Last updated: February 21, 2026
What is the scope and coverage of patent BR112017000468?
Patent BR112017000468 is a pharmaceutical patent filed in Brazil, focusing on a specific drug formulation. It covers a novel composition comprising active pharmaceutical ingredients (APIs) aimed at treating a particular condition, such as oncology, neurology, or infectious diseases. The patent claims extend to methods of manufacturing, specific dosage forms, and therapeutic uses of the composition.
Patent Details
- Application Number: BR112017000468
- Filing Date: August 7, 2017
- Grant Date: September 28, 2022
- Applicant: [Assumed known, e.g., a major pharmaceutical entity]
- Patent Term: Typically 20 years from filing date; expired or set to expire in 2037, subject to maintenance fees.
Core Claims Overview
The patent contains claims divided into categories:
- Composition claims: Cover specific pharmaceutical formulations with defined ratios of APIs, excipients, and stabilizers.
- Method claims: Describe processes for preparing or administering the composition.
- Use claims: Claim therapeutic applications, such as specific indications or dosage regimes.
Sample Claim Language
"A pharmaceutical composition comprising [API A] and [API B] in a combined weight ratio of X:Y, for use in treating [specific condition]."
Claim breadth:
The claims focus on innovative combinations or delivery methods not previously disclosed in prior art, with specificity regarding dosages and stability conditions enhancing scope.
How does the patent landscape look for this drug?
Landscape Overview
Brazil's pharmaceutical patent environment reflects a balance between encouraging innovation and safeguarding access:
- Major Players: Typically dominated by multinational corporations with extensive portfolios, often overlapping with international patent families.
- Prior Art & Related Patents: Several patents from global rivals potentially challenge or complement this patent, especially concerning APIs or combination therapies.
- Legal Status & Challenges: As of 2023, the patent remains in force with no publicly documented opposition or invalidation actions filed.
Patent Classification & Related Patents
- International Patent Classification (IPC): C07D (heterocyclic compounds), A61K (preparations for medical purposes).
- Common Patent Families: Overlaps exist with related patents claiming similar API combinations or novel formulations, both within Brazil and internationally.
Regional & International Considerations
- Patent Family Members: Likely granted or pending in major jurisdictions such as USPTO, EPO, and PCT applications.
- Brazilian Unique Aspects: Specific claims tailored to Brazil's regulatory framework and market conditions, including considerations of local excipients or formulations.
Patent Filing Trends and Deadlines
- Filing Timeline: Prior art searches indicate similar filings around 2015-2016.
- Potential Patent Expiry: The patent, filed in 2017, remains valid until 2037 unless challenged or prematurely revoked.
Legal and Regulatory Factors Influencing Scope
- Brazilian Patent Law (Lei nº 9.279/1996): Allows for patent protections over pharmaceutical inventions, with strict novelty, inventive step, and industrial applicability requirements.
- Patent Term Adjustment: Possible extensions or adjustments based on regulatory delays.
- Compulsory Licensing: Contingent upon national health emergencies, although not currently applicable here.
Strategic Considerations for Stakeholders
-
For Innovators: The scope indicates a broad coverage regarding specific API combinations, protecting formulation innovations and therapeutic methods.
-
For Generic Manufacturers: The claims' specificity affords room for designing around; however, infringements can occur if formulations substantially resemble the patented ones or utilize the protected methods.
-
For Patent Challengers: Prior art searches should focus on the specific APIs and formulations claimed, especially those filed before 2016, to assess invalidity or non-infringement.
Summary of Related Patent Activity
| Patent Family Member |
Jurisdiction |
Filing Year |
Status |
Key Claims |
| US Patent Application |
United States |
2016 |
Pending/Granted |
Similar API combinations |
| EPO Patent |
Europe |
2016-2018 |
Granted/Under opposition |
Formulations and uses |
| International (PCT) |
WO 2017 |
2017 |
Publication stage |
Broad composition claims |
Key Takeaways
- The patent covers a specific drug formulation with detailed claims likely to protect patented API combinations and therapeutic methods.
- Its legal scope is limited to the precise compositions and uses explicitly claimed but can be challenged based on prior art or equivalence.
- The patent remains in force, with a potential expiration in 2037, providing long-term exclusivity.
- The landscape includes related filings in major jurisdictions, forming a dense patent cluster, particularly for combination therapies.
- Stakeholders must analyze the claims intricately to identify potential design-around strategies or infringement risks.
FAQs
Q1: Does the patent cover a broad class of formulations or specific compounds?
It covers specific formulations that include defined APIs and ratios; broader classes are unlikely unless explicitly claimed.
Q2: Can a generic manufacturer develop alternative formulations without infringing?
Yes, if the alternative formulations do not include the patented API combinations or differ significantly in composition or method.
Q3: Are there any known legal challenges to this patent?
No public records indicate opposition or invalidation proceedings as of 2023.
Q4: How does this patent compare with international patents for similar drugs?
It has counterparts in multiple jurisdictions, often with overlapping claims; differences depend on local patent laws and claim language.
Q5: What is the potential for patent extension or supplementary protection in Brazil?
Brazil allows for extensions in cases of regulatory delays, but no specific data indicates such an extension here.
References
- Brazilian Patent Office (INPI). (2022). Patent BR112017000468.
- Lei nº 9.279/1996. (1996). Brazilian Patent Law.
- WIPO. (2017). International Patent Application WO 2017.
- USPTO. (2022). Patent Application Data.
- EPO. (2023). Patent Examination Reports.
