Case 2:21-cv-20320-CPO Document 1 Filed 12/02/21 Page 1 of 22 PageID: 1
`
`Betty H. Chen (to be admitted pro hac vice)
`(bchen@fr.com)
`FISH & RICHARDSON P.C.
`500 Arguello Street Suite 400
`Redwood City, CA 94063
`Telephone: (650) 839-5070
`Facsimile: (650) 839-5071
`
`Gregory D. Miller
`(gregory.miller@rivkin.com)
`Gene Y. Kang
`(gene.kang@rivkin.com)
`RIVKIN RADLER LLP
`25 Main Street, Suite 501
`Court Plaza North
`Hackensack, New Jersey 07601
`Telephone: 201-287-2460
`Facsimile: 201-489-0495
`
`Attorneys for Plaintiffs, Taro
`Pharmaceuticals U.S.A., Inc. and Taro
`Pharmaceuticals North America, Inc.
`
`
`TARO PHARMACEUTICALS U.S.A., INC.
`and TARO PHARMACEUTICALS NORTH
`AMERICA, INC.
`
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF NEW JERSEY
`
`
`
`
`
`C.A. No. ___
`
`Plaintiffs,
`
`
`v.
`
`LUPIN LIMITED, LUPIN
`PHARMACEUTICALS, INC., and LUPIN
`ATLANTIS HOLDING SA,
`
`
`Defendants.
`
`
`
`PLAINTIFFS TARO PHARMACEUTICALS U.S.A., INC. AND TARO
`PHARMACEUTICALS NORTH AMERICA, INC.’S COMPLAINT
`AGAINST LUPIN LIMITED, LUPIN PHARMACEUTICALS, INC., AND
`LUPIN ATLANTIS HOLDING SA
`
`Plaintiffs Taro Pharmaceuticals U.S.A., Inc. (“Taro USA”) and Taro Pharmaceuticals
`
`North America, Inc. (“Taro North Am.”) (together, “Taro” or “Plaintiffs”) for its complaint against
`
`defendants, Lupin Limited (“Lupin Ltd.”), Lupin Pharmaceuticals, Inc. (“LPI”), and Lupin
`
`
`
`
`
`

`

`Case 2:21-cv-20320-CPO Document 1 Filed 12/02/21 Page 2 of 22 PageID: 2
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`Atlantis Holding SA (“Lupin Atlantis”) (collectively, “Lupin” or “Defendants”), to the best of its
`
`knowledge, information and belief, allege as follows:
`
`NATURE OF THE ACTION
`
`1.
`
`This is an action under 35 U.S.C. § 271, et. seq., for infringement of United States
`
`Patent Nos. 8,277,780 (the “’780 patent”) (attached as Exhibit A) and 8,715,624 (the “’624
`
`patent,”) (attached as Exhibit B), relating to Taro’s commercially successful product, Topicort®
`
`(desoximetasone) Topical Spray, 0.25%. This action arises from Lupin’s filing of a supplemental
`
`Abbreviated New Drug Application with the United States Food and Drug Administration
`
`(“FDA”) seeking approval to market a generic version of Topicort® (desoximetasone) Topical
`
`Spray, 0.25% prior to the latest of the expiration dates of the patents-in-suit.
`
`THE PARTIES
`
`2.
`
`Taro USA is a company organized and existing under the laws of the State of New
`
`York, with a principal place of business at 3 Skyline Drive, Hawthorne, New York 10532.
`
`3.
`
`Taro North Am. is a company organized and existing under the laws of the Cayman
`
`Islands, with a principal place of business at 103 South Church Street, Grand Cayman, Cayman
`
`Islands.
`
`4.
`
`On information and belief, Defendant Lupin Ltd. is a corporation operating and
`
`existing under the laws of India, having a principal place of business at B/4 Laxmi Towers, Bandra
`
`Kurla Complex, Bandra (E), Mumbai 400 051, India, and its registered office at Kalpataru Inspire
`
`3rd Floor, Off Western Express Highway Santacruz (East), Mumbai 40055, India. Lupin Ltd. is
`
`one of the largest generic pharmaceutical companies in terms of global revenue.
`
`
`
`2
`
`

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`Case 2:21-cv-20320-CPO Document 1 Filed 12/02/21 Page 3 of 22 PageID: 3
`
`5.
`
`On information and belief, LPI is a corporation operating and existing under the
`
`laws of Delaware, having a place of business at 111 South Calvert Street, 21st Floor, Baltimore
`
`MD 21202.
`
`6.
`
`7.
`
`On information and belief, LPI is a wholly owned subsidiary of Lupin Ltd.
`
`LPI manufactures, sells, markets, and distributes generic pharmaceutical products
`
`throughout the United States, including in this district, in conjunction with or under the direction
`
`of Lupin Ltd. On information and belief, Lupin Ltd. has previously designated LPI as its US agent
`
`for other ANDA submissions.
`
`8.
`
`On information and belief, Lupin Atlantis is a corporation organized and existing
`
`under the laws of Switzerland, having its principal place of business at Landis + Gyr-Strasse 1,
`
`6300 Zug, Switzerland.
`
`9.
`
`On information and belief, Lupin Atlantis is a wholly owned subsidiary of Lupin
`
`Ltd.
`
`10.
`
`On information and belief, Lupin has engaged in conduct that reliably predicts New
`
`Jersey activities. By submitting ANDA No. 208124/S-004, Lupin has taken the significant step of
`
`applying to FDA for approval to manufacture, sell, offer to sell, and/or import its generic
`
`Desoximetasone Topical Spray, 0.25%, 30 ml, 50 ml, and 100 ml in the United States, including
`
`in this district.
`
`JURISDICTION AND VENUE
`
`11.
`
`This action arises under the patent laws of the United States of America, United
`
`States Code, Title 35, Section 1, et seq. Based on the facts alleged herein, this Court has
`
`jurisdiction over the subject matter of this action pursuant to 28 U.S.C. §§ 1331 and 1338, and has
`
`personal jurisdiction over both Lupin Ltd. and LPI.
`
`
`
`3
`
`

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`Case 2:21-cv-20320-CPO Document 1 Filed 12/02/21 Page 4 of 22 PageID: 4
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`12.
`
`On information and belief, Lupin Ltd. directed its agents LPI and Lupin Atlantis to
`
`participate and collaborate in the research and development of the proposed generic
`
`Desoximetasone Topical Spray, 0.25%, 30 ml, 50 ml, and 100 ml and in the preparation and filing
`
`of ANDA No. 208124/S-004.
`
`13.
`
`On information and belief, Lupin sought FDA approval because it intended to
`
`commit acts of patent infringement under 35 U.S.C. § 271(a), (b), and (c) through its manufacture,
`
`use, sell, and offer for sale of its generic Desoximetasone Topical Spray, 0.25% in New Jersey.
`
`14.
`
`This Court has personal jurisdiction over Lupin. Lupin avails itself of the benefits
`
`and protections of the laws of the State of New Jersey. For example, LPI is registered to do
`
`business in the State of New Jersey under Business ID Number 0100953673, and LPI is registered
`
`with the State of New Jersey as a manufacturer and wholesale distributor of drugs under
`
`Registration Numbers 5004060 and 5005159.
`
`15.
`
`This Court also has personal jurisdiction over Lupin by virtue of its systematic and
`
`continuous contacts with the State of New Jersey. On information and belief, Lupin Ltd., LPI,
`
`Lupin Atlantis, and their affiliates manufacture generic pharmaceuticals at a facility located at 400
`
`Campus Drive, Somerset, NJ. Lupin Ltd., LPI, and Lupin Atlantis sell, offer for sale, and distribute
`
`generic pharmaceuticals throughout the State of New Jersey.
`
`16.
`
`On information and belief, Lupin has at all relevant times maintained continuous
`
`and systematic contacts with the State of New Jersey, including but not limited to, its
`
`aforementioned business of preparing generic pharmaceuticals that Lupin distributes throughout
`
`the United States.
`
`17.
`
`Lupin has previously availed themselves of the jurisdiction of this Court by filing
`
`suit in this district, consenting to jurisdiction in this district, and/or asserting counterclaims in at
`
`
`
`4
`
`

`

`Case 2:21-cv-20320-CPO Document 1 Filed 12/02/21 Page 5 of 22 PageID: 5
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`least the following civil actions initiated in this district: Lupin Ltd., et al. v. Merck, Sharp & Dohme
`
`Corp., Civil Action No. 3:10-cv-00683; Senju Pharmaceutical Co., Ltd., et al. v. Lupin Ltd., et al.,
`
`Civil Action No. 1:15-cv-00335; Senju Pharmaceutical Co., Ltd., et al. v. Lupin Ltd., et al., Civil
`
`Action No. 1:14-cv-05144; Janssen Products, L.P., et al. v. Lupin Ltd., et al., Civil Action No.
`
`2:14-cv-01370; Takeda Pharmaceutical Co. Ltd., et al. v. Lupin Ltd., et al., Civil Action No. 3:12-
`
`cv-07333; AstraZeneca Pharmaceuticals LP, et al. v. Lupin Ltd., et al., Civil Action No. 3:12-cv-
`
`06888; Otsuka Pharmaceutical Co., Ltd. v. Lupin Ltd., et al., Civil Action No. 1:14-cv-07104; and
`
`Prime European Therapeuticals, S.p.A. v. Novel Labs., Inc., et al., Civil Action No. 3:17-cv-
`
`01944; Taro Pharmaceuticals USA, Inc., et al. v. Lupin Ltd., et al., Civil Action No. 2:18-cv-
`
`04225-JMV-MF.
`
`18.
`
`Venue is proper in this district under 28 U.S.C. §1400(b) because Lupin
`
`“committed an act of infringement” in this district and has a “regular place and established place
`
`of business” in this district. Lupin submitted ANDA No. 208124/S-004 pursuant to
`
`505(j)(2)(B)(ii) of the Federal Food, Drug, and Cosmetic Act (“FFDCA”), and upon receiving
`
`approval of ANDA No. 208124/S-004, will manufacture, sell, offer to sell, and/or import its
`
`proposed generic Desoximetasone Topical Spray, 0.25%, 30 ml, 50 ml, and 100 ml throughout the
`
`United States, including in this district. Thus, Lupin has committed an act of infringement in this
`
`district. Lupin also has a “regular and established place of business” at its 150,000-square-foot
`
`facility at 400 Campus Drive, Somerset, New Jersey where Lupin manufacturers about 3.5 billion
`
`standard units of pharmaceutical products.
`
`
`
`
`
`
`
`5
`
`

`

`Case 2:21-cv-20320-CPO Document 1 Filed 12/02/21 Page 6 of 22 PageID: 6
`
`BACKGROUND
`
`The FDA Marketing Approval Process
`
`19.
`
`The Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 301 et seq., as amended
`
`by the Hatch-Waxman Amendments, sets forth the rules that the FDA follows when considering
`
`the approval of applications for both brand-name and generic drugs.
`
`20.
`
`Under the Hatch-Waxman Amendments, an applicant seeking to market a new
`
`brand-name drug must prepare a New Drug Application (“NDA”) for consideration by the FDA.
`
`See 21 U.S.C. § 355.
`
`21.
`
`An NDA must include, among other things, the patent number of any patent that
`
`claims the drug or a method of using such drug, for which the applicant submitted the NDA and
`
`for which a claim of patent infringement could reasonably be asserted against an unauthorized
`
`party. See 21 U.S.C. § 355(b)(1) and (c)(2); 21 C.F.R. §§ 314.53(b) and (c)(2).
`
`22.
`
`Upon approval of the NDA, the FDA publishes patent information for the approved
`
`drug in its publication, Approved Drug Products with Therapeutic Equivalence Evaluation
`
`(“Orange Book”). See 21 U.S.C. § 355(j)(7)(A)(iii).
`
`23.
`
`A pharmaceutical company may seek to make a change to an Abbreviated New
`
`Drug Application (“ANDA”) by submitting a supplement to an approved ANDA under 21 U.S.C.
`
`§§ 314.70, 314.71 and 3.14.97. Specifically, the FDA regulations require a supplement when a
`
`change is major, moderate, or minor. Generally, a pharmaceutical company may seek to market a
`
`generic version of the innovator’s brand drug by submitting an ANDA under 21 U.S.C.
`
`§ 355(j). The generic company may then rely on the studies the innovator includes in its NDA.
`
`Here, Lupin likewise seeks to rely on studies submitted in conjunction with Taro’s NDA for
`
`
`
`6
`
`

`

`Case 2:21-cv-20320-CPO Document 1 Filed 12/02/21 Page 7 of 22 PageID: 7
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`Topicort® (desoximetasone) Topical Spray, NDA No. 204141 in seeking approval of ANDA No.
`
`208124/S-004.
`
`Taro’s Topicort® Product
`
`On April 11, 2013,
`
`the FDA approved Taro’s NDA for Topicort®
`
`
`24.
`
`(desoximetasone) Topical Spray, NDA No. 204141. Taro began marketing Topicort® shortly after
`
`that approval.
`
`25.
`
`Topicort® is a corticosteroid indicated for the treatment of plaque psoriasis in
`
`patients 18 years of age or older. Psoriasis is a systemic inflammatory disease of immune
`
`dysfunction that affects an estimated 2%-3% of the U.S. population.
`
`Taro’s Patents Covering Topicort®
`
`The United States Patent & Trademark Office (“PTO”) legally issued the ’780
`
`
`26.
`
`patent, titled “Stable Liquid Desoximetasone Compositions with Reduced Oxidized Impurity” on
`
`October 2, 2012. Taro North Am. owns the ’780 patent, which lists Srinivasa Rao, Suresh Dixit,
`
`Avraham Yacobi, and Arthur Bailey as its inventors. The invention provides a liquid
`
`formulation that contains ranges of desoximetasone, isopropyl myristate, a C2-C4 alcohol, and a
`
`stabilizing agent. The invention also provides processes for preparing such liquid formulations
`
`and methods for treating corticosteroid responsive dermatosis, including plaque psoriasis with
`
`such liquid formulations. Taro is the owner by assignment of all right, title, and interest in the
`
`’780 patent.
`
`27.
`
`The PTO legally issued the ’624 patent, titled “Stable Liquid Desoximetasone
`
`Compositions with Reduced Oxidized Impurity” on May 6, 2014. Taro North Am. owns the ’624
`
`patent, which lists Srinivasa Rao, Suresh Dixit, Avraham Yacobi, and Arthur Bailey as its
`
`inventors. The invention provides a liquid formulation that contains ranges of desoximetasone,
`
`
`
`7
`
`

`

`Case 2:21-cv-20320-CPO Document 1 Filed 12/02/21 Page 8 of 22 PageID: 8
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`isopropyl myristate, a C2-C4 alcohol, and a stabilizing agent. The invention also provides processes
`
`for preparing such liquid formulations and methods for treating corticosteroid responsive
`
`dermatosis, including plaque psoriasis, with such liquid formulations. Taro is the owner by
`
`assignment of all right, title, and interest in the ’624 patent.
`
`28.
`
`Though the Parties have previously stipulated to dismissal of the action styled Taro
`
`Pharmaceuticals USA, Inc., et al. v. Lupin Ltd., et al., Civil Action No. 2:18-cv-04225-JMV-MF
`
`relating to ANDA No. 208124, Taro has been unable to make any meaningful assessment of
`
`Lupin’s certification that its proposed generic described in ANDA No. 208124/S-004 will not
`
`infringe “any valid claim” of the ’780 or ’624 patents.
`
`COUNT I
`(Infringement of the ’780 Patent Under 35 U.S.C. § 271(e)(2)(A) by Lupin’s Proposed
`Generic Desoximetasone Topical Spray, 0.25%)
`
`29.
`
`30.
`
`Plaintiffs incorporate each of the preceding paragraphs as if fully set forth herein.
`
`Lupin submitted ANDA No. 208124/S-004 to the FDA under section 505(j) of the
`
`FFDCA to obtain approval to engage in the manufacture, use or sale throughout the United States,
`
`of Lupin’s proposed Desoximetasone Topical Spray, 0.25%, 30 ml, 50 ml, and 100 ml throughout
`
`the United States, including in this district. By submitting ANDA No. 208124/S-004, Lupin has
`
`committed an act of infringement of the ‘780 patent under 35 U.S.C. § 271(e)(2)(A).
`
`31.
`
`The commercial manufacture, use, offer for sale, sale, and/or importation of
`
`Lupin’s proposed generic Desoximetasone Topical Spray, 0.25%, 30 ml, 50 ml, and 100 ml as
`
`described in ANDA No. 208124/S-004 prior to the expiration date of the ’780 Patent will constitute
`
`an act of infringement of the ’780 patent.
`
`32.
`
`On information and belief, Lupin became aware of the ’780 patent no later than the
`
`date on which that patent was listed in the Orange Book.
`
`
`
`8
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`

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`Case 2:21-cv-20320-CPO Document 1 Filed 12/02/21 Page 9 of 22 PageID: 9
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`33.
`
`On information and belief, Lupin knows or should know that its commercial
`
`manufacture, use, offer for sale, sale and/or importation of its proposed generic Desoximetasone
`
`Topical Spray, 0.25%, 30 ml, 50 ml, and 100 ml as described in ANDA No. 208124/S-004 will
`
`actively induce and contribute to the actual infringement of the ’780 patent.
`
`34.
`
`On information and belief, Lupin knows or should know that Lupin’s proposed
`
`generic Desoximetasone Topical Spray, 0.25%, 30 ml, 50 ml, and 100 ml as described in ANDA
`
`No. 208124/S-004 will be especially made for or especially adapted for use in infringement of the
`
`’780 patent, and are not staple articles or commodities of commerce suitable for substantial non-
`
`infringing use, and that its commercial manufacture, use, offer for sale, sale, and/or importation of
`
`its proposed generic Desoximetasone Topical Spray, 0.25%, 30 ml, 50 ml, and 100 ml as described
`
`in ANDA No. 208124/S-004 will actively contribute to the actual infringement of the ’780 patent.
`
`35.
`
`The commercial manufacture, use, offer for sale, sale and/or importation of Lupin’s
`
`proposed generic Desoximetasone Topical Spray, 0.25%, 30 ml, 50 ml, and 100 ml as described
`
`in ANDA No. 208124/S-004 in violation of Plaintiffs’ patent rights will cause harm to Plaintiffs
`
`for which damages are inadequate.
`
`36.
`
`Plaintiffs do not have an adequate remedy at law and will be irreparably harmed by
`
`Lupin’s infringing conduct unless such conduct is enjoined by this Court.
`
`COUNT II
`(Declaratory Judgment of Infringement of the ’780 Patent Under U.S.C. § 271(a) by
`Lupin’s Proposed Generic Desoximetasone Topical Spray, 0.25%)
`
`37.
`
`38.
`
`Plaintiffs incorporate each of the preceding paragraphs as if fully set forth herein.
`
`This claim arises under the Declaratory Judgment Act, 28 U.S.C. §§ 2201 and 2202.
`
`
`
`9
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`

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`39.
`
`An actual case or controversy between Plaintiffs and Lupin exists such that the
`
`Court may entertain Plaintiffs’ request for declaratory relief consistent with Article III of the
`
`United States Constitution.
`
`40.
`
`Lupin has made, and will continue to make, substantial preparation in the United
`
`States to manufacture, sell, offer to sell and/or import its proposed generic Desoximetasone
`
`Topical Spray, 0.25%, 30 ml, 50 ml, and 100 ml as described in ANDA No. 208124/S-004.
`
`41.
`
`Lupin’s recent actions indicate that they do not intend to change their course of
`
`conduct.
`
`42.
`
`Any manufacture, use, offer for sale, sale and/or importation of Lupin’s proposed
`
`generic Desoximetasone Topical Spray, 0.25%, 30 ml, 50 ml, and 100 ml as described in ANDA
`
`No. 208124/S-004 prior to the expiration of the ’780 patent will constitute direct infringement of
`
`the ’780 patent.
`
`43.
`
`Plaintiffs are entitled to a declaratory judgment that any manufacture, use, offer for
`
`sale, sale and/or importation of the proposed generic Desoximetasone Topical Spray, 0.25%, 30
`
`ml, 50 ml, and 100 ml as described in ANDA No. 208124/S-004 by Lupin prior to the expiration
`
`of the ’780 patent will constitute direct infringement of said patent.
`
`44.
`
`On information and belief, despite having actual notice of the ’780 patent, Lupin
`
`continues to willfully, wantonly, and deliberately prepare to infringe the ’780 patent in disregard
`
`of Plaintiffs’ rights, making this case exceptional and entitling Plaintiffs to reasonable attorneys’
`
`fees pursuant to 35 U.S.C. § 285.
`
`COUNT III
`(Declaratory Judgment of Infringement of the ’780 Patent Under U.S.C. § 271(b) and (c) by
`Lupin’s Proposed Generic Desoximetasone Topical Spray, 0.25%)
`
`45.
`
`Plaintiffs incorporate each of the preceding paragraphs as if fully set forth herein.
`
`
`
`10
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`

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`
`46.
`
`47.
`
`This claim arises under the Declaratory Judgment Act, 28 U.S.C. §§ 2201 and 2202.
`
`An actual case or controversy between Plaintiffs and Lupin exists such that the
`
`Court may entertain Plaintiffs’ request for declaratory relief consistent with Article III of the
`
`United States Constitution.
`
`48.
`
`49.
`
`Lupin has actual knowledge of the ‘780 patent.
`
`On information and belief, Lupin became aware of the ‘780 patent no later than the
`
`date on which that patent was listed in the Orange Book.
`
`50.
`
`On information and belief, Lupin has acted with full knowledge of the ‘780 patent
`
`and without a reasonable basis for believing that Lupin would not be liable for actively inducing
`
`or contributing to the infringement of the ‘780 patent.
`
`51.
`
`The commercial manufacture, use, sale, offer for sale, and/or importation of
`
`Lupin’s proposed generic Desoximetasone Topical Spray, 0.25%, 30 ml, 50 ml, and 100 ml as
`
`described in ANDA No. 208124/S-004 will induce the actual infringement of the ‘780 patent.
`
`52.
`
`On information and belief, Lupin knows or should know that its commercial
`
`manufacture, use, sale, offer for sale, and/or importation of its proposed generic Desoximetasone
`
`Topical Spray, 0.25%, 30 ml, 50 ml, and 100 ml as described in ANDA No. 208124/S-004 will
`
`actively induce the actual infringement of the ‘780 patent.
`
`53.
`
`On information and belief, Lupin will encourage another’s infringement of the ‘780
`
`patent by and through the commercial manufacture, use, sale, offer for sale, and/or importation of
`
`its proposed generic Desoximetasone Topical Spray, 0.25%, 30 ml, 50 ml, and 100 ml as described
`
`in ANDA No. 208124/S-004, which is covered by the claims of the ‘780 patent.
`
`54.
`
`Lupin’s acts of infringement will be done with knowledge of the ‘780 patent and
`
`with the intent to encourage infringement.
`
`
`
`11
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`Case 2:21-cv-20320-CPO Document 1 Filed 12/02/21 Page 12 of 22 PageID: 12
`
`55.
`
`The foregoing actions by Lupin will constitute active inducement of infringement
`
`of the ‘780 patent.
`
`56.
`
`On information and belief, Lupin knows or should know that its proposed generic
`
`Desoximetasone Topical Spray, 0.25%, 30 ml, 50 ml, and 100 ml as described in ANDA No.
`
`208124/S-004 will be especially made or especially adapted for use in an infringement of the ‘780
`
`patent, and are not staple articles or commodities of commerce suitable for substantial non-
`
`infringing use.
`
`57.
`
`The commercial manufacture, use, sale, offer for sale, and/or importation of
`
`Lupin’s proposed generic Desoximetasone Topical Spray, 0.25%, 30 ml, 50 ml, and 100 ml as
`
`described in ANDA No. 208124/S-004 will contribute to the actual infringement of the ‘780
`
`patent.
`
`58.
`
`On information and belief, Lupin knows or should know that Lupin’s offer for sale,
`
`sale and/or importation of its proposed generic Desoximetasone Topical Spray, 0.25%, 30 ml, 50
`
`ml, and 100 ml as described in ANDA No. 208124/S-004 will contribute to the actual infringement
`
`of the ‘780 patent.
`
`59.
`
`The foregoing actions by Lupin will constitute contributory infringement of the
`
`‘780 patent.
`
`60.
`
`On information and belief, Lupin intends to, and will, actively induce and
`
`contribute to the infringement of the ‘780 patent when ANDA No. 208124/S-004 is approved, and
`
`plans and intends to, and will, do so immediately and imminently upon final approval.
`
`61.
`
`Plaintiffs are entitled to a declaratory judgment that future commercial
`
`manufacture, use, offer for sale, sale, and/or importation of Lupin’s proposed generic
`
`
`
`12
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`Case 2:21-cv-20320-CPO Document 1 Filed 12/02/21 Page 13 of 22 PageID: 13
`
`Desoximetasone Topical Spray, 0.25%, 30 ml, 50 ml, and 100 ml as described in ANDA No.
`
`208124/S-004 by Lupin will induce and/or contribute to infringement of the ‘780 patent.
`
`62.
`
`The commercial manufacture, use, offer for sale, sale and/or importation of Lupin’s
`
`proposed generic Desoximetasone Topical Spray, 0.25%, 30 ml, 50 ml, and 100 ml as described
`
`in ANDA No. 208124/S-004, which will actively induce and/or contribute to infringement of the
`
`‘780 patent, in violation of Plaintiffs’ patent rights, will cause harm to Plaintiffs for which damages
`
`are inadequate.
`
`63.
`
`Unless Lupin is enjoined from actively inducing and contributing to the
`
`infringement of the ‘780 patent, Plaintiffs will suffer irreparable injury for which damages are an
`
`inadequate remedy.
`
`64.
`
`On information and belief, despite having actual notice of the ‘780 patent, Lupin
`
`continues to willfully, wantonly, and deliberately prepare to actively induce and/or contribute to
`
`infringement of the ‘780 patent in disregard of Plaintiffs’ rights, making this case exceptional and
`
`entitling Plaintiffs to reasonable attorneys’ fees pursuant to 35 U.S.C. § 285.
`
`COUNT IV
`(Infringement of the ’624 Patent Under 35 U.S.C. § 271(e)(2)(A) by Lupin’s Proposed
`Generic Desoximetasone Topical Spray, 0.25%)
`
`65.
`
`66.
`
`Plaintiffs incorporate each of the preceding paragraphs as if fully set forth herein.
`
`Lupin submitted ANDA No. 208124/S-004 to the FDA under section 505(j) of the
`
`FFDCA to obtain approval to engage in the manufacture, use or sale throughout the United States,
`
`of Lupin’s proposed Desoximetasone Topical Spray, 0.25%, 30 ml, 50 ml, and 100 ml throughout
`
`the United States, including in this district. By submitting ANDA No. 208124/S-004, Lupin has
`
`committed an act of infringement of the ‘624 patent under 35 U.S.C. § 271(e)(2)(A).
`
`
`
`13
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`

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`Case 2:21-cv-20320-CPO Document 1 Filed 12/02/21 Page 14 of 22 PageID: 14
`
`67.
`
`The commercial manufacture, use, offer for sale, sale, and/or importation of
`
`Lupin’s proposed generic Desoximetasone Topical Spray, 0.25%, 30 ml, 50 ml, and 100 ml as
`
`described in ANDA No. 208124/S-004 prior to the expiration date of the ’624 Patent will constitute
`
`an act of infringement of the ’624 patent.
`
`68.
`
`On information and belief, Lupin became aware of the ’624 patent no later than the
`
`date on which that patent was listed in the Orange Book.
`
`69.
`
`On information and belief, Lupin knows or should know that its commercial
`
`manufacture, use, offer for sale, sale and/or importation of its proposed generic Desoximetasone
`
`Topical Spray, 0.25%, 30 ml, 50 ml, and 100 ml as described in ANDA No. 208124/S-004 will
`
`actively induce and contribute to the actual infringement of the ’624 patent.
`
`70.
`
`On information and belief, Lupin knows or should know that Lupin’s proposed
`
`generic Desoximetasone Topical Spray, 0.25%, 30 ml, 50 ml, and 100 ml as described in ANDA
`
`No. 208124/S-004 will be especially made for or especially adapted for use in infringement of the
`
`’624 patent, and are not staple articles or commodities of commerce suitable for substantial non-
`
`infringing use, and that its commercial manufacture, use, offer for sale, sale, and/or importation of
`
`its proposed generic Desoximetasone Topical Spray, 0.25%, 30 ml, 50 ml, and 100 ml as described
`
`in ANDA No. 208124/S-004 will actively contribute to the actual infringement of the ’624 patent.
`
`71.
`
`The commercial manufacture, use, offer for sale, sale and/or importation of Lupin’s
`
`proposed generic Desoximetasone Topical Spray, 0.25%, 30 ml, 50 ml, and 100 ml as described
`
`in ANDA No. 208124/S-004 in violation of Plaintiffs’ patent rights will cause harm to Plaintiffs
`
`for which damages are inadequate.
`
`72.
`
`Plaintiffs do not have an adequate remedy at law and will be irreparably harmed by
`
`Lupin’s infringing conduct unless such conduct is enjoined by this Court.
`
`
`
`14
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`

`

`Case 2:21-cv-20320-CPO Document 1 Filed 12/02/21 Page 15 of 22 PageID: 15
`
`COUNT V
`(Declaratory Judgment of Infringement of the ‘624 Patent Under U.S.C. § 271(a) by
`Lupin’s Proposed Generic Desoximetasone Topical Spray, 0.25%)
`
`73.
`
`74.
`
`75.
`
`Plaintiffs incorporate each of the preceding paragraphs as if fully set forth herein.
`
`This claim arises under the Declaratory Judgment Act, 28 U.S.C. §§ 2201 and 2202.
`
`An actual case or controversy between Plaintiffs and Lupin exists such that the
`
`Court may entertain Plaintiffs’ request for declaratory relief consistent with Article III of the
`
`United States Constitution.
`
`76.
`
`Lupin has made, and will continue to make, substantial preparation in the United
`
`States to manufacture, sell, offer to sell and/or import its proposed generic Desoximetasone
`
`Topical Spray, 0.25%, 30 ml, 50 ml, and 100 ml as described in ANDA No. 208124/S-004.
`
`77.
`
`Lupin’s recent actions indicate that they do not intend to change their course of
`
`conduct.
`
`78.
`
`Any manufacture, use, offer for sale, sale and/or importation of Lupin’s proposed
`
`generic Desoximetasone Topical Spray, 0.25%, 30 ml, 50 ml, and 100 ml as described in ANDA
`
`No. 208124/S-004 prior to the expiration of the ‘624 patent will constitute direct infringement of
`
`the ‘624 patent.
`
`79.
`
`Plaintiffs are entitled to a declaratory judgment that any manufacture, use, offer for
`
`sale, sale and/or importation of the proposed generic Desoximetasone Topical Spray, 0.25%, 30
`
`ml, 50 ml, and 100 ml as described in ANDA No. 208124/S-004 by Lupin prior to the expiration
`
`of the ‘624 patent will constitute direct infringement of said patent.
`
`80.
`
`On information and belief, despite having actual notice of the ‘624 patent, Lupin
`
`continues to willfully, wantonly, and deliberately prepare to infringe the ‘624 patent in disregard
`
`
`
`15
`
`

`

`Case 2:21-cv-20320-CPO Document 1 Filed 12/02/21 Page 16 of 22 PageID: 16
`
`of Plaintiffs’ rights, making this case exceptional and entitling Plaintiffs to reasonable attorneys’
`
`fees pursuant to 35 U.S.C. § 285.
`
`COUNT VI
`(Declaratory Judgment of Infringement of the ‘624 Patent Under U.S.C. § 271(b) and (c) by
`Lupin’s Proposed Generic Desoximetasone Topical Spray, 0.25%)
`
`81.
`
`82.
`
`83.
`
`Plaintiffs incorporate each of the preceding paragraphs as if fully set forth herein.
`
`This claim arises under the Declaratory Judgment Act, 28 U.S.C. §§ 2201 and 2202.
`
`An actual case or controversy between Plaintiffs and Lupin exists such that the
`
`Court may entertain Plaintiffs’ request for declaratory relief consistent with Article III of the
`
`United States Constitution.
`
`84.
`
`85.
`
`Lupin has actual knowledge of the ‘624 patent.
`
`On information and belief, Lupin became aware of the ‘624 patent no later than the
`
`date on which that patent was listed in the Orange Book.
`
`86.
`
`On information and belief, Lupin has acted with full knowledge of the ‘624 patent
`
`and without a reasonable basis for believing that Lupin would not be liable for actively inducing
`
`or contributing to the infringement of the ‘624 patent.
`
`87.
`
`The commercial manufacture, use, sale, offer for sale, and/or importation of
`
`Lupin’s proposed generic Desoximetasone Topical Spray, 0.25%, 30 ml, 50 ml, and 100 ml as
`
`described in ANDA No. 208124/S-004 will induce the actual infringement of the ‘624 patent.
`
`88.
`
`On information and belief, Lupin knows or should know that its commercial
`
`manufacture, use, sale, offer for sale, and/or importation of its proposed generic Desoximetasone
`
`Topical Spray, 0.25%, 30 ml, 50 ml, and 100 ml as described in ANDA No. 208124/S-004 will
`
`actively induce the actual infringement of the ‘624 patent.
`
`
`
`16
`
`

`

`Case 2:21-cv-20320-CPO Document 1 Filed 12/02/21 Page 17 of 22 PageID: 17
`
`89.
`
`On information and belief, Lupin will encourage another’s infringement of the ‘624
`
`patent by and through the commercial manufacture, use, sale, offer for sale, and/or importation of
`
`its proposed generic Desoximetasone Topical Spray, 0.25%, 30 ml, 50 ml, and 100 ml as described
`
`in ANDA No. 208124/S-004, which is covered by the claims of the ‘624 patent.
`
`90.
`
`Lupin’s acts of infringement will be done with knowledge of the ‘624 patent and
`
`with the intent to encourage infringement.
`
`91.
`
`The foregoing actions by Lupin will constitute active inducement of infringement
`
`of the ‘624 patent.
`
`92.
`
`On information and belief, Lupin knows or should know that its proposed generic
`
`Desoximetasone Topical Spray, 0.25%, 30 ml, 50 ml, and 100 ml will as described in ANDA No.
`
`208124/S-004 be especially made or especially adapted for use in an infringement of the ‘624
`
`patent, and are not staple articles or commodities of commerce suitable for substantial non-
`
`infringing use.
`
`93.
`
`The commercial manufacture, use, sale, offer for sale, and/or importation of
`
`Lupin’s proposed generic Desoximetasone Topical Spray, 0.25%, 30 ml, 50 ml, and 100 ml as
`
`described in ANDA No. 208124/S-004 will contribute to the actual infringement of the ‘624
`
`patent.
`
`94.
`
`On information and belief, Lupin knows or should know that Lupin’s offer for sale,
`
`sale and/or importation of its proposed generic Desoximetasone Topical Spray, 0.25%, 30 ml, 50
`
`ml, and 100 ml as described in ANDA No. 208124/S-004 will contribute to the actual infringement
`
`of the ‘624 patent.
`
`95.
`
`The foregoing actions by Lupin will constitute contributory infringement of the
`
`‘624 patent.
`
`
`
`17
`
`

`

`Case 2:21-cv-20320-CPO Document 1 Filed 12/02/21 Page 18 of 22 PageID: 18
`
`96.
`
`On information and belief, Lupin intends to, and will, actively induce and
`
`contribute to the infringement of the ‘624 patent when ANDA No. 208124/S-004 is approved, and
`
`plans and intends to, and will, do so immediately and imminently upon final approval.
`
`97.
`
`Plaintiffs are entitled to a declaratory judgment that future commercial
`
`manufacture, use, offer for sale, sale, and/or importation of Lupin’s proposed generic
`
`Desoximetasone Topical Spray, 0.25%, 30 ml, 50 ml, and 100 ml as described in ANDA No.
`
`208124/S-004 by Lupin will induce and/or contribute to infringement of the ‘624 patent.
`
`98.
`
`The commercial manufacture, use, offer for sale, sale and/or importation of Lupin’s
`
`proposed generic Desoximetasone Topical Spray, 0.25%, 30 ml, 50 ml, and 100 ml as described
`
`in ANDA No. 208124/S-004, which will actively induce and/or contribute to in