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Last Updated: December 16, 2025

Details for Patent: 10,603,290


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Which drugs does patent 10,603,290 protect, and when does it expire?

Patent 10,603,290 protects FINTEPLA and is included in one NDA.

Protection for FINTEPLA has been extended six months for pediatric studies, as indicated by the *PED designation in the table below.

This patent has thirty-two patent family members in fifteen countries.

Summary for Patent: 10,603,290
Title:Formulation for inhibiting formation of 5-HT2B agonists and methods of using same
Abstract:Drug combinations and their use are disclosed. A first drug is administered in combination with a second drug. The first drug such as fenfluramine is characterized by the formation of a metabolite including 5-HT2B agonists such as norfenfluramine with known adverse side effects. The second drug is in the form of a CYP inhibitor such as cannabidiol which modulates the formation of metabolite down thereby making the first drug safer.
Inventor(s):Stephen J. Farr, Brooks Boyd
Assignee: Zogenix International Ltd
Application Number:US16/193,812
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 10,603,290
Patent Claim Types:
see list of patent claims
Use; Formulation;
Patent landscape, scope, and claims:

Comprehensive Analysis of U.S. Patent 10,603,290: Scope, Claims, and Patent Landscape

Introduction

U.S. Patent No. 10,603,290, granted on February 25, 2020, represents a significant advancement in the pharmaceutical landscape, particularly in the realm of novel drug formulations or therapeutic methods. This patent's scope and claims define its proprietary boundary and influence subsequent innovation, licensing opportunities, and competitive intelligence. Understanding its detailed scope, claims structure, and the overarching patent landscape is vital for stakeholders, including pharmaceutical companies, patent practitioners, and investors.

This analysis dissects the patent's claims, elucidates the scope of protection, maps it within the current patent landscape, and discusses its implications for innovation and competition in the pharmaceutical sector.


Patent Overview and Context

Assignee and Inventors: The patent is assigned to a biotech or pharmaceutical entity, potentially focused on treating specific conditions with innovative compounds or delivery mechanisms (the actual assignee should be verified for accuracy).

Field of Invention: While the specific patent title is not provided here, patents like 10,603,290 typically relate to novel compounds, formulations, or therapeutic methods with pharmaceutical utility. The invention likely targets unmet medical needs, improves pharmacokinetics, enhances stability, or reduces toxicity.

General Significance: Securing such patents consolidates market position, prevents copycat competition, and fosters licensing advancements. The patent's scope directly influences freedom to operate and the innovation trajectory for related therapies.


Detailed Analysis of Claims

1. Claim Structure Overview

Independent Claims: Serve as broad protective statements covering core inventive concepts. They delineate the essence of the invention, often covering what the inventors consider novel and non-obvious.

Dependent Claims: Narrower claims that specify particular embodiments or refinements, narrowing the scope but providing fallback positions if independent claims are invalidated.

2. Claim Scope and Content

a. Main Claim Aspects

Although the exact claims are not provided here, typical claims in such patents might include:

  • Compound Claims: Covering a specific chemical entity or class of molecules. They specify molecular structures, substituents, stereochemistry, or derivatization.

  • Method Claims: Covering specific therapeutic methods, such as administering a compound at a specific dose, route, or combination.

  • Formulation Claims: Encompassing pharmaceutical compositions, including excipients, delivery mechanisms, or controlled-release properties.

  • Use Claims: Covering the use or efficacy of the compound or formulation in treating particular diseases.

b. Claim Language and Scope

The scope is often defined via chemical structure claims with Markush groups, ranges for concentrations or doses, and functional language specifying therapeutic effects. Functional language (e.g., "effective amount," "therapeutically effective") introduces variability but can narrow or broaden coverage depending on claim drafting.

A key point in assessing scope is whether claims are "product-by-process," "product-by-use," or purely structural/compositional, which has implications for infringement analysis.

3. Specificity and Breadth

  • Broad Claims: If the claims cover a class of compounds with minimal structural limitations, they offer extensive protection but may face validity challenges over prior art.

  • Narrow Claims: Highly specific claims (e.g., particular stereoisomers, specific formulations) are easier to defend but afford limited scope.

  • Claim Dependencies: Multiple layered dependent claims permit strategic fallback options if broader claims are invalidated.

4. Potential Novel Features

The patent likely emphasizes a novel molecular scaffold, unique delivery mechanism, or combination therapy. The claims aim to protect:

  • Unique chemical modifications enhancing bioavailability or stability.

  • Specific dosing regimens leading to better patient compliance or efficacy.

  • Innovative formulation techniques improving shelf-life or controlled release.


Patent Landscape and Strategic Positioning

1. Prior Art Context

In considering the patent’s scope relative to existing inventions, patent search indicates:

  • Chemical Space: The compounds or formulations intersect with known classes, such as kinase inhibitors, peptides, or biologics, depending on the therapeutic area.

  • Previous Patents: The landscape includes filings from competitors and academia, often centered around similar compounds or mechanisms.

  • Novelty and Inventive Step: The patent's claims are likely supported by inventive steps over prior art, possibly through unique structural features, surprising efficacy, or improved pharmacokinetics.

2. Patent Family and Continuations

  • The applicant may have parent or related applications expanding or narrowing claims to fortify patent protection or address patent examiner rejections.

  • International filings in jurisdictions like Europe, Japan, or China could extend protection footprint.

3. Patent Thickets and Freedom-to-Operate

  • The landscape may encompass overlapping patents, requiring careful freedom-to-operate (FTO) analyses.

  • The patent's broad or specific claims influence license strategies or the design of follow-on compounds.

4. Enforceability and Litigation Considerations

  • Strength depends on claim validity, written description, and enablement.

  • The patent's scope must be balanced against prior art to withstand potential challenges under patent laws such as obviousness and sufficiency.


Implications for Industry and Innovation

  • The patent provides a solid barrier against competitors, fostering exclusive commercial rights.

  • Its scope influences R&D directions, incentivizing innovation around the protected compounds or methods.

  • Litigation or licensing negotiations hinge on detailed claim interpretation and landscape positioning.


Key Takeaways

  • U.S. Patent 10,603,290 establishes a potentially broad or strategically narrow scope, depending on claim drafting and prosecution history.

  • Its claims likely cover specific chemical entities, formulations, or therapeutic methods pertinent to a niche but valuable segment of pharmaceuticals.

  • The patent's positioning within the active patent landscape determines its enforceability, licensing potential, and influence on future innovation.

  • A comprehensive FTO assessment must incorporate the patent's claims and relevant prior art to guide development pipelines.

  • Continued monitoring of related patent filings and legal status is essential for maintaining competitive advantages.


FAQs

Q1: How do the claims of patent 10,603,290 influence the development of similar drugs?
A: The claims delineate what is legally protected; broad claims can restrict competitors from developing similar compounds or formulations, requiring careful design-around strategies.

Q2: Can the patent be challenged based on prior art or obviousness?
A: Yes. Patent validity can be questioned if prior art discloses similar compounds, methods, or formulations, or if the claimed invention lacks an inventive step.

Q3: What is the importance of dependent claims in this patent?
A: Dependent claims narrow the scope, offering fallback positions and fortifying overall patent strength against validity challenges.

Q4: How does the patent landscape influence licensing deals?
A: A strong, broad patent can command higher licensing fees and provide leverage for negotiations, especially if it covers key therapeutic compounds.

Q5: What strategies can applicants pursue to strengthen future patents related to this innovation?
A: Applicants should file continuation applications with diversified claims, seek international protections, and continuously monitor prior art to refine claim scope and robustness.


References

  1. [1] U.S. Patent No. 10,603,290.
  2. [(Additional references as applicable, depending on actual patent content)]

Note: For an exact and detailed claim-by-claim analysis, access to the full patent document is necessary.

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Drugs Protected by US Patent 10,603,290

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Ucb Inc FINTEPLA fenfluramine hydrochloride SOLUTION;ORAL 212102-001 Jun 25, 2020 RX Yes Yes 10,603,290*PED ⤷  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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