Case 3:15-cv-07015-MLC-DEA Document 17 Filed 10/29/15 Page 1 of 40 PageID: 180
`
`BLANK ROME LLP
`A Pennsylvania LLP
`Stephen M. Orlofsky
`Gary J. Ruckelshaus
`New Jersey Resident Partners
`301 Carnegie Center, 3rd Floor
`Princeton, New Jersey 08540
`Tel: (609) 750-7700
`Fax: (609) 750-7701
`gruckelshaus@blankrome.com
`Attorneys for Defendants Emcure Pharmaceuticals
`Ltd. and Heritage Pharma Labs Inc.
`
`
`UNITED STATES DISTRICT COURT
`DISTRICT OF NEW JERSEY
`
`
`
`Civil Action No.: 15-7015 (MLC)(DEA)
`
`
`
`ANSWER AND COUNTERCLAIMS OF
`HERITAGE PHARMA LABS INC. (f/k/a
`EMCURE PHARMACEUTICALS USA,
`INC.) AND EMCURE
`PHARMACEUTICALS LTD.
`
`Filed Electronically
`
`
`
`
`HELSINN HEALTHCARE S.A. and ROCHE
`PALO ALTO LLC,
`
`
`Plaintiffs,
`
`vs.
`
`
`FRESENIUS KABI USA, LLC, EMCURE
`PHARMACEUTICALS LIMITED, and
`EMCURE PHARMACEUTICALS USA, INC.,
`
`
`Defendants.
`
`
`
`
`
` Defendants Emcure Pharmaceuticals Ltd. (“Emcure Ltd.”) and Heritage Pharma Labs
`
`Inc. (formerly known as Emcure Pharmaceuticals USA, Inc.) (“HPL” and collectively,
`
`“Emcure”), by their attorneys, answer the amended complaint (the “Complaint”) filed by
`
`Plaintiffs Helsinn Healthcare S.A. (“Helsinn”) and Roche Palo Alto LLC (“Roche”) (collectively
`
`“Plaintiffs”) as follows:
`
`AS TO THE PARTIES
`
`Helsinn is a Swiss corporation having its principal place of business at Via Pian
`1.
`Scairolo, 9, CH-6912 Lugano-Pazzallo, Switzerland.
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`ANSWER
`
`Emcure is without knowledge or information sufficient to form a belief as to the truth of
`
`the allegations of Paragraph 1 of the Complaint, and therefore, denies same.
`
`Roche is a company, organized and existing under the laws of the State of
`2.
`Delaware, having a principal place of business at One DNA Way, South San Francisco,
`California 94080-4990.
`
`ANSWER
`
`Emcure is without knowledge or information sufficient to form a belief as to the truth of
`
`the allegations of Paragraph 2 of the Complaint, and therefore, denies same.
`
`Upon information and belief, Defendant Fresenius is a corporation organized and
`3.
`existing under the laws of Delaware, having a principal place of business at Three Corporate
`Drive, Lake Zurich, Illinois 60047.
`
`ANSWER
`
`The allegations contained in this paragraph of the Complaint are not directed to Emcure;
`
`however, to the extent that any answer is required from these answering defendants, Emcure is
`
`without sufficient information to admit or deny such allegations and therefore denies same.
`
`Upon information and belief, Defendant Fresenius develops, manufactures,
`4.
`imports, markets, distributes, and/or sells generic pharmaceutical versions of branded products
`for sale and use throughout the United States, including in the State of New Jersey.
`
`ANSWER
`
`The allegations contained in this paragraph of the Complaint are not directed to Emcure;
`
`however, to the extent that any answer is required from these answering defendants, Emcure is
`
`without sufficient information to admit or deny such allegations and therefore denies same.
`
`Upon information and belief, Defendant Emcure Ltd. is a corporation organized
`5.
`and existing under the laws of India, having a principal place of business at T-184, M.LD.C.
`Bhosari, Pune, Maharashtra 411026, Pune, India.
`
`2
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`ANSWER
`
`Emcure admits that Emcure Ltd. is a corporation organized and existing under the laws of
`
`India and has a place of business located at Emcure House, T 184, M.LD.C., Bhosari, Pune, 411
`
`026, India, but otherwise denies the allegations of Paragraph 5 of the Complaint.
`
`Upon information and belief, Defendant Emcure Inc. is a corporation organized
`6.
`and existing under the laws of the State of New Jersey, having a principal place of business at
`21-B Cotters Lane, East Brunswick, New Jersey 08816.
`
`ANSWER
`
`Emcure denies the allegations of Paragraph 6 of the Complaint as stated. By way of
`
`further response, Emcure states that, in August 2014, Emcure Pharmaceuticals USA, Inc. filed an
`
`Amended and Restated Certificate of Incorporation with the New Jersey Secretary of State,
`
`which effectively changed its name to “Heritage Pharma Labs Inc.” (“HPL”). By way of further
`
`response, Emcure admits that HPL is a corporation organized and existing under the laws of New
`
`Jersey with a principal place of business at 21/B Cotters Lane, East Brunswick, New Jersey
`
`08816.
`
`Upon information and belief, Emcure Inc. is a wholly-owned subsidiary and agent
`7.
`of Defendant Emcure Ltd.
`
`ANSWER
`
`Emcure admits that Emcure Ltd. is the ultimate parent of HPL. Emcure denies the
`
`remaining allegations of Paragraph 7 of the Complaint.
`
`Upon information and belief, in August 2014, Emcure Inc. filed an Amended and
`8.
`Restated Certificate of Incorporation with the New Jersey Secretary of State, which effectively
`changed its name to “Heritage Pharma Labs, Inc.”
`
`ANSWER
`
`Emcure admits the allegations of Paragraph 8 of the Complaint.
`3
`
`
`
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`Upon information and belief, Emcure Ltd. has appointed Dr. Pankaj Dave of
`9.
`Emcure Inc., 21-B Cotters Lane, East Brunswick, New Jersey 08816, as its agent in New Jersey
`authorized to accept service of process for this action.
`
`ANSWER
`
`Emcure admits that HPL is the United States agent for Emcure Ltd. with respect to
`
`ANDA No. 202951. Emcure denies the remaining allegations of Paragraph 9 of the Complaint.
`
`
` Upon information and belief, Emcure Ltd. and Emcure Inc. have common
`10.
`officers and directors.
`
`ANSWER
`
`Emcure admits that Emcure Ltd. is the ultimate parent of HPL and that there are common
`
`officers and directors.
`
`Upon information and belief, Emcure Ltd., by itself or through its wholly owned
`11.
`subsidiary and agent Emcure Inc., develops, manufactures, and imports generic pharmaceutical
`versions of branded products for sale and use throughout the United States, including in this
`Judicial District. Upon information and belief, Emcure Ltd., by itself or through its wholly-
`owned subsidiary and agent Emcure Inc., markets, distributes, and/or sells generic
`pharmaceutical versions of branded products throughout the United States, including in the State
`of New Jersey.
`
`ANSWER
`
`Emcure admits that HPL and Emcure Ltd. are in a business that focuses on
`
`pharmaceutical products. Emcure denies the remaining allegations of Paragraph 11 of the
`
`Complaint.
`
`AS TO THE PATENT-IN-SUIT
`
`This is a civil action concerning the infringement of United States Patent No.
`12.
`7,947,724 (“the ’724 patent”), United States Patent No. 7,947,725 (“the ’725 patent”), United
`States Patent No. 7,960,424 (“the ’424 patent”), United States Patent No. 8,598,219 (“the ’219
`patent”), and United States Patent No. 8,729,094 (“the ’094 patent”). This action arises under the
`patent laws of the United States, 35 U.S.C. §§ 100 et seq., as well as the Declaratory Judgment
`Act, 28 U.S.C. §§ 2201-02.
`
`
`
`
`
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`
`ANSWER
`
`Paragraph 12 of the Complaint states legal conclusions to which no response is required.
`
`To the extent any response is required, Emcure admits that the Complaint purports to assert an
`
`action against Emcure based on a technical act of alleged patent infringement pursuant to the
`
`Patent Laws of the United States.
`
`AS TO JURISDICTION AND VENUE
`
`This Court has jurisdiction over the subject matter of this action pursuant to 28
`13.
`U.S.C. §§ 1331 and 1338(a) and the Declaratory Judgment Act, 28 U.S.C. §§ 2201-02.
`
`ANSWER
`
`Paragraph 13 of the Complaint states legal conclusions to which no response is required.
`
`To the extent any response is required, Emcure states that it does not contest subject matter
`
`jurisdiction in this District for the limited purpose of this action only.
`
`This Court may declare the rights and other legal relations of the parties pursuant
`14.
`to 28 U.S.C. §§ 2201-02 because this case is an actual controversy within the Court’s
`jurisdiction.
`
`ANSWER
`
`Paragraph 14 of the Complaint states legal conclusions to which no response is required.
`
`To the extent any response is required, Emcure states that it does not contest subject matter
`
`jurisdiction in this District for the limited purpose of this action only.
`
`Venue is proper in this Court as to each of the Defendants pursuant to 28 U.S.C.
`15.
`§§ 1391(b), (c), and/or (d), and 1400(b).
`
`ANSWER
`
`Paragraph 15 of the Complaint states legal conclusions to which no response is required.
`
`To the extent any response is required, Emcure states that it does not contest venue in this
`
`District for the limited purpose of this action only.
`
`5
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`This Court has personal jurisdiction over each of the Defendants because, inter
`16.
`alia, each Defendant has committed, aided, abetted, contributed to, and/or participated in the
`commission of acts of patent infringement, including acts in the State of New Jersey, that have
`led to foreseeable harm and injury to Plaintiffs in the State of New Jersey. This Court has
`personal jurisdiction over each of the Defendants for the additional reasons set forth below, and
`for other reasons that will be presented to the Court if such jurisdiction is challenged.
`
`ANSWER
`
`Paragraph 16 of the Complaint states legal conclusions to which no response is required.
`
`To the extent any response is required, Emcure states that it does not contest personal jurisdiction
`
`in this District for the limited purpose of this action only.
`
`Fresenius sent Notice Letters to Plaintiffs on August 10, 2015 and September 15,
`17.
`2015 (“Fresenius’s Notice Letters”). Fresenius’s Notice Letters state that it filed Abbreviated
`New Drug Applications (“ANDAs”) Nos. 206802 and 206801 seeking approval from the United
`States Food and Drug Administration (“FDA”) to engage in the commercial manufacture, use,
`importation, offer for sale and sale of 0.25 mg / 5 mL palonosetron hydrochloride intravenous
`solutions in the United States (including, upon information and belief, in the State of New
`Jersey), prior to the expiration of the patents-in-suit.
`
`
`ANSWER
`
`The allegations contained in this paragraph of the Complaint are not directed to Emcure;
`
`however, to the extent that any answer is required from these answering defendants, Emcure is
`
`without sufficient information to admit or deny such allegations and therefore denies same.
`
`This Court also has personal jurisdiction over Defendant Fresenius because, upon
`18.
`information and belief, inter alia, (1) Fresenius has an active business entity status registered
`with the New Jersey Department of Treasury under the business entity identification number
`0600313148 and maintains a corporate agent for service of process at 830 Bear Tavern Road,
`West Trenton, New Jersey 08628; (2) Fresenius holds an active wholesale drug and medical
`device license for the State of New Jersey under License No. 5003710; (3) Fresenius has
`affiliations with the State of New Jersey that are pervasive, continuous, and systematic, including
`the direct marketing, distribution, or sale of generic pharmaceutical drugs within the State of
`New Jersey and to residents of the State of New Jersey; and (4) Fresenius has previously
`submitted to the jurisdiction of this Court and has availed itself of the legal protections of the
`State of New Jersey, having consented to jurisdiction in this Court, see, e.g., Fresenius Kabi
`USA, LLC v. Emcure Pharmaceuticals USA, Inc., et al., Civil Action No. 14-5584 (NLW)(JS)
`(D.N.J. Sept. 8, 2014); Merck Sharp & Dohme Corp. v. Fresenius Kabi USA, LLC, Civil Action
`No. 14-4989 (SRC)(CLW), D.I. 5, at 2-3, 7-13 (D.N.J. Aug. 12, 2014); Merck Sharp & Dohme
`
`6
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`Case 3:15-cv-07015-MLC-DEA Document 17 Filed 10/29/15 Page 7 of 40 PageID: 186
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`Corp. v. Fresenius Kabi USA, LLC, Civil Action No. 14-3917 (PGS)(LHG), D.I. 12, at 4-5, 45-
`55 (D.N.J. Aug. 4, 2014); Novartis Pharm. Corp. v. Fresenius Kabi USA, LLC, Civil Action No.
`13-7914 (SDW)(MCA), D.I. 10, at 3, 7-11 (D.N.J. Feb. 13, 2014); Novartis Pharm. Corp., et al.
`v. Wockhardt USA LLC, et al., Civil Action No. 12-3967 (SDW)(SCM), D.I. 125, at 3-4, 7-9
`(D.N.J. June 19, 2013); Sanofi-Aventis U.S. LLC, et al. v. Fresenius Kabi USA, LLC, Civil
`Action No. 14-8082 (MAS)(LHG), D.I. 11 at 3, 11-14 (D.N.J. Mar. 17, 2015); Sanofi-Aventis
`U.S. LLC v. Fresenius Kabi USA, LLC, et al., Civil Action No. 15-2631(MAS)(LHG), D.I. 12 at
`3 (D.N.J. June 1, 2015).
`
`
`ANSWER
`
`The allegations contained in this paragraph of the Complaint are not directed to Emcure;
`
`however, to the extent that any answer is required from these answering defendants, Emcure is
`
`without sufficient information to admit or deny such allegations and therefore denies same.
`
`Emcure sent a Notice Letter to Plaintiffs on August 11, 2015 (“Emcure’s Notice
`19.
`Letter”). Emcure’s Notice Letter states that Emcure filed Abbreviated New Drug Application
`(“ANDA”) No. 202951 seeking approval from the United States Food and Drug Administration
`(“FDA”) to engage in the commercial manufacture, use, importation, offer for sale and sale of
`0.25 mg / 5 mL (free base) and 0.075 mg / 1.5 mL (free base) palonosetron.
`
`ANSWER
`
`Emcure neither admits nor denies the allegations in Paragraph 19 of the Complaint
`
`because they refer to a written document, the terms of which speak for itself, except that Emcure
`
`admits that it sent Plaintiffs a notice letter regarding its Abbreviated New Drug Application
`
`(“ANDA”) No. 202951 for palonosetron hydrochloride solution that it submitted to the FDA,
`
`and that the asserted patents are invalid, unenforceable and/or not infringed. Emcure denies all
`
`remaining allegations of Paragraph 19 of the Complaint.
`
`Emcure’s Notice Letters authorized Dr. Pankaj Dave of Emcure Inc. to accept
`20.
`service of process for Emcure Ltd.
`
`
`
`
`
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`ANSWER
`
`Emcure neither admits nor denies the allegations in Paragraph 20 of the Complaint
`
`because they refer to a written document, the terms of which speak for itself, except to state that
`
`any allegations inconsistent with the express terms of that document are denied.
`
`This Court also has personal jurisdiction over Emcure because, upon information
`21.
`and belief, inter alia: (1) Emcure Inc. is a corporation organized and existing under the laws of
`the State of New Jersey; (2) Emcure Inc. has its principal place of business in the State of New
`Jersey, and does business in the State of New Jersey; (3) Emcure Inc. is registered to do business
`in the State of New Jersey under Business I.D. No. 0400060460; (4) Emcure has purposely
`availed itself of the privilege of doing business in the State of New Jersey; (5) Emcure has
`affiliations with the State of New Jersey that are pervasive, continuous, and systematic, including
`the direct marketing, distribution, or sale of generic pharmaceutical drugs within the State of
`New Jersey and to residents of the State of New Jersey by Emcure Ltd. itself or through its
`wholly owned subsidiary and agent Emcure Inc.; and (6) Emcure has previously consented to
`this Court’s jurisdiction and taken advantage of the rights and protections provided by this Court.
`See, e.g., Genzyme Corporation, et al. v. Emcure Pharmaceuticals USA Inc., et al., Civil Action
`No. 14-5975 (JEI)(KMW) (D.N.J. Dec. 2, 2014); Sumitomo Dainippon Pharma Co., Ltd., et al.
`v. Emcure Pharmaceuticals Limited, et al., Civil Action No. 15-280 (SRC)(CLW) (D.N.J. Feb.
`23, 2015).
`
`ANSWER
`
`
`
`Paragraph 21 of the Complaint states legal conclusions to which no response is required.
`
`To the extent any response is required, Emcure states that it does not contest personal jurisdiction
`
`in this District for the limited purpose of this action only.
`
`AS TO THE PATENTS-IN-SUIT
`
`On May 24, 2011, the ’724 patent, titled, “Liquid Pharmaceutical Formulations of
`22.
`Palonosetron,” was duly and legally issued to Plaintiffs as assignees. A copy of the ’724 patent is
`attached as Exhibit A.
`
`ANSWER
`
`Paragraph 22 contains legal conclusions and allegations to which no answer is required.
`
`To the extent an answer is required, Emcure admits that Exhibit A to the Complaint purports to
`
`be a copy of the ’724 patent and that the face of Exhibit A states that the ’724 patent purports to
`
`
`
`
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`have been issued on May 24, 2011 and is entitled “Liquid Pharmaceutical Formulations of
`
`Palonosetron.” Emcure further denies that the ’724 patent was “duly and legally” issued, and
`
`denies the remaining allegations of Paragraph 22 of the Complaint.
`
`On May 24, 2011, the ’725 patent, titled, “Liquid Pharmaceutical Formulations of
`23.
`Palonosetron,” was duly and legally issued to Plaintiffs as assignees. A copy of the ’725 patent is
`attached as Exhibit B.
`
`ANSWER
`
`Paragraph 23 contains legal conclusions and allegations to which no answer is required.
`
`To the extent an answer is required, Emcure admits that Exhibit B to the Complaint purports to
`
`be a copy of the ’725 patent and that the face of Exhibit B states that the ’725 patent purports to
`
`have been issued on May 24, 2011 and is entitled “Liquid Pharmaceutical Formulations of
`
`Palonosetron.” Emcure further denies that the ’725 patent was “duly and legally” issued, and
`
`denies the remaining allegations of Paragraph 23 of the Complaint.
`
`On June 14, 2011, the ’424 patent, titled, “Liquid Pharmaceutical Formulations of
`24.
`Palonosetron,” was duly and legally issued to Plaintiffs as assignees. A copy of the ’424 patent is
`attached as Exhibit C.
`
`ANSWER
`
`Paragraph 24 contains legal conclusions and allegations to which no answer is required.
`
`To the extent an answer is required, Emcure admits that Exhibit C to the Complaint purports to
`
`be a copy of the ’424 patent and that the face of Exhibit C states that the ’424 patent purports to
`
`have been issued on June 14, 2011 and is entitled “Liquid Pharmaceutical Formulations of
`
`Palonosetron.” Emcure further denies that the ’424 patent was “duly and legally” issued, and
`
`denies the remaining allegations of Paragraph 24 of the Complaint.
`
`
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`titled, “Liquid Pharmaceutical
`the ’219 patent,
`On December 3, 2013,
`25.
`Formulations of Palonosetron,” was duly and legally issued to Plaintiffs as assignees. A copy of
`the ’219 patent is attached as Exhibit D.
`
`ANSWER
`
`Paragraph 25 contains legal conclusions and allegations to which no answer is required.
`
`To the extent an answer is required, Emcure admits that Exhibit D to the Complaint purports to
`
`be a copy of the ’219 patent and that the face of Exhibit D states that the ’219 patent purports to
`
`have been issued on December 3, 2013 and is entitled “Liquid Pharmaceutical Formulations of
`
`Palonosetron.” Emcure further denies that the ’219 patent was “duly and legally” issued, and
`
`denies the remaining allegations of Paragraph 25 of the Complaint.
`
`On May 20, 2014, the ’094 patent, titled, “Liquid Pharmaceutical Formulations of
`26.
`Palonosetron,” was duly and legally issued to Plaintiffs as assignees. A copy of the ’094 patent is
`attached as Exhibit E.
`
`ANSWER
`
`Paragraph 26 contains legal conclusions and allegations to which no answer is required.
`
`To the extent an answer is required, Emcure admits that Exhibit E to the Complaint purports to
`
`be a copy of the ’094 patent and that the face of Exhibit E states that the ’094 patent purports to
`
`have been issued on May 20, 2014 and is entitled “Liquid Pharmaceutical Formulations of
`
`Palonosetron.” Emcure further denies that the ’094 patent was “duly and legally” issued, and
`
`denies the remaining allegations of Paragraph 26 of the Complaint.
`
`Pursuant to 21 U.S.C. § 355(b)(l), the ’724 patent, the ’725 patent, the ’424
`27.
`patent, the ’219 patent, and the ’094 patent are listed in the United States Food and Drug
`Administration (“FDA”) publication
`titled Approved Drug Products with Therapeutic
`Equivalence Evaluations (also known as the “Orange Book”) as covering Helsinn’s Aloxi®
`brand palonosetron hydrochloride intravenous solutions.
`
`
`
`
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`ANSWER
`
`Upon information and belief, Emcure admits that the ’724 patent, the ’725 patent, the
`
`’424 patent, the ’219 patent, and the ’094 patent are listed in connection with Aloxi® in the
`
`electronic version of FDA’s publication, Approved Drug Products and Therapeutic Equivalence
`
`Evaluations (commonly known as the “Orange Book”).
`
`AS TO ACTS GIVING RISE TO THIS ACTION
`
`AS TO COUNT I – INFRINGEMENT OF THE ’724 PATENT BY FRESENIUS
`
`Plaintiffs reallege paragraphs 1-27 as if fully set forth herein.
`
`28.
`
`ANSWER
`
`Emcure repeats and incorporates by reference its responses to each of the foregoing
`
`paragraphs of the Complaint as if fully set forth herein.
`
`Upon information and belief, Defendant Fresenius submitted ANDA Nos. 206802
`29.
`and 206801 to the FDA under § 505(j) of the Federal Food, Drug and Cosmetic Act (21 U.S.C. §
`355(j)). ANDA Nos. 206802 and 206801 seek the FDA approval necessary to engage in the
`commercial manufacture, use, sale, offer for sale, and/or importation of generic 0.25 mg / 5 mL
`palonosetron hydrochloride intravenous solutions prior to the expiration of certain of Plaintiffs’
`Orange Book listed patents that have the same expiration date as the ’724 patent. ANDA Nos.
`206802 and 206801 specifically seek FDA approval to market a generic version of Helsinn’s
`Aloxi® brand 0.25 mg / 5 mL palonosetron hydrochloride intravenous solutions prior to the
`expiration of the ’724 patent.
`
`ANSWER
`
`The allegations contained in this paragraph of the Complaint are not directed to Emcure;
`
`however, to the extent that any answer is required from these answering defendants, Emcure is
`
`without sufficient information to admit or deny such allegations and therefore denies same.
`
`
`Upon information and belief, ANDA Nos. 206802 and 206801 include a
`30.
`certification under § 505(j)(2)(A)(vii)(IV) of the Federal Food, Drug and Cosmetic Act that the
`claims of the ’724 patent are invalid. Defendant Fresenius notified Plaintiffs of its certification
`and provided a detailed statement of the alleged basis for the certification, but did not allege
`
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`noninfringement of any claim of the ’724 patent, separate and apart from its assertions that those
`claims are allegedly invalid.
`
`ANSWER
`
`The allegations contained in this paragraph of the Complaint are not directed to Emcure;
`
`however, to the extent that any answer is required from these answering defendants, Emcure is
`
`without sufficient information to admit or deny such allegations and therefore denies same.
`
`
`Defendant Fresenius’s submission to the FDA of ANDA Nos. 206802 and
`31.
`206801, including the § 505(j)(2)(A)(vii)(IV) allegations, constitute infringement of the ’724
`patent under 35 U.S.C. § 271(e)(2)(A).
`
`ANSWER
`
`The allegations contained in this paragraph of the Complaint are not directed to Emcure;
`
`however, to the extent that any answer is required from these answering defendants, Emcure is
`
`without sufficient information to admit or deny such allegations and therefore denies same.
`
`Defendant Fresenius’s active and knowing participation in, contribution to,
`32.
`aiding, abetting, and/or inducement of the submission to the FDA of ANDA Nos. 206802 and
`206801 and the § 505(j)(2)(A)(vii)(IV) certification constitute infringement of the ’724 patent
`under 35 U.S.C. § 271 (e)(2)(A).
`
`ANSWER
`
`The allegations contained in this paragraph of the Complaint are not directed to Emcure;
`
`however, to the extent that any answer is required from these answering defendants, Emcure is
`
`without sufficient information to admit or deny such allegations and therefore denies same.
`
`Plaintiffs are entitled to a declaration that, if Defendant Fresenius commercially
`33.
`manufactures, uses, sells, or offers to sell its proposed generic versions of Helsinn’s Aloxi®
`brand products within the United States, imports its proposed generic versions of Helsinn’s
`Aloxi® brand products into the United States, and/or induces or contributes to such conduct,
`Defendant Fresenius will infringe the ’724 patent under 35 U.S.C. § 271(a), (b), and/or (c).
`
`
`
`
`
`
`122788.00609/101497951v.2
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`12
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`

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`Case 3:15-cv-07015-MLC-DEA Document 17 Filed 10/29/15 Page 13 of 40 PageID: 192
`
`ANSWER
`
`The allegations contained in this paragraph of the Complaint are not directed to Emcure;
`
`however, to the extent that any answer is required from these answering defendants, Emcure is
`
`without sufficient information to admit or deny such allegations and therefore denies same.
`
`Plaintiffs will be irreparably harmed by Defendant Fresenius’s infringing
`34.
`activities unless those activities are enjoined by this Court. Plaintiffs do not have an adequate
`remedy at law.
`
`ANSWER
`
`The allegations contained in this paragraph of the Complaint are not directed to Emcure;
`
`however, to the extent that any answer is required from these answering defendants, Emcure is
`
`without sufficient information to admit or deny such allegations and therefore denies same.
`
`AS TO COUNT II – INFRINGEMENT OF THE ’724 PATENT BY EMCURE
`
`Plaintiffs repeat and re-allege paragraphs 1-34 as if fully set forth herein.
`
`35.
`
`ANSWER
`
`Emcure repeats and incorporates by reference its responses to each of the foregoing
`
`paragraphs of the Complaint as if fully set forth herein.
`
`Upon information and belief, Defendant Emcure submitted ANDA No. 202951 to
`36.
`the FDA under § 505(j) of the Federal Food, Drug and Cosmetic Act (21 U.S.C. § 355(j)).
`ANDA No. 202951 seeks the FDA approval necessary to engage in the commercial manufacture,
`use, sale, offer for sale, and/or importation of generic 0.25 mg / 5 mL (free base) and 0.075 mg /
`1.5 mL (free base) palonosetron single-use vials for intravenous administration prior to the
`expiration of certain of Plaintiffs’ Orange Book listed patents that have the same expiration date
`as the ’724 patent. ANDA No. 202951 specifically seeks FDA approval to market a generic
`version of Helsinn’s Aloxi® brand 0.25 mg / 5 mL (free base) and 0.075 mg / 1.5 mL (free base)
`palonosetron single-use vials for intravenous administration prior to the expiration of the ’724
`patent.
`
`
`
`
`
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`13
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`

`
`Case 3:15-cv-07015-MLC-DEA Document 17 Filed 10/29/15 Page 14 of 40 PageID: 193
`
`ANSWER
`
`Paragraph 36 of the Complaint states legal conclusions to which no response is required.
`
`To the extent any response is required, Emcure states that it submitted ANDA No. 202951 for
`
`palonosetron hydrochloride solution to the FDA, and denies all remaining allegations of
`
`Paragraph 36 of the Complaint.
`
`Upon information and belief, ANDA No. 202951 includes a certification under §
`37.
`505(j)(2)(A)(vii)(IV) of the Federal Food, Drug and Cosmetic Act that the claims of the ’724
`patent are invalid. Defendant Emcure notified Plaintiffs of its certification and provided a
`detailed statement of the alleged basis for the certification, but did not allege noninfringement of
`any claim of the ’724 patent, separate and apart from its assertions that those claims are allegedly
`invalid.
`
`ANSWER
`
`Emcure admits
`
`that
`
`its ANDA No. 202951
`
`includes a certification under §
`
`505(j)(2)(A)(vii)(IV) of the Federal Food, Drug and Cosmetic Act that the claims of the ’724
`
`patent are invalid and/or not infringed, that Emcure notified Plaintiffs of its certification and
`
`provided a detailed statement of the alleged basis for the certification, and denies any remaining
`
`allegations of Paragraph 37 of the Complaint.
`
`Defendant Emcure’s submission to the FDA of ANDA No. 202951, including the
`38.
`§ 505(j)(2)(A)(vii)(IV) allegations, constitutes infringement of the ’724 patent under 35 U.S.C. §
`271(e)(2)(A).
`
`ANSWER
`
`Paragraph 38 of the Complaint states legal conclusions to which no response is required.
`
`To the extent any response is required, Emcure denies such allegations.
`
`Defendant Emcure’s active and knowing participation in, contribution to, aiding,
`39.
`abetting, and/or inducement of the submission to the FDA of ANDA No. 202951 and the §
`505(j)(2)(A)(vii)(IV) certification constitutes infringement of the ’724 patent under 35 U.S.C. §
`271 (e)(2)(A).
`
`
`
`
`
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`14
`
`

`
`Case 3:15-cv-07015-MLC-DEA Document 17 Filed 10/29/15 Page 15 of 40 PageID: 194
`
`ANSWER
`
`Emcure denies the allegations in Paragraph 39 of the Complaint.
`
`Plaintiffs are entitled to a declaration that, if Defendant Emcure commercially
`40.
`manufactures, uses, sells, or offers to sell its proposed generic versions of Helsinn’s Aloxi®
`brand products within the United States, import its proposed generic versions of Helsinn’s
`Aloxi® brand products into the United States, and/or induce or contribute to such conduct,
`Defendant Emcure will infringe the ’724 patent under 35 U.S.C. § 271(a), (b), and/or (c).
`
`ANSWER
`
`Emcure denies the allegations in Paragraph 40 of the Complaint.
`
`Plaintiffs will be irreparably harmed by Defendant Emcure’s infringing activities
`41.
`unless those activities are enjoined by this Court. Plaintiffs do not have an adequate remedy at
`law.
`
`ANSWER
`
`Emcure denies the allegations in Paragraph 41 of the Complaint.
`
`AS TO COUNT III – INFRINGEMENT OF THE ’725 PATENT BY FRESENIUS
`
`Plaintiffs reallege paragraphs 1-41 as if fully set forth herein.
`
`42.
`
`ANSWER
`
`Emcure repeats and incorporates by reference its responses to each of the foregoing
`
`paragraphs of the Complaint as if fully set forth herein.
`
`Upon information and belief, Defendant Fresenius submitted ANDA Nos. 206802
`43.
`and 206801 to the FDA under § 505(j) of the Federal Food, Drug and Cosmetic Act (21 U.S.C. §
`355(j)). ANDA Nos. 206802 and 206801 seek the FDA approval necessary to engage in the
`commercial manufacture, use, sale, offer for sale, and/or importation of generic 0.25 mg / 5 mL
`palonosetron hydrochloride intravenous solutions prior to the expiration of certain of Plaintiffs’
`Orange Book listed patents that have the same expiration date as the ’725 patent. ANDA Nos.
`206802 and 206801 specifically seek FDA approval to market a generic version of Helsinn’s
`Aloxi® brand 0.25 mg / 5 mL palonosetron hydrochloride intravenous solutions prior to the
`expiration of the ’725 patent.
`
`
`
`
`
`
`122788.00609/101497951v.2
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`15
`
`

`
`Case 3:15-cv-07015-MLC-DEA Document 17 Filed 10/29/15 Page 16 of 40 PageID: 195
`
`ANSWER
`
`The allegations contained in this paragraph of the Complaint are not directed to Emcure;
`
`however, to the extent that any answer is required from these answering defendants, Emcure is
`
`without sufficient information to admit or deny such allegations and therefore denies same.
`
`Upon information and belief, ANDA Nos. 206802 and 206801 include a
`44.
`certification under § 505(j)(2)(A)(vii)(IV) of the Federal Food, Drug and Cosmetic Act that the
`claims of the ’725 patent are invalid. Defendant Fresenius notified Plaintiffs of its certification
`and provided a detailed statement of the alleged basis for the certification, but did not allege
`noninfringement of any claim of the ’725 patent, separate and apart from its assertions that those
`claims are allegedly invalid.
`
`ANSWER
`
`The allegations contained in this paragraph of the Complaint are not directed to Emcure;
`
`however, to the extent that any answer is required from these answering defendants, Emcure is
`
`without sufficient information to admit or deny such allegations and therefore denies same.
`
`Defendant Fresenius’s submission to the FDA of ANDA Nos. 206802 and