DCT

2:25-cv-01867

Janssen Products LP v. EVER Valinject GmbH

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 2:25-cv-01867, D.N.J., 04/21/2025
  • Venue Allegations: Venue is alleged to be proper based on Defendant Medchemexpress having a regular and established place of business at its headquarters within the District of New Jersey.
  • Core Dispute: Plaintiffs allege that Defendant’s submission of a New Drug Application to the FDA for a generic version of the cancer drug Yondelis® (trabectedin) infringes patents covering the drug's stable formulation and its synthetic manufacturing process.
  • Technical Context: The dispute is in the field of pharmaceutical chemistry, specifically concerning formulations to ensure the stability of a complex anti-tumor compound and the industrial-scale synthesis of that compound.
  • Key Procedural History: The complaint notes this action was severed from a case originally filed in the Northern District of Illinois and transferred to the District of New Jersey following Defendant’s motion challenging venue. The complaint also references prior litigations against other generic manufacturers concerning the same patents, which allegedly resulted in those parties either stipulating to infringement or being enjoined, a fact pattern Plaintiffs appear to be leveraging to support their current allegations.

Case Timeline

Date Event
2000-05-15 U.S. Patent No. 7,420,051 Priority Date
2004-10-29 U.S. Patent No. 8,895,557 Priority Date
2008-09-02 U.S. Patent No. 7,420,051 Issued
2014-11-25 U.S. Patent No. 8,895,557 Issued
2024-07-03 Defendant sends Paragraph IV Letter
2024-08-15 Plaintiffs file initial complaint in N.D. Illinois
2024-08-23 Defendant sends second Paragraph IV Letter
2024-10-03 Plaintiffs file second complaint in N.D. Illinois
2025-04-09 FDA issues tentative approval of Defendant's NDA 219617
2025-04-21 Amended Complaint for Patent Infringement Filed

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

U.S. Patent No. 8,895,557 - "Pharmaceutical Formulations of Ecteinascidin Compounds"

The Invention Explained

  • Problem Addressed: The patent describes the anti-tumor compound ecteinascidin 743 (ET-743, or trabectedin) as having limited aqueous solubility and poor stability (’557 Patent, col. 2:27-30). Conventional lyophilized (freeze-dried) formulations were unstable except under deep-freeze conditions (e.g., -20° C) and were prone to degradation via hydrolysis into an impurity known as ET-701 (’557 Patent, col. 3:9-15, col. 2:55-60).
  • The Patented Solution: The invention is a new formulation that uses a disaccharide, such as sucrose or lactose, as a bulking and stabilizing agent instead of the conventional mannitol (’557 Patent, col. 4:51-54). This use of a disaccharide is described as drastically reducing the formation of the ET-701 impurity and improving the storage stability of the lyophilized product over a wider temperature range (’557 Patent, col. 5:6-15).
  • Technical Importance: The invention provided a method to create a more stable, commercially viable drug product for a potent anti-cancer agent, potentially easing storage and handling requirements.

Key Claims at a Glance

  • The complaint asserts claims 1-8, 11-20, and 22-26 (Compl. ¶85). Independent claim 1 is representative.
  • Independent Claim 1 requires:
    • A lyophilised anti-tumor composition
    • comprising a single active anti-tumor compound and a disaccharide selected from sucrose, lactose and a combination thereof
    • wherein the anti-tumor compound is ET-743
    • and wherein the disaccharide is present in a sufficient amount to inhibit conversion of the ET-743 into ET-701, such that the ET-743 composition comprises less than 2% ET-701 after storage of the ET-743 composition at 5° C for 3 months.
  • The complaint explicitly reserves the right to assert other claims, including dependent claims (Compl. ¶85).

U.S. Patent No. 7,420,051 - "Synthetic Process for the Manufacture of an Ecteinascidin Compound"

The Invention Explained

  • Problem Addressed: The patent explains that while trabectedin can be isolated from a natural source (the marine tunicate Ecteinascidia turbinata), the yields are low (’051 Patent, col. 2:21-22). Existing synthetic methods were described as being "long and complicated" (’051 Patent, col. 2:27-28), hindering large-scale production.
  • The Patented Solution: The patent discloses new, multi-step synthetic processes for producing trabectedin and related compounds. The invention provides specific chemical pathways and intermediate compounds that enable a more efficient and scalable synthesis of the final active pharmaceutical ingredient (’051 Patent, col. 10:48-54). The specification details several alternative synthetic routes (e.g., Schemes 1-6) to achieve this outcome (’051 Patent, col. 12:50-51).
  • Technical Importance: The patented process was crucial for enabling the commercial-scale manufacture of trabectedin, making the drug available for widespread clinical use (Compl. ¶69).

Key Claims at a Glance

  • The complaint asserts at least claims 12-14 (Compl. ¶118). Independent claim 12 is representative.
  • Independent Claim 12 requires:
    • A process for the manufacture of an ecteinascidin compound,
    • wherein the process comprises converting stereospecifically an α-ketolactone of formula (36) to a spiroisoquinoline compound ET770, in accordance with a specified reaction scheme.
  • The complaint reserves the right to assert other claims (Compl. ¶118).

III. The Accused Instrumentality

Product Identification

  • The accused instrumentality is the generic trabectedin 1 mg/vial drug product for which Defendant Medchemexpress and its collaborators seek FDA approval via New Drug Application (NDA) No. 219617 (Compl. ¶2).

Functionality and Market Context

  • The proposed NDA Product is a generic version of Plaintiffs' Yondelis® drug, intended as a second-line treatment for certain types of sarcoma (Compl. ¶3). The complaint alleges that the active pharmaceutical ingredient (API), trabectedin, for the proposed NDA Product is manufactured by the process claimed in the ’051 Patent and that the final drug product is a formulation that infringes the ’557 Patent (Compl. ¶2, ¶52). The act of infringement cited under the Hatch-Waxman Act is the submission of the NDA seeking approval to market this product before the expiration of the patents-in-suit (Compl. ¶2).

IV. Analysis of Infringement Allegations

No probative visual evidence provided in complaint.

U.S. Patent No. 8,895,557 Infringement Allegations

The complaint alleges infringement of the ’557 Patent under the doctrine of equivalents. It concedes that the proposed NDA Product does not literally meet the "disaccharide" limitation of the claims (Compl. ¶75).

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A lyophilised anti-tumor composition The proposed NDA product is a lyophilized anti-tumor composition. The complaint alleges this element is not contested. ¶75 col. 27:58-59
comprising a single active anti-tumor compound...wherein the anti-tumor compound is ET-743 The proposed NDA product contains the single active anti-tumor compound ET-743 (trabectedin). The complaint alleges this element is not contested. ¶75 col. 28:1-2
and a disaccharide selected from sucrose, lactose and a combination thereof The proposed NDA Product uses L-arginine, an amino acid, instead of a disaccharide. Plaintiffs allege this is an insubstantial difference. ¶75, ¶76 col. 28:2-3
wherein the disaccharide is present in a sufficient amount to inhibit conversion of the ET-743 into ET-701, such that the ET-743 composition comprises less than 2% ET-701 after storage...at 5° C for 3 months. The L-arginine in the proposed product allegedly functions to stabilize the formulation by limiting the conversion of ET-743 to ET-701, achieving the same result of less than 2% ET-701 after storage. The complaint alleges this element is not contested. ¶75, ¶76 col. 28:5-10
  • Identified Points of Contention:
    • Scope Questions: The central dispute will be whether the scope of the term "disaccharide" can be extended under the doctrine of equivalents to cover L-arginine, which is an amino acid. The question for the court is whether an amino acid can be legally equivalent to a sugar for the claimed purpose.
    • Technical Questions: A key technical question is whether L-arginine actually performs "substantially the same function, in substantially the same way, to achieve substantially the same result" as a disaccharide in stabilizing the ET-743 molecule. The complaint alleges this equivalence (Compl. ¶76), but the underlying chemical mechanisms may become a point of significant factual dispute.

U.S. Patent No. 7,420,051 Infringement Allegations

The complaint does not provide an element-by-element infringement analysis for the ’051 process patent. Instead, it presents a narrative theory of infringement based on inference. The core allegation is that the trabectedin API in the proposed NDA Product is, and will be, made using the patented process because no other commercially viable process exists (Compl. ¶52, ¶53). The complaint alleges that prior art processes are not usable on a commercial scale and that other generic manufacturers who initially claimed to use such processes ultimately stipulated to infringement of the ’051 Patent (Compl. ¶53, ¶54). The complaint further states that Defendant's failure to produce manufacturing records supports the conclusion that the patented process will be used, giving rise to a presumption of infringement under 35 U.S.C. § 295 (Compl. ¶55).

  • Identified Points of Contention:
    • Scope Questions: The analysis may turn on the scope of the process steps defined in the claims, such as the specific conversion of the "α-ketolactone of formula (36)" recited in claim 12. A defense could argue that its process uses different intermediates or reaction pathways that fall outside the literal scope of the claims.
    • Technical Questions: This is primarily an evidentiary question. Can Plaintiffs prove, through discovery of Defendant’s confidential manufacturing information, that the process actually used practices the claimed steps? The case may depend on the strength of the factual evidence supporting the alleged non-viability of alternative, non-infringing manufacturing processes.

V. Key Claim Terms for Construction

  • The Term: "disaccharide" (’557 Patent, Claim 1)
  • Context and Importance: This term is the focal point of the infringement dispute for the ’557 Patent. Defendant's product allegedly uses L-arginine, an amino acid, not a disaccharide (Compl. ¶75). The viability of Plaintiffs' doctrine of equivalents argument depends entirely on the legal and technical relationship between the claimed "disaccharide" and the accused L-arginine. Practitioners may focus on this term because its construction, while seemingly straightforward, will define the boundaries for the equivalence analysis.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The specification describes the function of the disaccharide as a "bulking agent" that can "drastically reduce the formation of impurities" and "improve the storage conditions" (’557 Patent, col. 5:7-12). A party could argue that the term should be understood functionally, encompassing other excipients that achieve the same stabilizing result in the same way.
    • Evidence for a Narrower Interpretation: The claim itself provides a specific list: "selected from sucrose, lactose and a combination thereof." Furthermore, the specification provides an extensive list of other disaccharides, such as maltose, cellobiose, and turanose, but does not mention any other class of compound like amino acids (’557 Patent, col. 7:65-col. 9:8). This may suggest that the inventors specifically contemplated and claimed only this particular class of sugars.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges that Medchemexpress induced infringement of the ’557 patent by "actively inducing the remaining EVER Defendants to submit NDA No. 219617...knowing that the proposed NDA Product infringes" (Compl. ¶84). This is based on the allegation that the parties acted in concert to seek FDA approval (Compl. ¶8).
  • Willful Infringement: Willfulness is alleged for the ’051 Patent (Compl. ¶120). The complaint asserts that Defendant had actual and constructive notice of the patents prior to filing the NDA, pointing to the Paragraph IV certification letter which "cites to and reflects knowledge of the prior Hatch-Waxman litigations involving the ’557 Patent and ’051 Patent" (Compl. ¶78, ¶119).

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

  • A core issue will be one of chemical and legal equivalence: Can the function of L-arginine, an amino acid, in the accused formulation be found "insubstantially different" from the function of the claimed "disaccharide" under the doctrine of equivalents, or does the fundamental structural difference between a sugar and an amino acid preclude such a finding?
  • A second central issue will be one of evidentiary inference: For the ’051 process patent, can Plaintiffs leverage the alleged commercial failure of alternative manufacturing methods and the statutory presumption of 35 U.S.C. § 295 to compel a finding of infringement, or will Defendant be able to demonstrate a viable, non-infringing process for synthesizing trabectedin?