`
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
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`
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`
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`C.A. No. ________________
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`)))))))))))))
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`BOEHRINGER INGELHEIM
`PHARMACEUTICALS INC., BOEHRINGER
`INGELHEIM INTERNATIONAL GMBH and
`BOEHRINGER INGELHEIM CORPORATION,
`
`
`Plaintiffs,
`
`
`v.
`
`
`LUPIN LTD. and
`LUPIN PHARMACEUTICALS, 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, Lupin Ltd. and Lupin Pharmaceuticals, Inc., hereby allege
`
`as follows:
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`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
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`Food and Drug Administration (“FDA”) seeking approval to manufacture and sell generic
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`versions of Plaintiffs’ TRIJARDY® XR
`
`(empagliflozin,
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`linagliptin, and metformin
`
`hydrochloride extended release) tablets prior to the expiration of United States Patent Nos.
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`8,551,957, 9,155,705, 9,415,016, 9,949,998, 10,022,379, 10,258,637, and 10,406,172.
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`
`
`
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`Case 1:21-cv-00530-UNA Document 1 Filed 04/13/21 Page 2 of 25 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
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`business 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.
`
`
`
`Plaintiff Boehringer Ingelheim Corporation (“BIC”) is a corporation organized
`
`and existing under the laws of Nevada, having a principal place of business at 900 Ridgebury
`
`Road, Ridgefield, CT 06877.
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`
`
`BIPI, BII, and BIC are collectively referred to hereinafter as “Boehringer” or
`
`“Plaintiffs.”
`
`
`
`On information and belief, Defendant Lupin Ltd. is a corporation organized and
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`existing under the laws of India, having a principal place of business at Laxmi Towers, Bandra
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`Kurla Complex, Bandra (East), Mumbai, India 400051.
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`
`
`On information and belief, Lupin Ltd. controls and directs a wholly owned
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`subsidiary in the United States named Lupin Pharmaceuticals, Inc. (“Lupin Pharma”). Lupin
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`Pharma is a Delaware corporation having a principal place of business at 111 South Calvert
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`Street, Baltimore, Maryland 21202.
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`
`
`
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`Lupin Ltd. and Lupin Pharma are collectively referred to hereinafter as “Lupin.”
`
`On information and belief, Lupin 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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`including within the state of Delaware, through its own actions and through the actions of its
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`2
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`Case 1:21-cv-00530-UNA Document 1 Filed 04/13/21 Page 3 of 25 PageID #: 3
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`
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`agents and subsidiaries, including Lupin Pharma, from which Lupin Ltd. derives a substantial
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`portion of its revenue.
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`
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`On information and belief, Lupin Ltd. acted in concert with Lupin Pharma to
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`prepare and submit ANDA No. 215072 (the “Lupin ANDA”) for Lupin’s 5 mg/2.5 mg/1000 mg;
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`10 mg/5 mg/1000 mg; 12.5 mg/2.5 mg/1000 mg; 25 mg/5 mg/1000 mg
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`empagliflozin/linagliptin/metformin extended-release tablets (the “Lupin ANDA Product”),
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`which was done at the direction of, under the control of, and for the direct benefit of Lupin Ltd.
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`Following FDA approval of the Lupin ANDA, Lupin Ltd. will manufacture and supply the
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`approved generic product to Lupin Pharma, which will then market and sell the product
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`throughout the United States at the direction, under the control, and for the direct benefit of
`
`Lupin Ltd.
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`JURISDICTION AND VENUE
`
`
`
`This action arises under the patent laws of the United States, 35 U.S.C. §§ 100 et
`
`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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`
`
`Venue is proper in this Court because, among other things, Lupin Pharma is
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`incorporated in the State of Delaware and therefore “resides” in this judicial district and/or has
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`committed acts of infringement in this district and has a regular and established place of business
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`in this district. 28 U.S.C. § 1400(b). Lupin Ltd. is a foreign corporation not residing in any
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`United States district and may be sued in any judicial district. 28 U.S.C. § 1391(c). Moreover,
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`Lupin has litigated previous Hatch-Waxman patent infringement disputes in the District of
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`Delaware.
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`
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`3
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`Case 1:21-cv-00530-UNA Document 1 Filed 04/13/21 Page 4 of 25 PageID #: 4
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`
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`PERSONAL JURISDICTION OVER LUPIN LTD.
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`Plaintiffs reallege paragraphs 1-12 as if fully set forth herein.
`
`On information and belief, Lupin 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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`
`
`This Court has personal jurisdiction over Lupin Ltd. because, inter alia, Lupin
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`Ltd., on information and belief: (1) has substantial, continuous, and systematic contacts with this
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`State, either directly or through at least one of its wholly-owned subsidiaries or agents;
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`(2) intends to market, sell, and/or distribute Lupin Ltd. infringing ANDA Products to residents of
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`this State upon approval of ANDA No. 215072, either directly or through at least one of its
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`wholly-owned subsidiaries or agents; (3) enjoys substantial income from sales of its generic
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`pharmaceutical products in this State on its own and through Lupin Pharma, which is a Delaware
`
`corporation; and (4) wholly owns Lupin Pharma, which is a Delaware corporation and is
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`registered as a pharmacy wholesaler and controlled substances distributor/manufacturer with the
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`Delaware Division of Professional Regulation.
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`
`
`On information and belief, Lupin Ltd. has not contested jurisdiction in Delaware
`
`in 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 Pharm. Inc. v. Lupin Ltd., C.A. No. 18-1690-CFC
`
`(D. Del.); Bial-Portela v. Lupin Ltd., C.A. No. 18-312-CFC (D. Del.); Boehringer Ingelheim
`
`Pharmaceuticals Inc. et al v. Lupin Limited et al, C.A. No. 19-01866-CFC (D. Del.).
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`
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`Alternatively, to the extent the above facts do not establish personal jurisdiction
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`over Lupin Ltd., this Court may exercise jurisdiction over Lupin Ltd. pursuant to Fed. R. Civ. P.
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`4(k)(2) because: (a) Plaintiffs’ claims arise under federal law; (b) Lupin Ltd. would be a foreign
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`defendant not subject to personal jurisdiction in the courts of any State; and (c) Lupin 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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`4
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`Case 1:21-cv-00530-UNA Document 1 Filed 04/13/21 Page 5 of 25 PageID #: 5
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`
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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 Lupin Ltd.
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`satisfies due process.
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`PERSONAL JURISDICTION OVER LUPIN PHARMA
`
`Plaintiffs reallege paragraphs 1-17 as if fully set forth herein.
`
`On information and belief, Lupin Pharma develops, manufactures, and/or
`
`
`
`
`
`distributes generic drugs for sale and use throughout the United States, including in this judicial
`
`district.
`
`
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`This Court has personal jurisdiction over Lupin Pharma because, inter alia, Lupin
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`Pharma, on information and belief: (1) is incorporated under the laws of the State of Delaware;
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`(2) is registered as a pharmacy wholesaler and controlled substances distributor/manufacturer
`
`with the Delaware Division of Professional Regulation; (3) intends to market, sell, or distribute
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`Lupin’s ANDA Products to residents of this State; (4) makes its generic drug products available
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`in this State; and (5) enjoys substantial income from sales of its generic pharmaceutical products
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`in this State.
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`
`
`On information and belief, Lupin Pharma has not contested jurisdiction in
`
`Delaware in one or more prior cases arising out of the filing of its ANDAs, and it has filed
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`counterclaims in such cases. See, e.g., Boehringer Ingelheim Pharm. Inc. v. Lupin Ltd., C.A. No.
`
`18-1690-CFC (D. Del.); Alcon Research, Ltd. v. Lupin Ltd., C.A. No. 16-195-GMS-SRF
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`(D. Del.); Boehringer Ingelheim Pharmaceuticals Inc. et al v. Lupin Limited et al, C.A. No. 19-
`
`01866-CFC (D. Del.).
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`
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`5
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`Case 1:21-cv-00530-UNA Document 1 Filed 04/13/21 Page 6 of 25 PageID #: 6
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`
`
`BACKGROUND
`
`U.S. PATENT NO. 8,551,957
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`
`
`On October 8, 2013, the USPTO duly and legally issued United States Patent No.
`
`8,551,957
`
`(the “’957 Patent”) entitled “Pharmaceutical Composition Comprising a
`
`Glucopyranosyl-Substituted Benzene Derivate” to inventors Klaus Dugi, Michael Mark, Leo
`
`Thomas and Frank Himmelsbach. A true and correct copy of the ’957 Patent is attached as
`
`Exhibit 1. The ’957 Patent is assigned to BII. BIC and BIPI are licensees of the ’957 Patent.
`
`U.S. PATENT NO. 9,155,705
`
`
`
`On October 13, 2015, the USPTO duly and legally issued United States Patent
`
`No. 9,155,705 (the “’705 Patent”) entitled “DPP-IV Inhibitor Combined with a Further
`
`Antidiabetic Agent, Tablets Comprising Such Formulations, Their Use and Process for Their
`
`Preparation” to inventors Thomas Friedl, Michael Braun, Kenji Egusa, Hikaru Fujita, Megumi
`
`Maruyama, and Takaaki Nishioka. A true and correct copy of the ’705 Patent is attached as
`
`Exhibit 2. The ’705 Patent is assigned to BII. BIC and BIPI are licensees of the ’705 Patent.
`
`U.S. PATENT NO. 9,415,016
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`
`
`On August 16, 2016, the PTO duly and legally issued United States Patent No.
`
`9,415,016 (the “’016 Patent”) entitled “DPP-IV inhibitor combined with a further antidiabetic
`
`agent, tablets comprising such formulations, their use and process for their preparation” to
`
`inventors Thomas Friedl, Michael Braun, Kenji Egusa, Hikaru Fujita, Megumi Maruyama, and
`
`Takaaki Nishioka. A true and correct copy of the ’016 Patent is attached as Exhibit 3. The ’016
`
`Patent is assigned to BII. BIC and BIPI are licensees of the ’016 Patent.
`
`U.S. PATENT NO. 9,949,998
`
`
`
`On April 24, 2018, the USPTO duly and legally issued United States Patent No.
`
`9,949,998 (the “’998 Patent”) entitled “Pharmaceutical Composition, Methods for Treating and
`
`6
`
`
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`Case 1:21-cv-00530-UNA Document 1 Filed 04/13/21 Page 7 of 25 PageID #: 7
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`
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`Uses Thereof” to inventors Uli Christian Broedl, Sreeraj Macha, Maximilian von Eynatten, and
`
`Hans-Juergen Woerle. A true and correct copy of the ’998 Patent is attached as Exhibit 4. The
`
`’998 Patent is assigned to BII. BIC and BIPI are licensees of the ’998 Patent.
`
`U.S. PATENT NO. 10,022,379
`
`
`
`On July 17, 2018, the PTO duly and legally issued United States Patent No.
`
`10,022,379 (the “’379 Patent”) entitled “DPP-IV inhibitor combined with a further antidiabetic
`
`agent, tablets comprising such formulations, their use and process for their preparation” to
`
`inventors Thomas Friedl, Michael Braun, Kenji Egusa, Hikaru Fujita, Megumi Maruyama, and
`
`Takaaki Nishioka. A true and correct copy of the ’379 Patent is attached as Exhibit 5. The ’379
`
`Patent is assigned to BII. BIC and BIPI are licensees of the ’379 Patent.
`
`U.S. PATENT NO. 10,258,637
`
`
`
`On April 16, 2019, the USPTO duly and legally issued United States Patent No.
`
`10,258,637 (the “’637 Patent”) entitled “Pharmaceutical Composition, Method for Treating and
`
`Uses Thereof” to inventors Uli Christian Broedl, Sreeraj Macha, Maximilian von Eynatten, and
`
`Hans-Juergen Woerle. A true and correct copy of the ’637 Patent is attached as Exhibit 6. The
`
`’637 Patent is assigned to BII. BIC and BIPI are licensees of the ’637 Patent.
`
`U.S. PATENT NO. 10,406,172
`
`
`
`On September 10, 2019, the USPTO duly and legally issued United States Patent
`
`No. 10,406,172 (the “’172 Patent”) entitled “Pharmaceutical Composition, Method for Treating
`
`and Uses Thereof” to inventors Peter Eickelmann, Michael Mark, Leo John Seman, Leo Thomas,
`
`Uli Broedl, and Rolf Grempler. A true and correct copy of the ’172 Patent is attached as
`
`Exhibit 7. The ’172 Patent is assigned to BII. BIC and BIPI are licensees of the ’172 Patent.
`
`
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`7
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`
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`Case 1:21-cv-00530-UNA Document 1 Filed 04/13/21 Page 8 of 25 PageID #: 8
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`
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`TRIJARDY® XR
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`
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`BIPI is the holder of New Drug Application (“NDA”) No. 212614 for
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`empagliflozin-linagliptin-metformin hydrochloride extended-release tablets, for oral use, in
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`5 mg/2.5 mg/1000 mg, 10 mg/5 mg/1000 mg, 12.5 mg/2.5 mg/1000 mg, and 25 mg/5 mg/1000
`
`mg dosages, which is sold under the trade name TRIJARDY® XR.
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`
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`TRIJARDY® XR is listed in the FDA’s Approved Drug Products with
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`Therapeutic Equivalence Evaluations database (“Orange Book”).
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`
`
`Pursuant to 21 U.S.C. § 355(b)(1), and attendant FDA regulations, the ’957, ’705,
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`’016, ’998, ’379, ’637, and ’172 Patents are listed in the Orange Book with respect to
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`TRIJARDY® XR.
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`
`
`The ’957, ’705, ’016, ’998, ’379, ’637, and ’172 Patents cover the pharmaceutical
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`composition and use of TRIJARDY® XR.
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`ACTS GIVING RISE TO THIS ACTION
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`COUNT I — INFRINGEMENT OF THE ’957 PATENT
`
`Plaintiffs reallege paragraphs 1-32 as if fully set forth herein.
`
`On information and belief, Lupin submitted the Lupin ANDA to the FDA,
`
`
`
`
`
`pursuant to 21 U.S.C. § 355(j), seeking approval to market the Lupin ANDA Product.
`
`
`
`Lupin has represented that the Lupin ANDA refers to and relies upon the
`
`TRIJARDY® XR NDA and contains data that, according to Lupin, demonstrate the
`
`bioavailability or bioequivalence of the Lupin ANDA Products to TRIJARDY® XR.
`
`
`
`Plaintiffs received letters from Lupin on or about March 4, 2021 stating that
`
`Lupin had
`
`included certifications
`
`in
`
`the Lupin ANDA, pursuant
`
`to 21 U.S.C.
`
`§ 355(j)(2)(A)(vii)(IV), that, inter alia, certain claims of the ’957 Patent are either invalid or will
`
`not be infringed by the commercial manufacture, use, or sale of the Lupin ANDA Products (the
`
`8
`
`
`
`Case 1:21-cv-00530-UNA Document 1 Filed 04/13/21 Page 9 of 25 PageID #: 9
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`
`
`“Lupin Paragraph IV Certifications”). Lupin intends to engage in the commercial manufacture,
`
`use, offer for sale, and/or sale of the Lupin ANDA Products prior to the expiration of the ’957
`
`Patent.
`
`
`
`Lupin has infringed at least one claim of the ’957 Patent, pursuant to 35 U.S.C.
`
`§ 271(e)(2)(A), by submitting, or causing to be submitted the Lupin ANDA, by which Lupin
`
`seeks approval from the FDA to engage in the manufacture, use, offer to sell, sale, or importation
`
`of the Lupin ANDA Products prior to the expiration of the ’957 Patent.
`
`
`
`Lupin has declared its intent to manufacture, use, offer to sell, or sell in the United
`
`States or to import into the United States, the Lupin ANDA Products in the event that the FDA
`
`approves the Lupin ANDA. Accordingly, an actual and immediate controversy exists regarding
`
`Lupin’s infringement of the ’957 Patent under 35 U.S.C. §§ 271 (a), (b), and/or (c).
`
`
`
`Lupin’s use, offer to sell, or sale of the Lupin ANDA Products in the United
`
`States during the term of the ’957 Patent would further infringe at least one claim of the ’957
`
`Patent under 35 U.S.C. §§ 271 (a), (b), and/or (c).
`
`
`
`On information and belief, the Lupin ANDA Product, when offered for sale, sold,
`
`and/or when used as directed, would be used in a manner that would directly infringe at least one
`
`of the claims of the ’957 Patent either literally or under the doctrine of equivalents.
`
`
`
`On information and belief, the use of the Lupin ANDA Product constitutes a
`
`material part of at least one of the claims of the ’957 Patent; Lupin knows that its ANDA Product
`
`is especially made or adapted for use in infringing at least one of the claims of the ’957 Patent,
`
`either literally or under the doctrine of equivalents; and its ANDA Product is not a staple article
`
`of commerce or commodity of commerce suitable for substantial noninfringing use.
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`9
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`Case 1:21-cv-00530-UNA Document 1 Filed 04/13/21 Page 10 of 25 PageID #: 10
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`
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`On information and belief, the offering to sell or sale of the Lupin ANDA Product
`
`would contributorily infringe at least one of the claims of the ’957 Patent, either literally or under
`
`the doctrine of equivalents.
`
`
`
`On information and belief, Lupin had knowledge of the ’957 Patent and, by its
`
`promotional activities and package inserts for its ANDA Products, knows or should know that it
`
`will aid and abet another’s direct infringement of at least one of the claims of the ’957 Patent,
`
`either literally or under the doctrine of equivalents.
`
`
`
`On information and belief, the offering to sell or sale of the Lupin ANDA Product
`
`by Lupin would actively induce infringement of at least one of the claims of the ’957 Patent,
`
`either literally or under the doctrine of equivalents.
`
`
`
`On information and belief, Lupin does not deny that the Lupin ANDA Product
`
`will infringe the claims of the ’957 Patent and in the Lupin Paragraph IV Certification, Lupin did
`
`not deny that the Lupin ANDA Product subject to ANDA No. 215072 will infringe the claims of
`
`the ’957 Patent.
`
`
`
`Plaintiffs will be substantially and irreparably harmed if Lupin is not enjoined
`
`from infringing the ’957 Patent.
`
`
`
`This is an exceptional case within the meaning of 35 U.S.C. § 285, which
`
`warrants reimbursement of Boehringer’s reasonable attorney fees.
`
`COUNT II — INFRINGEMENT OF THE ’705 PATENT
`
`Plaintiffs reallege paragraphs 1-47 as if fully set forth herein.
`
`On information and belief, Lupin submitted the Lupin ANDA to the FDA,
`
`
`
`
`
`pursuant to 21 U.S.C. § 355(j), seeking approval to market the Lupin ANDA Product.
`
`10
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`
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`Case 1:21-cv-00530-UNA Document 1 Filed 04/13/21 Page 11 of 25 PageID #: 11
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`
`
`
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`Lupin has represented that the Lupin ANDA refers to and relies upon the
`
`TRIJARDY® XR NDA and contains data that, according to Lupin, demonstrate the
`
`bioavailability or bioequivalence of the Lupin ANDA Products to TRIJARDY® XR.
`
`
`
`Plaintiffs received letters from Lupin on or about March 4, 2021 stating that
`
`Lupin had
`
`included certifications
`
`in
`
`the Lupin ANDA, pursuant
`
`to 21 U.S.C.
`
`§ 355(j)(2)(A)(vii)(IV), that, inter alia, certain claims of the ’705 Patent are either invalid or will
`
`not be infringed by the commercial manufacture, use, or sale of the Lupin ANDA Products (the
`
`“Lupin Paragraph IV Certifications”). Lupin intends to engage in the commercial manufacture,
`
`use, offer for sale, and/or sale of the Lupin ANDA Products prior to the expiration of the ’705
`
`Patent.
`
`
`
`Lupin has infringed at least one claim of the ’705 Patent, pursuant to 35 U.S.C.
`
`§ 271(e)(2)(A), by submitting, or causing to be submitted the Lupin ANDA, by which Lupin
`
`seeks approval from the FDA to engage in the manufacture, use, offer to sell, sale, or importation
`
`of the Lupin ANDA Products prior to the expiration of the ’705 Patent.
`
`
`
`Lupin has declared its intent to manufacture, use, offer to sell, or sell in the United
`
`States or to import into the United States, the Lupin ANDA Product in the event that the FDA
`
`approves the Lupin ANDA. Accordingly, an actual and immediate controversy exists regarding
`
`Lupin’s infringement of the ’705 Patent under 35 U.S.C. §§ 271 (a), (b), and/or (c).
`
`
`
`Lupin’s use, offer to sell, or sale of the Lupin ANDA Products in the United
`
`States during the term of the ’705 Patent would further infringe at least one claim of the ’705
`
`Patent under 35 U.S.C. §§ 271 (a), (b), and/or (c).
`
`11
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`
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`Case 1:21-cv-00530-UNA Document 1 Filed 04/13/21 Page 12 of 25 PageID #: 12
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`
`
`
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`On information and belief, the Lupin ANDA Product, when offered for sale, sold,
`
`and/or when used as directed, would be used in a manner that would directly infringe at least one
`
`of the claims of the ’705 Patent either literally or under the doctrine of equivalents.
`
`
`
`On information and belief, the use of the Lupin ANDA Product constitutes a
`
`material part of at least one of the claims of the ’705 Patent; Lupin knows that its ANDA Product
`
`is especially made or adapted for use in infringing at least one of the claims of the ’705 Patent,
`
`either literally or under the doctrine of equivalents; and its ANDA Product is not a staple article
`
`of commerce or commodity of commerce suitable for substantial noninfringing use.
`
`
`
`On information and belief, the offering to sell or sale of the Lupin ANDA Product
`
`would contributorily infringe at least one of the claims of the ’705 Patent, either literally or under
`
`the doctrine of equivalents.
`
`
`
`On information and belief, Lupin had knowledge of the ’705 Patent and, by its
`
`promotional activities and package inserts for its ANDA Products, knows or should know that it
`
`will aid and abet another’s direct infringement of at least one of the claims of the ’705 Patent,
`
`either literally or under the doctrine of equivalents.
`
`
`
`On information and belief, the offering to sell or sale of the Lupin ANDA Product
`
`by Lupin would actively induce infringement of at least one of the claims of the ’705 Patent,
`
`either literally or under the doctrine of equivalents.
`
`
`
`Plaintiffs will be substantially and irreparably harmed if Lupin is not enjoined
`
`from infringing the ’705 Patent.
`
`
`
`This is an exceptional case within the meaning of 35 U.S.C. § 285, which
`
`warrants reimbursement of Boehringer’s reasonable attorney fees.
`
`
`
`
`
`12
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`Case 1:21-cv-00530-UNA Document 1 Filed 04/13/21 Page 13 of 25 PageID #: 13
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`
`
`COUNT III — INFRINGEMENT OF THE ’016 PATENT
`
`Plaintiffs reallege paragraphs 1-61 as if fully set forth herein.
`
`On information and belief, Lupin submitted the Lupin ANDA to the FDA,
`
`
`
`
`
`pursuant to 21 U.S.C. § 355(j), seeking approval to market the Lupin ANDA Product.
`
`
`
`Lupin has represented that the Lupin ANDA refers to and relies upon the
`
`TRIJARDY® XR NDA and contains data that, according to Lupin, demonstrate the
`
`bioavailability or bioequivalence of the Lupin ANDA Products to TRIJARDY® XR.
`
`
`
`Plaintiffs received letters from Lupin on or about March 4, 2021 stating that
`
`Lupin had
`
`included certifications
`
`in
`
`the Lupin ANDA, pursuant
`
`to 21 U.S.C.
`
`§ 355(j)(2)(A)(vii)(IV), that, inter alia, certain claims of the ’016 Patent are either invalid or will
`
`not be infringed by the commercial manufacture, use, or sale of the Lupin ANDA Products (the
`
`“Lupin Paragraph IV Certifications”). Lupin intends to engage in the commercial manufacture,
`
`use, offer for sale, and/or sale of the Lupin ANDA Products prior to the expiration of the ’016
`
`Patent.
`
`
`
`Lupin has infringed at least one claim of the ’016 Patent, pursuant to 35 U.S.C.
`
`§ 271(e)(2)(A), by submitting, or causing to be submitted the Lupin ANDA, by which Lupin
`
`seeks approval from the FDA to engage in the manufacture, use, offer to sell, sale, or importation
`
`of the Lupin ANDA Products prior to the expiration of the ’016 Patent.
`
`
`
`Lupin has declared its intent to manufacture, use, offer to sell, or sell in the United
`
`States or to import into the United States, the Lupin ANDA Product in the event that the FDA
`
`approves the Lupin ANDA. Accordingly, an actual and immediate controversy exists regarding
`
`Lupin’s infringement of the ’016 Patent under 35 U.S.C. §§ 271 (a), (b), and/or (c).
`
`13
`
`
`
`Case 1:21-cv-00530-UNA Document 1 Filed 04/13/21 Page 14 of 25 PageID #: 14
`
`
`
`
`
`Lupin’s use, offer to sell, or sale of the Lupin ANDA Products in the United
`
`States during the term of the ’016 Patent would further infringe at least one claim of the ’016
`
`Patent under 35 U.S.C. §§ 271 (a), (b), and/or (c).
`
`
`
`On information and belief, the Lupin ANDA Product, when offered for sale, sold,
`
`and/or when used as directed, would be used in a manner that would directly infringe at least one
`
`of the claims of the ’016 Patent either literally or under the doctrine of equivalents.
`
`
`
`On information and belief, the use of the Lupin ANDA Product constitutes a
`
`material part of at least one of the claims of the ’016 Patent; Lupin knows that its ANDA Product
`
`is especially made or adapted for use in infringing at least one of the claims of the ’016 Patent,
`
`either literally or under the doctrine of equivalents; and its ANDA Product is not a staple article
`
`of commerce or commodity of commerce suitable for substantial noninfringing use.
`
`
`
`On information and belief, the offering to sell or sale of the Lupin ANDA Product
`
`would contributorily infringe at least one of the claims of the ’016 Patent, either literally or under
`
`the doctrine of equivalents.
`
`
`
`On information and belief, Lupin had knowledge of the ’016 Patent and, by its
`
`promotional activities and package inserts for its ANDA Products, knows or should know that it
`
`will aid and abet another’s direct infringement of at least one of the claims of the ’016 Patent,
`
`either literally or under the doctrine of equivalents.
`
`
`
`On information and belief, the offering to sell or sale of the Lupin ANDA Product
`
`by Lupin would actively induce infringement of at least one of the claims of the ’016 Patent,
`
`either literally or under the doctrine of equivalents.
`
`
`
`Plaintiffs will be substantially and irreparably harmed if Lupin is not enjoined
`
`from infringing the ’016 Patent.
`
`14
`
`
`
`Case 1:21-cv-00530-UNA Document 1 Filed 04/13/21 Page 15 of 25 PageID #: 15
`
`
`
`
`
`This is an exceptional case within the meaning of 35 U.S.C. § 285, which
`
`warrants reimbursement of Boehringer’s reasonable attorney fees.
`
`COUNT IV — INFRINGEMENT OF THE ’998 PATENT
`
`Plaintiffs reallege paragraphs 1-75 as if fully set forth herein.
`
`On information and belief, Lupin submitted the Lupin ANDA to the FDA,
`
`
`
`
`
`pursuant to 21 U.S.C. § 355(j), seeking approval to market the Lupin ANDA Product.
`
`
`
`Lupin has represented that the Lupin ANDA refers to and relies upon the
`
`TRIJARDY® XR NDA and contains data that, according to Lupin, demonstrate the
`
`bioavailability or bioequivalence of the Lupin ANDA Products to TRIJARDY® XR.
`
`
`
`Plaintiffs received letters from Lupin on or about March 4, 2021 stating that
`
`Lupin had
`
`included certifications
`
`in
`
`the Lupin ANDA, pursuant
`
`to 21 U.S.C.
`
`§ 355(j)(2)(A)(vii)(IV), that, inter alia, certain claims of the ’998 Patent are either invalid or will
`
`not be infringed by the commercial manufacture, use, or sale of the Lupin ANDA Products (the
`
`“Lupin Paragraph IV Certifications”). Lupin intends to engage in the commercial manufacture,
`
`use, offer for sale, and/or sale of the Lupin ANDA Products prior to the expiration of the ’998
`
`Patent.
`
`
`
`Lupin has infringed at least one claim of the ’998 Patent, pursuant to 35 U.S.C.
`
`§ 271(e)(2)(A), by submitting, or causing to be submitted the Lupin ANDA, by which Lupin
`
`seeks approval from the FDA to engage in the manufacture, use, offer to sell, sale, or importation
`
`of the Lupin ANDA Products prior to the expiration of the ’998 Patent.
`
`
`
`Lupin has declared its intent to manufacture, use, offer to sell, or sell in the United
`
`States or to import into the United States, the Lupin ANDA Product in the event that the FDA
`
`approves the Lupin ANDA. Accordingly, an actual and immediate controversy exists regarding
`
`Lupin’s infringement of the ’998 Patent under 35 U.S.C. §§ 271 (a), (b), and/or (c).
`
`15
`
`
`
`Case 1:21-cv-00530-UNA Document 1 Filed 04/13/21 Page 16 of 25 PageID #: 16
`
`
`
`
`
`Lupin’s use, offer to sell, or sale of the Lupin ANDA Products in the United
`
`States during the term of the ’998 Patent would further infringe at least one claim of the ’998
`
`Patent under 35 U.S.C. §§ 271 (a), (b), and/or (c).
`
`
`
`On information and belief, the Lupin ANDA Product, when offered for sale, sold,
`
`and/or when used as directed, would be used in a manner that would directly infringe at least one
`
`of the claims of the ’998 Patent either literally or under the doctrine of equivalents.
`
`
`
`On information and belief, the use of the Lupin ANDA Product constitutes a
`
`material part of at least one of the claims of the ’998 Patent; Lupin knows that its ANDA Product
`
`is especially made or adapted for use in infringing at least one of the claims of the ’998 Patent,
`
`either literally or under the doctrine of equivalents; and its ANDA Product is not a staple article
`
`of commerce or commodity of commerce suitable for substantial noninfringing use.
`
`
`
`On information and belief, the offering to sell or sale of the Lupin ANDA Product
`
`would contributorily infringe at least one of the claims of the ’998 Patent, either literally or under
`
`the doctrine of equivalents.
`
`
`
`On information and belief, Lupin had knowledge of the ’998 Patent and, by its
`
`promotional activities and package inserts for its ANDA Products, knows or should know that it
`
`will aid and abet another’s direct infringement of at least one of the claims of the ’998 Patent,
`
`either literally or under the doctrine of equivalents.
`
`
`
`On information and belief, the offering to sell or sale of the Lupin ANDA Product
`
`by Lupin would actively induce infringement of at least one of the claims of the ’998 Patent,
`
`either literally or under the doctrine of equivalents.
`
`
`
`On information and belief, Lupin does not deny that the Lupin ANDA Product
`
`will infringe the claims of the ’998 Patent and in the Lupin Paragraph IV Certification, Lupin did
`
`16
`
`
`
`Case 1:21-cv-00530-UNA Document 1 Filed 04/13/21 Page 17 of 25 PageID #: 17
`
`
`
`not deny that the Lupin ANDA Product subject to ANDA No. 215072 will infringe the claims of
`
`the ’998 Patent.
`
`
`
`Plaintiffs will be substantially and irreparably harmed if Lupin is not enjoined
`
`from infringing the ’998 Patent.
`
`
`
`This is an exceptional case within the meaning of 35 U.S.C. § 285, which
`
`warrants reimbursement of Boehringer’s reasonable attorney fees.
`
`COUNT V — INFRINGEMENT OF THE ’379 PATENT
`
`Plaintiffs reallege paragraphs 1-90 as if fully set forth herein.
`
`On information and belief, Lupin submitted the Lupin ANDA to the FDA,
`
`
`
`
`
`pursuant to 21 U.S.C. § 355(j), seeking approval to market the Lupin ANDA Product.
`
`
`
`Lupin has represented that the Lupin ANDA refers to and relies upon the
`
`TRIJARDY® XR NDA and contains data that, according to Lupin, demonstrate the
`
`bioavailability or bioequivalence of the Lupin ANDA Products to TRIJARDY® XR.
`
`
`
`Plaintiffs received letters from Lupin on or about March 4, 2021 stating that
`
`Lupin had
`
`included certifications
`
`in
`
`the Lupin ANDA, pursuant
`
`to 21 U.S.C.
`
`§ 355(j)(2)(A)(vii)(IV), that, inter alia, certain claims of the ’379 Patent are either invalid or will
`
`not be infringed by the commercial manufacture, use, or sale of the Lupin ANDA Products (the
`
`“Lupin Paragraph IV Certifications”). Lupin intends to engage in the commercial manufacture,
`
`use, offer for sale, and/or sale of the Lupin ANDA Products prior to the expiration of the ’379
`
`Patent.
`
`
`
`Lupin has infringed at least one claim of the ’379 Patent, pursuant to 35 U.S.C.
`
`§ 271(e)(2)(A), by submitting, or causing to be submitted the Lupin ANDA, by which Lupin
`
`seeks approval from the FDA to engage in the manufacture, use, offer to sell, sale, or importation
`
`of the Lupin ANDA Products prior to the expiration of the ’379 Patent.
`
`17
`
`
`
`Case 1:21-cv-00530-UNA Document 1 Filed 04/13/21 Page 18 of 25 PageID #: 18
`
`
`
`
`
`Lupin has declared its intent to manufacture, use, offer to sell, or sell in the United
`
`States or to import into the United States, the Lupin ANDA Product in the event that the FDA
`
`approves the Lupin ANDA. Accordingly, an actual and immediate controversy exists regarding
`
`Lupin’s infringement of the ’379 Patent under 35 U.S.C. §§ 271 (a), (b), and/or (c).
`
`
`
`Lupin’s use, offer to sell, or sale of the Lupin ANDA Products in the United
`
`States during the term of the ’379 Patent would further infringe at least one claim of the ’379
`
`Patent under 35 U.S.C. §§ 271 (a), (b), and/or (c).
`
`
`
`On information and belief, the Lupin ANDA Product, when offered for sale, s