Case 1:22-cv-00978-UNA Document 1 Filed 07/26/22 Page 1 of 17 PageID #: 1
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
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`HOPE MEDICAL ENTERPRISES, INC., d/b/a
`Hope Pharmaceuticals,
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`Plaintiff,
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`v.
`ACCORD HEALTHCARE, INC. and INTAS
`PHARMACEUTICALS LTD.,
`Defendants.
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`C.A. No. _______________________
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`COMPLAINT FOR PATENT INFRINGEMENT
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`Plaintiff Hope Medical Enterprises, Inc., d/b/a Hope Pharmaceuticals (“Hope” or
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`“Plaintiff”), by its attorneys, brings this complaint against Defendants Intas Pharmaceuticals Ltd.
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`(“Intas”) and Accord Healthcare, Inc. (“Accord” or, collectively with Intas, “Defendants”), and
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`hereby alleges as follows:
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`NATURE OF THE ACTION
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`1.
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`This is an action for patent infringement under the patent laws of the United States,
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`35 U.S.C. § 100, et seq., that arises out of Defendants’ submission of an Abbreviated New Drug
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`Application (“ANDA”) to the U.S. Food and Drug Administration (“FDA”) seeking approval to
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`commercially manufacture, use, offer for sale, sell, and/or import a purported generic version of
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`Hope’s Sodium Thiosulfate Injection, 250 mg/mL, prior to the expiration of U.S. Patent Nos.
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`8,496,973 (“the ’973 patent”); 9,345,724 (“the ’724 patent”); 9,585,912 (“the ’912 patent”); and
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`10,479,686 (“the ’686 patent”) (collectively, “the patents-in-suit”).
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`PARTIES
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`2.
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`Plaintiff Hope is a corporation organized and existing under the laws of the State
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`of Arizona, having a principal place of business at 16416 N. 92nd Street #125, Scottsdale, AZ
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`85260.
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`3.
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`On information and belief, Defendant Intas is a corporation organized and existing
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`under the laws of India, having a principal place of business at Near Sola Bridge, Sarkhej –
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`Gandhinagar Highway, Thaltej, Ahmedabad, Gujarat 380054, India. On information and belief,
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`Intas is in the business of, among other things, manufacturing, promoting, marketing, selling,
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`offering for sale, using, distributing, and importing into the United States, generic versions of
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`branded pharmaceutical drugs for the U.S. market.
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`4.
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`On information and belief, Defendant Accord is a wholly owned subsidiary of Intas,
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`and is a corporation organized and existing under the laws of the State of North Carolina, having
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`a principal place of business at 1009 Slater Road #210B, Durham, NC 27703. On information and
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`belief, Accord is in the business of, among other things, manufacturing, promoting, marketing,
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`selling, offering for sale, using, distributing, and importing into the United States, generic versions
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`of branded pharmaceutical drugs for the U.S. market.
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`HOPE’S SODIUM THIOSULFATE DRUG PRODUCT
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`5.
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`Hope is the holder of New Drug Application (“NDA”) No. 203923, under which
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`the FDA approved the commercial marketing of Hope’s Sodium Thiosulfate Injection, 250 mg/mL
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`(“Hope’s NDA Product” or “the NDA Product”) on February 14, 2012, under Section 505(b) of
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`the Federal Food, Drug, and Cosmetic Act (“FDCA”), 21 U.S.C. § 355(a), for sequential use with
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`sodium nitrite for the treatment of acute cyanide poisoning that is judged to be serious or life-
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`threatening. Hope commenced commercial sales of its Sodium Thiosulfate Injection for this
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`indication in 2012 and it is marketed in the United States for sequential use with sodium nitrite
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`and sold either as a standalone injection or as part of Hope’s Nithiodote® kits (in combination
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`with a sodium nitrite injection).
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`6.
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`Hope’s NDA Product is covered by one or more claims of the patents-in-suit.
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`Pursuant to 21 U.S.C. § 355(b)(1) and attendant FDA regulations, the patents-in-suit have been
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`listed in connection with NDA No. 203923 in the FDA’s Approved Drug Products with
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`Therapeutic Equivalence Evaluations (“Orange Book”).
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`ACCORD’S ANDA AND NOTICE OF PARAGRAPH IV CERTIFICATION
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`7.
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`By a letter dated June 13, 2022 (“Accord Notice Letter”), Accord notified Plaintiff
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`that Defendants had submitted to the FDA ANDA No. 217214 (“Accord’s ANDA”) describing a
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`purported generic version of a sodium thiosulfate injection USP, 12.5 grams/50 mL (250 mg/mL)
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`single-dose vial (“Accord ANDA Product”). Defendants seek FDA approval to engage in the
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`commercial manufacture, use, sale, offer for sale, and/or importation of the Accord ANDA Product
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`in or into the United States, including Delaware, prior to the expiration of the patents-in-suit.
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`8.
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`On information and belief, Defendants know and intend that upon approval of
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`Accord’s ANDA, Defendants will manufacture, promote, market, sell, offer for sale, import, use,
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`and/or distribute the Accord ANDA Product throughout the United States, including in Delaware.
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`9.
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`On information and belief, Defendants have submitted or caused the submission of
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`Accord’s ANDA to the FDA under 21 U.S.C. § 355(j) to obtain approval to engage in the
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`commercial manufacture, use, offer to sell, or sale within the United States or importation into the
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`United States of the Accord ANDA Product, as a purported generic version of Hope’s NDA
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`Product, prior to the expiration of the patents-in-suit.
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`10.
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`The Accord Notice Letter acknowledged that the Reference Listed Drug for
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`Accord’s ANDA is Hope’s NDA Product.
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`11.
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`By filing the ANDA, Defendants have represented to the FDA that Accord’s
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`ANDA Product is bioequivalent to Hope’s NDA Product.
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`12.
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`The Accord Notice Letter also notified Plaintiff that, as part of Accord’s ANDA,
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`Defendants had filed a purported Paragraph IV Certification pursuant to 21 U.S.C.
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`§ 355(j)(2)(B)(iv)(II), with respect to the ’973, ’724, and ’912 patents.
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`13.
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`On information and belief, Defendants submitted Accord’s ANDA to the FDA
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`containing certifications pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV) asserting that the claims of
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`the ’973, ’724, and ’912 patents are invalid, unenforceable, and/or will not be infringed by the
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`manufacture, use, offer for sale, sale, and/or importation of the Accord ANDA Product.
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`14.
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`On information and belief, Defendants, through their own actions and through the
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`actions of their agents, affiliates, and subsidiaries, prepared and submitted Accord’s ANDA, and
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`intend to further prosecute Accord’s ANDA. On information and belief, if the FDA approves
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`Accord’s ANDA, Defendants will manufacture, distribute, promote, market, use, offer for sale, or
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`sell the Accord ANDA Product within the United States, or will import the Accord ANDA Product
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`into the United States. On information and belief, if the FDA approves Accord’s ANDA,
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`Defendants, through their own actions and through the actions of their agents, affiliates, and
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`subsidiaries, will actively induce or contribute to the manufacture, distribution, promotion,
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`marketing, use, offer for sale, sale, or importation of the Accord ANDA Product in or into the
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`United States.
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`15.
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`Plaintiff brings this action within forty-five days of receipt of the Accord Notice
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`Letter. Accordingly, Plaintiff is entitled to a stay of FDA approval pursuant to 21 U.S.C.
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`§ 355(j)(5)(B)(iii).
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`herein.
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`JURISDICTION AND VENUE
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`16.
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`Plaintiff incorporates each of the preceding paragraphs 1–15 as if fully set forth
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`17.
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`This action arises under the patent laws of the United States, 35 U.S.C. §§ 100 et
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`seq., generally, including 35 U.S.C. § 271(e)(2). This Court has jurisdiction over the subject matter
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`of this action pursuant to 28 U.S.C. §§ 1331, 1338(a), 2201, and 2202.
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`18.
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`Venue is proper in this Court because, among other things, Accord, through its
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`counsel, has consented to jurisdiction and venue in Delaware for purposes of this action, prior to
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`the filing of this Complaint.
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`19. Moreover, Defendants have litigated previous Hatch-Waxman patent infringement
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`disputes in the District of Delaware and/or have consented to jurisdiction in Delaware in one or
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`more prior cases arising out of the filing of ANDAs. See, e.g., Purdue Pharma LP et al. v. Accord
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`Healthcare Inc. et al., C.A. No. 22-913 (D. Del.), D.I. 1 ¶¶ 17–18; Eagle Pharms. Inc. v. Accord
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`Healthcare Inc. et al., C.A. No. 22-704 (D. Del.), D.I. 11 ¶¶ 13–28; Otsuka Pharm. Co. et al. v.
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`Accord Healthcare, Inc., C.A. No. 19-1987-LPS (D. Del.), D.I. 9 ¶¶ 8, 9, 13; Novartis Pharms.
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`Corp. v. Accord Healthcare, Inc. et al., C.A. No. 18-1043-LPS (D. Del.), D.I. 46 ¶¶ 11–13, 216–
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`221; Biogen Int’l GmbH et al. v. Accord Healthcare Inc., C.A. No. 17-872-LPS (D. Del.), D.I. 8
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`¶¶ 1 [sic], 3 [sic]; Purdue Pharma LP et al. v. Accord Healthcare Inc. et al., C.A. No. 20-1362-
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`RGA (D. Del.), D.I. 14 ¶¶ 18–25.
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`20.
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`Defendants are subject to personal jurisdiction in Delaware because, among other
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`things, Defendants have purposely availed themselves of the benefits and protections of
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`Delaware’s laws such that they should reasonably anticipate being sued in this Court. On
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`information and belief, Defendants develop, manufacture, import, market, distribute, use, offer to
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`sell, and/or sell generic drugs throughout the United States, including in the State of Delaware,
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`and therefore transact business within the State of Delaware related to Plaintiff’s claims, and/or
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`have engaged in systematic and continuous business contacts within the State of Delaware.
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`21.
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`On information and belief, Defendants intend a future course of conduct that
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`includes acts of patent infringement in Delaware. These acts have led and will continue to lead to
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`foreseeable harm and injury to Hope in Delaware and this Judicial District.
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`22.
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`Defendants have committed an act of infringement in this judicial district by filing
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`ANDA No. 217214 with the intent to make, use, sell, offer for sale, and/or import the Accord
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`ANDA Product in or into this judicial district, prior to the expiration of the patents-in-suit.
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`23.
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`Defendants have taken the costly, significant step of applying to the FDA for
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`approval to engage in future activities, including the marketing of the Accord ANDA Product, that
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`will be purposefully directed at Delaware and elsewhere in the United States.
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`24.
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`On information and belief, Defendants have systematic and continuous contacts
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`with Delaware; have established distribution channels for drug products in Delaware; regularly
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`and continuously conduct business in Delaware, including by selling drug products in Delaware,
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`either directly or indirectly through their subsidiaries, agents, or affiliates; have purposefully
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`availed themselves of the privilege of doing business in Delaware; and derive substantial revenue
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`from the sale of drug products in Delaware.
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`25.
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`On information and belief, if Accord’s ANDA is approved, Defendants will
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`manufacture, market, promote, sell, offer for sale, import, use and/or distribute the Accord ANDA
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`Product within the United States, including in Delaware, consistent with Defendants’ practices for
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`the marketing and distribution of other generic pharmaceutical products. On information and
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`belief, Defendants regularly do business in Delaware, and their practices with other generic
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`pharmaceutical products have involved placing those products into the stream of commerce for
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`distribution throughout the United States, including in Delaware. On information and belief,
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`Defendants’ generic pharmaceutical products are used and/or consumed within and throughout the
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`United States, including in Delaware. On information and belief, the Accord ANDA Product will
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`be prescribed by physicians practicing in Delaware, dispensed by pharmacies located within
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`Delaware, and used by patients in Delaware. Each of these activities would have a substantial
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`effect within Delaware and would constitute infringement of the patents-in-suit in the event that
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`the Accord ANDA Product is approved before the patents-in-suit expire.
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`26.
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`On information and belief, Defendants derive substantial revenue from generic
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`pharmaceutical products that are used and/or consumed within Delaware, and that are
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`manufactured by Defendants and/or for which Defendants are the named applicant(s) on approved
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`ANDAs. On information and belief, various products for which Defendants are the named
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`applicant(s) on approved ANDAs are available at hospital and/or retail pharmacies in Delaware.
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`27.
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`On information and belief, Defendants have consented to (or not contested)
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`personal jurisdiction in this Judicial District in one or more prior cases arising out of the filing of
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`ANDAs, and/or have filed counterclaims in such cases. See, e.g., Purdue Pharma LP et al. v.
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`Accord Healthcare Inc. et al., C.A. No. 22-913 (D. Del.), D.I. 1 ¶¶ 17–18; Eagle Pharms. Inc. v.
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`Accord Healthcare Inc. et al., C.A. No. 22-704 (D. Del.), D.I. 11 ¶¶ 13–28; Otsuka Pharm. Co. et
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`al. v. Accord Healthcare, Inc., C.A. No. 19-1987-LPS (D. Del.), D.I. 9 ¶¶ 8, 9, 13; Novartis
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`Pharms. Corp. v. Accord Healthcare, Inc. et al., C.A. No. 18-1043-LPS (D. Del.), D.I. 46 ¶¶ 11–
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`13, 216–221; Biogen Int’l GmbH et al. v. Accord Healthcare Inc., C.A. No. 17-872-LPS (D. Del.),
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`D.I. 8 ¶¶ 1 [sic], 3 [sic]; Purdue Pharma LP et al. v. Accord Healthcare Inc. et al., C.A. No. 20-
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`1362-RGA (D. Del.), D.I. 14 ¶¶ 18–25.
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`28.
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`This Court has personal jurisdiction over Intas because, among other things, it: (1)
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`has purposefully availed itself of the privilege of doing business in Delaware, including directly
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`or indirectly through its subsidiary, Accord; and (2) maintains extensive and systematic contacts
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`with the State of Delaware, including through the marketing, distribution, and/or sale of generic
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`pharmaceutical drugs in Delaware, including through, directly or indirectly, Accord.
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`29.
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`In the alternative, this Court has personal jurisdiction over Intas because the
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`requirements of Federal Rule of Civil Procedure 4(k)(2) are met as (a) Hope’s claims arise under
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`federal law; (b) Intas is a foreign defendant not subject to general personal jurisdiction in the courts
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`of any state; and (c) Intas has sufficient contacts with the United States as a whole, including, but
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`not limited to, preparing and submitting ANDAs to the FDA and/or manufacturing, importing,
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`offering to sell, and/or selling pharmaceutical products that are distributed throughout the United
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`States, such that this Court’s exercise of jurisdiction over Intas satisfies due process.
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`30.
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`On information and belief, Defendants work in privity and/or concert either directly
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`or indirectly through one or more of their wholly owned subsidiaries with respect to the regulatory
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`approval, manufacturing, use, importation, marketing, offer for sale, sale, and distribution of
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`generic pharmaceutical products throughout the United States, including in this Judicial District.
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`31.
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`On information and belief, each of the Defendants participated, directly or
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`indirectly, in the preparation and/or submission of Accord’s ANDA. On information and belief,
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`Defendants will work in privity and/or concert with each other and/or other related entities towards
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`the regulatory approval, manufacturing, use, importation, marketing, offer for sale, sale, and
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`distribution of generic pharmaceutical products, including Accord’s ANDA Product, throughout
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`the United States, including in Delaware and in this Judicial District, prior to the expiration of the
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`patents-in-suit.
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`32.
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`On information and belief, Intas intends to benefit directly if Accord’s ANDA is
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`approved by participating in the manufacture, importation, distribution, and/or sale of the generic
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`drug products that are the subject of Accord’s ANDA.
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`33.
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`Venue is proper in this Judicial District pursuant to 28 U.S.C. §§ 1391 and/or
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`1400(b).
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`34.
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`On information and belief, Defendants have consented to (or not contested) venue
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`in this Judicial District in one or more prior cases arising out of the filing of ANDAs, and/or have
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`filed counterclaims in such cases. See, e.g., Purdue Pharma LP et al. v. Accord Healthcare Inc.
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`et al., C.A. No. 22-913 (D. Del.), D.I. 1 ¶¶ 17–18; Eagle Pharms. Inc. v. Accord Healthcare Inc.
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`et al., C.A. No. 22-704 (D. Del.), D.I. 11 ¶¶ 13–28; Otsuka Pharm. Co. et al. v. Accord Healthcare,
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`Inc., C.A. No. 19-1987-LPS (D. Del.), D.I. 9 ¶¶ 8, 9, 13; Novartis Pharms. Corp. v. Accord
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`Healthcare, Inc. et al., C.A. No. 18-1043-LPS (D. Del.), D.I. 46 ¶¶ 11–13, 216–221; Biogen Int’l
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`GmbH et al. v. Accord Healthcare Inc., C.A. No. 17-872-LPS (D. Del.), D.I. 8 ¶¶ 1 [sic], 3 [sic];
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`Purdue Pharma LP et al. v. Accord Healthcare Inc. et al., C.A. No. 20-1362-RGA (D. Del.), D.I.
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`14 ¶¶ 18–25.
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`35.
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`Venue is also proper in this Judicial District with respect to Intas because, upon
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`information and belief, Intas is a foreign corporation that may be sued in any judicial district where
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`it is subject to the personal jurisdiction of the Court.
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`THE PATENTS-IN-SUIT
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`36.
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`The
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`’973 patent,
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`titled “Sodium Thiosulfate-Containing Pharmaceutical
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`Compositions” was duly and legally issued on July 30, 2013 (attached as Exhibit A). Plaintiff
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`Hope is the owner of all right, title, and interest in, and has all the rights to enforce, the ’973 patent.
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`37.
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`The ’973 patent is listed in the Orange Book in conjunction with Hope’s NDA
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`Product.
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`38.
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`The
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`’724 patent,
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`titled “Sodium Thiosulfate-Containing Pharmaceutical
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`Compositions” was duly and legally issued on May 24, 2016 (attached as Exhibit B). Plaintiff
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`Hope is the owner of all right, title, and interest in, and has all the rights to enforce, the ’724 patent.
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`39.
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`The ’724 patent is listed in the Orange Book in conjunction with Hope’s NDA
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`Product.
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`40.
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`The
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`’912 patent,
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`titled “Sodium Thiosulfate-Containing Pharmaceutical
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`Compositions” was duly and legally issued on March 7, 2017 (attached as Exhibit C). Plaintiff
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`Hope is the owner of all right, title, and interest in, and has all the rights to enforce, the ’912 patent.
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`41.
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`The ’912 patent is listed in the Orange Book in conjunction with Hope’s NDA
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`Product.
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`42.
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`The
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`’686 patent,
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`titled “Sodium Thiosulfate-Containing Pharmaceutical
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`Compositions” was duly and legally issued on November 19, 2019 (attached as Exhibit D).
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`Plaintiff Hope is the owner of all right, title, and interest in, and has all the rights to enforce, the
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`’686 patent.
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`43.
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`The ’686 patent is listed in the Orange Book in conjunction with Hope’s NDA
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`Product.
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`COUNT I – INFRINGEMENT OF THE ’973 PATENT
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`44.
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`Plaintiff incorporates each of the preceding paragraphs 1–43 as if fully set forth
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`herein.
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`45.
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`Defendants’ submission of Accord’s ANDA, with the accompanying Paragraph IV
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`Certification and notice to Hope of same, to engage in the commercial manufacture, sale, offer for
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`sale, or importation into the United States of Accord’s ANDA Product, prior to the expiration of
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`the ’973 patent, constitutes infringement of one or more claims of that patent under 35 U.S.C.
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`§ 271(e)(2)(A) by Defendants.
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`46.
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`There is a justiciable controversy between the parties hereto as to the infringement
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`of the ’973 patent.
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`47.
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`Unless enjoined by this Court, upon FDA approval of Accord’s ANDA, Defendants
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`will infringe one or more claims of the ’973 patent under 35 U.S.C. § 271(a) by making, using,
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`offering to sell, selling, and/or importing Accord’s ANDA Product in the United States.
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`48.
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`Unless enjoined by this Court, upon FDA approval of Accord’s ANDA, Defendants
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`will induce infringement of one or more claims of the ’973 patent under 35 U.S.C. § 271(b) by
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`making, using, offering to sell, selling, and/or importing Accord’s ANDA Product in the United
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`States. On information and belief, upon FDA approval of Accord’s ANDA, Defendants will
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`intentionally encourage acts of direct infringement with knowledge of the ’973 patent and
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`knowledge that their acts are encouraging infringement.
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`49.
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`Unless enjoined by this Court, upon FDA approval of Accord’s ANDA, Defendants
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`will contributorily infringe one or more claims of the ’973 patent under 35 U.S.C. § 271(c) by
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`making, using, offering to sell, selling, and/or importing Accord’s ANDA Product in the United
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`States. On information and belief, Defendants have had and continue to have knowledge that
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`Accord’s ANDA Product is especially adapted for a use that infringes one or more claims of the
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`’973 patent and that there is no substantial non-infringing use for Accord’s ANDA Product.
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`50.
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`Plaintiff will be substantially and irreparably damaged and harmed if Defendants’
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`infringement of the ’973 patent is not enjoined.
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`51.
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`Plaintiff does not have an adequate remedy at law.
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`COUNT II – INFRINGEMENT OF THE ’724 PATENT
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`52.
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`Plaintiff incorporates each of the preceding paragraphs 1–51 as if fully set forth
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`herein.
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`53.
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`Defendants’ submission of Accord’s ANDA, with the accompanying Paragraph IV
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`Certification and notice to Hope of same, to engage in the commercial manufacture, sale, offer for
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`sale, or importation into the United States of Accord’s ANDA Product, prior to the expiration of
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`the ’724 patent, constitutes infringement of one or more claims of that patent under 35 U.S.C.
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`§ 271(e)(2)(A) by Defendants.
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`54.
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`There is a justiciable controversy between the parties hereto as to the infringement
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`of the ’724 patent.
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`55.
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`Unless enjoined by this Court, upon FDA approval of Accord’s ANDA, Defendants
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`will infringe one or more claims of the ’724 patent under 35 U.S.C. § 271(a) by making, using,
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`offering to sell, selling, and/or importing Accord’s ANDA Product in the United States.
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`56.
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`Unless enjoined by this Court, upon FDA approval of Accord’s ANDA, Defendants
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`will induce infringement of one or more claims of the ’724 patent under 35 U.S.C. § 271(b) by
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`making, using, offering to sell, selling, and/or importing Accord’s ANDA Product in the United
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`States. On information and belief, upon FDA approval of Accord’s ANDA, Defendants will
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`intentionally encourage acts of direct infringement with knowledge of the ’724 patent and
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`knowledge that their acts are encouraging infringement.
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`57.
`
`Unless enjoined by this Court, upon FDA approval of Accord’s ANDA, Defendants
`
`will contributorily infringe one or more claims of the ’724 patent under 35 U.S.C. § 271(c) by
`
`making, using, offering to sell, selling, and/or importing Accord’s ANDA Product in the United
`
`States. On information and belief, Defendants have had and continue to have knowledge that
`
`Accord’s ANDA Product is especially adapted for a use that infringes one or more claims of the
`
`’724 patent and that there is no substantial non-infringing use for Accord’s ANDA Product.
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`{01823749;v1 }
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`Case 1:22-cv-00978-UNA Document 1 Filed 07/26/22 Page 13 of 17 PageID #: 13
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`
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`58.
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`Plaintiff will be substantially and irreparably damaged and harmed if Defendants’
`
`infringement of the ’724 patent is not enjoined.
`
`59.
`
`Plaintiff does not have an adequate remedy at law.
`
`COUNT III – INFRINGEMENT OF THE ’912 PATENT
`
`60.
`
`Plaintiff incorporates each of the preceding paragraphs 1–59 as if fully set forth
`
`herein.
`
`61.
`
`Defendants’ submission of Accord’s ANDA, with the accompanying Paragraph IV
`
`Certification and notice to Hope of same, to engage in the commercial manufacture, sale, offer for
`
`sale, or importation into the United States of Accord’s ANDA Product, prior to the expiration of
`
`the ’912 patent, constitutes infringement of one or more claims of that patent under 35 U.S.C.
`
`§ 271(e)(2)(A) by Defendants.
`
`62.
`
`There is a justiciable controversy between the parties hereto as to the infringement
`
`of the ’912 patent.
`
`63.
`
`Unless enjoined by this Court, upon FDA approval of Accord’s ANDA, Defendants
`
`will infringe one or more claims of the ’912 patent under 35 U.S.C. § 271(a) by making, using,
`
`offering to sell, selling, and/or importing Accord’s ANDA Product in the United States.
`
`64.
`
`Unless enjoined by this Court, upon FDA approval of Accord’s ANDA, Defendants
`
`will induce infringement of one or more claims of the ’912 patent under 35 U.S.C. § 271(b) by
`
`making, using, offering to sell, selling, and/or importing Accord’s ANDA Product in the United
`
`States. On information and belief, upon FDA approval of Accord’s ANDA, Defendants will
`
`intentionally encourage acts of direct infringement with knowledge of the ’912 patent and
`
`knowledge that their acts are encouraging infringement.
`
`65.
`
`Unless enjoined by this Court, upon FDA approval of Accord’s ANDA, Defendants
`
`will contributorily infringe one or more claims of the ’912 patent under 35 U.S.C. § 271(c) by
`
`{01823749;v1 }
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`Case 1:22-cv-00978-UNA Document 1 Filed 07/26/22 Page 14 of 17 PageID #: 14
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`
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`making, using, offering to sell, selling, and/or importing Accord’s ANDA Product in the United
`
`States. On information and belief, Defendants have had and continue to have knowledge that
`
`Accord’s ANDA Product is especially adapted for a use that infringes one or more claims of the
`
`’912 patent and that there is no substantial non-infringing use for Accord’s ANDA Product.
`
`66.
`
`Plaintiff will be substantially and irreparably damaged and harmed if Defendants’
`
`infringement of the ’912 patent is not enjoined.
`
`67.
`
`Plaintiff does not have an adequate remedy at law.
`
`COUNT IV – INFRINGEMENT OF THE ’686 PATENT
`
`68.
`
`Plaintiff incorporates each of the preceding paragraphs 1–67 as if fully set forth
`
`herein.
`
`69.
`
`Defendants’ submission of Accord’s ANDA to engage in the commercial
`
`manufacture, sale, offer for sale, or importation into the United States of Accord’s ANDA Product,
`
`prior to the expiration of the ’686 patent, constitutes infringement of one or more claims of that
`
`patent under 35 U.S.C. § 271(e)(2)(A) by Defendants.
`
`70.
`
`There is a justiciable controversy between the parties hereto as to the infringement
`
`of the ’686 patent.
`
`71.
`
`Unless enjoined by this Court, upon FDA approval of Accord’s ANDA, Defendants
`
`will infringe one or more claims of the ’686 patent under 35 U.S.C. § 271(a) by making, using,
`
`offering to sell, selling, and/or importing Accord’s ANDA Product in the United States.
`
`72.
`
`Unless enjoined by this Court, upon FDA approval of Accord’s ANDA, Defendants
`
`will induce infringement of one or more claims of the ’686 patent under 35 U.S.C. § 271(b) by
`
`making, using, offering to sell, selling, and/or importing Accord’s ANDA Product in the United
`
`States. On information and belief, upon FDA approval of Accord’s ANDA, Defendants will
`
`{01823749;v1 }
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`Case 1:22-cv-00978-UNA Document 1 Filed 07/26/22 Page 15 of 17 PageID #: 15
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`
`
`intentionally encourage acts of direct infringement with knowledge of the ’686 patent and
`
`knowledge that their acts are encouraging infringement.
`
`73.
`
`Unless enjoined by this Court, upon FDA approval of Accord’s ANDA, Defendants
`
`will contributorily infringe one or more claims of the ’686 patent under 35 U.S.C. § 271(c) by
`
`making, using, offering to sell, selling, and/or importing Accord’s ANDA Product in the United
`
`States. On information and belief, Defendants have had and continue to have knowledge that
`
`Accord’s ANDA Product is especially adapted for a use that infringes one or more claims of the
`
`’686 patent and that there is no substantial non-infringing use for Accord’s ANDA Product.
`
`74.
`
`Plaintiff will be substantially and irreparably damaged and harmed if Defendants’
`
`infringement of the ’686 patent is not enjoined.
`
`75.
`
`Plaintiff does not have an adequate remedy at law.
`
`PRAYER FOR RELIEF
`
`WHEREFORE, Plaintiff Hope respectfully requests the following relief:
`
`(a)
`
`A Judgment that Defendants have infringed the patents-in-suit by submitting
`
`ANDA No. 217214 with the accompanying Paragraph IV Certification and notice to Hope of same;
`
`(b)
`
`A Judgment that Defendants have infringed, and that Defendants’ making, using,
`
`selling, offering to sell, or importing Accord’s ANDA Product would infringe one or more claims
`
`of the patents-in-suit;
`
`(c)
`
`An Order that the effective date of FDA approval of ANDA No. 217214 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 Hope is or becomes entitled;
`
`(d)
`
`Preliminary and permanent injunctions enjoining Defendants and their officers,
`
`agents, attorneys and employees, and those acting in privity and/or concert with them, from
`
`making, using, offering to sell, selling, or importing Accord’s ANDA Product until after the
`
`{01823749;v1 }
`
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`Case 1:22-cv-00978-UNA Document 1 Filed 07/26/22 Page 16 of 17 PageID #: 16
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`
`
`expiration of the patents-in-suit, or any later expiration of exclusivity to which Hope is or becomes
`
`entitled;
`
`(e)
`
`A permanent injunction, pursuant to 35 U.S.C. § 271(e)(4)(B), restraining and
`
`enjoining Defendants, their officers, agents, attorneys and employees, and those acting in privity
`
`and/or concert with them, from practicing 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 Hope is or becomes entitled;
`
`(f)
`
`A Judgment that the commercial manufacture, use, offer for sale, sale, and/or
`
`importation into the United States of Accord’s ANDA Product would directly infringe, induce
`
`and/or contribute to infringement of the patents-in-suit;
`
`(g)
`
`To the extent that Defendants, their officers, agents, attorneys and/or employees, or
`
`those acting in privity and/or concert with them, have committed any acts of infringement of the
`
`patents-in-suit, other than those acts expressly exempted by 35 U.S.C. § 271(e)(1), a Judgment
`
`awarding Hope damages for such acts;
`
`(h)
`
`If Defendants, their officers, agents, attorneys and/or employees, or those acting in
`
`privity and/or concert with them, engage in the commercial manufacture, use, offer for sale, sale,
`
`and/or importation into the United States of Accord’s ANDA Product prior to the expiration of the
`
`patents-in-suit, a Judgment awarding damages to Hope resulting from such infringement, together
`
`with interest;
`
`(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 Hope its attorneys’ fees incurred in this action;
`
`(k)
`
`A Judgment awarding Hope its costs and expenses incurred in this action; and
`
`{01823749;v1 }
`
`-16-
`
`

`

`Case 1:22-cv-00978-UNA Document 1 Filed 07/26/22 Page 17 of 17 PageID #: 17
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`
`
`(l)
`
`Such further and other relief as this Court may deem just and proper.
`
`ASHBY & GEDDES
`
`/s/ John G. Day
`
`John G. Day (#2403)
`Andrew C. Mayo (#5207)
`500 Delaware Avenue, 8th Floor
`P.O. Box 1150
`Wilmington, DE 19899
`(302) 654-1888
`jday@ashbygeddes.com
`amayo@ashbygeddes.com
`
`Attorneys for Hope Medical Enterprises, Inc.
`d/b/a Hope Pharmaceuticals
`
`
`
`
`
`
`
`
`
`
`
`Of Counsel:
`
`Matthew J. Hertko
`Collin J. Kurtenbach
`JONES DAY
`110 North Wacker Drive, Suite 4800
`Chicago, Illinois 60606
`(312) 782-3939
`
`Anthony M. Insogna
`S. Christian Platt
`Meredith A. Stewart
`JONES DAY
`4655 Executive Drive, Suite 1500
`San Diego, California 92121-3134
`(858) 314-1200
`
`Christopher A. Buxton
`JONES DAY
`2727 North Harwood Street, Suite 500
`Dallas, Texas 75