Case 1:22-cv-00729-UNA Document 1 Filed 06/02/22 Page 1 of 14 PageID #: 1
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
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`Avion Pharmaceuticals, LLC and Albion
`Laboratories, Inc.,
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`Plaintiffs,
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`v.
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`Civil Action No.:
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`Lupin Limited and Lupin Pharmaceuticals,
`Inc.,
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`
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`Defendants.
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`COMPLAINT
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`Plaintiffs Avion Pharmaceuticals, LLC (“Avion”) and Albion Laboratories, Inc. (“Albion”)
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`(collectively, “Plaintiffs”) bring this action for patent infringement against Lupin Ltd. and Lupin
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`Pharmaceuticals, Inc. (“Lupin Pharma.”) (collectively, “Defendants”).
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`NATURE OF THE ACTION
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`1.
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`This is an action by Plaintiffs for infringement of United States Patent
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`No. 7,838,042 (“’042 patent” or the “Patent-In-Suit”).
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`2.
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`This action arises from the filing of Abbreviated New Drug Application (“ANDA”)
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`No. 217087 by Defendants seeking approval by the United States Food and Drug Administration
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`(“FDA”) to sell a proposed generic version of BALCOLTRA® (“Proposed ANDA Product”) prior
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`to the expiration of the Patent-in-Suit.
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`THE PARTIES
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`Plaintiffs
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`3.
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`Avion is a limited liability corporation with its principal place of business at 1880
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`McFarland Parkway, Suite 105, Alpharetta, Georgia 30005.
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`4.
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`Albion is a corporation organized and existing under the laws of the State of
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`Nevada, having its principal place of business at 67 South Main Street, Suite 200, Layton, Utah
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`84041.
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`Defendants
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`5.
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`On information and belief, Lupin Ltd. is a corporation organized under the laws of
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`India, having its principal place of business at Kalpataru Inspire, 3rd Floor, Off Western Express
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`Highway, Santacruz (East), Mumbai 400055, Maharashtra, India.
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`6.
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`On information and belief, Lupin Pharma. is a corporation organized and existing
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`under the laws of the State of Delaware, having its principal place of business at 11 South Calvert
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`Street, 21st Floor, Baltimore, Maryland 21202.
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`7.
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`On information and belief, Lupin Pharma. is a wholly-owned subsidiary of Lupin
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`Ltd.
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`8.
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`On information and belief, Lupin Pharma. is an agent of Lupin Ltd.
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`JURISDICTION AND VENUE
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`9.
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`This is an action for patent infringement arising under the Patent Laws of the United
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`States, 35 U.S.C. § 100 et seq., including § 271(e)(2), and also including an action seeking
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`declaratory judgment pursuant to the Declaratory Judgment Act, 28 U.S.C. §§ 2201-02 for patent
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`infringement arising under 35 U.S.C. § 100 et seq., including § 271(a)-(c), (g).
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`10.
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`This Court has jurisdiction over the subject matter of this action pursuant to 28
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`U.S.C. §§ 1331 and 1338(a).
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`11.
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`This Court has personal jurisdiction over Lupin Ltd. by virtue of, among other
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`things, (1) its substantial, continuous, and systematic contacts with Delaware; (2) its acts of patent
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`infringement that will result in foreseeable harm in Delaware; and (3) its sale of a substantial
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`volume of prescription drugs in Delaware.
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`12.
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`On information and belief, Lupin Ltd. purposefully conducted and continues to
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`conduct business in this judicial district.
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`13.
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`This Court has personal jurisdiction over Lupin Ltd. because, inter alia, this action
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`arises from actions of Lupin Ltd. directed toward Delaware. On information and belief, Lupin Ltd.
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`is in the business of, inter alia, developing, manufacturing, marketing, importing, and selling
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`pharmaceutical products, including generic drug products. On information and belief, Lupin Ltd.
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`directly or indirectly manufactures, markets, and sells generic drug products throughout the United
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`States and in this judicial district, and this judicial district is a likely destination for Defendants’
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`Proposed ANDA Product. Defendants submitted the ANDA seeking approval to commercially
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`manufacture, use, sell, offer for sale, or import the Proposed ANDA Product prior to the expiration
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`of the ’042 patent. If FDA approval is obtained, the Proposed ANDA Product would be sold in
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`Delaware, causing injury to Plaintiffs in Delaware.
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`14.
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`On information and belief, Lupin Ltd. has previously availed itself of the
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`jurisdiction of this Court by filing suit in this district, consenting to jurisdiction in this district,
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`and/or asserting counterclaims in at least the following civil actions initiated in this district:
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`Galderma Laboratories, LP et al v. Lupin Inc. et al, No. 21-1710; Gilead Sciences, Inc. et al v.
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`Lupin Limited et al, No. 21-1621; Gilead Sciences, Inc. v. Lupin Limited, No. 21-1615; Boehringer
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`Ingelheim Pharmaceuticals Inc. v. Lupin Limited et al, No. 21-1486; Zogenix, Inc. et al v. Lupin
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`Ltd., No. 21-1424; Neurocrine Biosciences, Inc. v. Lupin Limited et al, No. 21-1408; Supernus
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`Pharmaceuticals, Inc. v. Lupin Limited et al, No. 21-1293; Neurocrine Biosciences, Inc. v. Lupin
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`Limited et al, No. 21-1042; Vertex Pharmaceuticals Incorporated v. Lupin Ltd. et al, No. 21-1019;
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`Otsuka Pharmaceutical Co., Ltd. v. Lupin Ltd. et al, No. 21-900; Boehringer Ingelheim
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`Pharmaceuticals Inc. et al v. Lupin Ltd. et al, No. 21-530; Bayer Pharma AG et al v. Lupin Limited
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`et al, No. 21-314; Otsuka Pharmaceutical Co., Ltd. et al v. Lupin Limited et al, No. 20-1296;
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`Intercept Pharmaceuticals, Inc. et al v. Lupin Limited et al, No. 20-1155; Arbor Pharmaceuticals,
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`LLC et al v. Lupin Limited et al, No. 20-922; Merck Sharp & Dohme Corp. v. Lupin Limited et al,
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`No. 20-776.
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`15.
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`On information and belief, Lupin Pharma. has substantial, continuous, and
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`systematic contacts in Delaware.
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`16.
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`On information and belief, Lupin Pharma. develops, manufactures, markets, and
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`distributes pharmaceutical products, including generic pharmaceutical products, for sale in the
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`State of Delaware and throughout the United States.
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`17.
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`On information and belief, Lupin Pharma. has substantial, continuous, and
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`systematic contacts with Delaware, including that it is incorporated in Delaware, is registered to
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`do business in Delaware (Entity Id. No. 5983739) and is registered as a pharmacy wholesaler and
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`controlled substances distributor/manufacturer with the Delaware Division of Professional
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`Regulation (License Nos. A4-0002387 and DM-0012065).
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`18.
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`On information and belief, Lupin Pharma., alone or together with Lupin Ltd., has
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`committed, or aided, abetted, actively induced, contributed to, or participated in the commission
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`of the patent infringement under 35 U.S.C. § 271(e)(2) that has led or will lead to foreseeable harm
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`and injury to Plaintiffs throughout the United States, including Delaware.
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`19.
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`On information and belief, Lupin Pharma. consented to jurisdiction, did not contest
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`jurisdiction, or asserted counterclaims in Delaware in one or more prior litigations, for example:
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`Boehringer Ingelheim Pharmaceuticals Inc. v. Lupin Limited et al, No. 21-1486; Vertex
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`Pharmaceuticals Inc. v. Lupin Ltd. et al, No. 21-1019; Boehringer Ingelheim Pharmaceuticals Inc.
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`et al v. Lupin Ltd. et al, No. 21-530; Otsuka Pharmaceutical Co., Ltd. et al v. Lupin Limited et al,
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`No. 20-1296; Vifor Fresenius Medical Care Renal Pharma Ltd. et al v. Lupin Atlantis Holdings,
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`SA et al, No. 20-911; Merck Sharp & Dohme Corp. v. Lupin Limited et al, No. 20-776; Vifor
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`Fresenius Medical Care Renal Pharma Ltd. et al v. Lupin Atlantis Holdings, SA et al, No. 20-697;
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`ViiV Healthcare Company et al v. Lupin Limited et al, No. 20-293.
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`20.
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`This Court has personal jurisdiction over Lupin Pharma. by virtue of, among other
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`things, (1) its incorporation in Delaware; (2) its continuous and systematic contacts in Delaware;
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`(3) its acts of patent infringement that will result in foreseeable harm in Delaware; (4) its sale of a
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`substantial volume of prescription drugs in Delaware; and (5) its conduct by and through, and in
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`concert with, Lupin Ltd.
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`21.
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`This Court has personal jurisdiction over Lupin Pharma., because inter alia, this
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`action arises from actions of Lupin Pharma. directed toward Delaware. For example, Defendants
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`submitted the ANDA seeking approval to commercially manufacture, use, sell, offer for sale, or
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`import the Proposed ANDA Product prior to the expiration of the ’042 patent. If FDA approval is
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`obtained, the Proposed ANDA Product would be sold in Delaware, causing injury to Plaintiffs in
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`Delaware.
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`22.
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`Exercising personal jurisdiction over Lupin Pharma. in this judicial district would
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`not be unreasonable given Lupin Pharma.’s incorporation in Delaware, contacts in this judicial
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`district, and the interest in this district of resolving disputes related to products to be sold herein.
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`23.
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`Venue is proper in this judicial district under 28 U.S.C. § 1391(c)(3) because Lupin
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`Ltd. is a foreign corporation.
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`24.
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`Venue is proper in this judicial district under 28 U.S.C. § 1400(b) because Lupin
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`Pharma. is incorporated in Delaware and thus resides in this judicial district.
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`AVION’S BALCOLTRA® PRODUCT
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`25.
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`Plaintiff Avion researched, developed, applied for, and obtained FDA approval to
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`manufacture, sell, promote, and/or market a product, which Plaintiff Avion commercialized under
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`the mark BALCOLTRA®.
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`26.
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`Plaintiff Avion is the holder of New Drug Application (“NDA”) No. 208612,
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`approved by FDA for the use of Levonorgestrel Ethinyl Estradiol and Ferrous Bisglycinate tablets
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`marketed as BALCOLTRA®.
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`27.
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`On information and belief, Defendants know that Avion holds NDA No. 208612.
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`28.
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`BALCOLTRA® is a birth control pill (oral contraceptive) used by women to
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`prevent pregnancy. BALCOLTRA® is supplied as levonorgestrel and ethinyl estradiol tablets, and
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`ferrous bisglycinate tablets for oral administration.
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`29.
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`Pursuant to 21 U.S.C. § 355(b)(1) and attendant FDA regulations, the Patent-In-
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`Suit is listed in the Orange Book with respect to BALCOLTRA®.
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`30.
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`Plaintiff Avion’s BALCOLTRA® product or its use is covered by at least one claim
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`of the Patent-In-Suit.
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`THE PATENT-IN-SUIT
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`31.
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`The ’042 patent, entitled “Hypoallergenic metal amino acid chelates and metal
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`amino acid chelate-containing compositions,” was duly and legally issued on November 23, 2010.
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`32. Max. R. Motyka, Rick Harnish, Stephen D. Ashmead, and DeWayne H. Ashmead
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`are the named inventors of the ’042 patent.
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`33.
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`Albion is the sole owner by assignment of all rights, title and interest in the ’042
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`patent.
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`34.
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`Avion is the exclusive licensee of the ’042 patent in the market for branded
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`prescription oral contraceptive products in the United States.
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`35.
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`The ’042 patent is listed in the FDA publication “Approved Drug Products with
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`Therapeutic Equivalence Evaluations,” commonly referred to as the “Orange Book,” with respect
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`to BALCOLTRA®.
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`36.
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`On information and belief, Defendants know that the ’042 patent is listed in the
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`Orange Book as covering BALCOLTRA®.
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`37.
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`A true and correct copy of the ’042 patent is attached as Exhibit A.
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`DEFENDANTS’ ANDA
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`38.
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`On information and belief, Defendants filed an ANDA under 21 U.S.C. § 355(j)
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`seeking FDA approval to manufacture, use, offer for sale, sell in, and import into the United States
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`Defendants’ Proposed ANDA Product, prior to the expiration of the ’042 patent.
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`39.
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`On information and belief, FDA assigned the ANDA No. 217087 for Defendants’
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`Proposed ANDA Product.
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`40.
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`41.
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`On information and belief, FDA has not yet approved ANDA No. 217087.
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`On information and belief, Defendants intend to engage in the commercial
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`manufacture, use, import, offer for sale, and sale of Defendants’ Proposed ANDA Product
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`promptly upon receiving FDA approval to do so.
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`42.
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`By submitting ANDA No. 217087, Defendants have represented to FDA that
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`Defendants’ Proposed ANDA Product has
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`the same active
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`ingredient as Plaintiffs’
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`BALCOLTRA® product; has the same route of administration, dosage form, use, and strength as
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`Plaintiffs’ BALCOLTRA® product; and is bioequivalent to Plaintiffs’ BALCOLTRA® product.
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`43.
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`On information and belief, in connection with ANDA No. 217087, Defendants filed
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`with FDA a certification pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV) alleging that the claims of
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`the ’042 patent are invalid, unenforceable, and/or would not be infringed by the manufacture, use,
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`importation, sale, or offer for sale of Defendants’ Proposed ANDA Product (“Defendants’
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`Paragraph IV Certification”).
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`44.
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`By letter dated April 18, 2022, Lupin Ltd. notified Plaintiffs that it had filed ANDA
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`No. 217087 seeking approval to market Defendants’ Proposed ANDA Product prior to the
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`expiration of the ’042 patent (“Defendants’ Notice Letter”).
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`45.
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`46.
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`Plaintiffs received the Defendants’ Notice Letter on April 19, 2022.
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`This Action is being commenced before the expiration of forty-five days from the
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`date of receipt of Defendants’ Notice Letter.
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`47.
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`On information and belief, Defendants prepared and submitted ANDA No. 217087.
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`COUNT I: INFRINGEMENT OF THE ’042 PATENT
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`48.
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`The allegations of the preceding paragraphs are realleged and incorporated herein
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`by reference.
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`49.
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`On information and belief, Defendants’ Proposed ANDA Product is covered by one
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`or more claims of the ’042 patent.
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`50.
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`On information and belief, the commercial manufacture, use, offer for sale, sale,
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`marketing, distribution, and/or importation of Defendants’ Proposed ANDA Product would
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`infringe one or more claims of the ’042 patent.
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`51.
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`Under 35 U.S.C. § 271(e)(2)(A), Defendants’ submission to the FDA of
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`Defendants’ ANDA to obtain approval for Defendants’ Proposed ANDA Product with a
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`corresponding Paragraph IV Certification before the expiration of the ’042 patent constitutes an
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`act of infringement, and, on information and belief, if approved, the commercial manufacture, use,
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`offer to sell, sale, or importation of Defendants’ Proposed ANDA Product would infringe one or
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`more claims of the ’042 patent.
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`52.
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`On information and belief, Defendants were aware of the ’042 patent when
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`engaging in these knowing and purposeful activities and were aware that filing Defendants’ ANDA
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`with Defendants’ Paragraph IV Certification with respect to the ’042 patent constituted an act of
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`infringement of the ’042 patent.
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`53.
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`On information and belief, Defendants plan to, intend to, and will infringe the ’042
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`patent immediately and imminently upon approval of Defendants’ ANDA.
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`54.
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`On information and belief, immediately and imminently upon approval of
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`Defendants’ ANDA, there will be direct infringement of the claims of the ’042 patent under 35
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`U.S.C. § 271(a), either literally or under the doctrine of equivalents.
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`55.
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`On information and belief, Defendants’ offer for sale, sale, and/or importation of
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`Defendants’ Proposed ANDA Product will actively induce infringement of the claims of the ’042
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`patent under 35 U.S.C. § 271(b). On information and belief, Defendants had knowledge of the
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`’042 patent and know or should know that it will induce direct infringement of the claims of the
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`’042 patent, and Defendants specifically intend that others’ actions will directly infringe the claims
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`of the ’042 patent, due to at least Defendants’ labeling and promotional activities for Defendants’
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`Proposed ANDA Product.
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`56.
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`On information and belief, Defendants will, through the manufacture, use, import,
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`offer for sale, and/or sale of Defendants’ Proposed ANDA Product also contributorily infringe at
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`least one claim of the ’042 patent under 35 U.S.C. § 271(c).
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`57.
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`On information and belief, Defendants will, through the importation of Defendants’
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`Proposed ANDA Product into the United States and through the offer to sell, sale, or use of
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`Defendants’ Proposed ANDA Product in the United States, infringe at least one claim of the ’042
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`patent under 35 U.S.C. § 271(g).
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`58.
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` On information and belief, the actions described in this Complaint relating to
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`ANDA were done by and for the benefit of Defendants.
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`59.
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`Plaintiffs will be substantially and irreparably harmed by Defendants’ infringing
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`activities unless the Court enjoins those activities. Plaintiffs will have no adequate remedy at law
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`if Defendants are not enjoined from the commercial manufacture, use, offer to sell, sale, and
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`importation into the United States of Defendants’ Proposed ANDA Product.
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`60.
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`Defendants’ activities render this case an exceptional one, and Plaintiffs are entitled
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`to an award of their reasonable attorney fees under 35 U.S.C. § 285.
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`COUNT II - DECLARATORY JUDGMENT OF INFRINGEMENT OF THE ’042
`PATENT
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`61.
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`The allegations of the preceding paragraphs are realleged and incorporated herein
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`by reference.
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`62.
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`These claims arise under the Declaratory Judgment Act, 28 U.S.C. §§ 2201 and
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`2202.
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`63.
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`An actual controversy exists between Plaintiffs and Defendants such that the Court
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`may entertain Plaintiffs’ request for declaratory relief consistent with Article III of the United
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`States Constitution.
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`64.
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`On information and belief, Defendants’ Proposed ANDA Product is covered by one
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`or more claims of the ’042 patent.
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`65.
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`On information and belief, the commercial manufacture, use, offer for sale, sale,
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`marketing, distribution, and/or importation of Defendants’ Proposed ANDA Product would
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`infringe one or more claims of the ’042 patent.
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`66.
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`Under 35 U.S.C. § 271(e)(2)(A), Defendants’ submission to the FDA of
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`Defendants’ ANDA to obtain approval for Defendants’ Proposed ANDA Product with a
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`corresponding Paragraph IV Certification before the expiration of the ’042 patent constitutes an
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`act of infringement, and, on information and belief, if approved, the commercial manufacture, use,
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`offer to sell, sale, or importation of Defendants’ Proposed ANDA Product would infringe one or
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`more claims of the ’042 patent.
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`67.
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`On information and belief, Defendants were aware of the ’042 patent when
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`engaging in these knowing and purposeful activities and were aware that filing Defendants’ ANDA
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`with Defendants’ Paragraph IV Certification with respect to the ’042 patent constituted an act of
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`infringement of the ’042 patent.
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`68.
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`On information and belief, Defendants plan to, intend to, and will infringe the ’042
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`patent immediately and imminently upon approval of Defendants’ ANDA.
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`69.
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`On information and belief, immediately and imminently upon approval of
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`Defendants’ ANDA, there will be direct infringement of the claims of the ’042 patent under 35
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`U.S.C. § 271(a), either literally or under the doctrine of equivalents.
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`70.
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`On information and belief, Defendants’ offer for sale, sale, and/or importation of
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`Defendants’ Proposed ANDA Product will actively induce infringement of the claims of the ’042
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`patent under 35 U.S.C. § 271(b). On information and belief, Defendants had knowledge of the
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`’042 patent and know or should know that it will induce direct infringement of the claims of the
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`’042 patent, and Defendants specifically intend that others’ actions will directly infringe the claims
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`of the ’042 patent, due to at least Defendants’ labeling and promotional activities for Defendants’
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`Proposed ANDA Product.
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`71.
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`On information and belief, Defendants will, through the manufacture, use, import,
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`offer for sale, and/or sale of Defendants’ Proposed ANDA Product, also contributorily infringe at
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`least one claim of the ’042 patent under 35 U.S.C. § 271(c).
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`72.
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`On information and belief, Defendants will, through the importation of Defendants’
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`Proposed ANDA Product into the United States and through the offer to sell, sale, or use of
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`Defendants’ Proposed ANDA Product in the United States, infringe at least one claim of the ’042
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`patent under 35 U.S.C. § 271(g).
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`73.
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` On information and belief, the actions described in this Complaint relating to
`
`ANDA were done by and for the benefit of Defendants.
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`74.
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`Plaintiffs will be substantially and irreparably harmed by Defendants’ infringing
`
`activities unless the Court enjoins those activities. Plaintiffs will have no adequate remedy at law
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`if Defendants are not enjoined from the commercial manufacture, use, offer to sell, sale, and
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`importation into the United States of Defendants’ Proposed ANDA Product.
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`75.
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`Defendants’ activities render this case an exceptional one, and Plaintiffs are entitled
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`to an award of their reasonable attorney fees under 35 U.S.C. § 285.
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`PRAYER FOR RELIEF
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`WHEREFORE, Plaintiffs respectfully request the following relief:
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`a)
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`b)
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`a finding that the ’042 patent is valid and enforceable;
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`a declaratory judgment that Defendants’ submission of ANDA No. 217087 was an
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`act of infringement of one or more claims of the ’042 patent and that the making, using, offering
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`to sell, selling, marketing, distributing, or importing of Defendants’ Proposed ANDA Product prior
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`to the expiration of the ’042 patent will infringe, actively induce infringement of, and/or contribute
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`to the infringement of one or more claims of the ’042 patent;
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`c)
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`an Order pursuant to 35 U.S.C. § 271(e)(4)(A) providing that the effective date of
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`any FDA approval of the Defendants’ ANDA No. 217087 or any product the use of which infringes
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`the ’042 patent, shall be a date that is not earlier than the expiration of the ’042 patent;
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`d)
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`an Order pursuant to 35 U.S.C. § 271(e)(4)(B) permanently enjoining Defendants
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`and all persons acting in concert with Defendants from commercially manufacturing, using,
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`offering for sale, selling, marketing, distributing, or importing Defendants’ Proposed ANDA
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`Product, or any product the use of which infringes the ’042 patent, or induces or contributes to the
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`infringement of the ’042 patent, until after the expiration of the ’042 patent;
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`e)
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` an Order enjoining Defendants and all persons acting in concert with Defendants
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`from seeking, obtaining, or maintaining approval of the Defendants’ ANDA No. 217087 before
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`the expiration of the ’042 patent;
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`f)
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`an award of Plaintiffs’ damages with interest or other monetary relief to compensate
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`Plaintiffs if Defendants engage in the commercial manufacture, use, offer to sell, sale, or marketing
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`or distribution in, or importation into the United States of Defendants’ Proposed ANDA Product,
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`or any product or compound the use of which infringes the ’042 patent, or induces or contributes
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`to the foregoing, prior to the expiration of the ’042 patent in accordance with 35 U.S.C.
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`§ 271(e)(4)(C);
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`g)
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`a judgment that this is an exceptional case and awarding Plaintiffs their attorneys’
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`fees under 35 U.S.C. § 285;
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`an award of Plaintiffs’ reasonable costs and expenses in this action; and
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`an award of any further and additional relief to Plaintiffs as this Court deems just
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`h)
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`i)
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`and proper.
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`-13-
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`Case 1:22-cv-00729-UNA Document 1 Filed 06/02/22 Page 14 of 14 PageID #: 14
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`Dated: June 2, 2022
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`/s/Stamatios Stamoulis
`Stamatios Stamoulis #4606
`stamoulis@swdelaw.com
`STAMOULIS & WEINBLATT LLC
`800 N. West Street, Third Floor
`Wilmington, DE 19801
`Telephone: 302.999.1540
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`Attorney for Plaintiffs Avion Pharmaceuticals,
`LLC and Albion Laboratories, Inc.
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`Of Counsel:
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`Autumn N. Nero (Pro Hac Vice forthcoming)
`ANero@perkinscoie.com
`Andrew T. Dufresne (Pro Hac Vice
`forthcoming)
`ADufresne@perkinscoie.com
`Olivia S. Radics (Pro Hac Vice forthcoming)
`ORadics@perkinscoie.com
`PERKINS COIE LLP
`33 East Main Street, Suite 201
`Madison, WI 53703-3095
`Telephone: 608.663.7460
`Facsimile: 608.663.7499
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`Michael A. Chajon #5465
`MChajon@perkinscoie.com
`PERKINS COIE LLP
`700 Thirteenth Street, N.W., Suite 800
`Washington, D.C. 20005-3960
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`Attorneys for Plaintiff Avion Pharmaceuticals,
`LLC
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`-14-
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