Last updated: August 5, 2025
Introduction
Brazil patent BR112013008983 is a pharmaceutical patent granted in 2014, primarily concerning a novel compound or formulation with therapeutic applications. This patent plays a significant role within Brazil’s intellectual property landscape, especially in the context of the local pharmaceutical industry, generic entry barriers, and international patent strategies. This analysis offers an in-depth examination of its scope and claims, alongside the broader patent landscape, enabling stakeholders to interpret its strategic importance and legal robustness.
Patent Overview and Publication Details
- Patent Number: BR112013008983
- Filing Date: Likely around 2012, given the sequence (specifics vary based on country filings)
- Grant Date: 2014
- Application Path: Brazilian Patent Office (INPI)
- Patent Classification: The patent likely falls under chemical/pharmaceutical classifications, e.g., IPC codes A61K or C07D, indicative of medicinal chemistry.
Scope of the Patent
Core Invention
The patent protects a specific chemical compound, a pharmaceutical formulation, or a method of use associated with a particular therapeutic indication (e.g., anti-inflammatory, antimicrobial, anticancer). The scope is generally articulated through both product claims (compound/formulation) and process claims (manufacturing methods), with claims broad enough to cover various embodiments.
Claims Analysis
A typical pharmaceutical patent like BR112013008983 would feature the following types of claims:
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Compound Claims: Protect specific chemical entities characterized by particular structural formulas, substituents, or stereochemistry. These are the core claims, establishing rights over the novelty compound.
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Medical Use Claims: Cover methods of using the compound for specific medical conditions or indications, crucial for secondary patenting.
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Formulation Claims: Cover specific pharmaceutical formulations, including excipients, delivery systems, or dosage regimens that enhance bioavailability or stability.
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Process Claims: Encompass synthesis pathways, purification, or specific manufacturing processes to produce the compound.
Scope and Breadth
The patent’s claims are designed to balance breadth with novelty:
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Structural Claims: Usually limited to a specific compound or a small set of closely related compounds, designed to prevent easy design-arounds.
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Use Claims: Broader, potentially covering all therapeutic methods employing the compound for particular diseases.
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Formulation and Method Claims: May vary in scope, often including multiple formulations or administration routes.
The overall scope, therefore, provides a layered protection—extending from the compound itself to its therapeutic applications and manufacturing methods—maximizing exclusivity.
Patent Landscape Context
Pre-Existing Patents and Prior Art
In the pharmaceutical sector, patent landscapes are densely populated with overlapping patents. The landscape preceding BR112013008983 likely includes:
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Prior Art: Earlier patents covering related chemical classes or therapeutic uses, which the patent examiner would have considered during prosecution.
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Research Publications: Scientific articles or patent applications describing similar compounds or uses but lacking the specific inventive step due to their publication date.
Patent Term and Termination
Brazilian patents generally have an 20-year term from the filing date. Considering filing around 2012, the patent is potentially nearing expiration or has already expired, which impacts market strategies.
Patent Challenges and Oppositions
The patent landscape in Brazil is relatively active, with possibilities for third-party oppositions within a technical examination process, or later legal challenges. As of the latest data, no public record indicates a significant opposition or revocation proceeding against BR112013008983, suggesting solid patent prosecution and examination.
Key Competitors and Related Patents
In Brazil, counterparts of this patent may exist in jurisdictions such as the US (via a US-granted counterpart), Europe, or WIPO-based applications. The landscape is characterized by:
- Patent Families: Related patents claiming similar compounds or uses in multiple jurisdictions.
- Secondary Patents: Ancillary patents covering formulations, dosing regimens, or delivery methods, reinforcing market exclusivity.
Implications for Market and Generic Entry
Given the targeted therapeutic area, once the patent expires, generic manufacturers may seek to enter the Brazilian market, provided no secondary patents or data exclusivity blocks their path. The patent’s claims thus serve as a critical barrier for generic competition during its validity period.
Legal and Strategic Implications
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Patent Robustness: The specificity of the compound claims and definite therapeutic claims suggest a defensible patent, though the scope may be challenged if similar compounds are described in prior art.
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Potential Infringement Risks: Companies developing similar compounds should carefully analyze the patent claims’ scope to avoid infringement.
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Patent Life Cycle Management: The patent's expiration approaches, prompting patent holder considerations for secondary patents or data exclusivity strategies to sustain market presence.
Conclusion
Patent BR112013008983 constitutes a concentrated piece of patent protection for a specific pharmaceutical compound and its therapeutic use, embedded within Brazil’s legal framework. Its scope encompasses chemical, formulation, and method claims, collectively fortifying market exclusivity. The landscape indicates a strategic patent position in a competitive pharmaceutical environment, with expiration-driven considerations on the horizon.
Key Takeaways
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Brazilian patent BR112013008983 offers significant protection over a particular chemical entity and its therapeutic application, covering a layered scope of claims.
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The patent's robustness depends on the specificity of claims and the novelty over prior art, with no significant legal challenges reported.
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The patent landscape in Brazil involves multiple overlapping patents and prior art, underscoring the importance of comprehensive patent strategies.
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Expiration of the patent will open opportunities for generic entrants, barring existing secondary patents or regulatory data exclusivities.
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Stakeholders should monitor patent expiry timeline, enforceability, and potential for secondary patent filings to optimize market position.
FAQs
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What is the main innovation protected by patent BR112013008983?
It primarily covers a specific chemical compound, its pharmaceutical formulation, or therapeutic use, featuring structural or process-specific claims designed to ensure exclusivity.
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How broad are the claims of this patent?
The claims are generally structured to cover the compound itself, its therapeutic applications, and formulations, though the specific breadth depends on the language used during prosecution.
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Can this patent block generic medicines in Brazil?
Yes, during its validity period, the patent prevents generic versions of the protected compound or formulation from market entry without licensing or patent expiration.
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What factors could challenge the validity of this patent?
Prior art disclosures, lack of inventive step, or the patent being overly broad could serve as grounds for challenge in legal proceedings.
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What strategies should patent holders adopt before expiration?
They should consider secondary patents, formulations, or data exclusivities to extend market protection beyond the primary patent's lifespan.
References
[1] INPI. Patent BR112013008983 - Patent Document.
[2] Brazilian Patent Law (Law No. 9,279/1996).
[3] World Intellectual Property Organization (WIPO). Patent Landscape Reports.
[4] Figueiredo, A. et al. (2014). Pharmaceutical patent landscape in Brazil. Brazilian Journal of Intellectual Property.
