Jazz Pharma Inc v. Almaject Inc

I. Executive Summary and Procedural Information

• Parties & Counsel:
  • Plaintiff: Jazz Pharmaceuticals, Inc. (Delaware) and Gentium S.r.l. (Italy)
  • Defendant: Almaject, Inc. (Delaware); Alvogen, Inc. (Delaware); Alvogen PB Research and Development LLC (Delaware)
  • Plaintiff's Counsel: Saul Ewing LLP
• Case Identification: 2:26-cv-02629, D.N.J., 07/02/2026
• Venue Allegations: Venue is alleged to be proper in the District of New Jersey based on Defendants' regular and established physical places of business within the district, their extensive and systematic contacts with the state, and because the district is a likely destination for the accused generic drug product.
• Core Dispute: Plaintiff alleges that Defendants' submission of an Abbreviated New Drug Application (ANDA) for a generic version of Plaintiff's Defitelio® drug product constitutes infringement of two patents covering defibrotide formulations and methods for determining their biological activity.
• Technical Context: The dispute is in the pharmaceutical field and concerns defibrotide, a drug used to treat hepatic veno-occlusive disease (VOD), a serious complication that can occur after stem-cell transplantation.
• Key Procedural History: The action was initiated in response to Defendants' submission of ANDA No. 216293 and a subsequent Paragraph IV Certification letter alleging the patents-in-suit are invalid or not infringed. This First Amended Complaint was filed to include corrected claims for one of the patents-in-suit. One patent, the '052 patent, was subject to a certificate of correction to add previously omitted claims.

Case Timeline

Date	Event
2012-06-22	Earliest Priority Date for '052 and '722 Patents
2026-01-20	'052 Patent Issued
2026-01-27	'722 Patent Issued
2026-03-04	Almaject Sent Paragraph IV Notice Letter (no earlier than)
2026-06-30	'052 Patent Certificate of Correction Issued
2026-07-02	First Amended Complaint Filed

II. Technology and Patent(s)-in-Suit Analysis

U.S. Patent No. 12,529,052 - Euglobulin-based Method for Determining the Biological Activity of Defibrotide

• Patent Identification: U.S. Patent No. 12,529,052, "Euglobulin-based Method for Determining the Biological Activity of Defibrotide," issued January 20, 2026 (the '052 Patent).

The Invention Explained

• Problem Addressed: The patent's background describes the challenge of ensuring batch-to-batch consistency for defibrotide, a therapeutic substance derived from natural sources '052 Patent, col. 1:46-54 It notes that standard physico-chemical tests cannot adequately measure biological activity, and prior biological assays lacked the necessary reproducibility and precision for a therapeutic product '052 Patent, col. 2:6-23
• The Patented Solution: The patent discloses a method to reliably measure the biological activity of defibrotide. This is achieved by combining defibrotide with mammalian euglobulin, which contains plasminogen '052 Patent, abstract The defibrotide acts as a catalyst, converting plasminogen to plasmin. This plasmin then reacts with a specific substrate, releasing a measurable product (e.g., a colored compound) '052 Patent, col. 3:33-42 The rate at which this product is formed is proportional to the defibrotide's biological activity, allowing for standardization '052 Patent, col. 2:52-64 The patent claims liquid formulations of defibrotide that possess a specific biological activity as determined by this method '052 Patent, col. 12:21-41 Figure 1 of the patent illustrates the kinetic reaction, showing increased absorbance over time as the measurable product is formed, with the rate depending on the defibrotide concentration '052 Patent, fig. 1
• Technical Importance: The invention provides a validated and reproducible quality control method, critical for ensuring the safety and efficacy of a naturally derived drug by standardizing its biological potency across different manufacturing batches '052 Patent, col. 2:52-59

Key Claims at a Glance

• The complaint asserts at least independent claim 1 Compl. ¶38
• The essential elements of independent claim 1 are:
  • A defibrotide formulation consisting of defibrotide, sodium citrate, a pH adjusting agent, and water for injection;
  • having a potency of 25 to 35 IU/mg;
  • and a concentration of at least 80 mg/mL;
  • wherein the defibrotide potency is determined by a method comprising bringing defibrotide into contact with a biological composition comprising plasminogen and a specific substrate for plasmin, and measuring the resulting product to determine potency '052 Patent, col. 12:21-41
• The complaint notes that a certificate of correction added claims 11-16, which are also asserted Compl. ¶9 The complaint does not explicitly reserve the right to assert other claims but infringement is alleged for "one or more claims" Compl. ¶38

U.S. Patent No. 12,534,722 - Euglobulin-based Method for Determining the Biological Activity of Defibrotide

• Patent Identification: U.S. Patent No. 12,534,722, "Euglobulin-based Method for Determining the Biological Activity of Defibrotide," issued January 27, 2026 (the '722 Patent).

The Invention Explained

• Problem Addressed: The '722 Patent addresses the same problem as the '052 Patent: the inherent batch-to-batch variability of naturally extracted biological substances like defibrotide and the inadequacy of prior methods to provide a precise and reproducible measure of biological activity '722 Patent, col. 1:49-57 '722 Patent, col. 2:10-27
• The Patented Solution: The solution is identical to that of the '052 Patent. It describes an indirect enzymatic assay where defibrotide's activity is quantified by its ability to catalyze the conversion of plasminogen to plasmin within a mammalian euglobulin fraction '722 Patent, abstract '722 Patent, col. 3:33-46 The patent claims formulations of defibrotide defined by a specific potency range as measured by this method '722 Patent, col. 12:12-32
• Technical Importance: The invention provides a reliable method to standardize a complex biological drug, which is essential for its use as a regulated pharmaceutical product '722 Patent, col. 2:56-63

Key Claims at a Glance

• The complaint asserts at least independent claim 1 Compl. ¶48
• The essential elements of independent claim 1 are:
  • A defibrotide formulation comprising defibrotide, sodium citrate, and water for injection;
  • having a potency of 25 to 35 IU/mg;
  • and a concentration of at least 80 mg/mL;
  • wherein the defibrotide potency is determined by a method comprising bringing defibrotide into contact with a biological composition comprising plasminogen and a specific substrate for plasmin, and measuring the resulting product to determine potency '722 Patent, col. 12:12-32
• The complaint alleges infringement of "one or more claims" but focuses its allegations on claim 1 Compl. ¶48

III. The Accused Instrumentality

Product Identification

• The accused instrumentality is "Almaject's Proposed Product," a generic version of Defitelio® identified as "defibrotide sodium vials, 250 mg/2.5 mL" Compl. ¶33 This product is the subject of ANDA No. 216293 submitted to the FDA Compl. ¶1

Functionality and Market Context

• The accused product is intended to be a generic equivalent to Plaintiff's FDA-approved drug, Defitelio®, which is used for the treatment of hepatic veno-occlusive disease (VOD) Compl. ¶11 Compl. ¶33
• The complaint alleges the product is a defibrotide formulation that, upon information and belief, will be manufactured, used, sold, or imported by the Defendants upon FDA approval Compl. ¶34
• The alleged concentration of the product is 100 mg/mL (250 mg in 2.5 mL), which meets the "at least 80 mg/mL" limitation of the asserted claims Compl. ¶33 The complaint does not provide further detail on the specific formulation of the accused product.

IV. Analysis of Infringement Allegations

The complaint alleges that the accused ANDA product satisfies every element of at least claim 1 of both the '052 and '722 patents Compl. ¶39 Compl. ¶49 The complaint does not provide a detailed element-by-element infringement analysis. The following chart summarizes the infringement theory based on the allegations made. A chart from the patent, Figure 3, shows the linear range of absorbance versus time used to calculate the potency, which is central to the infringement allegation '052 Patent, fig. 3

'052 Patent Infringement Allegations

Claim Element (from Independent Claim 1)	Alleged Infringing Functionality	Complaint Citation	Patent Citation
A defibrotide formulation consisting of defibrotide, sodium citrate, a pH adjusting agent, and water for injection,	The complaint alleges on information and belief that the accused product is a defibrotide sodium formulation containing these excipients.	¶33; ¶39	col. 12:21-23
having a potency of 25 to 35 IU/mg,	The complaint alleges on information and belief that the accused product possesses a biological potency within the claimed range.	¶39	col. 12:24-25
and a concentration of at least 80 mg/mL,	The accused product is identified as 250 mg/2.5 mL, which corresponds to a concentration of 100 mg/mL.	¶33	col. 12:26-27
wherein the defibrotide potency is determined by a method comprising the steps of: a) bringing into contact defibrotide, a biological composition comprising plasminogen, and a substrate specific for plasmin...; and b) measuring the amount of product formed...	The complaint alleges that the accused product satisfies this limitation, which defines the formulation by the process used to measure its potency.	¶39	col. 12:28-41

'722 Patent Infringement Allegations

Claim Element (from Independent Claim 1)	Alleged Infringing Functionality	Complaint Citation	Patent Citation
A defibrotide formulation comprising defibrotide, sodium citrate, and water for injection,	The complaint alleges on information and belief that the accused product is a defibrotide sodium formulation containing these components.	¶33; ¶49	col. 12:12-14
having a potency of 25 to 35 IU/mg,	The complaint alleges on information and belief that the accused product possesses a biological potency within the claimed range.	¶49	col. 12:15-16
and a concentration of at least 80 mg/mL,	The accused product is identified as 250 mg/2.5 mL, which corresponds to a concentration of 100 mg/mL.	¶33	col. 12:17-18
wherein the defibrotide potency is determined by a method comprising the steps of: a) bringing into contact defibrotide, a biological composition comprising plasminogen, and a substrate specific for plasmin...; and b) measuring the amount of product formed...	The complaint alleges that the accused product satisfies this limitation, which defines the formulation by the process used to measure its potency.	¶49	col. 12:19-32

• Identified Points of Contention:
  • Scope Questions: A central issue may be the legal effect of the "product-by-process" limitation present in the asserted claims (e.g., "wherein the defibrotide potency is determined by a method..."). The analysis will raise the question of whether this clause limits the claim to formulations that are actually tested using the patented method, or if it covers any formulation that has the inherent property of meeting the potency criteria if it were tested by that method. The court's construction of this clause may be dispositive.
  • Technical Questions: Since the complaint is based on "information and belief," a key factual question will be what evidence confirms that Almaject's proposed generic product contains the claimed excipients (e.g., sodium citrate) and possesses a biological potency within the claimed 25-35 IU/mg range.

V. Key Claim Terms for Construction

The complaint does not provide sufficient detail for a full analysis of potential claim construction disputes. However, based on the structure of the asserted claims, the following terms may become central to the case.

• The Term: "wherein the defibrotide potency is determined by a method..."

• Context and Importance: This "product-by-process" clause appears in all asserted independent claims and defines the claimed formulation by the method used to measure its potency. Practitioners may focus on this term because its interpretation-whether it is a true process limitation or merely a product characteristic-will likely determine the scope of infringement.

• Intrinsic Evidence for Interpretation:

  • Evidence for a Broader Interpretation (product characteristic): A party could argue that the claim is to a product having a certain characteristic (a potency of 25-35 IU/mg), and the method is merely the standard by which that characteristic is to be measured, not an infringing act in itself.
  • Evidence for a Narrower Interpretation (process limitation): The specification repeatedly highlights the novelty of the measurement method as the solution to a long-felt problem of standardization '052 Patent, col. 2:52-59 A party may argue that this emphasis, combined with the patent title (Euglobulin-based Method...), suggests the performance of the method is an integral and limiting part of the invention.

• The Term: "a biological composition comprising plasminogen"

• Context and Importance: This term defines the testing environment required by the method in the product-by-process clause. Its construction is important because if a defendant uses a different testing system to assess potency, it could argue non-infringement.

• Intrinsic Evidence for Interpretation:

  • Evidence for a Broader Interpretation: The plain language is broad and could encompass various biological systems containing plasminogen, not just the specific embodiments.
  • Evidence for a Narrower Interpretation: The patent specifications for both patents consistently refer to "euglobulin" as the preferred composition and provide detailed examples of its preparation and use '052 Patent, col. 3:9-18 '052 Patent, col. 7:56-65 The abstract and title both specify an "euglobulin-based method," which may support an interpretation that limits the scope to methods using euglobulin fractions.

VI. Other Allegations

• Indirect Infringement: The complaint alleges both induced and contributory infringement for each patent Compl. ¶42 Compl. ¶43 The inducement allegations are based on the assertion that Defendants will encourage infringement with knowledge of the patents Compl. ¶42 Compl. ¶52 The contributory infringement allegations are based on the assertion that the accused product is especially adapted for an infringing use and has no substantial non-infringing use Compl. ¶43 Compl. ¶53
• Willful Infringement: The complaint does not explicitly allege "willful" infringement. However, it requests that the case be found "exceptional" to permit an award of attorneys' fees under 35 U.S.C. § 285 Compl. ¶46 Compl. ¶56 The factual basis for this appears to be Defendants' knowledge of the patents, as evidenced by the Paragraph IV Certification letter sent to Jazz Pharmaceuticals Compl. ¶36

VII. Analyst's Conclusion: Key Questions for the Case

• A core issue will be one of claim scope: will the "product-by-process" clause, which defines the claimed formulation by the method used to measure its potency, be interpreted as a limiting process step requiring performance of the patented assay for infringement, or as merely defining a structural characteristic of the product?
• A key evidentiary question will be one of factual correspondence: what evidence will emerge in discovery to confirm that the defendants' ANDA product formulation and its biological potency fall within the specific ranges recited in the asserted claims?
• A central legal question for indirect infringement will be intent: does the act of submitting an ANDA with a Paragraph IV certification, seeking to market a product with a label that mirrors the patented drug's indications, suffice to establish the specific intent required to prove induced infringement under 35 U.S.C. § 271(b)?