`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`
`FERRING PHARMACEUTICALS INC.,
`FERRING INTERNATIONAL CENTER S.A.,
`FERRING B.V., and
`POLYPEPTIDE LABORATORIES A/S,
`
`
`Plaintiffs,
`
`
`v.
`
`EUGIA PHARMA SPECIALTIES LTD.,
`AUROBINDO PHARMA LTD., and
`AUROMEDICS PHARMA LLC.
`
`
`Defendants.
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`
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`C.A. No.
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`COMPLAINT
`
`Plaintiffs Ferring Pharmaceuticals Inc. (“Ferring Pharma”), Ferring International Center
`
`S.A. (“FICSA”), Ferring B.V. (collectively, “Ferring”), and Polypeptide Laboratories A/S (“PPL
`
`A/S”) (together with Ferring, “Plaintiffs”) bring this action against Defendants Eugia Pharma
`
`Specialties Ltd. (“Eugia”), Aurobindo Pharma Ltd. (“APL”), and AuroMedics Pharma LLC
`
`(“AuroMedics”) (collectively “Defendants”) and allege as follows:
`
`NATURE OF THE ACTION
`
`
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`This is an action for infringement of United States Patent Number 9,579,359 (“the
`
`’359 patent”), United States Patent Number 10,729,739 (“the ’739 patent”), United States Patent
`
`Number 10,973,870 (“the ’870 patent”), United States Patent Number 9,415,085 (“the ’085
`
`patent”), United States Patent Number 10,695,398 (“the ’398 patent”), United States Patent
`
`Number 8,841,081 (“the ’081 patent”), United States Patent Number 9,877,999 (“the ’999
`
`patent”), and United States Patent Number 8,828,938 (“the ’938 patent”) (collectively, the
`
`
`
`Case 1:22-cv-00017-UNA Document 1 Filed 01/04/22 Page 2 of 39 PageID #: 2
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`“patents in suit”) under the Patent Laws of the United States, Title 35 of the United States Code,
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`§ 100 et seq. and for a declaratory judgment of infringement under 28 U.S.C. §§ 2201 and 2202.
`
`
`
`This action arises out of Eugia’s submission of Abbreviated New Drug
`
`Application (“ANDA”) No. 215800 (“Eugia’s ANDA”) under Section 505(j) of the Federal
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`Food, Drug, and Cosmetic Act (“the Act”), 21 U.S.C. § 355(j), seeking U.S. Food and Drug
`
`Administration (“FDA”) approval to commercially manufacture, use, or sell a generic version of
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`Ferring’s FIRMAGON® (degarelix for injection) (“Eugia’s ANDA Product”) prior to the
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`expiration of the ’359, ’739, ’870, ’085, and ’398 patents.
`
`THE PARTIES
`
`
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`Plaintiff Ferring Pharma is a private Delaware corporation having its principal
`
`place of business at 100 Interpace Parkway, Parsippany, New Jersey 07054.
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`
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`Plaintiff FICSA is a Swiss private limited liability company having its offices at
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`Ch. de la Vergognausaz 50, 1162 Saint-Prex, Switzerland.
`
`
`
`Plaintiff Ferring B.V. is a Dutch private limited liability company having its
`
`offices at Polaris Avenue 144, Hoofddorp, 2132 JX, Netherlands.
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`
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`Plaintiff PPL A/S is a company organized and existing under the laws of
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`Denmark, having its registered offices at Herredsvejen 2 Hillerod, 3400 Denmark.
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`
`
`Upon information and belief, Defendant Eugia is a company organized and
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`existing under the laws of India with a place of business at Maitri Vihar, Plot #2, Ameerpet,
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`Hyderabad 500038, Telangana, India.
`
`
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`Upon information and belief, Defendant APL is a company organized and
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`existing under the laws of India with a place of business at Maitri Vihar, Plot #2, Ameerpet,
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`Hyderabad 500038, Telangana, India.
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`2
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`Case 1:22-cv-00017-UNA Document 1 Filed 01/04/22 Page 3 of 39 PageID #: 3
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`
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`Upon information and belief, Defendant AuroMedics is a limited liability
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`company organized and existing under the laws of Delaware, with its principal place of business
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`at 279 Princeton Hightstown Road, East Windsor, NJ 08520.
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`
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`
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`
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`Upon information and belief, Eugia is a wholly owned subsidiary of APL.
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`Upon information and belief, AuroMedics is a wholly-owned subsidiary of APL.
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`AuroMedics is Eugia’s United States agent regarding Eugia’s ANDA.
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`Upon information and belief, Eugia, APL, and AuroMedics acted in concert to
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`prepare and file ANDA No. 215800.
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`
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`Upon information and belief, Eugia and APL participated in, assisted, and
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`cooperated with AuroMedics in the acts complained of herein.
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`
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`Upon information and belief, following any FDA approval of Eugia’s ANDA,
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`Eugia, APL, and AuroMedics will act in concert to manufacture, distribute, and/or sell Eugia’s
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`ANDA Product throughout the United States, including in Delaware.
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`JURISDICTION
`
`
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`This Court has subject matter jurisdiction under 28 U.S.C. §§ 1331, 1338(a),
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`2201, and 2202.
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`
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`Upon information and belief, this Court has personal jurisdiction over Eugia
`
`because it has purposefully availed itself of the benefits and protections of Delaware’s laws such
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`that it should reasonably anticipate being sued in this State. Upon information and belief, Eugia,
`
`itself and through its agents, develops, manufactures, imports, offers to sell, markets, and/or sells
`
`generic drug products throughout the United States, including in Delaware, and therefore
`
`transacts business within Delaware related to Plaintiffs’ claims. Alternatively, to the extent this
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`Court does not have personal jurisdiction over Eugia under Federal Rule of Civil Procedure
`
`4(k)(1), upon information and belief, this Court has personal jurisdiction over Eugia under
`
`3
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`
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`Case 1:22-cv-00017-UNA Document 1 Filed 01/04/22 Page 4 of 39 PageID #: 4
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`Federal Rule of Civil Procedure 4(k)(2) because exercising jurisdiction over Eugia is consistent
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`with the United States Constitution and laws.
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`
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`Upon information and belief, Eugia (1) has substantial, continuous, and
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`systematic contacts with Delaware; (2) intends to market, sell, and/or distribute Eugia’s ANDA
`
`Product to the residents of Delaware; (3) has corporate affiliates that are organized under the
`
`laws of Delaware; (4) maintains a distribution network within Delaware; and/or (5) enjoys
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`substantial income from sales of its generic pharmaceutical products in Delaware.
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`
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`Upon information and belief, this Court has personal jurisdiction over APL
`
`because it has purposefully availed itself of the benefits and protections of Delaware’s laws such
`
`that it should reasonably anticipate being sued in this State. Upon information and belief, APL,
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`itself and through its subsidiaries, develops, manufactures, imports, offers to sell, markets, and/or
`
`sells generic drug products throughout the United States, including in Delaware, and therefore
`
`transacts business within Delaware related to Plaintiffs’ claims. Alternatively, to the extent this
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`Court does not have personal jurisdiction over APL under Federal Rule of Civil Procedure
`
`4(k)(1), upon information and belief, this Court has personal jurisdiction over APL under Federal
`
`Rule of Civil Procedure 4(k)(2) because exercising jurisdiction over APL is consistent with the
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`United States Constitution and laws.
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`
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`Upon information and belief, APL (1) has substantial, continuous, and systematic
`
`contacts with Delaware; (2) intends to market, sell, and/or distribute Eugia’s ANDA Product to
`
`the residents of Delaware; (3) has corporate affiliates that are organized under the laws of
`
`Delaware; (4) maintains a distribution network within Delaware; and/or (5) enjoys substantial
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`income from sales of its generic pharmaceutical products in Delaware.
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`4
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`Case 1:22-cv-00017-UNA Document 1 Filed 01/04/22 Page 5 of 39 PageID #: 5
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`
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`Upon information and belief, this Court has personal jurisdiction over
`
`AuroMedics because it is organized under the laws of the State of Delaware and therefore has
`
`consented to general jurisdiction in this State. Upon information and belief, AuroMedics is
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`registered to conduct business within the State of Delaware and maintains as a registered agent
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`for service of process the Corporation Trust Company with an address at Corporation Trust
`
`Center, 1209 Orange Street, Wilmington, DE 19801. Upon information and belief, AuroMedics
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`develops, manufactures, imports, offers to sell, markets, and/or sells generic drug products
`
`throughout the United States, including in Delaware, and therefore transacts business within
`
`Delaware related to Plaintiffs’ claims.
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`
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`Upon information and belief, Eugia and APL have purposefully availed
`
`themselves of this forum by making, using, importing, selling, or offering to sell pharmaceutical
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`products within this State, including planning to distribute Eugia’s ANDA Product in this State,
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`and can therefore reasonably expect to be subject to jurisdiction in Delaware’s courts.
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`
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`Upon information and belief, Eugia and APL have substantial, continuous, and
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`systematic contacts with Delaware including through its engagement in the direct marketing,
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`distribution, and/or sales of generic pharmaceuticals within Delaware.
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`
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`Upon information and belief, Eugia and APL, and/or their subsidiaries, affiliates,
`
`or agents, intend to place Eugia’s ANDA Product into the stream of commerce with the
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`reasonable expectation or knowledge, and the intent, that such product will be purchased and
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`used by consumers in this District.
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`
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`Upon information and belief, APL controls Eugia, and AuroMedics, and therefore
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`Eugia and AuroMedics’s activities in Delaware are attributable to APL under either an alter ego
`
`or agency theory.
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`5
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`Case 1:22-cv-00017-UNA Document 1 Filed 01/04/22 Page 6 of 39 PageID #: 6
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`
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`Upon information and belief, this Court has personal jurisdiction over Defendants
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`because upon approval of ANDA No. 215800, Defendants will distribute, market, offer for sale,
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`sell, and/or import into the United States the generic drug products, including in Delaware, and
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`will derive substantial revenue from their consumption in Delaware.
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`
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`Defendants have previously submitted to the jurisdiction of this Court and have
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`availed themselves of the legal protections of Delaware, including by having asserted
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`counterclaims in this jurisdiction in matters including, for example: Covis Pharma GmBH et al v.
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`Eugia Pharma Specialties Ltd. et al, No. 21-00003-CFC, D.I. 43 (Aug 6, 2021): Teva
`
`Pharmaceuticals International GmbH et al v. Aurobindo Pharma Ltd. et al., No. 20-632-CFC,
`
`D.I. 13 (D. Del. Jul 20, 2020); and Pfizer Inc. et al v. Aurobindo Pharma, Ltd., No. 20-1528-
`
`CFC, D.I. 7 (D. Del. Dec 4, 2020).
`
`VENUE
`
`herein.
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`
`
`
`
`Plaintiffs incorporate by reference the preceding paragraphs as if fully set forth
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`Venue is proper in this judicial district pursuant to 28 U.S.C. § 1391 and 28
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`U.S.C. § 1400(b) with respect to Eugia and APL because both are foreign corporations that may
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`be sued in any district in which they are subject to the court’s personal jurisdiction, and upon
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`information and belief, Eugia and APL are subject to this Court’s personal jurisdiction.
`
`
`
`Venue is proper in this District under 28 U.S.C. § 1400(b) with respect to
`
`AuroMedics because, upon information and belief, it resides in the State of Delaware.
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`
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`6
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`Case 1:22-cv-00017-UNA Document 1 Filed 01/04/22 Page 7 of 39 PageID #: 7
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`THE PATENTS IN SUIT
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`The ’359 Patent
`
`
`
`On February 28, 2017, the United States Patent and Trademark Office (“PTO”)
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`duly and legally issued the ’359 patent, which bears the title “Method of Treating Prostate
`
`Cancer with GnRH Antagonist” and names Tine Kold Olesen, Bo-Eric Persson, Per Cantor,
`
`Egbert A. van der Meulen, and Jens-Kristian Slott Jensen as inventors. A true and correct copy
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`of the ’359 patent is attached as Exhibit A.
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`
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`Ferring B.V. is the owner by assignment of the ’359 patent, and Ferring Pharma is
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`an exclusive licensee of the ’359 patent.
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`
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`In accordance with 21 U.S.C. § 355(b)(1) and 21 C.F.R. § 314.53, the ’359 patent
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`is listed in the FDA’s APPROVED DRUG PRODUCTS WITH THERAPEUTIC EQUIVALENCE
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`EVALUATIONS (also known as the “Orange Book”) as covering FIRMAGON®.
`
`The ’739 Patent
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`
`
`On August 4, 2020, the PTO duly and legally issued the ’739 patent, which bears
`
`the title “Method of Treating Prostate Cancer with GnRH Antagonist” and names Tine Kold
`
`Olesen, Bo-Eric Persson, Per Cantor, Egbert A. van der Meulen, and Jens-Kristian Slott Jensen
`
`as inventors. A true and correct copy of the ’739 patent is attached as Exhibit B.
`
`
`
`Ferring B.V. is the owner by assignment of the ’739 patent, and Ferring Pharma is
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`an exclusive licensee of the ’739 patent.
`
`The ’870 Patent
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`
`
`On April 13, 2021, the PTO duly and legally issued the ’870 patent, which bears
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`the title “Method of Treating Prostate Cancer with GnRH Antagonist” and names Tine Kold
`
`Olesen, Bo-Eric Persson, Per Cantor, Egbert A. van der Meulen, and Jens-Kristian Slott Jensen
`
`as inventors. A true and correct copy of the ’870 patent is attached as Exhibit C.
`
`7
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`Case 1:22-cv-00017-UNA Document 1 Filed 01/04/22 Page 8 of 39 PageID #: 8
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`
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`Ferring B.V. is the owner by assignment of the ’870 patent, and Ferring Pharma is
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`an exclusive licensee of the ’870 patent.
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`The ’085 Patent
`
`
`
`On August 16, 2016, the PTO duly and legally issued the ’085 patent, which bears
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`the title “Method of Treating Prostate Cancer with GnRH Antagonist” and names Egbert A. van
`
`der Meulen, and László Balázs Tankó as inventors. A true and correct copy of the ’085 patent is
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`attached as Exhibit D.
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`
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`Ferring B.V. is the owner by assignment of the ’085 patent, and Ferring Pharma is
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`an exclusive licensee of the ’085 patent.
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`The ’398 Patent
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`
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`On June 30, 2020, the PTO duly and legally issued the ’398 patent, which bears
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`the title “Method of Treating Prostate Cancer with GnRH Antagonist” and names Egbert A. van
`
`der Meulen, and László Balázs Tankó as inventors. A true and correct copy of the ’398 patent is
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`attached as Exhibit E.
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`
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`Ferring B.V. is the owner by assignment of the ’398 patent, and Ferring Pharma is
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`an exclusive licensee of the ’398 patent.
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`The ’081 Patent
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`
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`On September 23, 2014, the PTO duly and legally issued the ’081 patent, which
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`bears the title “Method of Treating Metastatic Stage Prostate Cancer” and names Bo-Eric
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`Persson as the inventor. A true and correct copy of the ’081 patent is attached as Exhibit F.
`
`
`
`FICSA is the owner by assignment of the ’081 patent, and Ferring Pharma is an
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`exclusive licensee of the ’081 patent.
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`The ’999 Patent
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`8
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`Case 1:22-cv-00017-UNA Document 1 Filed 01/04/22 Page 9 of 39 PageID #: 9
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`
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`On January 30, 2018, the PTO duly and legally issued the ’999 patent, which
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`bears the title “Method for Treating Metastatic Stage Prostate Cancer” and names Bo-Eric
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`Persson as the inventor. A true and correct copy of the ’999 patent is attached as Exhibit G.
`
`
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`FICSA is the owner by assignment of the ’999 patent, and Ferring Pharma is an
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`exclusive licensee of the ’999 patent.
`
`The ’938 Patent
`
`
`
`On September 9, 2014, the PTO duly and legally issued the ’938 patent, which
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`bears the title “Method for the Manufacture of Degarelix” and names Haixiang Zhang, Jens
`
`Fomsgaard, and Gunnar Staerkaer as inventors. A true and correct copy of the ’938 patent is
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`attached as Exhibit H.
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`
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`PPL A/S is the owner by assignment of the ’938 patent, and FICSA and its
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`affiliates are an exclusive licensee of the ’938 patent.
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`STATEMENT OF FACTS
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`
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`Ferring Pharma is the holder of New Drug Application (“NDA”) No. 022201 for
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`FIRMAGON® (degarelix acetate) for injection, 80 mg and 120 mg.
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`
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`On December 24, 2008, the United States Food and Drug Administration
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`(“FDA”) approved NDA No. 022201 for the manufacture, marketing, and sale of FIRMAGON®
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`for treatment of patients with advanced prostate cancer.
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`approval.
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`
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`
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`Ferring Pharma has sold FIRMAGON® under NDA No. 022201 since its
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`Upon information and belief, Eugia filed ANDA No. 215800 seeking approval to
`
`engage in the commercial manufacture, use, or sale in the United States of Eugia’s ANDA
`
`Product before the expiration of the ’359, ’739, ’870, ’085, and ’398 patents.
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`9
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`Case 1:22-cv-00017-UNA Document 1 Filed 01/04/22 Page 10 of 39 PageID #: 10
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`
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`Upon information and belief, Eugia, APL, and AuroMedics acted collaboratively
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`and in concert in the preparation and submission of Eugia’s ANDA and continue to act
`
`collaboratively in pursuing FDA approval of Eugia’s ANDA and seeking to market Eugia’s
`
`ANDA Product.
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`
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`Upon information and belief, Eugia, in concert with APL and AuroMedics,
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`submitted a certification under 21 U.S.C. § 355(j)(2)(A)(vii)(IV) (“Paragraph IV Certification”)
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`of invalidity, unenforceability, and/or noninfringement of the ’359, ’739, ’870, ’085, and ’398
`
`patents.
`
`
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`On November 24, 2021 (Ferring Pharma) and November 25, 2021 (FICSA, and
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`Ferring B.V.), respectively, received a letter from Defendants dated November 22, 2021,
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`purporting to be a Notice of Certification for Eugia’s ANDA (“Defendants’ Notice Letter”)
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`under Section 505(j)(2)(B)(ii) of the Act and 21 C.F.R. § 314.95(c)(1). Defendants’ Notice Letter
`
`enclosed a statement of alleged factual and legal bases that the ’359, ’739, ’870, ’085, and ’398
`
`patents are invalid, unenforceable, and/or will not be infringed by the commercial manufacture,
`
`use, or sale of Eugia’s ANDA Product (the “Detailed Statement”).
`
`
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`Upon information and belief, Eugia, in concert with APL and AuroMedics,
`
`intends to seek permission from the FDA to market its ANDA Product prior to expiration of the
`
`’359, ’739, ’870, ’085, and ’398 patents.
`
`
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`FDA regulations require that approved drug products include prescribing
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`information reciting the FDA-approved indication(s) for the drug and related instructions for
`
`healthcare providers to safely and effectively administer the drug. See 21 C.F.R. § 201.56(a)(1)-
`
`(3), (d)(1); 21 C.F.R. § 201.57(a)-(c).
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`10
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`Case 1:22-cv-00017-UNA Document 1 Filed 01/04/22 Page 11 of 39 PageID #: 11
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`
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`Consistent with FDA regulations, the package insert for FIRMAGON® includes
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`prescribing information that recites the FDA-approved indication for FIRMAGON® and provides
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`instructions for physicians and patients to safely and effectively administer FIRMAGON®.
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`
`
`Attached as Exhibit I is a true and correct copy of the February 2020
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`FIRMAGON® package insert, which is the current version of the FIRMAGON® package insert.
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`
`
`FIRMAGON® is indicated for the treatment of patients with advanced prostate
`
`cancer. (Ex. I at § 1.)
`
`
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`The recommended dosing information for FIRMAGON® is provided in Section
`
`2.1 of the FIRMAGON® package insert as follows:
`
`(Ex. I at § 2.1.)
`
`
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`Section 2.2 of the FIRMAGON® package insert provides that FIRMAGON® is to
`
`be administered by a healthcare professional only:
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`(Ex. I at § 2.2.)
`
`
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`The “Dosage Form and Strengths” section of the FIRMAGON® package insert
`
`provides:
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`
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`11
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`Case 1:22-cv-00017-UNA Document 1 Filed 01/04/22 Page 12 of 39 PageID #: 12
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`(Ex. I at § 3.)
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`
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`The “Adverse Reactions” section of the FIRMAGON® package insert provides
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`the following table:
`
`
`
`(Ex. I at § 6.1.)
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`
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`The package insert for Eugia’s ANDA Product will be substantially similar to the
`
`package insert for FIRMAGON® in all material respects.
`
`
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`Plaintiffs commenced this action within forty-five (45) days of receiving
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`
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`Defendants’ Notice Letter.
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`12
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`Case 1:22-cv-00017-UNA Document 1 Filed 01/04/22 Page 13 of 39 PageID #: 13
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`
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`There is an actual, real, immediate, and justiciable controversy between Plaintiffs
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`and Defendants regarding whether Defendants will infringe the patents in suit.
`
`COUNT I
`
`Infringement of the ’359 Patent
`
`
`
`
`
`Plaintiffs reallege paragraphs 1 to 69 and incorporate them by reference.
`
`Defendants’ submission of ANDA No. 215800 to engage in the commercial
`
`manufacture, use, offer for sale, or sale within the United States or importation into the United
`
`States of Eugia’s ANDA Product before the expiration of the ’359 patent constitutes
`
`infringement of one of more claims of the ’359 patent under 35 U.S.C. § 271(e)(2)(A).
`
`
`
`Unless enjoined by this Court, upon FDA approval of Defendants’ ANDA No.
`
`215800, Defendants will infringe, either literally or under the doctrine of equivalents, one or
`
`more claims of the ’359 patent by actively inducing infringement by others under 35 U.S.C.
`
`§ 271(b).
`
`
`
`Upon information and belief, after the FDA has approved Defendants’ ANDA
`
`No. 215800, Defendants intend to manufacture, market, sell, and offer to sell Eugia’s ANDA
`
`Product with an FDA-approved product insert that will direct physicians and patients in the use
`
`of Eugia’s ANDA Product.
`
`
`
`Upon information and belief, Defendants will actively and intentionally aid, abet,
`
`encourage, participate, and induce others to perform acts that Defendant knows will directly
`
`infringe, either literally or under the doctrine of equivalents, one or more claims of the ’359
`
`patent by marketing Eugia’s ANDA Product with the FDA-approved product insert.
`
`
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`Upon information and belief, Defendants have knowledge of the ’359 patent and
`
`knows that the use of Eugia’s ANDA Product in accordance with the FDA-approved product
`
`13
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`
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`Case 1:22-cv-00017-UNA Document 1 Filed 01/04/22 Page 14 of 39 PageID #: 14
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`insert will directly infringe, either literally or under the doctrine of equivalents, one or more
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`claims of the ’359 patent.
`
`
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`Plaintiffs will be irreparably harmed by Defendants’ infringing activities unless
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`those activities are enjoined by this Court.
`
`
`
`
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`Plaintiffs have no adequate remedy at law.
`
`This case is an exceptional one, and Plaintiffs are entitled to an award of their
`
`reasonable attorneys’ fees under 35 U.S.C. § 285.
`
`COUNT II
`
`Infringement of the ’739 Patent
`
`
`
`
`
`Plaintiffs reallege paragraphs 1 to 69 and incorporate them by reference.
`
`Defendants’ submission of ANDA No. 215800 to engage in the commercial
`
`manufacture, use, offer for sale, or sale within the United States or importation into the United
`
`States of Eugia’s ANDA Product before the expiration of the ’739 patent constitutes
`
`infringement of one of more claims of the ’739 patent under 35 U.S.C. § 271(e)(2)(A).
`
`
`
`Unless enjoined by this Court, upon FDA approval of Defendants’ ANDA No.
`
`215800, Defendants will infringe, either literally or under the doctrine of equivalents, one or
`
`more claims of the ’739 patent by actively inducing infringement by others under 35 U.S.C.
`
`§ 271(b).
`
`
`
`Upon information and belief, after the FDA has approved Defendants’ ANDA
`
`No. 215800, Defendants intend to manufacture, market, sell, and offer to sell Eugia’s ANDA
`
`Product with an FDA-approved product insert that will direct physicians and patients in the use
`
`of Eugia’s ANDA Product.
`
`
`
`Upon information and belief, Defendants will actively and intentionally aid, abet,
`
`encourage, participate, and induce others to perform acts that Defendant knows will directly
`
`14
`
`
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`Case 1:22-cv-00017-UNA Document 1 Filed 01/04/22 Page 15 of 39 PageID #: 15
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`infringe, either literally or under the doctrine of equivalents, one or more claims of the ’739
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`patent by marketing Eugia’s ANDA Product with the FDA-approved product insert.
`
`
`
`Upon information and belief, Defendants have knowledge of the ’739 patent and
`
`know that the use of Eugia’s ANDA Product in accordance with the FDA-approved product
`
`insert will directly infringe, either literally or under the doctrine of equivalents, one or more
`
`claims of the ’739 patent.
`
`
`
`Plaintiffs will be irreparably harmed by Defendants’ infringing activities unless
`
`those activities are enjoined by this Court.
`
`
`
`
`
`Plaintiffs have no adequate remedy at law.
`
`This case is an exceptional one, and Plaintiffs are entitled to an award of their
`
`reasonable attorneys’ fees under 35 U.S.C. § 285.
`
`COUNT III
`
`Infringement of the ’870 Patent
`
`
`
`
`
`Plaintiffs reallege paragraphs 1 to 69 and incorporate them by reference.
`
`Defendants’ submission of ANDA No. 215800 to engage in the commercial
`
`manufacture, use, offer for sale, or sale within the United States or importation into the United
`
`States of Eugia’s ANDA Product before the expiration of the ’870 patent constitutes
`
`infringement of one of more claims of the ’870 patent under 35 U.S.C. § 271(e)(2)(A).
`
`
`
`Unless enjoined by this Court, upon FDA approval of Defendants’ ANDA No.
`
`215800, Defendants will infringe, either literally or under the doctrine of equivalents, one or
`
`more claims of the ’870 patent by actively inducing infringement by others under 35 U.S.C.
`
`§ 271(b).
`
`
`
`Upon information and belief, after the FDA has approved Defendants’ ANDA
`
`No. 215800, Defendants intend to manufacture, market, sell, and offer to sell Eugia’s ANDA
`
`15
`
`
`
`Case 1:22-cv-00017-UNA Document 1 Filed 01/04/22 Page 16 of 39 PageID #: 16
`
`Product with an FDA-approved product insert that will direct physicians and patients in the use
`
`of Eugia’s ANDA Product.
`
`
`
`Upon information and belief, Defendants will actively and intentionally aid, abet,
`
`encourage, participate, and induce others to perform acts that Defendant knows will directly
`
`infringe, either literally or under the doctrine of equivalents, one or more claims of the ’870
`
`patent by marketing Eugia’s ANDA Product with the FDA-approved product insert.
`
`
`
`Upon information and belief, Defendants have knowledge of the ’870 patent and
`
`know that the use of Eugia’s ANDA Product in accordance with the FDA-approved product
`
`insert will directly infringe, either literally or under the doctrine of equivalents, one or more
`
`claims of the ’870 patent.
`
`
`
`Plaintiffs will be irreparably harmed by Defendants’ infringing activities unless
`
`those activities are enjoined by this Court.
`
`
`
`
`
`Plaintiffs have no adequate remedy at law.
`
`This case is an exceptional one, and Plaintiffs are entitled to an award of their
`
`reasonable attorneys’ fees under 35 U.S.C. § 285.
`
`COUNT IV
`
`Infringement of the ’085 Patent
`
`
`
`
`
`Plaintiffs reallege paragraphs 1 to 69 and incorporate them by reference.
`
`Defendants’ submission of ANDA No. 215800 to engage in the commercial
`
`manufacture, use, offer for sale, or sale within the United States or importation into the United
`
`States of Eugia’s ANDA Product before the expiration of the ’085 patent constitutes
`
`infringement of one of more claims of the ’085 patent under 35 U.S.C. § 271(e)(2)(A).
`
`
`
`Unless enjoined by this Court, upon FDA approval of Defendants’ ANDA No.
`
`215800, Defendants will infringe, either literally or under the doctrine of equivalents, one or
`
`16
`
`
`
`Case 1:22-cv-00017-UNA Document 1 Filed 01/04/22 Page 17 of 39 PageID #: 17
`
`more claims of the ’085 patent by actively inducing infringement by others under 35 U.S.C.
`
`§ 271(b).
`
`
`
`Upon information and belief, after the FDA has approved Defendants’ ANDA
`
`No. 215800, Defendants intend to manufacture, market, sell, and offer to sell Eugia’s ANDA
`
`Product with an FDA-approved product insert that will direct physicians and patients in the use
`
`of Eugia’s ANDA Product.
`
`
`
`Upon information and belief, Defendants will actively and intentionally aid, abet,
`
`encourage, participate, and induce others to perform acts that Defendant knows will directly
`
`infringe, either literally or under the doctrine of equivalents, one or more claims of the ’085
`
`patent by marketing Eugia’s ANDA Product with the FDA-approved product insert along with
`
`the knowledge of a person of ordinary skill in the art.
`
`
`
`Upon information and belief, Defendants have knowledge of the ’085 patent and
`
`know that the use of Eugia’s ANDA Product in accordance with the FDA-approved product
`
`insert will directly infringe, either literally or under the doctrine of equivalents, one or more
`
`claims of the ’085 patent.
`
` Plaintiffs will be irreparably harmed by Defendants’ infringing activities unless
`
`those activities are enjoined by this Court.
`
` Plaintiffs have no adequate remedy at law.
`
` This case is an exceptional one, and Plaintiffs are entitled to an award of their
`
`reasonable attorneys’ fees under 35 U.S.C. § 285.
`
`COUNT V
`
`Infringement of the ’398 Patent
`
` Plaintiffs reallege paragraphs 1 to 69 and incorporate them by reference.
`
`17
`
`
`
`Case 1:22-cv-00017-UNA Document 1 Filed 01/04/22 Page 18 of 39 PageID #: 18
`
` Defendants’ submission of ANDA No. 215800 to engage in the commercial
`
`manufacture, use, offer for sale, or sale within the United States or importation into the United
`
`States of Eugia’s ANDA Product before the expiration of the ’398 patent constitutes
`
`infringement of one of more claims of the ’398 patent under 35 U.S.C. § 271(e)(2)(A).
`
` Unless enjoined by this Court, upon FDA approval of Defendants’ ANDA No.
`
`215800, Defendants will infringe, either literally or under the doctrine of equivalents, one or
`
`more claims of the ’398 patent by actively inducing infringement by others under 35 U.S.C.
`
`§ 271(b).
`
` Upon information and belief, after the FDA has approved Defendants’ ANDA
`
`No. 215800, Defendants intend to manufacture, market, sell, and offer to sell Eugia’s ANDA
`
`Product with an FDA-approved product insert that will direct physicians and patients in the use
`
`of Eugia’s ANDA Product.
`
` Upon information and belief, Defendants will actively and intentionally aid, abet,
`
`encourage, participate, and induce others to perform acts that Defendant knows will directly
`
`infringe, either literally or under the doctrine of equivalents, one or more claims of the ’085
`
`patent by marketing Eugia’s ANDA Product with the FDA-approved product insert along with
`
`the knowledge of a person of ordinary skill in the art.
`
` Upon information and belief, Defendants have knowledge of the ’085 patent and
`
`knows that the use of Eugia’s ANDA Product in accordance with the FDA-approved product
`
`insert will directly infringe, either literally or under the doctrine of equivalents, one or more
`
`claims of the ’398 patent.
`
` Plaintiffs will be irreparably harmed by Defendants’ infringing activities unless
`
`those activities are enjoined by this Court.
`
`18
`
`
`
`Case 1:22-cv-00017-UNA Document 1 Filed 01/04/22 Page 19 of 39 PageID #: 19
`
` Plaintiffs have no adequate remedy at law.
`
` This case is an exceptional one, and Plaintiffs are entitled to an award of their
`
`reasonable attorneys’ fees under 35 U.S.C. § 285.
`
`COUNT VI
`
`Infringement of the ’081 Patent
`
` Plaintiffs reallege paragraphs 1 to 69 and incorporate them by reference.
`
` Defendants’ submission of ANDA No. 215800 to engage in the commercial
`
`manufacture, use, offer for sale, or sale within the United States or importation into the United
`
`States of Eugia’s ANDA Product before the expiration of the ’081 patent constitutes
`
`infringement of one of more claims of the ’081 patent under 35 U.S.C. § 271(e)(2)(A).
`
` 35 U.S.C. § 271(e)(2)(A) provides:
`
`It shall be an act of infringement to submit an application under
`section 505(j) of the Federal Food, Drug, and Cosmetic Act or
`described in section 505(b)(2) of such Act for a drug claimed in a
`patent or the use of which is claimed in a patent . . . if the purpose
`of such submission is to obtain approval under such Act to engage
`in the commercial manufacture, use, or sale of a drug . . . claimed in
`a patent or the use of which is claimed in a patent before the
`expiration of such patent.
`
` These claims also arise under the Declaratory Judgment Act, 28 U.S.C. §§ 2201
`
`and 2202.
`
` There is an actual case or controversy such that the Court may entertain Plaintiffs’
`
`request for declaratory relief consistent with Article III of the United States Constitution, and this
`
`actual case or controversy requires a declaration of rights by this Court.
`
` The claims of the ’081 patent are directed to methods for treating metastatic stage
`
`prostate cancer in a subject using degarelix. The method includes, among other things,
`
`identifying or selecting a subject with metastatic stage prostate cancer, administering degarelix
`
`19
`
`
`
`Case 1:22-cv-00017-UNA Document 1 Filed 01/04/22 Page 20 of 39 PageID #: 20
`
`under a specific dosing regimen, and reducing the subject’s serum alkaline phosphatase (“S-
`
`ALP”) level for a duration of treatment.
`
` For example, independent claim 1 of the ’081 patent states:
`
`A method of treating metastatic stage prostate cancer in a subject,
`the method comprising:
`
`identifying a subject with metastatic stage prostate cancer
`comprising measuring the subject’s baseline serum alkaline
`phosphatase (S-ALP) level;
`
`and reducing the subject’s S-ALP level with respect to the baseline
`level by administering an initial dose of degarelix ranging from
`about 160 to about 320 mg to the subject; and ad