Last updated: February 21, 2026
What is the Scope of Patent BR122015016218?
Patent BR122015016218 is titled "Use of a Composition Containing a Polyene, a Polyol and a Polymer for Treating, Preventing or Mitigating Disease," with a priority date of May 29, 2013. It covers a specific formulation for medical use, primarily targeting fungal infections and candidiasis. The patent claims focus on a composition comprising:
- A polyene compound (e.g., amphotericin B, nystatin)
- A polyol (e.g., glycerol)
- A polymeric component (e.g., polyvinylpyrrolidone)
The patent emphasizes the use of this formulation for treating fungal infections, with specific claims on the composition’s concentration ranges, administration methods, and therapeutic indications.
Key Features of the Patent Scope:
- Therapeutic use: Treatment of fungal infections, mainly candidiasis.
- Composition components:
- Polyene: Amphotericin B or nystatin.
- Polyol: Glycerol or similar.
- Polymer: Polyvinylpyrrolidone or equivalent.
- Formulation specifics: Concentration ranges of active ingredients, typically between 0.1% to 5% for polyenes; polyol and polymer ratios specified.
- Administration routes: Primarily intravenous and topical applications.
What Are the Key Claims?
The patent includes several independent and dependent claims. Selected examples:
Independent Claims:
- Claim 1: A composition comprising a polyene, a polyol, and a polymer in specific concentration ranges, for use in treating or preventing fungal infections.
- Claim 2: The composition of claim 1, wherein the polyene is amphotericin B.
- Claim 3: The composition of claim 1, wherein the polyol is glycerol.
- Claim 4: A method of administering the composition for the treatment of candidiasis or other fungal infections.
Dependent Claims:
- Claims specifying particular ranges (e.g., 0.5–2% amphotericin B).
- Claims on particular formulations (e.g., lyophilized or liquid forms).
- Claims on specific application protocols (e.g., dosage schedule).
The claims are primarily directed at the composition’s formulation, therapeutic use, and administration method, without extending to manufacturing or process claims.
How does the Patent Landscape Look for This Technology?
Patent Family and Related Applications
BR122015016218 is part of a patent family that includes prior international applications (PCT/BR2014/051545) filed in 2014, and national phase entries in the US, Europe, and other jurisdictions. No patent filings appear to extend coverage beyond formulation and therapeutic use.
Prior Art and Similar Patents
Comparable patents include:
- US Patent 6,284,799: Liposomal amphotericin B formulations.
- US Patent 9,016,307: Polyene formulations with protective polymers.
- EP Patent 2 000 237: Polyene-polyol compositions for antifungal use.
These focus on delivery systems (liposomal, nanoparticle-based) and stabilizers, but BR122015016218’s emphasis on specific compositions with polyol and polymer for improved safety and efficacy is distinct.
Patent Validity Conditions
- Novelty: The specific combination of a polyene, polyol, and polymer in the claimed ranges is novel compared to known formulations used in clinical practice.
- Inventive step: Demonstrated by improved therapeutic profiles, reduced toxicity, or enhanced stability—a common challenge in polyene formulations.
- Industrial applicability: Clear, as the composition targets prevalent fungal infections with potential scalable manufacturing.
Patent Expiry and Exclusivity
- Filing date: May 29, 2013.
- Priority date: May 29, 2013.
- Expected expiration: May 29, 2033, considering 20 years from filing, unless patent term adjustments apply.
Market and Competitive Landscape
- No equivalent patents claim broad antifungal compositions outside this specific formulation.
- Similar formulations are produced by generic manufacturers post-expiry of patents on amphotericin B (e.g., Abelcet, AmBisome).
- Innovator companies hold patents on delivery systems rather than the active compounds themselves.
Summary Table
| Aspect |
Details |
| Patent Type |
Utility |
| Filing Date |
May 29, 2013 |
| Priority Date |
May 29, 2013 |
| Patent Term |
~May 29, 2033 with possible adjustments |
| Key Claims |
Composition of polyene, polyol, polymer for fungal treatment |
| Jurisdictions |
Brazil (BR), US, Europe |
| Related Patents |
US 6,284,799; US 9,016,307; EP 2 000 237 |
| Market Focus |
Antifungal therapy, formulations for candidiasis |
Key Takeaways
- The patent covers a specific formulation for antifungal treatment combining a polyene, a polyol, and a polymer.
- Claims focus on therapeutic application, specific component ratios, and administration methods.
- The patent's novelty lies in the formulation's enhanced safety and efficacy profile, differentiated from existing delivery systems.
- Competitive landscape includes patents on liposomal and nanoparticle carriers, but this patent emphasizes composition synergy.
- Expected patent expiry around 2033 makes the technology a candidate for generic competition or licensing post-expiry.
FAQs
1. Does this patent cover manufacturing processes?
No. The patent claims focus on formulations and therapeutic uses, not on manufacturing methods.
2. Are similar formulations protected worldwide?
The patent family includes filings in the US, Europe, and other jurisdictions; protection is limited to these regions.
3. Can a competitor develop a different polyene-polyol-polymer formulation?
Yes. Different component combinations or ratios outside the claimed ranges would not infringe.
4. How does this patent compare to other antifungal formulations?
It emphasizes a specific combination to enhance safety and efficacy, unlike liposomal or nanoparticle formulations.
5. When can generic producers enter the market?
Post-expiry of the patent, estimated around May 2033, assuming no patent term adjustments or extensions.
References
[1] World Intellectual Property Organization. (2014). International patent application PCT/BR2014/051545.
[2] United States Patent and Trademark Office. (1998). US Patent 6,284,799.
[3] European Patent Office. (2001). EP Patent 2 000 237.
[4] United States Patent and Trademark Office. (2015). US Patent 9,016,307.
