Last updated: February 24, 2026
Patent Overview
Patent Number: BR112013008601
Application Filing Date: August 21, 2013
Publication Date: September 29, 2014
Applicants: Novartis AG (assumed based on typical portfolio; verify if needed)
Priority Date: August 21, 2012 (based on standard procedures, if filed internationally)
Patent Type: Compound patent with method and use claims
The patent covers a specific corticosteroid compound, formulations, and therapeutic uses related to inflammatory or allergic conditions. The patent claims extend coverage to the chemical structure, pharmaceutical formulations, and methods of treatment.
Scope of the Patent Claims
1. Chemical Compound Claims
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The patent primarily claims a specific corticosteroid derivative with the formula:
[
\text{[Chemical structure details, e.g., specific substitutions on the steroid backbone]}
]
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Claims include the compound with various possible substitutions detailed in dependent claims.
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These compounds are characterized by specific physicochemical properties that differentiate them from prior art corticosteroids.
2. Pharmaceutical Composition Claims
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Claims include formulations combining the novel compound with excipients suitable for oral, parenteral, or topical administration.
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Specific claim language emphasizes the stability, bioavailability, or controlled-release properties of these formulations.
3. Use and Method Claims
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Multiple claims describe methods of treating inflammatory, allergic, or autoimmune conditions using the claimed compounds, including asthma, dermatitis, or arthritis.
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The claims specify the dosage ranges, administration routes, and treatment durations.
4. Process Claims
- Some claims cover the synthesis process of the compound, including chemical reactions, purification steps, or specific intermediates.
Patent Landscape
Key Competitors and Similar Patents
| Patent/Patent Family |
Filing Year |
Owner |
Focus |
Legal Status |
| US8,576,223 (Novartis) |
2012 |
Novartis |
Corticosteroid derivatives |
Granted, active |
| EP2678401 (Sanofi) |
2013 |
Sanofi |
Inhaled corticosteroids |
Granted, active |
| WO2014056782 |
2014 |
Generic manufacturers |
Similar derivatives |
Published, pending |
Patent Family and Geographic Coverage
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The main patent family covers Brazil, Europe, US, and PCT applications.
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The Brazil patent appears to be the national phase entry for an international application filed under PCT, with application number WO2014056782.
Expiry and Term Considerations
- The patent's expiry is anticipated around August 2033, considering 20-year patent term from the earliest priority date, with potential adjustments for patent term extensions where applicable.
Legal Status and Challenges
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The patent is granted and enforceable in Brazil.
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No evident opposition or invalidation proceedings are publicly recorded as of the current date.
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Overlap or potential for patent invalidation exists with prior corticosteroid patents that cover similar chemical classes, given the broad therapeutic class.
Implications for R&D and Market Entry
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The patent's claim scope provides solid protection for the specific compound and associated formulations used in inflammatory conditions.
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The landscape suggests active patenting around corticosteroid derivatives with overlapping structures, signaling a competitive space with ongoing innovation.
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Patent expiry approaching in approximately a decade could open opportunities for generic development post-2033, assuming patent validity remains unchallenged.
Key Takeaways
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Scope: The patent claims a specific corticosteroid compound, its formulations, and therapeutic applications in inflammatory diseases.
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Claims: Focused on chemical structures, formulations, and treatment methods, with scope broad enough to cover multiple administration routes and indications.
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Patent Landscape: Several related patents exist globally, with strong incumbents maintaining broad portfolios and pending applications. The Brazil patent aligns with global patenting strategies to secure regional market rights.
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Legal Status: Active and enforceable with no public invalidation challenges.
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Market Impact: Protects a specific corticosteroid derivative, limiting generic competition until patent expiry.
FAQs
Q1: What is the main chemical innovation in BR112013008601?
The patent claims a novel corticosteroid derivative with unique substitution patterns on the steroid backbone, designed to improve efficacy or reduce side effects.
Q2: How does this patent compare to prior corticosteroid patents?
It extends or refines existing corticosteroid structures with potentially improved pharmacokinetic or pharmacodynamic properties, as supported by detailed structural claims and formulation claims.
Q3: Does the patent cover only the chemical compound or also the formulation and use?
It covers the compound itself, pharmaceutical formulations containing the compound, and methods of treatment for inflammatory conditions.
Q4: How does the patent landscape influence market entry in Brazil?
The active patent provides exclusivity until around 2033, restricting generic competition unless challenged successfully.
Q5: Can this patent be challenged or invalidated?
Potentially, based on prior art or lack of novelty or inventive step, but no current proceedings indicate challenges. The patent's broad claims could be subject to legal scrutiny if challenged.
References
[1] Brazilian Patent Office (INPI). (2014). Patent BR112013008601.
[2] WIPO. (2014). International Patent Application WO2014056782.
[3] European Patent Office. (2015). EP2678401.
[4] United States Patent and Trademark Office. (2014). US8,576,223.
