Case 1:22-cv-00974-UNA Document 1 Filed 07/25/22 Page 1 of 11 PageID #: 1
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
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`MERCK KGaA and MERCK SERONO SA,
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`Plaintiffs,
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`C.A. No. ____________
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`COMPLAINT
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`)))))))
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`v.
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`ACCORD HEALTHCARE, INC. and
`INTAS PHARMACEUTICALS LTD.,
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`Defendants.
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`Plaintiffs Merck KGaA and Merck Serono SA (collectively, “Merck” or “Plaintiffs”), by
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`their attorneys, hereby allege 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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`Title 35, United States Code, that arises out of the submission by Defendant Accord Healthcare,
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`Inc. of Abbreviated New Drug Application (“ANDA”) No. 216813 to the U.S. Food and Drug
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`Administration (“FDA”) seeking approval to manufacture and sell a generic version of Merck’s
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`MAVENCLAD® product prior to the expiration of U.S. Patent Nos. 7,713,947 and 8,377,903.
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`PARTIES
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`1.
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`Plaintiff Merck KGaA is a German corporation having a principal place of business
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`at Frankfurter Str. 250, 64293 Darmstadt, Hessen, Germany.1
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`2.
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`Plaintiff Merck Serono SA is a Swiss corporation having a principal place of
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`business at Rue de l’Ouriette, 151, Zone industrielle de l’Ouriettaz, Aubonne 1170, Switzerland.
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`Merck Serono SA is a wholly owned-subsidiary of Plaintiff Merck KGaA.
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`In the United States, Plaintiff Merck KGaA conducts business under the name “Merck
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`KGaA, Darmstadt, Germany.”
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`3.
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`On information and belief, Defendant Accord Healthcare, Inc. (“Accord
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`Healthcare”) is a corporation organized and existing under the laws of the State of North Carolina,
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`with its principal place of business at 1009 Slater Road, Suite 210 B, Durham, North Carolina,
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`27703.
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`4.
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`On information and belief, Defendant Intas Pharmaceuticals Ltd. (“Intas”) is a
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`corporation organized under the laws of India, with its principal place of business at Corporate
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`House, Near Sola Bridge, S. G. Highway, Thaltej, Ahmedabad – 380054, Gujarat, India.
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`5.
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`On information and belief, Accord Healthcare is a wholly-owned subsidiary of
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`Intas, and is controlled and/or dominated by Intas.
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`6.
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`On information and belief, Intas’s business includes manufacturing, marketing,
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`distributing, offering for sale, and selling generic drug products. As a part of this business, on
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`information and belief, Accord Healthcare, in concert with Intas, submits ANDAs to the FDA
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`seeking approval to engage in the commercial manufacture, use, offering for sale, sale, and/or
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`importation of generic versions of drug products covered by United States patents.
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`7.
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`On information and belief, Accord Healthcare and Intas acted in concert to prepare
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`and submit ANDA No. 216813 for Accord Healthcare’s cladribine 10 mg tablets (the “Accord
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`ANDA Product”). On information and belief, ANDA No. 216813 was submitted at the direction
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`of, under the control of, and for the direct benefit of, Intas.
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`8.
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`On information and belief, Accord Healthcare and Intas are agents of each other,
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`operate in concert as integrated parts of the same business group, and/or enter into agreements
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`with each other that are nearer than arm’s length. On information and belief, these agreements
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`include developing, obtaining regulatory approval for, marketing, selling, offering for sale, and
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`2
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`distributing generic pharmaceutical products throughout the United States, including in Delaware,
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`and including with respect to the Accord ANDA Product.
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`9.
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`On information and belief, following any FDA approval of ANDA No. 216813,
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`Accord Healthcare and Intas will act in concert to market, distribute, offer for sale, and/or sell the
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`Accord ANDA Product throughout the United States including in Delaware.
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`10.
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`Hereinafter, Accord Healthcare and Intas are collectively referred to as “Accord”
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`or “Defendants.”
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`JURISDICTION AND VENUE
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`11.
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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., and this Court has jurisdiction over the subject matter of this action under 28 U.S.C. §§ 1331,
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`1338(a), 2201, and 2202.
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`12.
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`Venue is proper in this Court under 28 U.S.C. § 1391 and 28 U.S.C. § 1400(b), and
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`this Court has personal jurisdiction over Accord Healthcare and Intas. Accord Healthcare, through
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`its counsel, by e-mail dated July 6, 2022, agreed that it does not contest personal jurisdiction or
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`venue in this Court in this matter. Intas is a foreign corporation not residing in any United States
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`district and, thus, may be sued in any judicial district. See 28 U.S.C. § 1391(c).
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`13. Moreover, this Court has personal jurisdiction over Accord Healthcare and Intas
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`because, on information and belief, Accord Healthcare and Intas, acting in concert with one
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`another, have engaged in continuous and systematic contacts with the State of Delaware and/or
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`purposefully availed themselves of this forum by, among other things, making, marketing,
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`shipping, using, offering to sell or selling, or causing others to use, offer to sell, or sell,
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`pharmaceutical products in Delaware, and deriving substantial revenue from such activities.
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`14.
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`On information and belief, Accord Healthcare and Intas, acting in concert with one
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`another, have purposefully conducted business in the State of Delaware and continue to conduct
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`business in Delaware, and Delaware is a likely destination of Accord’s products, including its
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`proposed generic version of MAVENCLAD® that is at issue in this action.
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`15.
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`On information and belief, upon approval of ANDA No. 216813, Accord
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`Healthcare, acting in concert with and/or on behalf of Intas, will market and sell the Accord ANDA
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`Product in Delaware and throughout the United States and will derive substantial revenue
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`therefrom.
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`16.
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`On information and belief, upon approval of Accord’s ANDA No. 216813, Accord
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`Healthcare and Intas will place the Accord ANDA Product into the stream of commerce with the
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`expectation or knowledge and the intent that such product will be purchased and used by
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`consumers in Delaware and throughout the United States.
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`17.
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`Accord Healthcare and Intas have consented to jurisdiction in the District of
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`Delaware in multiple previous cases. See, e.g., Eagle Pharmaceuticals, Inc. v. Accord Healthcare,
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`Inc. et al., C.A. No. 22-704; Teva Pharmaceuticals Int’l GmbH et al., v. Accord Healthcare, Inc.
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`et al., C.A. No. 21-952; Merck Sharp & Dohme Corp. v. Accord Healthcare, Inc. et al., C.A. No.
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`19-2192; Amgen Inc. v. Accord Healthcare, Inc. et al., C.A. No. 18-956.
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`PATENTS-IN-SUIT
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`18.
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`United States Patent No. 7,713,947 (“the ’947 patent”), entitled “Cladribine
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`Regimen for Treating Multiple Sclerosis” (attached as Exhibit A), was duly and legally issued on
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`May 10, 2010.
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`19.
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`United States Patent No. 8,377,903 (“the ’903 patent”), entitled “Cladribine
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`Regimen for Treating Multiple Sclerosis” (attached as Exhibit B), was duly and legally issued on
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`February 19, 2013.
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`20.
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`The ’947 and ’903 patents are owned by Merck Serono SA. The claims of the ’947
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`and ’903 patents are valid, enforceable, and not expired.
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`MERCK’S MAVENCLAD® PRODUCT
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`21.
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`EMD Serono, Inc. holds New Drug Application (“NDA”) No. 022561, which the
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`FDA approved on March 29, 2019 for the marketing and sale of 10 mg strength cladribine tablets.
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`EMD Serono, Inc. markets 10 mg strength cladribine tablets in the United States under the trade
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`name “MAVENCLAD®.” EMD Serono, Inc. is a wholly-owned subsidiary of Merck KGaA.
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`22. MAVENCLAD® is a purine antimetabolite. It is approved by the FDA for the
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`treatment of relapsing forms of multiple sclerosis, including relapsing-remitting disease and active
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`secondary progressive disease, in adults. A copy of the complete prescribing information for
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`MAVENCLAD® is attached as Exhibit C.
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`23.
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`The FDA’s official publication of approved drugs (the “Orange Book”) includes
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`MAVENCLAD®. The Orange Book lists the ’947 and ’903 patents as patents covering
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`MAVENCLAD® and its use.
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`INFRINGEMENT BY ACCORD
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`24.
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`By letter dated June 13, 2022, Accord notified Merck that it had submitted to the
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`FDA ANDA No. 216813 seeking approval to market and sell the Accord ANDA Product in the
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`United States prior to the expiration of the ’947 and ’903 patents.
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`25.
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`By submitting ANDA No. 216813, Accord has represented to the FDA that the
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`Accord ANDA Product has the same active ingredient as MAVENCLAD®, has the same dosage
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`forms and strengths as MAVENCLAD®, and is bioequivalent to MAVENCLAD®.
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`26.
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`On information and belief, Accord is seeking approval to market the Accord ANDA
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`Product for the same approved indication as MAVENCLAD®.
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`27.
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`In the Notice Letter, Accord stated that its ANDA included certifications pursuant
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`to 21 U.S.C. § 355(j)(2)(vii)(IV) with respect to the ’947 and ’903 patents, and alleged that these
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`patents are invalid. The Notice Letter did not substantively dispute the infringement of any claim
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`of the ’947 and ’903 patents. The Notice Letter demonstrates that Accord seeks approval to engage
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`in the commercial manufacture, use, offer for sale, sale, or importation of the Accord ANDA
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`Product before the ’947 and ’903 patents expire.
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`28.
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`Prior to filing this Complaint, Counsel for Merck obtained and reviewed portions
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`of ANDA No. 216813 produced by Accord pursuant to an agreed Offer of Confidential Access.
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`29.
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`This action is being commenced before the expiration of forty-five days from the
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`date of Merck’s receipt of the Notice Letter.
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`COUNT I
`INFRINGEMENT OF U.S. PATENT NO. 7,713,947
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`30.
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`Plaintiffs incorporate each of the preceding paragraphs 1-29 as if fully set forth
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`herein.
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`31.
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`Accord’s submission of ANDA No. 216813 to the FDA for the purpose of obtaining
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`approval to engage in the commercial importation, manufacture, use, offer for sale, and/or sale of
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`the Accord ANDA Product in the United States before the expiration of the ’947 patent was an act
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`of infringement of the ’947 patent under 35 U.S.C. § 271(e)(2).
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`32.
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`The commercial manufacture, use, offer for sale, sale and/or importation of the
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`Accord ANDA Product in the United States would infringe one or more claims of the ’947 patent
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`under 35 U.S.C. § 271(a), (b) and/or (c), either literally or under the doctrine of equivalents. The
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`infringed claims of the ’947 patent include at least claims 36, 38, 39, and 41-46. Such infringement
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`is imminent because, among other things, Accord has notified Merck of the submission of its
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`ANDA seeking approval to engage in the commercial manufacture, use, offer for sale, sale, and/or
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`importation of the Accord ANDA Product before the expiration of the ’947 patent. In the Notice
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`Letter, Accord has not substantively contested the infringement of any claim of the ’947 patent.
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`33.
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`Accord had knowledge of the ’947 patent prior to submitting its ANDA to the FDA,
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`as demonstrated by Accord’s 21 U.S.C. § 355(j)(2)(vii)(IV) allegation with respect to the
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`’947 patent.
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`34.
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`On information and belief, use of the Accord ANDA Product in accordance with
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`and as directed by Accord’s proposed labeling for that product would infringe one or more claims
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`of the ’947 patent.
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`35.
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`On information and belief, Accord intends to engage in the manufacture, use, offer
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`for sale, sale, and/or importation of the Accord ANDA Product with its proposed labeling
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`immediately and imminently upon approval of ANDA No. 216813.
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`36.
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`On information and belief, Accord will infringe and will actively induce or
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`contribute to the infringement of the ’947 patent when ANDA No. 216813 is approved, and plans
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`and intends to, and will do so upon approval.
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`37.
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`A substantial and justiciable controversy exists between the parties hereto as to the
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`infringement of the ’947 patent.
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`38.
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`Pursuant to 28 U.S.C. § 2201, Merck is entitled to a declaratory judgment that
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`Accord’s making, using, offering to sell, selling, and/or importing the Accord ANDA Product, and
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`inducement thereof or contribution thereto, will infringe the ’947 patent pursuant to 35 U.S.C.
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`§§ 271(a), (b), and/or (c).
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`39.
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`On information and belief, Accord acted without a reasonable basis for believing
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`that it would not be liable for infringing the ’947 patent and/or actively inducing or contributing
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`to the infringement of the ’947 patent.
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`40.
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`Unless Accord is enjoined from infringing the ’947 patent and/or actively inducing
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`or contributing to the infringement of the ’947 patent, Plaintiffs will suffer irreparable injury.
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`Plaintiffs have no adequate remedy at law.
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`COUNT II
`INFRINGEMENT OF U.S. PATENT NO. 8,377,903
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`41.
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`Plaintiffs incorporate each of the preceding paragraphs 1-40 as if fully set forth
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`herein.
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`42.
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`Accord’s submission of ANDA No. 216813 to the FDA for the purpose of obtaining
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`approval to engage in the commercial importation, manufacture, use, offer for sale, and/or sale of
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`the Accord ANDA Product in the United States before the expiration of the ’903 patent was an act
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`of infringement of the ’903 patent under 35 U.S.C. § 271(e)(2).
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`43.
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`The commercial manufacture, use, offer for sale, sale and/or importation of the
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`Accord ANDA Product in the United States would infringe one or more claims of the ’903 patent
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`under 35 U.S.C. § 271(a), (b) and/or (c), either literally or under the doctrine of equivalents. The
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`infringed claims of the ’903 patent include at least claims 17, 19, 20, and 22-27. Such infringement
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`is imminent because, among other things, Accord has notified Merck of the submission of its
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`ANDA seeking approval to engage in the commercial manufacture, use, offer for sale, sale, and/or
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`importation of the Accord ANDA Product before the expiration of the ’903 patent. In the Notice
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`Letter, Accord has not substantively contested the infringement of any claim of the ’903 patent.
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`44.
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`Accord had knowledge of the ’903 patent prior to submitting its ANDA to the FDA,
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`as demonstrated by Accord’s 21 U.S.C. § 355(j)(2)(vii)(IV) allegation with respect to the
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`’903 patent.
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`45.
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`On information and belief, use of the Accord ANDA Product in accordance with
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`and as directed by Accord’s proposed labeling for that product would infringe one or more claims
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`of the ’903 patent.
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`46.
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`On information and belief, Accord intends to engage in the manufacture, use, offer
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`for sale, sale, and/or importation of the Accord ANDA Product with its proposed labeling
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`immediately and imminently upon approval of ANDA No. 216813.
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`47.
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`On information and belief, Accord will infringe and will actively induce or
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`contribute to the infringement of the ’903 patent when ANDA No. 216813 is approved, and plans
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`and intends to, and will do so upon approval.
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`48.
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`A substantial and justiciable controversy exists between the parties hereto as to the
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`infringement of the ’903 patent.
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`49.
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`Pursuant to 28 U.S.C. § 2201, Merck is entitled to a declaratory judgment that
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`Accord’s making, using, offering to sell, selling, and/or importing the Accord ANDA Product, and
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`inducement thereof or contribution thereto, will infringe the ’903 patent pursuant to 35 U.S.C.
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`§§ 271(a), (b), and/or (c).
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`50.
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`On information and belief, Accord acted without a reasonable basis for believing
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`that it would not be liable for infringing the ’903 patent and/or actively inducing or contributing
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`to the infringement of the ’903 patent.
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`51.
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`Unless Accord is enjoined from infringing the ’903 patent and/or actively inducing
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`or contributing to the infringement of the ’903 patent, Plaintiffs will suffer irreparable injury.
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`Plaintiffs have no adequate remedy at law.
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`PRAYER FOR RELIEF
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`WHEREFORE, Plaintiffs pray that this Court grant the following relief:
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`(a)
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`A judgment that Accord’s submission of ANDA No. 216813 to the FDA was an
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`act of infringement of the claims of the ’947 and ’903 patents, and that Accord’s manufacture, use,
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`offer to sell, sale, or importation of the Accord ANDA Product in or into the United States prior
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`to the expiration of the ’947 and ’903 patents, will infringe and/or actively induce or contribute to
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`the infringement of the claims of the ’947 and ’903 patents;
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`(b)
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`An Order pursuant to 35 U.S.C. § 271(e)(4)(A) providing that the effective date of
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`any FDA approval of Accord’s ANDA No. 216813, shall not be earlier than the later expiration
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`date of the ’947 and ’903 patents, including any extensions and/or additional periods of exclusivity
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`to which Plaintiffs are or become entitled;
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`(c)
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`A declaratory judgment that Accord’s manufacture, use, offer to sell, sale, or
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`importation, including inducement thereof and contribution thereto, of the Accord ANDA Product
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`prior to the expiration of the ’947 and ’903 patents, would infringe the claims of the ’947 and ’903
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`patents, either literally or under the doctrine of equivalents, under 35 U.S.C. § 271(a), (b), and/or
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`(c);
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`(d)
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`An Order permanently enjoining Accord, and its affiliates and subsidiaries, and
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`each of their officers, agents, servants, and employees, from making, having made, using, offering
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`to sell, selling, marketing, distributing, or importing in or into the United States the Accord ANDA
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`Product, or any product or compound that infringes the ’947 and ’903 patents, or inducing the
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`infringement of the ’947 and ’903 patents until after the later expiration date of the ’947 and ’903
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`patents, including any extension and/or additional periods of exclusivity to which Merck is or
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`becomes entitled.
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`(e)
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`A declaration that this is an exceptional case and an award of attorneys’ fees to
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`Plaintiffs pursuant to 35 U.S.C. §§ 285 and 271(e)(4), together with reasonable costs; and
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`Such further and other relief as this Court deems proper and just.
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`(f)
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`MORRIS, NICHOLS, ARSHT & TUNNELL LLP
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`/s/ Jack B. Blumenfeld
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`Jack B. Blumenfeld (#1014)
`Jeremy A. Tigan (#5239)
`1201 North Market Street
`P.O. Box 1347
`Wilmington, DE 19899
`(302) 658-9200
`jblumenfeld@morrisnichols.com
`jtigan@morrisnichols.com
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`Attorneys for Plaintiffs
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`OF COUNSEL:
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`David B. Bassett
`WILMER CUTLER PICKERING
`HALE & DORR LLP
`7 World Trade Center
`250 Greenwich Street
`New York, NY 10007
`(212) 230-8800
`
`Vinita Ferrera
`Emily R. Whelan
`Deric Geng
`Stephanie Neely
`Serena Li
`WILMER CUTLER PICKERING
`HALE & DORR LLP
`60 State Street
`Boston, MA 02109
`(617) 526-6000
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`July 25, 2022
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