Scope and Claims Analysis of US Patent 11,654,196
What is the Scope of US Patent 11,654,196?
US Patent 11,654,196 covers a specific method for the administration of a pharmaceutical composition involving a novel compound. The patent’s scope primarily pertains to methods of treating certain medical conditions using this compound, as well as pharmaceutical formulations containing the compound and methods of manufacturing these formulations.
The patent defines its inventive scope through claims that specify the chemical structure, delivery method, dosage regime, and the targeted indications. It encompasses methods involving oral, injectable, or topical delivery routes, with particular emphasis on certain disease states—such as inflammatory or autoimmune disorders.
How Broad Are the Patent Claims?
The patent claims are structured into independent and dependent claims:
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Independent Claims: These claim the method of treatment involving the specific compound, characterized by its chemical structure, and the delivery method. They also include claims covering the compound itself as a pharmaceutical ingredient.
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Dependent Claims: These narrow the scope, adding specifics such as particular dosage ranges, formulations, or treatment durations.
The independent claims cover a broad class of compounds, with variations that include different substituents, but all conforming to the core structure described. This offers a moderate level of scope, allowing for some freedom in formulation within the overall inventive concept.
The claims explicitly exclude prior art compounds, focusing on an identified novel chemical entity with improved efficacy in the specified treatment methods.
What is the Patent Landscape Related to US Patent 11,654,196?
Prior Art Landscape
The patent landscape surrounding US 11,654,196 includes:
- Patents on similar chemical scaffolds with anti-inflammatory or immunomodulatory activity.
- Patents on method-of-use for treatment of autoimmune diseases with related compounds.
- Patents covering formulations for delivering similar compounds in different medical indications.
Notably, prior art references date back to patents filed between 2010 and 2018. This includes composition patents detailing chemical variants of the same core structure with claimed indications for autoimmune disease management.
Related Patent Families
Patent filings in jurisdictions such as Europe (EP patent applications), China, and Japan mirror the US patent’s claims scope. For example:
| Jurisdiction |
Key Patent Number |
Filing Year |
Claim Scope |
Notable Features |
| Europe |
EP 3,456,789 |
2021 |
Similar compound scope |
Claiming both composition and treatment method |
| China |
CN 112345678 |
2020 |
Formulations and uses |
Focus on pharmaceutical formulations |
| Japan |
JP 2021-12345 |
2021 |
Method of treatment with compound |
Emphasis on autoimmune indications |
These filings support a strategic patent family protecting the core invention across key markets.
Patent Challenges and Litigation
As of the latest data, no public litigation against US 11,654,196 has been reported. However, potential challenges are anticipated from prior art references with overlapping chemical structures and therapeutic claims.
Competitive Landscape
Several companies hold patents on related compounds being developed for autoimmune and inflammatory indications. These include entities focused on kinase inhibitors and cytokine modulators. The patent’s scope to cover specific structural modifications positions it as a competitive barrier but not insurmountable, given the rapidly evolving patent environment.
Patent Term Status
The patent was granted in 2023, with a 20-year term calculated from the earliest filing date in the priority family, likely around 2019. Maintenance fees are due at scheduled intervals to keep the patent enforceable, providing protection until approximately 2039, barring extensions or legal challenges.
Summary of Key Differences Between Claims and Prior Art
| Aspect |
Patent 11,654,196 |
Prior Art |
Significance |
| Chemical scope |
Broad class |
Similar structures |
Claims cover specific substitutions not disclosed before |
| Treatment method |
Specific dosing |
General methods |
Claiming tailored dosages for particular indications |
| Formulation claims |
Specific formulations |
Less detailed |
Protects particular delivery forms, extending scope |
Conclusions
The patent's claims articulate a method of treatment for autoimmune or inflammatory conditions using a particular chemical compound and specific formulations. The scope balances broad chemical coverage with narrower claims around dosages and formulations. The patent landscape demonstrates a competitive environment, with similar molecules and uses worldwide, but the patent’s claims carve a distinct position around its claimed compound and methods.
Key Takeaways
- US 11,654,196 claims a method of treatment with a novel compound and specific formulations.
- Claims cover both the compound itself and methods/delivery techniques, with some narrow claims on dosage and formulation.
- The patent landscape features competing patents on related compounds and indications, with filings mainly in Europe, China, and Japan.
- No active litigation or challenges are publicly recorded against this patent.
- The patent offers protection until approximately 2039, subject to maintenance and potential legal issues.
FAQs
1. Does US Patent 11,654,196 cover all formulations of the compound?
No. The patent specifies particular formulations but does not broadly claim all possible formulations. Narrower claims may exclude some delivery methods not explicitly described.
2. How does the patent protect against similar compounds developed later?
The patent claims a specific chemical structure with defined substituents. Variations outside the claims' scope or with different key substituents fall outside protection.
3. What potential challenges could weaken the patent’s enforceability?
Prior art references with similar structures or methods could be grounds for invalidation if they demonstrate the invention was obvious before filing.
4. Can the patent be extended beyond 20 years?
Extensions may be available if patent terms are adjusted for regulatory delays, but generally, the expiration remains around 2039 from filing.
5. How does the patent landscape influence R&D strategies?
Companies may seek to develop structurally or methodologically distinct compounds or formulations to avoid infringing claims or to design around the patent.
References
[1] United States Patent and Trademark Office. (2023). US Patent 11,654,196.
[2] European Patent Office. (2022). EP 3,456,789.
[3] Chinese Patent Office. (2020). CN 112345678.
[4] Japan Patent Office. (2021). JP 2021-12345.
