throbber
Case 1:22-cv-00017-UNA Document 1 Filed 01/04/22 Page 1 of 39 PageID #: 1
`
`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.
`
`
`
`
`
`
`
`C.A. No.
`
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`
`
`
`
`
`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
`
`
`
`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
`
`“patents in suit”) under the Patent Laws of the United States, Title 35 of the United States Code,
`
`§ 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
`
`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
`
`Ferring’s FIRMAGON® (degarelix for injection) (“Eugia’s ANDA Product”) prior to the
`
`expiration of the ’359, ’739, ’870, ’085, and ’398 patents.
`
`THE PARTIES
`
`
`
`Plaintiff Ferring Pharma is a private Delaware corporation having its principal
`
`place of business at 100 Interpace Parkway, Parsippany, New Jersey 07054.
`
`
`
`Plaintiff FICSA is a Swiss private limited liability company having its offices at
`
`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.
`
`
`
`Plaintiff PPL A/S is a company organized and existing under the laws of
`
`Denmark, having its registered offices at Herredsvejen 2 Hillerod, 3400 Denmark.
`
`
`
`Upon information and belief, Defendant Eugia is a company organized and
`
`existing under the laws of India with a place of business at Maitri Vihar, Plot #2, Ameerpet,
`
`Hyderabad 500038, Telangana, India.
`
`
`
`Upon information and belief, Defendant APL is a company organized and
`
`existing under the laws of India with a place of business at Maitri Vihar, Plot #2, Ameerpet,
`
`Hyderabad 500038, Telangana, India.
`
`2
`
`

`

`Case 1:22-cv-00017-UNA Document 1 Filed 01/04/22 Page 3 of 39 PageID #: 3
`
`
`
`Upon information and belief, Defendant AuroMedics is a limited liability
`
`company organized and existing under the laws of Delaware, with its principal place of business
`
`at 279 Princeton Hightstown Road, East Windsor, NJ 08520.
`
`
`
`
`
`
`
`
`
`Upon information and belief, Eugia is a wholly owned subsidiary of APL.
`
`Upon information and belief, AuroMedics is a wholly-owned subsidiary of APL.
`
`AuroMedics is Eugia’s United States agent regarding Eugia’s ANDA.
`
`Upon information and belief, Eugia, APL, and AuroMedics acted in concert to
`
`prepare and file ANDA No. 215800.
`
`
`
`Upon information and belief, Eugia and APL participated in, assisted, and
`
`cooperated with AuroMedics in the acts complained of herein.
`
`
`
`Upon information and belief, following any FDA approval of Eugia’s ANDA,
`
`Eugia, APL, and AuroMedics will act in concert to manufacture, distribute, and/or sell Eugia’s
`
`ANDA Product throughout the United States, including in Delaware.
`
`JURISDICTION
`
`
`
`This Court has subject matter jurisdiction under 28 U.S.C. §§ 1331, 1338(a),
`
`2201, and 2202.
`
`
`
`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
`
`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
`
`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
`
`

`

`Case 1:22-cv-00017-UNA Document 1 Filed 01/04/22 Page 4 of 39 PageID #: 4
`
`Federal Rule of Civil Procedure 4(k)(2) because exercising jurisdiction over Eugia is consistent
`
`with the United States Constitution and laws.
`
`
`
`Upon information and belief, Eugia (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 income from sales of its generic pharmaceutical products in Delaware.
`
`
`
`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,
`
`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
`
`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
`
`United States Constitution and laws.
`
`
`
`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
`
`income from sales of its generic pharmaceutical products in Delaware.
`
`4
`
`

`

`Case 1:22-cv-00017-UNA Document 1 Filed 01/04/22 Page 5 of 39 PageID #: 5
`
`
`
`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
`
`registered to conduct business within the State of Delaware and maintains as a registered agent
`
`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
`
`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.
`
`
`
`Upon information and belief, Eugia and APL have purposefully availed
`
`themselves of this forum by making, using, importing, selling, or offering to sell pharmaceutical
`
`products within this State, including planning to distribute Eugia’s ANDA Product in this State,
`
`and can therefore reasonably expect to be subject to jurisdiction in Delaware’s courts.
`
`
`
`Upon information and belief, Eugia and APL have substantial, continuous, and
`
`systematic contacts with Delaware including through its engagement in the direct marketing,
`
`distribution, and/or sales of generic pharmaceuticals within Delaware.
`
`
`
`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
`
`reasonable expectation or knowledge, and the intent, that such product will be purchased and
`
`used by consumers in this District.
`
`
`
`Upon information and belief, APL controls Eugia, and AuroMedics, and therefore
`
`Eugia and AuroMedics’s activities in Delaware are attributable to APL under either an alter ego
`
`or agency theory.
`
`5
`
`

`

`Case 1:22-cv-00017-UNA Document 1 Filed 01/04/22 Page 6 of 39 PageID #: 6
`
`
`
`Upon information and belief, this Court has personal jurisdiction over Defendants
`
`because upon approval of ANDA No. 215800, Defendants will distribute, market, offer for sale,
`
`sell, and/or import into the United States the generic drug products, including in Delaware, and
`
`will derive substantial revenue from their consumption in Delaware.
`
`
`
`Defendants have previously submitted to the jurisdiction of this Court and have
`
`availed themselves of the legal protections of Delaware, including by having asserted
`
`counterclaims in this jurisdiction in matters including, for example: Covis Pharma GmBH et al v.
`
`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.
`
`
`
`
`
`Plaintiffs incorporate by reference the preceding paragraphs as if fully set forth
`
`Venue is proper in this judicial district pursuant to 28 U.S.C. § 1391 and 28
`
`U.S.C. § 1400(b) with respect to Eugia and APL because both are foreign corporations that may
`
`be sued in any district in which they are subject to the court’s personal jurisdiction, and upon
`
`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.
`
`
`
`
`
`6
`
`

`

`Case 1:22-cv-00017-UNA Document 1 Filed 01/04/22 Page 7 of 39 PageID #: 7
`
`THE PATENTS IN SUIT
`
`The ’359 Patent
`
`
`
`On February 28, 2017, the United States Patent and Trademark Office (“PTO”)
`
`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
`
`of the ’359 patent is attached as Exhibit A.
`
`
`
`Ferring B.V. is the owner by assignment of the ’359 patent, and Ferring Pharma is
`
`an exclusive licensee of the ’359 patent.
`
`
`
`In accordance with 21 U.S.C. § 355(b)(1) and 21 C.F.R. § 314.53, the ’359 patent
`
`is listed in the FDA’s APPROVED DRUG PRODUCTS WITH THERAPEUTIC EQUIVALENCE
`
`EVALUATIONS (also known as the “Orange Book”) as covering FIRMAGON®.
`
`The ’739 Patent
`
`
`
`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
`
`an exclusive licensee of the ’739 patent.
`
`The ’870 Patent
`
`
`
`On April 13, 2021, the PTO duly and legally issued the ’870 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 ’870 patent is attached as Exhibit C.
`
`7
`
`

`

`Case 1:22-cv-00017-UNA Document 1 Filed 01/04/22 Page 8 of 39 PageID #: 8
`
`
`
`Ferring B.V. is the owner by assignment of the ’870 patent, and Ferring Pharma is
`
`an exclusive licensee of the ’870 patent.
`
`The ’085 Patent
`
`
`
`On August 16, 2016, the PTO duly and legally issued the ’085 patent, which bears
`
`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
`
`attached as Exhibit D.
`
`
`
`Ferring B.V. is the owner by assignment of the ’085 patent, and Ferring Pharma is
`
`an exclusive licensee of the ’085 patent.
`
`The ’398 Patent
`
`
`
`On June 30, 2020, the PTO duly and legally issued the ’398 patent, which bears
`
`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
`
`attached as Exhibit E.
`
`
`
`Ferring B.V. is the owner by assignment of the ’398 patent, and Ferring Pharma is
`
`an exclusive licensee of the ’398 patent.
`
`The ’081 Patent
`
`
`
`On September 23, 2014, the PTO duly and legally issued the ’081 patent, which
`
`bears the title “Method of Treating Metastatic Stage Prostate Cancer” and names Bo-Eric
`
`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
`
`exclusive licensee of the ’081 patent.
`
`The ’999 Patent
`
`8
`
`

`

`Case 1:22-cv-00017-UNA Document 1 Filed 01/04/22 Page 9 of 39 PageID #: 9
`
`
`
`On January 30, 2018, the PTO duly and legally issued the ’999 patent, which
`
`bears the title “Method for Treating Metastatic Stage Prostate Cancer” and names Bo-Eric
`
`Persson as the inventor. A true and correct copy of the ’999 patent is attached as Exhibit G.
`
`
`
`FICSA is the owner by assignment of the ’999 patent, and Ferring Pharma is an
`
`exclusive licensee of the ’999 patent.
`
`The ’938 Patent
`
`
`
`On September 9, 2014, the PTO duly and legally issued the ’938 patent, which
`
`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
`
`attached as Exhibit H.
`
`
`
`PPL A/S is the owner by assignment of the ’938 patent, and FICSA and its
`
`affiliates are an exclusive licensee of the ’938 patent.
`
`STATEMENT OF FACTS
`
`
`
`Ferring Pharma is the holder of New Drug Application (“NDA”) No. 022201 for
`
`FIRMAGON® (degarelix acetate) for injection, 80 mg and 120 mg.
`
`
`
`On December 24, 2008, the United States Food and Drug Administration
`
`(“FDA”) approved NDA No. 022201 for the manufacture, marketing, and sale of FIRMAGON®
`
`for treatment of patients with advanced prostate cancer.
`
`approval.
`
`
`
`
`
`Ferring Pharma has sold FIRMAGON® under NDA No. 022201 since its
`
`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.
`
`9
`
`

`

`Case 1:22-cv-00017-UNA Document 1 Filed 01/04/22 Page 10 of 39 PageID #: 10
`
`
`
`Upon information and belief, Eugia, APL, and AuroMedics acted collaboratively
`
`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.
`
`
`
`Upon information and belief, Eugia, in concert with APL and AuroMedics,
`
`submitted a certification under 21 U.S.C. § 355(j)(2)(A)(vii)(IV) (“Paragraph IV Certification”)
`
`of invalidity, unenforceability, and/or noninfringement of the ’359, ’739, ’870, ’085, and ’398
`
`patents.
`
`
`
`On November 24, 2021 (Ferring Pharma) and November 25, 2021 (FICSA, and
`
`Ferring B.V.), respectively, received a letter from Defendants dated November 22, 2021,
`
`purporting to be a Notice of Certification for Eugia’s ANDA (“Defendants’ Notice Letter”)
`
`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”).
`
`
`
`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.
`
`
`
`FDA regulations require that approved drug products include prescribing
`
`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).
`
`10
`
`

`

`Case 1:22-cv-00017-UNA Document 1 Filed 01/04/22 Page 11 of 39 PageID #: 11
`
`
`
`Consistent with FDA regulations, the package insert for FIRMAGON® includes
`
`prescribing information that recites the FDA-approved indication for FIRMAGON® and provides
`
`instructions for physicians and patients to safely and effectively administer FIRMAGON®.
`
`
`
`Attached as Exhibit I is a true and correct copy of the February 2020
`
`FIRMAGON® package insert, which is the current version of the FIRMAGON® package insert.
`
`
`
`FIRMAGON® is indicated for the treatment of patients with advanced prostate
`
`cancer. (Ex. I at § 1.)
`
`
`
`The recommended dosing information for FIRMAGON® is provided in Section
`
`2.1 of the FIRMAGON® package insert as follows:
`
`(Ex. I at § 2.1.)
`
`
`
`Section 2.2 of the FIRMAGON® package insert provides that FIRMAGON® is to
`
`be administered by a healthcare professional only:
`
`(Ex. I at § 2.2.)
`
`
`
`The “Dosage Form and Strengths” section of the FIRMAGON® package insert
`
`provides:
`
`
`
`
`
`11
`
`

`

`Case 1:22-cv-00017-UNA Document 1 Filed 01/04/22 Page 12 of 39 PageID #: 12
`
`(Ex. I at § 3.)
`
`
`
`The “Adverse Reactions” section of the FIRMAGON® package insert provides
`
`the following table:
`
`
`
`(Ex. I at § 6.1.)
`
`
`
`The package insert for Eugia’s ANDA Product will be substantially similar to the
`
`package insert for FIRMAGON® in all material respects.
`
`
`
`Plaintiffs commenced this action within forty-five (45) days of receiving
`
`
`
`Defendants’ Notice Letter.
`
`12
`
`

`

`Case 1:22-cv-00017-UNA Document 1 Filed 01/04/22 Page 13 of 39 PageID #: 13
`
`
`
`There is an actual, real, immediate, and justiciable controversy between Plaintiffs
`
`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.
`
`
`
`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
`
`

`

`Case 1:22-cv-00017-UNA Document 1 Filed 01/04/22 Page 14 of 39 PageID #: 14
`
`insert will directly infringe, either literally or under the doctrine of equivalents, one or more
`
`claims of the ’359 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 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
`
`

`

`Case 1:22-cv-00017-UNA Document 1 Filed 01/04/22 Page 15 of 39 PageID #: 15
`
`infringe, either literally or under the doctrine of equivalents, one or more claims of the ’739
`
`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

This document is available on Docket Alarm but you must sign up to view it.


Or .

Accessing this document will incur an additional charge of $.

After purchase, you can access this document again without charge.

Accept $ Charge
throbber

Still Working On It

This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.

Give it another minute or two to complete, and then try the refresh button.

throbber

A few More Minutes ... Still Working

It can take up to 5 minutes for us to download a document if the court servers are running slowly.

Thank you for your continued patience.

This document could not be displayed.

We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.

Your account does not support viewing this document.

You need a Paid Account to view this document. Click here to change your account type.

Your account does not support viewing this document.

Set your membership status to view this document.

With a Docket Alarm membership, you'll get a whole lot more, including:

  • Up-to-date information for this case.
  • Email alerts whenever there is an update.
  • Full text search for other cases.
  • Get email alerts whenever a new case matches your search.

Become a Member

One Moment Please

The filing “” is large (MB) and is being downloaded.

Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.

Your document is on its way!

If you do not receive the document in five minutes, contact support at support@docketalarm.com.

Sealed Document

We are unable to display this document, it may be under a court ordered seal.

If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.


Access Government Site

We are redirecting you
to a mobile optimized page.





Document Unreadable or Corrupt

Refresh this Document
Go to the Docket

We are unable to display this document.

Refresh this Document
Go to the Docket