DCT
2:24-cv-11014
eVenus Pharmaceutical Laboratories Inc v. Pacira Pharma Inc
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: eVenus Pharmaceutical Laboratories, Inc. (New Jersey) and Jiangsu Hengrui Pharmaceuticals Co., Ltd. (China)
- Defendant: Pacira Pharmaceuticals, Inc. (California) and Pacira Biosciences, Inc. (Delaware)
- Plaintiff’s Counsel: Hill Wallack LLP
- Case Identification: 2:24-cv-11014, D.N.J., 12/10/2024
- Venue Allegations: Plaintiffs allege venue is proper in the District of New Jersey because Defendants have a regular and established place of business in the district and have previously filed five related patent lawsuits there against Plaintiffs.
- Core Dispute: Plaintiffs seek a declaratory judgment that their generic bupivacaine liposome injectable suspension does not infringe, and that Defendants' recently-issued patent covering batches of the drug is invalid.
- Technical Context: The technology involves commercial-scale manufacturing of multivesicular liposomes (MVLs) for the extended-release local anesthetic bupivacaine, a non-opioid pain management drug.
- Key Procedural History: This declaratory judgment action is part of a broader, multi-year litigation between the parties over a generic version of Defendants' drug, EXPAREL®. The complaint notes five prior lawsuits filed by Pacira in this district, one of which resulted in a finding that a related patent was invalid. This suit was filed seven days after the patent-in-suit issued, and on the same day the patent issued, Pacira sued one of the Plaintiffs in the Northern District of Illinois. This action appears calculated to consolidate the dispute in the District of New Jersey, where the prior litigation has occurred. The patent’s priority date of May 20, 2024, post-dates Plaintiffs' 2021 ANDA filing and the 2012 launch of Defendants' own EXPAREL® product, a fact central to Plaintiffs' invalidity contentions.
Case Timeline
| Date | Event |
|---|---|
| 2021-08-20 | Plaintiff Jiangsu Hengrui submits its ANDA to the FDA |
| 2024-02-XX | D.N.J. holds trial finding related '495 Patent invalid |
| 2024-05-20 | '940 Patent Priority Date (Provisional Application) |
| 2024-07-02 | '940 Patent Application Filing Date |
| 2024-07-XX | FDA grants final approval for Plaintiffs' ANDA Products |
| 2024-12-03 | '940 Patent issues |
| 2024-12-03 | Pacira files suit against Jiangsu Hengrui in N.D. Illinois |
| 2024-12-10 | Complaint for Declaratory Judgment filed in D.N.J. |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 12,156,940 - "Manufacturing of Bupivacaine Multivesicular Liposomes"
- Issued: December 3, 2024
The Invention Explained
- Problem Addressed: The patent background identifies an "urgent need for new and improved commercial scale productions of Exparel® to meet the substantial and growing market demand" ('940 Patent, col. 1:37-42). The problem is not creating a new drug, but rather developing a reliable, large-scale manufacturing process for an existing one.
- The Patented Solution: The invention is not a new composition or a new manufacturing method in isolation, but rather the output of an improved process: batches of bupivacaine multivesicular liposomes (MVLs) that exhibit specific, consistent, and stable characteristics ('940 Patent, Abstract). The patent claims are directed to plural "batches" of the drug product, defined by parameters such as the batch volume, the drug concentration, and, critically, the stability of the drug's in vitro release rate when stored for up to 12 months ('940 Patent, col. 51:24-52:12).
- Technical Importance: The claimed invention addresses the challenge of manufacturing consistency and stability for complex drug delivery systems like MVLs, which is crucial for ensuring product quality, obtaining regulatory approval, and meeting market demand for non-opioid analgesics ('940 Patent, col. 1:33-37).
Key Claims at a Glance
- The complaint seeks a declaratory judgment of non-infringement and invalidity as to all claims of the '940 Patent (Compl. ¶¶ 34, 41). Independent claims 1 and 19 are asserted.
- Independent Claim 1 recites:
- Batches comprising compositions of bupivacaine encapsulated multivesicular liposomes (MVLs).
- The batches are manufactured within a six-month period and have a volume of about 100 to 300 liters.
- Each batch has a cumulative bupivacaine release of 46% to 71% at a 24-hour time point.
- The batches exhibit an "average rate of change" in that 24-hour release of 0.05%/month to 0.5%/month after 12 months of storage.
III. The Accused Instrumentality
Product Identification
- Plaintiffs’ "ANDA Products," which are a bupivacaine liposome injectable suspension in 266 mg/20 mL and 133 mg/10 mL formulations (Compl. ¶1).
Functionality and Market Context
- The products are generic versions of Defendants' EXPAREL® product, intended for post-surgical local analgesia (Compl. ¶1). The complaint states that the U.S. Food & Drug Administration granted final approval for the ANDA Products in July 2024, positioning them for commercial launch as direct competitors to EXPAREL® (Compl. ¶1). The non-infringement defense is predicated on the assertion that these ANDA products, when manufactured, do not meet the specific quantitative limitations recited in the claims of the '940 Patent (Compl. ¶35).
IV. Analysis of Infringement Allegations
This is a declaratory judgment action for non-infringement. The table summarizes Plaintiffs' allegations of how their products fail to meet the claim limitations.
No probative visual evidence provided in complaint.
'940 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged (Non-)Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| wherein the batches are manufactured within a period of six months, and each of the batches has a volume of about 100 liters to about 300 liters | Plaintiffs allege that "batches of the ANDA Products do not have 'a volume of about 100 liters to about 300 liters,' as recited in each claim of the '940 Patent." | ¶35 | col. 51:39-41 |
| wherein an average rate of change in the cumulative percentage release of bupivacaine of the batches at the 24-hour time point is 0.05%/month to 0.5%/month after storage of the aliquots of each batch at 2° C. to 8° C. for about 12 months | Plaintiffs allege that batches of their ANDA Products "do not have 'an average rate of change...is 0.05%/month to 0.5%/month after storage...for about 12 months,' as recited in each claim..." | ¶35 | col. 51:50-55 |
- Identified Points of Contention:
- Factual Questions: The core of the non-infringement case appears to be a factual dispute over testing data. The case will likely involve extensive discovery and expert testimony concerning the actual batch volumes and measured stability profiles of Plaintiffs' ANDA Products to determine if they fall within the claimed numerical ranges.
- Scope Questions: The claims are directed to "batches" (plural) exhibiting an "average rate of change." A likely point of contention will be how many manufacturing runs are required to constitute "batches" and the precise statistical method required to calculate the "average rate of change" across them, as these terms are not explicitly defined in the claims.
V. Key Claim Terms for Construction
The Term: "batches"
Context and Importance: This plural term appears in the preamble and throughout the independent claims, suggesting the invention is not a single composition but a series of production runs meeting certain criteria. The definition of "batches" is critical because it dictates the amount and type of evidence required for the infringement analysis—for instance, whether data from two, ten, or one hundred manufacturing lots is needed to assess infringement.
Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The specification consistently refers to manufacturing a "plurality of batches" ('940 Patent, col. 4:3) and provides extensive data across many batches (e.g., FIGS. 5A-7), suggesting the term should be understood in its ordinary sense in pharmaceutical manufacturing to mean multiple, distinct production runs.
- Evidence for a Narrower Interpretation: The patent does not provide a specific numerical definition for "batches." Dependent claims and specification text refer to calculations based on "two to five batches" ('940 Patent, col. 3:25-27), which could be used to argue that the term requires a specific but small number of lots.
The Term: "average rate of change"
Context and Importance: This term defines the stability of the product, a key limitation distinguishing it from the prior art. The precise mathematical method for calculating this rate across multiple "batches" will be central to determining infringement. Practitioners may focus on this term because its potential ambiguity could be a basis for both non-infringement and invalidity (indefiniteness) arguments.
Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The specification includes graphs with trend lines (e.g., FIG. 3A) that are described as showing the "average rate of change," which may be argued to implicitly define the calculation method as a linear regression or similar statistical analysis of stability data over time ('940 Patent, col. 8:20-25).
- Evidence for a Narrower Interpretation: The claims do not specify the statistical model to be used (e.g., linear vs. non-linear regression, method of averaging across batches). A party could argue that without such specificity, a person of ordinary skill in the art would not know how to determine whether a set of batches meets the limitation, rendering the claim indefinite.
VI. Other Allegations
- Indirect Infringement: Plaintiffs seek a declaration of non-infringement of 35 U.S.C. §§ 271(b) and (c) on the grounds that because their ANDA Products do not directly infringe any valid claim, they cannot be liable for inducing or contributing to infringement (Compl. ¶¶ 36, 37).
- Exceptional Case: While not alleging willfulness, Plaintiffs request that the case be declared "exceptional" under 35 U.S.C. § 285 to recover attorneys' fees, citing what they characterize as Defendants' "prolonged campaign of patent harassment" and "forum shopping" (Compl. ¶¶ 1, 5; Prayer for Relief D).
VII. Analyst’s Conclusion: Key Questions for the Case
- A central question for the court will be one of validity: does the '940 Patent's May 20, 2024 priority date post-date public sales or uses of Defendants' own EXPAREL® product, which Plaintiffs allege embody the claimed invention? If so, this could render the claims invalid under the on-sale bar of 35 U.S.C. § 102.
- A key evidentiary question will be one of factual compliance: do Plaintiffs' generic ANDA Products, when manufactured in "batches," actually meet the specific quantitative limitations for volume and stability (i.e., "average rate of change") as defined in the asserted claims?
- A foundational issue for the infringement analysis will be one of claim construction: how should the court define the term "batches" and what is the proper methodology for calculating the "average rate of change" across those batches as required by the claims?