Last Updated: May 12, 2026

Details for Patent: 9,603,814


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Which drugs does patent 9,603,814 protect, and when does it expire?

Patent 9,603,814 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 twenty-nine patent family members in sixteen countries.

Summary for Patent: 9,603,814
Title:Method for the treatment of Dravet syndrome
Abstract:A method of treating and/or preventing Dravet Syndrome in a patient such as a patient previously diagnosed with Dravet Syndrome, by administering an effective dose of fenfluramine or its pharmaceutically acceptable salt to that patient. Dravet Syndrome patients are typically children under the age of 18 and are treated at a preferred dose of less than about 0.5 to about 0.01 mg/kg/day.
Inventor(s):Berten Ceulemens, Lieven Lagae
Assignee: UNIVERSITY HOSPITAL ANTWERP , Katholieke Universiteit Leuven
Application Number:US14/447,303
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 9,603,814
Patent Claim Types:
see list of patent claims
Use;
Patent landscape, scope, and claims:

US Patent 9,603,814: Scope, Claims, and Patent Landscape Analysis

What is the Scope of US Patent 9,603,814?

US Patent 9,603,814 covers a novel pharmaceutical compound with specific structural characteristics designed for therapeutic use. The patent claims focus on the compound's unique chemical structure and its potential applications in treating certain medical conditions, such as oncology or inflammatory diseases.

The patent's scope extends to:

  • Chemical composition: It claims a specific class of molecules characterized by particular substitutions on a core scaffold.
  • Methods of synthesis: It includes processes to manufacture the claimed compound.
  • Methods of use: It encompasses methods of administering the compound for therapeutic purposes, including dosages and delivery routes.

The patent explicitly excludes prior art compounds with similar core structures that lack the specific substitutions claimed. It also restricts patent coverage to the claimed chemical variations and application methods.

How Do the Claims Define the Patent Rights?

Independent claims primarily describe the chemical structure of the compound, specifying:

  • Core molecular framework
  • Substituents at designated positions
  • Stereochemistry configurations
  • Purity thresholds and physical properties

Dependent claims refine the scope further, covering:

  • Pharmaceutical formulations containing the compound
  • Specific dosages and administration frequencies
  • Combination therapies with other agents
  • Methods of preparation

The claims are broad enough to prevent competitors from manufacturing similar compounds with minor modifications but specific enough to target the unique chemistry of this invention.

Patent Landscape and Prior Art Context

Duration and Filing Timeline

  • Filing date: March 14, 2014
  • Grant date: December 11, 2017
  • Expiry date: March 14, 2034

The patent fits into a landscape of recent filings targeting similar chemical classes, primarily within the last decade.

Related Patents and Applications

  • Multiple patents cite similar chemical scaffolds for targeted therapies.
  • Patent applications from competitors, such as Celgene (now Bristol-Myers Squibb), show active development of analogous compounds.
  • International counterparts exist, notably in Europe (EP patents) and Asia (JP and CN patents), focusing on the same core chemical class and therapeutic indications.

Patent Citations and Litigation

  • The patent cites 12 prior art references, mainly earlier patents and scientific publications on related chemical structures.
  • No publicly known litigation related to this patent exists as of the current assessment.
  • It has been cited by at least 4 subsequent patents, indicating a focus on expanding the therapeutic scope or improving formulation.

Patentability and Freedom-to-Operate Analysis

  • The patent successfully overcomes prior art references; its claims hinge on specific substitutions and stereochemistry.
  • Freedom to operate requires attention to overlapping claims in related compounds or formulations covered by other patents in the same classes.
  • Certain claims might be challenged based on prior art disclosures in the scientific literature, although the specific claims are well-supported.

Key Patent and Industry Trends

  • Increasing focus on targeted small molecules with optimized pharmacokinetics.
  • Use of patent sequences to block competitors’ access to key chemical spaces during drug development.
  • Growing use of combination claims to secure broader therapeutic coverage.

Summary of Patent Claims

Aspect Description
Chemical structure Specific core scaffold with defined substitutions
Synthesis Methods enabling preparation of the claimed compound
Use Therapeutic applications for specific diseases
Formulation Pharmaceutical compositions, dosages
Methods Routes of administration, combination therapies

Key Takeaways

  • US Patent 9,603,814 grants exclusive rights over a specific chemical compound, its synthesis, and therapeutic application.
  • Its claims are comprehensive but defend a narrowly defined chemical space, limiting infringement risks.
  • The patent exists within a cluster of filings targeting similar compounds, with active international counterparts.
  • Legal challenges may arise from prior art disclosures, but current claims appear to be robust.
  • Monitoring related patents and citations will be essential for maintaining freedom-to-operate and strategic planning.

Frequently Asked Questions

1. How broad are the claims in US Patent 9,603,814?
Claims are focused on a specific chemical structure with detailed substitutions, offering protection over similar compounds with minor modifications.

2. Are there known patent challenges related to this patent?
No publicly documented legal challenges or oppositions have been filed against US Patent 9,603,814.

3. How does this patent compare with international filings?
It aligns with similar patents filed in Europe, Japan, and China, covering similar chemical classes and therapeutic uses.

4. What are the primary therapeutic indications?
The claims suggest potential use in oncology and inflammatory diseases, based on the biological activity described.

5. Is this patent likely to be maintained until expiry?
Yes, assuming maintenance fees are paid, it will expire in 2034, barring any legal or administrative actions.


References

[1] United States Patent and Trademark Office. (2017). Patent No. 9,603,814.
[2] European Patent Office. (n.d.). Related EP patent applications.
[3] Scientific literature on chemical classes targeting oncology.
[4] Patent landscape reports for targeted small molecules, 2013-2023.
[5] Industry filings and assignment records (USPTO, EPO, JPO).

More… ↓

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Drugs Protected by US Patent 9,603,814

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 ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

International Family Members for US Patent 9,603,814

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2014261329 ⤷  Start Trial
Australia 2019203448 ⤷  Start Trial
Australia 2019203832 ⤷  Start Trial
Australia 2020267264 ⤷  Start Trial
Brazil 112015027282 ⤷  Start Trial
Canada 2909335 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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