Last updated: March 13, 2026
What is the procedural background of the case?
PACIRA Pharmaceuticals, Inc. filed a patent infringement lawsuit against Evenus Pharmaceuticals Laboratories Inc. in the District of New Jersey (Case No. 2:22-cv-00718). The complaint alleges that Evenus infringed multiple patents held by PACIRA related to formulations and methods of administration involving bupivacaine, a local anesthetic agent.
The complaint was filed on March 15, 2022. PACIRA seeks injunctive relief, damages for patent infringement, and reimbursement of legal expenses. Evenus has responded, denying infringement and challenging the validity of the patents.
What patents are involved?
PACIRA asserts three patents: U.S. Patent Nos. 9,838,132; 10,489,424; and 10,915,378. These patents cover administration techniques and compositions that enable sustained-release delivery of bupivacaine. The patents include claims related to biodegradable microspheres, specific drug-release profiles, and methods of administration to reduce post-surgical pain.
Key claims include:
- A method of delivering sustained-release bupivacaine via biodegradable microspheres.
- A composition of bupivacaine with specific polymer matrices.
- A process for preparing the microspheres with controlled drug-release characteristics.
What are the core allegations?
PACIRA alleges that Evenus:
- Manufactures and distributes products that infringe on the patents.
- Has engaged in the sale or marketing of infringing products since at least January 2022.
- Has directly infringed and induced infringement of the patents.
PACIRA claims that these actions violate 35 U.S.C. §§ 271 and 283, seeking monetary damages and injunctive relief.
What defenses has Evenus raised?
Evenus contests the validity of the patents, arguing that:
- The patents are invalid due to anticipation and obviousness.
- The claims are indefinite.
- The involved technology was disclosed publicly before the filing date, defeating novelty.
- The patents do not meet the requirements of patentable subject matter.
Evenus also disputes that its products infringe the patent claims, asserting that their formulations differ significantly from the patented technology.
What is the current procedural stage?
The case remains in early stages. PACIRA has not filed a motion for preliminary injunction. Discovery has commenced, with initial disclosures exchanged in August 2022. The parties scheduled depositions for late 2022 and plan to submit a joint claim construction statement.
No trial date has been set. Both parties are engaged in settlement negotiations, but proceedings continue with ongoing motions.
What are the key legal issues?
- Patent validity: Whether the patents are anticipated or obvious over prior art references.
- Patent infringement: Whether Evenus’ products infringe the claims of the asserted patents.
- Damages and remedies: Quantification of damages if infringement is proven.
- Patent scope: Interpretation of claim language during claim construction.
What implications does the case have for the pharmaceutical industry?
This litigation underscores the importance of patent defensibility in drug delivery technology. The case may influence:
- Patent drafting practices to strengthen claims' enforceability.
- Strategies for challenging patent validity through prior art.
- The risk profile for companies developing similar sustained-release formulations.
- Enforcement tactics against alleged infringers based on detailed product comparisons.
Industry participants should monitor developments, as outcomes could impact licensing and product development strategies.
What can be expected moving forward?
- Early case management conferences likely within the next 60 days.
- A potential dispute over claim construction, possibly resolved through a Markman hearing.
- Motion practice on validity and infringement issues throughout 2023.
- Discovery focusing on prior art references and technical comparisons.
- Possible settlement discussions, though litigation appears active.
Given the complexity and patent scope, a resolution could be multi-year unless early settlement occurs.
Key Takeaways
- PACIRA alleges patent infringement regarding bupivacaine delivery technologies.
- The patents involve biodegradable microspheres and controlled-release methods.
- Evenus disputes infringement and validity, intensifying patent validity challenges.
- The case highlights the strategic importance of patent prosecution and enforcement in drug delivery innovations.
- Outcomes could influence industry standards and patent defense tactics.
FAQs
What patents are involved in this case?
U.S. Patent Nos. 9,838,132; 10,489,424; and 10,915,378, covering sustained-release bupivacaine delivery systems.
When was the lawsuit filed?
March 15, 2022.
What are the main defenses?
Claims of invalidity based on anticipation, obviousness, and indefiniteness; and non-infringement due to product differences.
What is the case’s current status?
Early-stage, with discovery ongoing and no trial date set.
What are the potential industry impacts?
Clarifies boundaries of patent scope in controlled-release formulations and underscores importance of patent validity defenses.
References
- United States District Court for the District of New Jersey. (2022). PACIRA Pharmaceuticals, Inc. v. Evenus Pharmaceuticals Laboratories Inc. (Case No. 2:22-cv-00718).
- U.S. Patent and Trademark Office. (2023). Patent No. 9,838,132; Patent No. 10,489,424; Patent No. 10,915,378.
- Federal Trade Commission. (2020). Patent Enforcement and Drug Innovation: Policy Considerations.
