Case 3:20-cv-19578 Document 1 Filed 12/17/20 Page 1 of 22 PageID: 1
`
`Sergei A. Orel
`MUNCK WILSON MANDALA LLP
`12770 Coit Road
`Dallas, Texas 75251
`Telephone: 972-628-3600
`Facsimile:
`972-628-3616
`sorel@munckwilson.com
`
`OF COUNSEL:
`
`Michael C. Wilson (pro hac vice forthcoming)
`Jordan C. Strauss (pro hac vice forthcoming)
`MUNCK WILSON MANDALA LLP
`12770 Coit Road
`Dallas, Texas 75251
`Telephone: 972-628-3600
`Facsimile:
`972-628-3616
`mwilson@munckwilson.com
`jstrauss@munckwilson.com
`ATTORNEYS FOR PLAINTIFFS
`GALDERMA LABORATORIES, L.P.,
`GALDERMA S.A., AND
`GALDERMA HOLDING S.A.
`
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF NEW JERSEY
`
`
`GALDERMA LABORATORIES, L.P.,
`GALDERMA S.A., and
`GALDERMA HOLDING S.A.
`
`
`v.
`
`ZYDUS PHARMACEUTICALS (USA)
`INC.,
`
`
`
`
`CIVIL ACTION NO. ______________
`
`
`Plaintiffs,
`
`Defendant.
`
`COMPLAINT FOR PATENT INFRINGEMENT
`
`
`
`Plaintiffs GALDERMA LABORATORIES, L.P., GALDERMA S.A., and GALDERMA
`
`HOLDING, S.A., (collectively, “Galderma” or “Plaintiffs”) file this Complaint for patent
`
`COMPLAINT FOR PATENT INFRINGEMENT
`
`PAGE 1
`
`

`

`Case 3:20-cv-19578 Document 1 Filed 12/17/20 Page 2 of 22 PageID: 2
`
`infringement against Defendant ZYDUS PHARMACEUTICALS (USA) INC. (“Zydus” or
`
`“Defendant”) as follows:
`
`THE PARTIES
`
`1.
`
` Galderma Laboratories, L.P. (“GLLP”) is a Texas limited partnership with its
`
`principal place of business at 14501 North Freeway, Fort Worth, Texas 76177. GLLP holds the
`
`exclusive right to use, manufacture, and sell Galderma’s patented products in the United States,
`
`including Soolantra® (ivermectin) Cream 1%, under FDA approval of New Drug Application
`
`(“NDA”) No. 206255, approved December 19, 2014. Moreover, GLLP is responsible for seeking
`
`regulatory approvals of Galderma’s products in the United States and is the sole owner of NDA
`
`No. 206255. Soolantra® (ivermectin) Cream, 1% is indicated for the treatment of inflammatory
`
`lesions of rosacea.
`
`2.
`
`Galderma S.A. (“GSA”) is a Swiss company with its principal place of business at
`
`World Trade Center, Avenue de Gratta-Paille 2, 1018 Lausanne, Switzerland. GSA is an
`
`exclusive licensee of the Asserted Patents. GSA has granted GLLP exclusive rights under the
`
`Asserted Patents to GLLP.
`
`3.
`
`Galderma Holding S.A. (“GSHSA”) is a Swiss company with its principal place
`
`of business at Avenue Gratta-Paille 2, CH-1018 Lausanne, Switzerland. GSHSA is the owner of
`
`U.S. Patent No. 9,089,587 (the “’587 Patent”), U.S. Patent No. 9,233,117 (the “’117 Patent”),
`
`U.S. Patent No. 9,233,118 (the “’118 Patent”), U.S. Patent No. 9,782,425 (the “’425 Patent”),
`
`and U.S. Patent No. 10,206,939 (the “’939 Patent”) (collectively, the “Asserted Patents”). A
`
`copy of the ’587 Patent is attached as Exhibit A. A copy of the ’117 Patent is attached as Exhibit
`
`B. A copy of the ’118 Patent is attached as Exhibit C. A copy of the ’425 Patent is attached as
`
`Exhibit D. A copy of the ’939 Patent is attached as Exhibit E.
`
`COMPLAINT FOR PATENT INFRINGEMENT
`
`PAGE 2
`
`

`

`Case 3:20-cv-19578 Document 1 Filed 12/17/20 Page 3 of 22 PageID: 3
`
`4.
`
`Zydus is a corporation organized and existing under the laws of the State of New
`
`Jersey with its principal place of business at 73 Route 31 North Pennington, New Jersey 08534.
`
`Zydus may be served with process by and through its registered agent for service of process,
`
`Joseph D. Renner at 73 Route 31 North Pennington, New Jersey 08534.
`
`JURISDICTION
`
`5.
`
`This is a complaint for patent infringement. This action arises under the patent
`
`laws of the United States, 35 U.S.C. §§ 100 et seq., as well as the Declaratory Judgment Act, 28
`
`U.S.C. §§ 2201-02. This Court has jurisdiction over the subject matter of the claims asserted
`
`pursuant to 28 U.S.C. §§ 1331 and 1338(a).
`
`6.
`
`This Court has personal jurisdiction over Zydus because Zydus is a New Jersey
`
`corporation with a principal place of business in New Jersey.
`
`VENUE
`
`7.
`
` Venue in this Court is proper under 28 U.S.C. § 1400(b) because Zydus is a New
`
`Jersey corporation with a principal place of business in New Jersey.
`
`BACKGROUND FACTS
`
`A.
`
`The ’587 Patent
`
`8.
`
`On July 28, 2015, the USPTO issued the ’587 Patent, entitled “Treatment of
`
`Papulopustular Rosacea with Ivermectin,” to GSA.
`
`9.
`
`The ’587 Patent is valid, enforceable, and has not expired.
`
`B.
`
`The ’117 Patent
`
`10.
`
`On January 12, 2016, the USPTO issued the ’117 Patent, entitled “Treatment of
`
`Inflammatory Lesions of Rosacea with Ivermectin,” to GSA.
`
`11.
`
`The ’117 Patent is valid, enforceable, and has not expired.
`
`COMPLAINT FOR PATENT INFRINGEMENT
`
`PAGE 3
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`

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`Case 3:20-cv-19578 Document 1 Filed 12/17/20 Page 4 of 22 PageID: 4
`
`C.
`
`The ’118 Patent
`
`12.
`
`On January 12, 2016, the USPTO issued the ’118 Patent, entitled “Treatment of
`
`Papulopustular Rosacea with Ivermectin,” to GSA.
`
`13.
`
`The ’118 Patent is valid, enforceable, and has not expired.
`
`D.
`
`The ’425 Patent
`
`14.
`
`On October 10, 2017, the USPTO issued the ’425 Patent, entitled “Treatment of
`
`Papulopustular Rosacea with Ivermectin,” to GSA.
`
`15.
`
`The ’425 Patent is valid, enforceable, and has not expired.
`
`E.
`
`The ’939 Patent
`
`16.
`
`On February 19, 2019, the USPTO issued the ’939 Patent, entitled “Treatment of
`
`Papulopustular Rosacea with Ivermectin,” to GSA.
`
`17.
`
`The ’939 Patent is valid, enforceable, and has not expired.
`
`F.
`
`Soolantra® (Ivermectin) Cream 1%
`
`18.
`
`GLLP is the exclusive owner of NDA No. 206255, giving it sole permission to
`
`market and sell Soolantra® (ivermectin) Cream, 1% in the United States. On December 19, 2014,
`
`GLLP obtained FDA approval to market Soolantra® (ivermectin) Cream, 1%. The ’587 Patent,
`
`’117 Patent, ’118 Patent, ’425 Patent, and ’939 Patent are listed in the FDA publication entitled,
`
`“Approved Drug Products with Therapeutic Equivalence Evaluations” (known as the “Orange
`
`Book”) as covering Soolantra® (ivermectin) Cream, 1%.
`
`G.
`
` Zydus’ Infringement
`
`19.
`
`Zydus is in the business of developing, manufacturing, and marketing generic
`
`pharmaceutical products.
`
`COMPLAINT FOR PATENT INFRINGEMENT
`
`PAGE 4
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`

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`Case 3:20-cv-19578 Document 1 Filed 12/17/20 Page 5 of 22 PageID: 5
`
`20.
`
`Prior to November 2, 2020, Zydus decided to file ANDA No. 215210 (the
`
`“ANDA”) covering a generic version of Soolantra® (Ivermectin) Cream 1% (the “Accused
`
`Product”) seeking FDA approval to market and sell a generic version of Soolantra® (Ivermectin)
`
`Cream 1%.
`
`21.
`
`During the process of preparing such application, Zydus reviewed the’587 Patent,
`
`’117 Patent, ’118 Patent, ’425 Patent, and ’939 Patent as well as certain commercial and
`
`economic information relating to Soolantra® (Ivermectin) Cream 1%. On information and belief,
`
`the information reviewed by Zydus relating to Soolantra® (Ivermectin) Cream 1% includes the
`
`FDA approved label for that drug product.
`
`22.
`
`Zydus submitted the ANDA seeking approval to engage in the commercial
`
`manufacture, use, and sale of the Accused Product prior to the expiration of the ’587 Patent, ’117
`
`Patent, ’118 Patent, ’425 Patent, and ’939 Patent.
`
`23.
`
`The Accused Product that is the subject of the ANDA will directly and indirectly
`
`infringe one or more claims of the ’587 Patent, ’117 Patent, ’118 Patent, ’425 Patent, and ’939
`
`Patent, either literally or under the doctrine of equivalents.
`
`24.
`
`On or about November 2, 2020, Zydus sent the Paragraph IV Certification to
`
`GLLP in Fort Worth, Texas as well as to GSA. Through the Paragraph IV Certification, Zydus
`
`first notified Plaintiffs that Zydus had filed the ANDA with the FDA relating to the Accused
`
`Product, and that the ANDA includes a certification under 21 U.S.C. § 355(j)(2)(A)(vii)(IV) that,
`
`in Zydus’ opinion, the claims of the ’587 Patent, ’117 Patent, ’118 Patent, ’425 Patent, and ’939
`
`Patent are invalid unenforceable, and/or will not be infringed by the commercial manufacture,
`
`use, offer for sale, sale, or importation of the Accused Product.
`
`COMPLAINT FOR PATENT INFRINGEMENT
`
`PAGE 5
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`

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`Case 3:20-cv-19578 Document 1 Filed 12/17/20 Page 6 of 22 PageID: 6
`
`25.
`
`Zydus was aware of the ’587 Patent, ’117 Patent, ’118 Patent, ’425 Patent, and
`
`’939 Patent when it filed the ANDA and/or sent the Paragraph IV Certification.
`
`26.
`
`Plaintiffs have commenced this action within 45 days of the date that they
`
`received the Paragraph IV Certification.
`
`27.
`
`Zydus intends to continue seeking approval of the ANDA from the FDA, and to
`
`engage in the commercial manufacture, marketing, and sale of the Accused Product (including
`
`commercial marketing and sale of the Accused Product in the State of New Jersey and this
`
`District), in the event that the FDA approves the ANDA.
`
`COUNT I:
`INFRINGEMENT OF U.S. PATENT NO. 9,089,587
`
`28.
`
`Plaintiffs incorporate paragraphs 1 through 27 above by reference as if fully set
`
`forth herein.
`
`29.
`
`30.
`
`The ’587 Patent is valid, enforceable, and has not expired.
`
`By seeking approval of the ANDA to engage in the commercial manufacture, use,
`
`sale, or offer for sale within the United States, or importation into the United States, of Zydus’
`
`Accused Product prior to the expiration of the ’587 Patent, Zydus has infringed at least claim 1
`
`of the ’587 Patent under 35 U.S.C. § 271(e)(2)(A), either literally or under the doctrine of
`
`equivalents.
`
`31.
`
`The Accused Product and/or its use as directed infringes one or more of the
`
`claims of the ’587 Patent, including at least claim 1, either literally or under the doctrine of
`
`equivalents. As such, under 35 U.S.C. § 271(e)(2)(A), Zydus has infringed the ’587 Patent by
`
`submitting the ANDA seeking permission to commercially manufacture, use, or sell the Accused
`
`Product prior to the expiration of the ’587 Patent.
`
`COMPLAINT FOR PATENT INFRINGEMENT
`
`PAGE 6
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`

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`Case 3:20-cv-19578 Document 1 Filed 12/17/20 Page 7 of 22 PageID: 7
`
`32.
`
`Zydus will induce infringement of one or more claims of the ’587 Patent—in
`
`violation of Plaintiffs’ patent rights—if the FDA approves the sale of the Accused Product with
`
`instructions and labeling that will result in direct infringement of one or more claims of the ’587
`
`Patent, including at least claim 1, by users of the Accused Product. The proposed label for the
`
`Accused Product must include the same information as the approved label for Soolantra®
`
`(Ivermectin) Cream 1%, including substantially identical dosage and administration information
`
`and drug product description.
`
`33.
`
`Zydus seeks approval of at least one indication for the Accused Product that is
`
`claimed in the ’587 Patent. Because the proposed label for the Accused Product must mirror the
`
`approved label for Soolantra® (Ivermectin) Cream 1%, if approved, the label for the Accused
`
`Product will state that the Accused Product is indicated for treatment of inflammatory lesions of
`
`rosacea in accordance with the methods claimed in the ’587 Patent. The proposed label also will
`
`include reference to clinical studies showing that use of the Accused Product in accordance with
`
`the methods claimed in the ’587 Patent will achieve certain clinical benefits and efficacy(ies),
`
`including with respect to reductions of inflammatory lesions and success in treating rosacea, as
`
`claimed in the ’587 Patent. Zydus’s sale and marketing of the Accused Product will therefore
`
`encourage use of the Accused Product for the treatment of rosacea as set forth in one or more
`
`claims of the ’587 Patent.
`
`34.
`
`Zydus intends that physicians will prescribe, and patients will use, the Accused
`
`Product in accordance with the indication(s) sought by Zydus and will therefore infringe one or
`
`more claims of the ’587 Patent under 35 U.S.C. § 271(b).
`
`35.
`
`Pursuant to the Drug Price Competition and Patent Term Restoration Act, 21
`
`U.S.C. § 355 et seq., Zydus’ ANDA must include information showing that the Accused Product
`
`COMPLAINT FOR PATENT INFRINGEMENT
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`PAGE 7
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`

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`Case 3:20-cv-19578 Document 1 Filed 12/17/20 Page 8 of 22 PageID: 8
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`(1) contains the same active ingredients as Soolantra® (Ivermectin) Cream 1% [21 U.S.C.
`
`§ 355(j)(2)(A)(II)]; (2) has the same route of administration, dosage form, and strength as
`
`Soolantra® (Ivermectin) Cream 1% [21 U.S.C. § 355(j)(2)(A)(iii)]; and (3) is bioequivalent
`
`and/or has the same therapeutic effect as Soolantra® (Ivermectin) Cream 1% [21 U.S.C. §
`
`355(j)(2)(A)(iv)].
`
`36.
`
`As such, under 35 U.S.C. § 271(e)(2)(A), Zydus has infringed the ’587 Patent by
`
`submitting the ANDA seeking permission to commercially manufacture, use, or sell the Accused
`
`Product prior to the expiration of the ’587 Patent.
`
`37.
`
`As a result of Zydus’ infringement, Plaintiffs are entitled to a declaration that the
`
`Accused Product infringes the ’587 Patent if made, used as directed, sold, offered for sale, or
`
`imported during the term of the ’587 Patent.
`
`38.
`
`Plaintiffs will be substantially and irreparably harmed by Zydus’ infringing
`
`activities unless those activities are enjoined by this Court. Plaintiffs have no adequate remedy at
`
`law.
`
`39.
`
`As a result of Zydus’ infringement, Plaintiffs are entitled to permanent injunctive
`
`relief, restraining and enjoining Zydus and all those in privity or acting in concert with Zydus
`
`from manufacturing, selling, offering to sell, or importing the Accused Product during the term
`
`of the ’587 Patent, or from otherwise infringing or inducing the infringement of the ’587 Patent.
`
`COUNT II:
`INFRINGEMENT OF U.S. PATENT NO. 9,233,117
`
`40.
`
`Plaintiffs incorporate paragraphs 1 through 39 above by reference as if fully set
`
`forth herein.
`
`41.
`
`The ’117 Patent is valid, enforceable, and has not expired.
`
`COMPLAINT FOR PATENT INFRINGEMENT
`
`PAGE 8
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`

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`Case 3:20-cv-19578 Document 1 Filed 12/17/20 Page 9 of 22 PageID: 9
`
`42.
`
`By seeking approval of the ANDA to engage in the commercial manufacture, use,
`
`sale, or offer for sale within the United States, or importation into the United States, of Zydus’
`
`Accused Product prior to the expiration of the ’117 Patent, Zydus has infringed at least claim 1
`
`of the ’117 Patent under 35 U.S.C. § 271(e)(2)(A), either literally or under the doctrine of
`
`equivalents.
`
`43.
`
`The Accused Product and/or its use as directed infringes one or more of the
`
`claims of the ’117 Patent, including at least claim 1, either literally or under the doctrine of
`
`equivalents. As such, under 35 U.S.C. § 271(e)(2)(A), Zydus has infringed the ’117 Patent by
`
`submitting the ANDA seeking permission to commercially manufacture, use, or sell the Accused
`
`Product prior to the expiration of the ’117 Patent.
`
`44.
`
`Zydus will induce infringement of one or more claims of the ’117 Patent—in
`
`violation of Plaintiffs’ patent rights—if the FDA approves the sale of the Accused Product with
`
`instructions and labeling that will result in direct infringement of one or more claims of the ’117
`
`Patent, including at least claim 1, by users of the Accused Product. The proposed label for the
`
`Accused Product must include the same information as the approved label for Soolantra®
`
`(Ivermectin) Cream 1%, including substantially identical dosage and administration information
`
`and drug product description.
`
`45.
`
`Zydus seeks approval of at least one indication for the Accused Product that is
`
`claimed in the ’117 Patent. Because the proposed label for the Accused Product must mirror the
`
`approved label for Soolantra® (Ivermectin) Cream 1%, if approved, the label for the Accused
`
`Product will state that the Accused Product is indicated for treatment of inflammatory lesions of
`
`rosacea in accordance with the methods claimed in the ’117 Patent. The proposed label also will
`
`include reference to clinical studies showing that use of the Accused Product in accordance with
`
`COMPLAINT FOR PATENT INFRINGEMENT
`
`PAGE 9
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`

`

`Case 3:20-cv-19578 Document 1 Filed 12/17/20 Page 10 of 22 PageID: 10
`
`the methods claimed in the ’117 Patent will achieve certain clinical benefits and efficacy(ies),
`
`including with respect to reductions of inflammatory lesions and success in treating rosacea, as
`
`claimed in the ’117 Patent. Zydus’s sale and marketing of the Accused Product will therefore
`
`encourage use of the Accused Product for the treatment of rosacea as set forth in one or more
`
`claims of the ’117 Patent.
`
`46.
`
`Zydus intends that physicians will prescribe, and patients will use, the Accused
`
`Product in accordance with the indication(s) sought by Zydus and will therefore infringe one or
`
`more claims of the ’117 Patent under 35 U.S.C. § 271(b).
`
`47.
`
`Pursuant to the Drug Price Competition and Patent Term Restoration Act, 21
`
`U.S.C. § 355 et seq., Zydus’ ANDA must include information showing that the Accused Product
`
`(1) contains the same active ingredients as Soolantra® (Ivermectin) Cream 1% [21 U.S.C.
`
`§ 355(j)(2)(A)(II)]; (2) has the same route of administration, dosage form, and strength as
`
`Soolantra® (Ivermectin) Cream 1% [21 U.S.C. § 355(j)(2)(A)(iii)]; and (3) is bioequivalent
`
`and/or has the same therapeutic effect as Soolantra® (Ivermectin) Cream 1% [21 U.S.C. §
`
`355(j)(2)(A)(iv)].
`
`48.
`
`As such, under 35 U.S.C. § 271(e)(2)(A), Zydus has infringed the ’117 Patent by
`
`submitting the ANDA seeking permission to commercially manufacture, use, or sell the Accused
`
`Product prior to the expiration of the ’117 Patent.
`
`49.
`
`As a result of Zydus’ infringement, Plaintiffs are entitled to a declaration that the
`
`Accused Product infringes the ’117 Patent if made, used as directed, sold, offered for sale, or
`
`imported during the term of the ’117 Patent.
`
`COMPLAINT FOR PATENT INFRINGEMENT
`
`PAGE 10
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`

`

`Case 3:20-cv-19578 Document 1 Filed 12/17/20 Page 11 of 22 PageID: 11
`
`50.
`
`Plaintiffs will be substantially and irreparably harmed by Zydus’ infringing
`
`activities unless those activities are enjoined by this Court. Plaintiffs have no adequate remedy at
`
`law.
`
`51.
`
`As a result of Zydus’ infringement, Plaintiffs are entitled to permanent injunctive
`
`relief, restraining and enjoining Zydus and all those in privity or acting in concert with Zydus
`
`from manufacturing, selling, offering to sell, or importing the Accused Product during the term
`
`of the ’117 Patent, or from otherwise infringing or inducing the infringement of the ’117 Patent.
`
`COUNT III:
`INFRINGEMENT OF U.S. PATENT NO. 9,233,118
`
`52.
`
`Plaintiffs incorporate paragraphs 1 through 51 above by reference as if fully set
`
`forth herein.
`
`53.
`
`54.
`
`The ’118 Patent is valid, enforceable, and has not expired.
`
`By seeking approval of the ANDA to engage in the commercial manufacture, use,
`
`sale, or offer for sale within the United States, or importation into the United States, of Zydus’
`
`Accused Product prior to the expiration of the ’118 Patent, Zydus has infringed at least claim 1
`
`of the ’118 Patent under 35 U.S.C. § 271(e)(2)(A), either literally or under the doctrine of
`
`equivalents.
`
`55.
`
`The Accused Product and/or its use as directed infringes one or more of the
`
`claims of the ’118 Patent, including at least claim 1, either literally or under the doctrine of
`
`equivalents. As such, under 35 U.S.C. § 271(e)(2)(A), Zydus has infringed the ’118 Patent by
`
`submitting the ANDA seeking permission to commercially manufacture, use, or sell the Accused
`
`Product prior to the expiration of the ’118 Patent.
`
`56.
`
`Zydus will induce infringement of one or more claims of the ’118 Patent—in
`
`violation of Plaintiffs’ patent rights—if the FDA approves the sale of the Accused Product with
`
`COMPLAINT FOR PATENT INFRINGEMENT
`
`PAGE 11
`
`

`

`Case 3:20-cv-19578 Document 1 Filed 12/17/20 Page 12 of 22 PageID: 12
`
`instructions and labeling that will result in direct infringement of one or more claims of the ’118
`
`Patent, including at least claim 1, by users of the Accused Product. The proposed label for the
`
`Accused Product must include the same information as the approved label for Soolantra®
`
`(Ivermectin) Cream 1%, including substantially identical dosage and administration information
`
`and drug product description.
`
`57.
`
`Zydus seeks approval of at least one indication for the Accused Product that is
`
`claimed in the ’118 Patent. Because the proposed label for the Accused Product must mirror the
`
`approved label for Soolantra® (Ivermectin) Cream 1%, if approved, the label for the Accused
`
`Product will state that the Accused Product is indicated for treatment of inflammatory lesions of
`
`rosacea in accordance with the methods claimed in the ’118 Patent. The proposed label also will
`
`include reference to clinical studies showing that use of the Accused Product in accordance with
`
`the methods claimed in the ’118 Patent will achieve certain clinical benefits and efficacy(ies),
`
`including with respect to reductions of inflammatory lesions and success in treating rosacea, as
`
`claimed in the ’118 Patent. Zydus’s sale and marketing of the Accused Product will therefore
`
`encourage use of the Accused Product for the treatment rosacea as set forth in one or more
`
`claims of the ’118 Patent.
`
`58.
`
`Zydus intends that physicians will prescribe, and patients will use, the Accused
`
`Product in accordance with the indication(s) sought by Zydus and will therefore infringe one or
`
`more claims of the ’118 Patent under 35 U.S.C. § 271(b).
`
`59.
`
`Pursuant to the Drug Price Competition and Patent Term Restoration Act, 21
`
`U.S.C. § 355 et seq., Zydus’ ANDA must include information showing that the Accused Product
`
`(1) contains the same active ingredients as Soolantra® (Ivermectin) Cream 1% [21 U.S.C.
`
`§ 355(j)(2)(A)(II)]; (2) has the same route of administration, dosage form, and strength as
`
`COMPLAINT FOR PATENT INFRINGEMENT
`
`PAGE 12
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`

`

`Case 3:20-cv-19578 Document 1 Filed 12/17/20 Page 13 of 22 PageID: 13
`
`Soolantra® (Ivermectin) Cream 1% [21 U.S.C. § 355(j)(2)(A)(iii)]; and (3) is bioequivalent
`
`and/or has the same therapeutic effect as Soolantra® (Ivermectin) Cream 1% [21 U.S.C. §
`
`355(j)(2)(A)(iv)].
`
`60.
`
`As such, under 35 U.S.C. § 271(e)(2)(A), Zydus has infringed the ’118 Patent by
`
`submitting the ANDA seeking permission to commercially manufacture, use, or sell the Accused
`
`Product prior to the expiration of the ’118 Patent.
`
`61.
`
`As a result of Zydus’ infringement, Plaintiffs are entitled to a declaration that the
`
`Accused Product infringes the ’118 Patent if made, used as directed, sold, offered for sale, or
`
`imported during the term of the ’118 Patent.
`
`62.
`
`Plaintiffs will be substantially and irreparably harmed by Zydus’ infringing
`
`activities unless those activities are enjoined by this Court. Plaintiffs have no adequate remedy at
`
`law.
`
`63.
`
`As a result of Zydus’ infringement, Plaintiffs are entitled to permanent injunctive
`
`relief, restraining and enjoining Zydus and all those in privity or acting in concert with Zydus
`
`from manufacturing, selling, offering to sell, or importing the Accused Product during the term
`
`of the ’118 Patent, or from otherwise infringing or inducing the infringement of the ’118 Patent.
`
`COUNT IV:
`INFRINGEMENT OF U.S. PATENT NO. 9,782,425
`
`64.
`
`Plaintiffs incorporate paragraphs 1 through 63 above by reference as if fully set
`
`forth herein.
`
`65.
`
`66.
`
`The ’425 Patent is valid, enforceable, and has not expired.
`
`By seeking approval of the ANDA to engage in the commercial manufacture, use,
`
`sale, or offer for sale within the United States, or importation into the United States, of Zydus’
`
`Accused Product prior to the expiration of the ’425 Patent, Zydus has infringed at least claim 1
`
`COMPLAINT FOR PATENT INFRINGEMENT
`
`PAGE 13
`
`

`

`Case 3:20-cv-19578 Document 1 Filed 12/17/20 Page 14 of 22 PageID: 14
`
`of the ’425 Patent under 35 U.S.C. § 271(e)(2)(A), either literally or under the doctrine of
`
`equivalents.
`
`67.
`
`The Accused Product and/or its use as directed infringes one or more of the
`
`claims of the ’425 Patent, including at least claim 1, either literally or under the doctrine of
`
`equivalents. As such, under 35 U.S.C. § 271(e)(2)(A), Zydus has infringed the ’425 Patent by
`
`submitting the ANDA seeking permission to commercially manufacture, use, or sell the Accused
`
`Product prior to the expiration of the ’425 Patent.
`
`68.
`
`Zydus will induce infringement of one or more claims of the ’425 Patent—in
`
`violation of Plaintiffs’ patent rights—if the FDA approves the sale of the Accused Product with
`
`instructions and labeling that will result in direct infringement of one or more claims of the ’425
`
`Patent, including at least claim 1, by users of the Accused Product. The proposed label for the
`
`Accused Product must include the same information as the approved label for Soolantra®
`
`(Ivermectin) Cream 1%, including substantially identical dosage and administration information
`
`and drug product description.
`
`69.
`
`Zydus seeks approval of at least one indication for the Accused Product that is
`
`claimed in the ’425 Patent. Because the proposed label for the Accused Product must mirror the
`
`approved label for Soolantra® (Ivermectin) Cream 1%, if approved, the label for the Accused
`
`Product will state that the Accused Product is indicated for treatment of inflammatory lesions of
`
`rosacea in accordance with the methods claimed in the ’425 Patent. The proposed label also will
`
`include reference to clinical studies showing that use of the Accused Product in accordance with
`
`the methods claimed in the ’425 Patent will achieve certain clinical benefits and efficacy(ies),
`
`including with respect to reductions of inflammatory lesions and success in treating rosacea, as
`
`claimed in the ’425 Patent. Zydus’s sale and marketing of the Accused Product will therefore
`
`COMPLAINT FOR PATENT INFRINGEMENT
`
`PAGE 14
`
`

`

`Case 3:20-cv-19578 Document 1 Filed 12/17/20 Page 15 of 22 PageID: 15
`
`encourage use of the Accused Product for the treatment of rosacea as set forth in one or more
`
`claims of the ’425 Patent.
`
`70.
`
`Zydus intends that physicians will prescribe, and patients will use, the Accused
`
`Product in accordance with the indication(s) sought by Zydus and will therefore infringe one or
`
`more claims of the ’425 Patent under 35 U.S.C. § 271(b).
`
`71.
`
`Pursuant to the Drug Price Competition and Patent Term Restoration Act, 21
`
`U.S.C. § 355 et seq., Zydus’ ANDA must include information showing that the Accused Product
`
`(1) contains the same active ingredients as Soolantra® (Ivermectin) Cream 1% [21 U.S.C.
`
`§ 355(j)(2)(A)(II)]; (2) has the same route of administration, dosage form, and strength as
`
`Soolantra® (Ivermectin) Cream 1% [21 U.S.C. § 355(j)(2)(A)(iii)]; and (3) is bioequivalent
`
`and/or has the same therapeutic effect as Soolantra® (Ivermectin) Cream 1% [21 U.S.C. §
`
`355(j)(2)(A)(iv)].
`
`72.
`
`As such, under 35 U.S.C. § 271(e)(2)(A), Zydus has infringed the ’425 Patent by
`
`submitting the ANDA seeking permission to commercially manufacture, use, or sell the Accused
`
`Product prior to the expiration of the ’425 Patent.
`
`73.
`
`As a result of Zydus’ infringement, Plaintiffs are entitled to a declaration that the
`
`Accused Product infringes the ’425 Patent if made, used as directed, sold, offered for sale, or
`
`imported during the term of the ’425 Patent.
`
`74.
`
`Plaintiffs will be substantially and irreparably harmed by Zydus’ infringing
`
`activities unless those activities are enjoined by this Court. Plaintiffs have no adequate remedy at
`
`law.
`
`75.
`
`As a result of Zydus’ infringement, Plaintiffs are entitled to permanent injunctive
`
`relief, restraining and enjoining Zydus and all those in privity or acting in concert with Zydus
`
`COMPLAINT FOR PATENT INFRINGEMENT
`
`PAGE 15
`
`

`

`Case 3:20-cv-19578 Document 1 Filed 12/17/20 Page 16 of 22 PageID: 16
`
`from manufacturing, selling, offering to sell, or importing the Accused Product during the term
`
`of the ’425 Patent, or from otherwise infringing or inducing the infringement of the ’425 Patent.
`
`COUNT V:
`INFRINGEMENT OF U.S. PATENT NO. 10,206,939
`
`76.
`
`Plaintiffs incorporate paragraphs 1 through 75 above by reference as if fully set
`
`forth herein.
`
`77.
`
`78.
`
`The ’939 Patent is valid, enforceable, and has not expired.
`
`By seeking approval of the ANDA to engage in the commercial manufacture, use,
`
`sale, or offer for sale within the United States, or importation into the United States, of Zydus’
`
`Accused Product prior to the expiration of the ’939 Patent, Zydus has infringed at least claim 1
`
`of the ’939 Patent under 35 U.S.C. § 271(e)(2)(A), either literally or under the doctrine of
`
`equivalents.
`
`79.
`
`The Accused Product and/or its use as directed infringes one or more of the
`
`claims of the ’939 Patent, including at least claim 1, either literally or under the doctrine of
`
`equivalents. As such, under 35 U.S.C. § 271(e)(2)(A), Zydus has infringed the ’939 Patent by
`
`submitting the ANDA seeking permission to commercially manufacture, use, or sell the Accused
`
`Product prior to the expiration of the ’939 Patent.
`
`80.
`
`Zydus will induce infringement of one or more claims of the ’939 Patent—in
`
`violation of Plaintiffs’ patent rights—if the FDA approves the sale of the Accused Product with
`
`instructions and labeling that will result in direct infringement of one or more claims of the ’939
`
`Patent, including at least claim 1, by users of the Accused Product. The proposed label for the
`
`Accused Product must include the same information as the approved label for Soolantra®
`
`(Ivermectin) Cream 1%, including substantially identical dosage and administration information
`
`and drug product description.
`
`COMPLAINT FOR PATENT INFRINGEMENT
`
`PAGE 16
`
`

`

`Case 3:20-cv-19578 Document 1 Filed 12/17/20 Page 17 of 22 PageID: 17
`
`81.
`
`Zydus seeks approval of at least one indication for the Accused Product that is
`
`claimed in the ’939 Patent. Because the proposed label for the Accused Product must mirror the
`
`approved label for Soolantra® (Ivermectin) Cream 1%, if approved, the label for the Accused
`
`Product will state that the Accused Product is indicated for treatment of inflammatory lesions of
`
`rosacea in accordance with the methods claimed in the ’939 Patent. The proposed label also will
`
`include reference to clinical studies showing that use of the Accused Product in accordance with
`
`the methods claimed in the ’939 Patent will achieve certain clinical benefits and efficacy(ies),
`
`including with respect to reductions of inflammatory lesions and success in treating rosacea, as
`
`claimed in the ’939 Patent. Zydus’s sale and marketing of the Accused Product will therefore
`
`encourage use of the Accused Product for the treatment rosacea as set forth in one or more
`
`claims of the ’939 Patent.
`
`82.
`
`Zydus intends that physicians will prescribe, and patients will use, the Accused
`
`Product in accordance with the indication(s) sought by Zydus and will therefore infringe one or
`
`more claims of the ’939 Patent under 35 U.S.C. § 271(b).
`
`83.
`
`Pursuant to the Drug Price Competition and Patent Term Restoration Act, 21
`
`U.S.C. § 355 et seq., Zydus’ ANDA must include information showing that the Accused Product
`
`(1) contains the same active ingredients as Soolantra® (Ivermectin) Cream 1% [21 U.S.C.
`
`§ 355(j)(2)(A)(II)]; (2) has the same route of administration, dosage form, and strength as
`
`Soolantra® (Ivermectin) Cream 1% [21 U.S.C. § 355(j)(2)(A)(iii)]; and (3) is bioequivalent
`
`and/or has the same therapeutic effect as Soolantra® (Ivermectin) Cream 1% [21 U.S.C. §
`
`355(j)(2)(A)(iv)].
`
`COMPLAINT FOR PATENT INFRINGEMENT
`
`PAGE 17
`
`

`

`Case 3:20-cv-19578 Document 1 Filed 12/17/20 Page 18 of 22 PageID: 18
`
`84.
`
`As such, under 35 U.S.C. § 271(e)(2)(A), Zydus has infringed the ’939 Patent by
`
`submitting the ANDA seeking permission to commercially manufacture, use, or sell the Accused
`
`Product prior to the expiration of the ’939 Patent.
`
`85.
`
`As a result of Zydus’ infringement, Plaintiffs are entitled to a declaration that the
`
`Accused Product infringes the ’939 Patent if made, used as directed, sold, offered for sale, or
`
`imported during the term of the ’939 Patent.
`
`86.
`
`Plaintiffs will be substantially and irreparably harmed by Zydus’ infringing
`
`activities unless those activities are enjoined by this Court. Plaintiffs have no adequate remedy at
`
`law.
`
`87.
`
`As a result of Zydus’ infringement, Plaintiffs are entitled to permanent injunctive
`
`relief, restraining and enjoining Zydus and all those in privity or acting in concert with Zydus
`
`from manufacturing, sell