Case 1:22-cv-00220-UNA Document 1 Filed 02/18/22 Page 1 of 9 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,
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`Plaintiffs,
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`v.
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`LAURUS LABS LTD. and
`LAURUS GENERICS INC.,
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`Defendants.
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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 Laurus Labs Ltd. and Laurus Generics Inc., hereby allege as follows:
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`NATURE OF THE ACTION
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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
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`Patent No. 11,090,323.
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`THE PARTIES
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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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`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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`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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`BIPI, BII, and BIC are collectively referred to hereinafter as “Boehringer” or
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`“Plaintiffs.”
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`On information and belief, Defendant Laurus Labs Ltd. (“Laurus Labs”) is a
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`corporation organized and existing under the laws of India, having a principal place of business at
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`Serene Chambers, Road No. 7, Banjara Hills, Hyderabad-500 034, Telangana, India.
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`On information and belief, Laurus Labs controls and directs a wholly owned
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`subsidiary in the United States named Laurus Generics Inc. (“Laurus Generics”). Laurus Generics
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`is a Delaware corporation having a principal place of business at 400 Connell Dr., Berkeley
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`Heights, New Jersey 07922.
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`Laurus Labs and Laurus Generics are collectively referred to hereinafter as
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`“Laurus.”
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`On information and belief, Laurus Labs 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 agents
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`and subsidiaries, including Laurus Generics, from which Laurus Labs derives a substantial portion
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`of its revenue.
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`On information and belief, Laurus Labs acted in concert with Laurus Generics to
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`prepare and submit ANDA No. 212421 (the “Laurus ANDA”) for Laurus Labs’ 10 mg and 25 mg
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`empagliflozin tablets (the “Laurus ANDA Products”), which was done at the direction of, under
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`the control of, and for the direct benefit of Laurus Labs. Following FDA approval of the Laurus
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`ANDA, Laurus Labs will manufacture and supply the approved generic products to Laurus
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`Generics, which will then market and sell the products throughout the United States at the
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`direction, under the control, and for the direct benefit of Laurus Labs.
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`JURISDICTION AND VENUE
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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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`Venue is proper in this Court because, among other things, Laurus Generics 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). Laurus Labs is a foreign corporation not residing in any United
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`States district and may be sued in any judicial district. 28 U.S.C. § 1391(c).
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`PERSONAL JURISDICTION OVER LAURUS LABS
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`Plaintiffs reallege paragraphs 1-12 as if fully set forth herein.
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`On information and belief, Laurus Labs 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 Laurus Labs because, inter alia, Laurus
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`Labs, 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; (2) intends
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`to market, sell, and/or distribute Laurus Labs’ infringing ANDA Products to residents of this State
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`upon approval of ANDA No. 212421, either directly or through at least one of its wholly-owned
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`subsidiaries or agents; (3) enjoys substantial income from sales of its generic pharmaceutical
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`products in this State on its own and through Laurus Generics, which is a Delaware corporation;
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`and (4) wholly owns Laurus Generics, which is a Delaware company.
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`Alternatively, to the extent the above facts do not establish personal jurisdiction
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`over Laurus Labs, this Court may exercise jurisdiction over Laurus Labs pursuant to Fed. R. Civ.
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`P. 4(k)(2) because: (a) Plaintiffs’ claims arise under federal law; (b) Laurus Labs would be a
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`foreign defendant not subject to personal jurisdiction in the courts of any State; and (c) Laurus
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`Labs has sufficient contacts with the United States as a whole, including, but not limited to, filing
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`an ANDA with the FDA and manufacturing and selling generic pharmaceutical products that are
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`distributed throughout the United States, such that this Court’s exercise of jurisdiction over Laurus
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`Labs satisfies due process.
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`PERSONAL JURISDICTION OVER LAURUS GENERICS
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`Plaintiffs reallege paragraphs 1-16 as if fully set forth herein.
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`On information and belief, Laurus Generics develops, manufactures, and/or
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`distributes generic drugs for sale and use throughout the United States, including in this judicial
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`district.
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`This Court has personal jurisdiction over Laurus Generics because, inter alia,
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`Laurus Generics, on information and belief: (1) is organized under the laws of the State of
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`Delaware; (2) intends to market, sell, or distribute Laurus’s ANDA Products to residents of this
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`State; (3) is controlled by Defendant Laurus Labs; (4) makes its generic drug products available in
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`this State; and (5) enjoys substantial income from sales of its generic pharmaceutical products in
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`this State.
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`BACKGROUND
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`U.S. PATENT NO. 11,090,323
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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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`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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`Pursuant to 21 U.S.C. § 355(b)(1), and attendant FDA regulations, the ’323 patent
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`is listed in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations
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`database (“Orange Book”) with respect to JARDIANCE®.
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`The ’323 patent covers the use of JARDIANCE®.
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`ACTS GIVING RISE TO THIS ACTION
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`COUNT I—INFRINGEMENT OF THE ’323 PATENT AS TO THE LAURUS ANDA
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`Plaintiffs reallege paragraphs 1-23 as if fully set forth herein.
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`On information and belief, Laurus submitted the Laurus ANDA to the FDA,
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`pursuant to 21 U.S.C. § 355(j), seeking approval to market the Laurus ANDA Products.
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`Laurus has represented that the Laurus ANDA refers to and relies upon the
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`JARDIANCE® NDA and contains data that, according to Laurus, demonstrate the bioavailability
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`or bioequivalence of the Laurus ANDA Products to JARDIANCE®.
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`Plaintiffs received a letter from Laurus on or about December 29, 2021 stating that
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`Laurus had
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`included a certification
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`in
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`the Laurus ANDA, pursuant
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`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 invalid, unenforceable,
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`and/or will not be infringed by the commercial manufacture, use, or sale of the Laurus ANDA
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`Products (the “Laurus Paragraph IV Certification”). Laurus intends to engage in the commercial
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`manufacture, use, importation, offer for sale, and/or sale of the Laurus ANDA Products prior to
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`the expiration of the ’323 patent.
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`Laurus 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 Laurus ANDA, by which Laurus
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`seeks approval from the FDA to engage in the manufacture, use, offer to sell, sale, or importation
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`of the Laurus ANDA Products prior to the expiration of the ’323 patent.
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`Laurus 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 Laurus ANDA Products in the event that the FDA
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`approves the Laurus ANDA. Accordingly, an actual and immediate controversy exists regarding
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`Laurus’s infringement of the ’323 patent under 35 U.S.C. §§ 271 (a), (b), and/or (c).
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`On information and belief, Laurus’s use, offer to sell, or sale of the Laurus ANDA
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`Products in the United States during the term of the ’323 patent would further infringe at least one
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`claim of the ’323 patent under 35 U.S.C. §§ 271 (a), (b), and/or (c).
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`On information and belief, the Laurus 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 Laurus ANDA Products constitutes a
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`material part of at least one of the claims of the ’323 patent; Laurus 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 or sale of the Laurus ANDA Products
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`would contributorily infringe at least one of the claims of the ’323 patent, either literally or under
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`the doctrine of equivalents.
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`On information and belief, Laurus had knowledge of the ’323 patent and, by at least
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`its package inserts for its ANDA Products, knows or should know that they will aid and abet
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`another’s direct infringement of at least one of the claims of the ’323 patent, either literally or
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`under the doctrine of equivalents.
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`On information and belief, the offering to sell or sale, of the Laurus ANDA
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`Products by Laurus would actively induce infringement of at least one of the claims of the ’323
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`patent, either literally or under the doctrine of equivalents.
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`Plaintiffs will be substantially and irreparably harmed if Laurus is not enjoined
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`from infringing the ’323 patent.
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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 Laurus
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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 Laurus has infringed at least one claim of the ’323
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`patent by submitting the Laurus ANDA;
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`That Laurus, 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 Laurus 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 Laurus’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 Laurus commercially uses, offers to
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`sell, or sells its respective proposed generic versions of JARDIANCE® or any other
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`product that infringes or induces or contributes to the infringement of the ’323
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`patent, within the United States, prior to the expiration of this patent, including any
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`extensions, and that any such monetary relief be awarded to Boehringer with
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`prejudgment interest;
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`e.
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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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`f.
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`g.
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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
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`Attorneys for Plaintiffs
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`OF COUNSEL:
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`Jeanna M. Wacker
`Sam Kwon
`Ashley L.B. Ross
`KIRKLAND & ELLIS LLP
`601 Lexington Avenue
`New York, NY 10022
`(212) 446-4679
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`James F. Hurst
`Bryan S. Hales
`KIRKLAND & ELLIS LLP
`300 North LaSalle
`Chicago, IL 60654
`(312) 862-2000
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`February 18, 2022
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