`
`
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`
`EXELA PHARMA SCIENCES, LLC,
`
`
`
`
`
`
`
`
`
`
`Plaintiff,
`
`
`
`
`
`
`v.
`
`
`
`
`
`
`
`
`
`
`
`ETON PHARMACEUTICALS, INC.,
`
`
`
`
`
`
`
`
`
`
`Defendant.
`
`
`)
`)
`)
`)
`)
`)
`)
`)
`)
`
`C.A. No. 20-00365-MN
`
`JURY TRIAL DEMANDED
`
`ETON PHARMACEUTICALS, INC.’S ANSWER
`AND AFFIRMATIVE DEFENSES TO COMPLAINT
`
`
`Defendant Eton Pharmaceuticals, Inc. (“Eton”), by and through its attorneys, hereby
`
`provides the following Answer and Affirmative Defenses to the Complaint filed by Plaintiff
`
`Exela Pharma Sciences, LLC (“Plaintiff”). Unless otherwise specifically admitted below, Eton
`
`denies all allegations in Plaintiff’s Complaint. See Fed. R. Civ. P. 8(b)(3).
`
`
`1.
`
`Eton admits that Plaintiff’s Complaint purports to bring an action for infringement
`
`NATURE OF ACTION
`
`of U.S. Patent Nos. 10,478,453 (“’453 Patent”) and 10,583,155 (“’155 Patent) (collectively,
`
`“Patents-in-Suit”) and that this action purports to arise under the Patent Laws of the United
`
`States, 35 U.S.C. § 1 et seq., and the Declaratory Judgment Act, 28 U.S.C. §§ 2201 and 2202.
`
`The remainder of Paragraph 1 is proffered as a legal conclusion to which no response is required.
`
`To the extent a response is required, Eton denies the remaining allegations of Paragraph 1.
`
`
`2.
`
`Eton lacks sufficient knowledge and information to form a belief as to the
`
`THE PARTIES
`
`allegations of Paragraph 2 and therefore denies the same.
`
`
`
`
`
`Eton Ex. 1077
`1 of 24
`
`
`
`Case 1:20-cv-00365-MN Document 8 Filed 05/06/20 Page 2 of 24 PageID #: 147
`
`
`
`3.
`
`Eton admits that it is a corporation organized and existing under the laws of the
`
`State of Delaware, with a principal place of business at 21925 West Field Parkway, Suite 235,
`
`Deer Park, IL 60010.
`
`JURISDICTION AND VENUE
`
`
`4.
`
`Paragraph 4 contains legal conclusions to which no response is required. To the
`
`extent a response is required, Eton does not contest subject matter jurisdiction over Plaintiff’s
`
`allegations against Eton under 35 U.S.C. § 271(e)(2) pursuant to 28 U.S.C. §§ 1331 and 1338(a)
`
`for purposes of this action only. Eton denies the remaining allegations of Paragraph 4.
`
`5.
`
`Paragraph 5 contains legal conclusions to which no response is required. To the
`
`extent a response is required, Eton does not contest personal jurisdiction for purposes of this
`
`action only and expressly reserves the right to contest personal jurisdiction in any other case as to
`
`any party, including Plaintiff. Eton also admits that “COGENCY GLOBAL INC., 850 NEW
`
`BURTON ROAD SUITE 201, DOVER, DE, 19904” is provided under the “REGISTERED
`
`AGENT INFORMATION” section of the State of Delaware’s Division of Corporations website
`
`as Eton’s registered agent in Delaware and is authorized to accept service on Eton’s behalf. Eton
`
`denies the remaining allegations of Paragraph 5.
`
`6.
`
`Paragraph 6 contains legal conclusions to which no response is required. To the
`
`extent a response is required, Eton does not contest venue for purposes of this action only and
`
`expressly reserves the right to contest venue in any other case as to any party, including Plaintiff.
`
`FACTUAL BACKGROUND
`
`
`A.
`
`
`7.
`
`The Development and FDA Approval of Exela’s ELCYS® L-Cysteine
`Product
`
`Eton lacks sufficient knowledge and information to form a belief as to the
`
`allegations of Paragraph 7 and therefore denies the same.
`
`
`
`2
`
`Eton Ex. 1077
`2 of 24
`
`
`
`Case 1:20-cv-00365-MN Document 8 Filed 05/06/20 Page 3 of 24 PageID #: 148
`
`
`
`8.
`
`Eton admits that L-cysteine is an amino acid that can be naturally synthesized in
`
`small amounts by humans, and that it may be provided as an L-Cysteine Hydrochloride Injection
`
`solution which, after combination with an Amino Acid Injection solution, is administered
`
`parenterally to meet the amino acid requirements of patients receiving total parenteral nutrition
`
`(“TPN”). Eton lacks sufficient knowledge and information to form a belief as to the remaining
`
`allegations of Paragraph 8 and therefore denies the same.
`
`9.
`
`Eton is without knowledge as to the timeframe during which Exela began
`
`developing its L-cysteine product, and therefore, it lacks sufficient knowledge to admit or deny
`
`that there was no FDA-approved intravenous L-cysteine hydrochloride product on the market in
`
`the United States at that time. Eton notes, however, that, in the 1980s, FDA approved a L-
`
`cysteine hydrochloride product (“Hospira L-cysteine product”). And, that no later than 2010,
`
`Sandoz Inc. offered an L-cysteine hydrochloride product (“Sandoz L-cysteine product”) in the
`
`United States market. Eton admits that aluminum is a known toxic impurity in parenteral
`
`nutritional compositions but denies that all L-cysteine products were known to contain high
`
`amounts of aluminum prior to the effective date of Exela’s purported invention. For example,
`
`the Sandoz L-cysteine product contained low levels of aluminum. Eton lacks sufficient
`
`knowledge and information to form a belief as to the remaining allegations of Paragraph 9 and
`
`therefore denies the same.
`
`10.
`
`Eton admits that the literature known to the pharmaceutical industry identifies
`
`various health problems associated with aluminum toxicity. Eton denies that all TPN
`
`admixtures, including those without L-cysteine, necessarily had high levels of aluminum. Eton
`
`lacks sufficient knowledge and information to form a belief as to the remaining allegations of
`
`Paragraph 10 and therefore denies the same.
`
`
`
`3
`
`Eton Ex. 1077
`3 of 24
`
`
`
`Case 1:20-cv-00365-MN Document 8 Filed 05/06/20 Page 4 of 24 PageID #: 149
`
`
`
`11.
`
`Eton admits that the FDA amended the labeling requirements for parenteral drug
`
`products, that these amendments were codified at 21 C.F.R. § 201.323, and that Paragraph 11
`
`includes a portion of the warning required by the FDA. Eton lacks sufficient knowledge and
`
`information to form a belief as to the remaining allegations of Paragraph 11 and therefore denies
`
`the same.
`
`12.
`
`Upon information and belief, Eton admits that Exela secured FDA approval in
`
`April 2019, for an injectable L-cysteine hydrochloride product. Eton denies that the product
`
`fulfilled a long-felt need for a low-aluminum injectable cysteine product. Eton lacks sufficient
`
`knowledge and information to form a belief as to the remaining allegations of Paragraph 12 and
`
`therefore denies the same.
`
`13.
`
`Eton admits that the Approved Drug Products with Therapeutic Equivalence
`
`Evaluations (an FDA publication commonly known as the “Orange Book”) identifies EXELA
`
`PHARMA SCIENCES LLC as the purported “Applicant Holder” for NDA 210660, purportedly
`
`for a solution containing CYSTEINE HYDROCHLORIDE as the “Active Ingredient,” and
`
`identifies ELCYS as the “Proprietary Name” for this product. Eton lacks sufficient knowledge
`
`and information to form a belief as to the remaining allegations of Paragraph 13 and therefore
`
`denies the same.
`
`14.
`
`Eton admits that Exhibit B purports to be a copy of ELCYS’s “HIGHLIGHTS OF
`
`PRESCRIBING INFORMATION,” revised 04/2019, and states in “11 DESCRIPTION,” that
`
`“ELCYS contains no more than 120 mcg/L of aluminum.” Eton lacks sufficient knowledge and
`
`information to form a belief as to the remaining allegations of Paragraph 14 and therefore denies
`
`the same.
`
`
`
`4
`
`Eton Ex. 1077
`4 of 24
`
`
`
`Case 1:20-cv-00365-MN Document 8 Filed 05/06/20 Page 5 of 24 PageID #: 150
`
`
`
`15.
`
`Eton admits that Exhibit B purports to be a copy of ELCYS’s “HIGHLIGHTS OF
`
`PRESCRIBING INFORMATION,” revised 04/2019, and states in “11 DESCRIPTION,” that
`
`“ELCYS (cysteine hydrochloride injection) is a sterile, nonpyrogenic solution for intravenous
`
`use” and that “[e]ach 10 mL of ELCYS contains 500 mg of cysteine hydrochloride, USP
`
`(equivalent to 345 mg of cysteine) in water for injection.” Eton lacks sufficient knowledge and
`
`information to form a belief as to the remaining allegations of Paragraph 15 and therefore denies
`
`the same.
`
`16.
`
`Eton admits that pyruvic acid and cystine were known oxidative degradation
`
`products of L-cysteine. Eton lacks sufficient knowledge and information to form a belief as to
`
`the remaining allegations of Paragraph 16 and therefore denies the same.
`
`17.
`
`Eton admits that Exhibit B purports to be a copy of ELCYS’s “HIGHLIGHTS OF
`
`PRESCRIBING INFORMATION,” revised 04/2019, and states in “1 INDICATIONS AND
`
`USAGE,” that “ELCYS is indicated for use as an additive to amino acid solutions to meet the
`
`nutritional requirements of newborn infants requiring total parenteral nutrition (TPN) and of
`
`adult and pediatric patients with severe liver disease who may have impaired enzymatic
`
`processes and require TPN” and that ELCYS “can also be added to amino acid solutions to
`
`provide a more complete profile of amino acids for protein synthesis.” Eton lacks sufficient
`
`knowledge and information to form a belief as to the remaining allegations of Paragraph 17 and
`
`therefore denies the same.
`
`18.
`
`Eton admits that Exhibit B purports to be a copy of ELCYS’s “HIGHLIGHTS OF
`
`PRESCRIBING INFORMATION,” revised 04/2019, and includes, in “2 DOSAGE AND
`
`ADMINISTRATION,” the following sections: “2.1 Important Administration Information”; “2.2
`
`Preparation and Administration Instructions”; “2.3 Preparation Instructions for Admixing Using
`
`
`
`5
`
`Eton Ex. 1077
`5 of 24
`
`
`
`Case 1:20-cv-00365-MN Document 8 Filed 05/06/20 Page 6 of 24 PageID #: 151
`
`
`
`a Parenteral Nutrition (PN) Container”; “2.4 Dosing Considerations”; and “2.5 Recommended
`
`Dosage in Pediatric Patients and Adults.” In “2.1 Important Administration Information,”
`
`Exhibit B provides that (1) “ELCYS is for admixing use only”; (2) ELCYS “is not for direct
`
`intravenous infusion”; and (3) “Prior to administration, ELCYS must be diluted and used as an
`
`admixture in parenteral nutrition (PN) solutions.” (emphases in original.) Eton lacks sufficient
`
`knowledge and information to form a belief as to the remaining allegations of Paragraph 18 and
`
`therefore denies the same.
`
`19.
`
`Eton admits that Exhibit B purports to be a copy of ELCYS’s “HIGHLIGHTS OF
`
`PRESCRIBING INFORMATION,” revised 04/2019, and that, in “2.4 Dosing Considerations,”
`
`provides that “[t]he dosage of the final PN solution containing ELCYS must be based on the
`
`concentrations of all components in the solution and the recommended nutritional requirements
`
`[see Dosage and Administration (2.5)].” (emphasis in original.) Eton lacks sufficient knowledge
`
`and information to form a belief as to the remaining allegations of Paragraph 19 and therefore
`
`denies the same.
`
`20.
`
`Eton admits that Exhibit B purports to be a copy of ELCYS’s “HIGHLIGHTS OF
`
`PRESCRIBING INFORMATION,” revised 04/2019, and includes, in “5 WARNINGS AND
`
`PRECAUTIONS,” several sections, including “5.7 Aluminum Toxicity,” which states the
`
`following:
`
`ELCYS contains aluminum that may be toxic.
`
`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.
`
`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
`
`
`
`6
`
`Eton Ex. 1077
`6 of 24
`
`
`
`Case 1:20-cv-00365-MN Document 8 Filed 05/06/20 Page 7 of 24 PageID #: 152
`
`
`
`central nervous system and bone toxicity. Tissue loading may occur at even lower rates
`of administration.
`
`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)].
`
`(emphases in original.) Eton lacks sufficient knowledge and information to form a belief as to
`
`the remaining allegations of Paragraph 20 and therefore denies the same.
`
`
`
`B.
`
`21.
`
`The Asserted ’453 Patent
`
`Eton admits that Exhibit C purports to be a copy of the ’453 Patent and that, on its
`
`face, Exhibit C is entitled, “Stable, Highly Pure L-Cysteine Compositions for Injection and
`
`Methods of Use.” Eton also admits that Exhibit C, on its face, indicates that the “Date of Patent”
`
`is “Nov. 19, 2019” and that the named “Inventors” are John Maloney, Aruna Koganti, and
`
`Phanesh Koneru. Eton denies the remaining allegations of Paragraph 21.
`
`22.
`
`Eton admits that Exhibit C indicates on its face that “Exela Pharma Sciences,
`
`LLC, Lenoir, NC (US)” is the “Assignee” of the ’453 Patent. Eton lacks sufficient knowledge
`
`and information to form a belief as to the remaining allegations of Paragraph 22 and therefore
`
`denies the same.
`
`23.
`
`Eton admits that the ’453 Patent is listed in the Orange Book for NDA 210660
`
`and that “11/19/2019” is identified as the “Submission Date” for the ’453 Patent. Eton lacks
`
`sufficient knowledge and information to form a belief as to the remaining allegations of
`
`Paragraph 23 and therefore denies the same.
`
`24.
`
`Eton lacks sufficient knowledge and information to form a belief as to the
`
`allegations of Paragraph 24 and therefore denies the same.
`
`
`
`7
`
`Eton Ex. 1077
`7 of 24
`
`
`
`Case 1:20-cv-00365-MN Document 8 Filed 05/06/20 Page 8 of 24 PageID #: 153
`
`
`
`25.
`
`Admitted.
`
`26.
`
`Admitted.
`
`27.
`
`Admitted.
`
`28.
`
`Eton lacks sufficient knowledge and information to form a belief as to the
`
`allegations of Paragraph 28 and therefore denies the same.
`
`
`
`C.
`
`29.
`
`The Asserted ’155 Patent
`
`Eton admits that Exhibit D purports to be a copy of the ’155 Patent and that, on its
`
`face, Exhibit D is entitled, “Stable, Highly Pure L-Cysteine Compositions for Injection and
`
`Methods of Use.” Eton also admits that Exhibit D, on its face, indicates that the “Date of Patent”
`
`is “*Mar. 10, 2020” and that the named “Inventors” are John Maloney, Aruna Koganti, and
`
`Phanesh Koneru. Eton denies the remaining allegations of Paragraph 29.
`
`30.
`
`Eton admits that Exhibit D indicates on its face that “Exela Pharma Sciences,
`
`LLC, Lenoir, NC (US)” is the “Assignee” of the ’155 Patent. Eton lacks sufficient knowledge
`
`and information to form a belief as to the remaining allegations of Paragraph 30 and therefore
`
`denies the same.
`
`31.
`
`Eton admits that the ’155 Patent is listed in the Orange Book NDA 210660 and
`
`that “03/10/2020” is identified as the “Submission Date” for the ’155 Patent. Eton lacks
`
`sufficient knowledge and information to form a belief as to the remaining allegations of
`
`Paragraph 31 and therefore denies the same.
`
`32.
`
`Eton lacks sufficient knowledge and information to form a belief as to the
`
`allegations of Paragraph 32 and therefore denies the same.
`
`33.
`
`Admitted.
`
`34.
`
`Admitted.
`
`
`
`8
`
`Eton Ex. 1077
`8 of 24
`
`
`
`Case 1:20-cv-00365-MN Document 8 Filed 05/06/20 Page 9 of 24 PageID #: 154
`
`
`
`35.
`
`Admitted.
`
`36.
`
`Eton lacks sufficient knowledge and information to form a belief as to the
`
`allegations of Paragraph 36 and therefore denies the same.
`
`ALLEGED ACTS GIVING RISE TO THIS ACTION FOR DEFENDANT’S ALLEGED
`INFRINGEMENT OF THE PATENTS-IN-SUIT
`
`Eton admits that a letter dated January 31, 2020 (“Notice Letter”) was sent on its
`
`37.
`
`behalf by Jeffrey Wolfson of the law firm of Haynes and Boone, LLP to Plaintiff, providing
`
`written notification pursuant to 21 U.S.C. § 355(j)(2)(B) that Eton filed Abbreviated New Drug
`
`Application (“ANDA”) 214082 to the FDA and that ANDA 214082 contains a Paragraph IV
`
`Certification for the ’453 Patent. Eton lacks sufficient knowledge and information to form a
`
`belief as to the remaining allegations of Paragraph 37 and therefore denies the same.
`
`38.
`
`Eton admits that the Notice Letter provided written notification pursuant to 21
`
`U.S.C. § 355(j)(2)(B) that Eton filed ANDA 214082 to the FDA and that ANDA 214082
`
`contains a Paragraph IV Certification for the ’453 Patent. Eton also admits that it is seeking
`
`FDA approval for the commercial manufacture, use, or sale of Eton’s Cysteine Hydrochloride
`
`Injection, USP, 50 mg/mL, 10 mL Fill, Single Dose Vial (“Eton’s ANDA Product”) before the
`
`expiration of the ’453 Patent. Eton denies the remaining allegations of Paragraph 38.
`
`39.
`
`Paragraph 39 contains legal conclusions to which no response is required. To the
`
`extent a response is required, Eton admits that Plaintiff’s Complaint was filed on March 16,
`
`2020. Eton lacks sufficient knowledge and information to form a belief as to the remaining
`
`allegations of Paragraph 39 and therefore denies the same.
`
`40.
`
`Eton admits that the reference listed drug that is the basis for ANDA 214082 is
`
`ELCYS® (Cysteine Hydrochloride) Injection, USP, 50 mg/mL. Eton also admits the electronic
`
`version of the Orange Book identifies EXELA PHARMA SCIENCES LLC as the purported
`
`
`
`9
`
`Eton Ex. 1077
`9 of 24
`
`
`
`Case 1:20-cv-00365-MN Document 8 Filed 05/06/20 Page 10 of 24 PageID #: 155
`
`
`
`“Applicant Holder” for NDA 210660, purportedly for a solution containing CYSTEINE
`
`HYDROCHLORIDE as the “Active Ingredient,” and identifies ELCYS as the “Proprietary
`
`Name” and “Apr 16, 2019” as the “Approval Date” for this product. Eton denies the remaining
`
`allegations of Paragraph 40.
`
`41.
`
`Eton admits that the Notice Letter to Plaintiff, providing written notification
`
`pursuant to 21 U.S.C. § 355(j)(2)(B) that Eton filed ANDA 214082 to the FDA and that ANDA
`
`214082 contains Paragraph IV Certifications for the ’453 Patent and that Eton’s ANDA includes
`
`any required bioavailability and bioequivalence data. Eton denies the remaining allegations of
`
`Paragraph 41.
`
`42.
`
`Eton admits that it is seeking FDA approval for the commercial manufacture, use,
`
`or sale of Eton’s ANDA Product before the expiration of the ’453 Patent. Eton denies the
`
`remaining allegations of Paragraph 42.
`
`43.
`
`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 43, and avers that the
`
`asserted claims are not infringed and/or invalid for additional reasons.
`
`44.
`
`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 44, and avers that the asserted
`
`claims are not infringed and/or invalid for additional reasons.
`
`
`
`10
`
`Eton Ex. 1077
`10 of 24
`
`
`
`Case 1:20-cv-00365-MN Document 8 Filed 05/06/20 Page 11 of 24 PageID #: 156
`
`
`
`45.
`
`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 45, and avers that the
`
`asserted claims are not infringed and/or invalid for additional reasons.
`
`46.
`
`47.
`
`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
`
`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 47.
`
`48.
`
`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 48.
`
`49.
`
`Paragraph 49 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 49.
`
`50.
`
`Eton admits that it filed ANDA 214082 to seek FDA approval to market Eton’s
`
`ANDA Product. Eton denies the remaining allegations of Paragraph 50.
`
`51.
`
`Eton admits that it filed ANDA 214082 to seek FDA approval to market Eton’s
`
`ANDA Product. Eton denies the remaining allegations of Paragraph 51.
`
`
`
`11
`
`Eton Ex. 1077
`11 of 24
`
`
`
`Case 1:20-cv-00365-MN Document 8 Filed 05/06/20 Page 12 of 24 PageID #: 157
`
`
`
`52.
`
`Paragraph 52 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 Patent and/or ’155 Patent, but denies that it has engaged in
`
`any acts of infringement and denies the remaining allegations of Paragraph 52.
`
`53.
`
`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 53.
`
`54.
`
`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 54.
`
`55.
`
`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 55.
`
`56.
`
`Paragraph 56 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 56.
`
`57.
`
`Paragraph 57 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 57.
`
`
`
`12
`
`Eton Ex. 1077
`12 of 24
`
`
`
`Case 1:20-cv-00365-MN Document 8 Filed 05/06/20 Page 13 of 24 PageID #: 158
`
`
`
`58.
`
`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 58.
`
`59.
`
`Paragraph 59 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 59 and therefore denies the same.
`
`60.
`
`Paragraph 60 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 60 and therefore denies the same.
`
`61.
`
`Paragraph 61 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 61 and therefore denies the same.
`
`62.
`
`Paragraph 62 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 62 and therefore denies the same.
`
`63.
`
`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 63.
`
`64.
`
`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 64.
`
`
`
`13
`
`Eton Ex. 1077
`13 of 24
`
`
`
`Case 1:20-cv-00365-MN Document 8 Filed 05/06/20 Page 14 of 24 PageID #: 159
`
`
`
`65.
`
`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 65.
`
`66.
`
`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 66.
`
`67.
`
`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 67.
`
`68.
`
`Paragraph 68 contains legal conclusions to which no response is required. To the
`
`extent a response is required, Eton denies the allegations of Paragraph 68.
`
`69.
`
`Eton lacks sufficient knowledge and information to form a belief as to the
`
`allegations of Paragraph 69 and therefore denies the same.
`
`70.
`
`Paragraph 70 contains legal conclusions to which no response is required. To the
`
`extent a response is required, Eton denies the allegations of Paragraph 70.
`
`71.
`
`Paragraph 71 contains legal conclusions to which no response is required. To the
`
`extent a response is required, Eton denies the allegations of Paragraph 71.
`
`COUNT I
`(Alleged Infringement of the ’453 Patent Under 35 U.S.C. § 271(e)(2))
`
`
`72.
`
`Eton restates and incorporates by reference its responses to the preceding
`
`paragraphs as if fully set forth herein.
`
`73.
`
`Eton admits that it filed ANDA 214082 to seek FDA approval for Eton’s ANDA
`
`Product. Eton denies the remaining allegations of Paragraph 73.
`
`74.
`
`Eton denies the allegations of Paragraph 74.
`
`
`
`14
`
`Eton Ex. 1077
`14 of 24
`
`
`
`Case 1:20-cv-00365-MN Document 8 Filed 05/06/20 Page 15 of 24 PageID #: 160
`
`
`
`75.
`
`Eton admits it became aware of the ’453 Patent at or about the time the ’453
`
`Patent was listed in the Orange Book in connection with ELCYS®. Eton denies the remaining
`
`allegations of Paragraph 75.
`
`76.
`
`Eton denies the allegations of Paragraph 76.
`
`77.
`
`Eton denies the allegations of Paragraph 77.
`
`78.
`
`Eton denies the allegations of Paragraph 78.
`
`79.
`
`Eton denies the allegations of Paragraph 79.
`
`COUNT II
`(Declaratory Judgment of Alleged Infringement of the ’453 Patent Under 35 U.S.C. §
`271(a))
`
`
`80.
`
`Eton restates and incorporates by reference its responses to the preceding
`
`paragraphs as if fully set forth herein.
`
`81.
`
`Eton admits that this claim purports to arise under the Declaratory Judgment Act,
`
`28 U.S.C. §§ 2201 and 2202. Eton denies that there is subject matter jurisdiction for this claim.
`
`82.
`
`Paragraph 82 contains legal conclusions to which no response is required. To the
`
`extent a response is required, Eton denies the allegations of Paragraph 82.
`
`83.
`
`Eton admits that it filed ANDA 214082 to seek FDA approval for Eton’s ANDA
`
`Product. Eton denies the remaining allegations of Paragraph 83.
`
`84.
`
`Eton admits that it filed ANDA 214082 to seek FDA approval for Eton’s ANDA
`
`Product. Eton denies the remaining allegations of Paragraph 84.
`
`85.
`
`Eton denies the allegations of Paragraph 85.
`
`86.
`
`Eton denies the allegations of Paragraph 86.
`
`87.
`
`Eton denies the allegations of Paragraph 87.
`
`88.
`
`Eton denies the allegations of Paragraph 88.
`
`
`
`15
`
`Eton Ex. 1077
`15 of 24
`
`
`
`Case 1:20-cv-00365-MN Document 8 Filed 05/06/20 Page 16 of 24 PageID #: 161
`
`
`
`COUNT III
`(Declaratory Judgment of Alleged Infringement of the ’453 Patent Under 35 U.S.C. §
`271(b))
`
`
`89.
`
`Eton restates and incorporates by reference its responses to the proceeding
`
`paragraphs as if fully set forth herein.
`
`90.
`
`Eton admits that this claim purports to arise under the Declaratory Judgment Act,
`
`28 U.S.C. §§ 2201 and 2202. Eton denies that there is subject matter jurisdiction for this claim.
`
`91.
`
`Paragraph 91 contains legal conclusions to which no response is required. To the
`
`extent a response is required, Eton denies the allegations of Paragraph 91.
`
`92.
`
`Admitted.
`
`93.
`
`Eton admits it became aware of the ’453 Patent at or about the time the ’453
`
`Patent was listed in the Orange Book in connection with ELCYS®. Eton denies the remaining
`
`allegations of Paragraph 93.
`
`94.
`
`Eton admits that it filed ANDA 214082 to seek FDA approval for Eton’s ANDA
`
`Product. Eton denies the remaining allegations of Paragraph 94.
`
`95.
`
`Eton admits that it filed ANDA 214082 to seek FDA approval for Eton’s ANDA
`
`Product. Eton denies the remaining allegations of Paragraph 95.
`
`96.
`
`Eton denies the allegations of Paragraph 96.
`
`97.
`
`Eton denies the allegations of Paragraph 97.
`
`98.
`
`Eton denies the allegations of Paragraph 98.
`
`99.
`
`Eton denies the allegations of Paragraph 99.
`
`100. Eton denies the allegations of Paragraph 100.
`
`101. 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
`
`
`
`16
`
`Eton Ex. 1077
`16 of 24
`
`
`
`Case 1:20-cv-00365-MN Document 8 Filed 05/06/20 Page 17 of 24 PageID #: 162
`
`
`
`not be infringed by the manufacture, use, or sale of Eton’s ANDA Product before the expiration
`
`of the ’453 Patent, but avers that there are additional bases of non-infringement and/or invalidity
`
`of claim 22. Eton denies the remaining allegations of Paragraph 101.
`
`102. Eton denies the allegations of Paragraph 102.
`
`103. Eton denies the allegations of Paragraph 103.
`
`104. Eton denies the allegations of Paragraph 104.
`
`COUNT IV
`(Declaratory Judgment of Alleged Infringement of the ’453 Patent Under 35 U.S.C. §
`271(c))
`
`
`105. Eton restates and incorporates by reference its responses to the preceding
`
`paragraphs as if fully set forth herein.
`
`106. Eton admits that this claim purports to arise under the Declaratory Judgment Act,
`
`28 U.S.C. §§ 2201 and 2202. Eton denies that there is subject matter jurisdiction for this claim.
`
`107. Paragraph 107 contains legal conclusions to which no response is required. To
`
`the extent a response is required, Eton denies the allegations of Paragraph 107.
`
`108. Admitted.
`
`109. Eton admits it became aware of the ’453 Patent at or about the time the ’453
`
`Patent was listed in the Orange Book in connection with ELCYS®. Eton denies the remaining
`
`allegations of Paragraph 109.
`
`110. Eton admits that it filed ANDA 214082 to seek FDA approval for Eton’s ANDA
`
`Product. Eton denies the remaining allegations of Paragraph 110.
`
`111. Eton admits that it filed ANDA 214082 to seek FDA approval for Eton’s ANDA
`
`Product. Eton denies the remaining allegations of Paragraph 111.
`
`112. Eton denies the allegations of Paragraph 112.
`
`
`
`17
`
`Eton Ex. 1077
`17 of 24
`
`
`
`Case 1:20-cv-00365-MN Document 8 Filed 05/06/20 Page 18 of 24 PageID #: 163
`
`
`
`113. Eton denies the allegations of Paragraph 113.
`
`114. Eton denies the allegations of Paragraph 114.
`
`115. Eton denies the allegations of Paragraph 115.
`
`116. Eton admits that Eton’s Notice Letter includes a statement of the factual and legal
`
`basis of its Paragraph IV Certification that the ’453 Patent is invalid, unenforceable, and/or will
`
`not be infringed by