`
`Michael R. Griffinger
`Charles H. Chevalier
`Christine A. Gaddis
`Rachel S. Johnston
`Gibbons P.C.
`One Gateway Center
`Newark, New Jersey 07102-5310
`Phone: (973) 596-4500
`
`OF COUNSEL:
`John J. Molenda
`Vishal C. Gupta
`Jordan P. Markham
`Tyler Doh
`STEPTOE & JOHNSON LLP
`1114 Avenue of the Americas
`New York, New York 10036
`Phone: (212) 506-3900
`
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF NEW JERSEY
`
`OREXO AB and OREXO US, INC.,
`
`
`Plaintiffs,
`
`
`
`v.
`
`
`SUN PHARMACEUTICAL
`INDUSTRIES LIMITED, SUN
`PHARMA GLOBAL FZE, and SUN
`PHARMACEUTICAL INDUSTRIES,
`INC.
`
`
`Defendants.
`
`
`)
`
`)
`
`)
`
`)
`) C.A. No.: ___________
`)
`
`)
`COMPLAINT FOR PATENT
`)
`INFRINGEMENT
`)
`)
`)
`)
`)
`
`
`
`
`
`
`
`
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`
`
`
`
`COMPLAINT FOR PATENT INFRINGEMENT
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`
`
`
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`Case 3:21-cv-13320 Document 1 Filed 07/02/21 Page 2 of 19 PageID: 2
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`Plaintiffs Orexo AB and Orexo US, Inc. (“Orexo US,” collectively with Orexo
`
`AB, “Orexo” or “Plaintiffs”), for their Complaint against defendants Sun Pharmaceuticals
`
`Industries Limited (“Sun Ltd.”), Sun Pharma Global FZE (“Sun FZE”),1 and Sun Pharmaceutical
`
`Industries, Inc. (“Sun Inc.”) (collectively, “Sun”) hereby allege as follows:
`
`NATURE OF THE ACTION
`
`1.
`
`This is an action for patent infringement under the Patent Laws of the United
`
`States, 35 U.S.C. §100, et seq., arising from Sun’s filing of an Abbreviated New Drug
`
`Application (“ANDA”) No. 214737 (“Sun’s ANDA”) with the United States Food and Drug
`
`Administration (“FDA”) seeking approval to commercially market generic versions of Orexo’s
`
`Zubsolv® (buprenorphine/naloxone sublingual tablets) at doses of 1.4/0.36 mg, 2.9/0.71 mg,
`
`5.7/1.4 mg, 8.6/2.1 mg, and 11.4/2.9 mg (“Sun’s ANDA Products”) prior to the expiration of
`
`United States Patent Nos. 10,874,661 (“the ’661 patent”) and 10,946,010 (“the ’010 patent”),
`
`both owned by Orexo AB (collectively, the “Patents-in-Suit”).
`
`THE PARTIES
`
`2.
`
`Plaintiff Orexo AB is a company organized and existing under the laws of
`
`Sweden, having its principal place of business at Virdings allé 32 A, 754 50 Uppsala, Sweden.
`
`3.
`
`Plaintiff Orexo US is a corporation organized and existing under the laws of the
`
`state of Delaware, having its principal place of business at 150 Headquarters Plaza, East Tower,
`
`Morristown, New Jersey 07960. Orexo US is a wholly owned subsidiary of Orexo AB.
`
`
`1 NTD: Sun Pharma Global Inc., which was included in the first complaint, is intentionally omitted.
`Sun’s corporate disclosure statement filed in response to the first complaint states that “Sun Global is no
`longer an existing corporation,” which is confirmed by Sun’s annual reports.
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`Case 3:21-cv-13320 Document 1 Filed 07/02/21 Page 3 of 19 PageID: 3
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`4.
`
`On information and belief, Sun Ltd. is a corporation organized and existing under
`
`the laws of India, having a principal place of business at Sun House, CTS No. 201 B/1, Western
`
`Express Highway, Goregaon (E), Mumbai 400 063, Maharashtra, India.
`
`5.
`
`On information and belief, Sun FZE is a corporation organized and existing under
`
`the laws of the United Arab Emirates, having a principal place of business at Office # 43, Block
`
`Y, SAIF-Zone, P.O. Box #122304, Sharjah, United Arab Emirates. On information and belief,
`
`Sun FZE is a wholly-owned subsidiary of Sun Ltd.
`
`6.
`
`On information and belief, Sun Inc. is a corporation organized and existing under
`
`the laws of the State of Michigan, having a principal place of business at 2 Independence Way,
`
`Princeton, New Jersey 08540. On information and belief, Sun Inc. is a wholly-owned subsidiary
`
`of Sun Ltd.
`
`JURISDICTION AND VENUE
`
`7.
`
`This is an action for patent infringement arising under the Patent Laws of the
`
`United States and the Food and Drug Laws of the United States, Titles 35 and 21, United States
`
`Code. This Court has jurisdiction over the subject matter of this action under 28 U.S.C. §§ 1331,
`
`1338, 2201, and/or 2202.
`
`Sun Ltd.
`
`8.
`
`This Court has personal jurisdiction over Sun Ltd. because it has purposely
`
`availed itself of the privilege of acting within New Jersey by committing an act of patent
`
`infringement under 35 U.S.C. § 271(e)(2), and has sent notice of that infringement to Orexo US
`
`in the State of New Jersey.
`
`9.
`
`On information and belief, Sun Ltd. intends a future course of conduct that
`
`includes acts of patent infringement in New Jersey. On information and belief, Sun Ltd. knows
`
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`Case 3:21-cv-13320 Document 1 Filed 07/02/21 Page 4 of 19 PageID: 4
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`and intends that, upon FDA approval of Sun’s ANDA, Sun’s ANDA Products will be distributed
`
`and sold, by Sun Ltd., in New Jersey and will thereby displace sales of Zubsolv®, causing injury
`
`to Orexo in this District.
`
`10.
`
`This Court has personal jurisdiction over Sun Ltd. also because Sun Ltd. has
`
`purposefully availed itself of the rights and benefits of New Jersey law by engaging in systematic
`
`and continuous contacts with the State of New Jersey. On information and belief, Sun Ltd. is in
`
`the business of manufacturing, marketing, importing, distributing, and selling pharmaceutical
`
`drug products, including generic drug products, either directly or through subsidiaries, agents,
`
`and/or alter egos, which Sun Ltd., either directly or indirectly, manufactures, distributes, markets
`
`and/or sells throughout the United States, including in this District.
`
`11.
`
`Sun Ltd.’s website states that its “U.S. headquarters are in Princeton, New
`
`Jersey,” that it has “distribution and customer service teams at multiple locations across the
`
`country,” and that “Sun Pharma is present in the U.S. through its legal entities [and] . . . continue
`
`to expand our product portfolio in the U.S. market.” Sun Pharmaceutical Industries Limited,
`
`http://www.sunpharma.com/usa (last visited June 1, 2021).
`
`12.
`
`Sun Ltd. has done business in New Jersey, including through its wholly-owned
`
`subsidiary, agent, and/or alter ego, Sun Inc., a company registered as a manufacturer and
`
`wholesaler with the New Jersey Department of Health under Registration No. 5003437 and
`
`registered with the State of New Jersey’s Division of Revenue and Enterprise Services as a
`
`business operating in New Jersey under Business ID Nos. 0100954087 and/or 0100970132. Sun
`
`Ltd. maintains extensive and systematic contacts with the State of New Jersey, including the
`
`marketing, distribution, and/or sale of generic pharmaceutical drugs in New Jersey, including
`
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`Case 3:21-cv-13320 Document 1 Filed 07/02/21 Page 5 of 19 PageID: 5
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`through, directly or indirectly, Sun Inc. On information and belief, Sun Inc. acts at the direction,
`
`and for the benefit, of Sun Ltd., and is controlled and/or dominated by Sun Ltd.
`
`13.
`
`This Court has personal jurisdiction over Sun Ltd. also because it has taken
`
`advantage of the jurisdiction of this Court by filing claims and counterclaims in this Court. On
`
`information and belief, Sun Ltd. has previously invoked, stipulated, and/or consented to personal
`
`jurisdiction in this Judicial District in numerous prior patent cases. For example, Sun Ltd. has
`
`previously been sued in this Judicial District and has availed itself of New Jersey courts through
`
`the assertion of counterclaims in suits brought in New Jersey, and has not challenged personal
`
`jurisdiction. See, e.g., Celgene Corp. v. Sun Pharm. Indus., Inc., et al., Civil Action No. 18-
`
`11630 (SDW)(LDW); Jazz Pharms., Inc., et al. v. Sun Pharm. Indus. Ltd., et al., Civil Action
`
`No. 15-8229 (ES)(JAD); Boehringer Ingelheim Pharms. Inc., et al. v. Sun Pharm. Indus. Ltd., et
`
`al., Civil Action No. 15-5982 (PGS)(TJB); Jazz Pharms., Inc. v. Sun Pharm. Indus. Ltd., et al.,
`
`Civil Action No. 15-3217 (ES)(JAD); Otsuka Pharm. Co. v. Sun Pharm. Indus. Ltd., et al., Civil
`
`Action No. 14-6397 (JBS)(KMW); Otsuka Pharm. Co. v. Sun Pharm. Indus., Inc., et al., Civil
`
`Action No. 14- 4307 (JBS)(KMW); Cephalon, Inc. v. Sun Pharm. Indus., Inc., et al., Civil
`
`Action No. 11-5474 (FLW)(DEA); Depomed, Inc., et al. v. Sun Pharm. Indus., Inc., et al., Civil
`
`Action No. 11-3553 (JAP)(TJB); Orexo AB et al. v. Sun Pharm. Indus. Ltd., et al., Civil Action
`
`No. 20-12588 (BRM)(DEA).
`
`14.
`
`Sun Ltd. has further availed itself of the jurisdiction of this Court by initiating
`
`litigation in this Judicial District. See, e.g., Sun Pharm. Indus. Ltd., et al. v. Altana Pharma AG,
`
`et al., Civil Action No. 05-2391 (KSH)(PS); Sun Pharm. Indus. Ltd., et al. v. Novartis Pharms.
`
`Corp., et al., Civil Action No. 19-21733.
`
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`Case 3:21-cv-13320 Document 1 Filed 07/02/21 Page 6 of 19 PageID: 6
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`15.
`
`In the alternative to the foregoing, this Court has personal jurisdiction over Sun
`
`Ltd., because the requirements of Federal Rule of Civil Procedure 4(k)(2) are met as (a) Orexo’s
`
`claims arise under federal law; (b) Sun Ltd. is a foreign defendant not subject to general personal
`
`jurisdiction in the courts of any state; and (c) Sun Ltd. has sufficient contacts with the United
`
`States as a whole, including, but not limited to, preparing and submitting ANDAs to the FDA
`
`and/or manufacturing, importing, offering to sell, and/or selling pharmaceutical products that are
`
`distributed throughout the United States, such that this Court’s exercise of jurisdiction over Sun
`
`Ltd. satisfies due process.
`
`16.
`
`Venue is proper in this district for Sun Ltd. pursuant to 28 U.S.C. §§ 1391 and
`
`1400(b) because, inter alia, Sun Ltd. is a corporation organized and existing under the laws of
`
`India and may be sued in any judicial district.
`
`Sun FZE
`
`17.
`
`This Court has personal jurisdiction over Sun FZE because it has purposely
`
`availed itself of the privilege of acting within New Jersey by committing an act of patent
`
`infringement. On information and belief, Sun FZE actively participated in the submission of
`
`Sun’s ANDA.
`
`18.
`
`On information and belief, Sun FZE intends a future course of conduct that
`
`includes acts of patent infringement in New Jersey. On information and belief, Sun FZE knows
`
`and intends that, upon FDA approval of Sun’s ANDA, Sun’s ANDA Products will be distributed
`
`and sold, by at least Sun FZE, in New Jersey and will thereby displace sales of Zubsolv®,
`
`causing injury to Orexo in this District.
`
`19.
`
`This Court has personal jurisdiction over Sun FZE also because Sun FZE has
`
`purposefully availed itself of the rights and benefits of New Jersey law by engaging in systematic
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`Case 3:21-cv-13320 Document 1 Filed 07/02/21 Page 7 of 19 PageID: 7
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`and continuous contacts with the State of New Jersey. On information and belief, Sun FZE has
`
`purposely conducted, and continues to conduct, business in this Judicial District. On information
`
`and belief, Sun FZE, in concert with at least Sun Ltd., is in the business of, among other things,
`
`manufacturing, marketing, importing, offering for sale, and selling pharmaceutical products,
`
`including generic drug products, throughout the United States, including in this Judicial District.
`
`20.
`
`This Court has personal jurisdiction over Sun FZE also because it has taken
`
`advantage of the jurisdiction of this Court by filing at least counterclaims in this Court; Sun FZE
`
`has also previously consented to this Court’s jurisdiction. See, e.g., Celgene Corp. v. Sun
`
`Pharm. Indus., Inc., et al., Civil Action No. 18-11630 (SDW)(LDW); Novartis Pharms. Corp., et
`
`al. v. Sun Pharma Global FZE, et al., Civil Action No. 12-4393 (SDW)(MCA); The Medicines
`
`Co. v. Sun Pharma Global FZE, et al., Civil Action No. 11-6819 (PGS)(DEA); Orexo AB et al.
`
`v. Sun Pharm. Indus. Ltd., et al., Civil Action No. 20-12588 (BRM)(DEA).
`
`21.
`
`Sun FZE has further availed itself of the jurisdiction of this Court by initiating
`
`litigation in this Judicial District. See, e.g., Sun Pharma Global FZE et al. v. Lupin Ltd. et al.,
`
`Civil Action No. 18-02213.
`
`22.
`
`On information and belief Sun FZE acts for the benefit of and at the direction of
`
`Sun Ltd., and is an agent and/or alter ego of Sun Ltd.
`
`23.
`
`In the alternative to the foregoing, this Court has personal jurisdiction over Sun
`
`FZE because the requirements of Federal Rule of Civil Procedure 4(k)(2) are met as (a) Orexo’s
`
`claims arise under federal law; (b) Sun FZE is a foreign defendant not subject to general personal
`
`jurisdiction in the courts of any state; and (c) Sun FZE has sufficient contacts with the United
`
`States as a whole, including, but not limited to, preparing and submitting ANDAs to the FDA
`
`and/or manufacturing, importing, offering to sell, and/or selling pharmaceutical products that are
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`Case 3:21-cv-13320 Document 1 Filed 07/02/21 Page 8 of 19 PageID: 8
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`distributed throughout the United States, such that this Court’s exercise of jurisdiction over Sun
`
`FZE satisfies due process.
`
`24.
`
`Venue is proper in this district for Sun FZE pursuant to 28 U.S.C. §§ 1391 and
`
`1400(b) because, inter alia, Sun FZE is a corporation organized and existing under the laws of
`
`the United Arab Emirates and may be sued in any judicial district.
`
`Sun Inc.
`
`25.
`
`This Court has personal jurisdiction over Sun Inc. because it has purposely
`
`availed itself of the privilege of acting within New Jersey by committing an act of patent
`
`infringement and intends a course of conduct of patent infringement in this District. On
`
`information and belief, Sun Inc. actively participated in the submission of Sun’s ANDA.
`
`26.
`
`On information and belief, Sun Inc. intends a future course of conduct that
`
`includes acts of patent infringement in New Jersey. On information and belief, Sun Inc. knows
`
`and intends that, upon FDA approval of Sun’s ANDA, Sun’s ANDA Products will be distributed
`
`and sold, by at least Sun Inc., in New Jersey and will thereby displace sales of Zubsolv®, causing
`
`injury to Orexo in this District.
`
`27.
`
`This Court has personal jurisdiction over Sun Inc. also because Sun Inc. has
`
`purposefully availed itself of the rights and benefits of New Jersey law by engaging in systematic
`
`and continuous contacts with the State of New Jersey. On information and belief, Sun Inc. has
`
`purposely conducted, and continues to conduct, business in this Judicial District. On information
`
`and belief, Sun Inc., in concert with at least Sun Ltd., is in the business of, among other things,
`
`manufacturing, marketing, importing, offering for sale, and selling pharmaceutical products,
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`including generic drug products, throughout the United States, including in this Judicial District.
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`Case 3:21-cv-13320 Document 1 Filed 07/02/21 Page 9 of 19 PageID: 9
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`28.
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`On information and belief, Sun Inc. maintains physical places of business in at
`
`least Princeton, New Jersey and Cranbury, New Jersey.
`
`29.
`
`On information and belief, Sun Inc. is registered with the State of New Jersey’s
`
`Division of Revenue and Enterprise Services as a business operating in New Jersey under
`
`Business ID Nos. 0100954087 and/or 0100970132 and is registered as a manufacturer and
`
`wholesaler with the New Jersey Department of Health under Registration No. 5003437.
`
`30.
`
`This Court has personal jurisdiction over Sun Inc. because, inter alia, it has taken
`
`advantage of the jurisdiction of this Court by filing at least counterclaims in this Court; Sun Inc.
`
`has also previously consented to this Court’s jurisdiction. See, e.g., Celgene Corp. v. Sun
`
`Pharm. Indus., Inc., et al., Civil Action No. 18-11630 (SDW)(LDW); Janssen Pharm. Inc. v. Sun
`
`Pharma Global FZE, et al., Civil Action No. 11-6089 (SRC)(CLW); Otsuka Pharm. Co. v. Sun
`
`Pharm. Indus. Ltd., et al., Civil Action No. 14-4307 (JBS)(KMW); Otsuka Pharm. Co. v. Sun
`
`Pharm. Indus. Ltd., Civil Action No. 14-6397 (JBS)(KMW); Orexo AB et al. v. Sun Pharm.
`
`Indus. Ltd., et al., Civil Action No. 20-12588 (BRM)(DEA).
`
`31.
`
`Sun Inc. has further availed itself of the jurisdiction of this Court by initiating
`
`litigation in this Judicial District. See, e.g., Sun Pharm. Indus. Ltd., et al. v. Novartis Pharms.
`
`Corp., et al., Civil Action No. 19-21733; Sun Pharma Global FZE et al. v. Lupin Ltd. et al., Civil
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`Action No. 18-02213.
`
`32.
`
`On information and belief Sun Inc. acts for the benefit of and at the direction of
`
`Sun Ltd., and is an agent and/or alter ego of Sun Ltd.
`
`33.
`
`Venue is proper in this district for Sun Inc. pursuant to 28 U.S.C. §§ 1391 and
`
`1400(b) because, inter alia, Sun Inc. is subject to personal jurisdiction and has a principal place
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`of business in this judicial district.
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`Case 3:21-cv-13320 Document 1 Filed 07/02/21 Page 10 of 19 PageID: 10
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`THE ZUBSOLV® DRUG PRODUCT
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`34.
`
`Orexo US holds approved New Drug Application (“NDA”) No. 204242 for
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`buprenorphine hydrochloride and naloxone hydrochloride sublingual tablets, which are
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`prescribed and sold in the United States under the trademark Zubsolv®.
`
`35.
`
`Zubsolv® sublingual tablets are indicated for the maintenance treatment of opioid
`
`dependence and for the induction of buprenorphine maintenance therapy in patients suffering
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`from opioid dependence.
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`THE PATENTS-IN-SUIT
`
`36.
`
`On December 29, 2020, the USPTO duly and lawfully issued the ’661 patent,
`
`entitled “Abuse-resistant pharmaceutical composition for the treatment of opioid dependence,” to
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`Orexo AB as assignee of the inventor Andreas Fischer. A copy of the ’661 patent is attached
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`hereto as Exhibit A. The ’661 patent is listed in the FDA’s Approved Drug Products with
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`Therapeutic Equivalence Evaluations (“the Orange Book”) for Zubsolv® sublingual tablets
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`(NDA No. 204242), 5.7/1.4 mg dose.
`
`37.
`
`On March 16, 2021, the USPTO duly and lawfully issued the ’010 patent, entitled
`
`“Abuse-resistant pharmaceutical composition for the treatment of opioid dependence,” to Orexo
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`AB as assignee of the inventor Andreas Fischer. A copy of the ’010 patent is attached hereto as
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`Exhibit B. The ’010 patent is listed in the Orange Book for Zubsolv® sublingual tablets (NDA
`
`No. 204242).
`
`ACTS GIVING RISE TO THIS SUIT
`
`38.
`
`Pursuant to Section 505 of the Federal Food, Drug and Cosmetic Act, Sun Ltd.
`
`filed Sun’s ANDA seeking approval to engage in the commercial manufacture, use, sale, offer
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`Case 3:21-cv-13320 Document 1 Filed 07/02/21 Page 11 of 19 PageID: 11
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`for sale, or importation into the United States of Sun’s ANDA Products before the Patents-in-
`
`Suit expire.
`
`39.
`
`On information and belief, Sun FZE and Sun Inc. aided, abetted, and/or acted in
`
`concert with Sun Ltd. to file Sun’s ANDA.
`
`40.
`
`On information and belief, following FDA approval of Sun’s ANDA, Sun will
`
`make, use, sell, or offer to sell Sun’s ANDA Products throughout the United States, or import
`
`such generic products into the United States.
`
`41.
`
`In connection with the filing of Sun’s ANDA as described above, Sun Ltd.
`
`provided a written certification to the FDA pursuant to Section 505 of the FFDCA, 21 U.S.C. §
`
`355(j)(2)(A)(vii)(IV), alleging that the claims of United States Patent Nos. 8,470,361 (“the ’361
`
`patent”), 8,658,198 (“the ’198 patent”), 8,940,330 (“the ’330 patent”), 9,259,421 (“the ’421
`
`patent”), and 9,439,900 (“the ’900 patent”) (collectively, the “First Suit Patents”) are invalid,
`
`unenforceable, and/or will not be infringed by the activities described in Sun’s ANDA (“Sun’s
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`First Paragraph IV Certification”).
`
`42.
`
`On August 3, 2020, Sun Ltd. sent written notice of Sun’s First Paragraph IV
`
`Certification to Plaintiffs (“Sun’s First Notice Letter”) regarding the First Suit Patents. Sun’s
`
`First Notice Letter alleged that the claims of the First Suit Patents will not be infringed by the
`
`activities described in Sun’s ANDA. Sun’s First Notice Letter also informed Plaintiffs that Sun
`
`seeks approval to market Sun’s ANDA Products before the First Suit Patents expire. Sun
`
`specifically directed Sun’s First Notice Letter to Orexo US’s headquarters in Morristown, New
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`Jersey, in this Judicial District. This resulted in Orexo filing a complaint in this Judicial District
`
`against Sun on September 11, 2020. See Orexo AB et al. v. Sun Pharm. Indus. Ltd., et al., Civil
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`Action No. 20-12588 (BRM)(DEA).
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`Case 3:21-cv-13320 Document 1 Filed 07/02/21 Page 12 of 19 PageID: 12
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`43.
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`In connection with the filing of Sun’s ANDA as described above, Sun Ltd.
`
`provided a written certification to the FDA pursuant to Section 505 of the FFDCA, 21 U.S.C. §
`
`355(j)(2)(A)(vii)(IV), alleging that the claims of the Patents-in-Suit are invalid, unenforceable,
`
`and/or will not be infringed by the activities described in Sun’s ANDA (“Sun’s Second
`
`Paragraph IV Certification”).
`
`44.
`
`Sun Ltd. sent or caused to be sent a written notice of Sun’s Second Paragraph IV
`
`Certification to Plaintiffs (“Sun’s Second Notice Letter”) dated May 21, 2021. Sun’s Second
`
`Notice Letter alleged that the claims of the Patents-in-Suit will not be infringed by the activities
`
`described in Sun’s ANDA. Sun’s Second Notice Letter also informed Plaintiffs that Sun seeks
`
`approval to market Sun’s ANDA Products before the Patents-in-Suit expire. Sun specifically
`
`directed Sun’s Second Notice Letter to Orexo US’s headquarters in Morristown, New Jersey, in
`
`this Judicial District.
`
`45.
`
`Sun’s Second Notice Letter contained an “Offer of Confidential Access.” Sun
`
`agreed that Sun’s ANDA production in Case No. 3:20-cv-12588-BRM-DEA may be reviewed
`
`pursuant to the terms of the Stipulated Protective Order in that case (ECF No. 30) for the
`
`purposes of determining whether to bring this infringement action.
`
`46.
`
`Based on its review of Sun’s Second Paragraph IV Certification and other
`
`information, Plaintiffs are informed and believe Sun’s ANDA infringes valid patent claims of the
`
`’661 and ’010 patents, and has therefore brought this action.
`
`COUNT I
`
`Infringement of the ’661 Patent
`
`47.
`
`Plaintiffs repeat and reallege the allegations of the preceding paragraphs as if fully
`
`set forth herein.
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`Case 3:21-cv-13320 Document 1 Filed 07/02/21 Page 13 of 19 PageID: 13
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`48.
`
`Sun, by the submission of its Second Paragraph IV Certification as part of Sun’s
`
`ANDA to the FDA, has indicated that it seeks approval to engage in the commercial
`
`manufacture, use, sale, offer for sale, or importation into the United States of Sun’s ANDA
`
`Products, prior to the expiration of the ’661 patent.
`
`49.
`
`Sun’s ANDA has been pending before the FDA since at least July 31, 2020, the
`
`date appearing on Sun’s First Notice Letter to Plaintiffs.
`
`50.
`
`Sun’s submission of Sun’s ANDA to engage in the commercial manufacture, use,
`
`sale, offer for sale, or importation into the United States of Sun’s ANDA Products, prior to the
`
`expiration of the ’661 patent, constitutes infringement of one or more of the claims of that patent
`
`under 35 U.S.C. § 271(e)(2)(A).
`
`51.
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`There is a justiciable controversy between the parties hereto as to the infringement
`
`of the ’661 patent.
`
`52.
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`Unless enjoined by this Court, upon FDA approval of Sun’s ANDA, Sun will
`
`infringe one or more claims of the ’661 patent under 35 U.S.C. § 271(a) by making, using,
`
`offering to sell, selling, and/or importing Sun’s ANDA Products in the United States.
`
`53.
`
`Unless enjoined by this Court, upon FDA approval of Sun’s ANDA, Sun will
`
`induce infringement of one or more claims of the ’661 patent under 35 U.S.C. § 271(b) by
`
`making, using, offering to sell, selling, and/or importing Sun’s ANDA Products in the United
`
`States. On information and belief, upon FDA approval of Sun’s ANDA, Sun will intentionally
`
`encourage acts of direct infringement with knowledge of the ’661 patent and knowledge that its
`
`acts are encouraging infringement.
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`54.
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`Unless enjoined by this Court, upon FDA approval of Sun’s ANDA, Sun will
`
`contributorily infringe one or more claims of the ’661 patent under 35 U.S.C. § 271(c) by
`
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`making, using, offering to sell, selling, and/or importing Sun’s ANDA Products in the United
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`States. On information and belief, Sun has had and continues to have knowledge that Sun’s
`
`ANDA Products are especially adapted for a use that infringes one or more claims of the ’661
`
`patent and that there is no substantial non-infringing use for Sun’s ANDA Products.
`
`55.
`
`Sun’s ANDA Products are required in accordance with 21 U.S.C. 355(j)(2)(v) to
`
`have the same clinical instructions on use, be administered in the same manner, and achieve the
`
`same results as inventions claimed in the ’661 patent.
`
`56.
`
`Plaintiffs will be substantially and irreparably damaged and harmed if Sun’s
`
`infringement of the ’661 patent is not enjoined.
`
`57.
`
`58.
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`Plaintiffs do not have an adequate remedy at law.
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`Sun did not contest the validity of any of the claims of the ’661 patent in Sun’s
`
`Second Notice Letter. If Sun had a factual or legal basis to contest the validity of the claims of
`
`the ’661 patent, it was required by applicable regulations to state such a basis in its Notice Letter.
`
`See 21 CFR § 314.95(c)(7); 21 CFR § 314.52.
`
`59.
`
`This case is an exceptional one, and Plaintiffs are entitled to an award of its
`
`reasonable attorneys’ fees under 35 U.S.C. § 285.
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`COUNT II
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`Infringement of the ’010 Patent
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`60.
`
`Plaintiffs repeat and reallege the allegations of the preceding paragraphs as if fully
`
`set forth herein.
`
`61.
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`Sun, by the submission of its Second Paragraph IV Certification as part of Sun’s
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`ANDA to the FDA, has indicated that it seeks approval to engage in the commercial
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`manufacture, use, sale, offer for sale, or importation into the United States of Sun’s ANDA
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`Products, prior to the expiration of the ’010 patent.
`
`62.
`
`Sun’s ANDA has been pending before the FDA since at least July 31, 2020, the
`
`date appearing on Sun’s First Notice Letter to Plaintiffs.
`
`63.
`
`Sun’s submission of Sun’s ANDA to engage in the commercial manufacture, use,
`
`sale, offer for sale, or importation into the United States of Sun’s ANDA Products, prior to the
`
`expiration of the ’010 patent, constitutes infringement of one or more of the claims of that patent
`
`under 35 U.S.C. § 271(e)(2)(A).
`
`64.
`
`There is a justiciable controversy between the parties hereto as to the infringement
`
`of the ’010 patent.
`
`65.
`
`Unless enjoined by this Court, upon FDA approval of Sun’s ANDA, Sun will
`
`infringe one or more claims of the ’010 patent under 35 U.S.C. § 271(a) by making, using,
`
`offering to sell, selling, and/or importing Sun’s ANDA Products in the United States.
`
`66.
`
`Unless enjoined by this Court, upon FDA approval of Sun’s ANDA, Sun will
`
`induce infringement of one or more claims of the ’010 patent under 35 U.S.C. § 271(b) by
`
`making, using, offering to sell, selling, and/or importing Sun’s ANDA Products in the United
`
`States. On information and belief, upon FDA approval of Sun’s ANDA, Sun will intentionally
`
`encourage acts of direct infringement with knowledge of the ’010 patent and knowledge that its
`
`acts are encouraging infringement.
`
`67.
`
`Unless enjoined by this Court, upon FDA approval of Sun’s ANDA, Sun will
`
`contributorily infringe one or more claims of the ’010 patent under 35 U.S.C. § 271(c) by
`
`making, using, offering to sell, selling, and/or importing Sun’s ANDA Products in the United
`
`States. On information and belief, Sun has had and continues to have knowledge that Sun’s
`
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`ANDA Products are especially adapted for a use that infringes one or more claims of the ’010
`
`patent and that there is no substantial non-infringing use for Sun’s ANDA Products.
`
`68.
`
`Sun’s ANDA Products are required in accordance with 21 U.S.C. 355(j)(2)(v) to
`
`have the same clinical instructions on use, be administered in the same manner, and achieve the
`
`same results as inventions claimed in the ’010 patent.
`
`69.
`
`Plaintiffs will be substantially and irreparably damaged and harmed if Sun’s
`
`infringement of the ’010 patent is not enjoined.
`
`70.
`
`71.
`
`Plaintiffs do not have an adequate remedy at law.
`
`Sun did not contest the validity of any of the claims of the ’010 patent in Sun’s
`
`Second Notice Letter. If Sun had a factual or legal basis to contest the validity of the claims of
`
`the ’010 patent, it was required by applicable regulations to state such a basis in its Notice Letter.
`
`See 21 CFR § 314.95(c)(7); 21 CFR § 314.52.
`
`72.
`
`This case is an exceptional one, and Plaintiffs are entitled to an award of its
`
`reasonable attorneys’ fees under 35 U.S.C. § 285.
`
`PRAYER FOR RELIEF
`
`WHEREFORE, Plaintiffs respectfully request the following relief:
`
`A.
`
`A Judgment that Sun has infringed the Patents-in-Suit by submitting ANDA No.
`
`214737;
`
`B.
`
`A Judgment that Sun has infringed, and that Sun’s making, using, offering to sell,
`
`selling, or importing Sun’s ANDA Products will infringe one or more claims of the Patents-in-
`
`Suit;
`
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`C.
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`An Order that the effective date of FDA approval of ANDA No. 214737 be a date
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`which is not earlier than the later of the expiration of the Patents-in-Suit, or any later expiration of
`
`exclusivity to which Plaintiffs are or becomes entitled;
`
`D.
`
`Preliminary and permanent injunctions enjoining Sun and its officers, agents,
`
`attorneys and employees, and those acting in privity or concert with them, from making, using,
`
`offering to sell, selling, or importing Sun’s ANDA Products until after the expiration of the
`
`Patents-in-Suit, or any later expiration of exclusivity to which Plaintiffs are or become entitled;
`
`E.
`
`A permanent injunction, pursuant to 35 U.S.C. § 271(e)(4)(B), restraining and
`
`enjoining Sun, its officers, agents, attorneys and employees, and those acting in privity or concert
`
`with them, from making, using, offering to sell, selling, or importing buprenorphine/naloxone
`
`sublingual tablets or compositions claimed in the Patents-in-Suit, or from actively inducing or
`
`contributing to the infringement of any claim of the Patents-in-Suit, until after the expiration of
`
`the Patents-in-Suit, or any later expiration of exclusivity to which Plaintiffs are or become entitled;
`
`F.
`
`A Judgment that the commercial manufacture, use, importation into the United
`
`States, sale, and/or offer for sale of Sun’s ANDA Products will directly infringe, induce and/or
`
`contribute to infringement of the Patents-in-Suit;
`
`G.
`
`To the extent that Sun has committed any acts with respect to the inventions
`
`claimed in the Patents-in-Suit, other than those acts expressly exempted by 35 U.S.C. § 271(e)(1),
`
`a Judgment awarding Plaintiffs damages for such acts;
`
`H.
`
`If Sun engages in the commercial manufacture, use, importation into the United
`
`States, sale, and/or offer for sale of Sun’s ANDA Products prior to the expiration of the Patents-
`
`in-Suit, a Judgment awarding damages to Plaintiffs resulting from such infringement, together with
`
`interest;
`
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`Case 3:21-cv-13320 Document 1 Filed 07/02/21 Page 18 of 19 PageID: 18
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`I.
`
`J.
`
`A Judgment declaring that the Patents-in-Suit remain valid and enforceable;
`
`A Judgment that this is an exceptional case pursuant to 35 U.S.C. § 285 and
`
`awarding Plaintiffs their attorneys’ fees incurred in this action;
`
`K.
`
`A Judgment awarding Plaintiffs their costs and expenses incurred in this action;
`
`and
`
`
`
`
`
`
`
`
`
`
`L.
`
`Such further and other relief as this Court may deem just and proper.
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`Case 3:21-cv-13320 Document 1 Filed 07/02/21 Page 19 of 19 PageID: 19
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`GIBBONS P.C.
`
`/S/ CHARLES H. CHEVALIER
`Michael R. Griffinger
`Charles H. Chevalier
`Christine A. Gaddis
`Rachel S. Johnston
`One Gateway Center
`Newark, New Jersey 07102-5310
`Phone: (973) 596-4500
`
`Attorneys for Plaintiffs
`Orexo AB and Orexo US, Inc.
`
`
`OF COUNSEL:
`John J. Molenda
`Vishal C. Gupta
`Jordan P. Markham
`Tyler Doh
`STEPTOE & JOHNSON LLP
`1114 Avenue of the Americas
`New Yor