MYLAN - EXHIBIT 1055
`Mylan Laboratories Limited v. Aventis Pharma S.A.
`IPR2016-00712
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`

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`Case 3:15—cv—03392—MAS—LHG Document 19 Filed 07/16/15 Page 2 of 18 Page|D: 162
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`Defendant Mylan Laboratories Limited f/k/a Onco Therapies Ltd., (“MLL”) answers and
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`responds to each of the allegations in the Complaint filed by Plaintiffs Sanofi-Aventis U.S. LLC
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`(“Sanofi U.S.”), Aventis Pharma S.A. (“Aventis”), and Sanofi (collectively “Plaintiffs”). To the
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`extent not specifically admitted herein, the allegations of the Complaint are denied.
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`THE PARTIES
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`Plaintiff Sanofi U.S. is an indirectly wholly owned U.S. subsidiary of Sanofi and
`1.
`is a company organized and existing under the laws of the State of Delaware, having commercial
`headquarters at 55 Corporate Drive, Bridgewater, New Jersey 08807.
`
`ANSWER: MLL lacks knowledge or information sufficient to form a belief as to the
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`truth of the allegations of paragraph 1 and therefore denies them.
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`Plaintiff Aventis is a corporation organized and existing under the laws of France,
`2.
`having its principal place of business at 20 avenue Raymond Aron, 92160 Antony, France.
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`ANSWER: MLL lacks knowledge or information sufficient to form a belief as to the
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`truth of the allegations of paragraph 2 and therefore denies them.
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`Plaintiff Sanofi is a corporation organized and existing under the laws of France,
`3.
`having its principal place of business at 54 rue La Boétie, 75008 Paris, France.
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`ANSWER: MLL lacks knowledge or information sufficient to form a belief as to the
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`truth of the allegations of paragraph 3 and therefore denies them.
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`Plaintiff Sanofi is a global research-driven pharmaceutical company that
`4.
`discovers, develops, manufactures and markets a broad range of innovative products to improve
`human and animal health.
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`ANSWER: MLL lacks knowledge or information sufficient to form a belief as to the
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`truth of the allegations of Paragraph 4 and therefore denies them.
`
`On information and belief, Onco is a corporation organized and existing under the
`5.
`laws of India, having its principal place of business at Strides House, Bilekahalli, Bannerghatta
`Road, Bangalore, Karnataka 560076, India.
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`ANSWER: MLL admits that it is a corporation organized and existing under the laws of
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`India. MLL avers that its principal place of business is at Opp. IIM, Bilekahalli, Bannerghatta
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`Case 3:15—cv—03392—MAS—LHG Document 19 Filed 07/16/15 Page 3 of 18 Page|D: 163
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`Road, Bangalore, Karnataka 560076, India. To the extent not expressly admitted, MLL denies
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`the allegations of paragraph 5.
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`On information and belief, Onco is a wholly-owned subsidiary of Strides Arcolab
`6.
`Limited (“hereinafter “Arcolab”). On information and belief, Arcolab is a corporation organized
`and existing under the laws of India, having its principal place of business at Strides House,
`Bilekahalli, Bannerghatta Road, Bangalore, Karnataka 560076, India.
`
`ANSWER: MLL denies that it is a wholly-owned subsidiary of Strides Arcolab Limited.
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`MLL lacks knowledge or information sufficient to form a belief as to the truth of the remaining
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`allegations of paragraph 6 and therefore denies them.
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`On information and belief, Onco conducts business through and with Agila
`7.
`Specialties Inc. (hereinafter “Agila”), formerly known as Strides, Inc. On information and belief,
`Agila is a corporation organized and existing under the laws of New Jersey, having its principal
`place of business at 201 South Main Street, Suite 3, Lambertville, New Jersey 08530. On
`information and belief, Agila is an agent or affiliate of Onco.
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`ANSWER: MLL admits that Agila Specialties Inc. is a corporation organized and
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`existing under the laws of New Jersey. To the extent not expressly admitted, MLL denies the
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`allegations of paragraph 7.
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`On information and belief, Onco conducts business through and with Strides
`8.
`Pharma Inc. (hereinafter “Strides Pharma”). On information and belief, Strides Pharma is a
`corporation organized and existing under the laws of New Jersey, having its principal place of
`business at 201 South Main Street, Suite 3, Lambertville, New Jersey 08530. On information
`and belief, Strides Pharma is a wholly-owned subsidiary of Arcolab. On information and belief,
`Strides Pharma is an agent or affiliate of Onco.
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`ANSWER: MLL denies that it conducts business through and with Strides Pharma Inc.
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`MLL denies that Strides Pharma Inc. is an agent or affiliate of MLL. MLL lacks knowledge or
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`information sufficient to form a belief as to the truth of the remaining allegations of paragraph 8
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`and therefore denies them.
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`Case 3:15—cv—03392—MAS—LHG Document 19 Filed 07/16/15 Page 4 of 18 Page|D: 164
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`9.
`On information and belief, Onco assembled and caused to be filed with the United
`States Food and Drug Administration (“FDA”), pursuant to 21 U.S.C. § 355(]') (Section 505(j) of
`the Federal Food, Drug and Cosmetic Act), Abbreviated New Drug Application (“ANDA”) No.
`207381 (hereinafter “the Onco ANDA”) concerning a proposed drug product, cabazitaxel
`injection [60 mg/1.5 mL] [40 mg/mL] (“Onco’s Proposed ANDA Product”).
`
`ANSWER: MLL admits the allegations of paragraph 9.
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`JURISDICTION AND VENUE
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`This action arises under the patent laws of the United States of America. This
`10.
`Court has jurisdiction over the subject matter of this action pursuant to 28 U.S.C. §§ 1331 and
`1 3 3 8(a).
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`ANSWER: Paragraph 10 states legal conclusions to which no answer is required. To
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`conserve the resources of the parties and the Court, and to the extent that an answer is required,
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`MLL does not contest the subject matter jurisdiction of this Court solely for the limited purposes
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`of this action. To the extent not expressly admitted, MLL denies the allegations of paragraph 10.
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`This Court has personal jurisdiction over Onco. On information and belief, Onco
`11.
`conducts business through and with Agila. On information and belief, Agila is a corporation
`organized and existing under the laws of New Jersey, having its principle place of business at
`201 South Main Street, Suite 3, Lambertville, New Jersey 08530. On information and belief,
`Agila is registered with the New Jersey Department of Treasury under entity identification
`number 0100791546. On information and belief, Agila maintains a registered corporate agent at
`37 Veronica Avenue, Somerset, New Jersey 08873. On infonnation and belief, Agila is an agent
`or affiliate of Onco. On information and belief, Onco conducts business through and with
`Strides Pharma. On information and belief, Strides Pharma is a corporation organized and
`existing under the laws of New Jersey, having its principal place of business at 201 South Main
`Street, Suite 3, Lambertville, New Jersey 08530. On information and belief, Strides Pharma is
`registered with the New Jersey Department of Treasury under entity identification number
`0400580219. On information and belief, Strides Pharma maintains a registered corporate agent
`at 201 South Main Street, Suite 3, Lambertville, New Jersey 08530. On information and belief,
`Stride Pharma holds an active wholesale drug and medical device license for the State of New
`Jersey under License No. 5004572.
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`ANSWER: Paragraph 11 states legal conclusions to which no answer is required. To the
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`extent an answer is required, MLL denies the allegation that this Court has personal jurisdiction
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`over MLL, whether by general or specific jurisdiction. However, to conserve the resources of
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`the parties and the Court, MLL will not contest personal jurisdiction in this judicial district for
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`Case 3:15—cv—03392—MAS—LHG Document 19 Filed 07/16/15 Page 5 of 18 Page|D: 165
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`the purposes of this litigation only. MLL lacks knowledge or information sufficient to form a
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`belief as to the truth of the remaining allegations of paragraph 11 and therefore denies them.
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`On information and belief, Onco directly or through its affiliates and agents
`12.
`develops, formulates, manufactures, markets, imports and sells pharmaceutical products,
`including generic drug products, which are copies of products invented and developed by
`innovator pharmaceutical companies, throughout the United States, including in this Judicial
`District.
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`ANSWER: MLL admits that it manufactures, sells and imports pharmaceutical products
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`directly or through its affiliates. To the extent not expressly admitted, MLL denies the
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`allegations of paragraph 12.
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`On information and belief, Onco has affiliations with the State of New Jersey that
`13.
`are pervasive, continuous, and systematic. On information and belief, Onco engages in direct
`marketing, distribution, and/or sale of generic pharmaceutical drugs within the State of New
`Jersey and to the residents of the State of New Jersey.
`
`ANSWER: MLL denies the allegations of paragraph 13.
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`On information and belief, Onco regularly conducts and/or solicits business,
`14.
`directly, or through its parent company, Arcolab, and/or affiliate or subsidiary companies, Agila,
`and Strides Pharma, in the State of New Jersey. On information and belief, Onco engages in
`other persistent courses of conduct, directly, or throught [sic] its parent company, Arcolab,
`and/or affiliate or subsidiary companies, Agila, and Strides Pharma, in the State of New Jersey,
`and/or derives substantial revenue from services or things used or consumed in the State of New
`Jersey.
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`ANSWER: MLL denies the allegations of paragraph 14.
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`Onco is also subject to personal jurisdiction in the State of New Jersey because,
`15.
`inter alia, Onco has committed, aided, abetted, contributed to, and/or participated in the
`commission of a tortious act of patent infringement under 35 U.S.C. § 271(e)(2) that has led
`and/or will lead to foreseeable harm and injury to Plaintiff Sanofi U.S., having commercial
`headquarters in the State of New Jersey. In its May 5, 2015 Paragraph IV Notice Letter, Onco
`states that it intends to engage in the commercial manufacture, use, and/or sale of Onco’s
`Proposed ANDA Product before the expiration of U.S. Patent Nos. 8,927,592 (“the ’592 patent,”
`copy attached as Exhibit A) throughout the United States including in this Judicial District.
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`ANSWER: Paragraph 15 states legal conclusions to which no answer is required. To the
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`extent an answer is required, MLL denies the allegations of paragraph 15.
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`Case 3:15—cv—03392—MAS—LHG Document 19 Filed 07/16/15 Page 6 of 18 Page|D: 166
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`In the alternative, Onco is subject to jurisdiction in the United States under the
`16.
`principles of general jurisdiction, and specifically in the State of New Jersey pursuant to Fed. R.
`Civ. P. 4(k)(2). Onco has contacts with the United States by, inter alia, its having filed an
`ANDA with the FDA.
`
`ANSWER: Paragraph 16 states legal conclusions to which no answer is required. To the
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`extent an answer is required, MLL denies the allegations of paragraph 16.
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`On information and belief, upon approval of the Onco ANDA, Onco and/or its
`17.
`affiliates, agents or subsidiaries will market, sell and/or distribute Onco’s Proposed ANDA
`Product throughout the United States, including in this Judicial District, and will derive
`substantial revenue therefrom.
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`ANSWER: MLL denies the allegations of paragraph 17.
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`On information and belief, upon approval of the Onco ANDA, Onco and/or its
`18.
`affiliates, agents or subsidiaries will place Onco’s Proposed ANDA Product into the stream of
`commerce with the reasonable expectation or knowledge and the intent that such product will
`ultimately be purchased and used by consumers in this Judicial District.
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`ANSWER: MLL denies the allegations of paragraph 18.
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`Venue is proper in this Court at least pursuant to 28 U.S.C. §§ 1391(b), (c), and/or
`19.
`((1), and 1400(b).
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`ANSWER: Paragraph 19 states legal conclusions to which no answer is required. To the
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`extent that an answer is required, and to conserve the resources of the parties and the Court,
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`MLL does not contest venue in this judicial district solely for the limited purposes of this action.
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`JEVTANA®
`
`Sanofi U.S. holds approved NDA No. 201023 for cabazitaxel injection, 60 mg/
`20.
`1.5 mL (40 mg/mL), which is prescribed and sold in the United States under the trademark
`JEVTANA® KIT (hereinafter “JEVTANA®”). The FDA approved NDA No. 201023 on June
`17, 2010. JEVTANA® is approved for use in combination with prednisone for the treatment of
`patients with horrnone-refractory metastatic prostate cancer previously treated with a docetaxel-
`containing treatment regimen.
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`ANSWER: MLL lacks knowledge or information sufficient to form a belief as to the
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`truth of the allegations of paragraph 20 and therefore denies them. However, MLL avers that
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`Sanofi Aventis US is identified in the electronic version of the FDA’s publication, Approved
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`Case 3:15—cv—03392—MAS—LHG Document 19 Filed 07/16/15 Page 7 of 18 Page|D: 167
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`Drug Products with Therapeutic Equivalence Evaluations (“the Orange Book”) as the holder of
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`NDA No. 201023 for cabazitaxel injection, 60 mg/ 1.5 mL (40 mg/mL). MLL avers the Orange
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`Book lists NDA No. 201023 as originally or tentatively approved on June 17, 2010, and lists the
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`drug name as JEVTANA KIT. MLL avers that the prescribing information for JEVTANA®
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`states that it is “indicated in combination with prednisone for treatment of patients with
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`horrnone-refractory metastatic prostate cancer previously treated with a docetaxel-containing
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`treatment regimen.”
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`PATENT-IN-SUIT
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`The ’5 92 patent is entitled “Antitumoral Use of Cabazitaxel” and was duly and
`21.
`legally issued by the United States Patent and Trademark Office (“USPTO”) on January 6, 2015.
`The ’592 patent claims, inter alia, methods for treating or increasing the survival of patients with
`prostate cancer, including the use of JEVTANA® in accordance with the labeling approved by
`the FDA. The ’592 patent is listed in the FDA’s Approved Drug Products with Therapeutic
`Equivalence Evaluations (the “Orange Book”) for JEVTANA® (NDA No. 201023).
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`ANSWER: United States Patent No. 8,927,592 speaks for itself with respect to the
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`contents thereof, and to the extent a response is required, MLL denies the remaining allegations
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`in paragraph 21. However, MLL avers that the face of the ’592 patent indicates that its title is
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`“Antitumoral Use of Cabazitaxel” and that the face of the ’592 patent indicates that it issued on
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`January 6, 2015. MLL avers that the ’592 patent is listed in an electronic version of the Orange
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`Book as purportedly relating to NDA No. 201023.
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`22.
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`The ’592 patent is owned by Aventis.
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`ANSWER: MLL lacks knowledge or information sufficient to form a belief as to the
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`truth of the allegations of paragraph 22 and therefore denies them.
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`Case 3:15—cv—03392—MAS—LHG Document 19 Filed 07/16/15 Page 8 of 18 Page|D: 168
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`CLAIMS FOR RELIEF — PATENT INFRINGEMENT
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`On information and belief, Onco submitted the Onco ANDA to the FDA seeking
`23.
`approval to engage in the commercial manufacture, use, offer for sale, sale, and/or importation of
`Onco’s Proposed ANDA Product.
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`ANSWER: MLL denies the allegations of paragraph 23, but avers that Agila submitted
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`the MLL ANDA on behalf of MLL to the FDA to seek approval to manufacture and sell the
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`MLL ANDA Product.
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`On information and belief, the Onco ANDA seeks FDA approval of Onco’s
`24.
`Proposed ANDA Product for use in combination with prednisone for the treatment of patients
`with hormone-refractory metastatic prostate cancer previously treated with a docetaxel-
`containing treatment regimen.
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`ANSWER: MLL admits that its ANDA seeks FDA approval for the MLL ANDA
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`Product in combination with prednisone for the treatment of patients with hormone-refractory
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`metastatic prostate cancer previously treated with a docetaxel-containing treatment regimen. To
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`the extent not expressly admitted, MLL denies the remaining allegations of paragraph 24.
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`On information and belief, Onco actively participated in and/or directed activities
`25.
`related to the submission of the Onco ANDA and the development of Onco’s Proposed ANDA
`Product, was actively involved in preparing the ANDA, and/or intends to directly benefit from
`and has a financial stake in the approval of the ANDA. On information and belief, upon
`approval of the Onco ANDA, Onco will be involved in the manufacture, distribution, and/or
`marketing of Onco’s Proposed ANDA Product.
`
`ANSWER: MLL denies the allegations of paragraph 25, but avers that Agila submitted
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`the MLL ANDA on behalf of MLL to the FDA.
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`By letter dated May 5, 2015 (the “May 5 Letter”), and pursuant to 21 U.S.C. §
`26.
`355(j)(2)(B)(ii) and 21 C.F.R. §314.95, Onco notified Plaintiffs that it had amended the Onco
`ANDA to indicate that Onco seeks approval to engage in the commercial manufacture, use, or
`sale of Onco’s Proposed ANDA Product before the expiration of the ’592 patent. The May 5
`Letter was received by Plaintiffs on May 6, 2015.
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`ANSWER: MLL admits that in a letter dated May 5, 2015, MLL notified Sanofi U.S.
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`and Aventis that it had amended ANDA No. 207381 to the FDA seeking approval to engage in
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`the commercial manufacture, use, or sale of the MLL ANDA Product prior to the expiration of
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`

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`Case 3:15—cv—03392—MAS—LHG Document 19 Filed 07/16/15 Page 9 of 18 Page|D: 169
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`the ’592 patent. MLL lacks knowledge or information sufficient to form a belief as to the truth
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`of the remaining allegations of paragraph 26 and therefore denies them.
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`In its May 5 Letter, Onco notified Plaintiffs, as part of the Onco ANDA, it had
`27.
`filed a certification of the type described in 21 U.S.C. § 355(j)(2)(A)(vii)(IV) (a “Paragraph IV
`Certification”) with respect to the ’592 patent. On information and belief, Onco certified that,
`the ’592 patent is invalid, unenforceable and/or will not be infringed by the manufacture, use or
`sale of Onco’s Proposed ANDA Product.
`
`ANSWER: MLL admits that in a letter dated May 5, 2015, MLL notified Sanofi U.S.
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`and Aventis that the MLL ANDA contained a Paragraph IV certification stating that the ’592
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`patent is invalid, unenforceable and/or will not be infringed by the manufacture, use, sale, or
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`importation of MLL’s ANDA Product. To the extent not expressly admitted, MLL denies the
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`remaining allegations of paragraph 27.
`
`28.
`JEVTANA®.
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`The Onco ANDA refers to and relies upon the Sanofi U.S. NDA No. 201023 for
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`ANSWER: MLL admits that the MLL ANDA refers to NDA No. 201023. To the extent
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`not expressly admitted, MLL denies the remaining allegations of paragraph 28.
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`COUNT I
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`INFRINGEMENT OF U.S. PATENT NO. 8,927,592
`
`29.
`
`Plaintiffs repeat and reallege paragraphs 1 through 28 above as if fully set forth
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`herein.
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`ANSWER: MLL incorporates by reference the above responses to paragraphs 1-28 as if
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`fully set forth herein.
`
`By submitting the Onco ANDA under 21 U.S.C. § 3550) for the purpose of
`30.
`obtaining approval to engage in the commercial manufacture, use or sale of Onco’s Proposed
`ANDA Product throughout the United States prior to the expiration of the ’592 patent, Onco
`committed an act of infringement of the ’592 patent under 35 U.S.C. § 27l(e)(2). On
`information and belief, Onco was aware of the ’592 patent at the time the Onco ANDA was
`submitted.
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`ANSWER: MLL denies the allegations of paragraph 30.
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`If Onco commercially makes, uses, offers to sell, or sells Onco’s Proposed ANDA
`31.
`Product within the United States, or imports Onco’s Proposed ANDA Product into the United
`States, or induces or contributes to any such conduct during the term of the ’592 patent, it would
`fl.lIthCI' infringe the ’592 patent under 35 U.S.C. §§ 271(a), (b), and/or (c).
`
`ANSWER: MLL denies the allegations of paragraph 31.
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`Plaintiffs will be irreparably harmed if Onco is not enjoined from infringing
`32.
`the ’592 patent. Plaintiffs do not have an adequate remedy at law.
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`ANSWER: MLL denies the allegations of paragraph 32.
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`Onco’s certification under 21 U.S.C. § 355(j)(2)(A)(vii)(IV) against the ’592
`33.
`patent was wholly unjustified, and thus this case is exceptional under 35 U.S.C. § 285.
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`ANSWER: MLL denies the allegations of paragraph 33.
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`PRAYER FOR RELIEF
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`All remaining allegations not specifically admitted herein are denied. It is further denied
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`that Plaintiffs are entitled to the relief requested in their Complaint or to any relief whatsoever.
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`MLL respectfully requests the Court to dismiss Plaintiffs’ suit with prejudice, enter judgment in
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`favor of MLL, assess costs and attorneys’ fees against Plaintiffs, and award MLL all other relief
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`the Court deems appropriate.
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`SEPARATE DEFENSES
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`Without prejudice to the denials set forth in its Answer, without admitting any averments
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`of the Complaint not otherwise admitted, and without undertaking any of the burdens imposed
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`by law on the Plaintiffs, Defendant avers and asserts the following Separate Defenses to the
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`Complaint:
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`FIRST SEPARATE DEFENSE
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`The Complaint fails to state a claim upon which relief can be granted.
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`SECOND SEPARATE DEFENSE
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`MLL has not directly or indirectly infringed the ’592 patent. The manufacture, use, offer
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`for sale, sale, marketing, distribution, and/or importation of the products specified in ANDA No.
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`207381 do not and will not infringe any valid and enforceable claim of the ’592 patent, either
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`literally or under the doctrine of equivalents.
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`THIRD SEPARATE DEFENSE
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`Each and every claim of the ’592 patent is invalid for failure to satisfy the requirements
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`of Title 35 of the United States Code, including without limitation one or more of 35 U.S.C.
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`§§ 101, 102, 103, 112, 116 and/or double patenting.
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`FOURTH SEPARATE DEFENSE
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`Plaintiffs’ allegations are barred by the doctrines of estoppel and prosecution history
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`estoppel.
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`FIFTH SEPARATE DEFENSE
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`MLL reserves all defenses, at law or equity that may now exist or in the future be
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`available on discovery and further factual investigation in this case.
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`COUNTERCLAIMS
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`Mylan Laboratories Ltd. (“MLL”) for its counterclaims against Sanofi-Aventis U.S., LLC
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`(“Sanofi U.S.”), Aventis Pharma S.A. (“Aventis”), and Sanofi (collectively “Plaintiffs”) avers as
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`follows:
`
`THE PARTIES
`
`1.
`
`Mylan Laboratories Limited is a corporation organized and existing under the
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`laws of India, having its principal place of business at Opp. IIM, Bilekahalli, Bannerghatta Road,
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`Bangalore, Kamataka 560076, India.
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`10
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`2.
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`On information and belief, Sanofi U.S. is a U.S. subsidiary of Sanofi and is a
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`company organized and existing under the laws of the State of Delaware, with its headquarters at
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`55 Corporate Drive, Bridgewater, New Jersey 08807.
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`3.
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`On information and belief, Aventis is a corporation organized and existing under
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`the laws of France, with its principal place of business at 20 avenue Raymond Aron, 92160
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`Antony, France.
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`4.
`
`On information and belief, Sanofi is a corporation organized and existing under
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`the laws of France, with its principal place of business at 54 rue La Boétie, 75008 Paris, France.
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`JURISDICTION AND VENUE
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`5.
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`This Court has original jurisdiction over the subject matter of these claims
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`pursuant to 28 U.S.C. §§ 1331 and 1338(a).
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`6.
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`This Court has personal jurisdiction over Plaintiffs because Plaintiffs commenced
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`and continue to maintain this action against MLL in this judicial district.
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`7.
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`Venue is proper in this district under 28 U.S.C. §§ l391(b) and (c), l400(b), and
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`because Plaintiffs have consented to venue in this Court by filing the instant action in this
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`jurisdiction.
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`FACTUAL BACKGROUND
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`8.
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`Plaintiffs have alleged in this action that Plaintiffs are the owner of the ’592
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`patent.
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`9.
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`On information and belief, Plaintiff Aventis is the present owner by assignment of
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`the whole right, title, and interest of the ’592 patent. On information and belief, Plaintiffs Sanofi
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`U.S. and Sanofi hold licenses to the ’592 patent. The ’592 patent is attached as Exhibit A to the
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`Complaint.
`
`ll
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`10.
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`MLL filed ANDA No. 207381 seeking approval from the FDA for cabazitaxel
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`injection, 60 mg/ 1.5 mL.
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`11.
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`On May 5, 2015 MLL timely sent Plaintiffs a letter notifying them that MLL had
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`amended ANDA No. 207381 and filed a paragraph IV certification with FDA with respect to,
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`inter alia, the’592 patent, and that the ’592 patent is invalid, unenforceable, or not infringed by
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`the product that is the subject of MLL’s ANDA No. 207381 (“the Notice Letter”). MLL’s
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`Notice Letter contained an Offer of Confidential Access that offered to provide Plaintiffs with
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`confidential access to information from ANDA Nos. 207381 for the purpose of Plaintiffs making
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`the determination of whether an infringement action could be brought.
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`12.
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`On information and belief, the Notice Letter was received on May 6, 2014.
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`13.
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`On May 15, 2015, Plaintiffs/Counterclaim Defendants filed the Complaint,
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`asserting infringement of the patent-in-suit.
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`DECLARATORY JUDGMENT
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`COUNT I: DECLARATORY JUDGMENT OF NONINFRINGEMENT OF
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`THE ’592 PATENT
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`14.
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`MLL repeats and realleges the allegations in Paragraphs 1-13 as if fully set forth
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`herein.
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`15.
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`This is a counterclaim for declaratory judgment pursuant to 28 U.S.C. § 2201 and
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`28 U.S.C. § 2202 for the purpose of determining an actual and justiciable controversy between
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`the parties.
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`16.
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`This Court has original jurisdiction over the subject matter of this Counterclaim
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`Count I pursuant to 21 U.S.C. § 355(j)(5)(C) and 35 U.S.C. § 271(e)(5).
`
`17.
`
`Plaintiffs have asserted the ’592 patent against MLL in the instant action.
`
`

`

`Case 3:15—cv—03392—MAS—LHG Document 19 Filed 07/16/15 Page 14 of 18 Page|D: 174
`
`18.
`
`MLL has not infringed, is not infringing, and will not infringe any claim of the
`
`’592 patent, either literally or under the doctrine of equivalents.
`
`19.
`
`Plaintiffs maintain, and MLL denies, that MLL is liable for infringement of the
`
`’592 patent.
`
`20.
`
`There is a definite and concrete, real and substantial, justiciable, and continuing
`
`case or controversy existing between the parties regarding the non-infringement of the ’592
`
`patent that is of sufficient immediacy and reality to warrant the issuance of a Declaratory
`
`Judgment.
`
`21.
`
`MLL is entitled to a judicial declaration that the product that is the subject of
`
`MLL’s ANDA No. 207381 does not infringe any claims of the ’592 patent.
`
`22.
`
`This case is an exceptional one, and MLL is entitled to an award of reasonable
`
`attorney fees under 35 U.S.C. § 285.
`
`COUNT II: DECLARATORY JUDGMENT OF INVALIDITY
`
`OF THE ’592 PATENT
`
`23.
`
`MLL repeats and realleges the allegations in Paragraphs 1-22 as if fully set forth
`
`herein.
`
`24.
`
`This is a counterclaim for declaratory judgment pursuant to 28 U.S.C. § 2201 and
`
`28 U.S.C. § 2202 for the purpose of determining an actual and justiciable controversy between
`
`the parties.
`
`25.
`
`Plaintiffs have asserted the ’592 patent against MLL in the instant action.
`
`26.
`
`The claims of the ’592 patent are invalid for failure to satisfy the requirements of
`
`Title 35 of the United States Code, including without limitation, one or more of 35 U.S.C.
`
`§§ 101, 102, 103, 112, 116 and/or double patenting.
`
`27.
`
`Plaintiffs maintain, and MLL denies, that the claims of the ’592 patent are valid.
`
`13
`
`

`

`Case 3:15—cv—03392—MAS—LHG Document 19 Filed 07/16/15 Page 15 of 18 Page|D: 175
`
`28.
`
`There is a definite and concrete, real and substantial, justiciable, and continuing
`
`case or controversy existing between the parties regarding the invalidity of the ’592 patent that is
`
`of sufficient immediacy and reality to warrant the issuance of a Declaratory Judgment.
`
`29.
`
`MLL is entitled to a judicial declaration that the claims of the ’592 patent are
`
`invalid.
`
`30.
`
`This case is an exceptional one, and MLL is entitled to an award of reasonable
`
`attorney fees under 35 U.S.C. § 285.
`
`PRAYER FOR RELIEF
`
`WHEREFORE, MLL respectfully requests entry ofjudgment in its favor and against
`
`Plaintiffs, providing the following relief:
`
`A.
`
`B.
`
`C.
`
`D.
`
`dismissing the Complaint, in its entirety, with prejudice;
`
`declaring that the submission of ANDA No. 207381 to the FDA and any manufacture,
`
`use, sale, offer for sale, marketing, distribution and/or importation of the product that is
`
`the subject of that ANDA does not and would not infringe any claim of the ’592 patent,
`
`literally or under the doctrine of equivalents, directly or indirectly;
`
`declaring that each and every claim of the ’592 patent is invalid;
`
`declaring that because the ’592 patent is invalid, the ’592 patent carmot be infringed as a
`
`matter of law;
`
`E.
`
`enjoining Plaintiffs/Counterclaim Defendants,
`
`their officers,
`
`agents,
`
`employees,
`
`attorneys, and representatives, and any successors and assigns thereof, from asserting
`
`infringement of any claim of the ’592 patent against MLL, or anyone in privity with
`
`MLL;
`
`l4
`
`

`

`Case 3:15—cv—03392—MAS—LHG Document 19 Filed 07/16/15 Page 16 of 18 Page|D: 176
`
`F.
`
`awarding MLL its costs and attorneys’ fees, including but not limited to, under 35 U.S.C.
`
`§ 285; and
`
`G.
`
`awarding MLL such other and further relief as the Court may deem proper.
`
`Dated: July 16, 2015
`
`Respectfiilly submitted,
`
`SAIBER LLC
`
`Attorneys for Defendant Mylan Laboratories
`Limited f/k/a Onco Therapies Limited
`
`By: s/ Arnold B. Calmarm
`Arnold B. Calmarm (abc@saiber.com)
`Jeffrey Soos (js@saiber.com)
`Geri L. Albin (gla@saiber.com)
`SAIBER LLC
`
`One Gateway Center, 10th Floor, Suite 1000
`Newark, New Jersey 07102
`Telephone: (973) 622-3333
`
`Matthew R. Reed (mreed@wsgr.com)
`WILSON SONSINI GOODRICH & ROSATI
`
`650 Page Mill Road
`Palo Alto, California 94304
`Telephone: (650) 493-9300
`
`Wendy L. Devine (wdeVine@wsgr.com)
`Clark Y. Lin (clin@wsgr.com)
`WILSON SONSINI GOODRICH & ROSATI
`
`12235 El Camino Real, Suite 200
`San Diego, California 92130
`Telephone: (858) 350-2300
`
`S. Brei Gussack (bgussack@wsgr.com)
`WILSON SONSINI GOODRICH & ROSATI
`
`1700 K Street, NW, Fifth Floor
`Washington, DC 20006
`Telephone: (202) 973-8800
`
`

`

`Case 3:15—cv—03392—MAS—LHG Document 19 Filed 07/16/15 Page 17 of 18 Page|D: 177
`
`LOCAL CIVIL RULE 11.2 CERTIFICATION
`
`Under Local Civil Rule 11.2, the undersigned counsel for Defendant hereby certifies that
`
`the matter in controversy in this action is related to the following litigation that is pending in the
`
`United States District Court for the District of New Jersey:
`
`Sanofi-Aventis US. LLC et al. v. Fresenius Kabi USA, LLC, C. A. No. 14-7869 (MAS)(LHG);
`
`Sanofi-Aventis US. LLC et al. v. Accord Healthcare, Inc., C. A. No. 14-8079 (MAS)(LHG);
`
`Sanofi-Aventis US. LLC et al. v. BPI Labs, LLC et al., C. A. No. 14-8081 (MAS)(LHG);
`
`Sanofi-Aventis US. LLC et al. v. Fresenius Kabi USA, LLC, C. A. No. 14-8082 (MAS)(LHG);
`
`Sanofi-Aventis US. LLC et al. v. Apotex Corp. et al., C. A. No. 15-0287 (MAS)(LHG);
`
`Sanofi-Aventis US. LLC et al. v. Breckenridge Pharmaceutical, Inc., C. A. No. 15-0289
`(MAS)(LHG);
`
`Sanofi-Aventis US. LLC et al. v. Onco Therapies Limited, C. A. No. 15-0290 (MAS)(LHG);
`
`Sanofi-Aventis US. LLC et al. v. Actavis LLC et al., C. A. No. 15-0776 (MAS)(LHG);
`
`Sanofi-Aventis US. LLC et al. v. Apotex Corp. et al., C. A. No. 15-1835 (MAS)(LHG);
`
`Sanofi-Aventis US. LLC et al. v. Breckenridge Pharmaceutical, Inc., C. A. No. 15-1836
`(MAS)(LHG);
`
`Sanofi-Aventis US. LLC et al. v. Accord Healthcare, Inc., C. A. No. 15-02520 (MAS)(LHG);
`
`Sanofi-Aventis US. LLC et al. v. BPI Labs, LLC et al., C. A. No. 15-02521 (MAS)(LHG);
`
`Sanofi-Aventis US. LLC et al. v. Dr. Reddy Laboratories, Inc. et al., C. A. No. 15-02522
`(MAS)(LHG);
`
`Sanofi-Aventis US. LLC et al. v. Glenmark Generics Inc. et al., C. A. No. 15-02523
`(MAS)(LHG);
`
`Sanofi-Aventis US. LLC et al. v. Fresenius Kabi USA, LLC, C. A. No. 15-02631 (MAS)(LHG);
`and
`
`Sanofi-Aventis US. LLC et al. v. Actavis LLC et al., C. A. No. 15-3107 (MAS)(LHG).
`
`Dated: July 16, 2015
`
`s/ Arnold B. Calmann
`Arnold B. Calmann (abc@saiber.com)
`
`

`

`Case 3:15—cv—03392—MAS—LHG Document 19 Filed 07/16/15 Page 18 of 18 Page|D: 178
`
`LOCAL CIVIL RULE 201.1 CERTIFICATION
`
`Under Local Civil Rule 201.1, the undersigned counsel for Defendants hereby certifies
`
`that Defendant seeks declaratory relief, and therefore this action is not appropriate for
`
`compulsory arbitration.
`
`Dated: July 16, 2015
`
`s/ Arnold B. Calmarm
`Arnold B. Calmann (abc@saiber.com)
`
`

`

`Case 3:15—cv—03392—MAS—LHG Document 19-1 Filed 07/16/15 Page 1 of 2 Page|D: 179
`
`Arnold B. Calmann (abc@saiber.com)
`Jeffrey Soos (j s@saiber.com)
`Geri L. Albin (g1a@saiber.com)
`SAIBER LLC
`
`One Gateway Center, 10th Floor, Suite 1000
`Newark, New Jersey 07102
`Telephone: (973) 622-3333
`
`Matthew R. Reed (rnreed@wsgr.com)
`WILSON SONSINI GOODRICH & ROSATI
`
`650 Page Mill Road
`Palo Alto, California 94304
`Telephone: (650) 493-9300
`
`Wendy Lyrm Devin