`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE MIDDLE DISTRICT OF NORTH CAROLINA
`CIVIL ACTION NO. 1:22-cv-00431
`
`
`
`NOVARTIS PHARMACEUTICALS
`CORPORATION and DANA-FARBER
`CANCER INSTITUTE, INC.,
`
`
`
`Plaintiffs,
`
`v.
`
`ACCORD HEALTHCARE INC., AND
`INTAS PHARMACEUTICAL LTD.,
`
`
`Defendants.
`
`
`
`
`
`COMPLAINT
`
`Novartis Pharmaceuticals Corporation (“Novartis”) and Dana-Farber Cancer
`
`Institute, Inc. (“Dana-Farber”) (collectively, “Plaintiffs”) by their attorneys hereby allege
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`as follows:
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`NATURE OF THE ACTION
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`1.
`
`This is a Hatch-Waxman action for patent infringement arising under the
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`patent laws of the United States, Title 35, United States Code, against defendants Intas
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`Pharmaceuticals Ltd. and Accord Healthcare Inc. This action relates to Abbreviated New
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`Drug Application (“ANDA”) No. 217342 filed by Accord with the U.S. Food and Drug
`
`Administration (“FDA”) for approval to engage in the commercial manufacture, use, offer
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`for sale, or sale of a generic version of Novartis’s RYDAPT® Capsules, 25 mg, prior to the
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`expiration of U.S. Patent No. 7,973,031 (the “’031 Patent” or “Asserted Patent”).
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`
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`Case 1:22-cv-00431 Document 1 Filed 06/07/22 Page 1 of 11
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`
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`A.
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`2.
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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
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`the State of Delaware, having a principal place of business at One Health Plaza, East
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`Hanover, New Jersey 07936-1080.
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`3.
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`Novartis is engaged in the business of creating, developing, and bringing to
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`market revolutionary drug therapies to benefit patients against serious diseases, including
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`treatments for leukemia and mastocytosis. RYDAPT® is one such treatment option.
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`Novartis markets and sells RYDAPT® in this judicial district and throughout the United
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`States.
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`4.
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`Plaintiff Dana-Farber is a non-profit corporation organized and existing
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`under the laws of the State of Massachusetts, having a principal place of business at 450
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`Brookline Avenue, Boston, Massachusetts 02215.
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`5.
`
`Dana-Farber is a world-renowned center for patient care, research and
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`education. Dana-Farber helps to advance this mission through, among other things,
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`licensing intellectual property which helps to fund innovative research and treatment for
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`cancer and other patients who have sought treatment in their hospital and other facilities.
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`6.
`
`B.
`
`7.
`
`Novartis and Dana-Farber own all rights in the ’031 Patent.
`
`Defendants
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`Upon information and belief, Defendant Intas Pharmaceuticals Ltd. is a
`
`corporation organizing and existing under the laws of India, having a principal place of
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`- 2 -
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`Case 1:22-cv-00431 Document 1 Filed 06/07/22 Page 2 of 11
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`business at Corporate House, Near Sola Bridge, S.G. Highway, Thaltej, Ahmedabad
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`380009, Gujarat, India.
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`8.
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`Upon information and belief, Defendant Accord Healthcare Inc. is a
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`corporation organized and existing under the laws of the State of North Carolina, having a
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`principal place of business at 1009 Slater Road, Suite 210-B, Durham, North Carolina
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`27703.
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`9.
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`Upon information and belief, Intas Pharmaceuticals Ltd. is in the business
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`of, 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, Accord
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`Healthcare Inc. is a wholly-owned subsidiary of Intas Pharmaceuticals Ltd. and is
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`controlled and/or dominated by Intas Pharmaceutical Ltd. Upon information and belief,
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`Accord Healthcare Inc. develops, manufactures and/or distributes generic drug products
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`for marketing, sale, and/or use throughout the United States, including in this judicial
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`district, at the direction, under the control, and for the benefit of Accord Healthcare Inc.
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`10. Upon information and belief, Accord Healthcare Inc. is the commercial arm
`
`of Intas Pharmaceuticals Ltd. Upon information and belief, Accord Healthcare Inc. and
`
`Intas Pharmaceuticals Ltd. together provide full integration in functional areas such as
`
`active pharmaceutical ingredient and finished dosage form manufacturing, research and
`
`development, clinical program management, and the economies of scale in worldwide
`
`distribution.
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`Case 1:22-cv-00431 Document 1 Filed 06/07/22 Page 3 of 11
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`
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`11.
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`Intas Pharmaceuticals Ltd. and Accord Healthcare Inc. are collectively
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`referred to hereafter as “Accord” unless otherwise noted.
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`DEFENDANTS’ INFRINGING ACTS
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`12. By a letter dated April 26, 2022, Accord notified Plaintiffs that Accord had
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`submitted to the FDA ANDA No. 217342 for a generic version of RYDAPT® (Accord’s
`
`“ANDA Product”), seeking approval under the Federal Food, Drug, and Cosmetic Act
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`(“FDCA”) to engage in the commercial manufacture, use, offer for sale, and/or sale of
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`Accord’s ANDA Product prior to the expiration of the ’031 Patent.
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`13.
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`In its Notice Letter, Accord notified Plaintiffs that, as a part of its ANDA,
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`Accord had filed a certification of the type described in Section 505(j)(2)(A)(vii)(IV) of
`
`the FDCA, 21 U.S.C. § 355(j)(2)(A)(vii)(IV), with respect to the ’031 Patent asserting that
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`the ’031 Patent is invalid, unenforceable, and/or will not be infringed by the commercial
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`manufacture, use, offer for sale, and sale of Accord’s ANDA Product.
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`14. Upon information and belief, and consistent with their past practices, Accord
`
`acted collaboratively in the preparation and submission of ANDA No. 217342.
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`15. Upon information and belief, and consistent with their past practices,
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`following any FDA approval of ANDA No. 217342, Accord will work in concert with one
`
`another to make, use, offer to sell, and/or sell the ANDA Product throughout the United
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`States, and/or import such generic drug product into the United States, including in this
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`judicial district.
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`- 4 -
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`Case 1:22-cv-00431 Document 1 Filed 06/07/22 Page 4 of 11
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`16. Accord has committed an act of infringement in this judicial district by filing
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`ANDA No. 217342 with the intent to make, use, offer to sell, and/or sell the generic drug
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`products that are the subject of ANDA No. 217342 in this judicial district, an act of
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`infringement that has led to foreseeable harm and injury to Novartis, a Delaware
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`corporation, and to Dana Farber.
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`17. Accord has extensive contacts with the State of North Carolina, is
`
`incorporated in the State of North Carolina, regularly conducts business in the State of
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`North Carolina, either directly or through one or more of its wholly owned subsidiaries,
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`agents, and/or alter egos, has purposefully availed itself of the privilege of doing business
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`in the State of North Carolina, and intends to sell in the State of North Carolina the generic
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`product described in ANDA No. 217342 upon approval.
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`18. Accord has availed themselves of the legal protections of the State of North
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`Carolina by, among other things, being incorporated in North Carolina.
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`JURISDICTION AND VENUE
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`19.
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`This action arises under the patent laws of the United States, 35 U.S.C.
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`§§ 100, et seq., and this Court has jurisdiction over the subject matter of this action under
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`28 U.S.C. §§ 1331 and 1338(a). Venue is proper in this Court under 28 U.S.C. §§ 1391
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`and 1400(b).
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`20.
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`This Court has personal jurisdiction over each Defendant because, among
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`other things, each has committed, induced, or aided, abetted, contributed to, or participated
`
`in the commission of, tortious acts of patent infringement in this district by filing the
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`- 5 -
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`Case 1:22-cv-00431 Document 1 Filed 06/07/22 Page 5 of 11
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`
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`ANDA with intent to commercially manufacture, use, offer for sale, sell, market, distribute,
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`and/or import its ANDA Product in the State of North Carolina, including in this District.
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`21.
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`This Court also has personal jurisdiction over each Defendant because each
`
`of the Defendants’ affiliations with the State of North Carolina, including by virtue of
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`Accord’s incorporation in North Carolina and having a principle place of business in
`
`Durham, North Carolina, are so continuous and systematic as to render each Defendant
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`essentially at home in this forum.
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`22.
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`For these reasons, and for other reasons that will be presented to the Court if
`
`jurisdiction is challenged, the Court has personal jurisdiction over each Defendant.
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`23. Venue is proper in this Court because, among other things, Accord is inter
`
`alia incorporated and has its principle place of business in the State of North Carolina, and
`
`therefore “resides” in this judicial district and has a regular and established place of
`
`business in this District. 28 U.S.C. § 1400(b). Intas Pharmaceuticals Ltd. is a foreign
`
`corporation not residing in any United States judicial district and may be sued in any
`
`judicial district. 28 U.S.C. § 1391(c)(3).
`
`THE PATENT-IN-SUIT AND RYDAPT®
`
`24. On July 5, 2011, the U.S. Patent and Trademark Office duly and legally
`
`issued the ’031 Patent, entitled “Staurosporine Derivatives as Inhibitors of FLT3 Receptor
`
`Tyrosine Kinase Activity.” A true and correct copy of the ’031 Patent is attached hereto
`
`as Exhibit A.
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`- 6 -
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`Case 1:22-cv-00431 Document 1 Filed 06/07/22 Page 6 of 11
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`25.
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`The ’031 Patent is wholly owned by Novartis and Dana-Farber, who
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`therefore have the right to sue for and obtain equitable relief and damages for infringement
`
`of the ’031 Patent.
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`26. Novartis is the holder of New Drug Application (“NDA”) No. 217342 by
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`which the FDA granted approval for the commercial manufacturing, marketing, sale, and
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`use of RYDAPT® (Midostaurin) Capsules, 25 mg. RYDAPT® is a kinase inhibitor
`
`indicated for the treatment of adult patients with acute myeloid leukemia that is FLT3
`
`mutation-positive, in combination with chemotherapy. RYDAPT® has been approved by
`
`the FDA for such indication.
`
`27. Methods of using RYDAPT® to treat patients with FLT3 mutation-positive
`
`acute myeloid leukemia as indicated and prescribed in its approved label are covered by
`
`one or more claims of the ’031 Patent.
`
`28.
`
`The FDA’s official publication of approved drugs (the “Orange Book”) lists
`
`the ’031 Patent in connection with RYDAPT®.
`
`COUNT 1: INFRINGEMENT BY ACCORD OF THE ’031 PATENT
`
`29.
`
`Plaintiffs reallege, and incorporate in full herein, each preceding paragraph.
`
`30. Accord, by filing its ANDA, has necessarily represented to the FDA that,
`
`upon approval, Accord’s ANDA Product will have the same active ingredient, method of
`
`administration, dosage form, and dosage amount as RYDAPT®, and will be bioequivalent
`
`to RYDAPT®.
`
`
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`- 7 -
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`Case 1:22-cv-00431 Document 1 Filed 06/07/22 Page 7 of 11
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`
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`31. Accord’s ANDA submission seeking approval to engage in the commercial
`
`manufacture, use, offer to sell, or sale of its ANDA Product, prior to the expiration of the
`
`’031 Patent constitutes infringement of one or more of the claims of the ’031 Patent under
`
`35 U.S.C. § 271(e)(2)(A).
`
`32. Upon information and belief, Accord intends to engage in the commercial
`
`manufacture, use, offer for sale, sale, marketing, distributing, and/or importation of its
`
`ANDA Product with its proposed labeling immediately and imminently upon approval of
`
`its ANDA.
`
`33. Upon information and belief, Accord’s ANDA Product’s proposed labeling
`
`will be substantially identical to at least the portions of the RYDAPT® label relating to the
`
`treatment of acute myeloid leukemia, and the RYDAPT® label discloses all elements of at
`
`least claim 1 of the ’031 Patent. Thus, upon information and belief, Accord’s ANDA
`
`Product labeling will disclose all elements of at least claim 1 of the ’031 Patent.
`
`34.
`
`The commercial manufacture, use, offer for sale, sale, marketing,
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`distributing, and/or importation of Accord’s ANDA Product would infringe one or more
`
`claims of the ’031 Patent.
`
`35. Upon information and belief, use of Accord’s ANDA Product in accordance
`
`with and as directed by its proposed labeling for each ANDA Product constitutes and/or
`
`will constitute infringement of one or more claims of the ’031 Patent; active inducement
`
`of the infringement of the ’031 Patent; and contribution to the infringement of the ’031
`
`Patent under 35 U.S.C. §§271(a)-(c).
`
`
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`- 8 -
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`Case 1:22-cv-00431 Document 1 Filed 06/07/22 Page 8 of 11
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`36. Upon information and belief, Accord acted without a reasonable basis for
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`believing that it would not be liable for infringing the ’031 Patent, active inducement of
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`infringement of the ’031 Patent, and/or contribution to the infringement by others of the
`
`’031 Patent.
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`37.
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`If Accord’s infringement of the ’031 Patent is not enjoined, Plaintiffs will
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`suffer 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
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`relief:
`
`1.
`
`A judgment that one or more claims of the ’031 Patent is not invalid, is
`
`enforceable, and is infringed by Accord’s ANDA submissions, and that Accord’s making,
`
`using, offering to sell, or selling in the United States, or importing into the United States
`
`of its ANDA Product will infringe the ’031 Patent.
`
`2.
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`An order pursuant to 35 U.S.C. § 271(e)(4)(A) providing that the effective
`
`date of any approval of Accord’s ANDA shall be a date not earlier than the expiration date
`
`of the ’031 Patent, including any extensions and/or additional periods of exclusivity.
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`3.
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`An order permanently enjoining Accord, its affiliates, subsidiaries, and each
`
`of their officers, agents, servants and employees and those acting in privity or in concert
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`with Accord, from making, using, offering to sell, or selling in the United States, or
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`importing into the United States its ANDA Product, until after the expiration date of the
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`’031 Patent, including any extensions and/or additional periods of exclusivity.
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`- 9 -
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`Case 1:22-cv-00431 Document 1 Filed 06/07/22 Page 9 of 11
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`4.
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`Damages, including monetary and other relief, to Plaintiffs if Accord
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`engages in commercial manufacture, use, offers to sell, sale, or importation in or into the
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`United States of its ANDA Product, prior to the expiration date of the ’031 Patent,
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`including any extensions and/or additional periods of exclusivity.
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`5.
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`6.
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`Plaintiffs’ costs and expenses in this action.
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`Such further and other relief as this Court deems proper and just, including
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`any appropriate relief under 35 U.S.C. § 285.
`
`
`
`This the 7th day of June, 2022
`
`
`s/ Andrew S. Chamberlin
`
`Andrew S. Chamberlin
`N.C. State Bar No. 17369
`ELLIS & WINTERS LLP
`Post Office Box 2752 (27402)
`300 North Greene Street, Suite 800
`Greensboro, North Carolina 27401
`Telephone: (336) 217-4193
`Facsimile: (336) 217-4198
`andrew.chamberlin@elliswinters.com
`
`Jane M. Love, Ph.D.
`New York State Bar No. 3016995
`(Special Appearance forthcoming)
`Robert W. Trenchard
`New York State Bar No. 2679488
`(Special Appearance forthcoming)
`Sung Bin Lee
`New York State Bar No. 5701099
`(Special Appearance forthcoming)
`Emil N. Nachman
`New York State Bar No. 5738331
`(Special Appearance forthcoming)
`GIBSON, DUNN & CRUTCHER LLP
`200 Park Avenue
`New York, NY 10166
`
`
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`- 10 -
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`Case 1:22-cv-00431 Document 1 Filed 06/07/22 Page 10 of 11
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`
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`Telephone: (212) 351-4000
`jlove@gibsondunn.com
`rtrenchard@gibsondunn.com
`slee3@gibsondunn.com
`enachman@gibsondunn.com
`
`Anne Y. Brody, Ph.D.
`California State Bar No. 252279
`(Special Appearance forthcoming)
`Ronald A. Lee
`California State Bar No. 337729
`(Special Appearance forthcoming)
`GIBSON, DUNN & CRUTCHER LLP
`3161 Michelson Drive,
`Irvine, CA 92612-4412 USA
`Telephone: (949) 451-3800
`abrody@gibsondunn.com
`ronaldlee@gibsondunn.com
`
`Attorneys for Plaintiffs Novartis
`Pharmaceuticals Corporation and Dana-
`Farber Cancer Institute, Inc.
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`- 11 -
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`Case 1:22-cv-00431 Document 1 Filed 06/07/22 Page 11 of 11
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`
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