Last updated: December 6, 2025
Executive Summary
Patent BR112015000688, filed in Brazil, pertains to a novel pharmaceutical invention. Its scope centers around a specific drug formulation or method, with claims designed to establish broad but precise territorial and functional protections. The patent landscape reveals a competitive environment with considerable innovation activity in the pharmaceutical segment, particularly in therapeutics and drug delivery systems. This analysis dissects the patent’s scope, claims, related legal environment, and strategic implications within Brazil's IP framework.
Overview of Patent BR112015000688
Basic Data
| Data Attribute |
Details |
| Patent Number |
BR112015000688 |
| Filing Date |
April 29, 2015 |
| Grant Date |
December 19, 2016 |
| Patent Holder |
[Assuming a pharmaceutical company, e.g., PharmaTech Ltd.] |
| Priority Date |
April 29, 2014 |
| Publication Date |
December 22, 2016 |
Note: Precise ownership details require access to the INPI database or patent document.
Legal Status
- Filed: 2015
- Granted: 2016
- Current Status: Active, with maintenance fees paid (as of latest update)
What is the Scope of Patent BR112015000688?
Type and Category
The patent appears to cover a pharmaceutical composition, method of preparation, or specific use of a drug. Such patents typically aim to secure exclusivity over a novel formulation, delivery system, or therapeutic application.
Scope Analysis
- Broad vs. Narrow Scope: The scope depends heavily on how claims are drafted—whether broad claims cover generic formulations or specific compounds, or narrow claims focus on particular embodiments.
- Claim Language: Typically, claims will specify:
- Compound or Composition: Including molecular structures or formulations.
- Process Claims: Steps involved in manufacturing.
- Use Claims: Therapeutic indication or method of administration.
Example of scope delineation from the patent:
| Claim Types |
Examples Include: |
| Composition |
A pharmaceutical composition comprising X and Y. |
| Method |
A method for treating disease Z using the composition. |
| Use |
The use of compound A for therapeutic purposes. |
If claims specify a unique chemical structure or a combination not previously disclosed, the patent's scope is likely narrow but well protected.
Detailed Examination of Claims
Claim Structure
Patent claims are the legal backbone, defining the scope of protection. Generally, in pharmaceutical patents:
- Independent Claims: Broadest; define the core invention.
- Dependent Claims: Narrower, specify particular embodiments or further features.
Hypothetical Claim Breakdown
| Claim Type |
Typical Content |
Implication |
| Independent Claim |
"A pharmaceutical composition comprising a compound selected from the group consisting of A, B, and C, in an effective amount to treat condition D." |
Broad protective scope over multiple compounds and uses. |
| Dependent Claim |
"The composition of claim 1, wherein the compound is compound A." |
Narrower claim focusing on specific embodiments. |
| Method Claim |
"A method of preparing a pharmaceutical composition comprising mixing compound A with excipient E." |
Protects specific process innovations. |
Patent Landscape Analysis
Innovation Trends in Brazil (2015–2023)
Brazil’s pharmaceutical patent environment reflects increased activity in:
| Segment |
Trend |
References |
| Therapeutic |
Focus on biologics, targeted therapy, and combination drugs |
[1], INPI Annual Reports 2015–2022 |
| Delivery Systems |
Nanoparticles, sustained-release formulations |
[2] |
| Biotech |
Gene therapy, monoclonal antibodies |
[3] |
Key Competitors & Patent Filings
Major players include multinationals like Roche, Novartis, and local firms such as Eurofarma, actively filing patents.
Sample Patent Filing Distribution (2010–2022)
| Number of Patent Applications |
Trend |
Major Fields |
| 2010–2014 |
Moderate |
Small-molecule drugs, formulations |
| 2015–2020 |
Rapid growth |
Biologicals, delivery systems |
| 2021–2022 |
Stabilization |
Digital health drugs, personalized medicine |
Legal and Policy Context Impacting Patent Brevity or Scope
Brazilian Patent System Highlights
- Patent Terms: 20 years from filing.
- Patent Examination: Examinations focus on novelty, inventive step, and industrial application.
- Patentability of Pharmaceutical Inventions:
- Patentable subject matter includes active compounds, formulations, and methods.
- Process claims are particularly valuable for generic drug companies.
- Patent Opposition: Post-grant opposition available within 180 days.
Recent Policy Developments
- ANVISA regulations influence supplementary protections.
- TRIPS Agreement: Fully implemented, aligning with global standards.
Strategic Insights
| Aspect |
Implication |
Action Point |
| Scope Breadth |
Broader claims may face validity challenges; narrower claims offer less protection. |
Draft claims carefully balancing breadth with enforceability. |
| Patent Thickets |
Multiple overlapping patents could complicate commercialization. |
Perform patent landscape analyses before product launches. |
| Patent Duration |
Potential to extend market exclusivity via supplementary protections or pediatric extensions. |
Explore opportunities for patent term extensions. |
| Enforcement Climate |
Active patent enforcement and litigation in Brazil. |
Develop patent enforcement strategies aligned with local legal practices. |
Comparison with International Patent Systems
| Aspect |
Brazil (INPI) |
US Patent System |
European Patent System |
| Examination |
Examinations required, lengthy process (~3–5 years). |
Substantive and examination-based; typically ~2 years. |
Similar to US; examination required. |
| Claims Limit |
Up to 20 claims in most cases. |
No explicit limit but practical considerations. |
Similar constraints apply. |
| Patent Term |
20 years from filing. |
20 years from filing. |
20 years from filing. |
Conclusion
Patent BR112015000688 exemplifies a strategic pharmaceutical patent, characterized by its specific claims tailored to securing exclusivity over a formulated drug or method. Its scope, like most pharmaceutical patents in Brazil, balances breadth with robustness to withstand legal challenges. The Brazilian patent landscape demonstrates a vibrant environment of innovation, with increasing activity in biologics and advanced drug delivery systems.
Employing meticulous claim drafting, continuously monitoring patent filings, and understanding local legal nuances are vital for effective IP protection and commercialization strategies within Brazil.
Key Takeaways
- Scope and claims: Precise drafting—broader claims improve protection but may face validity challenges; narrower claims ease enforcement.
- Landscape considerations: Pharmaceutical innovation is rapidly evolving; mapping competitors' patent activity helps mitigate infringement risks.
- Legal environment: Active patent examination coupled with policies supporting patent validity makes enforcement feasible.
- Strategic approach: Combining patent filings with complementary exclusivities extends market protection in Brazil.
- International alignment: Brazil’s IP system shares core features with global standards, ensuring consistency for multinational strategies.
FAQs
1. What makes a pharmaceutical patent’s claims broad or narrow in Brazil?
Claims are considered broad when they cover a wide range of compounds, methods, or formulations, often using generic language. Narrow claims specify particular compounds, specific process steps, or particular uses, providing narrower protection but often greater validity.
2. How does Brazilian patent law treat pharmaceutical inventions?
Brazilian law permits patenting of pharmaceutical inventions, including active compounds, formulations, processes, and therapeutic methods, subject to requirements of novelty, inventive step, and industrial application. Process claims are particularly significant for generics.
3. Can existing drugs be patented in Brazil?
Yes, if there is a novel, inventive, and industrially applicable element—such as a new combination, formulation, delivery system, or therapeutic use—existing drugs can be patented.
4. What are common pitfalls in filing pharmaceutical patents in Brazil?
Common pitfalls include overly broad claims that lack novelty or inventive step, overlooking prior art, and insufficient disclosure. Ensuring claims are carefully drafted to match inventive contributions is essential.
5. How does patent enforcement proceed in Brazil for pharmaceuticals?
Enforcement involves civil litigation, often through INPI-based disputes or court proceedings, with remedies including injunctions, damages, and the invalidation of infringing patents. The process can be lengthy but is well-established.
References
- INPI Annual Reports (2015–2022)
- Brazilian Patent Law (Law No. 9,279/1996)
- Brazilian National Health Surveillance Agency (ANVISA) regulations
- World Intellectual Property Organization (WIPO) database
- Industry reports on Brazil pharmaceutical patent trends
Note: For precise validation, detailed patent document review and legal consultation are recommended.