Case: 1:20-cv-05055 Document #: 1 Filed: 08/27/20 Page 1 of 12 PageID #:1
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`
`
`UNITED STATES DISTRICT COURT
`FOR THE NORTHERN DISTRICT OF ILLINOIS
`EASTERN DIVISION
`
`
`
`ASSERTIO THERAPEUTICS, INC. &
`APR APPLIED PHARMA RESEARCH SA,
`
`
`Plaintiffs,
`
`
`
`v.
`
`
`PATRIN PHARMA, INC.,
`
`
`Defendant.
`
`)
`)
`)
`)
`)
`)
`)
`)
`)
`
`C.A. No.
`
`Document Filed Electronically
`
`
`
`
`
`COMPLAINT
`
`Plaintiffs Assertio Therapeutics, Inc. (“Assertio”) and APR Applied Pharma Research SA
`
`(“APR”) (collectively “Plaintiffs”) by their undersigned attorneys, bring this action against
`
`defendant Patrin Pharma, Inc. (“Patrin” or “Defendant”), and hereby allege as follows:
`
`NATURE OF THE ACTION
`
`1.
`
`This is a civil action for patent infringement arising under the patent laws of the
`
`United States, Title 35 of the United States Code, involving U.S. Patent No. 7,759,394 (“the ’394
`
`patent”), U.S, Patent No. 8,097,651, (“the ’651 patent”), U.S. Patent No. 8,927,604 (“the ’604
`
`patent”) and U.S Patent No. 9,827,197 (“the ’197 patent”) (collectively, “the patents-in-suit”),
`
`attached hereto as Exhibits A-D.
`
`THE PARTIES
`
`2.
`
`Assertio is a corporation organized and existing under the laws of Delaware,
`
`having its principal place of business at 100 South Saunders Road, Ste. 300, Lake Forest, IL.
`
`Assertio is a wholly owned subsidiary of Assertio Holdings, Inc., which is a publicly traded
`
`
`
`
`
`

`

`Case: 1:20-cv-05055 Document #: 1 Filed: 08/27/20 Page 2 of 12 PageID #:2
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`company having its principal place of business at 100 South Saunders Road, Ste. 300, Lake
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`Forest, IL.
`
`3.
`
`APR is a corporation organized and existing under the laws of Switzerland,
`
`having its principal place of business at Via Corti 5, Balerna, Switzerland 6828.
`
`4.
`
`On information and belief, Patrin is a corporation organized and existing under
`
`the laws of the State of Illinois, having its principal place of business at 7817 Babb Ave, Skokie,
`
`IL, 60077-3636.
`
`5.
`
`On information and belief, Patrin is in the business of, among other things, the
`
`development, manufacture, marketing, sale, and distribution of generic pharmaceutical products
`
`throughout the United States, including in Illinois.
`
`6.
`
`On information and belief, Patrin derives substantial revenue from the sale of
`
`generic pharmaceutical products in the United States and Illinois.
`
`JURISDICTION AND VENUE
`
`7.
`
`This Court has jurisdiction over the subject matter of this action pursuant to
`
`28 U.S.C. §§ 1331, 1338(a), 2201 and 2202.
`
`8.
`
`This Court has personal jurisdiction over Patrin at least because, upon information
`
`and belief, Patrin is incorporated in Illinois; has its principal place of business in Skokie, Illinois;
`
`regularly does or solicits business in Illinois; engages in other persistent courses of conduct in
`
`Illinois; and/or derives substantial revenue from services or things used or consumed in Illinois;
`
`thereby demonstrating that Patrin has continuous and systematic contacts with Illinois.
`
`9.
`
`This Court has personal jurisdiction over Patrin at least because, upon information
`
`and belief, Patrin has submitted an Abbreviated New Drug Application (ANDA) (“Patrin’s
`
`ANDA”) seeking final approval to engage in the commercial use, sale, and/or distribution of
`
`
`
`– 2 –
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`

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`Case: 1:20-cv-05055 Document #: 1 Filed: 08/27/20 Page 3 of 12 PageID #:3
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`
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`generic diclofenac potassium powder for oral solution (50 mg) (“Patrin’s ANDA Product”)
`
`throughout the United States, including in Illinois, before the expiration of the patents-in-suit.
`
`10.
`
`This Court has personal jurisdiction over Patrin at least because, on information
`
`and belief, if Patrin’s ANDA receives final approval, Patrin’s ANDA Product will be
`
`manufactured, sold, distributed, and/or used by Patrin in Illinois; prescribed by physicians
`
`practicing in Illinois; and/or administered to patients in Illinois.
`
`11.
`
`This Court has personal jurisdiction over Patrin at least because, on information
`
`and belief, Patrin submitted its ANDA to the U.S. Food and Drug Administration (FDA) from
`
`Illinois.
`
`12.
`
`Venue is proper in this judicial district under 28 U.S.C. §§ 1391(b) and (c) and
`
`§ 1400(b).
`
`CAMBIA®
`
`13.
`
`Assertio is the owner of New Drug Application (NDA) No. 022165, which was
`
`approved by the FDA for the manufacture and sale of diclofenac potassium powder for oral
`
`solution (50 mg). Diclofenac potassium is a non-steroidal anti-inflammatory drug. Assertio
`
`markets its diclofenac potassium powder for oral solution under the trade name Cambia®.
`
`14.
`
`Cambia® is currently approved by the FDA for the acute treatment of migraine
`
`attacks with or without aura in adults 18 years of age or older.
`
`15.
`
`The ’394 patent, titled “Diclofenac Formulations and Methods of Use,” was duly
`
`and legally issued by the U.S. Patent and Trademark Office on July 20, 2010. The ’394 patent
`
`was subsequently assigned to APR.
`
`16.
`
`The ’651 patent, titled “Diclofenac Formulations and Methods of Use,” was duly
`
`and legally issued by the U.S. Patent and Trademark Office on January 17, 2012. The ’651
`
`patent was subsequently assigned to APR.
`
`
`
`– 3 –
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`

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`Case: 1:20-cv-05055 Document #: 1 Filed: 08/27/20 Page 4 of 12 PageID #:4
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`17.
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`The ’604 patent, titled “Diclofenac Formulations and Methods of Use,” was duly
`
`and legally issued by the U.S. Patent and Trademark Office on January 6, 2015. The ’604 patent
`
`was subsequently assigned to APR.
`
`18.
`
`The ’197 patent, titled “Diclofenac Formulations and Methods of Use,” was duly
`
`and legally issued by the U.S. Patent and Trademark Office on November 28, 2017. The ’197
`
`patent was subsequently assigned to APR.
`
`19.
`
`APR owns the entire right, title and interest in the patents-in-suit. Assertio has an
`
`exclusive license to Cambia® under the patents-in-suit.
`
`20.
`
`Pursuant to 21 U.S.C. § 355(b)(1), the ’394 patent, the ’651 patent, the ’604
`
`patent and the ’197 patent are listed in the FDA publication titled “Approved Drug Products with
`
`Therapeutic Equivalence Evaluations” (“the Orange Book”) for the Cambia® NDA No. 022165.
`
`21.
`
`The ’394 patent, the ’651 patent, the ’604 patent and the ’197 patent cover
`
`Cambia®.
`
`PATRIN’S ANDA
`
`22.
`
`On information and belief, Patrin submitted an ANDA to the FDA pursuant to
`
`§ 505(j) of the Federal Food, Drug, and Cosmetic Act (“FDCA”) (codified at 21 U.S.C. § 355(j))
`
`seeking approval to market Patrin’s diclofenac potassium powder for oral solution (50 mg)
`
`(“Patrin’s ANDA Product”).
`
`23.
`
`On information and belief, Patrin’s ANDA refers to and relies on NDA No.
`
`022165 and contains data that, according to Patrin, demonstrate the bioequivalence of the Patrin
`
`ANDA Product and Cambia®.
`
`24.
`
`Plaintiffs each received from Patrin a letter, dated July 15, 2020 (“the Patrin
`
`Notice Letter”) stating that Patrin’s ANDA had included a certification pursuant to 21 U.S.C.
`
`
`
`– 4 –
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`

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`Case: 1:20-cv-05055 Document #: 1 Filed: 08/27/20 Page 5 of 12 PageID #:5
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`
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`§ 355(j)(2)(A)(vii)(IV) (“Paragraph IV certification”) that the ’394 patent, the ’651 patent, the
`
`’604 patent and the ’197 patent are invalid, unenforceable and/or will not be infringed by the
`
`commercial manufacture, use or sale of the Patrin ANDA Product.
`
`25.
`
`The Patrin Notice Letter states that the Patrin ANDA seeks approval to engage in
`
`the commercial manufacture, use, sale, offering for sale, and/or importation of Patrin’s ANDA
`
`Product before the expiration of the ’394 patent, the ’651 patent, the ’604 patent, and the ’197
`
`patent.
`
`herein.
`
`FIRST COUNT
`(Patrin’s Infringement of the ’394 Patent)
`
`26.
`
`Plaintiffs repeat and re-allege each of the foregoing paragraphs as if fully set forth
`
`27.
`
`Under 35 U.S.C. § 271(e)(2)(A), Patrin has infringed the ’394 patent by
`
`submission of Patrin’s ANDA to the FDA for the purpose of obtaining approval to engage in the
`
`commercial manufacture, use, or sale of Patrin’s ANDA Product before the expiration of the
`
`’394 patent.
`
`28.
`
`Patrin’s commercial manufacture, use, offering to sell and/or sale within the
`
`United States, and/or importation into the United States, of Patrin’s ANDA Product would
`
`infringe, literally and/or under the doctrine of equivalents, one or more of the ’394 patent’s
`
`claims under 35 U.S.C. § 271(a), (b) and/or (c).
`
`29.
`
`Upon approval of Patrin’s ANDA, and the commercial marketing of Patrin’s
`
`ANDA Product, Patrin will actively induce and/or contribute to infringement of the ’394 patent.
`
`30.
`
`This action is being filed within 45 days of receipt by Plaintiffs of the Patrin
`
`Notice Letter dated July 15, 2020, which states that the Patrin ANDA includes a Paragraph IV
`
`Certification relative to the ’394 patent.
`
`
`
`– 5 –
`
`

`

`Case: 1:20-cv-05055 Document #: 1 Filed: 08/27/20 Page 6 of 12 PageID #:6
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`31.
`
`On information and belief, Patrin had actual and constructive notice of the ’394
`
`patent prior to filing Patrin’s ANDA, and Patrin’s infringement of the ’394 patent has been and
`
`continues to be, willful.
`
`32.
`
`Plaintiffs are entitled to the relief provided by 35 U.S.C. § 271(e)(4), including an
`
`order of this Court that the effective date of the approval of Patrin’s ANDA be a date that is not
`
`earlier than the expiration of the ’394 patent to which Plaintiffs or the patent may become
`
`entitled.
`
`33.
`
`Plaintiffs will be substantially and irreparably harmed if Patrin is not enjoined
`
`from infringing or actively inducing or contributing to the infringement of the ’394 patent.
`
`34.
`
`35.
`
`Plaintiffs have no adequate remedy at law.
`
`This case is exceptional, and Plaintiffs are entitled to an award of attorneys’ fees
`
`under 35 U.S.C. §285.
`
`SECOND COUNT
`(Patrin’s Infringement of the ’651 Patent)
`
`36.
`
`Plaintiffs repeat and re-allege each of the foregoing paragraphs as if fully set forth
`
`herein.
`
`37.
`
`Under 35 U.S.C. § 271(e)(2)(A), Patrin has infringed the ’651 patent by
`
`submission of Patrin’s ANDA to FDA for the purpose of obtaining approval to engage in the
`
`commercial manufacture, use, or sale of Patrin’s ANDA Product before the expiration of the
`
`’651 patent.
`
`38.
`
`Patrin’s commercial manufacture, use, offering to sell and/or sale within the
`
`United States, and/or importation into the United States, of Patrin’s ANDA Product would
`
`infringe, literally and/or under the doctrine of equivalents, one or more of the ’651 patent’s
`
`claims under 35 U.S.C. § 271(a), (b) and/or (c).
`
`
`
`– 6 –
`
`

`

`Case: 1:20-cv-05055 Document #: 1 Filed: 08/27/20 Page 7 of 12 PageID #:7
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`39.
`
`Upon approval of Patrin’s ANDA, and the commercial marketing of Patrin’s
`
`ANDA Product, Patrin will actively induce and/or contribute to infringement of the ’651 patent.
`
`40.
`
`This action is being filed within 45 days of receipt by Plaintiffs of the Patrin
`
`Notice Letter dated July 15, 2020, which states that the Patrin ANDA includes a Paragraph IV
`
`Certification relative to the ’651 patent.
`
`41.
`
`On information and belief, Patrin had actual and constructive notice of the ’651
`
`patent prior to filing Patrin’s ANDA, and Patrin’s infringement of the ’651 patent has been and
`
`continues to be, willful.
`
`42.
`
`Plaintiffs are entitled to the relief provided by 35 U.S.C. § 271(e)(4), including an
`
`order of this Court that the effective date of the approval of Patrin’s ANDA be a date that is not
`
`earlier than the expiration of the ’651 patent to which Plaintiffs or the patent may become
`
`entitled.
`
`43.
`
`Plaintiffs will be substantially and irreparably harmed if Patrin is not enjoined
`
`from infringing or actively inducing or contributing to the infringement of the ’651 patent.
`
`44.
`
`45.
`
`Plaintiffs have no adequate remedy at law.
`
`This case is exceptional, and Plaintiffs are entitled to an award of attorneys’ fees
`
`under 35 U.S.C. § 285.
`
`THIRD COUNT
`(Patrin’s Infringement of the ’604 Patent)
`
`46.
`
`Plaintiffs repeat and re-allege each of the foregoing paragraphs as if fully set forth
`
`herein.
`
`47.
`
`Under 35 U.S.C. § 271(e)(2)(A), Patrin has infringed the ’604 patent by
`
`submission of Patrin’s ANDA to FDA for the purpose of obtaining approval to engage in the
`
`
`
`– 7 –
`
`

`

`Case: 1:20-cv-05055 Document #: 1 Filed: 08/27/20 Page 8 of 12 PageID #:8
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`
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`commercial manufacture, use, or sale of Patrin’s ANDA Product before the expiration of the
`
`’604 patent.
`
`48.
`
`Patrin’s commercial manufacture, use, offering to sell and/or sale within the
`
`United States, and/or importation into the United States, of Patrin’s ANDA Product would
`
`infringe, literally and/or under the doctrine of equivalents, one or more of the ’604 patent’s
`
`claims under 35 U.S.C. § 271(a), (b) and/or (c).
`
`49.
`
`Upon approval of Patrin’s ANDA, and the commercial marketing of Patrin’s
`
`ANDA Product, Patrin will actively induce and/or contribute to infringement of the ’604 patent.
`
`50.
`
`This action is being filed within 45 days of receipt by Plaintiffs of the Patrin
`
`Notice Letter dated July 15, 2020, which states that the Patrin ANDA includes a Paragraph IV
`
`Certification relative to the ’604 patent.
`
`51.
`
`On information and belief, Patrin had actual and constructive notice of the ’604
`
`patent prior to filing Patrin’s ANDA, and Patrin’s infringement of the ’604 patent has been and
`
`continues to be, willful.
`
`52.
`
`Plaintiffs are entitled to the relief provided by 35 U.S.C. § 271(e)(4), including an
`
`order of this Court that the effective date of the approval of Patrin’s ANDA be a date that is not
`
`earlier than the expiration of the ’604 patent to which Plaintiffs or the patent may become
`
`entitled.
`
`53.
`
`Plaintiffs will be substantially and irreparably harmed if Patrin is not enjoined
`
`from infringing or actively inducing or contributing to the infringement of the ’604 patent.
`
`54.
`
`55.
`
`Plaintiffs have no adequate remedy at law.
`
`This case is exceptional, and Plaintiffs are entitled to an award of attorneys’ fees
`
`under 35 U.S.C. § 285.
`
`
`
`– 8 –
`
`

`

`Case: 1:20-cv-05055 Document #: 1 Filed: 08/27/20 Page 9 of 12 PageID #:9
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`
`
`herein.
`
`FOURTH COUNT
`(Patrin’s Infringement of the ’197 Patent)
`
`56.
`
`Plaintiffs repeat and re-allege each of the foregoing paragraphs as if fully set forth
`
`57.
`
`Under 35 U.S.C. § 271(e)(2)(A), Patrin has infringed the ’197 patent by
`
`submission of Patrin’s ANDA to FDA for the purpose of obtaining approval to engage in the
`
`commercial manufacture, use, or sale of Patrin’s ANDA Product before the expiration of the
`
`’197 patent.
`
`58.
`
`Patrin’s commercial manufacture, use, offering to sell and/or sale within the
`
`United States, and/or importation into the United States, of Patrin’s ANDA Product would
`
`infringe, literally and/or under the doctrine of equivalents, one or more of the ’197 patent’s
`
`claims under 35 U.S.C. § 271(a), (b) and/or (c).
`
`59.
`
`This action is being filed within 45 days of receipt by Plaintiffs of the Patrin
`
`Notice Letter dated July 15, 2020, which states that the Patrin ANDA includes a Paragraph IV
`
`Certification relative to the ’197 patent.
`
`60.
`
`On information and belief, Patrin had actual and constructive notice of the ’197
`
`patent prior to filing Patrin’s ANDA, and Patrin’s infringement of the ’197 patent has been and
`
`continues to be, willful.
`
`61.
`
`Plaintiffs are entitled to the relief provided by 35 U.S.C. § 271(e)(4), including an
`
`order of this Court that the effective date of the approval of Patrin’s ANDA be a date that is not
`
`earlier than the expiration of the ’197 patent to which Plaintiffs or the patent may become
`
`entitled.
`
`62.
`
`Plaintiffs will be substantially and irreparably harmed if Patrin is not enjoined
`
`from infringing the ’197 patent.
`
`
`
`– 9 –
`
`

`

`Case: 1:20-cv-05055 Document #: 1 Filed: 08/27/20 Page 10 of 12 PageID #:10
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`
`
`63.
`
`64.
`
`Plaintiffs have no adequate remedy at law.
`
`This case is exceptional, and Plaintiffs are entitled to an award of attorneys’ fees
`
`under 35 U.S.C. § 285.
`
`PRAYER FOR RELIEF
`
`WHEREFORE, Plaintiffs respectfully request the following relief:
`
`(A) A judgment declaring that Patrin has infringed one or more claims of the ’394
`
`patent;
`
`patent;
`
`patent;
`
`patent;
`
`(B) A judgment declaring that Patrin has infringed one or more claims of the ’651
`
`(C) A judgment declaring that Patrin has infringed one or more claims of the ’604
`
`(D) A judgment declaring that Patrin has infringed one or more claims of the ’197
`
`(E)
`
`If Patrin commercially manufactures, uses, offers to sell or sells the Patrin ANDA
`
`Product within the United States, or imports the Patrin ANDA Product into the United States,
`
`prior to the expiration of the ’394 patent, including any extensions, a judgment awarding
`
`Plaintiffs monetary relief together with interest;
`
`(F)
`
`If Patrin commercially manufactures, uses, offers to sell or sells the Patrin ANDA
`
`Product within the United States, or imports the Patrin ANDA Product into the United States,
`
`prior to the expiration of the ’651 patent, including any extensions, a judgment awarding
`
`Plaintiffs monetary relief together with interest;
`
`(G)
`
`If Patrin commercially manufactures, uses, offers to sell or sells the Patrin ANDA
`
`Product within the United States, or imports the Patrin ANDA Product into the United States,
`
`
`
`– 10 –
`
`

`

`Case: 1:20-cv-05055 Document #: 1 Filed: 08/27/20 Page 11 of 12 PageID #:11
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`
`
`prior to the expiration of the ’604 patent, including any extensions, a judgment awarding
`
`Plaintiffs monetary relief together with interest;
`
`(H)
`
`If Patrin commercially manufactures, uses, offers to sell or sells the Patrin ANDA
`
`Product within the United States, or imports the Patrin ANDA Product into the United States,
`
`prior to the expiration of the ’197 patent, including any extensions, a judgment awarding
`
`Plaintiffs monetary relief together with interest;
`
`(I)
`
`That an order be issued under 35 U.S.C. § 271(e)(4)(A) that the effective date of
`
`any FDA approval of the Patrin ANDA shall be a date not earlier than the expiration date of the
`
`’394 patent, inclusive of any extensions;
`
`(J)
`
`That an order be issued under 35 U.S.C. § 271(e)(4)(A) that the effective date of
`
`any FDA approval of the Patrin ANDA shall be a date not earlier than the expiration date of the
`
`’651 patent, inclusive of any extensions;
`
`(K)
`
`That an order be issued under 35 U.S.C. § 271(e)(4)(A) that the effective date of
`
`any FDA approval of the Patrin ANDA shall be a date not earlier than the expiration date of the
`
`’604 patent, inclusive of any extensions;
`
`(L)
`
`That an order be issued under 35 U.S.C. § 271(e)(4)(A) that the effective date of
`
`any FDA approval of the Patrin ANDA shall be a date not earlier than the expiration date of the
`
`’197 patent, inclusive of any extensions;
`
`(M) A judgment, pursuant to 35 U.S.C. § 285, declaring that this is an exceptional
`
`case and awarding Plaintiffs their attorneys’ fees and costs;
`
`(N)
`
`Such other and further relief as this Court may deem just and proper.
`
`
`
`– 11 –
`
`

`

`Case: 1:20-cv-05055 Document #: 1 Filed: 08/27/20 Page 12 of 12 PageID #:12
`
`Dated: August 27, 2020
`
`
`
`
`
`
`
`
`
`
`
`Respectfully submitted,
`
`By: /s/ Robert F. Green
`
`Robert F. Green (ARDC No. 1045466)
`rgreen@greengriffith.com
`Christopher T. Griffith (ARDC No. 6197487)
`cgriffith@greengriffith.com
`Emer L. Simic (ARDC No. 6297628)
`esimic@greengriffith.com
`GREEN, GRIFFITH & BORG-BREEN LLP
`City Place, Suite 3900
`676 North Michigan Avenue
`Chicago, Illinois 60611
`Telephone: (312) 883-8000
`Facsimile: (312) 883-8001
`
`Attorneys for Plaintiffs
`Assertio Therapeutics, Inc. &
`APR Applied Pharma Research SA
`
`Dennis A. Bennett
`GLOBAL PATENT GROUP, LLC
`East Professional and Medical Center Building
`Second Floor
`Carretera #3 Km 19.9
`Canóvanas, Puerto Rico 00729
`
`Of Counsel for Plaintiff
`Assertio Therapeutics, Inc.
`
`– 12 –
`
`

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