Case 1:15-cv-00920-GMS Document 1 Filed 10/13/15 Page 1 of 15 PageID #: 1
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
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`
`VANDA PHARMACEUTICALS INC.,
`
`
`Plaintiff,
`
`
`TARO PHARMACEUTICALS USA, INC. and
`TARO PHARMACEUTICAL INDUSTRIES,
`LTD.,
`
`
`
`C.A. No.
`
`)))))))))))
`
`
`
`v.
`
`
`
`
`
`Defendants.
`
`COMPLAINT FOR PATENT INFRINGEMENT
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`Plaintiff Vanda Pharmaceuticals Inc. (“Vanda”) for its Complaint against
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`Defendants Taro Pharmaceuticals USA, Inc. and Taro Pharmaceutical Industries, Ltd.
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`(collectively “Taro”) alleges as follows:
`
`I.
`
`THE PARTIES
`
`1.
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`Plaintiff Vanda is a Delaware corporation with its principal place of
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`business at 2200 Pennsylvania Ave NW, Washington, DC 20037. Vanda is a pharmaceutical
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`company that focuses on the development and commercialization of new medicines to address
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`unmet medical needs, including FANAPT® (iloperidone oral tablets), for the treatment of
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`schizophrenia.
`
`2.
`
`On information and belief, Defendant Taro Pharmaceuticals USA, Inc. is a
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`corporation organized and existing under the laws of the State of New York, with a principal
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`place of business at 3 Skyline Drive, Hawthorne, New York 10532.
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`3.
`
`On information and belief, Defendant Taro Pharmaceutical Industries, Ltd.
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`is a corporation organized and existing under the laws of Israel with its principal place of
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`business at 14 Hakitor Street, Haifa Bay 2624761, Israel.
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`

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`4.
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`On information and belief Taro Pharmaceuticals USA, Inc. and Taro
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`Pharmaceutical Industries, Ltd. collaborate to manufacture, import, market, distribute, and sell
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`pharmaceutical products (including generic drug products manufactured and sold pursuant to
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`approved abbreviated new drug applications) in the State of Delaware and the United States.
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`5.
`
`On information and belief, Taro is in the business of manufacturing
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`generic pharmaceutical drugs that it distributes and sells in the State of Delaware and throughout
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`the United States.
`
`II.
`
`NATURE OF THE ACTION
`
`6.
`
`This is an action arising under the patent laws of the United States (Title
`
`35, United States Code, § 100, et seq.) based upon Taro’s infringement of one or more claims of
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`Vanda’s U.S. Patent No. 8,586,610 (“the ’610 patent”) and Taro’s infringement of claim 1 of
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`Vanda’s U.S. Patent No. 9,138,432 (“the ’432 patent”), which relate to the field of schizophrenia
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`treatment.
`
`7.
`
`On information and belief, Taro Pharmaceuticals USA, Inc., by and with
`
`Taro Pharmaceutical Industries, Ltd., filed an Abbreviated New Drug Application No. 207098
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`(the “Taro ANDA”) under § 505(j) of the Federal Food, Drug, and Cosmetic Act (the
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`“FFDCA”), to obtain approval to commercially manufacture and sell generic iloperidone tablets
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`in their 1 mg, 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, and 12 mg strengths for the treatment of
`
`schizophrenia.
`
`8.
`
`Taro has infringed one or more claims of the ’610 patent under 35 U.S.C.
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`§ 271(e)(2)(A) by virtue of the filing of the Taro ANDA seeking FDA approval to commercially
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`manufacture, use, offer for sale, sell, distribute in, or import into the United States generic
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`iloperidone for the treatment of schizophrenia prior to the expiration of the ’610 patent, or any
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`extensions thereof. Taro will infringe one or more claims of the ’610 patent under 35 U.S.C.
`
`2
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`

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`§ 271(a), (b), or (c) should it engage in the commercial manufacture, use, offer for sale, sale,
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`distribution in, or importation into the United States of generic iloperidone for the treatment of
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`schizophrenia prior to the expiration of the ’610 patents, or any extensions thereof.
`
`9.
`
`Taro has infringed claim 1 of the ’432 patent under 35 U.S.C.
`
`§ 271(e)(2)(A) by virtue of the filing of the Taro ANDA, including its filing of any amendments
`
`or supplements thereto, seeking FDA approval to commercially manufacture, use, offer for sale,
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`sell, distribute in, or import into the United States generic iloperidone for the treatment of
`
`schizophrenia prior to the expiration of the ’432 patent, or any extensions thereof. Taro will
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`infringe claim 1 of the ’432 patent under 35 U.S.C. § 271(a), (b), or (c) should it engage in,
`
`induce, or contribute to the commercial manufacture, use, offer for sale, sale, distribution in, or
`
`importation into the United States of generic iloperidone for the treatment of schizophrenia
`
`according to the methods of the ’432 patent prior to the expiration of that patent, or any
`
`extensions thereof.
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`III.
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`JURISDICTION AND VENUE
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`10.
`
`This Court has subject matter
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`jurisdiction over Vanda’s patent
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`infringement claims under 28 U.S.C. §§ 1331, 1338(a), 2201, and 2202.
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`11.
`
`This Court has personal jurisdiction over Taro by virtue of the fact that,
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`inter alia, both Taro Pharmaceuticals USA, Inc. and Taro Pharmaceutical Industries, Ltd. have
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`committed, induced, contributed to, aided, abetted, or participated in in the commission of the
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`tortious act of patent infringement that has led to foreseeable harm and injury to Vanda, a
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`Delaware corporation. This Court has personal jurisdiction over Taro for the additional reasons
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`set forth below.
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`12.
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`This Court has personal jurisdiction over Taro, by virtue of, inter alia, its
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`activities (e.g., filing the Taro ANDA seeking approval to market generic iloperidone prior to the
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`3
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`

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`expiration of the ’610 and ’432 patents along with a Paragraph IV certification regarding its
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`intent to market generic iloperidone and sending notice of that Paragraph IV certification), which
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`were purposefully directed to the State of Delaware, where Vanda is organized. As a result, the
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`consequences of Taro’s actions were (and will be) suffered in Delaware. Taro knew or should
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`have known that Vanda is a Delaware corporation and thus Taro knew or should have known
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`that the consequences of its actions were (and will be) suffered in Delaware.
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`13.
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`This Court also has personal jurisdiction over Taro because at the time
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`Taro sent notice of a Paragraph IV certification, it was reasonably foreseeable that Taro would be
`
`sued within 45 days in this District, where Vanda is organized and where related ANDA
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`litigation over generic iloperidone, including litigation based on infringement of the ’610 patent,
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`had already been filed (C.A. Nos. 13-1973 (GMS), 14-757 (GMS) (consolidated); C.A. No. 15-
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`362 (GMS)). Taro knew or should have known that Vanda is a Delaware corporation and Taro
`
`knew or should have known that there is related ANDA litigation over generic iloperidone,
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`including litigation based on infringement of the ’610 patent, pending in Delaware.
`
`14.
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`This Court also has personal jurisdiction over Taro because this suit arises
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`out of and relates to Taro’s activities that are, and will be, directed to Delaware. On information
`
`and belief, Taro develops, manufactures, seeks approval for, and sells FDA-approved generic
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`pharmaceutical drugs, which are being marketed, distributed, and sold in Delaware and
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`throughout the United States. Thus, on information and belief, Taro does substantial business in
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`Delaware, derives substantial revenue from Delaware, and engages in other persistent courses of
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`conduct in Delaware. These continuous and systematic contacts, including, but not limited, to
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`those described above and below, are more than sufficient for this Court to exercise personal
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`jurisdiction over Taro.
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`4
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`

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`15.
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`This Court also has personal jurisdiction over Taro because, on
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`information and belief, Taro has previously availed itself of this forum for purposes of litigating
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`its patent disputes. For example, Taro brought a patent infringement lawsuit in this district to
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`protect two patents on July 28, 2014 (C.A. No. 14-989 (RGA)). Taro Pharmaceuticals USA, Inc.
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`was listed as a Plaintiff, and Taro Pharmaceutical Industries, Ltd. states that it had filed the
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`lawsuit in its most recent Securities and Exchange Commission Form 20-F, for the fiscal year
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`ended March 31, 2015. Additionally, Taro Pharmaceuticals USA, Inc. brought another patent
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`infringement lawsuit in this district on September 22, 2015 (C.A. No. 15-859 (RGA)).
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`16.
`
`On information and belief, Taro, following any FDA approval of the Taro
`
`ANDA, will sell the generic product that is the subject of the infringement claims in this action
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`in the State of Delaware and throughout the United States.
`
`17.
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`Venue is proper in this Court pursuant to 28 U.S.C. §§ 1391(b) and (c) and
`
`1400(b).
`
`IV.
`
`THE PATENTS-IN-SUIT – U.S. PATENT NOS. 8,586,610 AND 9,138,432
`
`18.
`
`19.
`
`The allegations of ¶¶ 1-17 are incorporated herein by reference.
`
`On May 6, 2009, FDA approved Vanda’s new drug application 22-192 for
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`FANAPT® (iloperidone oral tablets) in their 1 mg, 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, and 12 mg
`
`strengths under § 505(b) of the FFDCA, 21 U.S.C. § 355(b), for the treatment of schizophrenia
`
`(“FANAPT® NDA”).
`
`20.
`
`Vanda is the owner of all rights, title and interest in the ’610 patent,
`
`entitled “Methods for the Administration of Iloperidone.” The United States Patent and
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`Trademark Office (“USPTO”) duly and legally issued the ’610 patent on November 19, 2013, to
`
`Curt D. Wolfgang and Mihael H. Polymeropoulos, which was assigned to Vanda. A true and
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`correct copy of the ’610 patent is attached to this Complaint as Exhibit A.
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`5
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`21.
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`The ’610 patent covers methods of using FANAPT® (iloperidone oral
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`tablets) for the treatment of schizophrenia in certain patients based on whether the patients are
`
`poor metabolizers of FANAPT®. The patients that are poor metabolizers of FANAPT® have
`
`certain mutations of a gene known as CYP2D6. The ’610 patent covers the identification of
`
`patients that are poor metabolizers by genotyping and making a specific dose reduction—the
`
`dosage must be halved—in those patients to avoid prolonged QTc as measured by an
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`electrocardiogram (“EKG”). Various studies have shown that patients with QTc prolongation
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`may have an increased risk of cardiovascular side effects, including serious arrhythmias, such as
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`ventricular tachycardia, ventricular fibrillation, and irregular heartbeats (torsades de pointes or
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`TDP), which could lead to cardiac death.
`
`22.
`
`The prescribing information for FANAPT® (“FANAPT® Label”),
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`instructs physicians to (1) determine whether the patient is a poor CYP2D6 metabolizer using
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`available laboratory tests,1 and (2) administer either the target dose if the patient is a normal
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`CYP2D6 metabolizer or a halved dosage if the patient is a poor CYP2D6 metabolizer.
`
`23.
`
`On information and belief, the Taro ANDA essentially copies the
`
`FANAPT® Label as required by FDA, see 21 C.F.R. § 314.94(a)(iv), and therefore instructs
`
`physicians to administer either the target dose if the patient is a normal CYP2D6 metabolizer or a
`
`halved dosage if the patient is a poor CYP2D6 metabolizer.
`
`24.
`
`Thus, the use of FANAPT® (iloperidone oral tablets) and any generic
`
`iloperidone for the treatment of schizophrenia is covered by the ’610 patent, and Vanda has the
`
`right to enforce the ’610 patent.
`
`
`1
`There are numerous commercially available genotyping assays (offered by Laboratory
`Corporation of America, Roche Molecular Systems, Illumina, Quest Diagnostics,
`AutoGenomics, etc.).
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`6
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`25.
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`FDA listed the ’610 patent in the Orange Book for FANAPT® in its 1 mg,
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`2 mg, 4 mg, 6 mg, 8 mg, 10 mg, and 12 mg strengths on January 15, 2015.
`
`26.
`
`Vanda is the owner of all rights, title and interest in the ’432 patent,
`
`entitled “Methods for the Administration of Iloperidone.” The United States Patent and
`
`Trademark Office (“USPTO”) duly and legally issued the ’432 patent on September 22, 2015, to
`
`Curt D. Wolfgang and Mihael H. Polymeropoulos, which was assigned to Vanda. A true and
`
`correct copy of the ’432 patent is attached to this Complaint as Exhibit B.
`
`27.
`
`The ’432 patent claims “[a] method of decreasing a risk of QT
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`prolongation in a patient being treated for schizophrenia with iloperidone, the method
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`comprising: administering to the patient a dose of iloperidone that is 24 mg/day if, and because,
`
`the patient is not being treated with fluoxetine; and administering to the patient a dose of
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`iloperidone that is 12 mg/day if, and because, the patient is being treated with fluoxetine.”
`
`28.
`
`The FANAPT® Label
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`instructs physicians
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`that “The maximum
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`recommended dose is 12 mg twice daily (24 mg/day)” and that “FANAPT dose should be
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`reduced by one-half [i.e., the dose should be reduced to 6 mg twice daily (12 mg/day)] when
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`administered concomitantly with strong CYP2D6 inhibitors such as fluoxetine or paroxetine.”
`
`29.
`
`On information and belief, the Taro ANDA essentially copies the
`
`FANAPT® Label as required by FDA, see 21 C.F.R. § 314.94(a)(iv), and therefore instructs
`
`physicians to administer either the maximum recommended dose of 24 mg/day if the patient is
`
`not being treated with fluoxetine or a halved dosage of 12 mg/day if the patient is being treated
`
`with fluoxetine.
`
`7
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`30.
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`Thus, the use of FANAPT® (iloperidone oral tablets) and any generic
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`iloperidone for the treatment of schizophrenia is covered by the ’432 patent, and Vanda has the
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`right to enforce the ’432 patent.
`
`31.
`
`FDA listed the ’432 patent in the Orange Book for FANAPT® in its 1 mg,
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`2 mg, 4 mg, 6 mg, 8 mg, 10 mg, and 12 mg strengths on September 23, 2015.
`
`COUNT I
`(INFRINGEMENT OF THE ’610 PATENT)
`
`32.
`
`33.
`
`The allegations of ¶¶ 1-31 are incorporated herein by reference.
`
`On information and belief, Taro filed the Taro ANDA under § 505(j) of
`
`the FFDCA to obtain approval to commercially manufacture, use, offer to sell, and sell generic
`
`iloperidone for the treatment of schizophrenia before the expiration of the ’610 patent, and any
`
`extensions thereof.
`
`34.
`
`On or about September 4, 2015, Vanda received a letter (“Taro Notice
`
`Letter”) dated September 3, 2015, stating that Taro Pharmaceuticals USA, Inc. and Taro
`
`Pharmaceutical Industries, Ltd. had filed the Taro ANDA seeking approval to manufacture, use,
`
`offer to sell, and sell generic iloperidone in its 1 mg, 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, and 12 mg
`
`strengths for the treatment of schizophrenia. On information and belief, Taro seeks to do so
`
`before the expiration of the ’610 patent or any extensions thereof.
`
`35.
`
`On information and belief, the Taro ANDA essentially copies the
`
`FANAPT® Label as required by FDA, see 21 C.F.R. § 314.94(a)(iv), and therefore instructs
`
`physicians to (1) determine whether the patient is a poor CYP2D6 metabolizer using available
`
`laboratory tests, and (2) administer either the target dose if the patient is a normal CYP2D6
`
`metabolizer or a halved dosage if the patient is a poor CYP2D6 metabolizer.
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`8
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`36.
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`Taro has infringed the ’610 patent under 35 U.S.C. § 271(e)(2)(A) by
`
`virtue of its submission of the Taro ANDA to FDA for generic iloperidone tablets in its 1 mg, 2
`
`mg, 4 mg, 6 mg, 8 mg, 10 mg, and 12 mg strengths, for the treatment of schizophrenia, which are
`
`covered by one or more claims of the ’610 patent.
`
`37.
`
`Taro Pharmaceuticals USA, Inc. and Taro Pharmaceutical Industries, Ltd.
`
`are jointly and severally liable for the infringement of one or more claims of the ’610 patent.
`
`Taro’s participation in, contribution to, inducement of, aiding or abetting the submission of the
`
`Taro ANDA to FDA constitutes direct, contributory, or induced infringement of one or more
`
`claims of the ’610 patent under 35 U.S.C. § 271(e)(2)(A).
`
`38.
`
`The commercial manufacture, use, offer to sell, sale, distribution, or
`
`importation of products under the Taro ANDA would infringe directly or contribute to or induce
`
`the infringement of one or more claims of the ’610 patent.
`
`39.
`
`Vanda seeks entry of an order pursuant to 35 U.S.C. § 271(e)(4), including
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`an order of this Court that the effective date of any FDA approval of the Taro ANDA be a date
`
`that is not earlier than the expiration of the ’610 patent, or any later expiration of exclusivity for
`
`the ’610 patent to which Vanda becomes entitled.
`
`40.
`
`Vanda will be irreparably harmed if Taro is not enjoined from infringing
`
`or actively inducing or contributing to infringement of one or more claims of the ’610 patent.
`
`Pursuant to 35 U.S.C. § 283, Vanda is entitled to a permanent injunction against further
`
`infringement. Vanda does not have an adequate remedy at law.
`
`41.
`
`On information and belief, Taro’s statement of the factual and legal basis
`
`for its opinion regarding the validity of the ’610 patent is devoid of an objective good faith basis
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`9
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`in either the facts or the law. This case is exceptional and Vanda is entitled to attorneys’ fees
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`pursuant to 35 U.S.C. § 285.
`
`42.
`
`To the extent Taro commercializes its product, Vanda will also be entitled
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`to damages under 35 U.S.C. § 284.
`
`COUNT II
`(INFRINGEMENT OF THE ’432 PATENT)
`
`43.
`
`44.
`
`The allegations of ¶¶ 1-42 are incorporated herein by reference.
`
`On information and belief, Taro filed the Taro ANDA under § 505(j) of
`
`the FFDCA to obtain approval to commercially manufacture, use, offer to sell, and sell generic
`
`iloperidone for the treatment of schizophrenia before the expiration of the ’432 patent, and any
`
`extensions thereof.
`
`45.
`
`On or about September 4, 2015, Vanda received the Taro Notice Letter
`
`dated September 3, 2015, stating that Taro Pharmaceuticals USA, Inc. and Taro Pharmaceutical
`
`Industries, Ltd. had filed the Taro ANDA seeking approval to manufacture, use, offer to sell, and
`
`sell generic iloperidone in its 1 mg, 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, and 12 mg strengths for the
`
`treatment of schizophrenia. On information and belief, Taro seeks to do so before the expiration
`
`of the ’432 patent, or any extensions thereof.
`
`46.
`
`On information and belief, the Taro ANDA essentially copies the
`
`FANAPT® Label as required by FDA, see 21 C.F.R. § 314.94(a)(iv), and therefore instructs
`
`physicians to administer either the maximum recommended dose of 24 mg/day if the patient is
`
`not being treated with fluoxetine or a halved dosage of 12 mg/day if the patient is being treated
`
`with fluoxetine.
`
`47.
`
`Taro infringes the ’432 patent under 35 U.S.C. § 271(e)(2)(A) by virtue of
`
`its submission of the Taro ANDA, including any amendments or supplements thereto, to FDA
`
`10
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`

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`for generic iloperidone in their 1 mg, 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, and 12 mg strengths for
`
`the treatment of schizophrenia, which are covered by claim 1 of the ’432 patent.
`
`48.
`
`Taro Pharmaceuticals USA, Inc. and Taro Pharmaceutical Industries, Ltd.
`
`are jointly and severally liable for the infringement of claim 1 of the ’432 patent. Taro’s
`
`participation in, contribution to, inducement of, aiding or abetting the submission of the Taro
`
`ANDA to FDA constitutes direct, contributory, or induced infringement of claim 1 of the ’432
`
`patent under 35 U.S.C. § 271(e)(2)(A).
`
`49.
`
`Vanda seeks entry of an order pursuant to 35 U.S.C. § 271(e)(4), including
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`an order of this Court that the effective date of any FDA approval of the Taro ANDA be a date
`
`that is not earlier than the expiration of the ’432 patent, or any later expiration of exclusivity for
`
`the ’432 patent to which Vanda becomes entitled.
`
`50.
`
`Vanda will be irreparably harmed if Taro is not enjoined from infringing
`
`or actively inducing or contributing to infringement of claim 1 of the ’432 patent. Pursuant to 35
`
`U.S.C. § 283, Vanda is entitled to a permanent injunction against further infringement. Vanda
`
`does not have an adequate remedy at law.
`
`51.
`
`To the extent Taro commercializes its product, Vanda will also be entitled
`
`to damages under 35 U.S.C. § 284.
`
`COUNT III
`(DECLARATORY JUDGMENT OF INFRINGMENT OF THE ’432 PATENT)
`
`52.
`
`53.
`
`The allegations of ¶¶ 1-51 are incorporated herein by reference.
`
`Upon information and belief, Taro intends to, and will manufacture, use,
`
`offer to sell, or sell within the United States, or import into the United States, generic iloperidone
`
`in its 1 mg, 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, and 12 mg strengths immediately and imminently
`
`upon FDA approval of the Taro ANDA.
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`11
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`54.
`
`If Taro manufactures, uses, offers to sell, or sells within the United States,
`
`or imports into the United States, generic iloperidone in its 1 mg, 2 mg, 4 mg, 6 mg, 8 mg,
`
`10 mg, and 12 mg strengths prior to the expiration of the ’432 Patent for the methods of use
`
`claimed in that patent, Taro will infringe claim 1 of the ’432 Patent under 35 U.S.C. § 271 (a),
`
`(b), and/or (c).
`
`55.
`
`An actual controversy has arisen and now exists between the parties
`
`concerning whether Taro’s generic iloperidone will infringe claim 1 of the’432 Patent.
`
`56.
`
`An actual controversy has also arisen and now exists between the parties
`
`concerning whether Taro’s filing of the Taro ANDA will infringe 35 U.S.C. § 271(e)(2)(A) if
`
`Taro amends the Taro ANDA after the ’432 Patent issued and was timely listed in the Orange
`
`Book and/or if Taro issues a Paragraph IV certification regarding the ’432 Patent.
`
`57.
`
`Pursuant to the Declaratory Judgment Act, 28 U.S.C. § 2201 et seq., the
`
`Court has the power to, and should, declare the rights of the parties regarding any infringement
`
`by Taro of the ’432 Patent.
`
`PRAYER FOR RELIEF
`
`WHEREFORE, Vanda respectfully requests that this Court enter judgment in its
`
`favor against Taro and grant the following relief:
`
`A.
`
`an adjudication that Taro has infringed directly, contributed to, or induced
`
`the infringement of one or more claims of the ’610 patent under 35 U.S.C. § 271(e)(2)(A), by
`
`submitting to FDA the Taro ANDA to obtain approval for the commercial manufacture, use,
`
`offer for sale, sale, distribution in, or importation into the United States of generic iloperidone for
`
`the treatment of schizophrenia before the expiration of the ’610 patent;
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`12
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`B.
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`a judgment that Taro infringes claim 1 of the ’432 patent under 35 U.S.C.
`
`§ 271(e)(2)(A) by submitting to FDA the Taro ANDA to obtain approval for the commercial
`
`manufacture, use, offer for sale, sale, distribution in, or importation into the United States of
`
`generic iloperidone for the treatment of schizophrenia, including any amendments or
`
`supplements thereto, before the expiration of the ’432 patent;
`
`C.
`
`a judgment declaring that Taro will infringe directly, contribute to, or
`
`induce the infringement of claim 1 of the ’432 patent under 35 U.S.C. § 271(e)(2)(A) if Taro
`
`amends the Taro ANDA after the ’432 Patent issued and was timely listed in the Orange Book or
`
`issues a Paragraph IV certification directed at that patent;
`
`D.
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`a judgment declaring that the commercial manufacture, use, offer for sale,
`
`sale, or importation of the products described in the Taro ANDA would constitute infringement
`
`of claim 1 of the ’432 patent, or inducement of or contribution to such conduct, by Taro pursuant
`
`to 35 U.S.C. § 271 (a), (b), or (c);
`
`E.
`
`an order pursuant to 35 U.S.C. § 271(e)(4)(A) providing that the effective
`
`date of any FDA approval of the Taro ANDA for generic iloperidone be a date that is not earlier
`
`than the date of the expiration of the ’610 patent or any later period of exclusivity to which
`
`Vanda is or may become entitled;
`
`F.
`
`an order pursuant to 35 U.S.C. § 271(e)(4)(A) providing that the effective
`
`date of any FDA approval of the Taro ANDA for generic iloperidone be a date that is not earlier
`
`than the date of the expiration of the ’432 patent or any later period of exclusivity to which
`
`Vanda is or may become entitled;
`
`G.
`
`a permanent injunction enjoining Taro, their officers, agents, servants,
`
`employees, attorneys, affiliates, divisions, subsidiaries, and those persons in active concert or
`
`13
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`

`
`Case 1:15-cv-00920-GMS Document 1 Filed 10/13/15 Page 14 of 15 PageID #: 14
`
`participation with any of them from infringing the ’610 patent, or contributing to or inducing
`
`anyone to do the same, including the manufacture, use, offer to sell, sale, distribution, or
`
`importation of any current or future versions of the product described in the Taro ANDA;
`
`H.
`
`a permanent injunction enjoining Taro, their officers, agents, servants,
`
`employees, attorneys, affiliates, divisions, subsidiaries, and those persons in active concert or
`
`participation with any of them from infringing the ’432 patent, or contributing to or inducing
`
`anyone to do the same, including the manufacture, use, offer to sell, sale, distribution, or
`
`importation of any current or future versions of the product described in the Taro ANDA;
`
`I.
`
`an order enjoining Taro, its officers, agents, servants, employees,
`
`attorneys, affiliates, divisions, subsidiaries, and those persons in active concert or participation
`
`with any of them from infringing the ’610 patent, contributing to, or inducing anyone to do the
`
`same, including the manufacture, use, offer to sell, sale, distribution, or importation of any
`
`current or future versions of the product described in the Taro ANDA while the litigation is
`
`pending;
`
`J.
`
`an order enjoining Taro, its officers, agents, servants, employees,
`
`attorneys, affiliates, divisions, subsidiaries, and those persons in active concert or participation
`
`with any of them from infringing the ’432 patent, contributing to, or inducing anyone to do the
`
`same, including the manufacture, use, offer to sell, sale, distribution, or importation of any
`
`current or future versions of the product described in the Taro ANDA while the litigation is
`
`pending;
`
`K.
`
`a judgment declaring that the manufacture, use, offer to sell, sale,
`
`distribution, or importation of the products described in the Taro ANDA would constitute
`
`14
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`

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`Case 1:15-cv-00920-GMS Document 1 Filed 10/13/15 Page 15 of 15 PageID #: 15
`
`infringement of one or more claims of the ’610 patent, or inducement of or contribution to such
`
`conduct, by Taro pursuant to 35 U.S.C. § 271 (a), (b), or (c);
`
`L.
`
`an assessment of pre-judgment and post-judgment interest and costs
`
`against Taro, together with an award of such interest and costs, in accordance with 35 U.S.C.
`
`§ 284;
`
`M.
`
`an award to Vanda of its attorneys’ fees incurred in connection with this
`
`lawsuit pursuant to 35 U.S.C. § 285; and
`
`such other and further relief as this Court may deem just and proper.
`
`N.
`
`
`
`MORRIS, NICHOLS, ARSHT & TUNNELL LLP
`
`/s/ Karen Jacobs
`____________________________________
`Jack B. Blumenfeld (#1014)
`Karen Jacobs (#2881)
`Ethan H. Townsend (#5813)
`1201 North Market Street
`P.O. Box 1347
`Wilmington, DE 19899-1347
`(302) 658-9200
`jblumenfeld@mnat.com
`kjacobs@mnat.com
`etownsend@mnat.com
`
`Attorneys for Plaintiff
`Vanda Pharmaceuticals Inc.
`
`
`
`OF COUNSEL:
`
`Nicholas Groombridge
`Eric Alan Stone
`Kira A. Davis
`Josephine Young
`PAUL, WEISS, RIFKIND, WHARTON
` & GARRISON LLP
`1285 Avenue of the Americas
`New York, NY 10019
`(212) 373-3000
`
`October 13, 2015
`9530913
`
`
`15