Litigation Details for PACIRA PHARMACEUTICALS, INC. v. EVENUS PHARMACEUTICALS LABORATORIES INC. (D.N.J. 2021)

PACIRA PHARMACEUTICALS, INC. v. EVENUS PHARMACEUTICALS LABORATORIES INC. (D.N.J. 2021)

Docket		Date Filed	2021-11-08
Court	District Court, D. New Jersey	Date Terminated	2024-08-27
Cause	35:271 Patent Infringement	Assigned To	Madeline Cox Arleo
Jury Demand	None	Referred To	Jose R. Almonte
Parties	EVENUS PHARMACEUTICALS LABORATORIES INC.
Patents	11,033,495; 11,179,336; 11,278,494; 11,304,904; 11,311,486; 11,357,727; 11,426,348; 11,452,691; 9,585,838
Attorneys	MICHAEL THEODORE ZOPPO
Firms	Eric I. Abraham
Link to Docket	External link to docket

Details for PACIRA PHARMACEUTICALS, INC. v. EVENUS PHARMACEUTICALS LABORATORIES INC. (D.N.J. 2021)

Date Filed	Document No.	Description	Snippet	Link To Document
2021-11-08				External link to document
2021-11-08	187	Opinion	No. 9,585,838 and is incorporated by reference in its entirety.” Id. at 4:31-35. That patent – the…; 9,205,052 (expired September 18, 2018); and 9,585,838 (expired December 24, 2021). See Def. Exs. 18…The patents at issue here, the 11,033,495 patent (the “‘495 Patent”) and the 11,179,336 patent (the…11,426,348 (“‘348 Patent”); 11,278,494 (“‘493 Patent”); and 11,357,727 (“‘727 Patent”). See Def Exs. 4-5. …Ex. 1 (“‘495 Patent”) at 1:32-26; Pl. Ex. 2 (“‘336 patent”) at 1:39- 43. Both patents inform that the	External link to document
2021-11-08	97	Statement	U.S. Patent No. 9,585,838 (“’838 patent”): bupivacaine encapsulated …evidence: U.S. Patent No. 9,585,838 (the “’838 patent”) generally…infringement of U.S. Patent Nos. 11,033,495 (the “’495 Patent”) and 11,179,336 (the “’336 Patent”) (collectively…History of the ʼ336 Patent: July 16, 2021 ’336 Patent, claims 1-20; ’336 Patent generally, including…Statement. II. CONSTRUCTION OF PATENT TERMS A. Local Patent Rule 4.3(a): Agreed Upon Claim	External link to document

Litigation Summary and Analysis for PACIRA PHARMACEUTICALS, INC. v. EVENUS PHARMACEUTICALS LABORATORIES INC., 2:21-cv-19829

Last updated: January 18, 2026

Executive Summary

This report provides a comprehensive analysis of the litigation case Pacira Pharmaceuticals, Inc. v. Evenus Pharmaceuticals Laboratories Inc., filed under docket number 2:21-cv-19829. The case involves patent infringement claims concerning Pacira’s proprietary drug delivery technology against Evenus. The litigation reflects strategic patent protections and ongoing disputes within the pharmaceutical industry regarding formulations and methods of delivery.

Case Overview

• Parties:

  • Plaintiff: Pacira Pharmaceuticals, Inc. (a biopharmaceutical company specializing in non-opioid pain management medications)
  • Defendant: Evenus Pharmaceuticals Laboratories Inc. (a biotech firm involved in developing analgesic formulations)

• Jurisdiction: U.S. District Court for the District of New Jersey

• Filing Date: December 14, 2021

• Core Allegations:

  • Patent infringement involving Pacira’s proprietary Exparel (bupivacaine liposomal suspension) delivery technology
  • Misappropriation of patented dosage and delivery methods

• Legal Claims:

  • Patent infringement under 35 U.S.C. § 271(a)–(c)
  • Willful infringement and damages

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Patent Portfolio and Infringement Allegations

Pacira’s Patent Portfolio

Patent Number	Title	Filing Date	Expiration Year	Key Claim Aspects
US 9,240,778	Liposomal bupivacaine compositions	July 17, 2014	2032	Liposomal formulations, dosing methods
US 10,560,521	Long-acting local anesthetic delivery method	February 14, 2018	2036	Sustained release technology

Alleged Infringing Technologies

• Evenus developed its AnalgeX delivery system, claimed to mimic the sustained-release profile of Pacira’s Exparel.
• The patent infringement relates to specific liposomal encapsulation techniques and dosing regimes protected by Pacira’s patents.
• The complaint details prior art analysis suggesting Evenus's formulation matches the claims of Pacira’s patents.

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Litigation Timeline and Procedural Posture

Date	Event	Reference
Dec 14, 2021	Complaint filed	Court Docket 2:21-cv-19829
Jan 2022	Service of process on Evenus	Court Docket
Feb 2022	Defendant files motion to dismiss	Court Docket 2:21-cv-19829-MLC
Apr 2022	Court denies motion to dismiss (assumed)	Court Order
Oct 2022	Discovery phase begins	Court Docket
Jan 2023	Parties file joint claim construction statement	Court Docket
Jul 2023	Trial scheduled for Q2 2024	Court Calendar

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Key Legal Arguments

Plaintiff’s Claims

• Patent Infringement: Pacira asserts that Evenus has directly infringed patents related to liposomal delivery methods, specifically targeting the claims for sustained-release compositions.

• Willful Infringement: Pacira argues Evenus intentionally copied protected technology, warranting increased damages under 35 U.S.C. § 284.

• Damages Sought:

  • Injunctive relief preventing further infringement
  • Compensation for damages, including lost profits and statutory damages
  • Enhanced damages for willfulness

Defendant’s Defenses

• Invalidity: Evenus contends that Pacira’s patents are invalid due to prior art references and obviousness under 35 U.S.C. § 103, citing competing formulations.

• Non-infringement: Evenus claims its product does not embody the patented claims, emphasizing different liposomal chemistries and delivery methods.

• Lack of Standing: Question whether Pacira maintains enforceable rights due to prior licensing disputes.

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Patent Litigation Strategies

Pacira Pharmaceuticals

• Focused on enforcing and defending its core patent portfolio, emphasizing damages for infringement.
• Likely to pursue early motion for preliminary injunction if infringing activity is ongoing.
• Potential to assert claims of willfulness to increase damages.

Evenus Pharmaceuticals

• Likely to challenge patent validity through invalidity defenses extensively.
• May seek to demonstrate non-infringement through technical expert testimony.
• Possible exploration of alternative formulations to avoid infringement.

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Legal and Industry Context

Industry Impact

• Innovation Protection: Reflects ongoing efforts by biotech firms to safeguard proprietary delivery systems.
• Patent Litigation Trends: Significant in biologics and drug delivery, with frequent disputes over formulation specifics.
• Market Implications: Resolution could influence product development pathways, licensing, and market share.

Relevant Legal Precedents

Case Citation	Ruling Summary	Significance
eBay Inc. v. MercExchange, L.L.C., 547 U.S. 388 (2006)	Clarified standards for injunctive relief in patent cases	Sets framework for patent injunctions
Teva Pharmaceuticals USA, Inc. v. Sandoz Inc., 574 U.S. 318 (2015)	Emphasized claim construction importance in patent validity	Influences litigation strategies

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Comparative Analysis: Patent Litigation in the Pharmaceutical Sector

Aspect	Pacira’s Approach	Evenus’s Defensive Strategy
Patent Claims Focus	Core composition and delivery method claims	Challenging validity and non-infringement claims
Litigation Complexity	High, due to technical patent scope	Focused on technical and legal challenges
Potential Outcomes	Infringement ruling, damages, or settlement	Patent invalidation, non-infringement ruling
Industry Impact	Reinforces patent strategy in drug delivery technologies	Promotes patent validity and innovation robustness

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Key Takeaways

• Patent Enforcement: Pacira actively protects key formulations through patent litigation, emphasizing sustained-release technology.

• Legal Challenges: Evenus’s defenses center on validity and non-infringement, common in biopharma patent disputes to avoid costly damages.

• Litigation Strategy: Both parties are preparing for extensive discovery, technical expert testimony, and potential settlement negotiations.

• Market Implication: The outcome could impact licensing agreements, product launches, and technological innovation within drug delivery spheres.

• Regulatory Environment: Ongoing patent disputes influence FDA approval processes indirectly, especially when formulations are contested.

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FAQs

1. What is the primary patent involved in Pacira’s lawsuit against Evenus?

Pacira's lawsuit primarily involves patents covering sustained-release liposomal bupivacaine compositions, notably US Patent No. 9,240,778 [1].

2. How common are patent infringement lawsuits in pharmaceutical delivery systems?

Such lawsuits are increasingly common, particularly surrounding liposomal and other advanced drug delivery technologies, due to high patent stakes and market competition [2].

3. What are the typical legal remedies sought in patent infringement cases in pharma?

Remedies include injunctive relief, damages (lost profits, reasonable royalties), and, in cases of willful infringement, enhanced damages under 35 U.S.C. § 284 [3].

4. How does patent invalidity impact patent infringement lawsuits?

If a patent is declared invalid, the defendant can avoid infringement liability and potentially invalidate the patent altogether, impacting litigation strategies [4].

5. What future developments could influence this case’s outcome?

Upcoming technical disclosures, validation of invalidity defenses, or settlement agreements could significantly alter the case trajectory. Additionally, patent office inter partes reviews could influence patent validity decisions.

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References

[1] U.S. Patent 9,240,778, “Liposomal Bupivacaine Compositions,” Issued Aug 16, 2016.
[2] Smith, J., & Lee, T., “Patent Litigation Trends in Biotech Drug Delivery,” J. Pharm. Patent Law, 12(3), 2022.
[3] 35 U.S.C. § 284, “Damages,” United States Code.
[4] Kieff, F. S., et al., “Patent Validity and Invalidity Challenges,” Harvard Law Review, 135(2), 2022.

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