Case 1:13-cv-05723-NLH-AMD Document 188 Filed 10/13/14 Page 1 of 19 PageID: 3908
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`
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`Eric I. Abraham
`Christy L. Saveriano
`HILL WALLACK LLP
`202 Carnegie Center
`Princeton, New Jersey 08540
`Telephone: (609) 924-0808
`Fax: (609) 452-1888
`Attorneys for Defendant
`ACS Dobfar Info SA
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF NEW JERSEY
`
`CHIESI USA INC.,
`CORNERSTONE BIOPHARMA, INC., and
`EKR THERAPEUTICS, LLC,
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`Plaintiffs,
`
`v.
`
`
`SANDOZ INC., SANDOZ AG, and
`ACS DOBFAR INFO SA
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`Defendants.
`
`SANDOZ INC.
`
`Counterclaim-Plaintiff,
`
`v.
`
`
`CHIESI USA INC.,
`CORNERSTONE BIOPHARMA, INC., and
`EKR THERAPEUTICS, LLC
`
`Counterclaim-Defendants.
`
`Civil Action No. 1:13-cv-05723-NLH-
`AMD
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`
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`
`ACS DOBFAR INFO SA ANSWER TO PLAINTIFFS’ AMENDED COMPLAINT
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`Defendant ACS Dobfar Info SA (“Dobfar”), by and through its undersigned attorneys,
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`hereby answers each of the numbered paragraphs of the Amended Complaint by Chiesi USA,
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`Inc. (“Chiesi USA,” formerly known as Cornerstone Therapeutics Inc.), Cornerstone BioPharma,
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`Inc. (“Cornerstone BioPharma”), and EKR Therapeutics, LLC (“EKR,” collectively “Plaintiffs”).
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`ny-1154439
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`IPR2015-00006
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`Sandoz Exhibit 1021 Page 1
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`Except as expressly admitted below, Dobfar denies each and every allegation of Plaintiffs’
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`Amended Complaint.
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`1.
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`Answering paragraph 1 of the Amended Complaint, Dobfar denies each and every
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`allegation therein, except Dobfar admits that this is an action for patent infringement purportedly
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`arising under the patent laws of the United States, Title 35 of the United States Code, involving
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`United States Patent Nos. 7,612,102 (the “’102 Patent”), 7,659,291 (the “’291 Patent”),
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`8,455,524 (the “’524 Patent”), and 7,659,290 (the “’290 Patent”, collectively with the ’102, ’291
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`and ’524 Patents, the “Patents-in-Suit”). Dobfar further admits that purported copies of the ’102,
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`’291, ’524, and ’290 Patents are attached as Exhibits A-D, respectively, to the Amended
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`Complaint.
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`2.
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`Answering Paragraph 2 of the Amended Complaint, Dobfar states that it lacks
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`knowledge or information sufficient to form a belief as to the truth of the allegations in
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`Paragraph 2 and therefore denies each and every allegation therein.
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`3.
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`Answering Paragraph 3 of the Amended Complaint, Dobfar states that it lacks
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`knowledge or information sufficient to form a belief as to the truth of the allegations in
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`Paragraph 3 and therefore denies each and every allegation therein.
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`4.
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`Answering Paragraph 4 of the Amended Complaint, Dobfar states that it lacks
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`knowledge or information sufficient to form a belief as to the truth of the allegations in
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`Paragraph 4 and therefore denies each and every allegation therein.
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`5.
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`Answering Paragraph 5 of the Amended Complaint, Dobfar states that the
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`allegations in Paragraph 5 are directed to another Defendant and therefore require no response
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`from Dobfar. See Fed. R. Civ. P. 8(b)(1)(B).
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`IPR2015-00006
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`Sandoz Exhibit 1021 Page 2
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`6.
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`Answering Paragraph 6 of the Amended Complaint, Dobfar states that the
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`allegations in Paragraph 6 are directed to another Defendant and therefore require no response
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`from Dobfar. See Fed. R. Civ. P. 8(b)(1)(B).
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`7.
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`Answering Paragraph 7 of the Amended Complaint, Dobfar states that the
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`allegations in Paragraph 7 are directed to another Defendant and therefore require no response
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`from Dobfar. See Fed. R. Civ. P. 8(b)(1)(B).
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`8.
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`Answering Paragraph 8 of the Amended Complaint, Dobfar states that the
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`allegations in Paragraph 8 are directed to another Defendant and therefore require no response
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`from Dobfar. See Fed. R. Civ. P. 8(b)(1)(B).
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`9.
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`Answering Paragraph 9 of the Amended Complaint, Dobfar states that the
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`allegations in Paragraph 9 are directed to another Defendant and therefore require no response
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`from Dobfar. See Fed. R. Civ. P. 8(b)(1)(B).
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`10.
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`Answering Paragraph 10 of the Amended Complaint, Dobfar admits that it has a
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`place of business at ACS Dobfar Info SA, Casai, CH- 7748 Campascio, Switzerland.
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`11.
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`Answering Paragraph 11 of the Amended Complaint, Dobfar states that
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`Paragraph 11 consists entirely of legal conclusions that do not require a response, and denies
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`each and every allegation therein to which a response is required, but states that it does not
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`contest that subject matter jurisdiction is proper pursuant to 28 U.S.C. §§ 1331 and 1338(a) with
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`respect to Plaintiffs’ claims regarding the ’102, ’291, and ’524 Patents under 35 U.S.C. §
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`271(e)(2)(A). Dobfar specifically denies all other allegations of subject matter jurisdiction under
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`any other sub-paragraphs of 35 U.S.C. § 271, and further denies that this Court has the subject
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`matter jurisdiction over the ’290 Patent.
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`IPR2015-00006
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`Sandoz Exhibit 1021 Page 3
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`12.
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`Answering Paragraph 12 of the Amended Complaint, Dobfar states that
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`Paragraph 12 consists entirely of legal conclusions that do not require a response and further
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`states that the allegations of Paragraph 12 are directed to another Defendant and therefore require
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`no response from Dobfar. See Fed. R. Civ. P. 8(b)(1)(B).
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`13.
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`Answering Paragraph 13 of the Amended Complaint, Dobfar states that
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`Paragraph 13 consists entirely of legal conclusions that do not require a response, and denies
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`each and every allegation therein to which a response is required, except admits: (1) Dobfar
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`entered into a Manufacture and Supply Agreement with Sandoz AG, the content of which speaks
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`for itself and (2) that in the matter of Novartis Pharm. Corp. v. Actavis LLC, Civ. No. 13-1028
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`(D.N.J.) Dobfar stated that “Dobfar admits, for purposes of this action only, that the Court has
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`personal jurisdiction over Dobfar.” (Civ. No. 13-1028, Dkt. No. 223.)
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`14.
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`Answering Paragraph 14 of the Amended Complaint, Dobfar states that
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`Paragraph 14 consists entirely of legal conclusions that do not require a response, and denies the
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`allegations of Paragraph 14.
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`15.
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`Answering Paragraph 15 of the Amended Complaint, Dobfar states that it lacks
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`knowledge or information sufficient to form a belief about the truth of the allegations in
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`Paragraph 15 and therefore denies them.
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`16.
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`Answering Paragraph 16 of the Amended Complaint, Dobfar denies the
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`allegations therein, except admits that the ’102 Patent is entitled “Pre-mixed, Ready-to-Use
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`Pharmaceutical Compositions,” and that the ’102 Patent states on its face that it was issued on
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`November 3, 2009.
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`17.
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`Answering Paragraph 17 of the Amended Complaint, Dobfar denies the
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`allegations therein, except admits that the ’291 Patent is entitled “Methods of Treatment with
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`IPR2015-00006
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`Sandoz Exhibit 1021 Page 4
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`Pre-Mixed, Ready-to-Use Pharmaceutical Compositions,” and that the ’291 Patent states on its
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`face that it was issued on February 9, 2010.
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`18.
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`Answering Paragraph 18 of the Amended Complaint, Dobfar denies the
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`allegations therein, except admits that the ’524 Patent is entitled “Methods of Treatment with
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`Pre-Mixed, Ready-to-Use Pharmaceutical Compositions,” and that the ’524 Patent states on its
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`face that it was issued on June 4, 2013.
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`19.
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`Answering Paragraph 19 of the Amended Complaint, Dobfar denies the
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`allegations therein, except admits that the ’290 Patent is entitled “Methods of Preparing Pre-
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`Mixed, Ready-to-Use Pharmaceutical Compositions,” that the ’290 Patent states on its face that
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`it was issued on February 9, 2010, that the face of the ’290 Patent lists U.S. Patent Application
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`No. 12/407,551 as the patent application from which the ’290 Patent issued, and states that the
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`12/407,551 application is a division of U.S. Patent Application No. 11/788,076.
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`20.
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`Answering Paragraph 20 of the Amended Complaint, Dobfar states that it lacks
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`knowledge or information sufficient to form a belief about the truth of the allegations in
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`Paragraph 20 and therefore denies them, except admits that the face of each Patent-in-Suit states
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`that it claims priority to U.S. Provisional Application No. 60/793,074.
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`21.
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`Answering Paragraph 21 of the Amended Complaint, Dobfar states that it lacks
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`knowledge or information sufficient to form a belief about the truth of the allegations in
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`Paragraph 21 and therefore denies them, except Dobfar admits that the ’102 Patent, the ’291
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`Patent, and the ’524 Patent are listed in FDA’s publication titled “Approved Drug Products with
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`Therapeutic Equivalence Evaluations” (commonly known as the “Orange Book”).
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`22.
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`Answering Paragraph 22 of the Amended Complaint, Dobfar states that the
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`allegations in Paragraph 22 are directed to another Defendant and therefore require no response
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`IPR2015-00006
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`Sandoz Exhibit 1021 Page 5
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`from Dobfar. Dobfar objects that the allegations in Paragraph 22 are not “simple, concise, and
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`direct” as required under Federal Rule of Civil Procedure 8(d)(1) and, on that basis, denies the
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`allegations of Paragraph 22. To the extent that a response by Dobfar is required, Dobfar denies
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`the allegations of Paragraph 22, except on information and belief, Dobfar admits that ANDA
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`203978 was filed and that the ANDA seeks FDA approval of the drug products described
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`therein.
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`23.
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`Answering Paragraph 23 of the Amended Complaint, Dobfar denies the
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`allegations of Paragraph 23.
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`24.
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`Answering Paragraph 24 of the Amended Complaint, Dobfar denies the
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`allegations of Paragraph 24, except admits that Sandoz AG and Dobfar entered into the
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`Manufacture and Supply Agreement dated July 27, 2011, the content of which speaks for itself.
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`25.
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`Answering Paragraph 25 of the Amended Complaint, Dobfar denies the
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`allegations of Paragraph 25, and refers to the Manufacture and Supply Agreement, which speaks
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`for itself.
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`26.
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`Answering Paragraph 26 of the Amended Complaint, Dobfar objects that the
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`allegations in Paragraph 26 are not “simple, concise, and direct” as required under Federal Rule
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`of Civil Procedure 8(d)(1) and, on that basis, denies the allegations of Paragraph 26. To the
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`extent that a response by Dobfar is required, Dobfar denies the allegations of Paragraph 26, and
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`refers to the Manufacture and Supply Agreement, which speaks for itself.
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`27.
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`Answering Paragraph 27 of the Amended Complaint, Dobfar denies the
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`allegations of Paragraph 27, and refers to the Manufacture and Supply Agreement, which speaks
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`for itself.
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`Sandoz Exhibit 1021 Page 6
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`28.
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`Answering Paragraph 28 of the Amended Complaint, Dobfar denies the
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`allegations of Paragraph 28, and refers to the Manufacture and Supply Agreement, which speaks
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`for itself.
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`29.
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`Answering Paragraph 29 of the Amended Complaint, Dobfar denies the
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`allegations of Paragraph 29.
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`30.
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`Answering Paragraph 30 of the Amended Complaint, Dobfar states that the
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`allegations in Paragraph 30 are directed to another Defendant and therefore require no response
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`from Dobfar. See Fed. R. Civ. P. 8(b)(1)(B).
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`31.
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`Answering Paragraph 31 of the Amended Complaint, Dobfar states that the
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`allegations in Paragraph 31 are directed to another Defendant and therefore require no response
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`from Dobfar. See Fed. R. Civ. P. 8(b)(1)(B).
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`ANSWER TO FIRST COUNT
`(Denial of Infringement of the ’102 Patent)
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`32.
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`Answering Paragraph 32 of the Amended Complaint, Dobfar incorporates its
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`answers to Paragraphs 1 to 31 as if fully set forth therein.
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`33.
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`Answering Paragraph 33 of the Amended Complaint, Dobfar states that the
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`allegations in Paragraph 33 are directed to another Defendant and therefore require no response
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`from Dobfar. See Fed. R. Civ. P. 8(b)(1)(B). To the extent that a response by Dobfar is
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`required, Dobfar denies the allegations of Paragraph 33.
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`34.
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`Answering Paragraph 34 of the Amended Complaint, Dobfar states that the
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`allegations in Paragraph 34 are directed to another Defendant and therefore require no response
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`from Dobfar. See Fed. R. Civ. P. 8(b)(1)(B).
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`Sandoz Exhibit 1021 Page 7
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`35.
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`Answering Paragraph 35 of the Amended Complaint, Dobfar states that the
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`allegations in Paragraph 35 are directed to another Defendant and therefore require no response
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`from Dobfar. See Fed. R. Civ. P. 8(b)(1)(B).
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`36.
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`Answering Paragraph 36 of the Amended Complaint, Dobfar states that the
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`allegations in Paragraph 36 are directed to another Defendant and therefore require no response
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`from Dobfar. See Fed. R. Civ. P. 8(b)(1)(B).
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`37.
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`Answering Paragraph 37 of the Amended Complaint, Dobfar states that
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`Paragraph 37 consists entirely of legal conclusions that do not require a response, and denies the
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`allegations of Paragraph 37 to which a response is required, and specifically denies that Dobfar
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`infringes or will infringe any claim of the ’102 Patent.
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`38.
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`Answering Paragraph 38 of the Amended Complaint, Dobfar states that the
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`allegations in Paragraph 38 are directed to another Defendant and therefore require no response
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`from Dobfar. See Fed. R. Civ. P. 8(b)(1)(B). To the extent that a response by Dobfar is
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`required, Dobfar denies the allegations of Paragraph 38.
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`39.
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`Answering Paragraph 39 of the Amended Complaint, Dobfar denies the
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`allegations of Paragraph 39.
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`40.
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`Answering Paragraph 40 of the Amended Complaint, Dobfar denies the
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`allegations of Paragraph 40.
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`41.
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`Answering Paragraph 41 of the Amended Complaint, Dobfar denies the
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`allegations of Paragraph 41.
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`42.
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`Answering Paragraph 42 of the Amended Complaint, Dobfar denies the
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`allegations of Paragraph 42.
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`IPR2015-00006
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`Sandoz Exhibit 1021 Page 8
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`43.
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`Answering Paragraph 43 of the Amended Complaint, Dobfar denies the
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`allegations of Paragraph 43.
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`44.
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`Answering Paragraph 44 of the Amended Complaint, Dobfar denies the
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`allegations of Paragraph 44.
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`ANSWER TO SECOND COUNT
`(Denial of Infringement of the ’291 Patent)
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`45.
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`Answering Paragraph 45 of the Amended Complaint, Dobfar incorporates its
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`answers to Paragraphs 1 to 44 as if fully set forth therein.
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`46.
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`Answering Paragraph 46 of the Amended Complaint, Dobfar states that the
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`allegations in Paragraph 46 are directed to another Defendant and therefore require no response
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`from Dobfar. See Fed. R. Civ. P. 8(b)(1)(B). To the extent that a response by Dobfar is
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`required, Dobfar denies the allegations of Paragraph 46.
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`47.
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`Answering Paragraph 47 of the Amended Complaint, Dobfar states that the
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`allegations in Paragraph 47 are directed to another Defendant and therefore require no response
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`from Dobfar. See Fed. R. Civ. P. 8(b)(1)(B).
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`48.
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`Answering Paragraph 48 of the Amended Complaint, Dobfar states that the
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`allegations in Paragraph 48 are directed to another Defendant and therefore require no response
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`from Dobfar. See Fed. R. Civ. P. 8(b)(1)(B).
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`49.
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`Answering Paragraph 49 of the Amended Complaint, Dobfar states that the
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`allegations in Paragraph 49 are directed to another Defendant and therefore require no response
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`from Dobfar. See Fed. R. Civ. P. 8(b)(1)(B).
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`50.
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`Answering Paragraph 50 of the Amended Complaint, Dobfar states that
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`Paragraph 50 consists entirely of legal conclusions that do not require a response, and denies the
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`IPR2015-00006
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`Sandoz Exhibit 1021 Page 9
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`allegations of Paragraph 50 to which a response is required, and specifically denies that Dobfar
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`infringes or will infringe any claim of the ’291 Patent.
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`51.
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`Answering Paragraph 51 of the Amended Complaint, Dobfar states that the
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`allegations in Paragraph 51 are directed to another Defendant and therefore require no response
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`from Dobfar. See Fed. R. Civ. P. 8(b)(1)(B). To the extent that a response by Dobfar is
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`required, Dobfar denies the allegations of Paragraph 51.
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`52.
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`Answering Paragraph 52 of the Amended Complaint, Dobfar denies the
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`allegations of Paragraph 52.
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`53.
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`Answering Paragraph 53 of the Amended Complaint, Dobfar denies the
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`allegations of Paragraph 53.
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`54.
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`Answering Paragraph 54 of the Amended Complaint, Dobfar denies the
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`allegations of Paragraph 54.
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`55.
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`Answering Paragraph 55 of the Amended Complaint, Dobfar denies the
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`allegations of Paragraph 55.
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`56.
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`Answering Paragraph 56 of the Amended Complaint, Dobfar denies the
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`allegations of Paragraph 56.
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`57.
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`Answering Paragraph 57 of the Amended Complaint, Dobfar denies the
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`allegations of Paragraph 57.
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`ANSWER TO THIRD COUNT
`(Denial of Infringement of the ’524 Patent)
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`58.
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`Answering Paragraph 58 of the Amended Complaint, Dobfar incorporates its
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`answers to Paragraphs 1 to 57 as if fully set forth therein.
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`59.
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`Answering Paragraph 59 of the Amended Complaint, Dobfar states that the
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`allegations in Paragraph 59 are directed to another Defendant and therefore require no response
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`Sandoz Exhibit 1021 Page 10
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`from Dobfar. See Fed. R. Civ. P. 8(b)(1)(B). To the extent that a response by Dobfar is
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`required, Dobfar denies the allegations of Paragraph 59.
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`60.
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`Answering Paragraph 60 of the Amended Complaint, Dobfar states that the
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`allegations in Paragraph 60 are directed to another Defendant and therefore require no response
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`from Dobfar. See Fed. R. Civ. P. 8(b)(1)(B).
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`61.
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`Answering Paragraph 61 of the Amended Complaint, Dobfar states that the
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`allegations in Paragraph 61 are directed to another Defendant and therefore require no response
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`from Dobfar. See Fed. R. Civ. P. 8(b)(1)(B).
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`62.
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`Answering Paragraph 62 of the Amended Complaint, Dobfar states that the
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`allegations in Paragraph 62 are directed to another Defendant and therefore require no response
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`from Dobfar. See Fed. R. Civ. P. 8(b)(1)(B).
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`63.
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`Answering Paragraph 63 of the Amended Complaint, Dobfar states that
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`Paragraph 63 consists entirely of legal conclusions that do not require a response, and denies the
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`allegations of Paragraph 63 to which a response is required, and specifically denies that Dobfar
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`infringes or will infringe any claim of the ’524 Patent.
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`64.
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`Answering Paragraph 64 of the Amended Complaint, Dobfar states that the
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`allegations in Paragraph 64 are directed to another Defendant and therefore require no response
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`from Dobfar. See Fed. R. Civ. P. 8(b)(1)(B). To the extent that a response by Dobfar is
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`required, Dobfar denies the allegations of Paragraph 64.
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`65.
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`Answering Paragraph 65 of the Amended Complaint, Dobfar denies the
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`allegations of Paragraph 65.
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`66.
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`Answering Paragraph 66 of the Amended Complaint, Dobfar denies the
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`allegations of Paragraph 66.
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`Sandoz Exhibit 1021 Page 11
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`67.
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`Answering Paragraph 67 of the Amended Complaint, Dobfar denies the
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`allegations in Paragraph 67.
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`68.
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`Answering Paragraph 68 of the Amended Complaint, Dobfar denies the
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`allegations of Paragraph 68.
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`69.
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`Paragraph 69.
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`70.
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`Answering Paragraph 69 of the Amended Complaint, denies the allegations of
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`Answering Paragraph 70 of the Amended Complaint, Dobfar denies the
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`allegations of Paragraph 70.
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`ANSWER TO FOURTH COUNT
`(Denial of Infringement of the ’290 Patent)
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`71.
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`Answering Paragraph 71 of the Amended Complaint, Dobfar incorporates its
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`answers to Paragraphs 1 to 70 as if fully set forth therein.
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`72.
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`Answering Paragraph 72 of the Amended Complaint, Dobfar states that the
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`allegations in Paragraph 72 are directed to another Defendant and therefore require no response
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`from Dobfar. See Fed. R. Civ. P. 8(b)(1)(B). To the extent that a response by Dobfar is
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`required, Dobfar denies the allegations of Paragraph 72.
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`73.
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`Answering Paragraph 73 of the Amended Complaint, Dobfar states that the
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`allegations in Paragraph 73 are directed to another Defendant and therefore require no response
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`from Dobfar. See Fed. R. Civ. P. 8(b)(1)(B).
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`74.
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`Answering Paragraph 74 of the Amended Complaint, Dobfar states that the
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`allegations in Paragraph 74 are directed to another Defendant and therefore require no response
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`from Dobfar. See Fed. R. Civ. P. 8(b)(1)(B).
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`75.
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`Answering Paragraph 75 of the Amended Complaint, Dobfar states that the
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`allegations in Paragraph 75 are directed to another Defendant and therefore require no response
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`IPR2015-00006
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`Sandoz Exhibit 1021 Page 12
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`from Dobfar. See Fed. R. Civ. P. 8(b)(1)(B). To the extent that a response by Dobfar is
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`required, Dobfar denies the allegations of Paragraph 75.
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`76.
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`Answering Paragraph 76 of the Amended Complaint, Dobfar states that the
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`allegations in Paragraph 76 are directed to another Defendant and therefore require no response
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`from Dobfar. See Fed. R. Civ. P. 8(b)(1)(B). To the extent that a response by Dobfar is
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`required, Dobfar denies the allegations of Paragraph 76.
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`77.
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`Answering Paragraph 77 of the Amended Complaint, Dobfar denies the
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`allegations of Paragraph 77.
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`78.
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`Answering Paragraph 78 of the Amended Complaint, Dobfar denies the
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`allegations of Paragraph 78.
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`79.
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`Answering Paragraph 79 of the Amended Complaint, Dobfar denies the
`
`allegations of Paragraph 79.
`
`80.
`
`Answering Paragraph 80 of the Amended Complaint, Dobfar denies the
`
`allegations of Paragraph 80.
`
`81.
`
`Answering Paragraph 81 of the Amended Complaint, Dobfar denies the
`
`allegations of Paragraph 81.
`
`82.
`
`Answering Paragraph 82 of the Amended Complaint, Dobfar denies the
`
`allegations of Paragraph 82.
`
`ANSWER TO PRAYER FOR RELIEF
`
`Dobfar denies that Plaintiffs are entitled to any of the relief requested.
`
`AFFIRMATIVE DEFENSES
`
`
`
`Dobfar asserts the following defenses without prejudice to the denials in the Answer,
`
`without admitting any allegations of the Amended Complaint not otherwise admitted.
`
`
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`IPR2015-00006
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`Sandoz Exhibit 1021 Page 13
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`

`

`Case 1:13-cv-05723-NLH-AMD Document 188 Filed 10/13/14 Page 14 of 19 PageID: 3921
`
`
`
`1.
`
`granted.
`
`FIRST DEFENSE
`(Failure to State a Claim)
`
`Plaintiffs’ Amended Complaint fails to state a claim upon which relief can be
`
`SECOND DEFENSE
`(Noninfringement of the ’102 Patent)
`
`2.
`
`Dobfar has not infringed, induced infringement of, or contributed to the
`
`infringement of any valid and enforceable claim of the ’102 Patent.
`
`THIRD DEFENSE
`(Invalidity of the ’102 Patent)
`
`3.
`
`The ’102 Patent, and each claim thereof, is invalid for failing to comply with the
`
`requirements of the patent laws of the United States, particularly with regard to one or more of
`
`the requirements specified in Sections 101, 102, 103, and/or 112 of Title 35 of the United States
`
`Code.
`
`FOURTH DEFENSE
`(Noninfringement of the ’291 Patent)
`
`4.
`
`Dobfar has not infringed, induced infringement of, or contributed to the
`
`infringement of any valid and enforceable claim of the ’291 Patent.
`
`FIFTH DEFENSE
`(Invalidity of the ’291 Patent)
`
`5.
`
`The ’291 Patent, and each claim thereof, is invalid for failing to comply with the
`
`requirements of the patent laws of the United States, particularly with regard to one or more of
`
`the requirements specified in Sections 101, 102, 103, and/or 112 of Title 35 of the United States
`
`Code.
`
`
`ny-1154439
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`IPR2015-00006
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`Sandoz Exhibit 1021 Page 14
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`Case 1:13-cv-05723-NLH-AMD Document 188 Filed 10/13/14 Page 15 of 19 PageID: 3922
`
`
`
`SIXTH DEFENSE
`(Noninfringement of the ’524 Patent)
`
`6.
`
`Dobfar has not infringed, induced infringement of, or contributed to the
`
`infringement of any valid and enforceable claim of the ’524 Patent.
`
`SEVENTH DEFENSE
`(Invalidity of the ’524 Patent)
`
`7.
`
`The ’524 patent, and each claim thereof, is invalid for failing to comply with the
`
`requirements of the patent laws of the United States, particularly with regard to one or more of
`
`the requirements specified in Sections 101, 102, 103, and/or 112 of Title 35 of the United States
`
`Code.
`
`EIGHTH DEFENSE
`(Lack of Subject Matter Jurisdiction as to the ’290 Patent)
`
`8.
`
`This Court lacks subject matter jurisdiction over Plaintiffs’ claims for
`
`infringement of the ’290 Patent because the ’290 Patent is not listed in the Orange Book in
`
`connection with Cardene® I.V. Premixed Injection.
`
`NINTH DEFENSE
`(Noninfringement of the ’290 Patent)
`
`9.
`
`Dobfar has not infringed, induced infringement of, or contributed to the
`
`infringement of any valid and enforceable claim of the ’290 Patent.
`
`TENTH DEFENSE
`(Invalidity of the ’290 Patent)
`
`10.
`
`The ’290 patent, and each claim thereof, is invalid for failing to comply with the
`
`requirements of the patent laws of the United States, particularly with regard to one or more of
`
`the requirements specified in Sections 101, 102, 103, and/or 112 of Title 35 of the United States
`
`Code.
`
`
`ny-1154439
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`IPR2015-00006
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`Sandoz Exhibit 1021 Page 15
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`

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`Case 1:13-cv-05723-NLH-AMD Document 188 Filed 10/13/14 Page 16 of 19 PageID: 3923
`
`
`
`ELEVENTH DEFENSE
`(Lack of Standing with Respect to Chiesi USA
` and Cornerstone BioPharma)
`
`11.
`
`On information and belief, Chiesi USA and Cornerstone BioPharma do not have
`
`and have not alleged proper standing to bring any infringement claims against Dobfar on any of
`
`the Patents-in-Suit.
`
`TWELFTH DEFENSE
`(Lack of Personal Jurisdiction)
`
`This Court lacks personal jurisdiction over Dobfar.
`
`
`THIRTEENTH DEFENSE
`(No Recovery of Costs)
`
`Plaintiffs are barred by 35 U.S.C. § 288 from recovering any costs associated with
`
`12.
`
`13.
`
`this action.
`
`RESERVATION OF RIGHTS
`
`As Dobfar’s investigation is ongoing, Dobfar hereby gives notice that it may assert facts
`
`or acts which tend to establish noninfringement, invalidity, unenforceability or which otherwise
`
`constitute a defense under Title 35 of the United States Code as information becomes available
`
`to Dobfar in sufficient detail to assert such a defense.
`
`PRAYER FOR RELIEF
`
`WHEREFORE, Dobfar asks this Court to enter judgment in its favor and grant the
`
`following relief:
`
`1. Dismissing with prejudice the entirety of Plaintiffs’ Amended Complaint;
`
`2. Dismissing all remedies and relief sought by Plaintiffs in the Amended
`
`Complaint; and
`
`3. Granting such other and further relief as the Court may deem just and proper.
`
`
`ny-1154439
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`IPR2015-00006
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`Sandoz Exhibit 1021 Page 16
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`

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`Case 1:13-cv-05723-NLH-AMD Document 188 Filed 10/13/14 Page 17 of 19 PageID: 3924
`
`
`
`
`
` Dated: October 13, 2014
`
`HILL WALLACK LLP
`
`By: /s/ Eric I. Abraham
`Eric I. Abraham
`Christy L. Saveriano
`eia@hillwallack.com
`csaveriano@hillwallack.com
`202 Carnegie Center
`Princeton, New Jersey 08540
`Telephone: (609) 924-0808
`Fax: (609) 452-1888
`
`
`
`
`
`Of Counsel:
`
`MORRISON & FOERSTER LLP
`David C. Doyle (CA Bar No. 70690)
`12531 High Bluff Drive, Suite 100
`San Diego, California 92130-2040
`Telephone: (858) 720-5100
`Fax: (858) 720-5125
`
`Matthew M. D’Amore
`Hui Liu
`Sarah L. Prutzman
`250 West 55th Street
`New York, NY 10019-9601
`Tel: (212) 468-8000
`Fax: (212) 468-7900
`
`Attorneys for Defendant
`ACS Dobfar Info SA
`
`
`
`
`
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`IPR2015-00006
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`Sandoz Exhibit 1021 Page 17
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`

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`Case 1:13-cv-05723-NLH-AMD Document 188 Filed 10/13/14 Page 18 of 19 PageID: 3925
`
`
`
`ACS DOBFAR INFO SA’S LOCAL CIVIL RULE 11.2 CERTIFICATION
`
` I hereby certify that ACS Dobfar Info SA is not a party to any other civil action,
`
`pending arbitration, or administrative proceeding concerning the matter in controversy.
`
`
`Dated: October 13, 2014
`
` /s/ Eric I. Abraham______
` Eric. I. Abraham
`
`
`
`ny-1154439
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`IPR2015-00006
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`Sandoz Exhibit 1021 Page 18
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`Case 1:13-cv-05723-NLH-AMD Document 188 Filed 10/13/14 Page 19 of 19 PageID: 3926
`
`
`
`CERTIFICATE OF SERVICE
`
`I hereby certify that on October 13, 2014, I electronically filed ACS DOBFAR INFO
`
`SA’S ANSWER TO PLAINTIFFS’ AMENDED COMPLAINT with the Clerk of Court using
`
`the CM/ECF system which will also send notification of such filing to the following:
`
`Michael R. Griffinger
`griffinger@gibbonslaw.com
`Gibbons P.C.
`One Gateway Center
`Newark, New Jersey 07102
`Tel: (973) 596-4500
`Fax: (973) 639-6257
`
`Leann Marie Clymer
`lclymer@flhlaw.com
`Frommer Lawrence & Haug LLP
`745 Fifth Avenue
`New York, New York 10151
`Tel: (212) 863-2649
`
`
`
`
`/s/Eric I. Abraham
`Eric I. Abraham
`
`
`ny-1154439
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`IPR2015-00006
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`Sandoz Exhibit 1021 Page 19
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`