Case 3:21-cv-14428-MAS Document 1 Filed 07/30/21 Page 1 of 10 PageID: 1
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`IN THE UNITED STATES DISTRICT COURT
`DISTRICT OF NEW JERSEY
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`Civil Action No. _____
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`))))))))))))))
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`NOVARTIS PHARMACEUTICALS
`CORPORATION and DANA-FARBER
`CANCER INSTITUTE, INC.,
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`Plaintiffs,
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`v.
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`DR. REDDY’S LABORATORIES, INC.
`and DR. REDDY’S LABORATORIES, LTD.,
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`Defendants.
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`COMPLAINT
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`Novartis Pharmaceuticals Corporation (“Novartis”) and Dana-Farber Cancer Institute, Inc.
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`(“Dana-Farber”) (collectively, “Plaintiffs”) by its attorneys hereby allege as follows:
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`NATURE OF THE ACTION
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`1.
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`This is an action for patent infringement arising under the patent laws of the United
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`States, Title 35, United States Code, against defendants Dr. Reddy’s Laboratories, Inc. and Dr.
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`Reddy’s Laboratories, Ltd. (collectively, “DRL”). This action relates to Abbreviated New Drug
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`Application (“ANDA”) No. 215921 filed by DRL with the U.S. Food and Drug Administration
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`(“FDA”) for approval to engage in the commercial manufacture, use, offer for sale, or sale of a
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`generic version of Novartis’s RYDAPT® Capsules, 25 mg, prior to the expiration of U.S. Patent
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`No. 7,973,031 (the “’031 Patent” or “Asserted Patent”).
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`PARTIES
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`Plaintiffs
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`Plaintiff Novartis is a corporation organized and existing under the laws of the State
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`A.
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`2.
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`of Delaware, having a principal place of business at One Health Plaza, East Hanover, New Jersey
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`07936-1080.
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`3.
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`Novartis is engaged in the business of creating, developing, and bringing to market
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`revolutionary drug therapies to benefit patients against serious diseases, including treatments for
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`leukemia and mastocytosis. RYDAPT® is one such treatment option. Novartis markets and sells
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`RYDAPT® in this judicial district and throughout the United States.
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`4.
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`Plaintiff Dana-Farber is a non-profit corporation organized and existing under the
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`laws of the State of Massachusetts, having a principal place of business at 450 Brookline Avenue,
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`Boston, Massachusetts 02215.
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`5.
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`Dana-Farber is a world-renowned center for patient care, research and education.
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`Dana-Farber helps to advance this mission through, among other things, licensing intellectual
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`property which helps to fund innovative research and treatment for cancer and other patients who
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`have sought treatment in their hospital and other facilities.
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`6.
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`B.
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`7.
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`Novartis and Dana-Farber own all rights in the ’031 Patent.
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`Defendant DRL
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`Upon information and belief, Defendant Dr. Reddy’s Laboratories, Inc. is a
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`corporation organized and existing under the laws of the State of New Jersey, having a principal
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`place of business at 107 College Road East, Princeton, New Jersey 08540.
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`8.
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`Upon information and belief, Defendant Dr. Reddy’s Laboratories Ltd. is a
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`corporation organized and existing under the laws of India, having a principal place of business at
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`8-2-377, Road No. 3, Banjara Hills, Hyderabad, 50034, India.
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`9.
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`Upon information and belief, Dr. Reddy’s Laboratories, Ltd. is in the business of,
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`among other things, developing, manufacturing, and selling generic versions of branded
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`pharmaceutical products for the U.S. market. Upon information and belief, Dr. Reddy’s
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`Laboratories, Inc. is a wholly-owned subsidiary of Dr. Reddy’s Laboratories, Ltd. and is controlled
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`and/or dominated by Dr. Reddy’s Laboratories, Ltd. Upon information and belief, Dr. Reddy’s
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`Laboratories, Inc. develops, manufactures and/or distributes generic drug products for marketing,
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`sale, and/or use throughout the United States, including in this judicial district, at the direction,
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`under the control, and for the benefit of Dr. Reddy’s Laboratories, Ltd.
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`10.
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`Dr. Reddy’s Laboratories Ltd. and Dr. Reddy’s Laboratories, Inc. are collectively
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`referred to hereafter as “DRL” unless otherwise noted.
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`DEFENDANTS’ INFRINGING ACTS
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`11.
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`By a letter dated June 16, 2021, DRL notified Plaintiffs that DRL had submitted to
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`the FDA ANDA No. 215921 for a generic version of RYDAPT® (DRL’s “ANDA Product”),
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`seeking approval under the Federal Food, Drug, and Cosmetic Act (“FDCA”) to engage in the
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`commercial manufacture, use, offer for sale, and/or sale of DRL’s ANDA Product prior to the
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`expiration of the ’031 Patent.
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`12.
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`In its Notice Letter, DRL notified Plaintiffs that, as a part of its ANDA, DRL had
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`filed a certification of the type described in Section 505(j)(2)(A)(vii)(IV) of the FDCA, 21 U.S.C.
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`§ 355(j)(2)(A)(vii)(IV), with respect to the ’031 Patent asserting that the ’031 Patent is invalid,
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`unenforceable, and/or will not be infringed by the commercial manufacture, use, offer for sale, and
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`sale of DRL’s ANDA Product.
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`13.
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`Upon information and belief, and consistent with their past practices, Dr. Reddy’s
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`Laboratories, Ltd. and Dr. Reddy’s Laboratories, Inc. acted collaboratively in the preparation and
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`submission of ANDA No. 215921.
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`14.
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`Upon information and belief, and consistent with their past practices, following any
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`FDA approval of ANDA No. 215921, Dr. Reddy’s Laboratories, Ltd. and Dr. Reddy’s
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`Laboratories, Inc. will work in concert with one another to make, use, offer to sell, and/or sell the
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`ANDA Product throughout the United States, and/or import such generic drug product into the
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`United States, including in this judicial district.
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`15.
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`DRL has committed an act of infringement in this judicial district by filing ANDA
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`No. 215921 with the intent to make, use, offer to sell, and/or sell the generic drug products that are
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`the subject of ANDA No. 215921 in this judicial district, an act of infringement that has led to
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`foreseeable harm and injury to Novartis, a corporation having a principal place of business in New
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`Jersey.
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`16.
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`DRL has extensive contacts with the State of New Jersey, regularly conducts
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`business in the State of New Jersey, either directly or through one or more of its wholly owned
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`subsidiaries, agents, and/or alter egos, has purposefully availed itself of the privilege of doing
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`business in the State of New Jersey, and intends to sell in the State of New Jersey the generic
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`product described in ANDA No. 215921 upon approval. Furthermore, upon information and
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`belief, DRL is incorporated in this judicial district and has a principal, regular, and established
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`place of business in this judicial district.
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`17.
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`Dr. Reddy’s Laboratories, Ltd. and Dr. Reddy’s Laboratories, Inc. have availed
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`themselves of the legal protections of the State of New Jersey by, among other things, admitting
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`jurisdiction and asserting claims and counterclaims in lawsuits filed in the United States District
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`Court for the District of New Jersey. See e.g., Dr. Reddy’s Laboratories, Inc. et al. v. AstraZeneca
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`AB et al., C.A. No. 18-16057 (D.N.J.); Celgene Corporation v. Dr. Reddy's Laboratories, Ltd. et
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`al., C.A. No. 21-02111 (D.N.J.); Merck Sharp & Dohme BV et al v. Dr. Reddy's Laboratories, Inc.
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`et al., C.A. No. 20-02909 (D.N.J.); Mitsubishi Tanabe Pharma Corporation et al. v. Dr. Reddy's
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`Laboratories, Inc. et al., 19-18764 (D.N.J.); Bristol-Myers Squibb Company v. Dr. Reddy's
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`Laboratories, Ltd. et al, C.A. No. 19-18686 (D.N.J.).
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`JURISDICTION AND VENUE
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`18.
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`This action arises under the patent laws of the United States, 35 U.S.C. §§ 100, et
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`seq., and this Court has jurisdiction over the subject matter of this action under 28 U.S.C. §§ 1331
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`and 1338(a). Venue is proper in this Court under 28 U.S.C. §§ 1391 and 1400(b).
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`19.
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`This Court has personal jurisdiction over DRL because, among other things, DRL
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`has committed, or aided, abetted, contributed to, or participated in the commission of, tortious acts
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`of patent infringement in filing its ANDA that has led to foreseeable harm and injury to Novartis,
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`a corporation having a principal place of business in New Jersey.
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`20.
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`This Court also has personal jurisdiction over DRL because of its affiliations with
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`the State of New Jersey, including in many instances by virtue of its incorporation in New Jersey
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`or the incorporation in New Jersey of subsidiaries, are so continuous and systematic as to render
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`DRL essentially at home in this forum.
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`21.
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`This Court also has personal jurisdiction over DRL because it has frequently
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`availed itself of the legal protections of the State of New Jersey by, among other things, selecting
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`the State of New Jersey as the place of incorporation for itself and their subsidiaries and admitting
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`jurisdiction and filing lawsuits and asserting counterclaims in lawsuits filed in the United States
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`District Court for the District of New Jersey.
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`22.
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`For these reasons, and for other reasons that will be presented to the Court if
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`jurisdiction is challenged, the Court has personal jurisdiction over DRL.
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`23.
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`Venue is proper in this Court because, among other things, DRL has committed
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`acts of infringement in this district and has a regular and established place of business in this
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`district. 28 U.S.C. § 1400(b). Dr. Reddy’s Laboratories Ltd. is a foreign corporation not residing
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`in any United States judicial district and may be sued in any judicial district. 28 U.S.C. §
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`1391(c)(3). Moreover, DRL has litigated previous Hatch-Waxman patent infringement disputes
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`in the District of New Jersey.
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`THE PATENTS-IN-SUIT AND RYDAPT®
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`24.
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`On July 5, 2011, the U.S. Patent and Trademark Office duly and legally issued the
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`’031 Patent, entitled “Staurosporine Derivatives as Inhibitors of FLT3 Receptor Tyrosine Kinase
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`Activity.” A true and correct copy of the ’031 Patent is attached hereto as Exhibit A.
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`25.
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`The ’031 Patent is wholly owned by Novartis and Dana-Farber, who therefore have
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`the right to sue for and obtain equitable relief and damages for infringement of the ’031 Patent.
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`26.
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`Novartis is the holder of New Drug Application (“NDA”) No. 207997 by which the
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`FDA granted approval for the commercial manufacturing, marketing, sale, and use of RYDAPT®
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`(Midostaurin) Capsules, 25 mg. RYDAPT® is a kinase inhibitor indicated for the treatment of
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`adult patients with acute myeloid leukemia that is FLT3 mutation-positive, in combination with
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`chemotherapy. RYDAPT® has been approved by the FDA for such indication.
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`27. Methods of using RYDAPT® to treat patients with FLT3 mutation-positive acute
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`myeloid leukemia as indicated and prescribed in its approved label are covered by one or more
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`claims of the ’031 Patent.
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`28.
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`The FDA’s official publication of approved drugs (the “Orange Book”) lists the
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`’031 Patent in connection with RYDAPT®.
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`COUNT 1: INFRINGEMENT BY DRL OF THE ’031 PATENT
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`Plaintiffs reallege, and incorporate in full herein, each preceding paragraph.
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`DRL, by filing its ANDA, has necessarily represented to the FDA that, upon
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`29.
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`30.
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`approval, DRL’s ANDA Product will have the same active ingredient, method of administration,
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`dosage form, and dosage amount as RYDAPT®, and will be bioequivalent to RYDAPT®.
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`31.
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`DRL’s ANDA submission seeking approval to engage in the commercial
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`manufacture, use, offer to sell, or sale of its ANDA Product, prior to the expiration of the ’031
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`Patent constitutes infringement of one or more of the claims of the ’031 Patent under 35 U.S.C.
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`§ 271(e)(2)(A).
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`32.
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`Upon information and belief, DRL intends to engage in the commercial
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`manufacture, use, offer for sale, sale, marketing, distributing, and/or importation of its ANDA
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`Product with its proposed labeling immediately and imminently upon approval of its ANDA.
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`33.
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`Upon information and belief, DRL’s ANDA Product’s proposed labeling will be
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`substantially identical to at least the portions of the RYDAPT® label relating to the treatment of
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`acute myeloid leukemia, and the RYDAPT® label discloses all elements of at least claim 1 of the
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`’031 Patent. Thus, upon information and belief, DRL’s ANDA Product labeling will disclose all
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`elements of at least claim 1 of the ’031 Patent.
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`34.
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`The commercial manufacture, use, offer for sale, sale, marketing, distributing,
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`and/or importation of DRL’s ANDA Product would infringe one or more claims of the ’031 Patent.
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`35.
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`Upon information and belief, use of DRL’s ANDA Product in accordance with and
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`as directed by its proposed labeling for each ANDA Product constitutes and/or will constitute
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`infringement of one or more claims of the ’031 Patent; active inducement of infringement of the
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`’031 Patent; and contribution to the infringement of the ’031 Patent under 35 U.S.C. §§271(a)-(c).
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`36.
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`Upon information and belief, DRL acted without a reasonable basis for believing
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`that it would not be liable for infringing the ’031 Patent, active inducement of infringement of the
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`’031 Patent, and/or contribution to the infringement by others of the ’031 Patent.
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`37.
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`If DRL’s infringement of the ’031 Patent is not enjoined, Plaintiffs will suffer
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`substantial and irreparable harm for which there is no remedy at law.
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`PRAYER FOR RELIEF
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`WHEREFORE, Novartis and Dana-Farber pray that this Court grant the following relief:
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`1.
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`A judgment that one or more claims of the ’031 Patent is not invalid, is enforceable,
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`and is infringed by DRL’s ANDA submissions, and that DRL’s making, using, offering to sell, or
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`selling in the United States, or importing into the United States of its ANDA Product will infringe
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`the ’031 Patent.
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`2.
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`An order pursuant to 35 U.S.C. § 271(e)(4)(A) providing that the effective date of
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`any approval of DRL’s ANDA shall be a date not earlier than the expiration date of the ’031 Patent,
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`including any extensions and/or additional periods of exclusivity.
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`3.
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`An order permanently enjoining DRL, its affiliates, subsidiaries, and each of their
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`officers, agents, servants and employees and those acting in privity or in concert with DRL, from
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`making, using, offering to sell, or selling in the United States, or importing into the United States
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`its ANDA Product, until after the expiration date of the ’031 Patent, including any extensions
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`and/or additional periods of exclusivity.
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`4.
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`Damages, including monetary and other relief, to Plaintiffs if DRL engages in
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`commercial manufacture, use, offers to sell, sale, or importation in or into the United States of its
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`ANDA Product, prior to the expiration date of the ’031 Patent, including any extensions and/or
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`additional periods of exclusivity.
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`5.
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`Plaintiffs’ costs and expenses in this action.
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`6.
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`Such further and other relief as this Court deems proper and just, including any
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`McCARTER & ENGLISH, LLP
`
`By:
`
`/s/ John E. Flaherty
`John E. Flaherty
`Cynthia S. Betz
`100 Mulberry Street
`4 Gateway Center
`Newark, NJ 07102
`(973) 622-4444
`jflaherty@mccarter.com
`cbetz@mccarter.com
`
`Attorneys for Novartis Pharmaceuticals
`Corporation and Dana-Farber Cancer
`Institute, Inc.
`
`appropriate relief under 35 U.S.C. § 285.
`
`Dated: July 30, 2021
`
`OF COUNSEL:
`
`Jane M. Love, Ph.D.
`Kyanna Sabanoglu
`Sung Bin Lee
`GIBSON, DUNN & CRUTCHER LLP
`200 Park Avenue
`New York, New York 10166
`(212) 351-4000
`jlove@gibsondunn.com
`ksabanoglu@gibsondunn.com
`slee3@gibsondunn.com
`
`Anne Y. Brody, Ph.D.
`Ronald A. Lee
`GIBSON, DUNN & CRUTCHER LLP
`3161 Michelson Drive,
`Irvine, CA 92612-4412 USA
`(949) 451-3800
`abrody@gibsondunn.com
`ronaldlee@gibsondunn.com
`
`Attorneys for Novartis Pharmaceuticals
`Corporation and Dana-Farber Cancer
`Institute, Inc.
`
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`CERTIFICATION PURSUANT TO L. CIV. R. 11.2
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`Plaintiffs Novartis Pharmaceuticals Corporation and Dana-Farber Cancer Institute, Inc., by
`their undersigned attorneys, hereby certify pursuant to Local Civil Rule 11.2 that the matter in
`controversy is the subject of the following pending actions involving and/or relating to RYDAPT®
`and the Patent In Suit: Novartis Pharmaceuticals Corp. v. Lupin, Inc., No. 21-cv-1105 (D. Del.);
`Novartis Pharmaceuticals Corp., et al. v. Dr. Reddy’s Laboratories, Inc., et al., No. 21-cv-1106
`(D. Del.); and Novartis Pharmaceuticals Corp., et al. v. Lotus Pharmaceutical Co., Ltd., et al.,
`No. 21-cv-1107 (D. Del.).
`
`McCARTER & ENGLISH, LLP
`
`By:
`
`/s/ John E. Flaherty
`John E. Flaherty
`Cynthia S. Betz
`100 Mulberry Street
`4 Gateway Center
`Newark, NJ 07102
`(973) 622-4444
`jflaherty@mccarter.com
`cbetz@mccarter.com
`
`Attorneys for Novartis Pharmaceuticals
`Corporation and Dana-Farber Cancer
`Institute, Inc.
`
`OF COUNSEL:
`
`Jane M. Love, Ph.D.
`Kyanna Sabanoglu
`Sung Bin Lee
`GIBSON, DUNN & CRUTCHER LLP
`200 Park Avenue
`New York, New York 10166
`(212) 351-4000
`jlove@gibsondunn.com
`ksabanoglu@gibsondunn.com
`slee3@gibsondunn.com
`
`Anne Y. Brody, Ph.D.
`Ronald A. Lee
`GIBSON, DUNN & CRUTCHER LLP
`3161 Michelson Drive,
`Irvine, CA 92612-4412 USA
`(949) 451-3800
`abrody@gibsondunn.com
`ronaldlee@gibsondunn.com
`
`Attorneys for Novartis Pharmaceuticals
`Corporation and Dana-Farber Cancer
`Institute, Inc.
`
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