Case 1:21-cv-01487-UNA Document 1 Filed 10/22/21 Page 1 of 24 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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`COMPLAINT
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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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`SUN PHARMACEUTICAL INDUSTRIES
`LIMITED, SUN PHARMACEUTICAL
`INDUSTRIES, INC. and
`OHM LABORATORIES, INC.,
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`Defendants.
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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 Sun Pharmaceutical Industries Limited, Sun Pharmaceutical Industries, Inc.,
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`and Ohm Laboratories, 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 Defendant’s submissions of Abbreviated New Drug Applications (“ANDAs”) to the Food
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`and Drug Administration (“FDA”) seeking approval to manufacture and sell generic versions of
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`Plaintiffs’ JARDIANCE® (empagliflozin) tablets, GLYXAMBI® (empagliflozin/linagliptin),
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`SYNJARDY XR® (empagliflozin/metformin extended release), and/or TRIJARDY XR®
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`Case 1:21-cv-01487-UNA Document 1 Filed 10/22/21 Page 2 of 24 PageID #: 2
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`(empagliflozin/linagliptin/metformin extended release) tablets prior to the expiration of United
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`States 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 Sun Pharmaceutical Industries Limited (“Sun
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`Ltd.”) is a corporation organized and existing under the laws of India, having a principal place of
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`business at Sun House, Plot No. 201 B/1, Western Express Highway, Goregaon (E), Mumbai,
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`Maharashtra, India, 400063.
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`On information and belief, Sun Ltd. controls and directs a wholly owned subsidiary
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`in the United States named Sun Pharmaceutical Industries, Inc. (“Sun Inc.”). Sun Inc. is a Delaware
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`corporation having a principal place of business at 2 Independence Way, Princeton, New Jersey
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`08540.
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`On information and belief, Sun Ltd. controls and directs a wholly owned subsidiary
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`in the United States named Ohm Laboratories, Inc. (“Ohm Labs”). Ohm Labs is a Delaware
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`corporation, having a principal place of business at 14 Terminal Rd, New Brunswick, NJ 08901.
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`Sun Ltd., Sun Inc., and Ohm Labs are collectively referred to as “Sun.”
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`On information and belief, Sun 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 agents
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`and subsidiaries, including Sun Inc. and Ohm Labs from which Sun derives a substantial portion
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`of its revenue.
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`On information and belief, Sun Ltd. acted in concert with Sun Inc. and Ohm Labs
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`to prepare and submit ANDA No. 212343 (the “Sun empagliflozin ANDA”) for Sun’s 10 mg and
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`25 mg empagliflozin tablets (the “Sun empagliflozin ANDA Product”).
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` On information and belief, Sun Ltd. acted in concert with Sun Inc. and Ohm Labs
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`to prepare and submit ANDA No. 212339 (the “Sun empagliflozin/linagliptin ANDA”) for Sun’s
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`10 mg/5 mg and 25 mg/5 mg empagliflozin/linagliptin tablets (the “Sun empagliflozin/linagliptin
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`ANDA Product”).
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`On information and belief, Sun Ltd. acted in concert with Sun Inc. and Ohm Labs
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`to prepare and submit ANDA No. 215529 (the “Sun empagliflozin/metformin extended-release
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`ANDA”) for Sun’s 5 mg/1000 mg, 10 mg/1000 mg, 12.5mg/1000 mg, and 25 mg/1000 mg
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`extended-release tablets (the “Sun empagliflozin/metformin extended-release ANDA Product”).
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`On information and belief, Sun Ltd. acted in concert with Sun Inc. and Ohm Labs
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`to prepare and submit ANDA No. 214843 (the “Sun empagliflozin/linagliptin/metformin
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`extended-release ANDA”) for Sun’s 5 mg/2.5 mg/1000 mg; 10 mg/5 mg/1000 mg;
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`12.5 mg/2.5 mg/1000 mg; 25 mg/5 mg/1000 mg empagliflozin/linagliptin/metformin extended-
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`release tablets (the “Sun empagliflozin/linagliptin/metformin extended-release ANDA Product”).
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`The Sun empagliflozin ANDA, Sun empagliflozin/linagliptin ANDA, Sun
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`empagliflozin/metformin extended-release ANDA, and Sun empagliflozin/metformin extended-
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`release ANDA are collectively referred to hereinafter as the “Sun ANDAs.”
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`The Sun empagliflozin ANDA Product, Sun empagliflozin/linagliptin ANDA
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`Product, Sun
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`empagliflozin/metformin
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`extended-release ANDA Product,
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`and Sun
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`empagliflozin/linagliptin/metformin extended-release ANDA Product are collectively referred to
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`hereinafter as the “Sun ANDA Products.”
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`On information and belief, following FDA approval of the Sun ANDAs, Ohm Labs
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`will manufacture and supply the Sun ANDA Products to Sun Inc., which will then market and sell
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`the products throughout the United States, all at the direction, under the control, and for the direct
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`benefit of Sun Ltd.
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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, each Defendant 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 and/or is a foreign corporation or the agent of a foreign corporation not residing in
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`any United States judicial district, which may be sued in any judicial district. 28 U.S.C. § 1391(c);
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`28 U.S.C. § 1400(b). Moreover, Sun has litigated previous Hatch-Waxman patent infringement
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`disputes in the District of Delaware.
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`PERSONAL JURISDICTION OVER SUN
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`Plaintiffs reallege paragraphs 1-19 as if fully set forth herein.
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`On information and belief, Sun 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 Sun Ltd. because, inter alia, Sun Ltd, on
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`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 the infringing Sun ANDA Products to residents of this State upon
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`approval of Sun’s ANDAs, either directly or through at least one of its wholly-owned subsidiaries
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`or agents; and (3) enjoys substantial income from sales of its generic pharmaceutical products in
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`this State on its own and through Ohm Labs, which is incorporated in Delaware and through Sun
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`Inc., which
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`is
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`registered as a pharmacy wholesaler and controlled
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`substances
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`distributor/manufacturer with the Delaware Division of Professional Regulation; (4) wholly owns
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`Ohm Labs, which is a Delaware corporation; and (5) wholly owns Sun Inc., which is registered as
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`a pharmacy wholesaler and controlled substances distributor/manufacturer with the Delaware
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`Division of Professional Regulation.
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`On information and belief, Sun 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 Pharm. Inc. v. Sun Pharm. Indus. Ltd., C.A. No. 18-
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`1765-CFC (D. Del.); Pfizer Inc. et al. v. Sun Pharmaceutical Industries Ltd. et al., C.A. No. 17-
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`1597-LPS (D. Del.); Boehringer Ingelheim Pharm. Inc. v. Sun Pharm. Indus. Ltd., C.A. No. 20-
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`1153-CFC (D. Del.); Boehringer Ingelheim Pharm. Inc. v. Sun Pharm. Indus. Ltd., C.A. No. 20-
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`1585-CFC (D. Del.).
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`Alternatively, to the extent the above facts do not establish personal jurisdiction
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`over Sun Ltd., this Court may exercise jurisdiction over Sun pursuant to Fed. R. Civ. P. 4(k)(2)
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`because: (a) Plaintiffs’ claims arise under federal law; (b) Sun Ltd. would be a foreign defendant
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`not subject to personal jurisdiction in the courts of any State; and (c) Sun Ltd. has sufficient
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`contacts with the United States as a whole, including, but not limited to, filing ANDAs with the
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`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 Sun Ltd. satisfies
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`due process.
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`PERSONAL JURISDICTION OVER OHM LABS
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`Plaintiffs reallege paragraphs 1-24 as if fully set forth herein.
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`On information and belief, Ohm 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 Ohm Labs because, inter alia, Ohm Labs,
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`on information and belief: (1) is incorporated under the laws of the State of Delaware; (2) intends
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`to make Sun’s ANDA Products available in this State; and (3) enjoys substantial income from
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`sales of its generic products in this State.
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`On information and belief, Ohm Labs has not contested jurisdiction in Delaware in
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`one or more prior cases arising out of the filing of its ANDAs. See, e.g., Boehringer Ingelheim
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`Pharm. Inc. v. Sun Pharm. Indus. Ltd., C.A. No. 18-1765-CFC (D. Del.); Boehringer Ingelheim
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`Pharm. Inc. v. Sun Pharm. Indus. Ltd., C.A. No. 20-1153-CFC (D. Del.); Boehringer Ingelheim
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`Pharm. Inc. v. Sun Pharm. Indus. Ltd., C.A. No. 20-1585-CFC (D. Del.); Shire LLC et al. v.
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`Ranbaxy Laboratories Ltd. et al., C.A. No. 14-827-RGA (D. Del.).
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`PERSONAL JURISDICTION OVER SUN INC.
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`Plaintiffs reallege paragraphs 1-28 as if fully set forth herein.
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`On information and belief, Sun 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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`This Court has personal jurisdiction over Sun Inc. because, inter alia, Sun Inc., on
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`information and belief: (1) is incorporated under the laws of the State of Delaware; (2) is registered
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`as a pharmacy wholesaler and controlled substances distributor/manufacturer with the Delaware
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`Division of Professional Regulation; (3) intends to market, sell, or distribute Sun’s ANDA
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`Products to residents of this State; (4) makes its generic drug products available in this State; and
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`(5) enjoys substantial income from sale of its generic pharmaceutical products in this State.
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`On information and belief, Sun 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. See, e.g., Boehringer Ingelheim
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`Pharm. Inc. v. Sun Pharm. Indus. Ltd., C.A. No. 18-1765-CFC (D. Del.); Boehringer Ingelheim
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`Pharm. Inc. v. Sun Pharm. Indus. Ltd., C.A. No. 20-1153-CFC (D. Del.); Boehringer Ingelheim
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`Pharm. Inc. v. Sun Pharm. Indus. Ltd., C.A. No. 20-1585-CFC (D. Del.); Novartis
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`Pharmaceuticals Corporation v. Sun Pharmaceutical Industries, Ltd. et al., C.A. No. 18-1040-
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`LPS (D. Del.).
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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 No.
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`11,090,323 (“the ’323 patent”) entitled “Pharmaceutical composition, methods for treating and
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`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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`GLYXAMBI®
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`BIPI is the holder of New Drug Application (“NDA”) No. 206073 for
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`empagliflozin/linagliptin, for oral use, in 10 mg/5 mg and 25 mg/5 mg dosages, which is sold under
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`the trade name GLYXAMBI®.
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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 Orange Book with respect to GLYXAMBI®.
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`The ’323 patent covers the GLYXAMBI® product and its use.
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`SYNJARDY® XR
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`BIPI is the holder of New Drug Application (“NDA”) No. 208658 for empagliflozin
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`and metformin hydrochloride, extended release, for oral use, in 5 mg/1 g, 10 mg/1 g, 12.5 mg/1 g,
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`and 25 mg/1 g dosages, which is sold under the trade name SYNJARDY® XR.
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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 Orange Book with respect to SYNJARDY® XR.
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`The ’323 patent covers the SYNJARDY® XR product and its use.
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`TRIJARDY® XR
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`BIPI is the holder of New Drug Application (“NDA”) No. 212614 for empagliflozin
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`and metformin hydrochloride, extended release, for oral use, in 5 mg/2.5 mg/1 g, 10 mg/5 mg/1 g,
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`12.5 mg/2.5 mg/1 g, and 25 mg/5 mg/1 g dosages, which is sold under the trade name TRIJARDY®
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`XR.
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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 Orange Book with respect to TRIJARDY® XR.
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`The ’323 patent covers the TRIJARDY® XR 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 SUN
`EMPAGLIFLOZIN ANDA
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`Plaintiffs reallege paragraphs 1-45 as if fully set forth herein.
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`On information and belief, Sun submitted the Sun empagliflozin ANDA to the
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`FDA, pursuant to 21 U.S.C. § 355(j), seeking approval to market the Sun empagliflozin ANDA
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`Product.
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`Sun has represented that the Sun empagliflozin ANDA refers to and relies upon the
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`JARDIANCE® NDA and contains data that, according to Sun, demonstrate the bioavailability or
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`bioequivalence of the Sun empagliflozin ANDA Product to JARDIANCE®.
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`Plaintiffs received a letter (the “Sun empagliflozin Notice Letter”) from Sun on or
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`about September 30, 2021 stating that Sun had included a certification in the Sun empagliflozin
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`ANDA, pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV), that, inter alia, certain claims of the ’323
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`patent are either invalid or will not be infringed by the commercial manufacture, use, or sale of the
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`Sun empagliflozin ANDA Product (the “Sun empagliflozin Paragraph IV Certification”). The Sun
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`empagliflozin Notice Letter included a detailed statement of the factual and legal bases for Sun’s
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`empagliflozin Paragraph IV Certification (the “Sun empagliflozin Detailed Statement”). Sun
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`intends to engage in the commercial manufacture, use, offer for sale, and/or sale of the Sun
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`empagliflozin ANDA Product prior to the expiration of the ’323 patent.
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`Sun 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 Sun empagliflozin ANDA, by which
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`Sun seeks approval from the FDA to engage in the manufacture, use, offer to sell, sale, or
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`importation of the Sun empagliflozin ANDA Product prior to the expiration of the ’323 patent.
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`Sun 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 Sun empagliflozin ANDA Product in the event that
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`the FDA approves the Sun empagliflozin ANDA. Accordingly, an actual and immediate
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`controversy exists regarding Sun’s infringement of the ’323 patent under 35 U.S.C. §§ 271 (a),
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`(b), and/or (c).
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`Sun’s empagliflozin Detailed Statement does not deny that the Sun empagliflozin
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`ANDA Product subject to ANDA No. 212343 will infringe the claims of the ’323 patent.
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`On information and belief, Sun’s use, offer to sell, or sale of the Sun empagliflozin
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`ANDA Product in the United States during the term of the ’323 patent would further infringe at
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`least one 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 Sun empagliflozin ANDA Product, when offered for
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`sale, sold, and/or when used as directed, would be used in a manner that would directly infringe at
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`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 Sun empagliflozin ANDA Product
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`constitutes a material part of at least one of the claims of the ’323 patent; Sun knows that its
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`empagliflozin ANDA Product is especially made or adapted for use in infringing at least one of
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`the claims of the ’323 patent, either literally or under the doctrine of equivalents; and its
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`empagliflozin ANDA Product is not a staple article of commerce or commodity of commerce
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`suitable for substantial noninfringing use.
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`On information and belief, the offering to sell or sale of the Sun empagliflozin
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`ANDA Product 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, Sun had knowledge of the ’323 patent and, by its
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`promotional activities and package inserts for its empagliflozin ANDA Product, knows or should
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`know that it will aid and abet another’s direct 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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`On information and belief, the offering to sell or sale of the Sun empagliflozin
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`ANDA Product by Sun 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 Sun is not enjoined from
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`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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`COUNT II — INFRINGEMENT OF THE ’323 PATENT AS TO THE SUN
`EMPAGLIFLOZIN/LINAGLIPTIN ANDA
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`Plaintiffs reallege paragraphs 1-60 as if fully set forth herein.
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`On information and belief, Sun submitted the Sun empagliflozin/linagliptin ANDA
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`to
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`the FDA, pursuant
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`to 21 U.S.C. § 355(j), seeking approval
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`to market
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`the Sun
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`empagliflozin/linagliptin ANDA Product.
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`Sun has represented that the Sun empagliflozin/linagliptin ANDA refers to and
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`relies upon the GLYXAMBI® NDA and contains data that, according to Sun, demonstrate the
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`bioavailability or bioequivalence of the Sun empagliflozin/linagliptin ANDA Product to
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`GLYXAMBI®.
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`Plaintiffs received a letter (the “Sun empagliflozin/linagliptin Notice Letter”) from
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`Sun on or about September 30, 2021 stating that Sun had included a certification in the Sun
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`empagliflozin/linagliptin ANDA, pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV), that, inter alia,
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`certain claims of the ’323 patent are either invalid or will not be infringed by the commercial
`
`manufacture, use, or sale of the Sun empagliflozin/linagliptin ANDA Product (the “Sun
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`empagliflozin/linagliptin Paragraph IV Certification”). The Sun empagliflozin/linagliptin Notice
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`Letter
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`included a detailed statement of
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`the
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`factual and
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`legal bases
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`for Sun’s
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`empagliflozin/linagliptin Paragraph IV Certification (the “Sun empagliflozin/linagliptin Detailed
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`Statement”). Sun intends to engage in the commercial manufacture, use, offer for sale, and/or sale
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`of the Sun empagliflozin/linagliptin ANDA Product prior to the expiration of the ’323 patent.
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`
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`Sun 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 Sun empagliflozin/linagliptin
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`ANDA, by which Sun seeks approval from the FDA to engage in the manufacture, use, offer to
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`sell, sale, or importation of the Sun empagliflozin/linagliptin ANDA Product prior to the expiration
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`of the ’323 patent.
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`
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`Sun 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 Sun empagliflozin/linagliptin ANDA Product in the
`
`event that the FDA approves the Sun empagliflozin/linagliptin ANDA. Accordingly, an actual and
`
`12
`
`

`

`Case 1:21-cv-01487-UNA Document 1 Filed 10/22/21 Page 13 of 24 PageID #: 13
`
`
`
`immediate controversy exists regarding Sun’s infringement of the ’323 patent under 35 U.S.C.
`
`§§ 271 (a), (b), and/or (c).
`
`
`
`Sun’s empagliflozin/linagliptin Detailed Statement does not deny that the Sun
`
`ANDA empagliflozin/linagliptin Product subject to ANDA No. 212339 will infringe the claims of
`
`the ’323 patent.
`
`
`
`On information and belief, Sun’s use, offer to sell, or sale of the Sun
`
`empagliflozin/linagliptin ANDA Product in the United States during the term of the ’323 patent
`
`would further infringe at least one claim of the ’323 patent under 35 U.S.C. §§ 271 (a), (b), and/or
`
`(c).
`
`
`
`On information and belief, the Sun empagliflozin/linagliptin 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 ’323 patent either literally or under the doctrine of
`
`equivalents.
`
`
`
`On information and belief, the use of the Sun empagliflozin/linagliptin ANDA
`
`Product constitutes a material part of at least one of the claims of the ’323 patent; Sun knows that
`
`its empagliflozin/linagliptin ANDA Product is especially made or adapted for use in infringing at
`
`least one of the claims of the ’323 patent, either literally or under the doctrine of equivalents; and
`
`its empagliflozin/linagliptin 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 Sun
`
`empagliflozin/linagliptin ANDA Product would contributorily infringe at least one of the claims
`
`of the ’323 patent, either literally or under the doctrine of equivalents.
`
`13
`
`

`

`Case 1:21-cv-01487-UNA Document 1 Filed 10/22/21 Page 14 of 24 PageID #: 14
`
`
`
`
`
`On information and belief, Sun had knowledge of the ’323 patent and, by its
`
`promotional activities and package inserts for its empagliflozin/linagliptin ANDA Product, knows
`
`or should know that it will aid and abet another’s direct infringement of at least one of the claims
`
`of the ’323 patent, either literally or under the doctrine of equivalents.
`
`
`
`On
`
`information and belief,
`
`the offering
`
`to sell or sale of
`
`the Sun
`
`empagliflozin/linagliptin ANDA Product by Sun would actively induce infringement of at least
`
`one of the claims of the ’323 patent, either literally or under the doctrine of equivalents.
`
`
`
`Plaintiffs will be substantially and irreparably harmed if Sun is not enjoined from
`
`infringing the ’323 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 III — INFRINGEMENT OF THE ’323 PATENT AS TO THE SUN
`EMPAGLIFLOZIN/METFORMIN EXTENDED-RELEASE ANDA
`
`
`
`
`
`Plaintiffs reallege paragraphs 1-75 as if fully set forth herein.
`
`On information and belief, Sun submitted the Sun empagliflozin/metformin
`
`extended-release ANDA to the FDA, pursuant to 21 U.S.C. § 355(j), seeking approval to market
`
`the Sun empagliflozin/metformin extended-release ANDA Product.
`
`
`
`Sun has represented that the Sun empagliflozin/metformin extended-release ANDA
`
`refers to and relies upon the SYNJARDY® XR NDA and contains data that, according to Sun,
`
`demonstrate the bioavailability or bioequivalence of the Sun empagliflozin/metformin extended-
`
`release ANDA Product to SYNJARDY® XR.
`
`
`
`Plaintiffs received a letter (the “Sun empagliflozin/metformin extended-release
`
`Notice Letter”) from Sun on or about September 30, 2021 stating that Sun had included a
`
`certification in the Sun empagliflozin/metformin extended-release ANDA, pursuant to 21 U.S.C.
`
`14
`
`

`

`Case 1:21-cv-01487-UNA Document 1 Filed 10/22/21 Page 15 of 24 PageID #: 15
`
`
`
`§ 355(j)(2)(A)(vii)(IV), that, inter alia, certain claims of the ’323 patent are either invalid or will
`
`not be infringed by the commercial manufacture, use, or sale of the Sun empagliflozin/metformin
`
`extended-release ANDA Product (the “Sun empagliflozin/metformin extended-release Paragraph
`
`IV Certification”). The Sun empagliflozin/metformin extended-release Notice Letter included a
`
`detailed statement of the factual and legal bases for Sun’s empagliflozin/metformin extended-
`
`release Paragraph IV Certification (the “Sun empagliflozin/metformin extended-release Detailed
`
`Statement”). Sun intends to engage in the commercial manufacture, use, offer for sale, and/or sale
`
`of the Sun empagliflozin/metformin extended-release ANDA Product prior to the expiration of the
`
`’323 patent.
`
`
`
`Sun has infringed at least one claim of the ’323 patent, pursuant to 35 U.S.C.
`
`§ 271(e)(2)(A), by submitting, or causing to be submitted the Sun empagliflozin/metformin
`
`extended-release ANDA, by which Sun seeks approval from the FDA to engage in the
`
`manufacture, use, offer to sell, sale, or importation of the Sun empagliflozin/metformin extended-
`
`release ANDA Product prior to the expiration of the ’323 patent.
`
`
`
`Sun has declared its intent to manufacture, use, offer to sell, or sell in the United
`
`States or to import into the United States, the Sun empagliflozin/metformin extended-release
`
`ANDA Product in the event that the FDA approves the Sun empagliflozin/metformin extended-
`
`release ANDA. Accordingly, an actual and immediate controversy exists regarding Sun’s
`
`infringement of the ’323 patent under 35 U.S.C. §§ 271 (a), (b), and/or (c).
`
`
`
`Sun’s empagliflozin/metformin extended-release Detailed Statement does not deny
`
`that the Sun empagliflozin/metformin extended-release ANDA Product subject to ANDA
`
`No. 215529 will infringe the claims of the ’323 patent.
`
`15
`
`

`

`Case 1:21-cv-01487-UNA Document 1 Filed 10/22/21 Page 16 of 24 PageID #: 16
`
`
`
`
`
`On information and belief, Sun’s use, offer to sell, or sale of the Sun
`
`empagliflozin/metformin extended-release ANDA Product in the United States during the term of
`
`the ’323 patent would further infringe at least one claim of the ’323 patent under 35 U.S.C.
`
`§§ 271 (a), (b), and/or (c).
`
`
`
`On information and belief, the Sun empagliflozin/metformin extended-release
`
`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 ’323 patent either literally or
`
`under the doctrine of equivalents.
`
`
`
`On information and belief, the use of the Sun empagliflozin/metformin extended-
`
`release ANDA Product constitutes a material part of at least one of the claims of the ’323 patent;
`
`Sun knows that its empagliflozin/metformin extended-release ANDA Product is especially made
`
`or adapted for use in infringing at least one of the claims of the ’323 patent, either literally or under
`
`the doctrine of equivalents; and its empagliflozin/metformin extended-release 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 Sun
`
`empagliflozin/metformin extended-release ANDA Product would contributorily infringe at least
`
`one of the claims of the ’323 patent, either literally or under the doctrine of equivalents.
`
`
`
`On information and belief, Sun had knowledge of the ’323 patent and, by its
`
`promotional activities and package inserts for its empagliflozin/metformin extended-release
`
`ANDA Product, knows or should know that it will aid and abet another’s direct infringement of at
`
`least one of the claims of the ’323 patent, either literally or under the doctrine of equivalents.
`
`16
`
`

`

`Case 1:21-cv-01487-UNA Document 1 Filed 10/22/21 Page 17 of 24 PageID #: 17
`
`
`
`
`
`On
`
`information and belief,
`
`the offering
`
`to sell or sale of
`
`the Sun
`
`empagliflozin/metformin extended-release ANDA Product by Sun would actively induce
`
`infringement of at least one of the claims of the ’323 patent, either literally or under the doctrine
`
`of equivalents.
`
`
`
`Plaintiffs will be substantially and irreparably harmed if Sun is not enjoined from
`
`infringing the ’323 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 IV— INFRINGEMENT OF THE ’323 PATENT AS TO THE SUN
`EMPAGLIFLOZIN/LINAGLIPTIN/METFORMIN EXTENDED-RELEASE ANDA
`
`
`
`
`
`Plaintiffs reallege paragraphs 1-90 as if fully set forth herein.
`
`On
`
`information
`
`and
`
`belief,
`
`Sun
`
`submitted
`
`the
`
`Sun
`
`empagliflozin/linagliptin/metformin extended-release ANDA to the FDA, pursuant to 21 U.S.C.
`
`§ 355(j), seeking approval to market the Sun empagliflozin/linagliptin/metformin extended-release
`
`ANDA Product.
`
`
`
`Sun has represented that the Sun empagliflozin/linagliptin/metformin extended-
`
`release ANDA refers to and relies upon the TRIJARDY® XR NDA and contains data that,
`
`according
`
`to Sun, demonstrate
`
`the bioavailability or bioequivalence of
`
`the Sun
`
`empagliflozin/linagliptin/metformin extended-release ANDA Product to TRIJARDY® XR.
`
`
`
`Plaintiffs received a letter (the “Sun empagliflozin/linagliptin/metformin extended-
`
`release Notice Letter”) from Sun on or about September 30, 2021 stating that Sun had included a
`
`certification in the Sun empagliflozin/linagliptin/metformin extended-release ANDA, pursuant to
`
`21 U.S.C. § 355(j)(2)(A)(vii)(IV), that, inter alia, certain claims of the ’323 patent are either
`
`invalid or will not be infringed by the commercial manufacture, use, or sale of the Sun
`
`17
`
`

`

`Case 1:21-cv-01487-UNA Document 1 Filed 10/22/21 Page 18 of 24 PageID #: 18
`
`
`
`empagliflozin/linagliptin/metformin
`
`extended-release ANDA
`
`Product
`
`(the
`
`“Sun
`
`empagliflozin/linagliptin/metformin extended-release Paragraph IV Certification”). The Sun
`
`empagliflozin/linagliptin/metformin extended-release Notice Letter included a detailed statement
`
`of the factual and legal bases for Sun’s empagliflozin/linagliptin/metformin extended-release
`
`Paragraph IV Certification (the “Sun empagliflozin/linagliptin/metformin extended-release
`
`Detailed Statement”). Sun intends to engage in the commercial manufacture, use,