Case 1:13-cv-05723-NLH-AMD Document 187 Filed 10/13/14 Page 1 of 33 PageID: 3875
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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 and
`Counterclaim-Plaintiff Sandoz Inc.
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF NEW JERSEY
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`CHIESI USA INC.,
`CORNERSTONE BIOPHARMA, INC., and
`EKR THERAPEUTICS, LLC,
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`Plaintiffs,
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`v.
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`SANDOZ INC., SANDOZ AG, and
`ACS DOBFAR INFO SA
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`Defendants.
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`SANDOZ INC.
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`Counterclaim-Plaintiff,
`
`v.
`
`
`CHIESI USA INC.,
`CORNERSTONE BIOPHARMA, INC., and
`EKR THERAPEUTICS, LLC
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`Counterclaim-Defendants.
`
`Civil Action No. 1:13-cv-05723-NLH-
`AMD
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`SANDOZ INC.’S ANSWER TO PLAINTIFFS’ AMENDED COMPLAINT
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`Defendant Sandoz Inc., by and through its undersigned attorneys, hereby answers each of
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`the numbered paragraphs of the Amended Complaint by Chiesi USA, Inc. (“Chiesi USA,”
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`formerly known as Cornerstone Therapeutics Inc.), Cornerstone BioPharma, Inc. (“Cornerstone
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`BioPharma”), and EKR Therapeutics, LLC (“EKR,” collectively “Plaintiffs”).
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`ny-1154281
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`EKR Therapeutics, LLC Exhibit 2005 Page 1
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`The Amended Complaint’s definition of “Sandoz” is not “simple, concise, and direct” as
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`required under Federal Rule of Civil Procedure 8(d)(1), and leaves Sandoz Inc. with no certainty
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`as to what allegations are pleaded against it. Sandoz Inc. therefore treats every allegation against
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`“Sandoz” as an allegation against Sandoz Inc. Except as expressly admitted below, Sandoz Inc.
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`denies each and every allegation of Plaintiffs’ Amended Complaint.
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`1.
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`Answering Paragraph 1 of the Amended Complaint, Sandoz Inc. denies the
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`allegations therein, except Sandoz Inc. admits that this is an action for patent infringement
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`purportedly arising under the patent laws of the United States, Title 35 of the United States Code,
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`involving United States Patent Nos. 7,612,102 (the “’102 Patent”), 7,659,291 (the “’291
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`Patent”), 8,455,524 (the “’524 Patent”), and 7,659,290 (the “’290 Patent”, collectively with the
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`’102, ’291 and ’524 Patents, the “Patents-in-Suit”). Sandoz Inc. further admits that purported
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`copies of the ’102, ’291, ’524, and ’290 Patents are attached as Exhibits A-D, respectively, to the
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`Amended Complaint.
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`2.
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`Answering Paragraph 2 of the Amended Complaint, Sandoz Inc. states that it
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`lacks 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 the allegations therein, except on information and belief,
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`Sandoz Inc. admits that Chiesi USA was formerly known as Cornerstone Therapeutics Inc.
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`and has a place of business at 1255 Crescent Green Drive, Suite 250, Cary, North Carolina
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`27518.
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`3.
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`Answering Paragraph 3 of the Amended Complaint, Sandoz Inc. states that it
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`lacks 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 the allegations therein, except on information and belief,
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`EKR Therapeutics, LLC Exhibit 2005 Page 2
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`Sandoz Inc. admits that Cornerstone BioPharma has a place of business at 1255 Crescent Green
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`Drive, Suite 250, Cary, North Carolina 27518.
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`4.
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`Answering Paragraph 4 of the Amended Complaint, Sandoz Inc. states that it
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`lacks 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 the allegations therein, except on information and belief,
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`Sandoz Inc. admits that EKR was formerly known as EKR Therapeutics, Inc. and has a place of
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`business at 1255 Crescent Green Drive, Suite 250, Cary, North Carolina 27518.
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`5.
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`Answering Paragraph 5 of the Amended Complaint, Sandoz Inc. denies the
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`allegations therein and states that it is a corporation organized and existing under the laws of the
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`State of Colorado, having its principal place of business at 100 College Road West, Princeton,
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`New Jersey 08540.
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`6.
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`Answering Paragraph 6 of the Amended Complaint, Sandoz Inc. 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 Sandoz Inc. See Fed. R. Civ. P. 8(b)(1)(B). To the extent that a response is required, on
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`information and belief, Sandoz Inc. admits the allegations of Paragraph 6.
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`7.
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`Answering Paragraph 7 of the Amended Complaint, Sandoz Inc. states that
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`Paragraph 7 consists entirely of legal conclusions that do not require a response. To the extent a
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`response is required, Sandoz Inc. states that it and Sandoz AG are indirect subsidiaries of
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`Novartis AG.
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`8.
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`Answering Paragraph 8 of the Amended Complaint, Sandoz Inc. denies the
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`allegations of Paragraph 8.
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`9.
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`Answering Paragraph 9 of the Amended Complaint, Sandoz Inc. denies the
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`allegations therein, except admits that Sandoz Inc. holds Drug and Medical Device Certificate of
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`EKR Therapeutics, LLC Exhibit 2005 Page 3
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`Registration No. 5003732, as a Manufacturer and Wholesaler, issued on January 14, 2014, by the
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`New Jersey Department of Health and Senior Services, and expiring on January 31, 2015.
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`Sandoz Inc. does not contest personal jurisdiction in New Jersey for the purposes of this action.
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`10.
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`Answering Paragraph 10 of the Amended Complaint, Sandoz Inc. states that the
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`allegations in Paragraph 10 are directed to another Defendant and therefore require no response
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`from Sandoz Inc. See Fed. R. Civ. P. 8(b)(1)(B).
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`11.
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`Answering Paragraph 11 of the Amended Complaint, Sandoz Inc. states that
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`Paragraph 11 consists entirely of legal conclusions that do not require a response, and denies the
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`allegations therein to which a response is required, but states that it does not contest that subject
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`matter jurisdiction is proper pursuant to 28 U.S.C. §§ 1331 and 1338(a) with respect to Plaintiffs’
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`claims regarding the ’102, ’291, and ’524 Patents under 35 U.S.C. § 271(e)(2)(A). Sandoz Inc.
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`specifically denies all other allegations of subject matter jurisdiction under any other sub-
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`paragraphs of 35 U.S.C. § 271, and further denies that this Court has subject matter jurisdiction
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`over the ’290 Patent.
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`12.
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`Answering Paragraph 12 of the Amended Complaint, Sandoz Inc. states that
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`Paragraph 12 consists entirely of legal conclusions that do not require a response, and denies the
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`allegations therein to which a response is required. Sandoz Inc. further objects that the
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`allegations in Paragraph 12 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 12. To the
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`extent that a response by Sandoz Inc. is required, Sandoz Inc. denies the allegations therein,
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`except admits: (1) that Sandoz Inc. has a principal place of business in this judicial district; (2)
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`that Sandoz Inc. holds Drug and Medical Device Certificate of Registration No. 5003732, as a
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`Manufacturer and Wholesaler, issued on January 14, 2014, by the New Jersey Department of
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`EKR Therapeutics, LLC Exhibit 2005 Page 4
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`Health and Senior Services, and expiring on January 31, 2015; (3) that Sandoz Inc. is doing
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`business in this judicial district; (4) that Sandoz Inc. previously stated that it “does not contest
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`personal jurisdiction in New Jersey for the purposes of this action” (see Dkt No. 13 at ¶ 6); and
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`(5) Sandoz Inc. filed Abbreviated New Drug Application No. 203978 (“ANDA 203978”).
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`Although Sandoz does not admit that personal jurisdiction in this judicial district is proper,
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`Sandoz does not contest personal jurisdiction in New Jersey for the purposes of this action only.
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`13.
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`Answering Paragraph 13 of the Amended Complaint, Sandoz Inc. states that
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`Paragraph 13 consists entirely of legal conclusions that do not require a response, and further
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`states that the allegations of Paragraph 13 are directed to another Defendant and therefore require
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`no response from Sandoz Inc. To the extent that a response by Sandoz Inc. is required, Sandoz
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`Inc. denies the allegations in Paragraph 13
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`14.
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`Answering Paragraph 14 of the Amended Complaint, Sandoz Inc. 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 therein to which a response is required, but states that it does not contest venue in this
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`judicial district for the purposes of this action.
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`15.
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`Answering Paragraph 15 of the Amended Complaint, Sandoz Inc. states that it
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`lacks 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, except on information and belief, Sandoz Inc. admits
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`that Chiesi USA is the current owner of New Drug Application (“NDA”) No. 19-734.
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`16.
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`Answering Paragraph 16 of the Amended Complaint, Sandoz Inc. 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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`EKR Therapeutics, LLC Exhibit 2005 Page 5
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`17.
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`Answering Paragraph 17 of the Amended Complaint, Sandoz Inc. denies the
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`allegations therein, except admits that the ’291 Patent is entitled “Methods of Treatment with
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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, Sandoz Inc. 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, Sandoz Inc. 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, Sandoz Inc. states that it
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`lacks 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, Sandoz Inc. states that it
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`lacks 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 Sandoz Inc. 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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`EKR Therapeutics, LLC Exhibit 2005 Page 6
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`22.
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`Answering Paragraph 22 of the Amended Complaint, Sandoz Inc. denies the
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`allegations therein, except Sandoz Inc. admits that it filed ANDA 203978 and that the ANDA
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`seeks FDA approval of the drug products described therein.
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`23.
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`Answering Paragraph 23 of the Amended Complaint, Sandoz Inc. denies the
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`allegations therein.
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`24.
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`Answering Paragraph 24 of the Amended Complaint, Sandoz Inc. denies the
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`allegations of Paragraph 24.
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`25.
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`Answering Paragraph 25 of the Amended Complaint, Sandoz Inc. states that the
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`allegations in Paragraph 25 are directed to another Defendant and therefore require no response
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`from Sandoz Inc. See Fed. R. Civ. P. 8(b)(1)(B). To the extent that a response by Sandoz Inc. is
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`required, Sandoz Inc. denies the allegations of Paragraph 25.
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`26.
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`Answering Paragraph 26 of the Amended Complaint, Sandoz Inc. states that the
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`allegations in Paragraph 26 are directed to another Defendant and therefore require no response
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`from Sandoz Inc. See Fed. R. Civ. P. 8(b)(1)(B). To the extent that a response by Sandoz Inc. is
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`required, Sandoz Inc. denies the allegations of paragraph 26, except Sandoz Inc. admits that
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`Sandoz Inc. received certain information and materials supplied by Dobfar.
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`27.
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`Answering Paragraph 27 of the Amended Complaint, Sandoz Inc. states that the
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`allegations in Paragraph Inc. are directed to another Defendant and therefore require no response
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`from Sandoz Inc. See Fed. R. Civ. P. 8(b)(1)(B). To the extent that a response by Sandoz Inc. is
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`required, Sandoz Inc. denies the allegations of Paragraph 27.
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`28.
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`Answering Paragraph 28 of the Amended Complaint, Sandoz Inc. states that the
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`allegations in Paragraph 28 are directed to another Defendant and therefore require no response
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`EKR Therapeutics, LLC Exhibit 2005 Page 7
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`from Sandoz Inc. See Fed. R. Civ. P. 8(b)(1)(B). To the extent that a response by Sandoz Inc. is
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`required, Sandoz Inc. denies the allegations of Paragraph 28.
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`29.
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`Answering Paragraph 29 of the Amended Complaint, Sandoz Inc. states that the
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`allegations in Paragraph 29 are directed to another Defendant and therefore require no response
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`from Sandoz Inc.. See Fed. R. Civ. P. 8(b)(1)(B). To the extent that a response by Sandoz Inc. is
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`required, Sandoz Inc. denies the allegations of Paragraph 29.
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`30.
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`Answering Paragraph 30 of the Amended Complaint, Sandoz Inc. denies the
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`allegations therein, except Sandoz Inc. admits that Sandoz Inc. sent a letter to Cornerstone
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`Therapeutics, Cornerstone BioPharma, and EKR providing notification that ANDA 203978
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`contains a certification under 21 U.S.C. § 355(j)(2)(A)(vii)(IV) (a “Paragraph IV Certification”)
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`with respect to the ’102, ’291, and ’524 Patents (“Notice Letter”).
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`31.
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`Answering Paragraph 31 of the Amended Complaint, Sandoz Inc. denies the
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`allegations therein, denies that Sandoz Inc. infringes any claim of any of the Patents-in-Suit, and
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`states that the Notice Letter speaks for itself.
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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, Sandoz Inc. 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, Sandoz Inc. denies the
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`allegations therein, except Sandoz Inc. admits that it seeks FDA approval of ANDA 203978.
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`34.
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`Answering Paragraph 34 of the Amended Complaint, Sandoz Inc. denies the
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`allegations therein, except admits that Sandoz Inc. has certified to the FDA its belief that the
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`’102 Patent is not infringed, invalid, and/or unenforceable.
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`EKR Therapeutics, LLC Exhibit 2005 Page 8
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`35.
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`Answering Paragraph 35 of the Amended Complaint, Sandoz Inc. denies the
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`allegations therein, except Sandoz Inc. admits that it seeks FDA approval of ANDA 203978.
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`36.
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`Answering Paragraph 36 of the Amended Complaint, Sandoz Inc. denies the
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`allegations therein, except Sandoz Inc. admits that as of the date of Sandoz Inc.’s Notice Letter,
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`Sandoz Inc. was aware of the statutory provisions and regulations set forth in 21 U.S.C. §
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`355(j)(2)(B)(iv)(II) and 21 C.F.R. § 314.95(c)(6).
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`37.
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`Answering Paragraph 37 of the Amended Complaint, Sandoz Inc. 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 therein to which a response is required, and specifically denies that Sandoz Inc.
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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, Sandoz Inc. denies the
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`allegations therein.
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`39.
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`Answering Paragraph 39 of the Amended Complaint, states that the allegations in
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`Paragraph 39 are directed to other Defendants and therefore require no response from Sandoz
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`Inc. See Fed. R. Civ. P. 8(b)(1)(B). To the extent that a response by Sandoz Inc. is required,
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`Sandoz Inc. denies the allegations therein.
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`40.
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`Answering Paragraph 40 of the Amended Complaint, Sandoz Inc. denies the
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`allegations therein.
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`41.
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`Answering Paragraph 41 of the Amended Complaint, Sandoz Inc. states that the
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`allegations in Paragraph 41 are directed to another Defendant and therefore require no response
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`from Sandoz Inc. See Fed. R. Civ. P. 8(b)(1)(B). To the extent that a response by Sandoz Inc. is
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`required, Sandoz Inc. denies the allegations in Paragraph 41.
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`EKR Therapeutics, LLC Exhibit 2005 Page 9
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`42.
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`Answering Paragraph 42 of the Amended Complaint, Sandoz Inc. denies the
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`allegations therein.
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`43.
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`Answering Paragraph 43 of the Amended Complaint, Sandoz Inc. denies the
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`allegations therein.
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`44.
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`Answering Paragraph 44 of the Amended Complaint, Sandoz Inc. denies the
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`allegations therein.
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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, Sandoz Inc. 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, Sandoz Inc. denies the
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`allegations therein, except Sandoz Inc. admits that it seeks FDA approval of ANDA 203978.
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`47.
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`Answering Paragraph 47 of the Amended Complaint, Sandoz Inc. denies the
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`allegations therein, except admits that Sandoz Inc. has certified to the FDA its belief that the
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`’102 Patent is not infringed, invalid, and/or unenforceable.
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`48.
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`Answering Paragraph 48 of the Amended Complaint, Sandoz Inc. denies the
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`allegations therein, except Sandoz Inc. admits that it seeks FDA approval of ANDA 203978.
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`49.
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`Answering Paragraph 49 of the Amended Complaint, Sandoz Inc. denies the
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`allegations therein, except Sandoz Inc. admits that as of the date of Sandoz Inc.’s Notice Letter,
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`Sandoz Inc. was aware of the statutory provisions and regulations set forth in 21 U.S.C. §
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`355(j)(2)(B)(iv)(II) and 21 C.F.R. § 314.95(c)(6).
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`50.
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`Answering Paragraph 50 of the Amended Complaint, Sandoz Inc. 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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`EKR Therapeutics, LLC Exhibit 2005 Page 10
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`allegations therein to which a response is required, and specifically denies that Sandoz Inc.
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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, Sandoz Inc. denies the
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`allegations therein.
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`52.
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`Answering Paragraph 52 of the Amended Complaint, states that the allegations in
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`Paragraph 52 are directed to other Defendants and therefore require no response from Sandoz
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`Inc. See Fed. R. Civ. P. 8(b)(1)(B). To the extent that a response by Sandoz Inc. is required,
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`Sandoz Inc. denies the allegations therein.
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`53.
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`Answering Paragraph 53 of the Amended Complaint, Sandoz Inc. denies the
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`allegations therein.
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`54.
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`Answering Paragraph 54 of the Amended Complaint, Sandoz Inc. states that the
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`allegations in Paragraph 54 are directed to another Defendant and therefore require no response
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`from Sandoz Inc. See Fed. R. Civ. P. 8(b)(1)(B). To the extent that a response by Sandoz Inc. is
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`required, Sandoz Inc. denies the allegations in Paragraph 54.
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`55.
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`Answering Paragraph 55 of the Amended Complaint, Sandoz Inc. denies the
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`allegations therein.
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`56.
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`Answering Paragraph 56 of the Amended Complaint, Sandoz Inc. denies the
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`allegations therein.
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`57.
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`Answering Paragraph 57 of the Amended Complaint, Sandoz Inc. denies the
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`allegations therein.
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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, Sandoz Inc. incorporates its
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`answers to Paragraphs 1 to 57 as if fully set forth therein.
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`EKR Therapeutics, LLC Exhibit 2005 Page 11
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`59.
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`Answering Paragraph 59 of the Amended Complaint, Sandoz Inc. denies the
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`allegations therein, except Sandoz Inc. admits that it seeks FDA approval of ANDA 203978.
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`60.
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`Answering Paragraph 60 of the Amended Complaint, Sandoz Inc. denies the
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`allegations therein, except admits that Sandoz Inc. has certified to the FDA its belief that the
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`’524 Patent is not infringed, invalid, and/or unenforceable.
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`61.
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`Answering Paragraph 61 of the Amended Complaint, Sandoz Inc. denies the
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`allegations therein, except Sandoz Inc. admits that it seeks FDA approval of ANDA 203978.
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`62.
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`Answering Paragraph 62 of the Amended Complaint, Sandoz Inc. denies the
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`allegations therein, except Sandoz Inc. admits that as of the date of Sandoz Inc.’s Notice Letter,
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`Sandoz Inc. was aware of the statutory provisions and regulations set forth in 21 U.S.C. §
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`355(j)(2)(B)(iv)(II) and 21 C.F.R. § 314.95(c)(6).
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`63.
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`Answering Paragraph 63 of the Amended Complaint, Sandoz Inc. 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 therein to which a response is required, and specifically denies that Sandoz Inc.
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`infringes or will infringe any claim of the ’291 Patent.
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`64.
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`Answering Paragraph 64 of the Amended Complaint, Sandoz Inc. denies the
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`allegations therein.
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`65.
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`Answering Paragraph 65 of the Amended Complaint, states that the allegations in
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`Paragraph 65 are directed to other Defendants and therefore require no response from Sandoz
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`Inc. See Fed. R. Civ. P. 8(b)(1)(B). To the extent that a response by Sandoz Inc. is required,
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`Sandoz Inc. denies the allegations therein.
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`66.
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`Answering Paragraph 66 of the Amended Complaint, Sandoz Inc. denies the
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`allegations therein.
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`EKR Therapeutics, LLC Exhibit 2005 Page 12
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`67.
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`Answering Paragraph 67 of the Amended Complaint, Sandoz Inc. states that the
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`allegations in Paragraph 67 are directed to another Defendant and therefore require no response
`
`from Sandoz Inc. See Fed. R. Civ. P. 8(b)(1)(B). To the extent that a response by Sandoz Inc. is
`
`required, Sandoz Inc. denies the allegations in Paragraph 67.
`
`68.
`
`Answering Paragraph 68 of the Amended Complaint, Sandoz Inc. denies the
`
`allegations therein.
`
`69.
`
`Answering Paragraph 69 of the Amended Complaint, Sandoz Inc. denies the
`
`allegations therein.
`
`70.
`
`Answering Paragraph 70 of the Amended Complaint, Sandoz Inc. denies the
`
`allegations therein.
`
`ANSWER TO FOURTH COUNT
`(Denial of Infringement of the ’290 Patent)
`
`71.
`
`Answering Paragraph 71 of the Amended Complaint, Sandoz Inc. incorporates its
`
`answers to Paragraphs 1 to 70 as if fully set forth therein.
`
`72.
`
`Answering Paragraph 72 of the Amended Complaint, Sandoz Inc. denies the
`
`allegations therein, except Sandoz Inc. admits that it seeks FDA approval of ANDA 203978.
`
`73.
`
`Answering Paragraph 73 of the Amended Complaint, Sandoz Inc. denies the
`
`allegations therein, except Sandoz Inc. admits that it seeks FDA approval of ANDA 203978.
`
`74.
`
`Answering Paragraph 74 of the Amended Complaint, Sandoz Inc. denies the
`
`allegations therein, except Sandoz Inc. admits that it seeks FDA approval of ANDA 203978.
`
`75.
`
`Answering Paragraph 75 of the Amended Complaint, Sandoz Inc. states that
`
`Paragraph 75 consists entirely of legal conclusions that do not require a response, and denies the
`
`allegations therein to which a response is required, and specifically denies that Sandoz Inc.
`
`infringes or will infringe any claim of the’290 Patent.
`
`
`
`ny-1154281
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`- 13 -
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`EKR Therapeutics, LLC Exhibit 2005 Page 13
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`

`

`Case 1:13-cv-05723-NLH-AMD Document 187 Filed 10/13/14 Page 14 of 33 PageID: 3888
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`
`
`76.
`
`Answering Paragraph 76 of the Amended Complaint, Sandoz Inc. denies the
`
`allegations therein.
`
`77.
`
`Answering Paragraph 77 of the Amended Complaint, Sandoz Inc. states that the
`
`allegations in Paragraph 77 are directed to other Defendants and therefore require no response
`
`from Sandoz Inc. See Fed. R. Civ. P. 8(b)(1)(B). To the extent that a response by Sandoz Inc. is
`
`required, Sandoz Inc. denies the allegations in Paragraph 77.
`
`78.
`
`Answering Paragraph 78 of the Amended Complaint, Sandoz Inc. denies the
`
`allegations therein, except Sandoz Inc. admits that it seeks FDA approval of ANDA 203978.
`
`79.
`
`Answering Paragraph 79 of the Amended Complaint, Sandoz Inc. states that the
`
`allegations in Paragraph 79 are directed to another Defendant and therefore require no response
`
`from Sandoz Inc. See Fed. R. Civ. P. 8(b)(1)(B). To the extent that a response by Sandoz Inc. is
`
`required, Sandoz Inc. denies the allegations in Paragraph 79.
`
`80.
`
`Answering Paragraph 80 of the Amended Complaint, Sandoz Inc. denies the
`
`allegations therein.
`
`81.
`
`Answering Paragraph 81 of the Amended Complaint, Sandoz Inc. denies the
`
`allegations therein.
`
`82.
`
`Answering Paragraph 82 of the Amended Complaint, Sandoz Inc. denies the
`
`allegations therein.
`
`ANSWER TO PRAYER FOR RELIEF
`
`Sandoz Inc. denies that Plaintiffs are entitled to any of relief requested.
`
`ADDITIONAL DEFENSES
`
`Without admitting or implying that Sandoz Inc. bears the burden of proof as to any of
`
`them, Sandoz Inc. asserts, on information and belief, the following additional defenses to
`
`Plaintiffs’ claims:
`
`
`ny-1154281
`
`- 14 -
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`EKR Therapeutics, LLC Exhibit 2005 Page 14
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`

`

`Case 1:13-cv-05723-NLH-AMD Document 187 Filed 10/13/14 Page 15 of 33 PageID: 3889
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`
`
`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.
`
`Sandoz Inc. 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.
`
`Sandoz Inc. 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-1154281
`
`SIXTH DEFENSE
`(Noninfringement of the ’524 Patent)
`
`- 15 -
`
`EKR Therapeutics, LLC Exhibit 2005 Page 15
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`

`

`Case 1:13-cv-05723-NLH-AMD Document 187 Filed 10/13/14 Page 16 of 33 PageID: 3890
`
`
`
`6.
`
`Sandoz Inc. 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 and because Sandoz Inc. has not filed a
`
`Paragraph IV Certification with respect to the ’290 Patent in connection with ANDA 203978.
`
`NINTH DEFENSE
`(Noninfringement of the ’290 Patent)
`
`9.
`
`Sandoz Inc. 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-1154281
`
`- 16 -
`
`EKR Therapeutics, LLC Exhibit 2005 Page 16
`
`

`

`Case 1:13-cv-05723-NLH-AMD Document 187 Filed 10/13/14 Page 17 of 33 PageID: 3891
`
`
`
`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 Sandoz Inc. on
`
`any of the Patents-in-Suit.
`
`TWELFTH DEFENSE
`(No Recovery of Costs)
`
`12.
`
`this action.
`
`Plaintiffs are barred by 35 U.S.C. § 288 from recovering any costs associated with
`
`RESERVATION OF RIGHTS
`
`As Sandoz Inc.’s investigation is ongoing and discovery in this case is ongoing,
`
`Sandoz Inc. is without sufficient information regarding the existence or non-existence of other
`
`facts or acts that would constitute a defense to Plaintiffs’ claims of patent infringement or that
`
`would establish the invalidity and/or unenforceability of each of the Patents-in-Suit, including
`
`additional prior art or related patents. Sandoz Inc. 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 Sandoz Inc. in sufficient detail to assert such a defense.
`
`
`
`ny-1154281
`
`- 17 -
`
`EKR Therapeutics, LLC Exhibit 2005 Page 17
`
`

`

`Case 1:13-cv-05723-NLH-AMD Document 187 Filed 10/13/14 Page 18 of 33 PageID: 3892
`
`
`
`COUNTERCLAIMS
`
`Pursuant to Rule 13 of the Federal Rules of Civil Procedure, Defendant and
`
`Counterclaim-Plaintiff Sandoz Inc. hereby submits these Counterclaims against Plaintiffs and
`
`Counterclaim-Defendants Chiesi USA, Inc. (“Chiesi USA,” formerly known as Cornerstone
`
`Therapeutics Inc.), Cornerstone BioPharma, Inc. (“Cornerstone BioPharma”), and EKR
`
`Therapeutics, LLC (“EKR,” collectively with Chiesi USA and Cornerstone BioPharma,
`
`“Counterclaim-Defendants”):
`
`NATURE OF THE ACTION
`
`1.
`
`These Counterclaims are brought pursuant to Rule 13 of the Federal Rules of
`
`Civil Procedure as compulsory counterclaims in response to Counterclaim-Defendants’
`
`Complaint. Through these counterclaims, Sandoz Inc. seeks a declaratory judgment of invalidity
`
`of one or more claims of United States Patent Nos. 7,612,102 (the “’102 Patent”), 7,659,291 (the
`
`“’291 Patent”), 8,455,524 (the “’524 Patent”), and 7,659,290 (the “’290 Patent,” collectively
`
`with the ’102, ’291, and ’524 Patents, the “Patents-in-Suit”).
`
`THE PARTIES
`
`2.
`
`Sandoz Inc. is a corporation organized under the laws of the State of Colorado
`
`with its headquarters located at 100 College Road West, Princeton, New Jersey 08540.
`
`3.
`
`On information and belief, Counterclaim-Defendant Chiesi USA purpo