EXELA PHARMA SCIENCES, LLC,
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`
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`v.
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`ETON PHARMACEUTICALS, INC.,
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`
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`
`
`
`
`Plaintiff,
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`Defendant.
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`
`ETON PHARMACEUTICALS, INC.’S ANSWER
`AND AFFIRMATIVE DEFENSES TO AMENDED COMPLAINT
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`Case 1:20-cv-00365-MN Document 20 Filed 08/11/20 Page 1 of 29 PageID #: 598
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`
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
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`
`C.A. No. 20-365-MN
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`JURY TRIAL DEMANDED
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`Defendant Eton Pharmaceuticals, Inc. (“Eton”), by and through its attorneys, hereby
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`provides the following Answer and Affirmative Defenses to the Amended Complaint filed by
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`Plaintiff Exela Pharma Sciences, LLC (“Plaintiff”) on July 28, 2020. Unless otherwise specifically
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`admitted below, Eton denies all allegations in Plaintiff’s Amended Complaint. See Fed. R. Civ. P.
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`8(b)(3).
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`1.
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`NATURE OF ACTION
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`Eton admits that Plaintiff’s Amended Complaint purports to bring an action for
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`infringement of U.S. Patent Nos. 10,478,453 (“’453 Patent”), 10,583,155 (“’155 Patent”), and
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`10,653,719 (“’719 patent”) (collectively, “Patents-in-Suit”) and that this action purports to arise
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`under the Patent Laws of the United States, 35 U.S.C. § 1 et seq., and the Declaratory Judgment
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`Act, 28 U.S.C. §§ 2201 and 2202. The remainder of Paragraph 1 is proffered as a legal conclusion
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`to which no response is required. To the extent a response is required, Eton denies the remaining
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`allegations of Paragraph 1.
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`Case 1:20-cv-00365-MN Document 20 Filed 08/11/20 Page 2 of 29 PageID #: 599
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`2.
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`THE PARTIES
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`Eton lacks sufficient knowledge and information to form a belief as to the
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`allegations of Paragraph 2 and therefore denies the same.
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`3.
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`Eton admits that it is a corporation organized and existing under the laws of the
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`State of Delaware, with a principal place of business at 21925 West Field Parkway, Suite 235,
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`Deer Park, IL 60010.
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`JURISDICTION AND VENUE
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`Paragraph 4 contains legal conclusions to which no response is required. To the
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`4.
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`extent a response is required, Eton does not contest subject matter jurisdiction over Plaintiff’s
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`allegations against Eton under 35 U.S.C. § 271(e)(2) pursuant to 28 U.S.C. §§ 1331 and 1338(a)
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`for purposes of this action only. Eton denies the remaining allegations of Paragraph 4.
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`5.
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`Paragraph 5 contains legal conclusions to which no response is required. To the
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`extent a response is required, Eton does not contest personal jurisdiction for purposes of this action
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`only and expressly reserves the right to contest personal jurisdiction in any other case as to any
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`party, including Plaintiff. Eton also admits that “COGENCY GLOBAL INC., 850 NEW
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`BURTON ROAD SUITE 201, DOVER, DE, 19904” is provided under the “REGISTERED
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`AGENT INFORMATION” section of the State of Delaware’s Division of Corporations website
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`as Eton’s registered agent in Delaware and is authorized to accept service on Eton’s behalf. Eton
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`denies the remaining allegations of Paragraph 5.
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`6.
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`Paragraph 6 contains legal conclusions to which no response is required. To the
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`extent a response is required, Eton does not contest venue for purposes of this action only and
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`expressly reserves the right to contest venue in any other case as to any party, including Plaintiff.
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`Case 1:20-cv-00365-MN Document 20 Filed 08/11/20 Page 3 of 29 PageID #: 600
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`A.
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`7.
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`FACTUAL BACKGROUND
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`The Development and FDA Approval of Exela’s ELCYS® L-Cysteine
`Product
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`Eton lacks sufficient knowledge and information to form a belief as to the
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`allegations of Paragraph 7 and therefore denies the same.
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`8.
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`Eton admits that L-cysteine is an amino acid that can be naturally synthesized in
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`small amounts by humans, and that it may be provided as an L-Cysteine Hydrochloride Injection
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`solution which, after combination with an Amino Acid Injection solution, is administered
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`parenterally to meet the amino acid requirements of patients receiving total parenteral nutrition
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`(“TPN”). Eton lacks sufficient knowledge and information to form a belief as to the remaining
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`allegations of Paragraph 8 and therefore denies the same.
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`9.
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`Eton is without knowledge as to the timeframe during which Exela began
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`developing its L-cysteine product, and therefore, it lacks sufficient knowledge to admit or deny
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`that there was no FDA-approved intravenous L-cysteine hydrochloride product on the market in
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`the United States at that time. Eton notes, however, that, in the 1980s, FDA approved a L-
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`cysteine hydrochloride product (“Hospira L-cysteine product”). And, that no later than 2010,
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`Sandoz Inc. offered an L-cysteine hydrochloride product (“Sandoz L-cysteine product”) in the
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`United States market. Eton admits that aluminum is a known toxic impurity in parenteral
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`nutritional compositions but denies that all L-cysteine products were known to contain high
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`amounts of aluminum prior to the effective date of Exela’s purported invention. For example,
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`the Sandoz L-cysteine product contained low levels of aluminum. Eton lacks sufficient
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`knowledge and information to form a belief as to the remaining allegations of Paragraph 9 and
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`therefore denies the same.
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`10.
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`Eton admits that the literature known to the pharmaceutical industry identifies
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`various health problems associated with aluminum toxicity. Eton denies that all TPN
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`admixtures, including those without L-cysteine, necessarily had high levels of aluminum. Eton
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`lacks sufficient knowledge and information to form a belief as to the remaining allegations of
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`Paragraph 10 and therefore denies the same.
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`11.
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`Eton admits that the FDA amended the labeling requirements for parenteral drug
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`products, that these amendments were codified at 21 C.F.R. § 201.323, and that Paragraph 11
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`includes a portion of the warning required by the FDA. Eton lacks sufficient knowledge and
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`information to form a belief as to the remaining allegations of Paragraph 11 and therefore denies
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`the same.
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`12.
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`Upon information and belief, Eton admits that Exela secured FDA approval in
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`April 2019, for an injectable L-cysteine hydrochloride product. Eton denies that the product
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`fulfilled a long-felt need for a low-aluminum injectable cysteine product. Eton lacks sufficient
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`knowledge and information to form a belief as to the remaining allegations of Paragraph 12 and
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`therefore denies the same.
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`13.
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`Eton admits that the Approved Drug Products with Therapeutic Equivalence
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`Evaluations (an FDA publication commonly known as the “Orange Book”) identifies EXELA
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`PHARMA SCIENCES LLC as the purported “Applicant Holder” for NDA 210660, purportedly
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`for a solution containing CYSTEINE HYDROCHLORIDE as the “Active Ingredient,” and
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`identifies ELCYS as the “Proprietary Name” for this product. Eton lacks sufficient knowledge
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`and information to form a belief as to the remaining allegations of Paragraph 13 and therefore
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`denies the same.
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`14.
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`Eton admits that Exhibit B purports to be a copy of ELCYS’s “HIGHLIGHTS OF
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`PRESCRIBING INFORMATION,” revised 04/2019, and states in “11 DESCRIPTION,” that
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`“ELCYS contains no more than 120 mcg/L of aluminum,” but denies that the label includes the
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`language “throughout the shelf life of the product.” Eton lacks sufficient knowledge and
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`information to form a belief as to the remaining allegations of Paragraph 14 and therefore denies
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`the same.
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`15.
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`Eton admits that Exhibit B purports to be a copy of ELCYS’s “HIGHLIGHTS OF
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`PRESCRIBING INFORMATION,” revised 04/2019, and states in “11 DESCRIPTION,” that
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`“ELCYS (cysteine hydrochloride injection) is a sterile, nonpyrogenic solution for intravenous
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`use,” that “[e]ach 10 mL of ELCYS contains 500 mg of cysteine hydrochloride, USP (equivalent
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`to 345 mg of cysteine) in water for injection,” and that “[t]he chemical name of cysteine
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`hydrochloride is L-cysteine hydrochloride monohydrate.” Eton lacks sufficient knowledge and
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`information to form a belief as to the remaining allegations of Paragraph 15 and therefore denies
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`the same.
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`16.
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`Eton admits that Exhibit B purports to be a copy of ELCYS’s “HIGHLIGHTS OF
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`PRESCRIBING INFORMATION,” revised 04/2019, and states in “11 DESCRIPTION,” that
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`“[t]he pH range is 1.0 to 2.5.” Eton lacks sufficient knowledge and information to form a belief
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`as to the remaining allegations of Paragraph 16 and therefore denies the same.
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`17.
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`Eton admits that pyruvic acid and cystine were known oxidative degradation
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`products of L-cysteine. Eton lacks sufficient knowledge and information to form a belief as to
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`the remaining allegations of Paragraph 17 and therefore denies the same.
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`18.
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`Eton lacks sufficient knowledge and information to form a belief as to the
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`allegations of Paragraph 18 and therefore denies the same.
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`Case 1:20-cv-00365-MN Document 20 Filed 08/11/20 Page 6 of 29 PageID #: 603
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`19.
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`Eton admits that Exhibit B purports to be a copy of ELCYS’s “HIGHLIGHTS OF
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`PRESCRIBING INFORMATION,” revised 04/2019, and states in “1 INDICATIONS AND
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`USAGE,” that “ELCYS is indicated for use as an additive to amino acid solutions to meet the
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`nutritional requirements of newborn infants requiring total parenteral nutrition (TPN) and of
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`adult and pediatric patients with severe liver disease who may have impaired enzymatic
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`processes and require TPN” and that ELCYS “can also be added to amino acid solutions to
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`provide a more complete profile of amino acids for protein synthesis.” Eton lacks sufficient
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`knowledge and information to form a belief as to the remaining allegations of Paragraph 19 and
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`therefore denies the same.
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`20.
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`Eton admits that Exhibit B purports to be a copy of ELCYS’s “HIGHLIGHTS OF
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`PRESCRIBING INFORMATION,” revised 04/2019, and includes, in “2 DOSAGE AND
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`ADMINISTRATION,” the following sections: “2.1 Important Administration Information”; “2.2
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`Preparation and Administration Instructions”; “2.3 Preparation Instructions for Admixing Using
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`a Parenteral Nutrition (PN) Container”; “2.4 Dosing Considerations”; and “2.5 Recommended
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`Dosage in Pediatric Patients and Adults.” In “2.1 Important Administration Information,”
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`Exhibit B provides that (1) “ELCYS is for admixing use only”; (2) ELCYS “is not for direct
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`intravenous infusion”; and (3) “Prior to administration, ELCYS must be diluted and used as an
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`admixture in parenteral nutrition (PN) solutions.” (emphases in original.) Eton lacks sufficient
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`knowledge and information to form a belief as to the remaining allegations of Paragraph 20 and
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`therefore denies the same.
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`21.
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`Eton admits that Exhibit B purports to be a copy of ELCYS’s “HIGHLIGHTS OF
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`PRESCRIBING INFORMATION,” revised 04/2019, and that, in “2.3 Preparation Instructions
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`for Admixing Using a Parenteral Nutrition (PN) Container,” states “Remove ELCYS vial from
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`the carton and inspect for particulate matter.” Eton lacks sufficient knowledge and information
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`to form a belief as to the remaining allegations of Paragraph 21 and therefore denies the same.
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`22.
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`Eton admits that Exhibit B purports to be a copy of ELCYS’s “HIGHLIGHTS OF
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`PRESCRIBING INFORMATION,” revised 04/2019, and that, in “2.2 Preparation and
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`Administration Instructions,” states “Visually inspect the diluted PN solution containing ELCYS
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`for particular matter before admixing, after admixing, and prior to administration. The solution
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`should be clear and there should be no precipitates.” Eton lacks sufficient knowledge and
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`information to form a belief as to the remaining allegations of Paragraph 22 and therefore denies
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`the same.
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`23.
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`Eton admits that Exhibit B purports to be a copy of ELCYS’s “HIGHLIGHTS OF
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`PRESCRIBING INFORMATION,” revised 04/2019, and that, in “2.5 Recommended Dosage in
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`Pediatric Patients and Adults,” provides a table labeled “Table 1. Recommended Daily Dosage
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`of ELCYS in Pediatric Patients and Adults,” with the following age groups: “Preterm and term
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`infants less than 1 month of age”; “Pediatric patients 1 month to less than 1 year of age”;
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`“Pediatric patients 1 year to 11 years of age”; “Pediatric patients 12 years to 17 year of age”;
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`“Adults: Stable Patients”; and “Adults: Critically Ill Patients.” Eton lacks sufficient knowledge
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`and information to form a belief as to the remaining allegations of Paragraph 23 and therefore
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`denies the same.
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`24.
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`Eton admits that Exhibit B purports to be a copy of ELCYS’s “HIGHLIGHTS OF
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`PRESCRIBING INFORMATION,” revised 04/2019, and that, in “2.4 Dosing Considerations,”
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`provides that “[t]he dosage of the final PN solution containing ELCYS must be based on the
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`concentrations of all components in the solution and the recommended nutritional requirements
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`[see Dosage and Administration (2.5)].” (emphasis in original.) Eton lacks sufficient knowledge
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`and information to form a belief as to the remaining allegations of Paragraph 24 and therefore
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`denies the same.
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`25.
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`Eton admits that Exhibit B purports to be a copy of ELCYS’s “HIGHLIGHTS OF
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`PRESCRIBING INFORMATION,” revised 04/2019, and includes, in “5 WARNINGS AND
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`PRECAUTIONS,” several sections, including “5.7 Aluminum Toxicity,” which states the
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`following:
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`ELCYS contains aluminum that may be toxic.
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`Aluminum may reach toxic levels with prolonged parenteral administration in patients
`with renal impairment. Preterm infants are particularly at risk for aluminum toxicity
`because their kidneys are immature, and they require large amounts of calcium and
`phosphate solutions, which also contain aluminum.
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`Patients with renal impairment, including preterm infants, who receive greater than 4 to 5
`mcg/kg/day of parenteral aluminum can accumulate aluminum to levels associated with
`central nervous system and bone toxicity. Tissue loading may occur at even lower rates
`of administration.
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`Exposure to aluminum from ELCYS is not more than 0.21 mcg/kg/day when preterm and
`term infants less than 1 month of age are administered the recommended maximum
`dosage of ELCYS (15 mg cysteine/g of amino acids and 4 g of amino acids/kg/day) [see
`Table 1, Dosage and Administration (2.5)]. When prescribing ELCYS for use in PN
`containing other small volume parenteral products, the total daily patient exposure to
`aluminum from the admixture should be considered and maintained at no more than 5
`mcg/kg/day [see Use in Specific Populations (8.4)].
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`(emphases in original.) Eton lacks sufficient knowledge and information to form a belief as to
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`the remaining allegations of Paragraph 25 and therefore denies the same.
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`B.
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`26.
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`The Asserted ’453 Patent
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`Eton admits that Exhibit C purports to be a copy of the ’453 Patent and that, on its
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`face, Exhibit C is entitled, “Stable, Highly Pure L-Cysteine Compositions for Injection and
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`Methods of Use.” Eton also admits that Exhibit C, on its face, indicates that the “Date of Patent”
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`is “Nov. 19, 2019” and that the named “Inventors” are John Maloney, Aruna Koganti, and
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`Phanesh Koneru. Eton denies the remaining allegations of Paragraph 26.
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`27.
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`Eton admits that Exhibit C indicates on its face that “Exela Pharma Sciences,
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`LLC, Lenoir, NC (US)” is the “Assignee” of the ’453 Patent. Eton lacks sufficient knowledge
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`and information to form a belief as to the remaining allegations of Paragraph 27 and therefore
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`denies the same.
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`28.
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`Eton admits that the ’453 Patent is listed in the Orange Book for NDA 210660
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`and that “11/19/2019” is identified as the “Submission Date” for the ’453 Patent. Eton lacks
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`sufficient knowledge and information to form a belief as to the remaining allegations of
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`Paragraph 28 and therefore denies the same.
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`29.
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`Eton lacks sufficient knowledge and information to form a belief as to the
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`allegations of Paragraph 29 and therefore denies the same.
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`30.
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`31.
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`32.
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`33.
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`Admitted.
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`Admitted.
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`Admitted.
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`Eton lacks sufficient knowledge and information to form a belief as to the
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`allegations of Paragraph 33 and therefore denies the same.
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`C.
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`34.
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`The Asserted ’155 Patent
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`Eton admits that Exhibit D purports to be a copy of the ’155 Patent and that, on its
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`face, Exhibit D is entitled, “Stable, Highly Pure L-Cysteine Compositions for Injection and
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`Methods of Use.” Eton also admits that Exhibit D, on its face, indicates that the “Date of Patent”
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`is “*Mar. 10, 2020” and that the named “Inventors” are John Maloney, Aruna Koganti, and
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`Phanesh Koneru. Eton denies the remaining allegations of Paragraph 34.
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`35.
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`Eton admits that Exhibit D indicates on its face that “Exela Pharma Sciences,
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`LLC, Lenoir, NC (US)” is the “Assignee” of the ’155 Patent. Eton lacks sufficient knowledge
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`and information to form a belief as to the remaining allegations of Paragraph 35 and therefore
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`denies the same.
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`36.
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`Eton admits that the ’155 Patent is listed in the Orange Book NDA 210660 and
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`that “03/10/2020” is identified as the “Submission Date” for the ’155 Patent. Eton lacks
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`sufficient knowledge and information to form a belief as to the remaining allegations of
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`Paragraph 36 and therefore denies the same.
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`37.
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`Eton lacks sufficient knowledge and information to form a belief as to the
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`allegations of Paragraph 37 and therefore denies the same.
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`38.
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`39.
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`40.
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`41.
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`Admitted.
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`Admitted.
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`Admitted.
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`Eton lacks sufficient knowledge and information to form a belief as to the
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`allegations of Paragraph 41 and therefore denies the same.
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`D.
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`42.
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`The Asserted ’719 Patent
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`Eton admits that Exhibit E purports to be a copy of the ’719 Patent and that, on its
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`face, Exhibit E is entitled, “Stable, Highly Pure L-Cysteine Compositions for Injection and
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`Methods of Use.” Eton also admits that Exhibit E, on its face, indicates that the “Date of Patent”
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`is “*May 19, 2020” and that the named “Inventors” are John Maloney, Aruna Koganti, and
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`Phanesh Koneru. Eton denies the remaining allegations of Paragraph 42.
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`43.
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`Eton admits that Exhibit E indicates on its face that “Exela Pharma Sciences,
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`LLC, Lenoir, NC (US)” is the “Assignee” of the ’719 Patent. Eton lacks sufficient knowledge
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`and information to form a belief as to the remaining allegations of Paragraph 43 and therefore
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`denies the same.
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`44.
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`Eton admits that the ’719 Patent is listed in the Orange Book NDA 210660 and
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`that “07/02/2020” is identified as the “Submission Date” for the ’719 Patent. Eton lacks
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`sufficient knowledge and information to form a belief as to the remaining allegations of
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`Paragraph 44 and therefore denies the same.
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`45.
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`Eton lacks sufficient knowledge and information to form a belief as to the
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`allegations of Paragraph 45 and therefore denies the same.
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`46.
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`47.
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`48.
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`49.
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`50.
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`Admitted.
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`Admitted.
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`Admitted.
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`Admitted.
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`Eton lacks sufficient knowledge and information to form a belief as to the
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`allegations of Paragraph 50 and therefore denies the same.
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`ALLEGED ACTS GIVING RISE TO THIS ACTION FOR DEFENDANT’S ALLEGED
`INFRINGEMENT OF THE PATENTS-IN-SUIT
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`Eton admits that a letter dated January 31, 2020 (“Notice Letter”) was sent on its
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`51.
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`behalf by Jeffrey Wolfson of the law firm of Haynes and Boone, LLP to Plaintiff, providing
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`written notification pursuant to 21 U.S.C. § 355(j)(2)(B) that Eton filed Abbreviated New Drug
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`Application (“ANDA”) 214082 to the FDA and that ANDA 214082 contains a Paragraph IV
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`Certification for the ’453 Patent. Eton lacks sufficient knowledge and information to form a
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`belief as to the remaining allegations of Paragraph 51 and therefore denies the same.
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`52.
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`Eton admits that the Notice Letter provided written notification pursuant to 21
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`U.S.C. § 355(j)(2)(B) that Eton filed ANDA 214082 to the FDA and that ANDA 214082
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`contains a Paragraph IV Certification for the ’453 Patent. Eton also admits that it is seeking
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`FDA approval for the commercial manufacture, use, or sale of Eton’s Cysteine Hydrochloride
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`Injection, USP, 50 mg/mL, 10 mL Fill, Single Dose Vial (“Eton’s ANDA Product”) before the
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`expiration of the ’453 Patent. Eton denies the remaining allegations of Paragraph 52.
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`53.
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`Paragraph 53 contains legal conclusions to which no response is required. To the
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`extent a response is required, Eton admits that Plaintiff’s Complaint was filed on March 16,
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`2020, and Plaintiff’s Amended Complaint was filed on July 28, 2020. Eton lacks sufficient
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`knowledge and information to form a belief as to the remaining allegations of Paragraph 53 and
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`therefore denies the same.
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`54.
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`Eton admits that the reference listed drug that is the basis for ANDA 214082 is
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`ELCYS® (Cysteine Hydrochloride) Injection, USP, 50 mg/mL. Eton also admits the electronic
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`version of the Orange Book identifies EXELA PHARMA SCIENCES LLC as the purported
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`“Applicant Holder” for NDA 210660, purportedly for a solution containing CYSTEINE
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`HYDROCHLORIDE as the “Active Ingredient,” and identifies ELCYS as the “Proprietary
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`Name” and “Apr 16, 2019” as the “Approval Date” for this product. Eton denies the remaining
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`allegations of Paragraph 54.
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`55.
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`Eton admits that the Notice Letter to Plaintiff, providing written notification
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`pursuant to 21 U.S.C. § 355(j)(2)(B) that Eton filed ANDA 214082 to the FDA and that ANDA
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`214082 contains Paragraph IV Certifications for the ’453 Patent and that Eton’s ANDA includes
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`any required bioavailability and bioequivalence data. Eton denies the remaining allegations of
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`Paragraph 55.
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`Case 1:20-cv-00365-MN Document 20 Filed 08/11/20 Page 13 of 29 PageID #: 610
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`56.
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`Eton admits that it is seeking FDA approval for the commercial manufacture, use,
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`or sale of Eton’s ANDA Product before the expiration of the ’453 Patent. Eton denies the
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`remaining allegations of Paragraph 56.
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`57.
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`Eton admits that Eton’s Notice Letter includes a statement of the factual and legal
`
`bases of its Paragraph IV Certification that the ’453 Patent is invalid, unenforceable, and/or will
`
`not be infringed by the manufacture, use, or sale of Eton’s ANDA Product before the expiration
`
`of the ’453 Patent. Eton denies the remaining allegations of Paragraph 57, and avers that the
`
`asserted claims are not infringed and/or invalid for additional reasons.
`
`58.
`
`Eton admits that Eton’s Notice Letter includes a statement of the factual and legal
`
`bases of its Paragraph IV Certification that the ’453 Patent is invalid, unenforceable, and/or will
`
`not be infringed by the manufacture, use, or sale of Eton’s ANDA Product before the expiration
`
`of the ’453 Patent, including bases for alleging claims 1-21 are not infringed and claim 22 is
`
`invalid. Eton denies the remaining allegations of Paragraph 58, and avers that the asserted
`
`claims are not infringed and/or invalid for additional reasons.
`
`59.
`
`Eton admits that Eton’s Notice Letter includes a statement of the factual and legal
`
`bases of its Paragraph IV Certification that the ’453 Patent is invalid, unenforceable, and/or will
`
`not be infringed by the manufacture, use, or sale of Eton’s ANDA Product before the expiration
`
`of the ’453 Patent. Eton denies the remaining allegations of Paragraph 59, and avers that the
`
`asserted claims are not infringed and/or invalid for additional reasons.
`
`60.
`
`61.
`
`Eton admits that Eton’s Notice Letter was not marked as confidential.
`
`Eton admits that Eton’s Notice Letter included an Offer of Confidential Access
`
`(“OCA”) to ANDA 214082, and that, to date, the parties have not reached an agreement
`
`regarding the OCA. Eton further avers that the terms of Eton’s OCA are no more restrictive than
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`those typically found in a Protective Order, and, based upon information and belief, the terms in
`
`Eton’s OCA are similar to those proposed by Exela when similarly situated as Eton. Eton denies
`
`the remaining allegations of Paragraph 61.
`
`62.
`
`Eton admits that the parties have attempted to reach an agreement on an OCA,
`
`and that, to date, the parties have not reached an agreement regarding the OCA. Eton denies the
`
`remaining allegations of Paragraph 62.
`
`63.
`
`Paragraph 63 contains legal conclusions to which no response is required. To the
`
`extent a response is required, Eton admits that the FDA has not yet approved Eton’s ANDA
`
`Product. Eton denies the remaining allegations of Paragraph 63.
`
`64.
`
`Eton admits that, to date, the parties have not reached an agreement regarding the
`
`OCA and, therefore, Eton has not produced a complete copy of ANDA No. 214082. Eton denies
`
`the remaining allegations of Paragraph 64.
`
`65.
`
`Eton admits that a letter dated May 6, 2020 (“Second Notice Letter”) was sent on
`
`its behalf by Jeffrey Wolfson of the law firm Haynes and Boone, LLP to Plaintiff, providing
`
`written notification pursuant to 21 U.S.C. § 355(j)(2)(B) that Eton’s ANDA 214082 contains a
`
`Paragraph IV certification for the ’155 Patent and that Eton’s ANDA includes any required
`
`bioavailability and bioequivalence data. Eton further admits that Eton’s Second Notice Letter
`
`includes a statement of the factual and legal bases of its Paragraph IV Certification that the ’155
`
`Patent is invalid, unenforceable, and/or will not be infringed by the manufacture, use, or sale of
`
`Eton’s ANDA Product before the expiration of the ’155 Patent. Eton denies the remaining
`
`allegations of Paragraph 65.
`
`66.
`
`Eton admits that it filed ANDA 214082 to seek FDA approval to market Eton’s
`
`ANDA Product. Eton denies the remaining allegations of Paragraph 66.
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`67.
`
`Eton admits that it filed ANDA 214082 to seek FDA approval to market Eton’s
`
`ANDA Product. Eton denies the remaining allegations of Paragraph 67.
`
`68.
`
`Paragraph 68 contains legal conclusions to which no response is required. To the
`
`extent a response is required, Eton admits that there is a justiciable controversy between the
`
`parties with respect to whether the act of filing ANDA No. 214082 constitutes an act of
`
`infringement with respect to the’453, ’155, and ’719 Patents, but denies that it has engaged in
`
`any acts of infringement and denies the remaining allegations of Paragraph 68.
`
`69.
`
`Eton admits that ANDA 214082 contains labeling as required by applicable FDA
`
`statutes and regulations and states that the proposed labeling speaks for itself. Eton denies the
`
`remaining allegations of Paragraph 69.
`
`70.
`
`Eton admits that ANDA 214082 contains labeling as required by applicable FDA
`
`statutes and regulations and states that the proposed labeling speaks for itself. Eton denies the
`
`remaining allegations of Paragraph 70.
`
`71.
`
`Eton admits that ANDA 214082 contains labeling as required by applicable FDA
`
`statutes and regulations and states that the proposed labeling speaks for itself. Eton denies the
`
`remaining allegations of Paragraph 71.
`
`72.
`
`Eton admits that ANDA 214082 contains labeling as required by applicable FDA
`
`statutes and regulations and states that the proposed labeling speaks for itself. Eton denies the
`
`remaining allegations of Paragraph 72.
`
`73.
`
`Eton admits that ANDA 214082 contains labeling as required by applicable FDA
`
`statutes and regulations and states that the proposed labeling speaks for itself. Eton denies the
`
`remaining allegations of Paragraph 73.
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`74.
`
`Paragraph 74 contains legal conclusions to which no response is required. To the
`
`extent a response is required, Eton admits that the subject of Eton’s ANDA 214082 is an L-
`
`Cysteine Hydrochloride Injection Product for injection containing 500 mg/10 mL (50 mg/mL).
`
`Eton denies the remaining allegations of Paragraph 74.
`
`75.
`
`Paragraph 75 contains legal conclusions to which no response is required. To the
`
`extent a response is required, Eton lacks sufficient knowledge and information to form a belief as
`
`to the allegations of Paragraph 75 and therefore denies the same.
`
`76.
`
`Paragraph 76 contains legal conclusions to which no response is required. Eton
`
`admits that the product that is the subject of Eton’s ANDA 214082, meets any applicable
`
`stability requirements required by applicable FDA statutes and regulations. Eton denies the
`
`remaining allegations of Paragraph 76.
`
`77.
`
`Eton lacks sufficient knowledge and information to form a belief as to the
`
`allegations of Paragraph 77 and therefore denies the same.
`
`78.
`
`Eton lacks sufficient knowledge and information to form a belief as to the
`
`allegations of Paragraph 78 and therefore denies the same.
`
`79.
`
`Eton admits that ANDA 214082 contains labeling as required by applicable FDA
`
`statutes and regulations and states that the proposed labeling speaks for itself. Eton denies the
`
`remaining allegations of Paragraph 79.
`
`80.
`
`Paragraph 80 contains legal conclusions to which no response is required. To the
`
`extent a response is required, Eton lacks sufficient knowledge and information to form a belief as
`
`to the allegations of Paragraph 80 and therefore denies the same.
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`81.
`
`Paragraph 81 contains legal conclusions to which no response is required. To the
`
`extent a response is required, Eton lacks sufficient knowledge and information to form a belief as
`
`to the allegations of Paragraph 81 and therefore denies the same.
`
`82.
`
`Paragraph 82 contains legal conclusions to which no response is required. To the
`
`extent a response is required, Eton lacks sufficient knowledge and information to form a belief as
`
`to the allegations of Paragraph 82 and therefore denies the same.
`
`83.
`
`Paragraph 83 contains legal conclusions to which no response is required. To the
`
`extent a response is required, Eton lacks sufficient knowledge and information to form a belief as
`
`to the allegations of Paragraph 83 and therefore denies the same.
`
`84.
`
`Eton admits that ANDA 214082 contains labeling as required by applicable FDA
`
`statutes and regulations and states that the proposed labeling speaks for itself. Eton denies the
`
`remaining allegations of Paragraph 84.
`
`85.
`
`Eton admits that ANDA 214082 contains labeling as required by applicable FDA
`
`statutes and regulations and states that the proposed labeling speaks for itself. Eton denies the
`
`remaining allegations of Paragraph 85.
`
`86.
`
`Eton admits that ANDA 214082 contains labeling as required by applicable FDA
`
`statutes and regulations and states that the proposed labeling speaks for itself. Eton denies the
`
`remaining allegations of Paragraph 86.
`
`87.
`
`Eton admits that ANDA 214082 contains labeling as required by applicable FDA
`
`statutes and regulations and states that the proposed labeling speaks for itself. Eton denies the
`
`remaining allegations of Paragraph 87.
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`88.
`
`Eton admit