Last updated: April 23, 2025
Overview of Key Findings
The Brazilian patent BR112020009867A2, titled "Composição Formadora de Cremosidade" (Creaminess-Forming Composition), pertains to betulin-containing birch bark extracts and their formulations for therapeutic and cosmetic applications. This patent, part of a global family including WO2019134982A1 and US11083733B2, emphasizes novel extraction methods, stabilization techniques, and specific medical uses. Its claims span formulations (e.g., oleogels, emulsions), manufacturing processes, and treatment applications for skin conditions like ulcers and radiodermatitis[1][2][3][9]. The patent reflects a strategic focus on natural product innovation, aligning with Brazil’s growing bioinputs sector[7].
Technical Scope and Claim Analysis
Extraction and Formulation Methods
The patent claims a method for extracting betulin from birch bark using non-polar solvents such as hexane or pentane, followed by purification steps to isolate triterpenes[1][2]. Key formulation innovations include:
- Oleogel-Based Delivery Systems: Betulin is integrated into oleogels (oil-based semi-solid matrices) to enhance stability and skin permeability. These oleogels combine birch bark extract with oils like sunflower or coconut oil and gelling agents (e.g., hydrogenated castor oil)[1][9].
- Emulsions: Water-in-oil (w/o) emulsions are prioritized for topical use, ensuring prolonged release and reduced irritation[2][3].
- Creaminess Optimization: The composition’s texture is tailored for consumer acceptability, leveraging emulsifiers like glyceryl stearate and cetyl alcohol[9].
Therapeutic Claims
The patent specifies treating:
- Chronic Skin Lesions: Including diabetic ulcers, pressure sores, and radiation-induced dermatitis[1][2].
- Inflammatory Conditions: Such as eczema and psoriasis, attributed to betulin’s anti-inflammatory and antimicrobial properties[3][9].
- Wound Healing: Accelerated tissue regeneration through triterpene-mediated modulation of cytokine expression[2].
Manufacturing and Stability
Claims cover sterilization methods (e.g., gamma irradiation) and shelf-life extension via antioxidant additives like tocopherol[1]. The inclusion of propellants in aerosol formulations is also protected, enabling sprayable products[2].
Patent Landscape in Brazil
Competitive Positioning
- Bioinputs Regulation: Brazil’s new bioinputs law (Law #15,070/2024) incentivizes natural product innovation, creating opportunities for betulin-based therapies[7]. However, on-farm production allowances may risk unauthorized replication of patented formulations without robust oversight[7].
- Local Competitors: While BR112020009867A2 is not listed among expiring patents in Brazil[6], competing natural extract patents (e.g., Morus alba for diabetes) highlight the need for strong differentiation in claims[6][12].
- Global Family Strength: With 26 family members across jurisdictions, including the US, EU, and China, the patent demonstrates a multinational filing strategy[3][9]. This broad coverage mitigates market entry risks but requires careful navigation of enablement standards, particularly for functional genus claims[14].
Regulatory and Maintenance Considerations
- Annuity Fees: Brazilian patent maintenance requires annual payments starting from the third year post-filing[13]. For BR112020009867A2 (filed in 2019), fees accrued from 2022 onward, with a six-month grace period for late payments[13].
- Enablement Requirements: Recent U.S. Supreme Court rulings (Amgen v. Sanofi) emphasize that broad functional claims must disclose a “general quality” unifying the genus[14]. While BR112020009867A2’s formulation claims are structurally defined, international enforcement may face challenges if deemed overly broad without representative examples[14].
Strategic Recommendations
For Patent Holders
- Strengthen Domestic Enforcement: Monitor on-farm production under Brazil’s bioinputs law to prevent infringement[7].
- Expand Therapeutic Indications: File secondary patents for new uses (e.g., oncology-supportive care) to extend exclusivity.
- Leverage PatentSight Analytics: Use competitive impact metrics to identify licensing opportunities and assess rival portfolios[12].
For Competitors
- Design-Around Strategies: Develop alternative extraction solvents (e.g., supercritical CO₂) or synthetic betulin derivatives to bypass existing claims[1][11].
- Challenge Enablement: Argue undue experimentation if the patent’s guidance for formulating creaminess is insufficient[14].
Conclusion
BR112020009867A2 exemplifies Brazil’s evolving role in natural product innovation, combining traditional knowledge with advanced formulation science. Its scope is robust in extraction and delivery methods, but its landscape is shaped by regulatory shifts in bioinputs and global enablement standards. For stakeholders, proactive portfolio management and vigilance against infringement will be critical to maximizing commercial potential.
References
- https://patents.google.com/patent/WO2019134982A1/en
- https://patents.google.com/patent/US11083733B2/en
- https://pubchem.ncbi.nlm.nih.gov/patent/EP-4249057-A2
- https://curity.io/resources/learn/scopes-vs-claims/
- https://curity.io/resources/learn/scopes-claims-and-the-client/
- https://www.drugpatentwatch.com/p/expiring-drug-patents-generic-entry/Brazil
- https://patentblog.kluweriplaw.com/2025/01/13/brazil-understanding-the-new-bioinputs-regulation-and-patent-landscape/
- https://static.poder360.com.br/2025/03/Estudo-The-Brazilian-Landscape-of-Science-Technology-and-Innovation-in-Artificial-Intelligence-1.pdf
- https://patents.google.com/patent/BR112020009867A2/de
- https://www.scielo.br/j/rgenf/a/4PjnTHmYRFqzskPqZbQjTGL/
- https://chinapatentstrategy.com/compositions-limited-by-use-a-cautionary-tale/
- https://www.lexisnexisip.com/resources/patent-landscape-analysis/
- https://cnv.com.br/everything-about-patent-maintenance-fees-in-brazil/
- https://www.thepatentplaybook.com/2023/05/the-supreme-court-kept-the-door-open-to-genus-claims/
