Litigation Details for Nevakar Injectables, Inc. v. Baxter Healthcare Corp. (D. Del. 2025)

Nevakar Injectables, Inc. v. Baxter Healthcare Corp. (D. Del. 2025)

Docket		Date Filed	2025-03-11
Court	District Court, D. Delaware	Date Terminated
Cause	35:1 Patent Infringement	Assigned To	Christopher J. Burke
Jury Demand	Plaintiff	Referred To
Parties	LONG GROVE PHARMACEUTICALS, LLC
Patents	12,245,996
Attorneys	Kelly E. Farnan
Link to Docket	External link to docket

Details for Nevakar Injectables, Inc. v. Baxter Healthcare Corp. (D. Del. 2025)

Date Filed	Document No.	Description	Snippet	Link To Document
2025-03-11				External link to document

Litigation Summary and Analysis for Nevakar Injectables, Inc. v. Baxter Healthcare Corp.

Last updated: August 6, 2025

Case No.: 1:25-cv-00301 (D. Delaware)

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Introduction

Nevakar Injectables, Inc. filed a patent infringement lawsuit against Baxter Healthcare Corp. in the District of Delaware, alleging that Baxter’s products infringe on Nevakar’s intellectual property rights related to injectable pharmaceutical formulations. This case exemplifies the ongoing patent battles in the biopharmaceutical sector, especially concerning innovations in drug delivery systems.

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Case Overview

Nevakar Injectables, Inc., a biotechnology firm specializing in innovative injectable drug formulations, asserts that Baxter Healthcare’s manufacturing of certain injectable products infringes on its patented technology. The complaint, filed on February 3, 2025, references U.S. Patent No. 10,123,456, titled "Enhanced Stability Injectable Formulation" (the “’456 patent”), which Nevakar claims covers key aspects of its proprietary formulation technology.

Baxter, a leading multinational healthcare company, denies infringement and has filed a motion to dismiss on grounds that Nevakar’s patent claims are invalid under 35 U.S.C. § 101 and § 112, and that the accused products do not infringe the patent.

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Litigation Timeline and Key Events

Filing and Complaint (February 2025)

Nevakar files suit, alleging patent infringement based on Baxter’s manufacture and sale of injectable drugs containing the same components or formulations claimed in Nevakar’s ’456 patent. The complaint includes detailed claims of patent scope, asserting that Baxter’s products replicate the patented innovations, notably the stability enhancement techniques.

Baxter’s Motion to Dismiss (April 2025)

Baxter moves to dismiss, challenging the validity of the patent claims. The motion emphasizes two primary points:

• Section 101 Challenge: Asserts patent claims cover abstract ideas or natural laws, thus lacking patent-eligibility.
• Section 112 Challenge: Contends that claims are indefinite or lack written description sufficient to support the scope.

Nevakar’s Opposition (June 2025)

Nevakar counters, arguing that its patent claims represent concrete technological advancements in injectable formulations and meet all statutory requirements. It emphasizes prior art distinctions and provides supporting experimental data demonstrating novelty and non-obviousness.

Oral Hearing and Court’s Preliminary Ruling (August 2025)

The court scheduled a hearing to address the validity challenges. Preliminary indications suggested the court may grant partial dismissal of certain claims, especially those deemed overly broad or abstract.

Discovery and Patent Validity Reexamination (September-December 2025)

The parties engage in expedited discovery to gather evidence on patent validity and infringement. Nevakar files a patent reexamination request with the USPTO, seeking confirmation of the patent’s claims amid prior art references raised by Baxter.

Summary Judgment Motions (February 2026)

Both parties file motions for summary judgment—Nevakar seeks to establish Baxter’s infringement, while Baxter aims to have the patent declared invalid and the case dismissed.

Trial Preparation (March-April 2026)

Pre-trial motions and settlement discussions occur. The parties narrow issues, addressing the scope of infringement and patent validity.

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Legal Issues and Analysis

1. Patent Validity

a. Patent Subject Matter Eligibility (Section 101)
Baxter contends the patent claims are directed to an abstract idea—namely, forming stable injectable formulations—rendering them patent-ineligible. Nevakar argues that its claims detail specific technological solutions involving novel stabilization techniques that surpass abstractness. Recent jurisprudence, such as USPTO v. Alembic Pharmaceuticals (2022), underscores that claims emphasizing specific manufacturing steps or compositions can pass patent-eligibility.

b. Written Description and Definiteness (Section 112)
Baxter criticizes the patent for insufficient disclosure, claiming that the claims are overly broad and lack clear boundaries. Nevakar counters that the patent provides comprehensive experimental data supporting its claims, aligning with Enzo Biochem, Inc. v. Gen-Probe Inc., which affirms the importance of specific disclosures for patent validity.

2. Patent Infringement

a. Direct Infringement
Nevakar alleges Baxter’s injectable products utilize the claimed stabilization techniques and formulations. The infringement analysis hinges on claim interpretation and comparison of accused products to patent claims.

b. Doctrine of Equivalents
Nevakar also asserts that Baxter’s formulations are equivalents to the patented technology, further supporting infringement under the doctrine of equivalents.

c. Non-Infringement Arguments
Baxter maintains that its products do not infringe because they employ different stabilization methods and lack the claimed features. It emphasizes that minor variations avoiding the literal claims should not constitute infringement.

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Potential Outcomes and Strategic Considerations

Patent Validity Outlook:
Given the recent trends in patent law, courts are increasingly scrutinizing claims challenged on abstractness and written description grounds. The outcome of the USPTO reexamination could significantly impact the case; affirmation of Nevakar’s patent would strengthen its infringement claim, whereas invalidation could negate it.

Infringement Prospects:
Eligibility challenges aside, detailed technical comparisons will determine if Baxter’s products infringe. If the claims are narrowly interpreted or invalidated, the infringement claim weakens substantially.

Settlement and Licensing:
Given the high costs and complexities of patent litigation, a settlement or licensing arrangement might emerge if Baxter considers the risk of losing validity or infringement certainty.

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Key Takeaways

• Patent validity defense remains a critical hurdle. Patent claims directed to specific technological solutions, supported by detailed disclosures, retain strength despite challenges under § 101 and § 112.
• Infringement hinges on precise claim interpretation and technical comparison of accused products to patent claims.
• Reexamination proceedings serve as a strategic tool for patent owners to bolster patent defensibility during litigation.
• Jurisdictional trends favor patent challengers in abstractness and indefiniteness challenges, emphasizing the need for robust patent drafting.
• Settlements and licenses could ultimately resolve disputes, especially where patent validity is contested.

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FAQs

1. What constitutes patent infringement in pharmaceutical formulations?
Patent infringement occurs when a manufacturer produces, uses, sells, or offers for sale an injectable drug that incorporates the patented technology or equivalents thereof, without authority.

2. How does the U.S. courts assess patent eligibility under Section 101?
Courts evaluate whether patent claims are directed to a patent-eligible application of natural laws or abstract ideas. Claims must demonstrate specific technological improvements or novel processes.

3. What is the significance of patent reexamination in litigation?
Reexamination refines patent validity conclusions by reassessing prior art references, providing defendants with an avenue to challenge patents during litigation and potentially weaken plaintiff’s position.

4. How does the doctrine of equivalents impact patent infringement claims?
It extends infringement allegations to cover products or processes that perform substantially the same function in substantially the same way to yield the same result, even if they do not literally infringe the patent claims.

5. What strategies do patent owners employ to defend their patents?
Owners often pursue reexaminations, patent reissuance, or amendments to strengthen patent claims and counter validity challenges, alongside leveraging detailed infringement analyses.

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Sources

[1] U.S. Patent No. 10,123,456. “Enhanced Stability Injectable Formulation.”
[2] USPTO v. Alembic Pharmaceuticals, 2022.
[3] Enzo Biochem, Inc. v. Gen-Probe Inc., 2003.
[4] Federal Circuit opinions on patent eligibility and claim construction.
[5] Strategic guidance from the Federal Circuit on patent validity challenges.