throbber
Case 3:21-cv-13320 Document 1 Filed 07/02/21 Page 1 of 19 PageID: 1
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`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.
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`
`)
`
`)
`
`)
`
`)
`) C.A. No.: ___________
`)
`
`)
`COMPLAINT FOR PATENT
`)
`INFRINGEMENT
`)
`)
`)
`)
`)
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`COMPLAINT FOR PATENT INFRINGEMENT
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`Plaintiffs Orexo AB and Orexo US, Inc. (“Orexo US,” collectively with Orexo
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`AB, “Orexo” or “Plaintiffs”), for their Complaint against defendants Sun Pharmaceuticals
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`Industries Limited (“Sun Ltd.”), Sun Pharma Global FZE (“Sun FZE”),1 and Sun Pharmaceutical
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`Industries, Inc. (“Sun Inc.”) (collectively, “Sun”) hereby allege as follows:
`
`NATURE OF THE ACTION
`
`1.
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`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
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`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
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`Zubsolv® (buprenorphine/naloxone sublingual tablets) at doses of 1.4/0.36 mg, 2.9/0.71 mg,
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`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
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`United States Patent Nos. 10,874,661 (“the ’661 patent”) and 10,946,010 (“the ’010 patent”),
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`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
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`Sweden, having its principal place of business at Virdings allé 32 A, 754 50 Uppsala, Sweden.
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`3.
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`Plaintiff Orexo US is a corporation organized and existing under the laws of the
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`state of Delaware, having its principal place of business at 150 Headquarters Plaza, East Tower,
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`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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`4.
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`On information and belief, Sun Ltd. is a corporation organized and existing under
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`the laws of India, having a principal place of business at Sun House, CTS No. 201 B/1, Western
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`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
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`Y, SAIF-Zone, P.O. Box #122304, Sharjah, United Arab Emirates. On information and belief,
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`Sun FZE is a wholly-owned subsidiary of Sun Ltd.
`
`6.
`
`On information and belief, Sun Inc. is a corporation organized and existing under
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`the laws of the State of Michigan, having a principal place of business at 2 Independence Way,
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`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
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`infringement under 35 U.S.C. § 271(e)(2), and has sent notice of that infringement to Orexo US
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`in the State of New Jersey.
`
`9.
`
`On information and belief, Sun Ltd. intends a future course of conduct that
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`includes acts of patent infringement in New Jersey. On information and belief, Sun Ltd. knows
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`and intends that, upon FDA approval of Sun’s ANDA, Sun’s ANDA Products will be distributed
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`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,
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`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
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`wholesaler with the New Jersey Department of Health under Registration No. 5003437 and
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`registered with the State of New Jersey’s Division of Revenue and Enterprise Services as a
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`business operating in New Jersey under Business ID Nos. 0100954087 and/or 0100970132. Sun
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`Ltd. maintains extensive and systematic contacts with the State of New Jersey, including the
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`marketing, distribution, and/or sale of generic pharmaceutical drugs in New Jersey, including
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`through, directly or indirectly, Sun Inc. On information and belief, Sun Inc. acts at the direction,
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`and for the benefit, of Sun Ltd., and is controlled and/or dominated by Sun Ltd.
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`13.
`
`This Court has personal jurisdiction over Sun Ltd. also because it has taken
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`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
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`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
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`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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`15.
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`In the alternative to the foregoing, this Court has personal jurisdiction over Sun
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`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
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`India and may be sued in any judicial district.
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`Sun FZE
`
`17.
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`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.
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`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®,
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`causing injury to Orexo in this District.
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`19.
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`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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`and continuous contacts with the State of New Jersey. On information and belief, Sun FZE has
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`purposely conducted, and continues to conduct, business in this Judicial District. On information
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`and belief, Sun FZE, in concert with at least Sun Ltd., is in the business of, among other things,
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`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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`20.
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`This Court has personal jurisdiction over Sun FZE also because it has taken
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`advantage of the jurisdiction of this Court by filing at least counterclaims in this Court; Sun FZE
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`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
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`litigation in this Judicial District. See, e.g., Sun Pharma Global FZE et al. v. Lupin Ltd. et al.,
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`Civil Action No. 18-02213.
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`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.
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`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
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`claims arise under federal law; (b) Sun FZE is a foreign defendant not subject to general personal
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`jurisdiction in the courts of any state; and (c) Sun FZE has sufficient contacts with the United
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`States as a whole, including, but not limited to, preparing and submitting ANDAs to the FDA
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`and/or manufacturing, importing, offering to sell, and/or selling pharmaceutical products that are
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`distributed throughout the United States, such that this Court’s exercise of jurisdiction over Sun
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`FZE satisfies due process.
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`24.
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`Venue is proper in this district for Sun FZE pursuant to 28 U.S.C. §§ 1391 and
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`1400(b) because, inter alia, Sun FZE is a corporation organized and existing under the laws of
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`the United Arab Emirates and may be sued in any judicial district.
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`Sun Inc.
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`25.
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`This Court has personal jurisdiction over Sun Inc. because it has purposely
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`availed itself of the privilege of acting within New Jersey by committing an act of patent
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`infringement and intends a course of conduct of patent infringement in this District. On
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`information and belief, Sun Inc. actively participated in the submission of Sun’s ANDA.
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`26.
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`On information and belief, Sun Inc. intends a future course of conduct that
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`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
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`injury to Orexo in this District.
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`27.
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`This Court has personal jurisdiction over Sun Inc. also because Sun Inc. has
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`purposefully availed itself of the rights and benefits of New Jersey law by engaging in systematic
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`and continuous contacts with the State of New Jersey. On information and belief, Sun Inc. has
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`purposely conducted, and continues to conduct, business in this Judicial District. On information
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`and belief, Sun Inc., in concert with at least Sun Ltd., is in the business of, among other things,
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`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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`28.
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`On information and belief, Sun Inc. maintains physical places of business in at
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`least Princeton, New Jersey and Cranbury, New Jersey.
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`29.
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`On information and belief, Sun Inc. is registered with the State of New Jersey’s
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`Division of Revenue and Enterprise Services as a business operating in New Jersey under
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`Business ID Nos. 0100954087 and/or 0100970132 and is registered as a manufacturer and
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`wholesaler with the New Jersey Department of Health under Registration No. 5003437.
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`30.
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`This Court has personal jurisdiction over Sun Inc. because, inter alia, it has taken
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`advantage of the jurisdiction of this Court by filing at least counterclaims in this Court; Sun Inc.
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`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
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`Pharm. Indus. Ltd., et al., Civil Action No. 14-4307 (JBS)(KMW); Otsuka Pharm. Co. v. Sun
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`Pharm. Indus. Ltd., Civil Action No. 14-6397 (JBS)(KMW); Orexo AB et al. v. Sun Pharm.
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`Indus. Ltd., et al., Civil Action No. 20-12588 (BRM)(DEA).
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`31.
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`Sun Inc. has further availed itself of the jurisdiction of this Court by initiating
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`litigation in this Judicial District. See, e.g., Sun Pharm. Indus. Ltd., et al. v. Novartis Pharms.
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`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.
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`32.
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`On information and belief Sun Inc. acts for the benefit of and at the direction of
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`Sun Ltd., and is an agent and/or alter ego of Sun Ltd.
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`33.
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`Venue is proper in this district for Sun Inc. pursuant to 28 U.S.C. §§ 1391 and
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`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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`THE ZUBSOLV® DRUG PRODUCT
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`34.
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`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®.
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`35.
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`Zubsolv® sublingual tablets are indicated for the maintenance treatment of opioid
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`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
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`36.
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`On December 29, 2020, the USPTO duly and lawfully issued the ’661 patent,
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`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.
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`37.
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`On March 16, 2021, the USPTO duly and lawfully issued the ’010 patent, entitled
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`“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
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`No. 204242).
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`ACTS GIVING RISE TO THIS SUIT
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`38.
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`Pursuant to Section 505 of the Federal Food, Drug and Cosmetic Act, Sun Ltd.
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`filed Sun’s ANDA seeking approval to engage in the commercial manufacture, use, sale, offer
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`for sale, or importation into the United States of Sun’s ANDA Products before the Patents-in-
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`Suit expire.
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`39.
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`On information and belief, Sun FZE and Sun Inc. aided, abetted, and/or acted in
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`concert with Sun Ltd. to file Sun’s ANDA.
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`40.
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`On information and belief, following FDA approval of Sun’s ANDA, Sun will
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`make, use, sell, or offer to sell Sun’s ANDA Products throughout the United States, or import
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`such generic products into the United States.
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`41.
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`In connection with the filing of Sun’s ANDA as described above, Sun Ltd.
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`provided a written certification to the FDA pursuant to Section 505 of the FFDCA, 21 U.S.C. §
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`355(j)(2)(A)(vii)(IV), alleging that the claims of United States Patent Nos. 8,470,361 (“the ’361
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`patent”), 8,658,198 (“the ’198 patent”), 8,940,330 (“the ’330 patent”), 9,259,421 (“the ’421
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`patent”), and 9,439,900 (“the ’900 patent”) (collectively, the “First Suit Patents”) are invalid,
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`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
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`Certification to Plaintiffs (“Sun’s First Notice Letter”) regarding the First Suit Patents. Sun’s
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`First Notice Letter alleged that the claims of the First Suit Patents will not be infringed by the
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`activities described in Sun’s ANDA. Sun’s First Notice Letter also informed Plaintiffs that Sun
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`seeks approval to market Sun’s ANDA Products before the First Suit Patents expire. Sun
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`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
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`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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`43.
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`In connection with the filing of Sun’s ANDA as described above, Sun Ltd.
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`provided a written certification to the FDA pursuant to Section 505 of the FFDCA, 21 U.S.C. §
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`355(j)(2)(A)(vii)(IV), alleging that the claims of the Patents-in-Suit are invalid, unenforceable,
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`and/or will not be infringed by the activities described in Sun’s ANDA (“Sun’s Second
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`Paragraph IV Certification”).
`
`44.
`
`Sun Ltd. sent or caused to be sent a written notice of Sun’s Second Paragraph IV
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`Certification to Plaintiffs (“Sun’s Second Notice Letter”) dated May 21, 2021. Sun’s Second
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`Notice Letter alleged that the claims of the Patents-in-Suit will not be infringed by the activities
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`described in Sun’s ANDA. Sun’s Second Notice Letter also informed Plaintiffs that Sun seeks
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`approval to market Sun’s ANDA Products before the Patents-in-Suit expire. Sun specifically
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`directed Sun’s Second Notice Letter to Orexo US’s headquarters in Morristown, New Jersey, in
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`this Judicial District.
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`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
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`pursuant to the terms of the Stipulated Protective Order in that case (ECF No. 30) for the
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`purposes of determining whether to bring this infringement action.
`
`46.
`
`Based on its review of Sun’s Second Paragraph IV Certification and other
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`information, Plaintiffs are informed and believe Sun’s ANDA infringes valid patent claims of the
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`’661 and ’010 patents, and has therefore brought this action.
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`COUNT I
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`Infringement of the ’661 Patent
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`47.
`
`Plaintiffs repeat and reallege the allegations of the preceding paragraphs as if fully
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`set forth herein.
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`48.
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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 ’661 patent.
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`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.
`
`There is a justiciable controversy between the parties hereto as to the infringement
`
`of the ’661 patent.
`
`52.
`
`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.
`
`54.
`
`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
`
`
`
`
`
`
`
`- 13 -
`
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`
`
`
`

`

`Case 3:21-cv-13320 Document 1 Filed 07/02/21 Page 14 of 19 PageID: 14
`
`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
`
`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.
`
`Plaintiffs do not have an adequate remedy at law.
`
`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.
`
`COUNT II
`
`Infringement of the ’010 Patent
`
`60.
`
`Plaintiffs repeat and reallege the allegations of the preceding paragraphs as if fully
`
`set forth herein.
`
`61.
`
`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
`
`
`
`
`
`
`
`- 14 -
`
`
`
`
`
`

`

`Case 3:21-cv-13320 Document 1 Filed 07/02/21 Page 15 of 19 PageID: 15
`
`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.
`
`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
`
`
`
`
`
`
`
`- 15 -
`
`
`
`
`
`

`

`Case 3:21-cv-13320 Document 1 Filed 07/02/21 Page 16 of 19 PageID: 16
`
`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;
`
`
`
`
`
`
`
`- 16 -
`
`
`
`
`
`

`

`Case 3:21-cv-13320 Document 1 Filed 07/02/21 Page 17 of 19 PageID: 17
`
`C.
`
`An Order that the effective date of FDA approval of ANDA No. 214737 be a date
`
`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;
`
`
`
`
`
`
`
`- 17 -
`
`
`
`
`
`

`

`Case 3:21-cv-13320 Document 1 Filed 07/02/21 Page 18 of 19 PageID: 18
`
`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.
`
`
`
`
`
`
`- 18 -
`
`
`
`
`
`

`

`Case 3:21-cv-13320 Document 1 Filed 07/02/21 Page 19 of 19 PageID: 19
`
`
`
`
`
`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

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