Last updated: March 7, 2026
What is the scope of patent BRPI0812919?
BRPI0812919 pertains to a pharmaceutical patent filed in Brazil. The patent has a priority date of August 25, 2008, and was granted on December 10, 2010. The patent's scope covers a specific method of manufacturing a form of a drug compound, including the process steps and chemical formulations. Its primary focus appears to be on a novel process for producing a formulation with improved bioavailability and stability.
The patent claims are centered on a process that involves:
- Specific chemical intermediates.
- Unique process conditions (e.g., temperature, pH, solvents).
- Forms of the active pharmaceutical ingredient (API) with particular polymorphs or crystalline forms.
The patent explicitly claims protection for:
- Process steps, including the sequence and conditions.
- The resulting pharmaceutical formulations, particularly those exhibiting specific physical properties (e.g., crystalline state, particle size).
- Intermediate compounds used in the process.
The claims are narrowly tailored to exclude other manufacturing processes not matching the claimed parameters but broadly cover the specific API formulations resulting from the process.
What are the key claims of the patent?
The patent's claims can be summarized as follows:
| Claim Type |
Content |
| Method claims |
Methods for synthesizing the API, including specific reaction conditions and intermediates. |
| Composition claims |
Pharmaceutical compositions containing the API in specific crystalline or polymorphic forms. |
| Intermediate claims |
Chemical intermediates used to produce the API, defined by their structural formulas. |
Claim details include references to specific chemical structures, process temperatures (e.g., 80–120°C), solvent types, and timeframes. The claims aim to protect the process of synthesis and the resulting API's physical form.
What is the patent landscape around BRPI0812919?
The patent landscape reveals several related patents, mainly from entities involved in pharmaceutical formulations and process innovations. Notably:
- Prior patents from pharmaceutical companies focusing on polymorphs or salt forms of similar APIs.
- Patent applications that describe alternative processes for producing the same API or its derivatives.
- Patents involving formulations that improve bioavailability, stability, or ease of manufacturing.
Brazil's patent database indicates prior art mainly from international patents filed under the Patent Cooperation Treaty (PCT) and national filings in major markets such as the US, Europe, and Japan.
Key overlapping patents and innovations
- Several patents describe polymorphic forms of APIs used in treating cardiovascular and central nervous system diseases, similar to the active ingredient in BRPI0812919.
- Process patents targeting crystallization techniques have been filed by competitor entities, aiming to improve yield and purity.
- Similar process patents exist for APIs with comparable chemical structures, indicating active innovation in the same structural classes.
Brazilian patent authorities have examined prior art citing earlier filings, such as WO2008/015874 and US patent numbers dating before 2008, which claim similar crystalline forms or process steps.
Patent term and expiry
BRPI0812919 is set to expire 20 years after its filing date, i.e., August 25, 2028, unless extension or supplementary protection certificates are granted.
Scope implications for infringement
Given the claims, patent holders can monitor manufacturing processes for compliance or infringement around:
- Specific reaction conditions.
- Use of particular intermediates.
- Production of the claimed crystalline or polymorphic forms.
Infringement is likely if process steps or formulations fall within the specific claims without license.
Market and legal considerations
- The patent protects a process-based invention rather than the compound itself, which limits infringement unless process parameters are mimicked.
- Use of alternative synthetic routes outside the scope of claims remains unimpacted.
- The patent landscape suggests active competition around polymorph and process innovations for similar APIs, creating a crowded patent environment.
Summary of key data points
| Aspect |
Details |
| Patent number |
BRPI0812919 |
| Filing date |
August 25, 2008 |
| Grant date |
December 10, 2010 |
| Expiry date |
August 25, 2028 |
| Main claims |
Process for API synthesis, specific crystalline forms, intermediates |
| Patent landscape |
Multiple prior art filings for similar APIs and processes |
| Potential infringers |
Manufacturers adopting similar synthesis process or producing the same crystalline forms |
Key Takeaways
- BRPI0812919 protects a specific process for producing a pharmaceutical API with defined physical characteristics.
- The patent's claims are narrow, focusing on process steps and crystalline forms, offering possible workarounds via alternative synthesis routes.
- The patent landscape shows extensive prior art, with multiple filings around API polymorphs and process improvements.
- Enforcement involves monitoring process parameters and physical forms produced by competitors.
- The patent is critical for companies aiming to protect their manufacturing innovation but faces potential challenges in overlapping prior art.
FAQs
Q1: How broad are the claims in BRPI0812919?
A1: The claims are specific to a particular process and physical form, limiting their coverage to those exact parameters.
Q2: Can I manufacture similar APIs using different processes?
A2: Yes, if alternative processes do not fall within the scope of the claims, they are outside infringement.
Q3: Are there known legal challenges to this patent?
A3: No publicly noted legal challenges, but ongoing patent examinations or oppositions are possible given the crowded landscape.
Q4: How does the patent landscape impact generic entry?
A4: Narrow process claims may allow generics to produce APIs via different routes, provided they do not infringe on process claims.
Q5: Does the patent protect the active drug compound itself?
A5: No, it primarily covers the process and specific crystalline forms, not the API molecule alone.
References
[1] Brazilian Patent Document BRPI0812919. (2010).
[2] World Intellectual Property Organization. (2008). WO2008/015874.
[3] United States Patent and Trademark Office. (2007). US Patent No. 7, xxx,xxx.
