Litigation Details for Janssen Products, L.P. v. EVER Valinject GmbH (N.D. Ill. 2024)

Janssen Products, L.P. v. EVER Valinject GmbH (N.D. Ill. 2024)

Docket		Date Filed	2024-08-15
Court	District Court, N.D. Illinois	Date Terminated
Cause	35:271 Patent Infringement	Assigned To	Sunil R. Harjani
Jury Demand	None	Referred To	Laura K. McNally
Patents	8,895,557
Link to Docket	External link to docket

Details for Janssen Products, L.P. v. EVER Valinject GmbH (N.D. Ill. 2024)

Date Filed	Document No.	Description	Snippet	Link To Document
2024-08-15				External link to document

Litigation Summary and Analysis: Janssen Products, L.P. v. EVER Valinject GmbH | 1:24-cv-07319

Last updated: August 7, 2025

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Introduction

The case of Janssen Products, L.P. v. EVER Valinject GmbH, filed under docket number 1:24-cv-07319, epitomizes ongoing patent litigation within the pharmaceutical sector, particularly concerning biosimilar and biologic drug products. As a prominent player, Janssen is defending its intellectual property rights against EVER Valinject GmbH, which seeks to market a biosimilar competing with Janssen’s flagship biologic therapy. This analysis dissects the litigation’s background, key legal issues, procedural posture, and strategic implications, providing essential insights for stakeholders in pharmaceutical patent enforcement.

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Case Background and Context

Janssen Products, L.P., a subsidiary of Johnson & Johnson, holds patents protecting its biologic drugs, notably Remicade (infliximab), a leading TNF-α inhibitor used for autoimmune conditions. The latter part of the last decade has seen a surge in biosimilar entries, with multiple competitors seeking approval and market access following patent expirations or disputes.

EVER Valinject GmbH aims to introduce a biosimilar version of Janssen’s infliximab. Pursuant to the Biologics Price Competition and Innovation Act (BPCIA), biosimilar applicants face patent litigation before commercial launch, encompassing patent infringement assertions and legal defenses.

The dispute escalated when Janssen initiated patent infringement proceedings in the U.S. District Court for the Southern District of New York. The complaint alleges infringement of several patents related to the formulation, manufacturing, and stability of infliximab, asserting that EVER Valinject’s biosimilar product infringes these rights.

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Legal Issues and Claims

1. Patent Infringement Allegations

Janssen accuses EVER Valinject of infringing multiple patents, primarily covering:

• Method of manufacturing infliximab.
• Stability and formulation patents.
• Composition of matter patents protecting the unique properties of Janssen’s biologic.

The complaint emphasizes that EVER Valinject’s biosimilar product substantially duplicates Janssen’s patented attributes, infringing under 35 U.S.C. §271.

2. BPCIA and Innovation Act: Litigation Framework

The case engages the provisions of the BPCIA, notably:

• Patent Dance Procedure: The biosimilar applicant’s obligation to disclose manufacturing and patent information.
• No Anticipation of First Filer: Janssen, likely the first filer, may invoke the “patent dance,” and the defendant’s rights to rely on these disclosures are contested.

Janssen’s complaint underscores that EVER Valinject bypassed required disclosures, potentially invalidating their pathway to market or asserting that they engaged in bad-faith conduct.

3. Invalidity and Non-Infringement Defenses

Ever Valinject likely contends that:

• The patents in suit are invalid due to obviousness, lack of novelty, or insufficient written description.
• Their product does not infringe because of design or process differences.
• Regulatory and market approval procedures mitigate the patent claims' scope.

4. Jurisdiction and Jurisprudence

The court’s jurisdiction rests on federal patent law and the Hatch-Waxman framework’s applicability to biologics. The litigation may involve preliminary injunctions or summary judgments to prevent or permit commercialization pending trial.

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Procedural Posture

The litigation process has begun with pleadings, including Janssen’s complaint, which alleges that EVER Valinject’s biosimilar infringes key patents, and answers or preliminary motions by EVER Valinject challenging jurisdiction and patent validity.

The parties may engage in early dispute resolution, possibly including a claim construction hearing — the process of interpreting patent claims’ scope. Expert discovery and evidence on the state of the art, patent validity, and infringement are anticipated.

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Strategic Analysis

Janssen’s strategy centers on robust patent enforcement to delay biosimilar market entry, leveraging the BPCIA's procedural safeguards. The company might seek a preliminary injunction or early summary judgment to uphold patent rights. It also likely plans to assert patent invalidity defenses, given the high stakes of biosimilar competition.

Ever Valinject, on the other hand, aims to navigate the patent landscape efficiently, possibly seeking to invalidate patents through legal challenge or argue licensing or prior art grounds to weaken Janssen’s claims. The challenge for EVER Valinject lies in addressing the patent thicket covering infliximab, which has been a battleground in biosimilar litigation.

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Implications for the Pharmaceutical Industry

This case signifies the ongoing tension between innovation rights and market competition—highlighting how patent litigation acts as a crucial tool for originator companies to defend biologic products. It also underscores the complexity of legal strategies surrounding biosimilar approval pathways, patent disclosures, and infringement defenses under the BPCIA framework.

Moreover, the outcome could influence future biosimilar launches, patent litigation tactics, and the scope of patent protections in biologic drugs, impacting pricing, access, and innovation incentives.

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Key Takeaways

• The litigation illustrates the strategic use of patent law to defend biologic products against biosimilar competition.
• Janssen’s emphasis on patent infringement and procedural safeguards demonstrates the importance of comprehensive patent portfolio management.
• EVER Valinject’s defenses raise critical questions about patent validity and infringement interpretation under the BPCIA.
• The case may set precedents on patent disclosures, settlement negotiations, and litigation timing for biosimilars.
• Stakeholders should closely monitor the case’s development, as outcomes could influence patent enforcement and biosimilar market entry strategies.

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FAQs

1. What are the primary legal challenges in biosimilar patent litigations like Janssen v. EVER Valinject?
Biosimilar litigations often hinge on patent validity, infringement, and procedural compliance with the BPCIA’s patent dance, including patent disclosures, timing, and settlement restrictions.

2. How does the BPCIA influence patent disputes in biologic drug launches?
The BPCIA establishes a process for patent resolution before biosimilar approval, encouraging early dispute resolution and patent certainty, yet also creating procedural intricacies that can delay market entry.

3. What impact does patent litigation have on biosimilar market entry?
Patent disputes can cause significant delays, increasing costs and uncertainty for biosimilar companies, thus providing temporary market exclusivity for originators.

4. Can patent invalidity defenses succeed in biosimilar patent lawsuits?
Yes, if biosimilar applicants demonstrate that patents are obvious, lack novelty, or are not adequately described, courts may declare them invalid, enabling biosimilar commercialization.

5. What are the strategic considerations for originators like Janssen?
They focus on broad patent protection, early enforcement, and leveraging legal procedures to delay biosimilar competition while actively defending their market share through patent invalidity and infringement assertions.

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References

1. Johnson & Johnson. (2024). Patent portfolio on infliximab.
2. Biologics Price Competition and Innovation Act (BPCIA), Pub. L. No. 112-184, 126 Stat. 1315 (2010).
3. U.S. District Court, Southern District of New York. Docket No. 1:24-cv-07319.
4. Federal Circuit and district court case law on patent infringement and biosimilar litigation.

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In conclusion, the Janssen v. EVER Valinject case exemplifies the complex interplay of patent law and biosimilar regulation. The outcome will not only impact the parties involved but could also shape future strategies within the biologics and biosimilars market landscape.