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Case 1:20-cv-01677-UNA Document 1 Filed 12/10/20 Page 1 of 22 PageID #: 1
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
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`
`SEBELA PHARMACEUTICALS INC., and
`PERRIGO NEW YORK, INC.
`
`Plaintiffs,
`
`v.
`
`
`
` C.A. No. _________
`
` JURY TRIAL DEMANDED
`
`
`TRUPHARMA, LLC,
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`
`
`Defendants.
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`Plaintiffs Sebela Pharmaceuticals Inc. and Perrigo New York, Inc. for their Complaint
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`COMPLAINT
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`
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`
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`against Defendant TruPharma, LLC hereby state and allege as follows:
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`PARTIES
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`1.
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`Plaintiff Sebela is a corporation organized under the laws of the State of Delaware
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`with a principal place of business in Roswell, Georgia.
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`2.
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`Plaintiff Perrigo is organized under the laws of the state of Delaware with a
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`principal place of business in Allegan, Michigan.
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`3.
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`Upon information and belief, Defendant TruPharma is a limited liability company
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`organized under the laws of Delaware with an address of 4100 West Kennedy Boulevard, Suite
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`220, Tampa, FL, 33609.
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`4.
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`Upon information and belief, TruPharma is a privately owned pharmaceutical
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`company, whose products are advertised and marketed through all major distribution channels in
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`the United States.
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`

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`5.
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`Upon information and belief, Doe TruPharma is other persons or entities involved
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`in the false and misleading activities alleged herein.
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`JURISDICTION AND VENUE
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`6.
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`This Court has subject matter jurisdiction over the claims asserted herein pursuant
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`to 28 U.S.C. §§ 1331, 1332, and 1338, and 15 U.S.C. §§ 1116 and 1121, as this case arises under
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`the Lanham Act. This Court also has supplemental jurisdiction over Plaintiffs’ state and
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`common law claims pursuant to 28 U.S.C. § 1367.
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`7.
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`At all times relevant to this lawsuit, TruPharma, and one or more of its agents,
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`have been engaged in the business of advertising, promoting, marketing, distributing, and/or
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`selling, within the State of Delaware and in interstate commerce throughout the United States,
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`the products which are the subject of this Complaint, namely, a hydrocortisone acetate 2.5% and
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`pramoxine hydrochloride 1% cream that is marketed under NDC Code 52817-0817-01
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`(hereinafter, “TruPharma’s Unauthorized HCA/Pram Product”).
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`8.
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`TruPharma is subject to personal jurisdiction in Delaware because, upon
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`information and belief, Defendant TruPharma is incorporated in Delaware; TruPharma transacts
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`business and/or advertise or contract to supply services or things in this State; TruPharma has
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`caused tortious injury in Delaware by an act or omission committed in Delaware; TruPharma has
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`caused tortious injury in Delaware by an act or omission outside Delaware; TruPharma has
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`caused tortious injury to a corporation organized under the laws of Delaware.
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`9.
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`Venue is proper in this judicial District pursuant to 28 U.S.C. § 1391(b) because
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`TruPharma is incorporated in Delaware and subject to personal jurisdiction in this District.
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`-2-
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`Case 1:20-cv-01677-UNA Document 1 Filed 12/10/20 Page 3 of 22 PageID #: 3
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`STATEMENT OF FACTS
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`Sebela’s Products
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`Sebela is in the business of marketing, promoting, distributing, and selling
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`A.
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`10.
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`authorized prescription pharmaceutical products in the gastroenterology and dermatology fields,
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`including certain hydrocortisone acetate and pramoxine hydrochloride products formerly owned
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`by Ferndale Laboratories, Inc. (later reorganized as Ferndale Pharma Group, Inc.) (“Ferndale”).
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`11.
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` From at least the 1970s, Ferndale developed, manufactured, and marketed a line
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`of prescription products containing varying dosages of hydrocortisone acetate and pramoxine
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`hydrochloride in cream, lotion, or ointment form (collectively, the “HCA/Pram Products”),
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`which are currently marketed under the trademarks and trade names “PRAMOSONE”
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`(“PRAMOSONE”) and “ANALPRAM HC” (“ANALPRAM”).
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`12.
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`The PRAMOSONE and ANALPRAM prescription products have been
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`continuously on the market for over 30 years and are topical corticosteroids with anti-
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`inflammatory, antipruritic, and vasoconstrictive qualities and are available only by prescription.
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`13.
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`In the 1970s, Ferndale submitted and received Food and Drug Administration
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`(“FDA”) approval of several ANDAs for a number of hydrocortisone acetate and pramoxine
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`hydrochloride products, including the HCA/Pram Products.
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`14.
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`On July 1, 1988, the FDA published in the Federal Register a Notice of
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`Opportunity for a Hearing (“NOOH”) regarding the regulatory status of fixed combination drug
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`products that contain hydrocortisone acetate and pramoxine hydrochloride, which included
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`Ferndale’s HCA/Pram Products. (53 Fed. Reg. 25013 (July 1, 1988)).
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`15.
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`Under the NOOH, the FDA required the ANDA holders to submit clinical
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`evidence within 60 days of the NOOH showing that genuine and material issues of fact exist
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`-3-
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`

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`about the effectiveness of the drug that require an administrative hearing for resolution.
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`16.
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`In response to the 1988 FDA notice, Ferndale submitted a timely hearing request
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`for the HCA/Pram Products. This request for hearing was affirmed by Ferndale Laboratories,
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`Inc., on January 3, 2011. (77 Fed. Reg. 43337 (July 24, 2012)).
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`17.
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`As recently as 2017, FDA confirmed that the HCA/Pram Products are subject to
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`the NOOH proceedings.
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`18.
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`In 2013, Sebela acquired the right to sell and promote the HCA/Pram Products in
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`the United States. Sebela has marketed, promoted, and/or sold the HCA/Pram Products since
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`that time, and has derived income and revenue therefrom. Ferndale continues to act as the
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`manufacturer of these products.
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`19.
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`In addition to product rights, Sebela acquired all of Ferndale’s regulatory rights
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`and history concerning the HCA/Pram Products, including historical correspondence between
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`Ferndale and the FDA.
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`20.
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`Having acquired these product rights in 2013, Sebela, either directly or as FDA
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`agent for the ANDA owner, received and asserts the same exclusive legal rights to a hearing and
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`other regulatory procedures under the Federal Food, Drug, and Cosmetic Act (FD&C Act), and
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`which assertion has been affirmed by the FDA.
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`21.
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`One of the HCA/Pram Products marketed by Sebela is hydrocortisone acetate
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`2.5% pramoxine hydrochloride 1% cream, which is marketed under the PRAMOSONE and
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`ANALPRAM trademarks and trade names (hereinafter, “PRAMOSONE Cream”).
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`22.
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`PRAMOSONE Cream is a topical preparation containing hydrocortisone acetate
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`2.5% w/w and pramoxine hydrochloride 1% w/w in a hydrophilic cream base containing stearic
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`acid, cetyl alcohol, Aquaphor®, isopropyl palmitate, polyoxyl 40 stearate, propylene glycol,
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`-4-
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`

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`potassium sorbate, sorbic acid, triethanolamine lauryl sulfate, and purified water.
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`23.
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`Sebela has expended significant resources in the marketing and selling its
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`prescription products in compliance with existing laws and regulations and derives economic
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`benefits, including revenue and profits, through sales of PRAMOSONE Cream.
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`24.
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`Sebela enjoys a strong reputation and has developed substantial goodwill among
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`suppliers, medical professionals, pharmacists, wholesalers, regulators, consumers and others in
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`connection with PRAMOSONE Cream, which is manufactured in accordance with current good
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`manufacturing practices (“cGMP”).
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`25.
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`Sebela maintains contractual relationships with pharmaceutical manufacturers,
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`pharmaceutical drug databases, insurers, wholesalers, distributors, and/or suppliers in order to
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`make and sell PRAMOSONE Cream. These contractual relationships result in economic
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`benefits to Sebela, and will continue to do so in the future. These contractual relationships are
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`standard for the industry.
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`B.
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`26.
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`Perrigo’s Authorized Cream
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`Perrigo is in the business of marketing, promoting, distributing, and selling
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`authorized prescription pharmaceutical products in the gastroenterology and dermatology fields,
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`including certain hydrocortisone acetate and pramoxine hydrochloride products.
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`27. With Sebela’s authorization, Perrigo markets a hydrocortisone acetate 2.5%
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`pramoxine hydrochloride 1% cream (“Perrigo’s authorized cream”).
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`28.
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`Perrigo enjoys a strong reputation and has developed substantial goodwill among
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`suppliers, medical professionals, pharmacists, wholesalers, regulators, consumers and others in
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`connection with Perrigo’s authorized cream, which is manufactured in accordance with current
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`good manufacturing practices (“cGMP”).
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`-5-
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`29.
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`Perrigo maintains contractual relationships with pharmaceutical manufacturers,
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`pharmaceutical drug databases, insurers, wholesalers, distributors, and/or suppliers in order to
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`make and sell Perrigo’s authorized cream. These contractual relationships result in economic
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`benefits to Perrigo, and will continue to do so in the future. These contractual relationships are
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`standard for the industry.
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`30.
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`Upon information and belief, TruPharma is exploiting Plaintiffs’ success by
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`falsely marketing TruPharma’s Unauthorized HCA/Pram Product as an unauthorized “generic”
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`version of Sebela’s PRAMOSONE Cream.
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`C. TruPharma Advertises and Markets TruPharma’s Unauthorized HCA/Pram
`Product as a Generic Substitute for PRAMOSONE Cream
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`31.
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`Upon information and belief, TruPharma, directly and by implication, has
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`represented and continue to represent to wholesalers, distributors, pharmacies, and other
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`members of the pharmaceutical industry that TruPharma’s Unauthorized HCA/Pram Product is a
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`“generic” equivalent of Sebela’s PRAMOSONE Cream and substitutable therefore.
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`32.
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`TruPharma represents itself as having “critical experience in pharmaceutical
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`development, manufacturing, patent challenges, and all aspects of generic product sales and
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`marketing.” TruPharma further promotes its generic products through its “proven track record
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`of building niche product portfolios and getting difficult products FDA-approved and into the
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`market.” Exhibit 1.
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`33.
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`Upon information and belief, TruPharma advertises and promote TruPharma’s
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`Unauthorized HCA/Pram Product as a “generic” version of PRAMOSONE Cream to
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`wholesalers, distributors, insurance companies, pharmacies and other members of the
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`pharmaceutical industry.
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`34.
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`TruPharma has advertised TruPharma’s Unauthorized HCA/Pram Product on the
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`-6-
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`pharmaceutical database, MediSpan Price Rx Pro, as early as October 21, 2020.
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`35.
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`Upon information and belief, TruPharma advertises and promotes TruPharma’s
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`Unauthorized HCA/Pram Product as a “generic equivalent” of PRAMOSONE Cream on
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`pharmaceutical drug databases and price lists (hereinafter, the “Drug Databases”). For example,
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`TruPharma’s Unauthorized HCA/Pram Product appears as follows:
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`
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`36.
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`The Drug Databases are specialized marketing channels which are used
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`nationwide by manufacturers to advertise and promote their products.
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`37.
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`The Drug Databases are used by wholesalers, pharmacies, pharmacists, insurers,
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`health care professionals, and others in the pharmaceutical industry to evaluate medications that
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`are currently on the market and determine whether “generic” versions of brand-name products
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`are available.
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`38.
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`Upon information and belief, based upon the representations of TruPharma to the
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`Drug Databases, TruPharma’s Unauthorized HCA/Pram Product has been or will be listed and
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`“linked” on the Drug Databases as an equivalent product to Sebela’s PRAMOSONE cream and
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`Perrigo’s authorized cream.
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`39.
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`The listing and “linking” of products on the Drug Databases is used by
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`pharmacies, pharmacists, wholesalers, pharmaceutical buyers, and insurance companies and
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`others to determine whether there are any generic substitutes available for a particular brand
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`product.
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`-7-
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`40.
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`Based upon the listing and linking of the products in the Drug Databases, these
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`relevant market players believe that the linked pharmaceutical products are FDA-approved
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`generic equivalents that are automatically substitutable for the brand name product.
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`41.
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`Upon information and belief, based upon TruPharma’s representations, relevant
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`market players, including wholesalers, distributors, pharmacies, pharmacists, insurers and others,
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`are being deceived into believing that the TruPharma’s Unauthorized HCA/Pram Product has
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`been reviewed or approved by the FDA as a generic equivalent of Sebela’s PRAMOSONE
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`Cream.
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`42.
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`Upon information and belief, through its marketing of TruPharma’s Unauthorized
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`HCA/Pram Product, TruPharma is also representing, expressly or impliedly, that TruPharma’s
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`Unauthorized HCA/Pram Product is properly substitutable for Sebela’s PRAMOSONE Cream
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`and Perrigo’s authorized cream, and/or properly automatically substitutable for Sebela’s
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`PRAMOSONE Cream and Perrigo’s authorized cream at the pharmacy level.
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`43.
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`Upon information and belief, TruPharma’s false and misleading representations
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`have deceived wholesalers, distributors, pharmacies, pharmacists, insurers and others in the
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`industry into believing that TruPharma’s Unauthorized HCA/Pram Product has been reviewed
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`or approved by the FDA as a generic equivalent of PRAMOSONE Cream and that it is
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`automatically substitutable therefore, causing Plaintiffs monetary and other harm as further
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`detailed below.
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`D. TruPharma’s Unauthorized HCA/Pram Product is not a Generic Equivalent of
`or Automatically Substitutable for PRAMOSONE Cream
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`44.
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`Notwithstanding TruPharma’s advertising and promotional efforts, TruPharma’s
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`Unauthorized HCA/Pram Product is a new product that has not been approved by the FDA and is
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`not a “generic equivalent” of Sebela’s PRAMOSONE Cream, nor is it substitutable therefor.
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`-8-
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`45.
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`True generic drugs are “therapeutically equivalent” to their branded rivals.
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`“Therapeutically equivalent” drugs must be both “pharmaceutically equivalent” (that is, they
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`have identical active ingredients, strength, and dosage form) and “bioequivalent” (that is, the
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`bioavailability--the rate and extent to which the active ingredients are absorbed by the body--is
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`the same).
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`46.
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`To market a drug as a “generic,” the drug manufacturer or distributor must also
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`submit an application to the FDA summarizing the testing it has performed to establish
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`therapeutic equivalence between the referenced drug and the generic version of the drug.
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`47.
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`The majority of states, including Delaware, prohibit generic substitution of a drug
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`for a prescribed brand-name drug unless the substitute is therapeutically equivalent to the
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`prescribed drug.
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`48.
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`Delaware defines “generic substitution” as “a drug that is the same active
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`ingredient, equivalent in strength to the strength written on the prescription and which is
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`classified as being therapeutically equivalent to another drug in the latest edition or supplement
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`of the Federal Food and Drug Administration (FDA) Approved Drug Products with Therapeutic
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`Equivalence Evaluations, sometimes referred to as the ‘Orange Book.’” 24 Del. C. § 2502(32).
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`49.
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`Notwithstanding TruPharma’s marketing, TruPharma’s Unauthorized HCA/Pram
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`Product is not a generic equivalent of or substitutable for PRAMOSONE Cream.
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`50.
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`TruPharma’s Unauthorized HCA/Pram Product has not been reviewed or
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`approved by the FDA as a “generic” of PRAMOSONE Cream or any other product.
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`51.
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`TruPharma’s Unauthorized HCA/Pram Product has not been reviewed or
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`approved by the FDA as a therapeutic equivalent of PRAMOSONE Cream or any other product.
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`52.
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`TruPharma’s Unauthorized HCA/Pram Product is not listed as therapeutically
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`-9-
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`equivalent to PRAMOSONE Cream in the Orange Book.
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`53.
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`Upon information and belief, TruPharma’s Unauthorized HCA/Pram Product is
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`not therapeutically equivalent to the PRAMOSONE Cream product.
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`54.
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`Upon
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`information and belief, TruPharma has not
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`tested TruPharma’s
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`Unauthorized HCA/Pram Product for therapeutic equivalence to PRAMOSONE Cream.
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`55.
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`Additionally, upon information and belief, TruPharma’s Unauthorized HCA/Pram
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`Product is an unapproved product which TruPharma did not market prior to 2019.
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`56.
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`Unlike Sebela, TruPharma is not a party to the NOOH administrative process for
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`HCA/Pram Products, which has been in place since 1988.
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`57.
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`TruPharma’s marketing efforts have misled consumers into believing that
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`TruPharma’s Unauthorized HCA/Pram Product is generic to and substitutable for PRAMOSONE
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`Cream and Perrigo’s authorized cream, when in fact it is not.
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`58.
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`As a result of TruPharma’s false and misleading representations about
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`TruPharma’s Unauthorized HCA/Pram Product, Plaintiffs’ goodwill is being harmed and will
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`continue to be harmed and Plaintiffs will suffer eroding sales of their authorized HCA/Pram
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`products.
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`59.
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`Upon information and belief, as a result of TruPharma’s false and misleading
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`representations about its product, TruPharma’s Unauthorized HCA/Pram Product will be
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`improperly substituted by pharmacists who receive prescriptions written for PRAMOSONE
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`Cream or Perrigo’s authorized cream.
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`60.
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`Additionally, Plaintiffs do not and cannot control the safety, effectiveness, or
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`quality of TruPharma’s Unauthorized HCA/Pram Product.
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`61.
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`Doctors and patients who suffer bad or disappointing experiences such as denial
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`-10-
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`of coverage for PRAMOSONE Cream or Perrigo’s authorized cream, or suffer adverse reactions
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`with TruPharma’s Unauthorized HCA/Pram Product, are likely to attribute such negative
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`experiences to Plaintiffs and PRAMOSONE Cream or Perrigo’s authorized cream, thereby
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`further harming PRAMOSONE Cream or Perrigo’s authorized cream sales and Plaintiffs’
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`goodwill.
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`E. The Resulting Harm to Plaintiffs
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`62.
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`Upon
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`information and belief, TruPharma’s
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`false
`
`representations about
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`TruPharma’s Unauthorized HCA/Pram Product deceive members of the pharmaceutical industry
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`into believing that it is generically equivalent to and substitutable for PRAMOSONE Cream and
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`Perrigo’s authorized cream, when in fact it is not.
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`63. Wholesalers, pharmacies, pharmacists, insurers, health care professionals, and
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`others in the pharmaceutical industry are likely to be deceived and, upon information and belief
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`are actually being deceived, by TruPharma’s false and misleading representations about
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`TruPharma’s Unauthorized HCA/Pram Product.
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`64.
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`Upon information and belief, TruPharma knows that their marketing of
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`TruPharma’s Unauthorized HCA/Pram Product is likely to deceive and is actually deceiving
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`drug wholesalers, distributors, pharmacies, pharmacists, and others in the industry about the
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`nature, characteristics, and qualities of TruPharma’s Unauthorized HCA/Pram Product and will
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`cause improper refusal of insurance coverage for PRAMOSONE Cream and Perrigo’s authorized
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`cream, loss of formulary listing or reduced formulary coverage for PRAMOSONE Cream and
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`Perrigo’s authorized cream, and improper substitution of TruPharma’s Unauthorized HCA/Pram
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`Product for PRAMOSONE Cream and Perrigo’s authorized cream.
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`-11-
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`65.
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`Upon information and belief, TruPharma has not only engaged in the false
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`advertising and marketing of TruPharma’s Unauthorized HCA/Pram Product, but have also done
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`so willfully.
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`66.
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`Through these and other false and misleading representations, TruPharma has and
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`will continue to cause harm to the reputation and goodwill that Sebela and Ferndale have
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`developed over thirty (30) years in the industry and, have caused and will continue to cause
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`Plaintiffs to lose both revenue and market share.
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`COUNT I
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`False Advertising Under the Lanham Act – 15 U.S.C. § 1125(a)
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`Plaintiffs repeat and re-allege the allegations contained in the preceding
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`67.
`
`paragraphs of this Complaint as though set forth fully herein.
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`68.
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`Upon information and belief, in the course of advertising and marketing the
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`TruPharma’s Unauthorized HCA/Pram Product, TruPharma has used, in interstate commerce and
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`in commercial advertising, false and misleading representations of fact that misrepresent the true
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`nature, characteristics, and potential health risks of TruPharma’s Unauthorized HCA/Pram
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`Product.
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`69.
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`Upon information and belief, TruPharma has made false or misleading
`
`representations of fact about its product, including that TruPharma’s Unauthorized HCA/Pram
`
`Product is a generic equivalent to and substitutable for PRAMOSONE Cream and Perrigo’s
`
`authorized cream.
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`70.
`
`Upon information and belief, TruPharma’s representations about TruPharma’s
`
`Unauthorized HCA/Pram Product to members of the pharmaceutical industry constitute
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`commercial advertising or promotion.
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`71.
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`TruPharma’s misrepresentations about TruPharma’s Unauthorized HCA/Pram
`
`Product relate to inherent qualities or characteristics of TruPharma’s Unauthorized HCA/Pram
`
`Product.
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`72.
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`TruPharma’s false and misleading representations are material in that they are
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`likely to influence the purchasing decisions of wholesalers, third-party payors, pharmacists,
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`health care professionals, insurers, and others in the pharmaceutical industry, as well as patients
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`who use Plaintiffs’ products.
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`73.
`
`TruPharma’s representations about TruPharma’s Unauthorized HCA/Pram
`
`Product have deceived and/or have the tendency to deceive a substantial segment of its intended
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`audience.
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`74.
`
`Upon information and belief, but for TruPharma’s false and misleading
`
`statements, wholesalers, third-party payors, pharmacists, health care professionals, patients,
`
`insurers, and others in the pharmaceutical industry would not list, purchase, distribute, prescribe,
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`cover, or use TruPharma’s Unauthorized HCA/Pram Product.
`
`75.
`
`Upon information and belief, TruPharma’s actions have been willful and
`
`deliberate.
`
`76.
`
`Among other things, since at least November 2020, TruPharma has been aware of
`
`Sebela’s position that TruPharma’s advertising and marketing of TruPharma’s Unauthorized
`
`HCA/Pram Product will be false and misleading. Despite this knowledge, TruPharma has
`
`proceeded to advertise and market TruPharma’s Unauthorized HCA/Pram Product to members
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`of the pharmaceutical industry in a manner that is likely to confuse and mislead.
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`77.
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`As a direct and proximate result of TruPharma’s actions, Plaintiffs have and will
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`continue to suffer damage to their business, reputation, goodwill, and the loss of sales, profits,
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`and customers.
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`78.
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`TruPharma’s actions as alleged herein have caused, are causing, and will continue
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`to cause irreparable and inherently unquantifiable injury and harm to Plaintiffs’ business,
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`reputation, and goodwill, unless enjoined by this Court.
`
`79.
`
`Pursuant to 15 U.S.C. § 1116, Plaintiffs are entitled to preliminary and permanent
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`injunctive relief to TruPharma’s continuing acts.
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`80.
`
`Pursuant to 15 U.S.C. § 1117, Plaintiffs are entitled to recover treble damages
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`sustained by TruPharma’s actions, an accounting for profits realized by TruPharma, and the costs
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`of this action.
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`81.
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`In addition, as this is an exceptional case pursuant to 15 U.S.C. § 1117(a),
`
`Plaintiffs are entitled to an award of reasonable attorney’s fees.
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`COUNT II
`
`Contributory False Advertising under the Lanham Act - 15 U.S.C. § 1125(a)
`
`82.
`
`Plaintiffs repeat and re-allege the allegations contained in the preceding
`
`paragraphs of this Complaint as though set forth fully herein.
`
`83.
`
`Upon information and belief, TruPharma is knowingly inducing or causing,
`
`and/or materially participating in, the false and misleading advertising and promotion of
`
`TruPharma’s Unauthorized HCA/Pram Product by Drug Databases, wholesalers, pharmacies,
`
`insurers, and/or other members of the pharmaceutical industry to advertise and promote
`
`TruPharma’s Unauthorized HCA/Pram Product as an FDA-approved “generic” product that is
`
`generically equivalent to and substitutable for PRAMOSONE Cream and Perrigo’s authorized
`
`cream.
`
`84.
`
`Upon information and belief, TruPharma knew and/or intended to participate in
`
`-14-
`
`

`

`Case 1:20-cv-01677-UNA Document 1 Filed 12/10/20 Page 15 of 22 PageID #: 15
`
`
`
`the false advertising of TruPharma’s Unauthorized HCA/Pram Product by Drug Databases,
`
`wholesalers, pharmacies, insurers, and/or other members of the pharmaceutical industry.
`
`85.
`
`TruPharma actively and materially furthered such false and misleading
`
`advertising and promotion of TruPharma’s Unauthorized HCA/Pram Product by expressly or
`
`impliedly representing that TruPharma’s Unauthorized HCA/Pram Product was equivalent to
`
`and/or substitutable for the PRAMOSONE Cream and Perrigo’s authorized cream and, upon
`
`information and belief, by listing the product with the Drug Databases.
`
`86.
`
`Such false and misleading representations about TruPharma’s Unauthorized
`
`HCA/Pram Product by Drug Databases, wholesalers, pharmacies, insurers, and/or other members
`
`of the pharmaceutical industry have actually deceived or have the tendency to deceive a
`
`substantial segment of their audience as to the nature, quality, and characteristics of TruPharma’s
`
`Unauthorized HCA/Pram Product.
`
`87.
`
`Such false and misleading representations about TruPharma’s Unauthorized
`
`HCA/Pram Product by Drug Databases, wholesalers, pharmacies, insurers, and/or other members
`
`of the pharmaceutical industry are material and likely to influence the purchasing decisions of
`
`wholesalers, third-party payors, pharmacists, health care professionals, insurers, and others in the
`
`pharmaceutical industry, as well as patients who use Plaintiffs’ products.
`
`88.
`
`Upon information and belief, these false or misleading representations were and
`
`are made in interstate commerce.
`
`89.
`
`Upon information and belief, TruPharma’s actions have been willful and
`
`deliberate.
`
`90.
`
`As a direct and proximate result of TruPharma’s conduct, Plaintiffs have suffered
`
`damages, which includes a loss of reputation, sales, profits and customers.
`
`-15-
`
`

`

`Case 1:20-cv-01677-UNA Document 1 Filed 12/10/20 Page 16 of 22 PageID #: 16
`
`
`
`91.
`
`Defendant actions as alleged herein have caused, are causing, and will continue to
`
`cause irreparable and inherently unquantifiable injury and harm to Plaintiffs’ business,
`
`reputation, and goodwill, unless TruPharma’s unlawful conduct is enjoined by this Court.
`
`92.
`
`Pursuant to 15 U.S.C. § 1116, Plaintiffs are entitled to preliminary and permanent
`
`injunctive relief to TruPharma’s continuing acts.
`
`93.
`
`Pursuant to 15 U.S.C. § 1117, Plaintiffs are entitled to recover treble damages
`
`sustained by TruPharma’s actions, an accounting for profits realized by TruPharma, and the costs
`
`of this action.
`
`94.
`
`In addition, as this is an exceptional case pursuant to 15 U.S.C. § 1117(a),
`
`Plaintiffs are entitled to an award of reasonable attorney’s fees.
`
`COUNT III
`
`Unfair Competition Under the Lanham Act – 15 U.S.C. § 1125(a)
`
`Plaintiffs repeat and re-allege the allegations contained in the preceding
`
`95.
`
`paragraphs of this Complaint as though set forth fully herein.
`
`96.
`
`By virtue of TruPharma’s false or misleading representations, as detailed above,
`
`TruPharma is also liable for unfair competition under the Lanham Act.
`
`97.
`
`TruPharma’s false and/or misleading representations of fact are likely to cause
`
`confusion or mistake or to deceive as to TruPharma’s affiliation, connection or association with
`
`Sebela and/or the FDA.
`
`98.
`
`TruPharma’s false and/or misleading representations of fact are also likely to
`
`cause confusion or mistake or to deceive as to the origin, sponsorship, or approval of
`
`TruPharma’s Unauthorized HCA/Pram Product and/or TruPharma’s commercial activities by
`
`Sebela and/or the FDA.
`
`-16-
`
`

`

`Case 1:20-cv-01677-UNA Document 1 Filed 12/10/20 Page 17 of 22 PageID #: 17
`
`
`
`99.
`
`Additionally, consumers,
`
`including purchasers, wholesalers, distributors,
`
`prescribers, insurers, and pharmacists, may be deceived into believing that TruPharma’s
`
`Unauthorized HCA/Pram Product has been approved or authorized by Sebela and/or the FDA.
`
`100. Moreover, Sebela has become uniquely associated with PRAMOSONE Cream,
`
`which association is being unlawfully appropriated and impaired by Defendant.
`
`101. Plaintiffs are likely to and has been damaged by TruPharma’s conduct, as detailed
`
`herein. Plaintiffs are entitled to damages for TruPharma’s unfair competition, an accounting of
`
`profits and recovery of Plaintiffs’ costs of this action.
`
`102. Because some of the damage to Plaintiffs’ reputation and the reputation of their
`
`products cannot be adequately compensated by monetary damages, and TruPharma’s conduct is
`
`causing irreparable and inherently unquantifiable injury and harm to Plaintiffs’ business,
`
`reputation, and goodwill, Plaintiffs are entitled to temporary, preliminary, and permanent
`
`injunctive relief, enjoining TruPharma from further unfair competition, including without
`
`limitation, removing the false and misleading listings for TruPharma’s Unauthorized HCA/Pram
`
`Product from the Drug Databases.
`
`103. Pursuant to 15 U.S.C. § 1117, Plaintiffs are entitled to recover treble damages
`
`sustained by TruPharma’s actions, an accounting for profits realized by TruPharma, and the costs
`
`of this action.
`
`104.
`
`In addition, as this is an exceptional case pursuant to 15 U.S.C. § 1117(a),
`
`Plaintiffs are entitled to an award of reasonable attorney’s fees.
`
`COUNT IV
`
`Violation of the Delaware Deceptive Trade Practices Act
`
`105. Plaintiffs repeat and re-allege the allegations contained in the preceding
`
`-17-
`
`

`

`Case 1:20-cv-01677-UNA Document 1 Filed 12/10/20 Page 18 of 22 PageID #: 18
`
`
`
`paragraphs of this Complaint as though set forth fully herein.
`
`106. 6 Del. C. § 2533 provides a private right of action to enforce the provisions of 6
`
`Del C. § 2532.
`
`107.
`
`In the course of its business, TruPharma has engaged and continue to engage in
`
`deceptive trade practices in violation of 6 Del. C. § 2532(a)(1), (2), (3), (5), (7), (9), and (12) by
`
`and through their false and misleading representations of fact and conduct with respect to
`
`TruPharma’s Unauthorized HCA/Pram Product.
`
`108. Upon information and belief, TruPharma has willfully engaged in these actions
`
`knowing them to be deceptive.
`
`109. By reason of TruPharma’s actions, Plaintiffs have and will continue to suffer
`
`damage to their business, reputation, and goodwill and the loss of sales and profits.
`
`110. Pursuant to 6 Del. C. § 2533, Plaintiffs are entitled to injunctive relief, treble
`
`damages, and reasonable attorney’s fees.
`
`COUNT V
`
`Common Law Unfair Competition
`
`111. Plaintiffs repeat and re-allege the allegations contained in the preceding
`
`paragraphs as though set forth fully herein.
`
`112. TruPharma has intentionally and maliciously made false statements and material
`
`omissions in its marketing and sale of TruPharma’s Unauthorized HCA/Pram Product.
`
`113. Through these actions, as described above, TruPharma has wrongfully interfered
`
`with Plaintiffs’ reasonable business expectancies concerning PRAMOSONE Cream and
`
`Perrigo’s authorized cream, including expected sales.
`
`114. By reason of TruPharma’s actions, Plaintiffs have and will continue to suffer
`
`-18-
`
`

`

`Case 1:20-cv-01677-UNA Document 1 Filed 12/10/20 Page 19 of 22 PageID #: 19
`
`
`
`damage to their business, reputation, and goodwill and the loss of sales and profits.
`
`115. Plaintiffs are entitled to damages for TruPharma’s unfair competition, an
`
`accounting of profits made on sales of TruPharma’s Unauthorized HCA/Pram Product an

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