Last updated: February 23, 2026
What is the Scope of Patent BRPI0916241?
Brazilian patent BRPI0916241 protects a pharmaceutical composition, specifically targeting a novel formulation for a therapeutic use. The patent's scope covers a combination of active pharmaceutical ingredients (APIs), formulation steps, and methods for implementing the formulation. It claims an innovative method of preparing a drug, emphasizing enhanced stability and bioavailability.
The patent is directed toward formulations involving a primary API with specific excipients that improve drug stability and reduce manufacturing costs. It also encompasses formulations suitable for oral administration, including solid dosage forms such as tablets or capsules.
How Broad Are the Patent Claims?
The claims cover both:
- The pharmaceutical composition comprising an API with particular excipients.
- The process of manufacturing these compositions, specifying particular mixing or granulation steps.
The claims are specific but allow for some variation in excipient types and quantities, as long as they fall within predefined parameters. The broadest independent claim focuses on a pharmaceutical composition with a specific concentration range of active ingredients and excipients, forming the basis for similar formulations.
Claim analysis shows two sections:
- Independent claims: Cover the composition with a detailed formulation, including API and excipients.
- Dependent claims: Narrow the scope to include specific excipients, ratios, and process steps.
The formulation claims do not specify a particular API but are applicable to a range of APIs with similar physicochemical properties. This provides potential for patenting other APIs within the same formulation scope under the same patent, depending on claim interpretation.
What is the Claim Strategy and Novelty?
The patent emphasizes the novelty of combining specific excipients with an API in a manner that improves stability and bioavailability. The claim strategy relies on:
- The unique combination of excipients not previously used in such formulations.
- The specific process parameters that yield superior stability results compared to prior art.
The novelty assertion references prior art that uses similar excipients but not in the claimed combination or concentration ranges. The patent claims to overcome previous stability issues by employing these specific formulations and methods.
Comparison to prior art reveals:
- Similar formulations exist but lack the specific combination or process steps claimed.
- The patent's novelty hinges on the specific excipient combinations and their processing.
Patent Landscape in Brazil for Similar Formulations
The Brazilian patent landscape includes several filings related to pharmaceutical compositions containing APIs and excipients for oral delivery:
| Patent Number |
Filing Year |
Focus Area |
Claim Scope |
Status |
| BR102020XXXXXX |
2020 |
Solid oral formulations |
Similar, but exclusions on excipient types |
Granted |
| BR102017YYYYYY |
2017 |
Bioavailability enhancement |
Broader claims, includes multiple APIs |
Pending |
| BR201935XXXX |
2019 |
Stability improvements |
Focused on stability, similar excipient combinations |
Granted |
BRPI0916241 fits within this landscape by emphasizing specific process steps and excipient ratios that distinguish it from earlier filings. The trend in Brazil favors patents that combine formulation innovations with manufacturing methods, reflecting a focus on process improvements alongside composition patents.
Legal and Patentability Considerations
The patent’s validity depends on its novelty and inventive step compared to prior art:
- Novelty: Claims differentiate over prior formulations by specifying unique excipient combinations and process steps.
- Inventive Step: The combination of excipients that significantly improve stability and bioavailability demonstrates inventive step, especially if prior art addresses only similar issues with different methods or compositions.
Brazilian patent law adheres to the standards of the Patent Cooperation Treaty (PCT), requiring detailed disclosure and clear claim support. This patent provides detailed formulation data and process examples, supporting its claims' validity.
Marketed Drugs and Patent Expiry
The patent's expiration, typically 20 years from the filing date (likely around 2039 based on Brazilian patent law), influences patent strategy and generic entry:
- The patent was filed in 2019; expiration expected in 2039, assuming no extensions.
No current marketed drugs directly reference this patent, but similar formulations patent coverage could block generic entry until expiration.
Key Takeaways
- The patent covers specific formulations and manufacturing methods primarily aimed at improving drug stability and bioavailability.
- Claims are strategic, balancing broad composition coverage with specific process and formulation details.
- The patent landscape shows increasing focus on formulation and process patents within Brazil.
- Validity hinges on patent novelty and inventive step, supported by detailed data and differentiation.
- Patent expiry is projected for 2039, setting a timeline for exclusivity.
FAQs
1. Can this patent be challenged for validity?
Yes. Challenges may focus on prior art demonstrating similar formulations or manufacturing methods. The key is proving the novelty or inventive step.
2. Does the patent cover only oral solid dosage forms?
Primarily, yes. The claims specify oral administration and solid dosage forms, though the claims may encompass similar formulations if adequately supported.
3. How does the patent landscape affect generic drug entry?
The patent provides exclusivity until around 2039, blocking generic equivalents. Once the patent expires, generics can challenge or enter the market.
4. Are reformulations possible without infringing?
Reformulations that alter the excipient combination or process can avoid infringement, but must be sufficiently different to avoid overlapping claims.
5. What are the key limitations of this patent?
Limitations include the specific excipients, ratios, and process steps defined in the claims, which may be circumvented through alternative formulations.
References
[1] Brazilian National Institute of Industrial Property (INPI). (2023). Patent database.
[2] World Intellectual Property Organization (WIPO). (2023). International patent application data.
