torrent ANDA Products by Torrent will induce and/or contribute to third-party infringement of
`
`one or more claims of the ’576 patent under 35 U.S.C. § 271.
`
`

`

`Case 3:21-cv-14268 Document 1 Filed 07/28/21 Page 17 of 32 PageID: 17
`
`66.
`
`Upon information and belief, the factual and legal bases in the June 15 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).
`
`67.
`
`Torrent 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’ fee