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IN THE UNITED STATES DISTRICT COURT

FOR THE NORTHERN DISTRICT OF TEXAS

FORTH WORTH DIVISION

IPSEN BIOPHARM LTD.,

Plaintiff,

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v.

GALDERMA LABORATORIES, L.P., 

Defendant.

CIVIL ACTION NO. ________ 

COMPLAINT FOR INJUNCTIVE RELIEF

Plaintiff Ipsen Biopharm Ltd. (“Ipsen”), alleges as follows:

INTRODUCTION

1. This is an action for injunctive relief in which Ipsen seeks an order to maintain the

status quo and prevent Defendant Galderma Laboratories, L.P. (“GLP”) from misappropriating 

Ipsen’s confidential and trade secret information in relation to QM-1114, an experimental, liquid 

formulation preparation derived from Botulinim toxin A (USAN: relabotulinutoxin-A) for the 

treatment of facial glabellar lines (frown) and lateral canthal lines (crow’s feet). Ipsen is the owner 

of all rights and intellectual property in QM-1114, which is being developed under license by GLP, 

the U.S. arm of Galderma S.A. (“GSA”), a Swiss company. Ipsen and GSA are embroiled in an 

arbitration in Belgium. In the midst of the arbitration, GLP, which is a Texas limited partnership 

and not a party to the arbitration, announced that it intends to use Ipsen’s trade secrets to make 

unauthorized filings with the United States Food and Drug Administration (“FDA”) and seek 

approval in its own name. GSA’s threats constitute threatened misappropriation under the Defend 

Trade Secrets Act, 18 U.S.C. § 1836 and Texas state law. Ipsen seeks a limited injunction to 

prevent GSA from making such disclosures prior to final resolution by the arbitral panel. 

4:22-cv-00662

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THE PARTIES

2. Plaintiff Ipsen is a company organized under the laws of the United Kingdom with 

its principal place of business at Ash Rd N, Wrexham LL13 9UF, United Kingdom. Ipsen is in 

the business of developing, manufacturing, and marketing pharmaceutical products, particularly 

in the field of neurosciences. 

3. Defendant GLP is a Texas limited partnership registered in the State of Texas with 

its principal place of business at 14501 North Freeway, Fort Worth, Texas 76177. GLP’s 

registered agent for service of process is CCS Global Solutions, Inc. located at 3610-2 North Josey 

Lane, Suite 223, Carrollton, Texas 75007. Upon information and belief, GLP’s partners are 

Galderma Limited, LLC and Galderma General, LLC, both of which are incorporated and 

registered to do business in Delaware with a principal place of business at 14501 North Freeway, 

Fort Worth, Texas 76177. 

4. GLP is a U.S.-based subsidiary of Galderma S.A. (“GSA”), a Swiss pharmaceutical 

company specializing in dermatological treatments and skin care products. GLP operates as 

GSA’s U.S. authorized agent for regulatory filings and submissions to the FDA. 

JURISDICTION AND VENUE

5. The Court has subject matter jurisdiction over Ipsen’s cause of action for 

misappropriation of trade secrets under the Defend Trade Secrets Act (18 U.S.C. § 1836(b) & (c)). 

6. On information and belief, the Court also has jurisdiction over the subject matter of 

this action because there is diversity of citizenship between the parties pursuant to 28 U.S.C. § 

1332(a) and the amount in controversy exceeds $75,000, exclusive of interests and costs. Ipsen is 

a citizen of a foreign state, the United Kingdom. The citizenship of GLP, a limited partnership, is 

determined by the citizenship of each partner of the entity. Carden v. Arkoma Assocs., 494 U.S. 

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185, 195-96 (1990). Upon information and belief, GLP’s partners are Galderma Limited, LLC 

and Galderma General, LLC, which are incorporated in Delaware and have a principal place of 

business at 14501 North Freeway, Fort Worth, Texas 76177. The citizenship of a limited liability 

company is also determined by the citizenship of each member of the entity. Harvey v. Grey Wolf 

Drilling Co., 542 F.3d 1077, 1079 (5th Cir. 2008). Upon information and belief, Galderma 

Services, Inc. is the sole member of both Galderma Limited, LLC and Galderma General, LLC. 

As a corporation, Galderma Services, Inc. is deemed to be a citizen in (a) every state where it is 

incorporated; and (b) the state where it has its principal place of business. 28 USC § 1332(c)(1). 

Galderma Services, Inc. is a corporation incorporated and registered to do business in Delaware 

with a principal place of business at 14501 North Freeway, Fort Worth, Texas 76177. 

Accordingly, for purposes of evaluating diversity of citizenship, Galderma Services, Inc., and by 

extension GLP, is a citizen of Delaware and Texas. 

7. The Court has supplemental jurisdiction over Ipsen’s other causes of action arising 

under state law pursuant to 28 U.S.C. § 1367 because the claims are so closely related to Ipsen’s 

claim under the Defend Trade Secrets Act as to form part of the same case or controversy.

8. This Court has personal jurisdiction over GLP because GLP is a partnership 

organized under Texas law, is registered to do business in the State of Texas and has appointed a 

registered agent for service of process in the State of Texas. Moreover, GLP maintains a place of 

business in the State of Texas and sells and distributes pharmaceutical, aesthetic, and/or 

dermatological products through the United States, including Texas and/or has engaged in 

systematic and continuous business contacts within the State of Texas. 

9. Venue is proper in the Northern District of Texas pursuant to 28 U.S.C. § 

1391(b)(1) because GLP resides in the Northern District of Texas. 

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FACTUAL ALLEGATIONS

A. Background 

10. Since 2007, Ipsen and GSA have been partners in the field of aesthetic and 

dermatology products. Over the course of their partnership, Ipsen and GSA have successfully 

developed and marketed two prescription drug products containing botulinum toxins worldwide 

and in Europe under the brand names Dysport® and Azzalure®, respectively. 

11. Biological products (or “biologics”) are a diverse category of products and are 

generally large, complex molecules that are often produced through biotechnology in a living 

system such as a microorganism, plant cell, or animal cell. 

12. Botulinum toxin is one of the most poisonous biological substances known. It is a 

neurotoxin produced by the bacterium Clostridium botulinum that exists in eight forms (A, B, C1, 

C2, D, E, F and G). The toxin causes the disease botulism. Botulinum toxin A is produced in 

sterile form for aesthetic and therapeutic uses.

13. Pursuant to their partnership, Ipsen and GSA have been working together to 

develop and, upon regulatory approval, manufacture and market a new liquid form of Botulinum 

toxin type A, known as QM-1114 (USAN: relabotulinumtoxinA). 

14. QM-1114 is delivered by injection into muscle tissue, with a proposed indication 

of temporarily improving the appearance of moderate to severe glabellar lines (located between 

the eyes and/or eyebrows) associated with corrugator and/or procerus muscle activity, and/or 

moderate to severe lateral canthal lines (LCL) associated with orbicularis oculi activity in adults 

18 years and older. 

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B. The QM Agreement 

15. On July 9, 2014, Ipsen and GSA entered into agreement for the purpose of 

developing, manufacturing, and/or selling QM-1114 (Botulinum Toxin Type A), in various 

jurisdictions, including the United States (“QM Agreement”). 

16. GLP is not a signatory to the QM Agreement. 

17. Under the QM Agreement, GSA assigned to Ipsen all intellectual property and 

proprietary information covering QM-1114, including all existing and future research, 

development, manufacturing, selling and promoting rights in the United States and certain other 

jurisdictions (“Licensed Territory”). 

18. Under the QM Agreement, GSA was appointed as Ipsen’s exclusive distributor and 

marketing partner for a certain field of use in the Licensed Territory. GSA was also tasked with 

preparing and submitting applications for the regulatory approval of QM-1114 on behalf and in 

the name of Ipsen. Under the QM Agreement, neither GSA, GLP, nor their affiliates are authorized 

to seek regulatory approval for the covered QM-1114 products on their own behalf or in their own 

names in the Licensed Territory including the United States. They can do so only with the express 

approval of Ipsen and only on behalf and in the name of Ipsen. 

19. The QM Agreement provides that Ipsen owns all regulatory approvals, 

submissions, and issued certificates, together with all data, information, files developed, gathered, 

and drafted by Galderma, which includes GSA and Defendant GLP. 

20. The proprietary information, data, and know-how concerning QM-1114 in the 

Licensed Territory, which have been assigned to Ipsen under the QM Agreement, are highly 

valuable to Ipsen. Indeed, Ipsen paid GSA 10 million Euros for the rights to the assigned 

intellectual property concerning QM-1114. 

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21. To protect Ipsen’s intellectual property rights concerning QM-1114, the QM 

Agreement provided that all information related to the agreement and the performance under it 

would be kept confidential by the parties, except in certain limited circumstances not at issue here. 

C. GLP’s Draft QM-114 Regulatory Application Contains Ipsen’s Trade Secrets 

22. To formally request approval to market a biologic drug like QM-1114 in the United 

States, an applicant or sponsor must submit a Biologics License Application (“BLA”) to the FDA. 

23. The purpose of a BLA is to submit documentation that demonstrates the safety and 

efficacy of the biologic for which a marketing application is being sought. In addition to safety 

and efficacy data, information regarding Chemistry, Manufacturing, and Control is also submitted. 

BLAs are submitted in a format known as the Common Technical Document (“CTD”). The CTD 

is a lengthy and multipart application organized into the following five modules.

 Module 1: Administrative Information; 

 Module 2: Summaries of Modules 3-5 (commonly known as the Expert Report)

 Module 3: Quality (containing Chemistry, Manufacturing, and Control data); 

 Module 4: Nonclincial Study Reports; and 

 Module 5: Clinical Study Reports.

24. These modules contain comprehensive information about the safety, purity, and 

potency of the biologic product ascertained during the development process. These modules 

include vast data including the Chemistry, Manufacturing, and Control information, as well as 

non-clinical pharmacology and toxicology studies, human pharmacokinetics and bioavailability 

studies, clinical data, and labeling information about the biologic substance and product. 

25. Once a BLA is approved by the FDA, the sponsor or applicant is granted a license 

for the biological product, which permits its introduction into interstate commerce. 

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26. In the course of the Ipsen-GSA partnership to develop, manufacture, and market 

QM-1114, Defendant GLP prepared a draft BLA for the QM-1114 product (the “QM-1114 BLA”), 

portions of which it transmitted to Ipsen for its review and approval. 

27. The draft QM-1114 BLA comprises thousands of pages of Ipsen’s proprietary 

information, data, and know-how about QM-1114, including, for example: 

 A description of the chemical structure, primary (sequence) and secondary and tertiary 

subunit structure, molecular weight, and molecular formula of QM-1114;

 Analytical testing and characterization performed, which may include, amino acid 

sequence analysis, high-performance liquid chromatography (“HPLC”), mass 

spectroscopy, detection of product related proteins, detection of host cell proteins and 

DNA, potency and structuring testing of QM-1114; 

 An identification of all raw materials and reagents used in the manufacture of QM1114; 

 Flow charts of the manufacturing process along with detailed descriptions of any raw 

material sources, cellular sources, equipment, batch records and results; 

 In-process controls, such as those used throughout fermentation, harvesting, and 

purification; 

 A description and documentation of the validation studies for the manufacturing 

process (cell growth expression, harvesting, purification, formulation, and sterilization 

processes); 

 Non-clinical pharmacology and toxicology studies and related data; and 

 Related clinical data. 

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28. Under the QM Agreement, the information, data, and know-how contained in the 

draft QM-1114 BLA belongs to Ipsen and are Ipsen’s trade secrets. 

29. Upon review of the draft QM-1114 BLA, Ipsen informed GLP and GSA that Ipsen 

disagreed and had concerns about certain testing methods supporting the proposed BLA 

submission, and the sufficiency of Chemistry, Manufacturing, and Controls sections of the BLA. 

30. In a series of communications between July 2, 2021 and July 16, 2021, Ipsen 

informed GSA and GLP that it would not authorize the submission of any regulatory applications 

concerning QM-1114 globally, including with the FDA, due to certain disagreements about the 

contents of the BLA and divergent views over the regulatory submission strategy. 

31. GLP cannot obtain approval for the draft QM-1114 BLA without using and 

incorporating Ipsen’s trade secrets. 

32. GSA initiated a request for arbitration before the International Chamber of 

Commerce against Ipsen raising allegations pertaining to the QM-1114 product (“ICC Arbitration 

Proceeding”). Arbitrators were appointed in the fourth quarter of 2021. 

33. Defendant GLP is not a party to the ICC Arbitration Proceeding. 

34. Ipsen intends to fully defend and vindicate its rights against GSA’s allegations 

before the ICC. 

35. To date, the ICC Arbitration Proceeding has not been resolved and is still pending. 

The arbitral tribunal in that proceeding is expected to render a final decision in or around 

September 2023. 

D. GLP Threatens Unauthorized Disclosure and Use of Ipsen’s Trade Secrets 

36. Despite Ipsen’s unambiguous express statements refusing to authorize GSA or GLP 

to submit the draft QM-1114 BLA containing Ipsen’s proprietary information and intellectual 

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property to the FDA, and the pendency of the ICC Arbitration, just last month GSA and GLP 

informed Ipsen that they nevertheless intend to submit the draft QLM-1114 BLA to the FDA in 

September 2022 in the name of GLP.

37. In an email dated July 4, 2022, GSA informed Ipsen of its intent to submit the QM1114 BLA to the FDA on our around mid-September 2022, followed by the relevant regulatory 

submissions in Canada, Australia, Europe, and other jurisdictions. 

38. GLP’s threatened submissions contain Ipsen’s proprietary information, data, and 

know-how concerning the QM-1114 product. If GLP proceeds with submission, Ipsen’s trade 

secrets will be disclosed to the FDA without Ipsen’s authorization. 

COUNT I

MISAPPROPRIATION OF TRADE SECRETS

IN VIOLATION OF THE DEFEND TRADE SECRETS ACT, 

18 U.S.C. § 1836(b) ET SEQ.

39. Ipsen re-alleges and incorporate Paragraphs 1 through 38 as if fully set forth herein. 

40. The proprietary information, data, and know-how contained in the draft QM-1114 

BLA, including information concerning the scientific research and development of the QM-1114 

biologic product, constitute Ipsen’s trade secrets under the Defend Trade Secrets Act, 18 U.S.C. 

§§ 1836(b) et seq. Over the course of preparing the QM-1114 BLA, GLP came into possession of 

Ipsen’s trade secrets. 

41. The aforementioned proprietary information is intended for use in seeking FDA 

approval of the QM-1114 BLA, which if approved, would be marketed in interstate commerce. 

42. This information derives independent economic value by not being accessible, 

through proper means, to competitors who can profit from its use or disclosure. The proprietary 

information, data, and know-how concerning the QM-1114 contained in the QM-1114 BLA is not 

readily available to the public. 

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43. Development of a novel biologic product like QM-1114 for approval in the United 

States is an extremely expensive and lengthy process. Ipsen has expended significant sums, both 

in financial and human resources, to support GSA and have the proprietary information protected, 

which is of great value to any competitor. 

44. Ipsen has taken reasonable measures under the circumstances to maintain the 

secrecy of this information. In particular, the QM Agreement was intended, among other things, 

to protect trade secrets from unauthorized use or disclosure to any third parties. It includes a clear 

confidentiality provision preventing GSA from disclosing to any third party the proprietary 

information, data, and know-how concerning QM-1114. 

45. GLP knew or had reason to know that Ipsen considered its proprietary information 

to be trade secrets. 

46. GLP knew or had reason to know that it had obtained Ipsen’s trade secrets under 

circumstances giving rise to an express duty to maintain the secrecy of the trade secrets and limit 

the use or disclosure of the trade secrets. 

47. GLP threatens to imminently misappropriate Ipsen’s trade secrets on or around 

September 2022 by seeking to file a BLA with the FDA, which contains Ipsen’s trade secrets, 

without Ipsen’s consent and notwithstanding Ipsen’s express withholding of authorization due to 

concerns over the content of the BLA. 

48. GLP’s conduct in this manner is both willful and malicious. 

49. GLP’s unauthorized disclosure of Ipsen’s trade secrets to the FDA through the QM1114 BLA submission will cause irreparable harm to Ipsen, including: the loss of Ipsen’s 

contractual right of control over the QM-1114 BLA, including the timing and scope of the BLA 

and other communications about it with the FDA; possible adverse decisions from the FDA 

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approval process arising from Ipsen’s inability to exercise its right of control over the submission 

process; the unauthorized use and disclosure of Ipsen’s proprietary information, data, and 

intellectual property for GLP’s and GSA’s benefit; and the potential of serious reputational harm 

and loss of goodwill arising from a possible backlash by the public, customers, and investors 

against any appearance of a violation of Ipsen’s well-publicized policies and practices.

50. GLP’s threatened unauthorized disclosure and use of Ipsen’s trade secrets warrant 

injunctive relief and may further entitle Ipsen to compensatory damages.

COUNT II

MISAPPROPRIATION OF TRADE SECRETS

IN VIOLATION OF TEX. CIV. PRAC. & REM. CODE, CH. 134A

51. Ipsen re-alleges and incorporate Paragraphs 1 through 50 as if fully set forth herein. 

52. The proprietary information, data, and know-how contained in the draft QM-1114 

BLA, including information concerning the scientific research and development of the QM-1114 

biologic product, constitute Ipsen’s trade secrets under the Texas Uniform Trade Secrets Act 

(“TUTSA”), Tex. Civ. Prac. & Rem. Code, § 134A. Over the course of preparing the QM-1114 

BLA, GLP came into possession of Ipsen’s trade secrets. 

53. This information derives independent economic value by not being accessible, 

through proper means, to competitors who can profit from its use or disclosure. The proprietary 

information, data, and know-how concerning the QM-1114 contained in the QM-1114 BLA is not 

readily available to the public. 

54. Development of a novel biologic product like QM-1114 for approval in the United 

States is an extremely expensive and lengthy process. Ipsen has expended significant sums, both 

in financial and human resources, to support GSA and have the proprietary information protected, 

which is of great value to any competitor. 

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55. Ipsen has taken reasonable measures under the circumstances to maintain the 

secrecy of this information. In particular, the QM Agreement was intended, among other things, 

to protect trade secrets from unauthorized use or disclosure to any third parties. It includes a clear 

confidentiality provision preventing GSA from disclosing to any third party the proprietary 

information, data, and know-how concerning QM-1114. 

56. GLP knew or had reason to know that Ipsen considered its proprietary information 

to be trade secrets. 

57. GLP knew or had reason to know that it had obtained Ipsen’s trade secrets under 

circumstances giving rise to an express duty to maintain the secrecy of the trade secrets and limit 

the use or disclosure of the trade secrets. 

58. GLP threatens to imminently misappropriate Ipsen’s trade secrets on or around 

September 2022 by seeking to file a BLA with the FDA, which contains Ipsen’s trade secrets, 

without Ipsen’s consent and notwithstanding Ipsen’s express withholding of authorization due to 

concerns over the content of the BLA. 

59. GLP’s conduct in this manner is both willful and malicious. 

60. GLP’s unauthorized disclosure of Ipsen’s trade secrets to the FDA through the QM1114 BLA submission will cause irreparable harm to Ipsen, including: the loss of Ipsen’s 

contractual right of control over the QM-1114 BLA, including the timing and scope of the BLA 

and other communications about it with the FDA; possible adverse decisions from the FDA 

approval process arising from Ipsen’s inability to exercise its right of control over the submission 

process; the unauthorized use and disclosure of Ipsen’s proprietary information, data, and 

intellectual property for GLP’s and GSA’s benefit; and the potential of serious reputational harm 

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and loss of goodwill arising from a possible backlash by the public, customers, and investors 

against any appearance of a violation of Ipsen’s well-publicized policies and practices.

61. GLP’s threatened unauthorized disclosure and use of Ipsen’s trade secrets warrant 

injunctive relief under Tex. Civ. Prac. & Rem. Code § 134A.003. On information and belief, 

GLP’s actions may further entitle Ipsen to compensatory damages under § 134A.004(a).

PRAYER FOR RELIEF 

WHEREFORE, based on the allegations set forth above and/or additional facts that will be 

revealed through discovery, Ipsen requests judgment against GLP and the following relief: 

a. a temporary restraining order, preliminary injunction, and/or permanent injunction 

preventing GLP from seeking FDA approval of the QM-1114 product pending the 

outcome of the ICC Arbitration Proceeding;

b. a temporary restraining order, preliminary injunction, and/or permanent injunction 

preventing GLP from participating or aiding in obtaining approval of the QM-1114 

product outside of the United States in countries for which Ipsen possesses the 

corresponding contractual rights pending the outcome of the ICC Arbitration Proceeding;

c. a temporary restraining order, preliminary injunction, and/or permanent injunction 

preventing GLP from participating or aiding in the authorized use or disclosure of any 

Ipsen trade secrets or proprietary information; 

d. an award of interest, costs, fees and other expenses associated with this action, including 

reasonable attorneys’ fees; and 

e. such further and other legal or equitable relief as this Court deems just and proper. 

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Dated: August 2, 2022 

Of Counsel (pro hac vice forthcoming): 

Katherine A. Helm 

DECHERTLLP 

Three Bryant Park 

1095 A venue of the Americas 

New York, NY 10036-6797 

(212) 698-3500 

khelm@dechert.com 

Jeffrey S. Edwards 

DECHERTLLP 

Cira Centre 

2929 Arch Street 

Philadelphia, PA 

(215) 994-2000 

j effrey.edwards@dechert.com 

Pejmon Pashai 

DECHERTLLP 

1900 K Street, NW 

Washington, D.C. 20006 

(202) 261-3300 

pejmon.pashai@dechert.com 

Respectfully submitted, 

By: J ,-~Jj ~ Chad Arnette 

Texas Bar No. 24014751 

Scott Wiehle 

Texas Bar No. 24043991 

KELLY HART & HALLMAN LLP 

201 Main Street, Suite 2500 

Fort Worth, TX 76102 

Tel.: (817) 332-2500 

Fax.: (817) 878-9280 

chad.arnette@kellyhart.com 

scott. wiehle@kellyhart.com 

ATTORNEYS FOR PLAINTIFF 

IPSEN BIO PHARMA LTD. 

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