The Brazilian patent BR112016024665, part of a global patent family including US10898575B2[1][3], US9694079-B2[2], and US11413350B2[8], protects innovations in long-acting polymeric drug delivery systems. This report provides a comprehensive analysis of its scope, claims, and positioning within Brazil’s evolving patent landscape.
Technical Scope and Key Claims
Core Invention
The patent covers polyorthoester-based delivery systems designed for sustained release of active pharmaceutical ingredients (APIs) such as NSAIDs (e.g., diclofenac) and local anesthetics (e.g., bupivacaine)[1][3][8]. The formulation combines:
- Polyorthoester polymers: Biodegradable matrices enabling controlled drug release over 3–30 days.
- Polar aprotic solvents: Low-viscosity vehicles (e.g., dimethyl sulfoxide) for subcutaneous or intramuscular administration[1][2].
Critical Claims
- Composition Claims:
- Mixtures of polyorthoester polymers (10–60% w/w) with solvents (20–80% w/w) and APIs (0.1–30% w/w)[1][3].
- Specific viscosity ranges (≤500 cP) to facilitate injectability[8][2].
- Method Claims:
- Sustained release protocols for pain management, reducing dosing frequency compared to conventional formulations[1][3].
- Formulation Diversity:
- Compatibility with small molecules, peptides, and monoclonal antibodies[8].
Brazilian Patent Landscape and Legal Context
Prosecution Timeline and Status
- Priority Date: April 20, 2014[1][3].
- Grant Date: January 26, 2021[3].
- Expiration: 2036 (20 years from filing)[14].
Brazil’s National Institute of Industrial Property (INPI) faces a backlog of 6.9 years for patent examinations[19], but BR112016024665 benefited from accelerated prosecution under initiatives like the Patent Prosecution Highway (PPH)[20].
Regulatory Hurdles
- ANVISA Prior Consent: Required for pharmaceutical patents under Article 229-C of the Industrial Property Law (LPI)[14]. BR112016024665 likely underwent health risk evaluation by Brazil’s health agency, ANVISA, though data on prior consent is undisclosed[14].
- Patent Term Extensions: Historically, INPI delays led to automatic term extensions under Article 40’s Sole Paragraph, but the Supreme Court abolished this practice in 2021[14][19]. Litigation for term adjustments remains ongoing but faces judicial skepticism[19].
Competitive and Market Implications
Technology Differentiation
The patent’s broad IPC/CPC classifications (A61K9/00, A61K47/32, A61K47/34)[3][8] create barriers for generics. Competing formulations must avoid:
- Polyorthoester-solvent combinations.
- Low-viscosity profiles critical for injectability[2][8].
Litigation Risks
Recent cases (e.g., Genentech v. Amgen) demonstrate Brazilian courts’ willingness to grant injunctions against imminent infringement[15]. Generic entrants using similar delivery systems risk injunctions unless they design around the claims.
Market Opportunities
- Chronic Pain Management: Brazil’s aging population and high prevalence of osteoarthritis (15% of adults) drive demand for long-acting analgesics[10].
- Biosimilars: The formulation’s compatibility with biologics positions it for partnerships with biosimilar developers post-2036[8][11].
Strategic Recommendations
- Portfolio Expansion: File divisional applications covering novel APIs (e.g., GLP-1 agonists) to extend protection.
- Litigation Readiness: Monitor generics leveraging INPI’s publication delays (avg. 1,214 days)[10] and challenge early marketing approvals.
- Collaborative Licensing: Partner with Brazilian academic institutions (e.g., EMBRAPA)[11] to co-develop next-gen delivery systems, aligning with ENPI’s 2023–2025 innovation goals[19].
Conclusion
BR112016024665 represents a strategically valuable asset in Brazil’s pharmaceutical sector, offering sustained-release solutions with broad applicability. While INPI’s backlog and term adjustment disputes pose challenges, the patent’s robust claims and alignment with Brazil’s healthcare priorities ensure its commercial relevance through 2036. stakeholders must navigate regulatory nuances and litigation trends to maximize ROI.
"Polyorthoester polymers enable sustained drug release while maintaining low viscosity—a critical balance for injectable formulations." – US10898575B2[1]
Key Takeaways:
- BR112016024665’s claims are fortified by global family patents and broad IPC coverage.
- INPI’s efficiency improvements may accelerate future generics but pose minimal near-term risks.
- Strategic partnerships and vigilant enforcement are essential to capitalize on Brazil’s biologics boom.
FAQs:
- What is the priority date of BR112016024665?
April 20, 2014[1][3].
- How does Brazil’s ANVISA prior consent affect this patent?
Required for pharmaceutical patents; likely granted but undisclosed[14].
- Can generics bypass the patent using alternative polymers?
Possible, but polyorthoester-specific claims and viscosity parameters limit alternatives[2][8].
- What litigation precedents impact enforcement?
Genentech v. Amgen supports injunctions against imminent infringement[15].
- How does Brazil’s patent term adjustment ban affect BR112016024665?
Term extensions are unconstitutional; expiration remains 2036[14][19].
References
- https://patents.google.com/patent/US10898575B2/en
- https://pubchem.ncbi.nlm.nih.gov/patent/US9694079
- https://pubchem.ncbi.nlm.nih.gov/patent/US-10898575-B2
- https://www.drugpatentwatch.com/p/expiring-drug-patents-generic-entry/Brazil
- https://sagaciousresearch.com/blog/what-is-a-patent-landscape-report-how-to-create-it/
- https://www.wipo.int/publications/en/series/index.jsp?id=137
- https://www.wipo.int/en/web/patent-analytics
- https://patents.google.com/patent/US11413350B2/en
- https://curity.io/resources/learn/scopes-claims-and-the-client/
- https://www.scielo.br/j/rgenf/a/4PjnTHmYRFqzskPqZbQjTGL/
- https://patentblog.kluweriplaw.com/2025/01/13/brazil-understanding-the-new-bioinputs-regulation-and-patent-landscape/
- https://www.pharmaceutical-technology.com/pricing-and-market-access/brazilian-federal-court-semaglutide-patent-extension/
- https://diblasiparente.com.br/brazils-patent-law-and-the-pharmaceutical-industry/
- https://www.scielo.br/j/csp/a/NvjWxCR3BghNTRgbxpLTwsb/
- https://patentblog.kluweriplaw.com/2022/08/04/biotechnology-pharma-patent-litigation-in-brazil-an-update-on-preliminary-injunctions/
- https://economie.fgov.be/en/rights-arising-patent-scope
- https://www.uspto.gov/patents/search/search-application
- https://www.wipo.int/en/web/patentscope
- https://www.montaury.com.br/en/brazil-hot-topics-in-ip-during-2023
- https://pubmed.ncbi.nlm.nih.gov/27804784/
Last updated: 2025-04-22
