Case 1:22-cv-01102-UNA Document 1 Filed 08/22/22 Page 1 of 10 PageID #: 1
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
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`C.A. No. _________________
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`BOEHRINGER INGELHEIM
`PHARMACEUTICALS INC.,
`BOEHRINGER INGELHEIM
`INTERNATIONAL GMBH, and
`BOEHRINGER INGELHEIM
`CORPORATION,
`
`
`Plaintiffs,
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`
`
`v.
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`DR. REDDY’S LABORATORIES LTD.
`and DR. REDDY’S LABORATORIES,
`INC.,
`
`
`Defendants.
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`
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`COMPLAINT
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`Plaintiffs Boehringer Ingelheim Pharmaceuticals Inc., Boehringer Ingelheim International
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`GmbH, and Boehringer Ingelheim Corporation, by their undersigned attorneys, for their Complaint
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`against Defendants, Dr. Reddy’s Laboratories Ltd. and Dr. Reddy’s Laboratories, Inc., hereby
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`allege as follows:
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`NATURE OF THE ACTION
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`
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`This is an action for patent infringement arising under the Food and Drug Laws and
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`Patent Laws of the United States, Titles 21 and 35 of the United States Code, respectively, arising
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`from Defendants’ submission of an Abbreviated New Drug Application (“ANDA”) to the Food
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`and Drug Administration (“FDA”) seeking approval to manufacture and sell a generic version of
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`Plaintiffs’ JARDIANCE® (empagliflozin) tablets prior to the expiration of United States Patent
`
`No. 11,090,323.
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`
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`
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
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`C.A. No. _________________
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`BOEHRINGER INGELHEIM
`PHARMACEUTICALS INC.,
`BOEHRINGER INGELHEIM
`INTERNATIONAL GMBH, and
`BOEHRINGER INGELHEIM
`CORPORATION,
`
`
`Plaintiffs,
`
`
`
`v.
`
`
`DR. REDDY’S LABORATORIES LTD.
`and DR. REDDY’S LABORATORIES,
`INC.,
`
`
`Defendants.
`
`
`
`
`
`COMPLAINT
`
`Plaintiffs Boehringer Ingelheim Pharmaceuticals Inc., Boehringer Ingelheim International
`
`GmbH, and Boehringer Ingelheim Corporation, by their undersigned attorneys, for their Complaint
`
`against Defendants, Dr. Reddy’s Laboratories Ltd. and Dr. Reddy’s Laboratories, Inc., hereby
`
`allege as follows:
`
`NATURE OF THE ACTION
`
`
`
`This is an action for patent infringement arising under the Food and Drug Laws and
`
`Patent Laws of the United States, Titles 21 and 35 of the United States Code, respectively, arising
`
`from Defendants’ submission of an Abbreviated New Drug Application (“ANDA”) to the Food
`
`and Drug Administration (“FDA”) seeking approval to manufacture and sell a generic version of
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`Plaintiffs’ JARDIANCE® (empagliflozin) tablets prior to the expiration of United States Patent
`
`No. 11,090,323.
`
`
`
`
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`Case 1:22-cv-01102-UNA Document 1 Filed 08/22/22 Page 2 of 10 PageID #: 2
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`
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`THE PARTIES
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`
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`Plaintiff Boehringer Ingelheim Pharmaceuticals Inc. (“BIPI”) is a corporation
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`organized and existing under the laws of the State of Delaware, having a principal place of business
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`at 900 Ridgebury Rd., Ridgefield, CT 06877.
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`
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`Plaintiff Boehringer Ingelheim International GmbH (“BII”) is a private limited
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`liability company organized and existing under the laws of Germany, having a principal place of
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`business at Binger Strasse 173, 55216 Ingelheim, Germany.
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`
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`Plaintiff Boehringer Ingelheim Corporation (“BIC”) is a corporation organized and
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`existing under the laws of Nevada, having a principal place of business at 900 Ridgebury Road,
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`Ridgefield, CT, 06877.
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`
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`BIPI, BII, and BIC are collectively referred to hereinafter as “Boehringer” or
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`“Plaintiffs.”
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`
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`On information and belief, Defendant Dr. Reddy’s Laboratories Ltd. (“DRL Ltd.”)
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`is a corporation organized and existing under the laws of India, having a principal place of business
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`at 8-2-337 Road No. 3, Banjara Hills, Hyderabad, 500034, India.
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`
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`On information and belief, DRL Ltd. controls and directs a wholly owned
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`subsidiary in the United States named Dr. Reddy’s Laboratories, Inc. (“DRL Inc.”). DRL Inc. is
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`a New Jersey corporation having a principal place of business at 107 College Road East, Princeton,
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`New Jersey 08540.
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`
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`DRL Ltd. and DRL Inc. are collectively referred to hereinafter as “DRL.”
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`On information and belief, DRL Ltd. is in the business of, among other things,
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`developing, preparing, manufacturing, selling, marketing, and distributing generic drugs,
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`including distributing, selling, and marketing generic drugs throughout the United States,
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`2
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`Case 1:22-cv-01102-UNA Document 1 Filed 08/22/22 Page 3 of 10 PageID #: 3
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`including within the state of Delaware, through its own actions and through the actions of its agents
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`and subsidiaries, including DRL Inc., from which DRL Ltd. derives a substantial portion of its
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`revenue.
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`On information and belief, DRL Inc. acted in concert with DRL Ltd. to prepare and
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`submit ANDA No. 212336 (the “DRL ANDA”) for DRL Ltd.’s 10 mg and 25 mg empagliflozin
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`tablets (“DRL ANDA Products”), which was done at the direction of, under the control of, and for
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`the direct benefit of DRL Ltd. Following FDA approval of the DRL ANDA, DRL Ltd. will
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`manufacture and supply the approved generic products to DRL Inc., which will then market and
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`sell the products throughout the United States at the direction, under the control, and for the direct
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`benefit of DRL Ltd.
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`JURISDICTION AND VENUE
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`
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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., generally, and 35 U.S.C. § 271(e)(2), specifically, and this Court has jurisdiction over the
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`subject matter of this action under 28 U.S.C. §§ 1331 and 1338(a).
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`
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`Venue is proper in this Court because, among other things, each Defendant is a
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`foreign corporation or the agent of a foreign corporation not residing in any United States district
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`and may be sued in any judicial district. 28 U.S.C. § 1391(c). Moreover, DRL has litigated
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`previous Hatch-Waxman patent infringement disputes in the District of Delaware and has not
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`contested venue in those cases. See, e.g., Boehringer Ingelheim Pharmaceuticals Inc. et al. v.
`
`Dr. Reddy’s Laboratories, Ltd. et al., C.A. No. 19-1495, D.I. 9 (D. Del. Sept. 4, 2019); Boehringer
`
`Ingelheim Pharmaceuticals Inc. et al. v. Dr. Reddy's Laboratories, Ltd. et al., C.A. No. 18-779,
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`D.I. 12 (D. Del. Jan. 11, 2019); Novartis Pharmaceuticals Corporation v. Dr. Reddy’s
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`Laboratories Inc. et al., C.A. No. 22-498, D.I. 12 (D. Del. May 10, 2022). Further, DRL did not
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`3
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`Case 1:22-cv-01102-UNA Document 1 Filed 08/22/22 Page 4 of 10 PageID #: 4
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`
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`contest venue, and filed counterclaims, in this District in the prior case in which Boehringer filed
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`a lawsuit against DRL arising from DRL’s submission of the DRL ANDA. See Boehringer,
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`C.A. No. 19-1495, D.I. 9; Boehringer, C.A. No. 18-1779, D.I. 12.
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`PERSONAL JURISDICTION OVER DRL LTD.
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`Plaintiffs reallege paragraphs 1-12 as if fully set forth herein.
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`On information and belief, DRL Ltd. develops, manufactures, and/or distributes
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`generic drugs for sale and use throughout the United States, including in this judicial district.
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`
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`This Court has personal jurisdiction over DRL Ltd. because, inter alia, DRL Ltd.,
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`on information and belief: (1) has substantial, continuous, and systematic contacts with this State,
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`either directly or through at least one of its wholly-owned subsidiaries or agents; (2) intends to
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`market, sell, and/or distribute DRL’s infringing ANDA Products to residents of this State upon
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`approval of ANDA No. 212336, either directly or through at least one of its wholly-owned
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`subsidiaries or agents; (3) makes its generic drug products available in this State; and (4) enjoys
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`substantial income from sales of its generic pharmaceutical products in this State on its own and
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`through DRL Inc.
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`
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`On information and belief, DRL Ltd. has not contested jurisdiction in Delaware in
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`one or more prior cases arising out of the filing of its ANDAs, and it has filed counterclaims in
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`such cases. See, e.g., Boehringer Ingelheim Pharmaceuticals Inc. et al. v. Dr. Reddy’s
`
`Laboratories, Ltd. et al., C.A. No. 19-1495, D.I. 9 (D. Del. Sept. 4, 2019); Boehringer Ingelheim
`
`Pharmaceuticals Inc. et al. v. Dr. Reddy’s Laboratories, Ltd. et al., C.A. No. 18-1779, D.I. 12
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`(D. Del. Jan. 11, 2019); Novartis Pharmaceuticals Corporation v. Dr. Reddy’s Laboratories Inc.
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`et al., C.A. No. 22-498, D.I. 12 (D. Del. May 10, 2022).
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`4
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`Case 1:22-cv-01102-UNA Document 1 Filed 08/22/22 Page 5 of 10 PageID #: 5
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`Alternatively, to the extent the above facts do not establish personal jurisdiction
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`over DRL Ltd., this Court may exercise jurisdiction over DRL Ltd. pursuant to Fed. R. Civ. P.
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`4(k)(2) because: (a) Plaintiffs’ claims arise under federal law; (b) DRL Ltd. would be a foreign
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`defendant not subject to personal jurisdiction in the courts of any State; and (c) DRL Ltd. has
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`sufficient contacts with the United States as a whole, including, but not limited to, filing ANDAs
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`with the FDA and manufacturing and selling generic pharmaceutical products that are distributed
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`throughout the United States, such that this Court’s exercise of jurisdiction over DRL Ltd. satisfies
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`due process.
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`PERSONAL JURISDICTION OVER DRL INC.
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`Plaintiffs reallege paragraphs 1-17 as if fully set forth herein.
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`On information and belief, DRL Inc. develops, manufactures, and/or distributes
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`generic drugs for sale and use throughout the United States, including in this judicial district.
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`
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`This Court has personal jurisdiction over DRL Inc. because, inter alia, DRL Inc.,
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`on information and belief: (1) intends to market, sell, or distribute DRL’s infringing ANDA
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`Products to residents of this State; (2) is controlled by Defendant DRL Ltd. and is acting on behalf
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`of DRL Ltd. with respect to the DRL ANDA; (3) makes its generic drug products available in this
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`State; and (4) enjoys substantial income from sales of its generic pharmaceutical products in this
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`State.
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`
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`On information and belief, DRL Inc. has not contested jurisdiction in Delaware in
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`one or more prior cases arising out of the filing of its ANDAs, and it has filed counterclaims in
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`such cases. See, e.g., Boehringer Ingelheim Pharmaceuticals Inc. et al. v. Dr. Reddy’s
`
`Laboratories, Ltd. et al., C.A. No. 19-1495, D.I. 9 (D. Del. Sept. 4, 2019); Boehringer Ingelheim
`
`Pharmaceuticals Inc. et al. v. Dr. Reddy’s Laboratories, Ltd. et al., C.A. No. 18-1779, D.I. 12
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`5
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`Case 1:22-cv-01102-UNA Document 1 Filed 08/22/22 Page 6 of 10 PageID #: 6
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`
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`(D. Del. Jan. 11, 2019); Novartis Pharmaceuticals Corporation v. Dr. Reddy’s Laboratories Inc.
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`et al., C.A. No. 22-498, D.I. 12 (D. Del. May 10, 2022).
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`BACKGROUND
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`U.S. PATENT NO. 11,090,323
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`
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`On August 17, 2021, the USPTO duly and legally issued United States Patent
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`No. 11,090,323 (“the ’323 patent”) entitled “Pharmaceutical composition, methods for treating
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`and uses thereof” to inventors Uli Christian Broedl, Sreeraj Macha, Maximilian von Eynatten, and
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`Hans-Juergen Woerle. A true and correct copy of the ’323 patent is attached as Exhibit A. The
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`’323 patent is assigned to BII. BIC and BIPI are licensees of the ’323 patent.
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`JARDIANCE®
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`
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`BIPI is the holder of New Drug Application (“NDA”) No. 204629 for
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`empagliflozin, for oral use, in 10 mg and 25 mg dosages, which is sold under the trade name
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`JARDIANCE®.
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`
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`Pursuant to 21 U.S.C. § 355(b)(1), and attendant FDA regulations, the ’323 patent
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`is among the patents listed in the FDA’s Approved Drug Products with Therapeutic Equivalence
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`Evaluations database (“Orange Book”) with respect to JARDIANCE®.
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`
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`The ’323 patent covers the JARDIANCE® product and its use.
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`ACTS GIVING RISE TO THIS ACTION
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`COUNT I—INFRINGEMENT OF THE ’323 PATENT AS TO THE DRL ANDA
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`Plaintiffs reallege paragraphs 1-25 as if fully set forth herein.
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`On information and belief, DRL submitted the DRL ANDA to the FDA, pursuant
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`to 21 U.S.C. § 355(j), seeking approval to market the DRL ANDA Products.
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`6
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`Case 1:22-cv-01102-UNA Document 1 Filed 08/22/22 Page 7 of 10 PageID #: 7
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`DRL has represented that the DRL ANDA refers to and relies upon the
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`JARDIANCE® NDA and contains data that, according to DRL, demonstrate the bioavailability or
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`bioequivalence of the DRL ANDA Products to JARDIANCE®.
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`
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`Plaintiffs received a letter from DRL on or about July 21, 2022 stating that DRL
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`was amending its ANDA to include a certification in the DRL ANDA, pursuant to 21 U.S.C.
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`§ 355(j)(2)(A)(vii)(IV), that, inter alia, certain claims of the ’323 patent are either invalid or will
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`not be infringed by the commercial manufacture, use, or sale of the DRL ANDA Products (the
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`“DRL Paragraph IV Certification”). DRL intends to engage in the commercial manufacture, use,
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`offer for sale, and/or sale of the DRL ANDA Products prior to the expiration of the ’323 patent.
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`
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`DRL has infringed at least one claim of the ’323 patent, pursuant to 35 U.S.C.
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`§ 271(e)(2)(A), by submitting, or causing to be submitted the DRL ANDA, by which DRL seeks
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`approval from the FDA to engage in the manufacture, use, offer to sell, sale, or importation of the
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`DRL ANDA Products prior to the expiration of the ’323 patent.
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`
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`DRL has declared its intent to manufacture, use, offer to sell, or sell in the United
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`States or to import into the United States, the DRL ANDA Products in the event that the FDA
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`approves the DRL ANDA. Accordingly, an actual and immediate controversy exists regarding
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`DRL’s infringement of the ’323 patent under 35 U.S.C. §§ 271 (a), (b), and/or (c).
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`
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`DRL’s manufacture, use, offer to sell, or sale of the DRL ANDA Products in the
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`United States or importation of the DRL ANDA Products into the United States during the term
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`of the ’323 patent would further infringe at least one claim of the ’323 patent under 35 U.S.C.
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`§§ 271 (a), (b), and/or (c).
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`7
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`Case 1:22-cv-01102-UNA Document 1 Filed 08/22/22 Page 8 of 10 PageID #: 8
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`On information and belief, the DRL ANDA Products, when offered for sale, sold,
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`and/or imported, and when used as directed, would be used in a manner that would directly infringe
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`at least one of the claims of the ’323 patent either literally or under the doctrine of equivalents.
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`On information and belief, the use of the DRL ANDA Products constitutes a
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`material part of at least one of the claims of the ’323 patent; DRL knows that its ANDA Products
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`are especially made or adapted for use in infringing at least one of the claims of the ’323 patent,
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`either literally or under the doctrine of equivalents; and its ANDA Products are not staple articles
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`of commerce or commodities of commerce suitable for substantial noninfringing use.
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`On information and belief, the offering to sell, sale, and/or importation of the DRL
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`ANDA Products would contributorily infringe at least one of the claims of the ’323 patent, either
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`literally or under the doctrine of equivalents.
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`On information and belief, DRL had knowledge of the ’323 patent and, by its
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`promotional activities and package inserts for its ANDA Products, knows or should know that it
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`will aid and abet another’s direct infringement of at least one of the claims of the ’323 patent,
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`either literally or under the doctrine of equivalents.
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`On information and belief, the offering to sell, sale, and/or importation of the DRL
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`ANDA Products by DRL would actively induce infringement of at least one of the claims of the
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`’323 patent, either literally or under the doctrine of equivalents.
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`
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`On information and belief, DRL does not deny that the DRL ANDA Products will
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`infringe the claims of the ’323 patent. In the DRL Paragraph IV Certification, DRL did not deny
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`that the DRL ANDA Products will infringe the claims of the ’323 patent.
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`Plaintiffs will be substantially and irreparably harmed if DRL is not enjoined from
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`infringing the ’323 patent.
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`8
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`Case 1:22-cv-01102-UNA Document 1 Filed 08/22/22 Page 9 of 10 PageID #: 9
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`This is an exceptional case within the meaning of 35 U.S.C. § 285, which warrants
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`reimbursement of Boehringer’s reasonable attorney fees.
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`PRAYER FOR RELIEF
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`WHEREFORE, Plaintiffs respectfully request that the Court enter judgment against DRL
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`and for the following relief:
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`a.
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`b.
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`A Judgment be entered that DRL has infringed at least one claim of the ’323 patent
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`by submitting the DRL ANDA;
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`That DRL, its officers, agents, servants, employees, and those persons acting in
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`active concert or participation with all or any of them be preliminarily and
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`permanently enjoined from: (i) engaging in the commercial manufacture, use, offer
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`to sell, or sale within the United States, or importation into the United States, of
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`drugs or methods of administering drugs claimed in the ’323 patent, and
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`(ii) seeking, obtaining, or maintaining approval of the DRL ANDA until the
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`expiration of the ’323 patent or such other later time as the Court may determine;
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`c.
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`A judgment ordering that pursuant to 35 U.S.C. § 271(e)(4)(A), the effective date
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`of any approval of DRL’s ANDA under § 505(j) of the Federal Food, Drug and
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`Cosmetic Act (21 U.S.C. § 355(j)) shall not be earlier than the expiration date of
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`the ’323 patent, including any extensions;
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`d.
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`That Boehringer be awarded monetary relief if DRL commercially uses, offers to
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`sell, or sells its proposed generic versions of JARDIANCE® or any other product
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`that infringes or induces or contributes to the infringement of the ’323 patent, within
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`the United States, prior to the expiration of this patent, including any extensions,
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`and that any such monetary relief be awarded to Boehringer with prejudgment
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`interest;
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`9
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`Case 1:22-cv-01102-UNA Document 1 Filed 08/22/22 Page 10 of 10 PageID #: 10
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`e.
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`f.
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`g.
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`A Judgment be entered that this case is exceptional, and that Plaintiffs are entitled
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`to their reasonable attorneys’ fees pursuant to 35 U.S.C. § 285;
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`Costs and expenses in this action; and
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`Such other and further relief as the Court deems just and appropriate.
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`MORRIS, NICHOLS, ARSHT & TUNNELL LLP
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`/s/ Megan E. Dellinger
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`
`
`
`Jack B. Blumenfeld (#1014)
`Brian P. Egan (#6227)
`Megan E. Dellinger (#5739)
`1201 North Market Street
`P.O. Box 1347
`Wilmington, DE 19899
`(302) 658-9200
`jblumenfeld@morrisnichols.com
`began@morrisnichols.com
`mdellinger@morrisnichols.com
`
`Attorneys for Plaintiffs
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`OF COUNSEL:
`
`Jeanna M. Wacker
`Sam Kwon
`Ashley L.B. Ross
`KIRKLAND & ELLIS LLP
`601 Lexington Avenue
`New York, NY 10022
`(212) 446-4679
`
`James F. Hurst
`Bryan S. Hales
`KIRKLAND & ELLIS LLP
`300 North LaSalle
`Chicago, IL 60654
`(312) 862-2000
`
`August 22, 2022
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`10
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