Case 1:22-cv-00974-GBW Document 19 Filed 10/06/22 Page 1 of 18 PageID #: 224
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
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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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`
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`
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`
`
`C.A. No. 22-974 (GBW)
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`ACCORD HEALTHCARE INC.’S ANSWER AND AFFIRMATIVE DEFENSES
`TO PLAINTIFFS’ FIRST AMENDED COMPLAINT
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`Defendant Accord Healthcare Inc. (“Accord”) responds to the First Amended Complaint
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`(“Complaint,” D.I. 15) by Plaintiffs Merck KGaA, Merck Serono SA, and Ares Trading SA
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`(collectively, “Merck” or “Plaintiffs”) 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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`ANSWER: Accord admits that Plaintiffs purport to bring this action for alleged
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`infringement of the ’947, ’903, and ’919 patents under the patent laws of the United States, Title
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`
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`Petitioner TWi Pharms., Inc.
`EX1034, Page 1 of 18
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`35, United States Code. Accord admits that it submitted ANDA No. 216813 in the name of Accord
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`Healthcare Inc. Accord denies any remaining allegations in this paragraph.
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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.
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`ANSWER: Defendant lacks knowledge or information sufficient to form a belief about
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`the truth of the allegations in this paragraph, and therefore denies them.
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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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`ANSWER: Defendant lacks knowledge or information sufficient to form a belief about
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`the truth of the allegations in this paragraph, and therefore denies them.
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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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`ANSWER: Defendant lacks knowledge or information sufficient to form a belief about
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`the truth of the allegations in this paragraph, and therefore denies them.
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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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`ANSWER: Admitted.
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`2
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`Petitioner TWi Pharms., Inc.
`EX1034, Page 2 of 18
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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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`ANSWER: Defendant admits that Accord Healthcare Inc. markets and distributes
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`generic pharmaceutical products in the United States and submits ANDAs to the FDA seeking
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`approval to market generic pharmaceutical products in the United States. Defendant denies any
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`remaining allegations in this paragraph.
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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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`ANSWER: Admitted.
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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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`ANSWER: Defendant admits that Accord Healthcare Inc. filed ANDA No. 216813 with
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`a Paragraph IV certification with respect to the ’947 and ’903 patents seeking FDA approval to
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`market the Accord ANDA product in the United States. Defendant denies any remaining
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`allegations in this paragraph.
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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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`3
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`Petitioner TWi Pharms., Inc.
`EX1034, Page 3 of 18
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`ANSWER: Paragraph 9 states a legal conclusion to which no answer is required. To the
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`extent an answer is required, Defendant admits that this Court generally has subject matter
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`jurisdiction over a civil action properly alleging infringement of a U.S. patent under 28 U.S.C. §§
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`1331, 1338(a), 2201, and 2202. Defendant denies any remaining allegations in this paragraph.
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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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`ANSWER: Defendant admits that it agreed not to contest personal jurisdiction or venue
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`in the District of Delaware for the purposes of this case only. Defendant denies any remaining
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`allegations in this paragraph.
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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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`ANSWER: Defendant does not contest personal jurisdiction in this proceeding.
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`Defendant denies any remaining allegations in this paragraph.
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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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`4
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`Petitioner TWi Pharms., Inc.
`EX1034, Page 4 of 18
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`ANSWER: Defendant does not contest personal jurisdiction in this proceeding.
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`Defendant denies any remaining allegations in this paragraph.
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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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`ANSWER: Defendant does not contest personal jurisdiction in this proceeding.
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`Defendant denies any remaining allegations in this paragraph.
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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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`ANSWER: Defendant does not contest personal jurisdiction in this proceeding.
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`Defendant denies any remaining allegations in this paragraph.
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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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`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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`ANSWER: Defendant does not contest personal jurisdiction in this proceeding.
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`Defendant denies any remaining allegations in this paragraph.
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`5
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`Petitioner TWi Pharms., Inc.
`EX1034, Page 5 of 18
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`Case 1:22-cv-00974-GBW Document 19 Filed 10/06/22 Page 6 of 18 PageID #: 229
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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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`ANSWER: Defendant admits that the ’947 patent is titled “Cladribine Regimen for
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`Treating Multiple Sclerosis” and the ’947 patent states on its face that it was issued on May 11,
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`2010. Defendant admits that a copy of the ’747 patent was attached to the Complaint as Exhibit A.
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`Defendant denies any remaining allegations in this paragraph.
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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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`ANSWER: Defendant admits that the ’903 patent is titled “Cladribine Regimen for
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`Treating Multiple Sclerosis” and the ’903 patent states on its face that it was issued on February
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`19, 2013. Defendant admits that a copy of the ’903 patent was attached to the Complaint as Exhibit
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`B. Defendant denies any remaining allegations in this paragraph.
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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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`ANSWER: Defendant admits that the ’919 patent is titled “Cladribine Regimen for
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`Treating Progressive Forms of Multiple Sclerosis” and the ’919 patent states on its face that it was
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`issued on December 1, 2020. Defendant admits that a copy of the ’919 patent was attached to the
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`Complaint as Exhibit D. Defendant denies any remaining allegations in this paragraph.
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`6
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`Petitioner TWi Pharms., Inc.
`EX1034, Page 6 of 18
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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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`ANSWER: Defendant lacks knowledge or information sufficient to form a belief about
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`the truth of the ownership allegations in this paragraph, and therefore denies them. Defendant
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`denies any remaining allegations in this paragraph.
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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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`ANSWER: Defendant admits that EMD Serono, Inc. is the holder of New Drug
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`Application (“NDA”) No. 022561 for 10 mg strength cladribine tablets. Defendant lacks
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`knowledge of information sufficient to form a belief about the truth of any remaining allegations
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`in this paragraph, and therefore denies them.
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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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`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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`ANSWER: Defendant admits that a copy of the prescribing information for
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`MAVENCLAD® was attached to the Complaint as Exhibit C. Defendant admits that the attached
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`Exhibit C states “MAVENCLAD is a purine antimetabolite indicated for the treatment of relapsing
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`forms of multiple sclerosis (MS), to include relapsing-remitting disease and active secondary
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`7
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`Petitioner TWi Pharms., Inc.
`EX1034, Page 7 of 18
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`progressive disease, in adults.” Defendant lacks knowledge or information sufficient to form a
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`belief about the truth of any remaining allegations in this paragraph, and therefore denies them.
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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.
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`ANSWER: Admitted.
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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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`ANSWER: Defendant admits that Accord Healthcare Inc. sent a letter dated June 13,
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`2022 to Plaintiffs providing a Notice of Paragraph IV Certification with respect to Accord’s
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`ANDA and the ’947 and ’903 patents, pursuant to § 505(j)(2)(B)(iv) of the Federal Food, Drug,
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`and Cosmetic Act. Defendant admits that Accord seeks FDA approval to market Accord’s ANDA
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`Product in the United States. Defendant denies any remaining allegations in this paragraph.
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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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`ANSWER: Admitted.
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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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`ANSWER: Admitted.
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`8
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`Petitioner TWi Pharms., Inc.
`EX1034, Page 8 of 18
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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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`ANSWER: Defendant admits that Accord Healthcare Inc. sent a letter dated June 13,
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`2022 to Plaintiffs providing a Notice of Paragraph IV Certification with respect to Accord’s
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`ANDA and the ’947 and ’903 patents, pursuant to § 505(j)(2)(B)(iv) of the Federal Food, Drug,
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`and Cosmetic Act. Defendant admits that Accord seeks FDA approval to market Accord’s ANDA
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`Product in the United States. Defendant denies any remaining allegations in this paragraph.
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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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`ANSWER: Defendant admits that it produced to counsel for Merck its ANDA No.
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`216813 pursuant to an agreed Offer of Confidential Access. Defendant lacks knowledge or
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`information sufficient to form a belief about the truth of the remaining allegations in this paragraph,
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`and therefore denies them.
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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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`ANSWER: Admitted.
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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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`9
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`Petitioner TWi Pharms., Inc.
`EX1034, Page 9 of 18
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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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`ANSWER: Defendant lacks knowledge or information sufficient to form a belief about
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`the truth of the allegations in this paragraph, and therefore denies them.
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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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`ANSWER: Defendant incorporates its answers to each of the prior paragraphs.
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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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`ANSWER: Denied.
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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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`ANSWER: Denied.
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`10
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`Petitioner TWi Pharms., Inc.
`EX1034, Page 10 of 18
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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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`ANSWER:
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` Defendant admits that Accord Healthcare Inc. sent a letter dated June 13,
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`2022 to Plaintiffs providing a Notice of Paragraph IV Certification with respect to Accord’s
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`ANDA and the ’947 patent, pursuant to § 505(j)(2)(B)(iv) of the Federal Food, Drug, and Cosmetic
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`Act. Defendant denies any remaining allegations in this paragraph.
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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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`ANSWER: Denied.
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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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`ANSWER: Denied.
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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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`ANSWER: Denied.
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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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`ANSWER: Denied.
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`11
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`Petitioner TWi Pharms., Inc.
`EX1034, Page 11 of 18
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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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`ANSWER: Denied.
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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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`ANSWER: Denied.
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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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`ANSWER: Denied.
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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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`ANSWER: Defendant incorporates their answers to each of the prior paragraphs.
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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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`ANSWER: Denied.
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`12
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`Petitioner TWi Pharms., Inc.
`EX1034, Page 12 of 18
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`Case 1:22-cv-00974-GBW Document 19 Filed 10/06/22 Page 13 of 18 PageID #: 236
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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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`ANSWER: Denied.
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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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`ANSWER: Defendant admits that Accord Healthcare Inc. sent a letter dated June 13,
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`2022 to Plaintiffs providing a Notice of Paragraph IV Certification with respect to Accord’s
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`ANDA and the ’903 patent, pursuant to § 505(j)(2)(B)(iv) of the Federal Food, Drug, and Cosmetic
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`Act. Defendant denies any remaining allegations in this paragraph.
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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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`ANSWER: Denied.
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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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`13
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`Petitioner TWi Pharms., Inc.
`EX1034, Page 13 of 18
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`Case 1:22-cv-00974-GBW Document 19 Filed 10/06/22 Page 14 of 18 PageID #: 237
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`ANSWER: Denied.
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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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`ANSWER: Denied.
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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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`ANSWER: Denied.
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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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`ANSWER: Denied.
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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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`ANSWER: Denied.
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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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`ANSWER: Denied.
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`14
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`Petitioner TWi Pharms., Inc.
`EX1034, Page 14 of 18
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`Case 1:22-cv-00974-GBW Document 19 Filed 10/06/22 Page 15 of 18 PageID #: 238
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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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`ANSWER: Defendant incorporates its answers to each of the prior paragraphs.
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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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`ANSWER: Denied.
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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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`ANSWER: Denied.
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`15
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`Petitioner TWi Pharms., Inc.
`EX1034, Page 15 of 18
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`Case 1:22-cv-00974-GBW Document 19 Filed 10/06/22 Page 16 of 18 PageID #: 239
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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 e-
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`mail.
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`ANSWER: Defendant admits that its counsel received an e-mail from Plaintiffs’
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`counsel on July 12, 2022 identifying U.S. Patent No. 10,849,919. Defendant denies the remaining
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`allegations in this paragraph.
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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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`ANSWER: Denied.
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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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`ANSWER:
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` Denied.
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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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`ANSWER: Denied.
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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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`ANSWER: Denied.
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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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`
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`16
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`Petitioner TWi Pharms., Inc.
`EX1034, Page 16 of 18
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`

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`Case 1:22-cv-00974-GBW Document 19 Filed 10/06/22 Page 17 of 18 PageID #: 240
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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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`ANSWER: Denied.
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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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`ANSWER: Denied.
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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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`ANSWER: Denied.
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`ANSWER TO PRAYER FOR RELIEF
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`Defendant denies that Plaintiffs are entitled to the requested relief or to any relief
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`whatsoever.
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`AFFIRMATIVE DEFENSES
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`FIRST AFFIRMATIVE DEFENSE
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`The claims of the ’947 Patent are invalid for failure to satisfy one or more of the conditions
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`for patentability of 35 U.S.C. § 101 et seq., at least for the reasons set forth in Accord’s Notice
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`Letter dated June 13, 2022.
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`SECOND AFFIRMATIVE DEFENSE
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`The claims of the ’903 patent are invalid for failure to satisfy one or more of the conditions
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`for patentability of 35 U.S.C. § 101 et seq., at least for the reasons set forth in Accord’s Notice
`
`Letter dated June 13, 2022.
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`
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`17
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`Petitioner TWi Pharms., Inc.
`EX1034, Page 17 of 18
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`Case 1:22-cv-00974-GBW Document 19 Filed 10/06/22 Page 18 of 18 PageID #: 241
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`THIRD AFFIRMATIVE DEFENSE
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`The claims of the ’919 patent are invalid for failure to satisfy one or more of the conditions
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`for patentability of 35 U.S.C. § 101 et seq.
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`RESERVATION OF DEFENSES
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`Defendant reserves the right to assert any and all additional defenses and counterclaims
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`that discovery may reveal.
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`
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`Dated: October 6, 2022
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`OF COUNSEL:
`Alejandro Menchaca
`Ben J. Mahon
`Bradley P. Loren
`MCANDREWS, HELD & MALLOY, LTD.
`500 West Madison Street, 34th Floor
`Chicago, IL 60661
`(312) 775-8000
`
`GREENBERG TRAURIG, LLP
`
`/s/ Benjamin J. Schladweiler
`Benjamin J. Schladweiler (#4601)
`Renée Mosley Delcollo (#6442)
`The Nemours Building
`1007 North Orange Street, Suite 1200
`Wilmington, DE 19801
`(302) 661-7000
`schladweilerb@gtlaw.com
`renee.delcollo@gtlaw.com
`
`Attorneys for Defendant Accord
`Healthcare Inc.
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`18
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`Petitioner TWi Pharms., Inc.
`EX1034, Page 18 of 18
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