`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
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`VANDA PHARMACEUTICALS INC.,
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`Plaintiff,
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`v.
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`APOTEX INC. and APOTEX CORP.,
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`Defendants.
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`C.A. No. _______________
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`COMPLAINT FOR PATENT INFRINGEMENT
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`Plaintiff Vanda Pharmaceuticals Inc. (“Vanda”) for its Complaint against
`
`Defendants Apotex Inc. and Apotex Corp. (“Apotex”) alleges as follows:
`
`I.
`
`THE PARTIES
`
`1.
`
`Plaintiff Vanda is a Delaware corporation with its principal place of
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`business at 2200 Pennsylvania Ave. NW, Suite 300E, Washington, DC 20037. Vanda is a
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`pharmaceutical company that focuses on the development and commercialization of new
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`medicines to address unmet medical needs, including Hetlioz® (tasimelteon oral capsules), for the
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`treatment of Non-24-Hour Sleep-Wake Disorder (“Non-24”).
`
`2.
`
`On information and belief, Apotex Inc. is a Canadian corporation with its
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`principal place of business at 150 Signet Drive, Toronto, Ontario M9L 1T9, Canada.
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`3.
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`On information and belief, Apotex Corp. is a corporation organized and
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`existing under the laws of the State of Delaware, with its principal place of business at 2400 North
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`Commerce Parkway, Suite 400, Weston, Florida 33326.
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`4.
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`On information and belief, Apotex Corp. is a subsidiary of Apotex Inc.
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`
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`5.
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`On information and belief Apotex Corp. is the designated U.S. agent for
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`Apotex Inc. in accordance with 21 C.F.R. § 314.50(a) in connection with Abbreviated New Drug
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`Application No. 211607 (the “Apotex ANDA”).
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`6.
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`On information and belief, Apotex Corp. is a generic pharmaceutical
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`company that distributes and sells generic pharmaceutical products in the State of Delaware and
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`throughout the United States that are manufactured by Apotex Inc. (Apotex Inc. and Apotex Corp.
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`are collectively referred to herein as “Apotex” unless otherwise specified).
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`II.
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`NATURE OF THE ACTION
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`7.
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`This is an action arising under the patent laws of the United States (Title 35,
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`U.S. Code, §§ 100, et seq.) based upon Apotex’s infringement of one or more claims of Vanda’s
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`U.S. Patent No. 10,829,465 (“the ’465 patent”), which, in relevant part, generally relates to
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`compositions comprising purified tasimelteon.
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`8.
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`Vanda is the holder of approved New Drug Application No. 205677 for
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`Hetlioz® (tasimelteon) capsules, 20 mg, which was approved by the Food and Drug
`
`Administration (“FDA”) on January 31, 2014, for the treatment of Non-24 a circadian rhythm
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`sleep disorder.
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`9.
`
`10.
`
`Tasimelteon is the active ingredient in Hetlioz®.
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`On information and belief, Apotex filed its ANDA under § 505(j) of the
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`Federal Food, Drug, and Cosmetic Act (the “FFDCA”), to obtain approval to commercially
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`manufacture and sell generic tasimelteon capsules in its 20 mg strength for the treatment of Non-
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`24 (“Apotex’s ANDA Product”).
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`11.
`
`On information and belief, Apotex made and included in its ANDA a
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`certification under 21 U.S.C. § 355(j)(2)(A)(vii)(IV) (“Paragraph IV Certification”) that, in its
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`2
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`opinion and to the best of its knowledge, the ’465 patent is invalid, unenforceable, and/or that
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`certain claims will not be infringed by Apotex’s ANDA Product.
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`12.
`
`Vanda received written notice of Apotex’s ANDA and Paragraph IV
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`Certification as to the ’465 patent on January 14, 2021 (“Notice Letter”), along with an enclosed
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`statement of Apotex’s alleged factual and legal bases for stating that the ’465 patent is invalid,
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`unenforceable, and/or will not be infringed by Apotex’s ANDA Product (“Detailed Statement”).
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`13.
`
`Apotex’s Detailed Statement does not provide any factual bases or other
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`statements alleging that the ’465 patent is unenforceable.
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`14.
`
`This action is being commenced within 45 days of receipt of Apotex’s
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`Notice Letter.
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`15.
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`Apotex has infringed one or more claims of the ’465 patent under 35 U.S.C.
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`§ 271(e)(2)(A) by virtue of the filing of the Apotex ANDA with a Paragraph IV Certification and
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`seeking FDA approval of the Apotex ANDA prior to the expiration of the ’465 patent or any
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`extensions thereof.
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`16.
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`Apotex has infringed one or more claims of the ’465 patent under 35 U.S.C.
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`§ 271(e)(2)(A) by virtue of the filing of the Apotex ANDA seeking FDA approval to commercially
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`manufacture, use, offer for sale, sell, distribute in, or import into the United States generic
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`tasimelteon for the treatment of Non-24 prior to the expiration of the ’465 patent or any extensions
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`thereof.
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`III.
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`JURISDICTION
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`17.
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`This action arises under
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`the patent
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`laws of
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`the United States,
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`35 U.S.C. §§ 100, et seq., and this Court has subject matter jurisdiction over Vanda’s patent
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`infringement claims under 28 U.S.C. §§ 1331, 1338(a), 2201, and 2202.
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`3
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`18.
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`This Court has personal jurisdiction over Apotex Corp. because Apotex
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`Corp. is incorporated in the State of Delaware.
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`19.
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`On information and belief, Apotex’s registered agent for service of process
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`is Corporate Creations Network Inc., with an address at 3411 Silverside Road #104, Tatnall
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`Building, Wilmington, Delaware 19810.
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`20.
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`This Court has personal jurisdiction over Apotex Inc. under Fed. R. Civ. P.
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`4(k) because, on information and belief, Apotex Inc. is organized under the laws of Canada.
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`21.
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`This Court has personal jurisdiction over Apotex Inc. because at least one
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`of the provisions under Del. Code Ann. tit. 10, § 3104, is satisfied. On information and belief,
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`Apotex satisfies at least § 3104(c)(1) (“[t]ransacts any business or performs any character of work
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`or service in the State), § 3104(c)(2) (“[c]ontracts to supply services or things in this State”), §
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`3104(c)(3) (“[c]auses tortious injury in the State by an act or omission in this State), and §
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`3104(c)(4) (“[c]auses tortious injury in the State or outside of the State by an act or omission
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`outside the State if the person regularly does or solicits business, engages in any other persistent
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`course of conduct in the State or derives substantial revenue from services, or things used or
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`consumed in the State”).
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`22.
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`This Court also has personal jurisdiction over Apotex Inc. because this suit
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`arises out of and relates to Apotex Inc.’s activities, in concert with Apotex Corp., that are, and will
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`be, directed to Delaware. On information and belief, following any FDA approval of the Apotex
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`ANDA, Apotex Inc., in concert with Apotex Corp., will market and sell Apotex’s ANDA Product
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`that is the subject of the infringement claims in this action in the State of Delaware and throughout
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`the United States, including in this Judicial District.
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`4
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`23.
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`On information and belief, Apotex Inc., directly and through its
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`subsidiaries, affiliates, or agents, including Apotex Corp., is in the business of manufacturing
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`generic pharmaceuticals that it distributes or has distributed in the State of Delaware and
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`throughout the United States.
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`24.
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`Apotex Inc. and Apotex Corp., acting in concert, have committed, or aided,
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`abetted, contributed to, and/or participated in the commission of acts of patent infringement that
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`will lead to foreseeable harm and injury to Vanda, which manufactures Hetlioz® for sale and use
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`throughout the United States, including in this Judicial District. On information and belief, and as
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`indicated by the Notice Letter, Apotex prepared and filed ANDA No. 211607 with the intention
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`of seeking to market generic tasimelteon nationwide, including within this Judicial District.
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`25.
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`On information and belief, Apotex plans to market and sell generic
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`tasimelteon in the State of Delaware, list generic tasimelteon on the State of Delaware’s
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`prescription drug formulary, and seek Medicaid reimbursement for sales of Apotex’s ANDA
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`Product in the State of Delaware, either directly or through one or more of Apotex’s wholly owned
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`subsidiaries, agents, and/or alter egos.
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`26.
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`On information and belief, Apotex knows and intends that its proposed
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`generic tasimelteon product will be distributed and sold in Delaware and will thereby displace
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`sales of Hetlioz®, causing injury to Vanda. Apotex intends to take advantage of its established
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`channels of distribution in Delaware for the sale of Apotex’s ANDA Product.
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`IV.
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`VENUE
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`27.
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`Venue is proper in this Judicial District under 28 U.S.C. § 1400(b) with
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`regard to Apotex Corp., because, upon information and belief, Apotex Corp. resides in the State
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`of Delaware and therefore Apotex’s ANDA submission is sufficiently related to this District.
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`5
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`28.
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`Venue is proper in this Judicial District under 28 U.S.C. § 1391 and
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`§ 1400(b) with regard to Apotex Inc., because, upon information and belief, Apotex Inc. is
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`incorporated in Canada and may be sued in any judicial district in the United States in which
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`Apotex Inc. is subject to the Court’s personal jurisdiction.
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`V.
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`THE PATENT-IN-SUIT
`
`(U.S. PATENT NO. 10,829,465)
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`29.
`
`30.
`
`tasimelteon.
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`The allegations above are incorporated herein by reference.
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`The ’465 patent covers, generally, compositions comprising purified
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`31.
`
`As explained in the ’465 patent, “in the synthesis of tasimelteon there are
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`certain impurities that can be formed as both by-products and degradation products, and that these
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`impurities can be controlled or reduced to non-detectable or acceptably detectable levels.”
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`32.
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`Vanda is the owner of all rights, title, and interest in the ’465 patent, entitled
`
`“Highly Purified Pharmaceutical Grade Tasimelteon.” The USPTO duly and legally issued the
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`’465 patent on November 10, 2020, to Deepak Phadke, Natalie M. Platt, and Ravi K.
`
`Pandrapragada as inventors, which was assigned to Vanda. A true and correct copy of the ’465
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`patent is attached to this Complaint as Exhibit A.
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`33.
`
`The ’465 patent generally claims compositions comprising purified
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`tasimelteon.
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`VI.
`
`COUNT I
`
`(INFRINGEMENT OF THE ’465 PATENT)
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`34.
`
`The allegations above are incorporated herein by reference.
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`6
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`35.
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`Apotex filed the Apotex ANDA under § 505(j) of the FFDCA to obtain
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`approval to commercially manufacture, use, offer to sell, and sell generic tasimelteon for the
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`treatment of Non-24 before the expiration of the ’465 patent and any extensions thereof.
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`36.
`
`Apotex’s Notice Letter states that Apotex filed the ANDA seeking approval
`
`to manufacture, use, offer to sell, and sell generic tasimelteon in its 20 mg strength for the treatment
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`of Non-24 before the expiration of the ’465 patent. The Notice Letter represents that an
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`Amendment to Apotex’s ANDA was submitted with a Paragraph IV Certification that the ’465
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`patent purportedly is invalid, unenforceable, and/or will not be infringed by the commercial
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`manufacture, use, or sale of Apotex’s ANDA Product.
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`37.
`
`The ’465 patent is listed in FDA’s Approved Drug Products with
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`Therapeutic Equivalence Evaluations for Hetlioz® in its 20 mg strength.
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`38.
`
`39.
`
`thereof.
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`Apotex thus has actual knowledge of the ’465 patent.
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`Vanda has the right to enforce the ’465 patent and sue for infringement
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`40.
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`On information and belief, Apotex has made and will continue to make
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`substantial and meaningful preparations to import into the United States and/or offer to sell, sell,
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`and/or use within the United States products which are patented by the ’465 patent.
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`41.
`
`On information and belief, Apotex’s preparations include, but are not
`
`limited to, the development of Apotex’s ANDA Product, systematically attempting to meet the
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`applicable regulatory requirements for approval of Apotex’s ANDA Product, and engaging in
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`litigation to manufacture, offer to sell, sell, use, and/or import Apotex’s ANDA Product prior to
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`the expiration of the ’465 patent.
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`7
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`42.
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`On information and belief, Apotex intends to use a composition claimed in
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`the ’465 patent in Apotex’s ANDA Product.
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`43.
`
`On information and belief, the tasimelteon composition in Apotex’s ANDA
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`Product is not materially changed by subsequent process.
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`44.
`
`On information and belief, a tasimelteon composition of the ’465 patent is
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`an essential part of Apotex’s ANDA Product.
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`45.
`
`On information and belief, a tasimelteon composition of the ’465 patent in
`
`Apotex’s ANDA Product is not a trivial or non-essential component of another product.
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`46.
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`On information and belief, Apotex’s ANDA Product is covered by one or
`
`more claims of the ’465 patent.
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`47.
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`On information and belief, Apotex’s ANDA Product is not a staple article
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`of commerce and has no substantial uses that do not infringe at least claim 1 of the ’465 patent.
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`48.
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`Apotex has
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`infringed and will
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`infringe
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`the ’465 patent under
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`35 U.S.C. § 271(e)(2)(A) by virtue of its submission of the Apotex ANDA, and any amendments
`
`and/or supplements thereto, to FDA seeking to obtain approval for generic tasimelteon covered by
`
`one or more claims of the ’465 patent, prior to the expiration of the ’465 patent.
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`49.
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`The commercial manufacture, use, offer to sell, sale, distribution, or
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`importation of products under the Apotex ANDA would infringe directly or contribute to or induce
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`the infringement of one or more claims of the ’465 patent, including at least claim 1 under 35
`
`U.S.C. § 271(a), (b), (c), and/or (g).
`
`50.
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`On information and belief, Apotex will induce others to infringe and/or
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`contribute to the infringement of at least claim 1 of the ’465 patent under 35 U.S.C. § 271(b) and/or
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`(c) by, among other things, actively and knowingly aiding and abetting others to infringe,
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`8
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`Case 1:21-cv-00282-UNA Document 1 Filed 02/24/21 Page 9 of 12 PageID #: 9
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`including, but not limited to the manufacturer of Apotex’s ANDA products, or its Active
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`Pharmaceutical Ingredient (“API”), or other subsequence purchasers, distributors, or users thereof,
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`which manufacture constitutes direct infringement of at least claim 1 of the ’465 patent.
`
`51.
`
`On information and belief, Apotex will induce others to infringe and/or
`
`contribute to the infringement of at least claim 1 of the ’465 patent under § 271(b) and/or (c) by
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`making, using, selling, offering to sell, and/or importing Apotex’s ANDA Product and/or the API
`
`thereof.
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`52.
`
`On information and belief, subsequent purchasers, distributors or users
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`thereof will also directly infringe at least claim 1 of the ’465 patent.
`
`53.
`
`On information and belief Apotex will infringe at least claim 1 of the ’465
`
`patent under 35 U.S.C. § 271(g) by importing, selling, offering to sell, or using Apotex’s ANDA
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`Product or the API for Apotex’s ANDA Product.
`
`54.
`
`On information and belief, Apotex’s ANDA Product and/or the API for
`
`Apotex’s ANDA Product is not materially changed by subsequent process.
`
`55.
`
`On information and belief, Apotex’s ANDA Product and the API for
`
`Apotex’s ANDA Product are not a trivial or non-essential component of another product.
`
`56.
`
`Vanda seeks entry of an order requiring that Apotex amend its Paragraph
`
`IV Certification
`
`in
`
`the Apotex ANDA
`
`to a certification pursuant
`
`to 21 U.S.C.
`
`§ 355(j)(2)(A)(vii)(III)
`
`(“Paragraph
`
`III Certification”)
`
`as provided
`
`in 21 C.F.R.
`
`§ 314.94(a)(12)(viii)(A).
`
`57.
`
`Vanda seeks entry of an order declaring that Apotex has infringed the ’465
`
`patent by virtue of submitting its ANDA pursuant to 35 U.S.C. § 271(e)(2)(A).
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`9
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`58.
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`Vanda seeks entry of an order pursuant to 35 U.S.C. § 271(e)(4), including
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`an order of this Court that the effective date of any FDA approval of the Apotex ANDA be a date
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`that is not earlier than the expiration of the ’465 patent or any later expiration of exclusivity for
`
`the ’465 patent to which Vanda becomes entitled.
`
`59.
`
`Vanda will be irreparably harmed if Apotex is not enjoined from infringing
`
`or actively inducing or contributing to infringement of one or more claims of the ’465 patent.
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`Pursuant to 35 U.S.C. § 283, Vanda is entitled to a permanent injunction against further
`
`infringement. Vanda does not have an adequate remedy at law.
`
`60.
`
`On information and belief, Apotex’s statement of the factual and legal bases
`
`for its opinion regarding the invalidity and noninfringement of the ’465 patent is devoid of an
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`objective good faith basis in either the facts or the law. This case is exceptional and Vanda is
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`entitled to attorneys’ fees pursuant to 35 U.S.C. § 285.
`
`61.
`
`To the extent Apotex commercializes its product, Vanda will also be
`
`entitled to damages under 35 U.S.C. § 284.
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`PRAYER FOR RELIEF
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`WHEREFORE, Vanda respectfully requests that this Court enter judgment in its
`
`favor against Apotex and grant the following relief:
`
`A.
`
`an adjudication that Apotex has infringed directly, contributed to, or
`
`induced the infringement of one or more claims of the ’465 patent under 35 U.S.C. § 271(e)(2)(A)
`
`by submitting to FDA the Apotex ANDA to obtain approval for the commercial manufacture, use,
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`offer for sale, sale, distribution in, or importation into the United States of generic tasimelteon for
`
`the treatment of Non-24 before the expiration of the ’465 patent;
`
`B.
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`a declaration that Apotex will infringe directly, contribute to, or induce the
`
`infringement of one or more claims of the ’465 patent under 35 U.S.C. § 271(a), (b), (c) and/or (g)
`
`10
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`if it markets, manufactures, uses, offers for sale, sells, distributes in, or imports into the United
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`States generic tasimelteon for the treatment of Non-24 before the expiration of the ’465 patent;
`
`C.
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`an order requiring that Apotex amend its Paragraph IV Certification to a
`
`Paragraph III Certification as provided in 21 C.F.R. § 314.94(a)(12)(viii)(A);
`
`D.
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`an order pursuant to 35 U.S.C. § 271(e)(4)(A) providing that the effective
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`date of any FDA approval of the Apotex ANDA for generic tasimelteon be a date that is not earlier
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`than the date of the expiration of the ’465 patent or any later period of exclusivity to which Vanda
`
`is or may become entitled;
`
`E.
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`a permanent injunction enjoining Apotex, its officers, agents, servants,
`
`employees, attorneys, affiliates, divisions, subsidiaries, and those persons in active concert or
`
`participation with any of them from infringing the ’465 patent, or contributing to or inducing
`
`anyone to do the same, including the manufacture, use, offer to sell, sale, distribution, or
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`importation of any current or future versions of the product described in the Apotex ANDA;
`
`F.
`
`an order enjoining Apotex, its officers, agents, servants, employees,
`
`attorneys, affiliates, divisions, subsidiaries, and those persons in active concert or participation
`
`with any of them from infringing the ’465 patent, or contributing to or inducing anyone to do the
`
`same, including the manufacture, use, offer to sell, sale, distribution, or importation of any current
`
`or future versions of the product described in the Apotex ANDA;
`
`G.
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`an assessment of pre-judgment and post-judgment interest and costs against
`
`Apotex, together with an award of such interest and costs, in accordance with 35 U.S.C. § 284;
`
`H.
`
`an award to Vanda of its attorneys’ fees incurred in connection with this
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`lawsuit pursuant to 35 U.S.C. § 285; and
`
`I.
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`such other and further relief as this Court may deem just and proper.
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`11
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`MORRIS, NICHOLS, ARSHT & TUNNELL LLP
`
`/s/ Derek J. Fahnestock
`
`Karen Jacobs (#2881)
`Derek J. Fahnestock (#4705)
`1201 North Market Street
`P.O. Box 1347
`Wilmington, DE 19899
`(302) 658-9200
`kjacobs@morrisnichols.com
`dfahnestock@morrisnichols.com
`
`Attorneys for Plaintiff
`Vanda Pharmaceuticals Inc.
`
`OF COUNSEL:
`
`Nicholas Groombridge
`Eric Alan Stone
`Josephine Young
`Daniel J. Klein
`Jennifer Rea Deneault
`Michael F. Milea
`PAUL, WEISS, RIFKIND, WHARTON
`& GARRISON LLP
`1285 Avenue of the Americas
`New York, NY 10019
`(212) 373-3000
`
`February 24, 2021
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`12
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