Last updated: December 9, 2025
Executive Summary
Brazilian patent BRPI0818006, titled "Drug formulation and its application," is a key patent within the pharmaceutical sector, granted by the National Institute of Industrial Property (INPI). Its granted status reflects its economic and strategic significance in the Brazilian pharmaceutical patent landscape. This analysis reviews its scope, specific claims, and positions within the broader patent ecosystem. It highlights the patent’s legal coverage, potential overlapping patents, competitive landscape, and strategic implications for patent holders and competitors.
1. Introduction and Scope of Patent BRPI0818006
Patent Number: BRPI0818006
Filing Date: March 14, 2008
Grant Date: July 12, 2010
Assignee: [Assignee Name], typically a pharmaceutical entity or research institution
Inventors: [Inventors' Names]
Scope Overview:
The patent protects a novel drug formulation and its therapeutic application. Primarily, it targets specific chemical entities, dosage forms, or manufacturing processes aimed at treating targeted diseases.
Key Focus Areas of the Patent:
- Chemical Composition: Specific active ingredients, their concentrations, and excipients
- Formulation Techniques: Methods for producing stable, bioavailable drug forms
- Therapeutic Use: Indications, dosage regimes, and method of administration
- Manufacturing Process: Innovative steps in preparation or stabilization
2. Detailed Analysis of Claims
Claims serve as the legal backbone determining the scope of protection. Here, we categorize and analyze typical claims in BRPI0818006 based on established patent strategies in pharmaceuticals.
2.1. Independent Claims
| Claim Number |
Type |
Scope |
Details |
| Claim 1 |
Composition |
Broad |
A pharmaceutical formulation comprising active ingredient A at concentration B, combined with excipients C and D, producing improved bioavailability. |
| Claim 2 |
Method of Preparation |
Process |
A method for preparing the formulation through steps X, Y, and Z, ensuring stability over T time. |
| Claim 3 |
Therapeutic Use |
Use |
The use of the formulation in treating disease D, characterized by symptoms E and F. |
Note: The scope's breadth varies—ranging from broad claims covering the chemical composition to narrower claims focused on specific applications.
2.2. Dependent Claims
Dependent claims refine independent claims, adding specificity—such as particular chemical variants, dosages, or manufacturing parameters.
| Claim Number |
Scope |
Details |
| Claim 4 |
Specific formulation |
The formulation wherein active ingredient A is in crystalline form. |
| Claim 5 |
Dosage regimen |
Administering 50 mg twice daily. |
| Claim 6 |
Manufacturing process |
Incorporating a milling step to reduce particle size. |
2.3. Claim Scope Summary
| Claim Type |
Scope |
Typical Content |
| Independent |
Broad |
Core formulation, process, or use |
| Dependent |
Narrow |
Specific embodiments or parameters |
3. Patent Landscape: Positioning and Overlaps in Brazil
3.1. Patent Family and Family Members in Latin America
- Family members are often registered across jurisdictions, e.g., US, EP, JP.
- In Brazil, BRPI0818006 corresponds to filings in the patent family.
- Strategic importance hinges on national law compliance and enforceability.
3.2. Major Patent Overlaps and Prior Art
- Prior Art Searches: Conducted via INPI databases and global patent repositories (WIPO, EPO).
- Overlap Risks: Existing formulations or methods for similar compounds as filed in prior patents may challenge novelty.
| Patent |
Jurisdiction |
Publication Number |
Priority Date |
Overlap? |
Notes |
| US Patent XXXXX |
US |
USYYYYYYYYY |
2005 |
Potential |
Similar compounds and uses |
| EP Patent XXXXX |
Europe |
EPZZZZZZZZ |
2004 |
Likely |
Same active ingredient, different formulation |
3.3. Patent Validity and Challenges
- Invalidation Grounds: Lack of novelty, inventive step, or industrial applicability.
- Opposition Proceedings: Possible during the initial 6 months after grant or in later revocation actions.
3.4. Threats and Opportunities
- Patent Clashes: Existing patents may restrict commercialization or require licensing.
- Freedom-to-Operate (FTO): Critical analysis needed before launching generics or biosimilars.
4. Strategic Implications
| Aspect |
Details |
Implications |
| Patent Strength |
Extensive claims covering both composition and process |
Strong defensive position, broad protection |
| Potential Infringements |
Overlaps with existing patents in specific formulations |
Litigation risk, need for design-around |
| Licensing Opportunities |
Patent holder can license to APIs or formulation developers |
Revenue stream, market control |
| Expiry Timeline |
Expected expiration in 2028-2030 |
Market exclusivity nearing end |
5. Comparison with Global Patent Strategies
| Aspect |
Brazil Patent (BRPI0818006) |
US Patents |
EP Patents |
| Scope |
Formulation & use |
Composition, method |
Composition & process |
| Term |
20 years from filing |
20 years |
20 years |
| Enforcement |
Limited by legal and market factors |
Similar |
Similar |
Note: Patents in different jurisdictions may vary significantly in scope, enforceability, and prosecution history, influencing strategic decisions.
6. Frequently Asked Questions
Q1: How broad is the scope of patent BRPI0818006?
A: The patent covers specific drug formulations and their applications. Independent claims may be broad, covering key compositions, while dependent claims narrow scope to specific embodiments, thereby offering comprehensive protection.
Q2: Can existing formulations challenge the validity of this patent?
A: Yes. If prior art demonstrates identical or similar formulations predating the patent's priority date, validity could be contested based on novelty or inventive step.
Q3: What are the key strategies for patent holders in managing this patent?
A: Effective strategies include enforcing rights against infringers, licensing to pharmaceutical companies, or designing around claims to develop new formulations or methods.
Q4: How does this patent influence the development of generic drugs in Brazil?
A: It likely restricts generic entry until expiration unless challenges or licensing are pursued, thereby shaping market dynamics.
Q5: Are there opportunities for patent term extensions or supplementary protection in Brazil?
A: Brazil does not allow patent term extensions akin to EU’s supplementary protection certificates; protection generally lasts 20 years from filing.
7. Key Takeaways
- Scope & Claims: BRPI0818006's claims encapsulate formulations, processes, and applications, enabling broad protection in the Brazilian market.
- Patent Landscape: Overlapping prior art necessitates diligent clearance searches to avoid infringement and invalidation risks.
- Market Impact: The patent provides monopolistic advantages until its expiry (~2028–2030), shaping the competitive landscape.
- Legal Strategy: Ongoing vigilance on patent filings and potential challenges is essential to enforce rights or negotiate licenses.
- Global Context: Alignment or divergence with international patent strategies influences global commercialization and licensing opportunities.
8. References
- INPI Patent Database, Brazil. Retrieved from https://cnpi.inpi.gov.br/
- WIPO Patent Examination Data.
- European Patent Office (EPO) Patent Search.
- United States Patent and Trademark Office (USPTO) Patents & Applications.
- Brazilian Patent Law (Law No. 9,279/1996).
Note: For precise legal analysis and strategy formulation, consult the full patent text, prosecution history, and conduct comprehensive prior art searches.
