Case 1:22-cv-00974-GBW Document 15 Filed 09/22/22 Page 1 of 14 PageID #: 101
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
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`C.A. No. 22-974 (GBW)
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`)))))))
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`MERCK KGaA, MERCK SERONO SA, and
`ARES TRADING SA,
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`Plaintiffs,
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`v.
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`ACCORD HEALTHCARE, INC.,
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`Defendant.
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`FIRST AMENDED COMPLAINT
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`Plaintiffs Merck KGaA, Merck Serono SA, and Ares Trading SA (collectively, “Merck”
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`or “Plaintiffs”), by 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, 8,377,903, and
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`10,849,919.
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`PARTIES
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`2.
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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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`1 In the United States, Plaintiff Merck KGaA conducts business under the name “Merck KGaA,
`Darmstadt, Germany.”
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`
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`Petitioner TWi Pharms., Inc.
`EX1010, Page 1 of 14
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`3.
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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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`4.
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`Plaintiff Ares Trading 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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`Ares Trading SA is a wholly owned subsidiary of Plaintiff Merck KGaA.
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`5.
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`On information and belief, Defendant Accord Healthcare, Inc. (“Accord
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`Healthcare” or “Accord”) is a corporation organized and existing under the laws of the State of
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`North Carolina, with its principal place of business at 1009 Slater Road, Suite 210 B, Durham,
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`North Carolina, 27703.
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`6.
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`On information and belief, Accord Healthcare’s business includes 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 submits ANDAs to the FDA seeking approval to engage
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`in the commercial manufacture, use, offering for sale, sale, and/or importation of generic versions
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`of drug products covered by United States patents.
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`7.
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`On information and belief, Accord Healthcare prepared and submitted ANDA No.
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`216813 for Accord Healthcare’s cladribine 10 mg tablets (the “Accord ANDA Product”).
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`8.
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`On information and belief, following any FDA approval of ANDA No. 216813,
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`Accord Healthcare will market, distribute, offer for sale, and/or sell the Accord ANDA Product
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`throughout the United States including in Delaware.
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`JURISDICTION AND VENUE
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`9.
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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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`2
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`Petitioner TWi Pharms., Inc.
`EX1010, Page 2 of 14
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`10.
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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. Accord Healthcare, through its
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`counsel, by e-mail dated July 6, 2022, agreed that it does not contest personal jurisdiction or venue
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`in this Court in this matter.
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`11. Moreover, this Court has personal jurisdiction over Accord Healthcare because, on
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`information and belief, Accord Healthcare has engaged in continuous and systematic contacts with
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`the State of Delaware and/or purposefully availed itself of this forum by, among other things,
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`making, marketing, shipping, using, offering to sell or selling, or causing others to use, offer to
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`sell, or sell, pharmaceutical products in Delaware, and deriving substantial revenue from such
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`activities.
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`12.
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`On information and belief, Accord Healthcare has purposefully conducted business
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`in the State of Delaware and continues to conduct business in Delaware, and Delaware is a likely
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`destination of Accord’s products, including its proposed generic version of MAVENCLAD® that
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`is at issue in this action.
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`13.
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`On information and belief, upon approval of ANDA No. 216813, Accord
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`Healthcare will market and sell the Accord ANDA Product in Delaware and throughout the United
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`States and will derive substantial revenue therefrom.
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`14.
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`On information and belief, upon approval of Accord’s ANDA No. 216813, Accord
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`Healthcare will place the Accord ANDA Product into the stream of commerce with the expectation
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`or knowledge and the intent that such product will be purchased and used by consumers in
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`Delaware and throughout the United States.
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`15.
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`Accord Healthcare has consented to jurisdiction in the District of Delaware in
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`multiple previous cases. See, e.g., Eagle Pharmaceuticals, Inc. v. Accord Healthcare, Inc. et al.,
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`3
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`Petitioner TWi Pharms., Inc.
`EX1010, Page 3 of 14
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`Case 1:22-cv-00974-GBW Document 15 Filed 09/22/22 Page 4 of 14 PageID #: 104
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`C.A. No. 22-704; Teva Pharmaceuticals Int’l GmbH et al., v. Accord Healthcare, Inc. et al., C.A.
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`No. 21-952; Merck Sharp & Dohme Corp. v. Accord Healthcare, Inc. et al., C.A. No. 19-2192;
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`Amgen Inc. v. Accord Healthcare, Inc. et al., C.A. No. 18-956.
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`PATENTS-IN-SUIT
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`16.
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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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`17.
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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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`18.
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`United States Patent No. 10,849,919 (“the ’919 patent”), entitled Cladribine
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`Regimen for Treating Progressive Forms of Multiple Sclerosis” (attached as Exhibit D), was duly
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`and legally issued on December 1, 2020.
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`19.
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`The ’947 and ’903 patents are owned by Merck Serono SA. The ’919 patent is
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`owned by Ares Trading SA. The claims of the ’947, ’903, and ’919 patents are valid, enforceable,
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`and not expired.
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`MERCK’S MAVENCLAD® PRODUCT
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`20.
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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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`21. 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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`4
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`Petitioner TWi Pharms., Inc.
`EX1010, Page 4 of 14
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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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`22.
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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, ’903, and ’919 patents as patents covering
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`MAVENCLAD® and its use.2
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`INFRINGEMENT BY ACCORD
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`23.
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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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`24.
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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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`25.
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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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`26.
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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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`27.
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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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`2 The ’919 patent was listed on the Orange Book on September 12, 2022.
`5
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`Petitioner TWi Pharms., Inc.
`EX1010, Page 5 of 14
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`28.
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`This action was commenced before the expiration of forty-five days from the date
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`of Merck’s receipt of the Notice Letter. Accord has not sent a new Notice Letter to Merck since
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`the ’919 patent was listed on the Orange Book.
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`29.
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`The ’947 and ’903 patents expire on October 16, 2026 and May 31, 2026,
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`respectively. The ’919 patent expires on November 23, 2038. Therefore, because the ’919 patent
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`expires later than the ’947 and ’903 patents, Accord is necessarily seeking approval of the Accord
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`ANDA Product before the ’919 patent’s expiration.
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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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`6
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`Petitioner TWi Pharms., Inc.
`EX1010, Page 6 of 14
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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 ’947
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`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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`7
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`Petitioner TWi Pharms., Inc.
`EX1010, Page 7 of 14
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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 ’903
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`patent.
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`8
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`Petitioner TWi Pharms., Inc.
`EX1010, Page 8 of 14
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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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`9
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`Petitioner TWi Pharms., Inc.
`EX1010, Page 9 of 14
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`herein.
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`COUNT III
`INFRINGEMENT OF U.S. PATENT NO. 10,849,919
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`52.
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`Plaintiffs incorporate each of the preceding paragraphs 1-51 as if fully set forth
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`53.
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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 ’919 patent was an act
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`of infringement of the ’919 patent under 35 U.S.C. § 271(e)(2).
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`54.
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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 ’919 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 ’919 patent include at least claims 1, 14, 24, and 27. Upon information and
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`belief, Accord has made and will continue to make substantial and meaningful preparations to
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`practice, induce and/or contribute to practicing of one or more of the claims of the ’919 patent
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`and/or import, offer to sell, sell, make, and/or use within the United States the Accord ANDA
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`Product prior to the expiration of the ’919 patent. For example, infringement of the ’919 patent is
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`imminent because, among other things, Accord has notified Merck of the submission of its ANDA
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`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 and ’903 patents, which
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`is before the expiration of the ’919 patent.
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`55.
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`Accord had knowledge of the ’919 patent at least as of July 12, 2022, when
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`Plaintiffs’ counsel notified Accord Healthcare’s counsel of the existence of the ’919 patent by
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`e-mail.
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`10
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`Petitioner TWi Pharms., Inc.
`EX1010, Page 10 of 14
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`56.
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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 ’919 patent.
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`57.
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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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`58.
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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 ’919 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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`59.
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`A substantial and justiciable controversy exists between the parties hereto as to the
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`infringement of the ’919 patent.
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`60.
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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 ’919 patent pursuant to 35 U.S.C.
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`§§ 271(a), (b), and/or (c).
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`61.
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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 ’919 patent and/or actively inducing or contributing
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`to the infringement of the ’919 patent.
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`62.
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`Unless Accord is enjoined from infringing the ’919 patent and/or actively inducing
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`or contributing to the infringement of the ’919 patent, Plaintiffs will suffer irreparable injury.
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`Plaintiffs have no adequate remedy at law.
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`11
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`Petitioner TWi Pharms., Inc.
`EX1010, Page 11 of 14
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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, ’903, and ’919 patents, and that Accord’s
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`manufacture, use, offer to sell, sale, or importation of the Accord ANDA Product in or into the
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`United States prior to the expiration of the ’947, ’903, and ’919 patents, will infringe and/or
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`actively induce or contribute to the infringement of the claims of the ’947, ’903, and ’919 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 latest expiration
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`date of the ’947, ’903, and ’919 patents, including any extensions and/or additional periods of
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`exclusivity 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, ’903, and ’919 patents, would infringe the claims of the ’947,
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`’903, and ’919 patents, either literally or under the doctrine of equivalents, under 35 U.S.C.
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`§ 271(a), (b), and/or (c);
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`(d)
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`A judgment declaring that the claims of the ’947, ’903, and ’919 patents are not
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`invalid and/or are not unenforceable;
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`(e)
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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, ’903, and ’919 patents, or inducing
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`the infringement of the ’947, ’903, and ’919 patents until after the latest expiration date of the
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`12
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`Petitioner TWi Pharms., Inc.
`EX1010, Page 12 of 14
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`’947, ’903, and ’919 patents, including any extension and/or additional periods of exclusivity to
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`which Merck is or becomes entitled.
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`(f)
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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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`(g)
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`Such further and other relief as this Court deems proper and just.
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`MORRIS, NICHOLS, ARSHT & TUNNELL LLP
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`/s/ Jeremy A. Tigan
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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
`Gillian T. Farrell
`WILMER CUTLER PICKERING
`HALE & DORR LLP
`7 World Trade Center
`250 Greenwich Street
`New York, NY 10007
`(212) 230-8800
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`Vinita Ferrera
`Emily R. Whelan
`Deric Geng
`Serena Li
`WILMER CUTLER PICKERING
`HALE & DORR LLP
`60 State Street
`Boston, MA 02109
`(617) 526-6000
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`September 22, 2022
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`13
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`Petitioner TWi Pharms., Inc.
`EX1010, Page 13 of 14
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`Case 1:22-cv-00974-GBW Document 15 Filed 09/22/22 Page 14 of 14 PageID #: 114
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`CERTIFICATE OF SERVICE
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`I hereby certify that on September 22, 2022, I caused the foregoing to be electronically
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`filed with the Clerk of the Court using CM/ECF, which will send notification of such filing to all
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`registered participants.
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`I further certify that I caused copies of the foregoing document to be served on
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`September 22, 2022, upon the following in the manner indicated:
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`VIA ELECTRONIC MAIL
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`VIA ELECTRONIC MAIL
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`/s/ Jeremy A. Tigan
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`Jeremy A. Tigan (#5239)
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`Benjamin J. Schladweiler, Esquire
`GREENBERG TRAURIG, LLP
`The Nemours Building, Suite 1200
`1007 North Orange Street
`Wilmington, DE 19801
`Attorneys for Defendant Accord Healthcare, Inc.
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`Aaron F. Barkoff, Esquire
`MCANDREWS, HELD & MALLOY, LTD.
`500 West Madison Street, 34th Floor
`Chicago, IL 60661
`Attorneys for Defendant Accord Healthcare, Inc.
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`Petitioner TWi Pharms., Inc.
`EX1010, Page 14 of 14
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