`
`
`
`IN THE UNITED STATES DISTRICT COURT
`
`FOR THE DISTRICT OF DELAWARE
`
`Plaintiff,
`
`
`TEVA PHARMACEUTICALS
`INTERNATIONAL GMBH, CEPHALON,
`INC., and EAGLE PHARMACEUTICALS,
`INC.,
`
`
`
`
`
`
`)
`)
`)
`)
`)
`)
`)
`) C.A. No. ________
`)
`)
`
`)
`)
`)
`)
`
`
`
`
`
`v.
`
`
`
`
`DR. REDDY’S LABORATORIES, LTD.,
`and DR. REDDY’S LABORATORIES,
`INC.,
`
`
`
`
`Defendants.
`
`
`
`
`COMPLAINT
`
`Plaintiffs Teva Pharmaceuticals International GmbH (“Teva Pharmaceuticals”),
`
`Cephalon, Inc. (“Cephalon”) (collectively, with Teva Pharmaceuticals, “Teva”), and Eagle
`
`Pharmaceuticals, Inc. (“Eagle”) (collectively, “Plaintiffs”), by their attorneys, for their Complaint,
`
`allege as follows:
`
`1.
`
`This is an action for patent infringement under the patent laws of the United
`
`States, 35 U.S.C., and for a declaratory judgment of patent infringement under 28 U.S.C. §§ 2201
`
`and 2202 and the patent laws of the United States, 35 U.S.C., which arises out of Dr. Reddy’s
`
`Laboratories Ltd. and Dr. Reddy’s Laboratories, Inc. (collectively, “Dr. Reddy’s”) submission of
`
`New Drug Application (“NDA”) No. 215668 to the U.S. Food and Drug Administration (“FDA”)
`
`seeking approval to commercially manufacture, use, offer for sale, sell, and/or import a generic
`
`version of Bendeka® (bendamustine hydrochloride) Injection, 100 mg/4 mL (25 mg/mL), prior to
`
`the expiration of U.S. Patent Nos. 8,609,707 (the “’707 patent”); 9,265,831 (the “’831 patent”);
`
`
`
`1
`
`
`
`Case 1:21-cv-00695-UNA Document 1 Filed 05/13/21 Page 2 of 66 PageID #: 2
`
`
`
`9,572,796 (the “’796 patent”); 9,572,797 (the “’797 patent”); 9,034,908 (the “’908 patent”);
`
`9,144,568 (the “’568 patent”); 9,572,887 (the “’887 patent”); 9,597,397 (the “’397 patent”);
`
`9,597,398 (the “’398 patent”); 9,597,399 (the “’399 patent”); 9,000,021 (the “’021 patent”);
`
`9,579,384 (the “’384 patent”), 10,010,533 (the “’533 patent”); and 10,052,385 (the “’385 patent”)
`
`(collectively, the “Patents-in-Suit”).
`
`PARTIES
`
`2.
`
`Plaintiff Teva Pharmaceuticals is a limited liability company organized and
`
`existing under the laws of Switzerland, having its corporate offices and principal place of business
`
`at Schlüsselstrasse 12, Jona (SG) 8645, Switzerland.
`
`3.
`
`Plaintiff Cephalon is a corporation organized and existing under the laws of
`
`Delaware, having its corporate offices and principal place of business at 145 Brandywine Parkway,
`
`West Chester, Pennsylvania 19380.
`
`4.
`
`Plaintiff Eagle is a corporation organized and existing under the laws of
`
`Delaware, having its corporate offices and principal place of business at 50 Tice Boulevard, Suite
`
`315, Woodcliff Lake, New Jersey 07677.
`
`5.
`
`On information and belief, Defendant Dr. Reddy’s Laboratories, Ltd. is a
`
`company organized and existing under the laws of the Republic of India having its corporate
`
`offices and principal place of business at Door No. 8-2-337, Road No. 3, Banjara Hills, Hyderabad
`
`500 034, Telangana, Republic of India. On information and belief, Dr. Reddy’s Laboratories, Ltd.
`
`is in the business of, among other things, manufacturing and selling generic versions of branded
`
`pharmaceutical drugs through various operating subsidiaries, including Dr. Reddy’s Laboratories,
`
`Inc.
`
`
`
`2
`
`
`
`Case 1:21-cv-00695-UNA Document 1 Filed 05/13/21 Page 3 of 66 PageID #: 3
`
`
`
`6.
`
`On information and belief, Defendant Dr. Reddy’s Laboratories, Inc. is a
`
`company organized and existing under the laws of the State of New Jersey having its corporate
`
`offices and principal place of business at 107 College Road East, Princeton, New Jersey 08540.
`
`On information and belief, Dr. Reddy’s Laboratories, Inc. is in the business of, among other things,
`
`manufacturing and selling generic versions of pharmaceutical drug products throughout the United
`
`States, including Delaware.
`
`7.
`
`On information and belief, Dr. Reddy’s Laboratories, Inc. is a wholly owned
`
`subsidiary of Dr. Reddy’s Laboratories, Ltd. and the U.S. agent for Dr. Reddy’s Laboratories, Ltd.
`
`8.
`
`On information and belief, Dr. Reddy’s Laboratories, Ltd. and Dr. Reddy’s
`
`Laboratories, Inc. acted in concert to prepare and submit Dr. Reddy’s NDA to FDA.
`
`9.
`
`On information and belief, Dr. Reddy’s Laboratories, Ltd. actively
`
`encouraged, recommended, and promoted that Dr. Reddy’s Laboratories, Inc. prepare and submit
`
`Dr. Reddy’s NDA to FDA and knew that the filing of Dr. Reddy’s NDA would infringe the
`
`Patents-in-Suit, including because Dr. Reddy’s Laboratories, Ltd. knew that Dr. Reddy’s NDA
`
`would include a Paragraph IV Certification pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV) with
`
`respect to the Patents-in-Suit.
`
`10.
`
`On information and belief, Dr. Reddy’s Laboratories, Ltd. and Dr. Reddy’s
`
`Laboratories, Inc. know and intend that upon approval of Dr. Reddy’s NDA, Dr. Reddy’s
`
`Laboratories, Ltd. will manufacture Dr. Reddy’s NDA Product; and Dr. Reddy’s Laboratories,
`
`Ltd. and Dr. Reddy’s Laboratories, Inc. will directly or indirectly market, sell, and distribute Dr.
`
`Reddy’s NDA Product throughout the United States, including in Delaware. On information and
`
`belief, Dr. Reddy’s Laboratories, Ltd. and Dr. Reddy’s Laboratories, Inc. are agents of each other
`
`and/or operate in concert as integrated parts of the same business group, including with respect to
`
`
`
`3
`
`
`
`Case 1:21-cv-00695-UNA Document 1 Filed 05/13/21 Page 4 of 66 PageID #: 4
`
`
`
`Dr. Reddy’s NDA Product, and enter into agreements that are nearer than arm’s length. On
`
`information and belief, Dr. Reddy’s Laboratories, Ltd. and Dr. Reddy’s Laboratories, Inc.
`
`participated, assisted, and cooperated in carrying out the acts complained about herein.
`
`11.
`
`On information and belief, following any FDA approval of Dr. Reddy’s
`
`NDA, Dr. Reddy’s Laboratories, Ltd. and Dr. Reddy’s Laboratories, Inc. will act in concert to
`
`distribute and sell Dr. Reddy’s NDA Product throughout the United States, including within
`
`Delaware.
`
`JURISDICTION AND VENUE
`
`12.
`
`This Court has subject matter jurisdiction over this action pursuant to 28
`
`U.S.C. §§ 1331, 1338(a), 2201, and 2202.
`
`13.
`
`Based on the facts and causes alleged herein, and for additional reasons to
`
`be further developed through discovery if necessary, this Court has personal jurisdiction over Dr.
`
`Reddy’s Laboratories, Ltd. and Dr. Reddy’s Laboratories, Inc.
`
`14.
`
`This Court has personal jurisdiction over Dr. Reddy’s Laboratories, Ltd.
`
`because, among other things, Dr. Reddy’s Laboratories, Ltd., itself and through its subsidiary Dr.
`
`Reddy’s Laboratories, Inc., has purposefully availed itself of the benefits and protections of
`
`Delaware’s laws such that it should reasonably anticipate being haled into court here. On
`
`information and belief, Dr. Reddy’s Laboratories, Ltd., itself and through its subsidiary Dr.
`
`Reddy’s Laboratories, Inc., develops, manufactures, imports, markets, offers to sell, sells, and/or
`
`imports generic drugs throughout the United States, including in Delaware, and therefore transacts
`
`business within Delaware, and/or has engaged in systematic and continuous business contacts
`
`within Delaware.
`
`
`
`4
`
`
`
`Case 1:21-cv-00695-UNA Document 1 Filed 05/13/21 Page 5 of 66 PageID #: 5
`
`
`
`15.
`
`In addition, this Court has personal jurisdiction over Dr. Reddy’s
`
`Laboratories, Ltd. because, on information and belief, Dr. Reddy’s Laboratories, Ltd. directs and
`
`controls Dr. Reddy’s Laboratories, Inc., and Dr. Reddy’s Laboratories, Ltd. and Dr. Reddy’s
`
`Laboratories, Inc. are alter egos of each other. Therefore, Dr. Reddy’s Laboratories, Inc.’s
`
`activities in Delaware are attributable to Dr. Reddy’s Laboratories, Ltd.
`
`16.
`
`This Court has personal jurisdiction over Dr. Reddy’s Laboratories, Inc.
`
`because, among other things, it has purposely availed itself of the benefits and protections of
`
`Delaware’s laws such that it should reasonably anticipate being haled into court here. On
`
`information and belief, Dr. Reddy’s Laboratories, Inc. is registered as a pharmacy wholesaler
`
`under license No. A-4-0002524 and as a controlled substances distributor/manufacturer under
`
`license No. DM-0013148 with the Delaware Division of Professional Regulation. In addition, on
`
`information and belief, Dr. Reddy’s Laboratories, Inc. develops, manufactures, imports, markets,
`
`offers to sell, sells, and/or imports generic drugs throughout the United States, including in
`
`Delaware, and therefore transacts business within Delaware relating to Plaintiffs’ claims, and/or
`
`has engaged in systematic and continuous business contacts within Delaware.
`
`17.
`
`In addition, this Court has personal jurisdiction over Dr. Reddy’s
`
`Laboratories, Inc. because, on information and belief, Dr. Reddy’s Laboratories, Ltd. and Dr.
`
`Reddy’s Laboratories, Inc. are alter egos of each other. Therefore, Dr. Reddy’s Laboratories,
`
`Ltd.’s activities in Delaware are attributable to Dr. Reddy’s Laboratories, Inc.
`
`18.
`
`In addition, this Court also has personal jurisdiction over Dr. Reddy’s
`
`Laboratories, Ltd. and Dr. Reddy’s Laboratories, Inc. because, among other things, on information
`
`and belief: (1) Dr. Reddy’s Laboratories, Ltd. and Dr. Reddy’s Laboratories, Inc. filed Dr. Reddy’s
`
`NDA for the purpose of seeking approval to engage in the commercial manufacture, use, offer for
`
`
`
`5
`
`
`
`Case 1:21-cv-00695-UNA Document 1 Filed 05/13/21 Page 6 of 66 PageID #: 6
`
`
`
`sale, sale, and/or importation of Dr. Reddy’s NDA Product in the United States, including in
`
`Delaware; and (2) upon approval of Dr. Reddy’s NDA, Dr. Reddy’s Laboratories, Ltd. and Dr.
`
`Reddy’s Laboratories, Inc. will market, distribute, offer for sale, sell, and/or import Dr. Reddy’s
`
`NDA Product in the United States, including in Delaware, and will derive substantial revenue from
`
`the use or consumption of Dr. Reddy’s NDA Product in Delaware. See Acorda Therapeutics Inc.
`
`v. Mylan Pharm. Inc., 817 F.3d 755, 763 (Fed. Cir. 2016). On information and belief, upon
`
`approval of Dr. Reddy’s NDA, Dr. Reddy’s NDA Product will, among other things, be marketed,
`
`distributed, offered for sale, sold, and/or imported in Delaware; prescribed by physicians practicing
`
`in Delaware; dispensed by pharmacies located within Delaware; and/or used by patients in
`
`Delaware, all of which would have a substantial effect on Delaware.
`
`19.
`
`In addition, this Court has personal jurisdiction over Dr. Reddy’s
`
`Laboratories, Ltd. and Dr. Reddy’s Laboratories, Inc. because they have committed, aided, abetted,
`
`induced, contributed to, or participated in the commission of the tortious act of patent infringement
`
`that has led and/or will lead to foreseeable harm and injury to Cephalon and Eagle, both Delaware
`
`corporations.
`
`20.
`
`In addition, this Court has personal jurisdiction over Dr. Reddy’s
`
`Laboratories, Ltd. and Dr. Reddy’s Laboratories, Inc. because they regularly engage in patent
`
`litigation concerning Dr. Reddy’s NDA or Abbreviated New Drug Application (“ANDA”)
`
`Products in this District, do not contest personal jurisdiction in this District, and have purposefully
`
`availed themselves of the rights and benefits of this Court by asserting claims and/or counterclaims
`
`in this District.1
`
`
`1 See, e.g., Bial Portella & CA S.A. et al. v. Dr. Reddy’s Labs., Ltd. & Dr. Reddy’s Labs.,
`Inc., C.A. No. 21-188-CFC (D. Del. Mar. 3, 2021), D.I. 6, at 4-6; Intercept Pharm., Inc. et al. v.
`Dr. Reddy’s Labs., Inc. Dr. Reddy’s Labs., Ltd., C.A. No. 21-35-MN (D. Del. Feb. 5, 2021), D.I.
`
`
`
`6
`
`
`
`Case 1:21-cv-00695-UNA Document 1 Filed 05/13/21 Page 7 of 66 PageID #: 7
`
`
`
`21.
`
`For the above reasons, it would not be fundamentally unfair or unreasonable
`
`for Dr. Reddy’s Laboratories, Ltd. and Dr. Reddy’s Laboratories, Inc. to litigate this action in this
`
`District, and the Court has personal jurisdiction over them here.
`
`VENUE
`
`22.
`
`Plaintiffs incorporate each of the proceeding paragraphs 1–21 as if fully set
`
`forth herein.
`
`23.
`
`Venue is proper in this District under 28 U.S.C. §§ 1391 and 1400(b) with
`
`respect to Dr. Reddy’s Laboratories, Ltd., at least because, on information and belief, Dr. Reddy’s
`
`Laboratories, Ltd. is a foreign corporation that may be sued in any judicial district in which it is
`
`subject to the Court’s personal jurisdiction.
`
`24.
`
`Venue is proper in this District under 28 U.S.C. § 1400(b) with respect to
`
`Dr. Reddy’s Laboratories, Inc., at least because, on information and belief, Dr. Reddy’s
`
`Laboratories Ltd. is the U.S. agent and alter ego of Dr. Reddy’s Laboratories, Ltd. (which is subject
`
`to venue in this District). In addition, Dr. Reddy’s Laboratories, Ltd. and Dr. Reddy’s
`
`Laboratories, Inc. regularly engage in patent litigation concerning Dr. Reddy’s NDA or ANDA
`
`Products in this District and do not contest venue in this District.2
`
`
`10, at 5-9, 39-59; Pfizer, Inc. et al. v. Dr. Reddy’s Labs., Inc. & Dr. Reddy’s Labs., Ltd., C.A.
`No. 20-1530-CFC (D. Del. Jan. 15, 2021), D.I. 10, at 3-4; Novartis Pharm. Corp. v. Dr. Reddy’s
`Labs., Inc.. & Dr. Reddy’s Labs., Ltd. et al., C.A. No. 19-2053-LPS (D. Del. Feb. 6, 2020), D.I.
`34, at 3-8. 29-32, 85-103; Genzyme Corp. et al. v. Dr. Reddy’s Labs., Inc.. & Dr. Reddy’s Labs.,
`Ltd., C.A. No. 18-1839-CFC (D. Del. Jan. 16, 2019), D.I. 13, at 2-3, 9-15; Onyx Therapeutics,
`Inc. v. Dr. Reddy’s Labs., Ltd. & Dr. Reddy’s Labs., Inc., C.A. No. 17-1811-LPS (D. Del. Jan.
`23, 2018), D.I. 11, at 4-7, 43-63; Bristol Myers Squibb Co. et. al. v. Dr. Reddy’s Labs., Ltd. &
`Dr. Reddy’s Labs., Inc., C.A. No. 17-401-LPS (D. Del. July 7, 2017), D.I. 11, at 3, 9-14; Amgen
`Inc. v. Dr. Reddy’s Labs., Ltd. & Dr. Reddy’s Labs., Inc., C.A. No. 16-900-GMS (D. Del. Nov.
`1, 2016), D.I. 8, at 1-2, 7-11.
`
`2 See supra n.1.
`
`
`
`7
`
`
`
`Case 1:21-cv-00695-UNA Document 1 Filed 05/13/21 Page 8 of 66 PageID #: 8
`
`
`
`BACKGROUND
`
`25.
`
`Bendeka®, which contains bendamustine hydrochloride, is an alkylating
`
`drug that is indicated for the treatment of patients with (1) chronic lymphocytic leukemia and (2)
`
`indolent B-cell non-Hodgkin lymphoma that has progressed during or within six months of
`
`treatment with rituximab or a rituximab-containing regimen.
`
`26.
`
`Eagle is the holder of NDA No. 208194 for Bendeka®, which has been
`
`approved by FDA.
`
`27.
`
`The ’707 patent, entitled “Formulations of Bendamustine” (Exhibit A), was
`
`duly and legally issued on December 17, 2013. Eagle Pharmaceuticals, Inc. is the owner and
`
`assignee of the ’707 patent, subject to the exclusive license referenced herein. The ’707 patent has
`
`been listed in connection with Bendeka® in the Orange Book.
`
`28.
`
`The ’831 patent, entitled “Formulations of Bendamustine” (Exhibit B), was
`
`duly and legally issued on February 23, 2016. Eagle Pharmaceuticals, Inc. is the owner and
`
`assignee of the ’831 patent, subject to the exclusive license referenced herein. The ’831 patent has
`
`been listed in connection with Bendeka® in the Orange Book.
`
`29.
`
`The ’796 patent, entitled “Formulations of Bendamustine” (Exhibit C), was
`
`duly and legally issued on February 21, 2017. Eagle Pharmaceuticals, Inc. is the owner and
`
`assignee of the ’796 patent, subject to the exclusive license referenced herein. The ’796 patent has
`
`been listed in connection with Bendeka® in the Orange Book.
`
`30.
`
`The ’797 patent, entitled “Formulations of Bendamustine” (Exhibit D), was
`
`duly and legally issued on February 21, 2017. Eagle Pharmaceuticals, Inc. is the owner and
`
`assignee of the ’797 patent, subject to the exclusive license referenced herein. The ’797 patent has
`
`been listed in connection with Bendeka® in the Orange Book.
`
`
`
`8
`
`
`
`Case 1:21-cv-00695-UNA Document 1 Filed 05/13/21 Page 9 of 66 PageID #: 9
`
`
`
`31.
`
`The ’908 patent, entitled “Formulations of Bendamustine” (Exhibit E), was
`
`duly and legally issued on May 19, 2015. Eagle Pharmaceuticals, Inc. is the owner and assignee
`
`of the ’908 patent, subject to the exclusive license referenced herein. The ’908 patent has been
`
`listed in connection with Bendeka® in the Orange Book.
`
`32.
`
`The ’568 patent, entitled “Formulations of Bendamustine” (Exhibit F), was
`
`duly and legally issued on September 29, 2015. Eagle Pharmaceuticals, Inc. is the owner and
`
`assignee of the ’568 patent, subject to the exclusive license referenced herein. The ’568 patent has
`
`been listed in connection with Bendeka® in the Orange Book.
`
`33.
`
`The ’887 patent, entitled “Formulations of Bendamustine” (Exhibit G), was
`
`duly and legally issued on February 21, 2017. Eagle Pharmaceuticals, Inc. is the owner and
`
`assignee of the ’887 patent, subject to the exclusive license referenced herein. The ’887 patent has
`
`been listed in connection with Bendeka® in the Orange Book.
`
`34.
`
`The ’397 patent, entitled “Formulations of Bendamustine” (Exhibit H), was
`
`duly and legally issued on March 21, 2017. Eagle Pharmaceuticals, Inc. is the owner and assignee
`
`of the ’397 patent, subject to the exclusive license referenced herein. The ’397 patent has been
`
`listed in connection with Bendeka® in the Orange Book.
`
`35.
`
`The ’398 patent, entitled “Formulations of Bendamustine” (Exhibit I), was
`
`duly and legally issued on March 21, 2017. Eagle Pharmaceuticals, Inc. is the owner and assignee
`
`of the ’398 patent, subject to the exclusive license referenced herein. The ’398 patent has been
`
`listed in connection with Bendeka® in the Orange Book.
`
`36.
`
`The ’399 patent, entitled “Formulations of Bendamustine” (Exhibit J), was
`
`duly and legally issued on March 21, 2017. Eagle Pharmaceuticals, Inc. is the owner and assignee
`
`
`
`9
`
`
`
`Case 1:21-cv-00695-UNA Document 1 Filed 05/13/21 Page 10 of 66 PageID #: 10
`
`
`
`of the ’399 patent, subject to the exclusive license referenced herein. The ’399 patent has been
`
`listed in connection with Bendeka® in the Orange Book.
`
`37.
`
`The ’021 patent, entitled “Method of Treating Bendamustine-Responsive
`
`Conditions in Patients Requiring Reduced Volumes for Administration” (Exhibit K), was duly and
`
`legally issued on April 7, 2015. Eagle Pharmaceuticals, Inc. is the owner and assignee of the ’021
`
`patent, subject to the exclusive license referenced herein. The ’021 patent has been listed in
`
`connection with Bendeka® in the Orange Book.
`
`38.
`
`The ’384 patent, entitled “Method of Treating Bendamustine-Responsive
`
`Conditions in Patients Requiring Reduced Volumes for Administration” (Exhibit L), was duly and
`
`legally issued on February 28, 2017. Eagle Pharmaceuticals, Inc. is the owner and assignee of the
`
`’384 patent, subject to the exclusive license referenced herein. The ’384 patent has been listed in
`
`connection with Bendeka® in the Orange Book.
`
`39.
`
`The ’533 patent, entitled “Formulations of Bendamustine” (Exhibit M), was
`
`duly and legally issued on July 3, 2018. Eagle Pharmaceuticals, Inc. is the owner and assignee of
`
`the ’533 patent, subject to the exclusive license referenced herein. The ’533 patent has been listed
`
`in connection with Bendeka® in the Orange Book.
`
`40.
`
`The ’385 patent, entitled “Formulations of Bendamustine” (Exhibit N), was
`
`duly and legally issued on August 21, 2018. Eagle Pharmaceuticals, Inc. is the owner and assignee
`
`of the ’385 patent, subject to the exclusive license referenced herein. The ’385 patent has been
`
`listed in connection with Bendeka® in the Orange Book.
`
`41.
`
`On or around February 13, 2015, Cephalon executed an exclusive license
`
`(the “Eagle License”) to, among other things, the ’707 patent, U.S. Patent Application No.
`
`14/031,879 (which later issued as the ’831 patent); U.S. Patent Application No. 13/838,090 (which
`
`
`
`10
`
`
`
`Case 1:21-cv-00695-UNA Document 1 Filed 05/13/21 Page 11 of 66 PageID #: 11
`
`
`
`later issued as the ’908 patent), U.S. Patent Application No. 13/838,267 (which later issued as the
`
`’021 patent), and all patent rights claiming priority to those patents or patent applications (which
`
`include the ’796, ’797, ’568, ’887, ’397, ’398, ’399, ’384, ’533, and ’385 patents), for the
`
`commercialization of Eagle’s bendamustine hydrochloride rapid infusion product, EP-3102, which
`
`became Bendeka®. The Eagle License provides Cephalon the right to sue for infringement of the
`
`licensed patents in the event of, among other things, the filing of an NDA that makes reference to
`
`Bendeka® and seeks approval before expiry of a licensed patent.
`
`42.
`
`On or around October 14, 2015, Cephalon assigned its rights in the Eagle
`
`License to Teva Pharmaceuticals.
`
`INFRINGEMENT BY DR. REDDY’S
`
`43.
`
`By letter dated March 31, 2021 (“Dr. Reddy’s Notice Letter”), Dr. Reddy’s
`
`Laboratories, Inc., as U.S. agent for Dr. Reddy’s Laboratories Ltd., notified Teva and Eagle that it
`
`had filed a Paragraph IV Certification with respect to the Patents-in-Suit and was seeking approval
`
`from FDA to engage in the commercial manufacture, use, offer for sale, sale, and/or importation
`
`of Dr. Reddy’s NDA Product prior to the expiration of the Patents-in-Suit. On information and
`
`belief, Dr. Reddy’s NDA contains a Paragraph IV Certification asserting that the Patents-in-Suit
`
`will not be infringed by the manufacture, use, offer for sale, sale, or importation of Dr. Reddy’s
`
`NDA Product, or alternatively, that the Patents-in-Suit are invalid.
`
`44.
`
`The purpose of Dr. Reddy’s submission of Dr. Reddy’s NDA was to obtain
`
`approval under the Federal Food, Drug and Cosmetic Act to engage in the commercial
`
`manufacture, use, offer for sale, sale, and/or importation into the United States of Dr. Reddy’s
`
`NDA Product prior to the expiration of the Patents-in-Suit.
`
`
`
`11
`
`
`
`Case 1:21-cv-00695-UNA Document 1 Filed 05/13/21 Page 12 of 66 PageID #: 12
`
`
`
`45.
`
`In Dr. Reddy’s Notice Letter, Dr. Reddy’s stated that the active ingredient
`
`of Dr. Reddy’s NDA Product is bendamustine hydrochloride.
`
`46.
`
`In Dr. Reddy’s Notice Letter, Dr. Reddy’s stated that Dr. Reddy’s NDA
`
`Product contains 100 mg/4 mg (25 mg/mL) bendamustine hydrochloride.
`
`47.
`
`In Dr. Reddy’s Notice Letter, Dr. Reddy’s did not disclose the composition
`
`of Dr. Reddy’s NDA product and furnish samples, data, or other information sufficient to confirm
`
`independently the exact composition of Dr. Reddy’s NDA product and assess the properties and
`
`functions of Dr. Reddy’s NDA Product.
`
`48.
`
`In Dr. Reddy’s Notice Letter, Dr. Reddy’s did not contest infringement,
`
`among other things, of claims 1-3, 8-13, or 16-29 of the ’887 Patent. For example, claim 1 of the
`
`’887 Patent recites: “1. A method of treating chronic lymphocytic leukemia or indolent B cell non-
`
`Hodgkin's lymphoma in a subject comprising: a. providing a non-aqueous liquid composition
`
`comprising from about 10 mg/mL to about 100 mg/mL of bendamustine or a pharmaceutically
`
`acceptable salt thereof, wherein the total impurities are less than about 5% as determined by HPLC
`
`at a wavelength of 223 nm after 15 months at a temperature of from about 5° C. to about 25° C.;
`
`b. diluting said non-aqueous liquid composition with a parenterally acceptable aqueous diluent;
`
`and c. parenterally administering said diluted composition to the subject at a bendamustine dosage
`
`ranging from about 25 mg/m2 to about 120 mg/m2, wherein said administering step is performed
`
`with a total volume of about 100 mL or less of the diluted composition administered over a period
`
`of less than or equal to about 15 minutes.” Claim 2 of the ’887 Patent recites: “2. The method of
`
`claim 1, wherein the non-aqueous liquid composition comprises a pharmaceutically acceptable
`
`fluid comprising polyethylene glycol, propylene glycol, ethanol, benzyl alcohol, glycofurol, or
`
`DMSO, or a mixture thereof.” Claim 3 of the ’887 Patent recites: “3. The method of claim 1,
`
`
`
`12
`
`
`
`Case 1:21-cv-00695-UNA Document 1 Filed 05/13/21 Page 13 of 66 PageID #: 13
`
`
`
`wherein the non-aqueous liquid composition comprises polyethylene glycol, propylene glycol, or
`
`a mixture thereof.”
`
`49.
`
`On
`
`information and belief, Dr. Reddy’s NDA Product contains
`
`bendamustine, propylene glycol, polyethylene glycol, and monothioglycerol, in the same or
`
`equivalent amounts as Bendeka®.
`
`50.
`
`On
`
`information and belief, Dr. Reddy’s NDA Product contains
`
`bendamustine, propylene glycol, polyethylene glycol, and monothioglycerol, or equivalent
`
`ingredients, in the same or equivalent amounts as Bendeka®.
`
`51.
`
`On information and belief, the proposed labeling for Dr. Reddy’s NDA
`
`Product recommends, encourages, instructs, and/or promotes administration to patients with
`
`chronic lymphocytic leukemia.
`
`52.
`
`On information and belief, the proposed labeling for Dr. Reddy’s NDA
`
`Product recommends, encourages, instructs, and/or promotes administration of a bendamustine
`
`dose of 100 mg/m2 to patients with chronic lymphocytic leukemia.
`
`53.
`
`On information and belief, the proposed labeling for Dr. Reddy’s NDA
`
`Product recommends, encourages, instructs, and/or promotes administration to patients with
`
`indolent B-cell non-Hodgkin lymphoma.
`
`54.
`
`On information and belief, the proposed labeling for Dr. Reddy’s NDA
`
`Product recommends, encourages, instructs, and/or promotes administration of a bendamustine
`
`dose of 120 mg/m2 to patients with indolent B-cell non-Hodgkin lymphoma.
`
`55.
`
`On information and belief, the proposed labeling for Dr. Reddy’s NDA
`
`Product recommends, encourages, instructs, and/or promotes the administration of Dr. Reddy’s
`
`NDA Product in a volume of about 50 mL or less over a time period of about 10-minutes or less.
`
`
`
`13
`
`
`
`Case 1:21-cv-00695-UNA Document 1 Filed 05/13/21 Page 14 of 66 PageID #: 14
`
`
`
`56.
`
`In an exchange of correspondence, counsel for Teva and counsel for Dr.
`
`Reddy’s discussed the terms of Dr. Reddy’s Offer for Confidential Access. The parties did not
`
`agree on terms under which Teva could review, among other things, Dr. Reddy’s NDA and certain
`
`portions of the Drug Master File referred to therein, and Dr. Reddy’s refused to produce samples
`
`of Dr. Reddy’s NDA product and other internal documents and materials relevant to infringement.
`
`In addition, Dr. Reddy’s Offer for Confidential Access placed unreasonable restrictions on the
`
`extent to which Teva could access the documents and materials subject to the offer. Without all
`
`of the materials requested by Teva, including samples of Dr. Reddy’s NDA product, which Dr.
`
`Reddy’s refused to produce, Teva could not confirm, and cannot confirm, the exact composition
`
`and properties of Dr. Reddy’s NDA product. Dr. Reddy’s filing of its NDA seeking approval to
`
`market a generic version of Bendeka® before expiry of the patents asserted herein constitutes an
`
`act of infringement.
`
`57.
`
`On May 12, 2021, shortly before forty-five days had elapsed following
`
`Plaintiffs’ receipt of Dr. Reddy’s Notice Letter, counsel for Dr. Reddy’s responded to Teva’s most-
`
`recent correspondence regarding Dr. Reddy’s Offer for Confidential Access, and the parties
`
`recognized that they were at an impasse.
`
`58.
`
`This action is being commenced before the expiration of forty-five days
`
`from the date of the receipt of Dr. Reddy’s Notice Letter.
`
`COUNT I – INFRINGEMENT BY DR. REDDY’S
`OF U.S. PATENT NO. 8,609,707 UNDER 35 U.S.C. § 271(e)(2)
`
`Plaintiffs incorporate each of the preceding paragraphs 1–58 as if fully set
`
`59.
`
`forth herein.
`
`60.
`
`Dr. Reddy’s submission of Dr. Reddy’s NDA for the purpose of obtaining
`
`approval to engage in the commercial manufacture, use, offer for sale, sale, and/or importation of
`
`
`
`14
`
`
`
`Case 1:21-cv-00695-UNA Document 1 Filed 05/13/21 Page 15 of 66 PageID #: 15
`
`
`
`Dr. Reddy’s NDA Product prior to the expiration of the ’707 patent was an act of infringement of
`
`the ’707 patent under 35 U.S.C. § 271(e)(2)(A).
`
`61.
`
`On information and belief, the manufacture, use, offer for sale, sale,
`
`marketing, distribution, and/or importation of Dr. Reddy’s NDA Product would infringe one or
`
`more claims of the ’707 patent, either literally or under the doctrine of equivalents.
`
`62.
`
`On information and belief, Dr. Reddy’s will engage in the manufacture, use,
`
`offer for sale, sale, marketing, distribution, and/or importation of Dr. Reddy’s NDA Product
`
`immediately and imminently upon FDA approval of Dr. Reddy’s NDA.
`
`63.
`
`On information and belief, the use of Dr. Reddy’s NDA Product in
`
`accordance with and as directed by Dr. Reddy’s proposed labeling for that product would infringe
`
`one or more claims of the ’707 patent.
`
`64.
`
`On information and belief, Dr. Reddy’s plans and intends to, and will,
`
`actively induce infringement of the ’707 patent when Dr. Reddy’s NDA is approved, and plans
`
`and intends to, and will, do so after approval.
`
`65.
`
`On information and belief, Dr. Reddy’s knows that Dr. Reddy’s NDA
`
`Product and its proposed labeling are especially made or adapted for use in infringing the ’707
`
`patent and that Dr. Reddy’s NDA Product and its proposed labeling are not suitable for substantial
`
`non-infringing use. On information and belief, Dr. Reddy’s plans and intends to, and will,
`
`contribute to infringement of the ’707 patent after approval of Dr. Reddy’s NDA.
`
`66.
`
`The foregoing actions by Dr. Reddy’s constitute and/or will constitute
`
`infringement of the ’707 patent, active inducement of infringement of the ’707 patent, and
`
`contribution to the infringement by others of the ’707 patent.
`
`
`
`15
`
`
`
`Case 1:21-cv-00695-UNA Document 1 Filed 05/13/21 Page 16 of 66 PageID #: 16
`
`
`
`67.
`
`On information and belief, Dr. Reddy’s has acted with full knowledge of
`
`the ’707 patent and without a reasonable basis for believing that it would not be liable for infringing
`
`the ’707 patent, actively inducing infringement of the ’707 patent, and contributing to the
`
`infringement by others of the ’707 patent.
`
`68.
`
`Unless Dr. Reddy’s is enjoined from infringing the ’707 patent, actively
`
`inducing infringement of the ’707 patent, and contributing to the infringement by others of the
`
`’707 patent, Plaintiffs will suffer irreparable injury. Plaintiffs have no adequate remedy at law.
`
`COUNT II – INFRINGEMENT BY DR. REDDY’S
`OF U.S. PATENT NO. 9,265,831 UNDER 35 U.S.C. § 271(e)(2)
`
`Plaintiffs incorporate each of the preceding paragraphs 1–68 as if fully set
`
`69.
`
`forth herein.
`
`70.
`
`Dr. Reddy’s submission of Dr. Reddy’s NDA for the purpose of obtaining
`
`approval to engage in the commercial manufacture, use, offer for sale, sale, and/or importation of
`
`Dr. Reddy’s NDA Product prior to the expiration of the ’831 patent was an act of infringement of
`
`the ’831 patent under 35 U.S.C. § 271(e)(2)(A).
`
`71.
`
`On information and belief, the manufacture, use, offer for sale, sale,
`
`marketing, distribution, and/or importation of Dr. Reddy’s NDA Product would infringe one or
`
`more claims of the ’831 patent, either literally or under the doctrine of equivalents.
`
`72.
`
`On information and belief, Dr. Reddy’s will engage in the manufacture, use,
`
`offer for sale, sale, marketing, distribution, and/or importation of Dr. Reddy’s NDA Product
`
`immediately and imminently upon FDA approval of Dr. Reddy’s NDA.
`
`73.
`
`On information and belief, the use of Dr. Reddy’s NDA Product in
`
`accordance with and as directed by Dr. Reddy’s proposed labeling for that product would infringe
`
`one or more claims of the ’831 patent.
`
`
`
`16
`
`
`
`Case 1:21-cv-00695-UNA Document 1 Filed 05/13/21 Page 17 of 66 PageID #: 17
`
`
`
`74.
`
`On information and belief, Dr. Reddy’s plans and intends to, and will,
`
`actively induce infringement of the ’831 patent when Dr. Reddy’s NDA is approved, and plans
`
`and intends to, and will, do so after approval.
`
`75.
`
`On information and belief, Dr. Reddy’s knows that Dr. Reddy’s NDA
`
`Product and its proposed labeling are especially made or adapted for use in infringing the ’831
`
`patent and that Dr. Reddy’s NDA Product and its proposed labeling are not suitable for substantial
`
`non-infringing use. On information and belief, Dr. Reddy’s plans and intends to, and will,
`
`contribute to infringement of the ’831 patent after approval of Dr. Reddy’s NDA.
`
`76.
`
`The foregoing actions by Dr. Reddy’s constitute and/or will constitute
`
`infringement of the ’831 patent, active inducement of infringement of the ’831 patent, and
`
`contribution to the infringement by others of the ’831 patent.
`
`77.
`
`On information and belief, Dr. Reddy’s has acted with full knowledge of
`
`the ’831 patent and without a reasonable basis for believin