Case 1:21-cv-00612-UNA Document 1 Filed 04/29/21 Page 1 of 11 PageID #: 1
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
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`MAYNE PHARMA LLC,
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`Plaintiff,
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`v.
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`PERRIGO ISRAEL PHARMACEUTICALS
`LTD. and PERRIGO CO. PLC,
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`Defendant.
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`C.A. No. ________________
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`COMPLAINT
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`Plaintiff Mayne Pharma LLC (“Mayne” or “Plaintiff”), by its undersigned attorneys, brings
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`this action against Defendants Perrigo Israel Pharmaceuticals Ltd. and Perrigo Company plc
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`(collectively, “Perrigo” or “Defendants”), and hereby alleges as follows:
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`NATURE OF ACTION
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`1.
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`This is an action for patent infringement of U.S. Patent No. 10,857,159 (the “’159
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`patent” or “patent-in-suit”) under the patent laws of the United States, Title 35, United States Code
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`§ 100, et seq. This action arises from Perrigo’s submission of Abbreviated New Drug Application
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`(“ANDA”) No. 215266 to the U.S. Food and Drug Administration (“FDA”). Through its ANDA,
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`Perrigo seeks approval to market 0.05% halobetasol propionate topical foam, a generic version of
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`Mayne’s LEXETTE® drug product (“Perrigo ANDA product”), prior to the expiration of the
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`patent-in-suit.
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`2.
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`This is also an action under 28 U.S.C. §§ 2201–02 for a declaratory judgment of
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`patent infringement arising under the patent laws of the United States, 35 U.S.C. § 1, et seq., and
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`in particular under 35 U.S.C. §§ 271(a), (b), and/or (c).
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`3.
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`Mayne is a Delaware limited liability company with a place of business at 1240
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`THE PARTIES
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`Sugg Parkway, Greenville, North Carolina 27834.
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`4.
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`Upon information and belief, Perrigo Israel Pharmaceuticals Ltd. (“Perrigo Israel”)
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`is an Israeli corporation with a place of business at 1 Rakefet St., Shoham 608500, Israel.
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`5.
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`Upon information and belief, Perrigo Company plc (“Perrigo Ireland”) is an Irish
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`corporation with a place of business at The Sharp Building, Hogan Place, Dublin 2, Ireland.
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`6.
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`Upon information and belief, Perrigo Israel is a wholly-owned subsidiary by
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`Perrigo Ireland.
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`7.
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`Upon information and belief, Perrigo prepared and submitted ANDA No. 215266
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`and continues to collaborate in seeking FDA approval of that application.
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`8.
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`Upon information and belief, Perrigo intends to commercially manufacture, market,
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`offer for sale, and sell the Perrigo ANDA product throughout the United States, including in the
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`State of Delaware, in the event the FDA approves ANDA No. 215266.
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`9.
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`Upon information and belief, Perrigo Israel manufactures, sells, markets, and
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`distributes generic pharmaceutical products throughout the United States, including in this district,
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`in conjunction with or under the direction of Perrigo Ireland.
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`JURISDICTION AND VENUE
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`10.
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`This Court has subject matter jurisdiction pursuant to 28 U.S.C. §§ 1331, 1338,
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`2201, 2202 because this is a patent infringement action that arises under the patent laws of the
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`United States, 35 U.S.C. § 100 et seq. and the Declaratory Judgment Act.
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`11.
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`This Court has personal jurisdiction over Perrigo Israel because, inter alia, it has
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`purposefully availed itself of the benefits and protections of Delaware’s laws such that it should
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`reasonably anticipate being haled into court here. Upon information and belief, Perrigo Israel
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`develops, manufactures, imports, markets, offers to sell, and/or sells generic drugs throughout the
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`United States, including in Delaware and therefore transacts business within Delaware related to
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`Mayne’s claims, and/or has engaged in systematic and continuous business contacts within
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`Delaware.
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`12.
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`This Court has personal jurisdiction over Perrigo Ireland because, inter alia, Perrigo
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`Ireland, itself and through its wholly-owned subsidiary Perrigo Israel, has purposefully availed
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`itself of the rights and benefits of Delaware law by engaging in systematic and continuous contacts
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`with Delaware. Upon information and belief, Perrigo Ireland regularly and continuously transacts
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`business within Delaware, including by selling pharmaceutical products in Delaware either
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`directly or indirectly through affiliated companies. Upon information and belief, Perrigo Ireland
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`derives substantial revenue from the sale of those products in Delaware and has availed itself of
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`the privilege of conducting business within Delaware. In addition, Perrigo Ireland is subject to
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`personal jurisdiction in Delaware because, upon information and belief, it controls Perrigo Israel
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`and therefore the activities of Perrigo Israel in this jurisdiction can be attributed to Perrigo Ireland.
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`13.
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`This Court has jurisdiction over Perrigo because, inter alia, Perrigo has committed
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`an act of patent infringement under 35 U.S.C. § 271(e)(2) and intends a future course of conduct
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`that includes acts of patent infringement in Delaware. These acts have led and will lead to
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`foreseeable harm and injury to Mayne, a Delaware limited liability company, in Delaware. For
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`example, on information and belief, following approval of ANDA No. 215266, Perrigo will make,
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`use, import, sell, and/or offer for sale the Perrigo ANDA product in the United States, including
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`in Delaware, prior to the expiration of the patent-in-suit.
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`14.
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`Perrigo reported in its 2020 Annual Report its “customers include major global,
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`national, and regional retail drug, supermarket, and mass merchandise chains such as Walmart,
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`Costco, CVS, Target, Walgreens Boots Alliance, Kroger, Dollar General, Sam’s Club, Topco, e-
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`commerce stores including Amazon, and major wholesalers, including McKesson, Amerisource
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`Bergen, and Cardinal Health.” Upon information and belief, Perrigo intends to sell the Perrigo
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`ANDA product through these same retail outlets in Delaware, such as Walmart, Costco, CVS,
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`Target, Walgreens, Dollar General, and Sam’s Club.
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`15.
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`Upon information and belief, Perrigo will market and distribute its Perrigo ANDA
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`product in Delaware, and this product will be prescribed by physicians practicing in this state, and
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`dispensed by pharmacies located in this state, all of which would have a substantial effect on
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`commerce.
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`16.
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`Upon information and belief, Perrigo is part of a corporate family that includes at
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`least twenty-two Delaware entities, which are incorporated in Delaware. Upon information and
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`belief, the Perrigo corporate family as a whole relies on Delaware for its successful business
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`operations.
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`17.
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`Upon information and belief, Perrigo Ireland works in concert with its subsidiary
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`Perrigo Israel to sell, market, and distribute its generic drugs in the United States, including in this
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`district.
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`18.
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`Perrigo Ireland has previously been involved in litigations brought in this judicial
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`district, for example, in Anacor Pharmaceuticals, Inc. v. Ascent Pharmaceuticals, Inc. et al., No.
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`18-cv-1673-RGA (D. Del.); and In re: Kerydin (Tavaborole) Topical Solution 5% Patent
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`Litigation, No. 19-md-02884-RGA (D. Del.).
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`19.
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`Perrigo Israel has previously consented to suit in this judicial district and has
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`availed itself of a Delaware court through the assertion of counterclaims in lawsuits brought in
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`Delaware, for example, in Taro Pharmaceuticals U.S.A., Inc. et al. v. Perrigo Israel
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`4
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`Pharmaceuticals Ltd., No. 14-cv-989-RGA (D. Del.); Sun Pharmaceutical Industries, Inc. et al.
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`v. Perrigo Company et al., No. 18-cv-703-CFC (D. Del.); Stiefel Research Australia Pty. Ltd. v.
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`Perrigo Co. & Perrigo Israel Pharmaceuticals, Ltd., No. 09-cv-758-JJF (D. Del.); Stiefel
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`Laboratories, Inc. et al. v. Perrigo Israel Pharmaceuticals Ltd. & Perrigo Co., No. 10-cv-592-
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`GMS (D. Del.); and Unimed Pharmaceuticals LLC et al. v. Perrigo Co. & Perrigo Israel
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`Pharmaceuticals Ltd., No. 13-cv-236-LPS (D. Del.). Perrigo Israel has further been involved in
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`several litigations in this judicial district, including, for example, KV Pharmaceutical Co. et al. v.
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`Perrigo Israel Pharmaceuticals Ltd. et al., No. 10-cv-641-SLR (D. Del.); Unimed
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`Pharmaceuticals, LLC et al. v. Perrigo Co. et al., No. 14-cv-985 (D. Del.); Unimed
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`Pharmaceuticals, LLC et al. v. Perrigo Co. et al., No. 14-cv-1003 (D. Del.).
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`20.
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`21.
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`Venue is proper in this Court under 28 U.S.C. §§ 1391 and/or 1400(b).
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`Venue is also proper in this District under 28 U.S.C. § 1391(c)(3) because on
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`information and belief, Perrigo Israel is an Israeli corporation and Perrigo Ireland is an Irish
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`company and both are not residents in the United States.
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`THE PATENT-IN-SUIT
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`22.
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`The ’159 patent, titled “Halobetasol Foam Composition and Method of Use
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`Thereof,” was duly and legally issued by the United States Patent and Trademark Office (“PTO”)
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`on December 8, 2020, to Robert T. Gauthier and James D. Hammer. Mayne Pharma, LLC, is
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`listed as the assignee and is currently the sole assignee of the ’159 patent.
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`23.
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`A true and correct copy of the ’159 patent is attached as Exhibit A.
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`PERRIGO’S INFRINGEMENT OF THE PATENT-IN-SUIT
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`24.
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`By a letter dated March 16, 2021, Perrigo Israel notified Mayne that Perrigo had
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`submitted ANDA No. 215266 to the FDA under Section 505(j) of the Federal Food, Drug, and
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`Cosmetic Act (21 U.S.C. § 355(j)) (“Perrigo Notice Letter”).
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`25.
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`The Perrigo Notice Letter provides that Perrigo Israel submitted ANDA No.
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`215266 seeking approval to engage in the commercial manufacture, use, sale, offer for sale, and/or
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`importation of a generic version of LEXETTE prior to the expiration of the patent-in-suit. Upon
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`information and belief, Perrigo intends to engage in the commercial manufacture, use, and sale of
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`the Perrigo ANDA Product, directly or indirectly.
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`26.
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`By filing ANDA No. 215266, Perrigo Israel has necessarily represented to the FDA
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`that the Perrigo ANDA product has the same active ingredient, the same dosage form, and the
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`same strength as LEXETTE and that the Perrigo ANDA product is bioequivalent to LEXETTE.
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`Upon information and belief, Perrigo further intends to market its ANDA product for the same
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`indication as LEXETTE: topical treatment of plaque psoriasis in patients 18 years of age and older.
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`27.
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`The Perrigo Notice Letter provides that the ’159 patent is unenforceable, invalid,
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`and/or not infringed, either literally or under the doctrine of equivalents, by the manufacture, use,
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`sale, offer for sale, and/or importation of the Perrigo ANDA product and that Perrigo Israel has
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`included a Paragraph IV certification in its ANDA pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV).
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`28.
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`The Perrigo Notice Letter further contained a purported detailed statement of the
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`factual and legal basis for its Paragraph IV certification.
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`29.
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`In the Perrigo Notice Letter, Perrigo Israel offered confidential access to portions
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`of its ANDA No. 215266, in specific terms and conditions set forth in the Offer of Confidential
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`Access (“OCA”) included in the Perrigo Notice Letter. Perrigo Israel requested that Mayne accept
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`the OCA before receiving access to its ANDA. The OCA contained unreasonable restrictions well
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`beyond those that would apply under a protective order on who could view the ANDA. For
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`example, the OCA limited access to a single outside law firm. Further, the OCA included a broad
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`patent prosecution bar, which did not have a carve out for inter partes review. The OCA further
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`unreasonably prohibited Mayne from disclosing information to outside scientific consultants or
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`other outside counsel. The requirements Perrigo Israel placed on access to ANDA No. 215266
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`contravene 21 U.S.C. § 355(j)(5)(C)(i)(III), which provides that an offer of confidential access
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`“shall contain such restrictions as to persons entitled to access, and on the use and disposition of
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`any information accessed, as would apply had a protective order been entered for the purpose of
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`protecting trade secrets and other confidential business information.” The parties discussed
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`modifying the OCA but ultimately were unable to reach an agreement that would provide sufficient
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`time to review the ANDA.
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`30.
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`Upon information and belief, the Perrigo ANDA product is covered by the claims
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`of the ’159 patent.
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`31.
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`This action is being brought pursuant to 21 U.S.C. § 355(j)(5)(B)(iii) within forty-
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`five days of Mayne’s receipt of the Perrigo Notice Letter.
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`COUNT I
`(Infringement of the ’159 Patent)
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`32. Mayne re-alleges and incorporates by reference paragraphs 1 through 31 as if fully
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`alleged herein.
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`33.
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`Perrigo’s submission of ANDA No. 215266 to the FDA under section 505(j) of the
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`U.S. Federal Food, Drug, and Cosmetic Act to obtain approval to engage in the commercial
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`manufacture, use, offer to sell, or sale of the Perrigo ANDA product prior to the expiration of the
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`7
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`’159 patent constitutes a technical act of infringement of at least one of the claims of the ’159
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`patent, either literally or under the doctrine of equivalents, under 35 U.S.C. § 271(e)(2)(A).
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`34.
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`Unless enjoined by the Court, upon FDA approval of Perrigo’s ANDA No. 215266,
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`upon information and belief, Perrigo will infringe one or more claims of the ’159 patent, either
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`literally or under the doctrine of equivalents, by making, using, offering to sell, and selling the
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`Perrigo ANDA product in the United States and/or importing said product into the United States,
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`and/or by actively inducing and contributing to infringement of the ’159 patent by others.
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`35.
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`If Perrigo’s marketing and sale of the Perrigo ANDA product prior to expiration of
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`the ’159 patent and all other relevant exclusivities are not enjoined, Mayne will suffer substantial
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`and irreparable harm for which there is no remedy at law.
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`36.
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`Perrigo had actual and constructive notice of the ’159 patent prior to filing ANDA
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`No. 215266 and was aware that the filing of the ANDA with the request for FDA approval prior
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`to the expiration of the ’159 patent would constitute an act of infringement of the ’159 patent.
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`Perrigo had no reasonable basis for asserting that the commercial manufacture, use, offer for sale,
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`or sale of the Perrigo ANDA product will not contribute to the infringement of and/or induce the
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`infringement of the ’159 patent.
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`37.
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`Perrigo’s Detailed Statement in the Notice Letter lacks any sufficient contention
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`that the Perrigo ANDA product will not infringe, contribute to the infringement of, or induce the
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`infringement of the ’159 patent.
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`38.
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`In addition, Perrigo filed ANDA No. 215266 without adequate justification for
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`asserting the ’159 patent to be invalid, unenforceable, and/or not infringed by the commercial
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`manufacture, use, offer for sale, or sale of the Perrigo ANDA product. Perrigo’s conduct in
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`certifying invalidity, unenforceability, and/or non-infringement with respect to the ’159 patent
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`renders this case “exceptional” under 35 U.S.C. § 285.
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`39. Mayne will be irreparably harmed if Perrigo is not enjoined from infringing, and
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`from actively inducing or contributing to the infringement of the ’159 patent. Mayne does not
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`have an adequate remedy at law, and considering the balance of hardships between Mayne and
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`Perrigo, a remedy in equity is warranted. Further, the public interest would not be disserved by
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`the entry of a permanent injunction.
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`COUNT II
`(Declaratory Judgment of Infringement of the ’159 Patent)
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`40. Mayne re-alleges and incorporates by reference paragraphs 1 through 39 as if
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`fully alleged herein.
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`41. Mayne’s claims also arise under the Declaratory Judgment Act, in the State of
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`Delaware, by or through Perrigo and its affiliates.
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`42.
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`The commercial manufacture, use, offer to sell, or sale of the Perrigo ANDA
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`product prior to the expiration of the ’159 patent will constitute direct infringement of one or
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`more claims of the ’159 patent under 35 U.S.C. § 271(a).
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`43.
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`On information and belief, Perrigo knows that health care professionals or
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`patients will use the Perrigo ANDA product in accordance with the labeling sought by ANDA
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`No. 215266, and Perrigo will therefore contribute to the infringement of and/or induce the
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`infringement of one or more claims of the ’159 patent under one or more of 35 U.S.C. §§ 271 (b)
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`and (c).
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`44.
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`On information and belief, Perrigo’s infringing activity, including the commercial
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`manufacture, use, offer to sell, sale, or importation of the Perrigo ANDA product complained of
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`herein will begin immediately after the FDA approves the ANDA No. 215266. Any such
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`conduct before the ’159 patent expires will contribute to the infringement of and/or induce the
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`infringement of one or more claims of the ’159 patent under one or more of 35 U.S.C. §§ 271 (b)
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`and (c).
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`45.
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`As a result of the foregoing facts, there is a real, substantial, and continuing
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`justiciable controversy between Mayne and Perrigo concerning liability for the infringement of
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`the ’159 patent for which this Court may grant declaratory relief consistent with Article III of the
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`United States Constitution.
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`46. Mayne will be substantially and irreparably harmed by Perrigo’s infringing
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`activities unless those activities are enjoined by this Court. Mayne may not have adequate
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`remedy at law.
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`47.
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`This case is exceptional, and Mayne is entitled to an award of attorneys’ fees
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`under 35 U.S.C. § 285.
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`REQUEST FOR RELIEF
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`WHEREFORE, Mayne respectfully requests the following relief:
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`A.
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`A judgment that the claims of the ’159 patent are not invalid, are not unenforceable,
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`and are infringed by Perrigo’s submission of ANDA No. 215266 under 35 U.S.C. § 271(e)(2)(A);
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`B.
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`A declaratory judgment that the claims of the ’159 patent are not invalid, are not
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`unenforceable, and that Perrigo’s commercial manufacture, use, offer for sale, or sale in, or
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`importation into, the United States of the Perrigo ANDA product, or inducing or contributing to
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`such conduct, would constitute infringement of one or more claims of the ’159 patent under 35
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`U.S.C. §§ 271(a), (b), and/or (c);
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`10
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`C.
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`A permanent injunction, pursuant to 35 U.S.C. § 271(e)(4)(B), restraining and
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`enjoining Perrigo, its affiliates and subsidiaries, and all persons and entities acting in concert with
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`Perrigo from commercially manufacturing, using, offering for sale, selling, or importing any
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`product that infringes the ’159 patent, including the Perrigo ANDA product;
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`D.
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`The entry of an order, pursuant to 35 U.S.C. § 271(e)(4)(A), that the effective date
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`of any FDA approval of ANDA No. 215266 shall be no earlier than the expiration date of the ’159
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`patent, or any later expiration of exclusivity for the ’159 patent, including any extensions or
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`regulatory exclusivities;
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`E.
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`An award of damages or other relief, pursuant to 35 U.S.C. § 271(e)(4)(C), if
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`Perrigo engages in the commercial manufacture, use, offer for sale, sale, and/or importation of the
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`Perrigo ANDA product, or any product that infringes the ’159 patent, or induces or contributes to
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`such conduct, prior to the expiration of the ’159 patent;
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`F.
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`The entry of judgment declaring that Perrigo’s acts render this case an exceptional
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`case, and awarding Mayne its attorneys’ fees pursuant to 35 U.S.C. §§ 271(e)(4) and 285;
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`G.
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`H.
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`An award to Mayne of its costs and expenses in this action; and
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`Such other and further relief as the Court may deem just and proper.
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`Dated: April 29, 2021
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`K&L GATES LLP
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`
`
`/s/ Steven L. Caponi
`Steven L. Caponi (No. 3484)
`Matthew B. Goeller (No. 6283)
`600 N. King Street, Suite 901
`Wilmington, DE 19801
`Phone: (302) 416-7080
`steven.caponi@klgates.com
`matthew.goeller@klgates.com
`
`Counsel for Mayne Pharma LLC
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`11
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