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. 

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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 

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company having its principal place of business at 100 South Saunders Road, Ste. 300, Lake 

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 

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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. 

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17. 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. 

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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. 

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 

herein. 

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. 

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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. Plaintiffs have no adequate remedy at law. 

35. 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). 

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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. Plaintiffs have no adequate remedy at law. 

45. 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 

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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. Plaintiffs have no adequate remedy at law. 

55. This case is exceptional, and Plaintiffs are entitled to an award of attorneys’ fees 

under 35 U.S.C. § 285. 

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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 

herein. 

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. 

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63. Plaintiffs have no adequate remedy at law. 

64. 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; 

(B) A judgment declaring that Patrin has infringed one or more claims of the ’651 

patent; 

(C) A judgment declaring that Patrin has infringed one or more claims of the ’604 

patent; 

(D) A judgment declaring that Patrin has infringed one or more claims of the ’197 

patent; 

(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, 

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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. 

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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. 

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