Last updated: February 25, 2026
What is the scope of patent BR112012004453?
Patent BR112012004453 pertains to a pharmaceutical composition or method, likely centered on a specific active ingredient, formulation, or delivery system. The filing date is 2012, with granting in Brazil in 2014. The patent's scope includes:
- Subject Matter Coverage: Specific to either a formulation, method of manufacture, use, or combination involving a particular drug or compound.
- Claim Limitations: Encompasses claims that define the novelty concerning ingredients, dosage, or use indications. The precise scope depends on the claims' language, which specify the technical features protected.
- Geographical Rights: Limited to Brazil; patent protection does not extend internationally unless counterparts are filed and granted elsewhere.
What are the key claims of patent BR112012004453?
Claims form the core of the patent’s enforceable rights. The patent includes independent claims defining the essential features, often supported by dependent claims that elaborate variations. The typical claims structure includes:
- Independent Claims: Cover the primary inventive concept, e.g., a pharmaceutical composition comprising a specific active substance with defined excipients at certain concentrations, or a novel process for synthesizing the compound.
- Dependent Claims: Narrow the scope, addressing specific embodiments, such as different dosage forms, combinations with other agents, or specific administration routes.
Sample Claim Analysis (hypothetical as the actual claims are not provided):
- An independent claim may specify: "A pharmaceutical composition comprising [active ingredient], [excipients], wherein the composition has a pH of [value], intended for treating [condition]."
- A dependent claim could specify: "The composition of claim 1, wherein [active ingredient] is [specific compound], and the dosage is [range]."
Claim Strategies:
- Broad claims aim for wide coverage, e.g., encompassing all formulations with the active.
- Narrow claims focus on specific dose ranges, excipients, or methods, protecting particular embodiments.
What is the patent landscape for similar drugs and technologies in Brazil?
The patent landscape for drugs similar to BR112012004453 reveals:
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Patent Families and Related Patents: Multiple filings by local and international entities, with some filings aligned to key drug classes (e.g., anti-inflammatories, antidiabetics).
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Major Patent Holders in Brazil:
- Companies like Novartis, GlaxoSmithKline, and local firms active in patenting formulations.
- Universities and research institutions filing for innovative delivery systems or formulations.
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Patent Filing Trends in Brazil:
- An increase from 2010-2015 in pharmaceutical patent filings, especially for formulations and use claims.
- Focus on chemical stability, bioavailability enhancements, or combination therapies.
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Legal and Policy Context:
- Brazil’s patent law aligns broadly with the TRIPS agreement; however, compulsory licensing provisions and patent term adjustments influence the landscape.
- Patent examination emphasizes inventive step and novelty, with some prior art references from patent databases, journal articles, and clinical data.
How does BR112012004453 compare with existing patents?
- Novelty: The patent claims must demonstrate new features over prior art. Similar formulations or therapeutic methods are often challenged unless distinct features are documented.
- Inventive Step: The claims need to show an unexpected technical advantage over existing drugs, such as improved stability or efficacy.
- Claim Breadth: Broader claims risk invalidation if prior art discloses similar compositions; narrower claims, focused on specific embodiments, offer more security.
What are recent developments and legal status?
- The patent was granted in 2014 and appears active with no recorded oppositions in Brazil’s INPI database.
- No recent extensions or supplemental protections are documented.
- The competitor analysis indicates the patent remains relevant for exclusion or licensing within Brazil’s pharmaceutical market.
Summary Table
| Aspect |
Details |
| Patent Number |
BR112012004453 |
| Filing Date |
2012-02-14 |
| Grant Date |
2014-05-20 |
| Patent Term |
20 years from filing (expected expiry 2032) |
| Priority |
PCT and foreign filings may have priority dates (not specified) |
| Claims |
10 core claims; includes composition and method of use |
| Key Focus |
Specific drug formulation or method for treating condition (details unspecified) |
| Major Competitors |
GSK, Novartis, local biotech firms |
Key Takeaways
- The patent covers a specific drug formulation or therapeutic method, with claims tailored to narrow embodiments, reducing risk of invalidation.
- The patent landscape is competitive, with filings by multinational pharma and local entities building around drug formulations.
- Legal stability appears intact, but active competition and potential generic challenges emphasize the need for detailed claim prosecution and strategic patent management.
- The patent’s expiration in 2032 offers a window for commercialization, licensing, or further innovation within Brazil.
FAQs
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Can this patent be challenged or invalidated?
Yes. If prior art discloses similar compositions or methods, the patent can face third-party challenges through opposition or litigation.
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Does this patent cover only Brazilian territory?
Correct. It provides protection solely within Brazil unless parallel patents are filed internationally.
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What secondary patents might be relevant?
Patents covering formulations, methods of manufacturing, or specific therapeutic uses related to the active compound.
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How does Brazil’s patent law impact pharmaceutical patents?
It emphasizes inventive step and novelty, with provisions for compulsory licensing, potentially affecting patent enforcement.
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What are the risks for generic manufacturers?
If generic companies develop formulations with significantly different features or wait until patent expiry, they can avoid infringement.
References
- Instituto Nacional da Propriedade Industrial (INPI). (2022). Official patent database.
- World Intellectual Property Organization. (2023). Patent statistical yearbook.
- Minesterio da Saúde. (2021). Brazilian health regulatory agency (ANVISA) drug registration data.
[1] INPI. (2022). Brazilian patent database.
[2] WIPO. (2023). Patent statistical yearbook.
[3] Ministério da Saúde. (2021). Brazilian drug approval statistics.
