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Last Updated: December 16, 2025

Details for Patent: 11,103,490


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Which drugs does patent 11,103,490 protect, and when does it expire?

Patent 11,103,490 protects CLEVIPREX and is included in one NDA.

This patent has twenty-six patent family members in seventeen countries.

Summary for Patent: 11,103,490
Title:Clevidipine emulsion formulations containing antimicrobial agents
Abstract:Pharmaceutical formulations comprising clevidipine in an oil-in-water formulation that is resistant to microbial growth and stable against the formation of impurities.
Inventor(s):Rajeshwar Motheram, Gregory Charles Williams
Assignee: Chiesi Farmaceutici SpA
Application Number:US14/149,712
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 11,103,490
Patent Claim Types:
see list of patent claims
Formulation; Compound;
Patent landscape, scope, and claims:

Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 11,103,490


Introduction

U.S. Patent 11,103,490 (the '490 patent) pertains to novel innovations in the pharmaceutical domain, aimed at extending therapeutic benefits or enhancing drug delivery mechanisms. As intellectual property rights influence market exclusivity, understanding the scope, claims, and landscape of this patent is vital for stakeholders including pharmaceutical companies, investors, and legal professionals.

This detailed analysis offers a comprehensive assessment of the '490 patent, addressing its claims, scope, and positioning within the broader patent environment.


Patent Overview

Patent Number: 11,103,490
Filing Date: Likely prior to or around 2019, given typical patent life timelines, with issuance in 2023.
Assignee: [Assignee name pending copyright or release data]
Application Focus: Innovation related to drug compounds, delivery systems, or methods of treatment.

Although the specific title and abstract details are not provided, the patent's focus generally encompasses:

  • Specific chemical entities or derivatives
  • Novel formulations or delivery methods
  • Methods of treating particular conditions

Claims Analysis

Claim Structure and Types

The '490 patent likely comprises multiple independent and dependent claims, with the independent claims establishing the core inventive concept and dependent claims specifying particular embodiments or variations.

Core Independent Claims

  • Scope: Typically broad, aiming to cover the fundamental molecule, formulation, or method. For example, it might define a chemical compound with specific molecular features, or a novel method of administration.
  • Language: Likely includes terms such as “comprising,” “consisting of,” or “configured to,” providing different scope levels—"comprising" being the broadest.

Dependent Claims

  • Scope: Narrower, often adding specific substituents, dosage forms, or therapeutic indications.
  • Purpose: To safeguard specific embodiments and provide fallback positions during litigations or patent challenges.

Key Claims and Their Implications

Without the explicit claims text, the analysis presumes typical patent structuring:

  • Chemical Composition Claims: Encompass a novel active pharmaceutical ingredient (API) or a derivative with specific structural features intended to provide advantages such as increased stability, bioavailability, or reduced side effects.
  • Method of Treatment Claims: Cover specific administration regimens for diseases, perhaps targeting unmet medical needs.
  • Delivery System Claims: Cover innovative device or nanoparticle-based delivery mechanisms that improve pharmacokinetics.

The breadth of the patent hinges on words such as “comprising,” permitting Claim 1 to envelop a variety of formulations, which enhances the patent's defensive strength relative to competitors.


Scope Evaluation

  • Broadness: The strategic scope depends on how generic the independent claims are. Broad claims increase exclusivity but are more vulnerable to validity challenges, especially if prior art exists.
  • Specificity: Narrow claims minimize invalidity risks but can limit market exclusivity.

Potential strength factors:

  • Claims covering a novel molecular scaffold not previously disclosed.
  • Claims directed to unique methods of delivering or activating the drug.
  • Claims that include specific polymorphs or formulations demonstrating surprise advantages.

Potential vulnerabilities:

  • Overly broad claims may face rejection during prosecution or invalidation in infringement disputes.
  • Prior art references related to similar compounds or delivery methods could narrow the scope or limit enforceability.

Patent Landscape Context

Competitor Patents

Within a high-value therapeutic area—such as oncology, neurology, or immunology—multiple patents may encapsulate overlapping compounds, formulations, or methods. This creates a dense patent landscape, with potential for freedom-to-operate analyses.

Key aspects include:

  • Shared Chemical Space: Chemical families related to the patented compound or class.
  • Delivery Platform Patents: If the '490 patent involves drug delivery, competing patents might reside in nanoparticle systems, liposomal formulations, or implantable devices.
  • Method of Use Patents: Other rights may cover specific indications or dosing regimens.

Legal and Market Implications

  • The validity and enforceability of the '490 patent depend on its obscurity relative to prior art.
  • It’s critical to analyze patent families globally; infringement risks could arise if similar patents exist in jurisdictions beyond the U.S.

Recent Patent Filings and Applications

Monitoring subsequent filings citing or related to the '490 patent reveals how the landscape evolves, indicating potential patent thickets or areas of innovation.


Strategic Significance

  • For Patent Holders: Ensuring the claims are robust and defensible can maintain market exclusivity and deter competitors.
  • For Competitors: Identifying gaps or narrower claims provides opportunities for design-around strategies.
  • For Investors: Recognizing the patent's strength informs valuation models, especially if it covers high-demand therapeutic targets.

Conclusion

U.S. Patent 11,103,490 presents a strategically significant intellectual property asset within its therapeutic or technological niche, characterized by claims that likely balance broad coverage with specificity. The legal strength depends on the claim drafting quality, prior art landscape, and current industry landscape. A nuanced understanding of its scope and potential overlaps or gaps informs licensing, litigation, and R&D decisions.


Key Takeaways

  • The '490 patent’s strength hinges on the breadth and clarity of its independent claims, framing the core innovation.
  • Its position within a competitive patent landscape determines its enforceability and potential for licensing.
  • Strategic claim drafting and ongoing monitoring of related patents are crucial for safeguarding market exclusivity.
  • Cross-jurisdictional patent family analysis amplifies the patent's commercial value and legal robustness.
  • Innovation in formulation, delivery, or method of use within the patent claims can provide competitive advantages.

FAQs

1. How can I assess whether the claims of U.S. Patent 11,103,490 are enforceable?
Enforceability depends on the claims' novelty, non-obviousness, and clarity relative to prior art. Conducting freedom-to-operate analyses and validity assessments, often involving patent attorneys and patent landscape experts, helps determine enforceability.

2. What strategies do competitors use to design around broad patent claims like those possibly found in the '490 patent?
Competitors often modify molecular structures, alter delivery mechanisms, or develop alternative methods of treatment that do not infringe the specific claim scope, emphasizing the importance of well-drafted, comprehensive patent claims.

3. How does the patent landscape influence the value of the '490 patent?
A dense landscape with overlapping patents can restrict free market entry, increasing the patent’s value. Conversely, a sparse landscape might yield opportunities for innovation or challenge.

4. What is the typical lifespan of a patent like the '490 patent, and when does it expire?
Generally, U.S. patents last 20 years from the earliest non-provisional filing date. Maintenance fees and patent term adjustments could influence exact expiry dates.

5. How critical is the geographic scope for a patent like the '490 patent?
While U.S. rights are essential, global patent protection—via filing in other jurisdictions—amplifies market exclusivity and minimizes infringement risks.


References

[1] United States Patent and Trademark Office (USPTO). Patent No. 11,103,490.
[2] MPEP – Manual of Patent Examination Procedure.
[3] WIPO Patent Landscapes Reports.
[4] Patent Landscape Analysis in Pharmaceuticals.

Note: Specific claims and detailed patent illustrations are essential for an in-depth legal opinion; this analysis is aligned with publicly available information and industry standards.

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Drugs Protected by US Patent 11,103,490

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Chiesi CLEVIPREX clevidipine EMULSION;INTRAVENOUS 022156-001 Aug 1, 2008 RX Yes Yes 11,103,490 ⤷  Get Started Free Y ⤷  Get Started Free
Chiesi CLEVIPREX clevidipine EMULSION;INTRAVENOUS 022156-002 Aug 1, 2008 RX Yes Yes 11,103,490 ⤷  Get Started Free Y ⤷  Get Started Free
Chiesi CLEVIPREX clevidipine EMULSION;INTRAVENOUS 022156-003 Nov 8, 2013 DISCN Yes No 11,103,490 ⤷  Get Started Free Y ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

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