Case 1:23-cv-00629-JFB-CJB Document 1 Filed 06/09/23 Page 1 of 34 PageID #: 1
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`ASTELLAS PHARMA INC., ASTELLAS
`IRELAND CO., LTD., ASTELLAS
`PHARMA US, INC., and ASTELLAS
`PHARMA GLOBAL DEVELOPMENT,
`INC.,
`
`Plaintiffs,
`
`v.
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`EVITALIN LLC, d/b/a menMD,
`PHARMALABS, LLC, and
`PHARMALABS HOLDCO, INC.,
`
`Defendant.
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`C.A. No. _______________________
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`JURY TRIAL DEMANDED
`
`COMPLAINT FOR PATENT INFRINGEMENT
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`Plaintiffs Astellas Pharma Inc., Astellas Ireland Co., Ltd., Astellas Pharma US, Inc., and
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`Astellas Pharma Global Development, Inc. (collectively, “Astellas” or “Plaintiffs”), by their
`
`undersigned attorneys, hereby allege as follows:
`
`THE PARTIES
`
`A.
`
`Astellas Pharma Inc., Astellas Ireland Co., Ltd., Astellas Pharma US, Inc., and
`Astellas Pharma Global Development, Inc. (Collectively, “Astellas,” or “Plaintiffs”)
`
`1.
`
`Plaintiff Astellas Pharma Inc. (“API”) is a corporation organized and existing under
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`the laws of Japan, having its principal place of business at 2-5-1, Nihonbashi-Honcho, Chuo-Ku,
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`Tokyo 103-8411, Japan. API was formed on April 1, 2005, from the merger of Yamanouchi
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`Pharmaceutical Co., Ltd. and Fujisawa Pharmaceutical Co., Ltd.
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`2.
`
`Plaintiff Astellas Ireland Co., Ltd. (“AICL”) is a corporation organized and existing
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`under the laws of Ireland, having its principal place of business at Damastown Road, Damastown
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`Industrial Park, Mulhuddart, Dublin 15, Ireland. AICL is a subsidiary of Plaintiff API.
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`3.
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`Astellas Pharma US, Inc. (“APUI”) is a corporation organized and existing under
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`the laws of Delaware, having its principal place of business at 1 Astellas Way, Northbrook, IL
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`60062. APUI is a subsidiary of Plaintiff API.
`
`4.
`
`Plaintiff Astellas Pharma Global Development, Inc. (“APGD”) is a corporation
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`organized and existing under the laws of the State of Delaware, having its principal place of
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`business at 1 Astellas Way, Northbrook, IL 60062. APGD is a subsidiary of Plaintiff API.
`
`B.
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`Evitalin LLC, d/b/a menMD (“Evitalin” or “menMD”)
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`5.
`
`On information and belief, Defendant Evitalin LLC does business, inter alia, under
`
`the name “menMD.”
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`6.
`
`On information and belief, Defendant Evitalin, LLC is a limited liability company
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`organized and existing under the laws of Delaware, having a principal place of business at 14440
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`Myerlake Circle, Clearwater, FL 33760.
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`7.
`
`On information and belief, menMD is in the business of providing sales, marketing,
`
`and consulting services to the medical community.
`
`C.
`
`PharmaLabs, LLC and PharmaLabs HoldCo, Inc. (together, “PharmaLabs”)
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`8.
`
`On information and belief, Defendant PharmaLabs, LLC is a limited liability
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`company organized and existing under the laws of Delaware, having a principal place of business
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`at 10901 Roosevelt Blvd N, Suite 1200C, St. Petersburg, FL 33716.
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`9.
`
`On information and belief, PharmaLabs, LLC is a compounding pharmacy that is
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`in the business of making and selling, inter alia, pharmaceutical products.
`
`10.
`
`On information and belief, the manager of PharmaLabs, LLC is PharmaLabs
`
`HoldCo, Inc.
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`11.
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`On information and belief, PharmaLabs HoldCo, Inc. is a corporation that is
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`incorporated under the laws of Delaware, having a principal place of business at 10901 Roosevelt
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`Blvd N, Suite 1200C, St. Petersburg, FL 33716.
`
`12.
`
`On information and belief, PharmaLabs HoldCo, Inc. is a management company
`
`that is, inter alia, the manager of PharmaLabs LLC.
`
`13.
`
`On information and belief, menMD and PharmaLabs share at least some common
`
`officers.
`
`NATURE OF ACTION
`
`14.
`
`This is an action for patent infringement arising under the United States patent laws,
`
`Title 35, United States Code, seeking monetary damages and other relief against menMD based
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`on menMD’s infringement of United States Patent Nos. 6,346,532 (“the ’532 Patent”), 7,342,117
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`(“the ’117 Patent”), 7,982,049 (“the ’049 Patent”), 8,835,474 (“the ’474 Patent”), and RE44,872
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`(“the ’872 Patent”).
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`15.
`
`This action relates to menMD’s selling and offering to sell mirabegron immediate
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`release capsules in the 20mg and 40mg dosage strengths (“Mirabegron Products”).
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` JURISDICTION AND VENUE
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`16.
`
`This Court has jurisdiction over the subject matter of this action under 28 U.S.C.
`
`§§ 1331 and 1338(a).
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`17.
`
`This Court has personal jurisdiction over menMD at least because, on information
`
`and belief, menMD is a limited liability company organized and existing under the laws of
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`Delaware.
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`18.
`
`On information and belief, menMD conducts business throughout the United
`
`States, including in this Judicial District, and has committed acts of infringement in this Judicial
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`District and elsewhere.
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`19.
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`On information and belief, menMD partners with affiliates, partners, and/or agents
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`such as pharmacies that engage in compounding medications, including those imported, sold,
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`offered for sale, and/or used in the pharmaceutical industry throughout the United States, including
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`in this Judicial District.
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`20.
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`On information and belief, menMD regularly solicits business throughout the
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`United States, including in Delaware, engages in other persistent courses of conduct in Delaware,
`
`and/or derives substantial revenue from services or things used or consumed in Delaware,
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`including by selling its pharmaceutical products in Delaware, and therefore can reasonably expect
`
`to be subject to jurisdiction in the Delaware courts.
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`21.
`
`On information and belief, menMD conducts marketing and sales activities
`
`throughout the United States, including in the State of Delaware, including but not limited to
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`distribution, marketing, and sales of pharmaceutical products to Delaware residents that are
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`continuous and systematic.
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`22.
`
`For these reasons, and for other reasons that will be presented to the Court if
`
`jurisdiction is challenged, the Court has personal jurisdiction over menMD.
`
`23.
`
`This Court has personal jurisdiction over PharmaLabs, LLC at least because, on
`
`information and belief, PharmaLabs, LLC is a limited liability company organized and existing
`
`under the laws of Delaware. On information and belief, PharmaLabs, LLC is registered with the
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`Delaware Department of State, Division of Professional Regulation as a Pharmacy (license number
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`A9-0001227) and further has a controlled substances license in Delaware under license number
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`PH-0011109. On information and belief, PharmaLabs, LLC had a retail pharmacy drug wholesale
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`distributor license in Florida, but that license was withdrawn.
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`24.
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`On information and belief, PharmaLabs, LLC conducts business throughout the
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`United States, including in this Judicial District, and has committed acts of infringement in this
`
`Judicial District and elsewhere.
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`25.
`
`On information and belief, PharmaLabs, LLC, together with its affiliates, partners,
`
`and/or agents, engage in compounding and selling medications, including those imported, sold,
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`offered for sale, and/or used in the pharmaceutical industry throughout the United States, including
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`in this Judicial District.
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`26.
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`On information and belief, PharmaLabs, LLC, directly or indirectly through its
`
`subsidiaries, affiliates, partners, and agents, regularly solicits business throughout the United
`
`States, including in Delaware, engages in other persistent courses of conduct in Delaware, and/or
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`derives substantial revenue from services or things used or consumed in Delaware, including by
`
`selling its pharmaceutical products in Delaware, and therefore can reasonably expect to be subject
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`to jurisdiction in the Delaware courts.
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`27.
`
`On information and belief, PharmaLabs, LLC, directly or indirectly through its
`
`subsidiaries, affiliates, partners, and agents, conducts marketing and sales activities throughout the
`
`United States, including in the State of Delaware, including but not limited to distribution,
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`marketing, and sales of pharmaceutical products to Delaware residents that are continuous and
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`systematic.
`
`28.
`
`For these reasons, and for other reasons that will be presented to the Court if
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`jurisdiction is challenged, the Court has personal jurisdiction over PharmaLabs, LLC.
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`29.
`
`This Court has personal jurisdiction over PharmaLabs HoldCo, Inc. at least
`
`because, on information and belief, PharmaLabs HoldCo, Inc. is a corporation that is incorporated
`
`under the laws of Delaware.
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`30.
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`On information and belief, PharmaLabs HoldCo, Inc. conducts business throughout
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`the United States, including in this Judicial District, and has committed acts of infringement in this
`
`Judicial District and elsewhere.
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`31.
`
`On information and belief, PharmaLabs HoldCo, Inc. together with its affiliates,
`
`partners, and/or agents, engage in compounding and selling medications, including those imported,
`
`sold, offered for sale, and/or used in the pharmaceutical industry throughout the United States,
`
`including in this Judicial District.
`
`32.
`
`On information and belief, PharmaLabs HoldCo, Inc. directly or indirectly through
`
`its subsidiaries, affiliates, partners, and agents, regularly solicits business throughout the United
`
`States, including in Delaware, engages in other persistent courses of conduct in Delaware, and/or
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`derives substantial revenue from services or things used or consumed in Delaware, including by
`
`selling its pharmaceutical products in Delaware, and therefore can reasonably expect to be subject
`
`to jurisdiction in the Delaware courts.
`
`33.
`
`On information and belief, PharmaLabs HoldCo, Inc. directly or indirectly through
`
`its subsidiaries, affiliates, partners, and agents, conducts marketing and sales activities throughout
`
`the United States, including in the State of Delaware, including but not limited to distribution,
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`marketing, and sales of pharmaceutical products to Delaware residents that are continuous and
`
`systematic.
`
`34.
`
`For these reasons, and for other reasons that will be presented to the Court if
`
`jurisdiction is challenged, the Court has personal jurisdiction over PharmaLabs HoldCo, Inc.
`
`35.
`
`On information and belief, menMD is registered to do business as Evitalin LLC in
`
`the State of Delaware and is organized as a “domestic” limited liability company under File
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`Number 4932400, and thus has purposely availed itself to the privileges of conducting business in
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`this Judicial District.
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`36.
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`On information and belief, in the State of Florida, where menMD has its principal
`
`place of business, it is registered to do business as Evitalin LLC as a “foreign” limited liability
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`company, identifying the State of Delaware as the jurisdiction under the laws of which it is
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`organized.
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`37.
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`On information and belief, PharmaLabs, LLC is registered to do business in the
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`State of Delaware and is organized as a “domestic” limited liability company under File Number
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`5180858, and thus has purposely availed itself to the privileges of conducting business in this
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`Judicial District.
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`38.
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`On information and belief, in the State of Florida, where PharmaLabs, LLC has its
`
`principal place of business, it is registered to do business as a “foreign” limited liability company,
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`identifying the State of Delaware as the jurisdiction under the laws of which it is organized.
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`39.
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`On information and belief, PharmaLabs Holdco, Inc. is incorporated in the State of
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`Delaware under File Number 6810333, and thus has purposely availed itself to the privileges of
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`conducting business in this Judicial District.
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`40.
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`For at least these reasons, venue is proper in this Court pursuant to 28 U.S.C. §§
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`1391 and 1400(b).
`
`A. The ’532 Patent
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`PATENTS-IN-SUIT
`
`41.
`
`The United States Patent & Trademark Office (“PTO”) duly and legally issued the
`
`’532 Patent, entitled “Amide Derivatives or Salts Thereof,” on February 12, 2002. On February
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`24, 2015, after an ex parte reexamination proceeding, the PTO duly and legally issued a
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`reexamination certificate confirming the validity and patentability of the ’532 Patent. A true and
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`correct copy of the ’532 Patent is attached as Exhibit A.
`
`42.
`
`The ’532 Patent claims, inter alia, the compound mirabegron and compositions
`
`containing mirabegron.
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`43.
`
`The ’532 Patent also claims, inter alia, a pharmaceutical composition containing
`
`mirabegron as an active ingredient.
`
`44.
`
`45.
`
`The ’532 Patent expired on March 27, 2022.
`
`The ’532 Patent was listed in the United States Food and Drug Administration
`
`(“FDA”) Approved Drug Products with Therapeutic Equivalence Evaluations (“Orange Book”) as
`
`covering Astellas’ Myrbetriq® products shortly after the Myrbetriq® products were approved in
`
`2012 until the expiry of its patent term and all regulatory exclusivities granted by FDA.
`
`46.
`
`Astellas has complied with the applicable marking requirements of 35 U.S.C. § 287
`
`with respect to the ’532 Patent.
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`B. The ’117 Patent
`
`47.
`
`The PTO duly and legally issued the ’117 Patent entitled “α-Form or β-Form
`
`Crystal of Acetanilide Derivative,” on March 11, 2008. A true and correct copy of the ’117 Patent
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`is attached as Exhibit B.
`
`48.
`
`49.
`
`50.
`
`The ’117 Patent claims, inter alia, crystal forms of mirabegron.
`
`The ’117 Patent expires no earlier than November 4, 2023.
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`The ’117 Patent has been listed in the Orange Book as covering Astellas’
`
`Myrbetriq® products since shortly after the Myrbetriq® products were approved by FDA in 2012.
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`51.
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`Astellas has complied with the applicable marking requirements of 35 U.S.C. § 287
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`with respect to the ’117 Patent.
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`C. The ’049 Patent
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`52.
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`The PTO duly and legally issued the ’049 Patent entitled “α-Form or β-Form
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`Crystal of Acetanilide Derivative,” on July 19, 2011. A true and correct copy of the ’049 Patent is
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`attached as Exhibit C.
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`53.
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`The ’049 Patent claims, inter alia, pharmaceutical compositions comprising crystal
`
`forms of mirabegron and a pharmaceutically acceptable carrier.
`
`54.
`
`55.
`
`The ’049 Patent expires no earlier than November 4, 2023.
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`The ’049 Patent has been listed in the Orange Book as covering Astellas’
`
`Myrbetriq® products since shortly after the Myrbetriq® products were approved by FDA in 2012.
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`56.
`
`Astellas has complied with the applicable marking requirements of 35 U.S.C. § 287
`
`with respect to the ’049 Patent.
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`D. The ’474 Patent
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`57.
`
`The PTO duly and legally issued the ’474 Patent, entitled “Remedy for Overactive
`
`Bladder Comprising Acetic Acid Anilide Derivative As The Active Ingredient,” on September 16,
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`2014. A true and correct copy of the ’474 patent is attached as Exhibit D.
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`58.
`
`The ’474 Patent claims, inter alia, methods of treating overactive bladder by
`
`administering mirabegron.
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`59.
`
`60.
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`The ’474 Patent expires no earlier than November 4, 2023.
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`The ’474 Patent has been listed in the Orange Book as covering Astellas’
`
`Myrbetriq® products since shortly after its issuance in 2014.
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`61.
`
`Astellas has complied with the applicable marking requirements of 35 U.S.C. § 287
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`with respect to the ’474 Patent.
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`E. The ’872 Patent
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`62.
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`The PTO duly and legally issued the ’872 Patent, entitled “Remedy for Overactive
`
`Bladder Comprising Acetic Acid Anilide Derivative As The Active Ingredient,” on April 29, 2014.
`
`A true and correct copy of the ’872 patent is attached as Exhibit E.
`
`63.
`
`The ’872 Patent claims, inter alia, methods of treating overactive bladder by
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`administering mirabegron to adult subjects.
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`64.
`
`The ’872 Patent also claims, inter alia, methods of treating overactive bladder by
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`administering mirabegron to non-adult subjects that are not suffering from diabetes.
`
`65.
`
`66.
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`The ’872 Patent expires no earlier than November 4, 2023.
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`The ’872 Patent has been listed in the Orange Book as covering Astellas’
`
`Myrbetriq® products since shortly after its issuance in 2014.
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`67.
`
`Astellas has complied with the applicable marking requirements of 35 U.S.C. § 287
`
`with respect to the ’872 Patent.
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`A. Myrbetriq®
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`FACTUAL BACKGROUND
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`68.
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`APGD holds approved New Drug Application (“NDA”) No. 202611 for
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`Myrbetriq® extended-release tablets, 25 mg and 50 mg, which contain the active ingredient,
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`mirabegron (“Myrbetriq® Tablets”). The FDA approved NDA No. 202611 on June 28, 2012 for
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`both the 25 mg and 50 mg extended-release Myrbetriq® Tablets.
`
`69.
`
`The FDA granted Myrbetriq® regulatory exclusivities, including on the patents-in-
`
`suit, that do not expire until at least May 4, 2024.
`
`70.
`
`The only FDA-approved formulations containing mirabegron that the FDA has
`
`determined to be sufficiently safe and effective for marketing approval are 25 mg and 50 mg
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`extended-release formulations of mirabegron, including Myrbetriq® Tablets.
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`71. Mirabegron has been referred to chemically as, inter alia, (R)-2-(2-aminothiazol-
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`4-yl)-4’-[2-(2-hydroxy-2-phenylethyl)amino]ethyl]acetic acid anilide, (R)-2-(2-aminothiazol-4-
`
`yl)-4’-[2-[(2-hydroxy-2-phenylethyl)amino]ethyl]acetanilide, and 2-(2-aminothiazol-4-yl)-N-[4-
`
`(2-{[(2R)-2-hydroxy-2-phenylethyl]amino}ethyl)phenyl]acetamide. Mirabegron can be depicted
`
`as, inter alia, the following formula:
`
`72.
`
`A mirabegron immediate-release formulation was found to be associated with an
`
`undesirable food effect that can cause harmful cardiovascular side effects.
`
`73. Myrbetriq® Tablets are indicated for, inter alia, the treatment of overactive bladder
`
`(“OAB”).
`
`74.
`
`75.
`
`API is the assignee of the ’532, ’117, ’049, ’474, and ’872 Patents.
`
`AICL is the exclusive licensee of the ’532, ’117, ’049, ’474 and ’872 Patents with
`
`the rights to develop, import, market, sell, distribute, and promote any and all pharmaceutical
`
`formulations in finished package forms which contain mirabegron as the active ingredient in the
`
`United States.
`
`76.
`
`APGD has contracted with AICL to, inter alia, clinically develop mirabegron,
`
`prepare and submit NDA No. 202611 for marketing approval of Myrbetriq® Tablets in the United
`
`States.
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`77.
`
`AICL has contracted with APUI to, inter alia, market and sell Myrbetriq® Tablets,
`
`in the United States on its behalf.
`
`78. Myrbetriq® Tablets are covered by, inter alia, the patents listed currently or at any
`
`time in the Orange Book associated with Myrbetriq® Tablets, including one or more claims of
`
`each of the ’532, ’117, ’049, ’474, and ’872 Patents.
`
`B. Defendants’ Infringing Product and Activities
`
`79.
`
`On information and belief, since at least 2013, menMD has provided an online
`
`platform that, inter alia, helps fill various treatment orders from healthcare providers through
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`partnering pharmacies. On information and belief, menMD has been in the business, inter alia, of
`
`providing sales, marketing, and consulting services to the medical community. On information and
`
`belief, menMD “has a background in various specialties and [its] providers are industry leaders
`
`from
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`the
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`top university and private hospital systems
`
`in
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`the country.” See, e.g.,
`
`https://menmd.com/about/. On information and belief, menMD has a nationwide network of
`
`physicians and healthcare providers who trust menMD to offer medication through accredited
`
`pharmacies. A true and correct copy of menMD’s webpage at https://menmd.com/about/ as of May
`
`16, 2023 is attached as Exhibit F.
`
`80.
`
`On information and belief, on or before May 2019, menMD, directly or indirectly
`
`through its affiliates, partners, and agents, started manufacturing, distributing, importing,
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`marketing, selling and/or offering for sale various treatments for bladder control conditions,
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`including 20 mg and 40 mg immediate release mirabegron formulations (“menMD’s Mirabegron
`
`Products”), through its website. On information and belief, menMD’s Mirabegron Products were
`
`listed under its website tab titled “Overactive Bladder”. A true and correct copy of the archived
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`webpage at http://menmd.com, archived on 05-31-2019, available via the “Internet Archive, the
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`WayBack Machine,” accessed at https://archive.org/web/ is attached as Exhibit G, as excerpted
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`and highlighted below:
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`81.
`
`On information and belief menMD’s Mirabegron Products have not been the
`
`subject of any marketing approval applications to the FDA, nor have menMD’s Mirabegron
`
`Products been approved by the FDA as a sufficiently safe and effective treatment for OAB.
`
`82.
`
`On or about June 14, 2019, Astellas sent a cease and desist letter to menMD
`
`informing menMD of, inter alia, its unlawful sales and offers for sale of unapproved 40 mg
`
`immediate-release version of Myrbetriq®, including menMD’s Mirabegron Products, through its
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`website at http://menmd.com/mirabegron. More specifically, Astellas’ June 14, 2019 letter notified
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`menMD that by marketing and selling menMD’s Mirabegron Products, menMD had infringed at
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`least U.S. Patent No. 6,346,532 (the “’532 Patent”), which was then-unexpired and listed in FDA’s
`
`Orange Book for Myrbetriq®. A true and correct copy of this letter is attached Exhibit H.
`
`83.
`
`On or about June 21, 2019, menMD responded to Astellas’ June 14, 2019 letter. A
`
`true and correct copy of this letter is attached Exhibit I.
`
`84.
`
`On or about June 28, 2019, menMD responded further to Astellas’ June 14, 2019
`
`letter, indicating that it had, inter alia, ceased marketing, offering to sell and selling its Mirabegron
`
`Products. In its June 28, 2019 letter, menMD represented that it “only started offering to sell and
`
`selling [its Mirabegron Products] on June 14, 2019, the date of Astellas’ cease and desist letter.”
`
`menMD also represented that it stopped referring patients to its dispensing pharmacy upon receipt
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`of Astellas’ June 14, 2019 letter. menMD further represented that any sales of its Mirabegron
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`Products would have occurred between June 14-17, 2019. menMD refused to provide the identities
`
`of its suppliers of its compounded Mirabegron Products and mirabegron API used to formulate
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`those products. A true and correct copy of this letter is attached Exhibit J.
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`85.
`
`On information and belief, on or before September 2022, menMD, directly or
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`indirectly through its affiliates, partners, and agents, were offering for sale and selling its
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`Mirabegron Products through its website. A true and correct copy of the archived webpage titled
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`“Treatment Options for Male Incontinence” at https://menmd.com/condition/male-incontinence/,
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`archived on 09-29-2022, available via the “Internet Archive, the WayBack Machine,” accessed at
`
`https://archive.org/web/ is attached as Exhibit K, and as excerpted below:
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`14
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`.
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`86.
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`On information and belief, on or before September 2022, menMD, directly or
`
`indirectly through its affiliates, partners, and agents, offered further details about its Mirabegron
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`Products through its website. A true and correct copy of the archived webpage titled “Mirabegron”
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`available at https://menmd.com/product/mirabegron/, archived on 09-29-2022, available via the
`
`“Internet Archive, the WayBack Machine,” accessed at https://archive.org/web/ is attached as
`
`Exhibit L, and as excerpted below:
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`15
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`Case 1:23-cv-00629-JFB-CJB Document 1 Filed 06/09/23 Page 16 of 34 PageID #: 16
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`.
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`87.
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`On information and belief, on or about February 2023, menMD, directly or
`
`indirectly through its affiliates, partners, and agents, listed its Mirabegron Products on it “Patient-
`
`specific price list” dated February 15, 2023, available for download at https://cdn.menmd.com/wp-
`
`content/uploads/2023/02/16101511/Price-List-All-States-UPDATED_-02.15.23.pdf; a true and
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`correct copy is also attached as Exhibit M.
`
`88.
`
`On or about February 15, 2023, Astellas sent another cease and desist letter to
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`menMD informing them that their sales of menMD’s Mirabegron Products were unlawful because,
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`Case 1:23-cv-00629-JFB-CJB Document 1 Filed 06/09/23 Page 17 of 34 PageID #: 17
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`inter alia, they infringed at least the ’117, ’049, ’474, and ’872 Patents. A true and correct copy of
`
`this letter is attached Exhibit N.
`
`89.
`
`On or about February 24, 2023, menMD responded to Astellas’ February 15, 2023
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`letter. A true and correct copy of this letter is attached Exhibit O. menMD’s February 24, 2023
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`letter claimed, inter alia, that menMD “has stopped printing any marketing materials concerning
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`mirabegron and has taken down all statements about mirabegron from its website.” See Exhibit O
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`at 1.
`
`90.
`
`On information and belief, on or about March 2023, menMD, directly or indirectly
`
`through its affiliates, partners, and agents, continued to list its Mirabegron Products on its “Patient-
`
`specific price list” dated March 28, 2023; a true and correct copy is also attached as Exhibit P.
`
`91.
`
`On information and belief, on or about March 2023, menMD, directly or indirectly
`
`through its affiliates, partners, and agents, continued to list its Mirabegron Products on the menMD
`
`Prescription Order Form, updated March 28, 2023; a true and correct copy is also attached as
`
`Exhibit Q.
`
`92.
`
`On information and belief, on or about March 2023, menMD, directly or indirectly
`
`through its affiliates, partners, and agents, continued to target healthcare professionals and
`
`provided them with marketing and promotional information for its Mirabegron Products, and Price
`
`List and Prescription Order Form listing those products. On information and belief, on or about
`
`March 2023, menMD, directly or indirectly through its affiliates, partners, and agents, continued
`
`to encourage healthcare professionals to prescribe its Mirabegron Products to patients in need. On
`
`information and belief, menMD encouraged healthcare professionals to order its Mirabegron
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`Products through PharmaLabs, located at 10901 Roosevelt Boulevard N, Suite #1200C, St.
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`Petersburg, FL 33716.
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`93.
`
`On information and belief, PharmaLabs is a compounding pharmacy. On
`
`information and belief, PharmaLabs is in the business of providing medications as a compounding
`
`pharmacy at least 2012. On information and belief, PharmaLabs is a pharmacy partner of menMD.
`
`94.
`
`On information and belief, PharmaLabs and menMD have certain common officers.
`
`On information and belief, PharmaLabs is an alter ego of menMD.
`
`95.
`
`On information and belief, PharmaLabs makes, inter alia, menMD’s Mirabegron
`
`Products, and/or provides those products to patients in need thereof. On information and belief,
`
`PharmaLabs makes, uses, or imports mirabegron active pharmaceutical ingredient (“API”) to make
`
`menMD’s Mirabegron Products and has done since at least May 2019.
`
`96.
`
`On information and belief, when patients filled prescriptions of menMD’s
`
`Mirabegron Products, PharmaLabs provided instructions to patients in need on how to use those
`
`products, including for the treatment of overactive bladder. On information and belief,
`
`PharmaLabs directs patients to menMD for instructions on how to use its products, including for
`
`the treatment of overactive bladder.
`
`97.
`
`On or about April 7, 2023, menMD sent Astellas a follow-up letter to its February
`
`24, 2023 letter. A true and correct copy of this letter is attached Exhibit R. In this April 7, 2023
`
`letter, menMD admitted that the mirabegron used in its Mirabegron Products is crystalline and
`
`contains certain peaks as measured by x-ray powder diffraction. On information and belief,
`
`menMD’s Mirabegron Products contain the crystalline form(s) of mirabegron as claimed in the
`
`’117 and ’049 Patents.
`
`98.
`
`On information and belief, despite menMD’s representations in its February 24,
`
`2023 letter that it has taken down all statements about mirabegron from its website, menMD has
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`continued to sell, and offer to sell menMD’s Mirabegron Products through its website
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`https://menmd.com/, as excerpted and highlighted below:
`
`99.
`
`Despite its representations in its February 24, 2023 letter, menMD continues to sell
`
`menMD’s Mirabegron Products through its website https://menmd.com/product/mirabegron/.
`
`menMD continues to offer incentives to its customers to purchase menMD’s Mirabegron Products
`
`by stating that patients may “[t]ransfer [their] existing prescription to menMD and get [their] first
`
`month of [mirabegron] free!” On its website, menMD promote menMD’s Mirabegron Products
`
`stating that they are “immediate release capsules” and that they are “used to treat urinary
`
`incontinence” and helps “prevent urgent, frequent, or uncontrolled urination.” In order to promote
`
`the efficacy of menMD’s Mirabegron Products, menMD, on its website, continues to provide a
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`link to the Korean Study titled “Effectiveness and persistence of mirabegron as a first-line
`
`treatment in patients with overactive bladder in real-life practice”. A true and correct copy of
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`19
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`menMD’s mirabegron webpage at https://menmd.com/product/mirabegron/, accessed April 27,
`
`2023, is attached as Exhibit S, as excerpted below:
`
`100. On information and belief, at least as of March 28, 2023, menMD continued to sell
`
`and offer to sell mirabegron by listing it in its patient-specific price list. See Exhibit P.
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`.
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`101. On information and belief, upon receiving orders from customers, menMD will
`
`provide its Mirabegron Products, with instructions to use them to treat overactive bladder.
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`CLAIMS FOR RELIEF
`
`COUNT I: DIRECT INFRINGEMENT OF THE ’532 PATENT BY MENMD
`
`102.
`
`Plaintiffs incorporate by reference and reallege paragraphs 1 through 101 above as
`
`though fully restated herein.
`
`103. menMD has infringed one or more claims of the ’532 Patent under 35 U.S.C. §
`
`271(a) at least by importing, using, manufacturing, offering to sell and/or selling mirabegron,
`
`and/or products containing mirabegron prior to the expiration of the ’532 Patent.
`
`104. menMD had knowledge of Myrbetriq® and its Orange Book listed patents,
`
`including the ’532 Patent, at least as of June 14, 2019. menMD had actual notice of the ’532 Patent
`
`at least as of June 14, 2019.
`
`105. menMD’s acts of infringement have caused damage to Plaintiffs. menMD’s
`
`infringement of the ’532 Patent has been willful and deliberate. Plaintiffs have been damaged and
`
`otherwise harmed by such willful infringement.
`
`COUNT II: DIRECT INFRINGEMENT OF THE ’532 PATENT BY PHARMALABS
`
`106.
`
`Plaintiffs incorporate by reference and reallege paragraphs 1 through 105 above as
`
`though fully restated herein.
`
`107.
`
`PharmaLabs has infringed one or more claims of the ’532 Patent under 35 U.S.C.
`
`§ 271(a) at least by importing, using, manufacturing, offering to sell and/or selling mirabegron,
`
`and/or products containing mirabegron prior to the expiration of the ’532 Patent.
`
`108.
`
`PharmaLabs had knowledge of Myrbetriq® and its Orange Book listed patents,
`
`includin