Case 1:21-cv-00498-UNA Document 1 Filed 04/05/21 Page 1 of 23 PageID #: 1
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`EPI HEALTH, LLC and ALLERGAN, INC.,
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`Plaintiffs,
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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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` )
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`v.
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`PERRIGO UK FINCO LIMITED
`PARTNERSHIP,
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`Defendant.
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`COMPLAINT FOR PATENT INFRINGEMENT
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`Plaintiffs EPI Health, LLC (“EPI Health”) and Allergan, Inc. (“Allergan”) (EPI Health and
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`Allergan, collectively, “Plaintiffs”), by their attorneys, 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 patent laws of the United
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`States, Title 35, United States Code, against Defendant Perrigo UK FINCO Limited Partnership
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`(“Perrigo”). This action relates to Abbreviated New Drug Application (“ANDA”) No. 211942
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`submitted by Perrigo to the U.S. Food and Drug Administration (“FDA”).
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`In ANDA No. 211942, Perrigo seeks approval to market an oxymetazoline cream
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`product (the “Perrigo ANDA Product”), a generic version of RHOFADE® (oxymetazoline HCl)
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`cream, 1%, prior to expiration of U.S. Patent Nos. 7,812,049 (the “’049 patent”); 8,420,688 (the
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`“’688 patent”); 8,815,929 (the “’929 patent”); 8,883,838 (the “’838 patent”); 9,974,773 (the “’773
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`patent”); 10,335,391 (the “’391 patent”), and 10,751,325 (the “’325 patent”). The ’049 patent,
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`’688 patent, ’929 patent, ’838 patent, ’773 patent, ’391 patent, and ’325 patent are collectively
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`referred to herein as the “Patents-in-Suit.”
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`PARTIES
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`Plaintiff EPI Health, LLC is a limited liability company organized and existing
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`under the laws of South Carolina with its headquarters at 134 Columbus St., Charleston,
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`South Carolina 29403.
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`EPI Health is a specialty pharmaceutical company focused on acquiring,
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`developing and marketing prescription medical dermatological products. RHOFADE® is a
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`product marketed by EPI Health for the treatment of persistent facial redness associated with
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`rosacea. EPI Health sells RHOFADE® in this judicial district and throughout the United States.
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`Plaintiff Allergan, Inc. is a corporation organized and existing under the laws of
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`Delaware with a place of business at 2525 DuPont Drive, Irvine, California 92612.
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`Allergan, Inc. is an affiliate of AbbVie Inc., a global research and development-
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`based biopharmaceutical company incorporated in Delaware and with its principal place of
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`business at 1 North Waukegan Road, North Chicago, Illinois 60064-6400. Allergan brought
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`RHOFADE® to the market in 2017.
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`On information and belief, Defendant Perrigo UK FINCO Limited Partnership is a
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`corporation organized and existing under the laws of the United Kingdom, having its principal
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`place of business at Wrafton, Braunton Devon, EX33 2DL, United Kingdom.
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`JURISDICTION AND VENUE
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`This case arises under the patent laws of the United States, 35 U.S.C. §§ 100, et
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`seq. This Court has jurisdiction over its subject matter under 28 U.S.C. §§ 1331, 1338(a), 2201,
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`and 2202.
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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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`2
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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 Plaintiffs, including Delaware corporation Allergan, in Delaware.
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`For example, on information and belief, following approval of ANDA No. 211942, Perrigo will
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`make, use, import, sell, and/or offer for sale the Perrigo ANDA Product in the United States,
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`including in Delaware, prior to the expiration of the Patents-in-Suit.
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`This Court also has jurisdiction over Perrigo because, inter alia, this action arises
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`from actions of Perrigo directed toward Delaware, and because Perrigo 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. On information and belief, Perrigo regularly and continuously transacts business
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`within Delaware, including by selling pharmaceutical products in Delaware either directly or
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`indirectly through affiliated companies. On information and belief, Perrigo derives substantial
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`revenue from the sale of those products in Delaware and has availed itself of the privilege of
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`conducting business within Delaware.
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`Venue is proper against Perrigo in this District under 28 U.S.C. §§ 1391(c)(3)
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`and/or 1400(b), because venue in a patent infringement action against a foreign defendant is proper
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`in any judicial district. TC Heartland LLC v. Kraft Foods Grp. Brands LLC, 137 S. Ct. 1514, 1520
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`n.2 (2017) (citing Brunette Mach. Works, Ltd. v. Kochum Indus., Inc., 406 U.S. 706, 711-714
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`(1972)).
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`Perrigo, through its counsel, by e-mail dated March 22, 2021, agreed that Perrigo
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`does not contest jurisdiction or venue in this Court for purposes of this case.
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`PATENTS-IN-SUIT
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`On October 12, 2010, the U.S. Patent and Trademark Office duly and legally issued
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`the ’049 patent, titled “Method and Therapeutic/Cosmetic Topical Compositions for the Treatment
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`3
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`of Rosacea and Skin Erythema Using α1-Adrenoceptor Agonists.” A true and correct copy of the
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`’049 patent is attached hereto as Exhibit A. The claims of the ’049 patent are valid, enforceable,
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`and not expired. Allergan is the owner of the ’049 patent, and EPI Health is the exclusive licensee
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`of the ’049 patent.
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`On April 16, 2013, the U.S. Patent and Trademark Office duly and legally issued
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`the ’688 patent, titled “Method and Therapeutic/Cosmetic Topical Compositions for the Treatment
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`of Rosacea and Skin Erythema Using α1-Adrenoceptor Agonists.” A true and correct copy of the
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`’688 patent is attached hereto as Exhibit B. The claims of the ’688 patent are valid, enforceable,
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`and not expired. Allergan is the owner of the ’688 patent, and EPI Health is the exclusive licensee
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`of the ’688 patent.
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`On August 26, 2014, the U.S. Patent and Trademark Office duly and legally issued
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`the ’929 patent, titled “Method and Therapeutic/Cosmetic Topical Compositions for the Treatment
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`of Rosacea and Skin Erythema Using α1-Adrenoceptor Agonists.” A true and correct copy of the
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`’929 patent is attached hereto as Exhibit C. The claims of the ’929 patent are valid, enforceable,
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`and not expired. Allergan is the owner of the ’929 patent, and EPI Health is the exclusive licensee
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`of the ’929 patent.
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`On November 11, 2014, the U.S. Patent and Trademark Office duly and legally
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`issued the ’838 patent, titled “Pharmaceutical Cream Compositions and Methods of Use.” A true
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`and correct copy of the ’838 patent is attached hereto as Exhibit D. The claims of the ’838 patent
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`are valid, enforceable, and not expired. EPI Health is the owner of the ’838 patent.
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`On May 22, 2018, the U.S. Patent and Trademark Office duly and legally issued
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`the ’773 patent, titled “Stabilized Oxymetazoline Formulations and Their Uses.” A true and
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`4
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`correct copy of the ’773 patent is attached hereto as Exhibit E. The claims of the ’773 patent are
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`valid, enforceable, and not expired. EPI Health is the owner of the ’773 patent.
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`On July 2, 2019, the U.S. Patent and Trademark Office duly and legally issued the
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`’391 patent, titled “Stabilized Oxymetazoline Formulations and Their Uses.” A true and correct
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`copy of the ’391 patent is attached hereto as Exhibit F. The claims of the ’391 patent are valid,
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`enforceable, and not expired. EPI Health is the owner of the ’391 patent.
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`On August 25, 2020, the U.S. Patent and Trademark Office duly and legally issued
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`the ’325 patent, titled “Stabilized Oxymetazoline Formulations and Their Uses.” A true and
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`correct copy of the ’325 patent is attached hereto as Exhibit G. The claims of the ’325 patent are
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`valid, enforceable, and not expired. EPI Health is the owner of the ’325 patent.
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`EPI Health is the holder of New Drug Application (“NDA”) No. 208552, by which
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`FDA granted approval for the marketing and sale of a 1% oxymetazoline hydrochloride cream.
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`EPI Health markets 1% oxymetazoline hydrochloride cream in the United States, under the trade
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`name “RHOFADE®.” The FDA’s official publication of approved drugs, Approved Drug
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`Products with Therapeutic Equivalence Evaluations (the “Orange Book”), lists the Patents-in-Suit
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`for RHOFADE®.
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`The active ingredient of RHOFADE® is an alpha1A adrenoceptor agonist used on
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`the skin (topically) of the face to treat persistent facial redness, also referred to as erythema,
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`associated with rosacea in adults. RHOFADE® is a vasoconstrictor and works by constricting
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`facial blood vessels to reduce facial redness associated with rosacea.
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`The prescribing information for RHOFADE® identifies the product as including
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`“an alpha1A adrenoceptor agonist indicated for the topical treatment of persistent facial erythema
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`associated with rosacea in adults.”
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`INFRINGEMENT BY PERRIGO
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`By a letter dated February 23, 2021 (the “Rhofade Notice Letter”), Perrigo notified
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`Plaintiffs that Perrigo had submitted ANDA No. 211942 to FDA under Section 505(j) of the
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`Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 355(j)).
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`The Rhofade Notice Letter states that Perrigo has submitted ANDA No. 211942
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`under 21 U.S.C. § 355(j) to engage in the commercial manufacture, use, importation, offer for sale,
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`or sale of the Perrigo ANDA Product before the expiration of all Patents-in-Suit.
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`On information and belief, Perrigo intends to—directly or indirectly—engage in
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`the commercial manufacture, use, importation, and/or sale of the Perrigo ANDA Product.
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`By submitting ANDA No. 211942 to the FDA, Perrigo has necessarily represented
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`to the FDA that the Perrigo ANDA Product has the same active ingredient as RHOFADE®, has
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`the same dosage form and strength as RHOFADE®, and is bioequivalent to RHOFADE®.
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`On information and belief, Perrigo is seeking approval to market the Perrigo ANDA
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`Product for the same approved indication as RHOFADE®.
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`On information and belief, ANDA No. 211942 includes a proposed package insert
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`with directions that instruct patients to administer and/or use and medical practitioners to prescribe
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`and/or administer the Perrigo ANDA Product.
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`On information and belief, the proposed package insert for the Perrigo ANDA
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`Product will include the same active ingredient, dosage strength, dosage form, and labeling
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`(including condition of use and dosing) as RHOFADE®, including an active ingredient of
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`oxymetazoline, a dosage strength of 1%, a dosage form of a topical cream, and an indication for
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`the topical treatment of persistent facial erythema associated with rosacea in adults with a once-
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`daily dose. The Rhofade Notice Letter fails to provide information about the formulation of the
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`6
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`proposed product subject to ANDA No. 211942. For example, apart from the active ingredient,
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`the Rhofade Notice Letter does not list any of the ingredients in the proposed generic product, or
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`the amount of any of those ingredients.
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`In the Rhofade Notice Letter, Perrigo alleged that the Patents-in-Suit are invalid,
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`unenforceable, and/or will not be infringed by the commercial manufacture, use, and sale of the
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`Perrigo ANDA Product.
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`Perrigo offered confidential access to portions of its ANDA No. 211942, on terms
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`and conditions set forth in the Rhofade Notice Letter (“the Perrigo Offer”). Perrigo requested that
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`Plaintiffs accept the Perrigo Offer before receiving access to Perrigo’s ANDA No. 211942. The
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`Perrigo Offer contained unreasonable restrictions well beyond those that would apply under a
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`protective order on who could view the ANDA. For example, the Perrigo Offer contained a broad
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`patent prosecution bar, which, among other things, does not have a carve out for inter partes
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`reviews, and a broad bar on any work related to actions before FDA. The Perrigo Offer
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`unreasonably restricted the ability of counsel to seek the opinions of Allergan’s or EPI Health’s
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`employees and outside experts. The Perrigo offer also unreasonably would have prevented
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`Plaintiffs from incorporating and relying on confidential information in this Complaint. The
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`restrictions Perrigo has placed on access to ANDA No. 211942 contravene 21 U.S.C.
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`§ 355(j)(5)(C)(i)(III), which states that an offer of confidential access “shall contain such
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`restrictions as to persons entitled to access, and on the use and disposition of any information
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`accessed, as would apply had a protective order been entered for the purpose of protecting trade
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`secrets and other confidential business information” (emphasis added).
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`Perrigo has not provided Plaintiffs with a sample of the Perrigo ANDA Product or
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`information that would assist Plaintiffs in confirming the formulation of the Perrigo ANDA
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`Product. The Perrigo ANDA Product is not commercially available, and Plaintiffs are unable to
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`obtain a sample of the Perrigo ANDA Product. In the absence of such information, Plaintiffs resort
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`to the judicial process and the aid of discovery to obtain under appropriate judicial safeguards such
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`information as is required to present to the Court evidence regarding whether Perrigo infringes one
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`or more claims of at least the ’838 patent.
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`Plaintiffs bring this action pursuant to 21 U.S.C. § 355(j)(5)(B)(iii) within forty-
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`five days of receipt of the Rhofade Notice Letter. See 21 U.S.C. § 355(c)(3)(C).
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`COUNT I
`INFRINGEMENT OF U.S. PATENT NO. 7,812,049
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`Each of the preceding paragraphs 1 to 33 is incorporated as if fully set forth herein.
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`Perrigo’s submission of ANDA No. 211942 to obtain approval to engage in the
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`commercial manufacture, use, importation, offer to sell, or sale of the Perrigo ANDA Product prior
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`to the expiration of the ’049 patent constituted a technical act of infringement of at least one claim
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`of the ’049 patent, either literally or under the doctrine of equivalents, including but not limited to
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`claim 1, under 35 U.S.C. § 271(e)(2)(A). In the Rhofade Notice Letter, Perrigo has not contested
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`the infringement of multiple claims of the ’049 patent, including at least claim1.
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`Perrigo’s commercial manufacture, use, offer to sell, sale, or importation of the
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`Perrigo ANDA Product prior to the expiration of the ’049 patent, and/or its inducement of or
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`contribution to such conduct, would further infringe at least one claim of the ’049 patent, including
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`at least claim 1, under at least 35 U.S.C. §§ 271(b) and/or (c).
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`Upon FDA approval of Perrigo’s ANDA No. 211942, Perrigo will infringe one or
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`more claims of the ’049 patent, including at least claim 1, by making, using, offering to sell, and
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`selling the Perrigo ANDA Product in the United States and/or importing said product into the
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`8
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`United States, and/or by actively inducing or contributing to infringement of the ’049 patent by
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`others, under at least 35 U.S.C. §§ 271(b) and/or (c), unless enjoined by the Court.
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`On information and belief, Perrigo specifically intends to actively induce
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`infringement by others of one or more claims of the ’049 patent. On information and belief,
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`Perrigo has filed an ANDA that includes a proposed package insert with directions that instruct
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`patients to administer and/or use and medical practitioners to prescribe and/or administer the
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`Perrigo ANDA Product.
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`On information and belief, the proposed package insert includes that the Perrigo
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`ANDA Product is indicated for the topical treatment of persistent facial erythema associated with
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`rosacea in adults, the active ingredient in Perrigo’s ANDA Product is oxymetazoline, its dosage
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`strength is 1%, and its proposed dosage form is a topical cream. On information and belief, the
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`proposed package insert for the Perrigo ANDA Product includes information indicating that the
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`Perrigo ANDA Product will effectively decrease erythema resulting from rosacea.
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`On information and belief, Perrigo is aware, has knowledge, and/or is willfully
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`blind to the fact that patients will administer and/or use and medical practitioners will prescribe
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`and/or administer the Perrigo ANDA Product at least according to Perrigo’s proposed package
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`insert and, therefore, will directly infringe at least one claim of the ’049 patent.
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`On information and belief, Perrigo will knowingly or with willful blindness induce
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`another’s direct infringement of at least one claim of the ’049 patent, by at least Perrigo’s proposed
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`package insert for the Perrigo ANDA Product.
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`On information and belief, Perrigo knows that the Perrigo ANDA Product and its
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`proposed labeling are especially made or adapted for use in infringing the ’049 patent, and that the
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`Perrigo ANDA Product and its proposed labeling are not suitable for substantial non-infringing
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`use. On information and belief, Perrigo plans and intends to, and will contribute to the
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`infringement of the ’049 patent under 35 U.S.C. § 271(c) immediately and imminently upon
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`approval of ANDA No. 211942.
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`Perrigo has knowledge of and is aware of the ’049 patent, including due to
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`RHOFADE®’s Orange Book entry listing the Patents-in-Suit and the filing of this Complaint.
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`If Perrigo’s marketing and sale of the Perrigo ANDA Product prior to expiration of
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`the ’049 patent and all other relevant exclusivities are not enjoined, Plaintiffs will suffer substantial
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`and irreparable harm for which there is no remedy at law.
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`COUNT II
`INFRINGEMENT OF U.S. PATENT NO. 8,420,688
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`Each of the preceding paragraphs 1 to 44 is incorporated as if fully set forth herein.
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`Perrigo’s submission of ANDA No. 211942 to obtain approval to engage in the
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`commercial manufacture, use, importation, offer to sell, or sale of the Perrigo ANDA Product prior
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`to the expiration of the ’688 patent constituted a technical act of infringement of at least one claim
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`of the ’688 patent, either literally or under the doctrine of equivalents, including but not limited to
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`claim 1, under 35 U.S.C. § 271(e)(2)(A). In the Rhofade Notice Letter, Perrigo has not contested
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`the infringement of multiple claims of the ’688 patent, including at least claim 1.
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`Perrigo’s commercial manufacture, use, offer to sell, sale, or importation of the
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`Perrigo ANDA Product prior to the expiration of the ’688 patent, and/or its inducement of or
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`contribution to such conduct, would further infringe at least one claim of the ’688 patent, including
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`at least claim 1, under at least 35 U.S.C. §§ 271(b) and/or (c).
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`Upon FDA approval of Perrigo’s ANDA No. 211942, Perrigo will infringe one or
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`more claims of the ’688 patent, including at least claim 1, by making, using, offering to sell, and
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`selling the Perrigo ANDA Product in the United States and/or importing said product into the
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`10
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`United States, and/or by actively inducing or contributing to infringement of the ’688 patent by
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`others, under at least 35 U.S.C. §§ 271(b) and/or (c), unless enjoined by the Court.
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`On information and belief, Perrigo specifically intends to actively induce
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`infringement by others of one or more claims of the ’688 patent. On information and belief,
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`Perrigo has filed an ANDA that includes a proposed package insert with directions that instruct
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`patients to administer and/or use and medical practitioners to prescribe and/or administer the
`
`Perrigo ANDA Product.
`
`
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`On information and belief, the proposed package insert includes that the Perrigo
`
`ANDA Product is indicated for the topical treatment of persistent facial erythema associated with
`
`rosacea in adults, the active ingredient in Perrigo’s ANDA Product is oxymetazoline, its dosage
`
`strength is 1%, and its proposed dosage form is a topical cream. On information and belief, Perrigo
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`is aware, has knowledge, and/or is willfully blind to the fact that patients will administer and/or
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`use and medical practitioners will prescribe and/or administer the Perrigo ANDA Product at least
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`according to Perrigo’s proposed package insert and, therefore, will directly infringe at least one
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`claim of the ’688 patent.
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`On information and belief, Perrigo will knowingly or with willful blindness induce
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`another’s direct infringement of at least one claim of the ’688 patent, by at least Perrigo’s proposed
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`package insert for the Perrigo ANDA Product.
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`On information and belief, Perrigo knows that the Perrigo ANDA Product and its
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`proposed labeling are especially made or adapted for use in infringing the ’688 patent, and that the
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`Perrigo ANDA Product and its proposed labeling are not suitable for substantial non-infringing
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`use. On information and belief, Perrigo plans and intends to, and will contribute to the
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`infringement of the ’688 patent under 35 U.S.C. § 271(c) immediately and imminently upon
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`approval of ANDA No. 211942.
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`Perrigo has knowledge of and is aware of the ’688 patent, including due to
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`RHOFADE®’s Orange Book entry listing the Patents-in-Suit and the filing of this Complaint.
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`If Perrigo’s marketing and sale of the Perrigo ANDA Product prior to expiration of
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`the ’688 patent and all other relevant exclusivities are not enjoined, Plaintiffs will suffer substantial
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`and irreparable harm for which there is no remedy at law.
`
`COUNT III
`INFRINGEMENT OF U.S. PATENT NO. 8,815,929
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`Each of the preceding paragraphs 1 to 54 is incorporated as if fully set forth herein.
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`Perrigo’s submission of ANDA No. 211942 to obtain approval to engage in the
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`
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`commercial manufacture, use, importation, offer to sell, or sale of the Perrigo ANDA Product prior
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`to the expiration of the ’929 patent constituted a technical act of infringement of at least one claim
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`of the ’929 patent, either literally or under the doctrine of equivalents, including but not limited to
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`claim 1, under 35 U.S.C. § 271(e)(2)(A). In the Rhofade Notice Letter, Perrigo has not contested
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`the infringement of multiple claims of the ’929 patent, including at least claim 1.
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`
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`Perrigo’s commercial manufacture, use, offer to sell, sale, or importation of the
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`Perrigo ANDA Product prior to the expiration of the ’929 patent, and/or its inducement of or
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`contribution to such conduct, would further infringe at least one claim of the ’929 patent, including
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`at least claim 1, under at least 35 U.S.C. §§ 271(b) and/or (c).
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`
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`Upon FDA approval of Perrigo’s ANDA No. 211942, Perrigo will infringe one or
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`more claims of the ’929 patent, including at least claim 1, by making, using, offering to sell, and
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`selling the Perrigo ANDA Product in the United States and/or importing said product into the
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`12
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`United States, and/or by actively inducing or contributing to infringement of the ’929 patent by
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`others, under at least 35 U.S.C. §§ 271(b) and/or (c), unless enjoined by the Court.
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`
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`On information and belief, Perrigo specifically intends to actively induce
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`infringement by others of one or more claims of the ’929 patent. On information and belief,
`
`Perrigo has filed an ANDA that includes a proposed package insert with directions that instruct
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`patients to administer and/or use and medical practitioners to prescribe and/or administer the
`
`Perrigo ANDA Product.
`
`
`
`On information and belief, the proposed package insert includes that the Perrigo
`
`ANDA Product is indicated for the topical treatment of persistent facial erythema associated with
`
`rosacea in adults, the active ingredient in Perrigo’s ANDA Product is oxymetazoline, its dosage
`
`strength is 1%, and its proposed dosage form is a topical cream.
`
`
`
`On information and belief, Perrigo is aware, has knowledge, and/or is willfully
`
`blind to the fact that patients will administer and/or use and medical practitioners will prescribe
`
`and/or administer the Perrigo ANDA Product at least according to Perrigo’s proposed package
`
`insert and, therefore, will directly infringe at least one claim of the ’929 patent.
`
`
`
`On information and belief, Perrigo will knowingly or with willful blindness induce
`
`another’s direct infringement of at least one claim of the ’929 patent, by at least Perrigo’s proposed
`
`package insert for the Perrigo ANDA Product.
`
`
`
`On information and belief, Perrigo knows that the Perrigo ANDA Product and its
`
`proposed labeling are especially made or adapted for use in infringing the ’929 patent, and that the
`
`Perrigo ANDA Product and its proposed labeling are not suitable for substantial non-infringing
`
`use. On information and belief, Perrigo plans and intends to, and will contribute to the
`
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`Case 1:21-cv-00498-UNA Document 1 Filed 04/05/21 Page 14 of 23 PageID #: 14
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`infringement of the ’929 patent under 35 U.S.C. § 271(c) immediately and imminently upon
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`approval of ANDA No. 211942.
`
`
`
`Perrigo has knowledge of and is aware of the ’929 patent, including due to
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`RHOFADE®’s Orange Book entry listing the Patents-in-Suit and the filing of this Complaint.
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`
`
`If Perrigo’s marketing and sale of the Perrigo ANDA Product prior to expiration of
`
`the ’929 patent and all other relevant exclusivities are not enjoined, Plaintiffs will suffer substantial
`
`and irreparable harm for which there is no remedy at law.
`
`COUNT IV
`INFRINGEMENT OF U.S. PATENT NO. 8,883,838
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`Each of the preceding paragraphs 1 to 65 is incorporated as if fully set forth herein.
`
`Perrigo’s submission of ANDA No. 211942 to obtain approval to engage in the
`
`
`
`
`
`commercial manufacture, use, importation, offer to sell, or sale of the Perrigo ANDA Product prior
`
`to the expiration of the ’838 patent constituted a technical act of infringement of at least one claim
`
`of the ’838 patent, either literally or under the doctrine of equivalents, including but not limited to
`
`claim 1, under 35 U.S.C. § 271(e)(2)(A). In the Rhofade Notice Letter, Perrigo has not contested
`
`the infringement of multiple claims of the ’838 patent, including at least claim 1.
`
`
`
`On information and belief, Perrigo’s commercial manufacture, use, offer to sell,
`
`sale, or importation of the Perrigo ANDA Product prior to the expiration of the ’838 patent and/or
`
`its inducement of or contribution to such conduct, would further infringe at least one claim of the
`
`’838 patent, including at least claim 1, under at least 35 U.S.C. § 271(a), either literally or under
`
`the doctrine of equivalents. For at least one claim, Perrigo’s failure to provide sufficient
`
`information regarding its ANDA and unreasonable restrictions on obtaining access to its ANDA
`
`have prevented Plaintiffs from learning additional facts that would support this allegation. In the
`
`absence of sufficient information regarding Perrigo’s ANDA, Plaintiffs resort to the judicial
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`Case 1:21-cv-00498-UNA Document 1 Filed 04/05/21 Page 15 of 23 PageID #: 15
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`
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`process and the aid of discovery to obtain under appropriate judicial safeguards such information
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`as is required to present to the Court evidence that Perrigo infringes certain claims of the ’838
`
`patent.
`
`
`
`On information and belief, upon FDA approval of Perrigo’s ANDA No. 211942,
`
`Perrigo will infringe one or more claims of the ’838 patent, including at least claim 1, by making,
`
`using, offering to sell, and selling the Perrigo ANDA Product in the United States and/or importing
`
`said product into the United States, and/or by actively inducing or contributing to infringement of
`
`the ’838 patent by others, under at least 35 U.S.C. § 271(a), unless enjoined by the Court.
`
`
`
`On information and belief, if Perrigo’s marketing and sale of the Perrigo ANDA
`
`Product prior to expiration of the ’838 patent and all other relevant exclusivities are not enjoined,
`
`Plaintiffs will suffer substantial and irreparable harm for which there is no remedy at law.
`
`COUNT V
`INFRINGEMENT OF U.S. PATENT NO. 9,974,773
`
`Each of the preceding paragraphs 1 to 70 is incorporated as if fully set forth herein.
`
`Perrigo’s submission of ANDA No. 211942 to obtain approval to engage in the
`
`
`
`
`
`commercial manufacture, use, importation, offer to sell, or sale of the Perrigo ANDA Product prior
`
`to the expiration of the ’773 patent constituted a technical act of infringement of at least one claim
`
`of the ’773 patent, either literally or under the doctrine of equivalents, including but not limited to
`
`claim 1, under 35 U.S.C. § 271(e)(2)(A). In the Rhofade Notice Letter, Perrigo has not contested
`
`the infringement of multiple claims of the ’773 patent, including at least claim 1.
`
`
`
`Perrigo’s commercial manufacture, use, offer to sell, sale, or importation of the
`
`Perrigo ANDA Product prior to the expiration of the ’773 patent, and/or its inducement of or
`
`contribution to such conduct, would further infringe at least one claim of the ’773 patent, including
`
`at least claim 1, under at least 35 U.S.C. §§ 271(b) and/or (c).
`
`15
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`Case 1:21-cv-00498-UNA Document 1 Filed 04/05/21 Page 16 of 23 PageID #: 16
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`
`
`
`Upon FDA approval of Perrigo’s ANDA No. 211942, Perrigo will infringe one or
`
`more claims of the ’773 patent, including at least claim 1, by making, using, offering to sell, and
`
`selling the Perrigo ANDA Product in the United States and/or importing said product into the
`
`United States, and/or by actively inducing or contributing to infringement of the ’773 patent by
`
`others, under at least 35 U.S.C. §§ 271(b) and/or (c), unless enjoined by the Court.
`
`
`
`On information and belief, Perrigo specifically intends to actively induce
`
`infringement by others of one or more claims of the ’773 patent. On information and belief,
`
`Perrigo has filed an ANDA that includes a proposed package insert with directions that instruct
`
`patients to administer and/or use and medical practitioners to prescribe and/or administer the
`
`Perrigo ANDA Product.
`
`
`
`On information and belief, the proposed package insert includes that the Perrigo
`
`ANDA Product is indicated for the topical treatment of persistent facial erythema associated with
`
`rosacea in adults, the active ingredient in Perrigo’s ANDA Product is oxymetazoline, its dosage
`
`strength is 1%, the Perrigo ANDA product should be administered once daily on the face, and that
`
`its proposed dosage form is a topical cream.
`
`
`
`On information and belief, Perrigo is aware, has knowledge, and/or is willfully
`
`blind to the fact that patients will administer and/or use and medical practitioners will prescribe
`
`and/or administer the Perrigo ANDA Product at least according to Perrigo’s proposed package
`
`insert and, therefore, will directly infringe at least one claim of the ’773 patent.
`
`
`
`On information and belief, Perrigo will knowingly or with willful blindness induce
`
`another’s direct infringement of at least one claim of the ’773 patent, by at least Perrigo’s proposed
`
`package insert for the Perrigo ANDA Product.
`
`16
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`Case 1:21-cv-00498-UNA Document 1 Filed 04/05/21 Page 17 of 23 PageID #: 17
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`
`
`
`
`On information and belief, Perrigo knows that the Perrigo ANDA Product and its
`
`proposed labeling are especially made or adapted for use in infringing the ’773 patent, and that the
`
`Perrigo ANDA Product and its proposed labeling are not suitable for substantial non-infringing
`
`use. On information and belief, Perrigo plans and intends to, and will contribute to the
`
`infringement of the ’773 patent under 35 U.S.C. § 271(c) immediately and imminently upon
`
`approval of ANDA No. 211942.
`
`
`
`Perrigo ha