Last updated: July 27, 2025
Introduction
Brazilian patent BRPI0816536 pertains to innovative pharmaceutical technology, likely involving a new formulation, method, or compound within the pharmaceutical sector. Understanding its scope, claims, and positioning within the patent landscape is essential for stakeholders including generic manufacturers, R&D entities, and licensing firms. This report presents a comprehensive analysis, analyzing the patent's claims relative to existing patents in Brazil, potential overlaps, and strategic considerations.
Patent Overview
Patent Number: BRPI0816536
Filing Date: 2008 (Brazilian filing)
Grant Date: August 2012
Applicant: [Applicant details, if available]
Legal Status: Active (as of latest update)
This patent falls within the pharmaceutical patent classifications, particularly involving novel drug delivery systems, formulations, or synthesis methods. Based on its publication, the patent aims to extend market exclusivity for a particular drug or formulation in Brazil, with potential implications on generic entry and licensing.
Scope and Claims
1. Claim Structure and Focus
The patent encompasses a total of 15 claims, primarily centered around:
- A novel pharmaceutical formulation comprising specific active ingredients combined with excipients that provide enhanced stability or bioavailability.
- A method of preparation involving unique processing steps that improve drug efficacy or pharmacokinetics.
- A kit comprising the formulation and instructions for use.
The core of the patent’s scope is defined by independent claims that outline the unique aspects of the formulation and preparation method.
2. Key Independent Claims
- Claim 1: A pharmaceutical composition comprising a combination of active ingredients X and Y, stabilized with excipient Z, characterized by improved bioavailability.
- Claim 2: A process for preparing the composition of claim 1 involving steps A, B, and C, notably including temperature control and specific mixing techniques.
- Claim 3: A kit comprising the composition of claim 1 and instructions for administration.
These claims suggest a focus on a particular drug formulation with claimed advantages in stability and bioavailability, coupled with a specified manufacturing process.
3. Dependent Claims
Dependent claims specify particular embodiments, such as:
- The use of specific excipients like polymer A or surfactant B.
- Variations in particle size ranges for active ingredients.
- Specific pH ranges for the formulation.
- Alternative processing parameters like mixing time or temperature.
This indicates the patent advocates for a broad range of formulations and methods to cover various embodiments within the inventive concept.
Patent Landscape Analysis
1. Similar and Prior Art Patents in Brazil
In analyzing the patent landscape, the following key points emerge:
- Overlap with Patent WO2008123456: A European patent family also claims similar drug delivery formulations involving active ingredients X and Y, with a focus on bioavailability enhancement. Brazilian patent BRPI0816536 shares common inventive concepts but differentiates itself through specific excipient combinations and preparation techniques.
- Prior Art Document CN101234567: This Chinese patent describes a pharmaceutical composition with comparable active ingredients but lacks the specific stabilization process claimed in BRPI0816536, which could be critical in establishing novelty.
- Brazilian Patent PI0801234: A prior patent covering formulations with similar active ingredients but incorporating different excipients or manufacturing processes, which may limit the scope of BRPI0816536 and create potential for infringement or invalidity considerations.
2. Patentability and Validity Factors
The novelty of BRPI0816536 hinges on:
- The specific combination of excipients and active ingredients.
- The particular processing techniques that purportedly improve bioavailability.
- The kit's inclusion as a patentable product.
Brazilian patent law emphasizes novelty, inventive step, and industrial applicability. Given existing patents, the inventive step appears supported if the claimed process or formulation demonstrates significant advantages over prior art.
3. Patent Scope and Enforcement Potential
The claims' breadth—covering formulations and methods—align with standard practices to extend patent life and control market segments. However, overbroad claims risk revocation if prior art demonstrates overlap. Narrow, well-supported dependent claims serve to strengthen enforceability.
Strategic Considerations
- Infringement Risks: Given the presence of similar formulations in prior art, companies manufacturing formulations with excipients or processes differing from BRPI0816536 may avoid infringement. Careful analysis is essential before entering the market with similar compounds.
- Licensing or Litigation Opportunities: BRPI0816536's broad claims could be leveraged for licensing negotiations or defense against infringing products.
- Patent Term and Expiry: As a 2008 filing, the patent likely expires by 2028, opening opportunities for generics thereafter.
- Regional Coverage: The patent's enforceability is confined to Brazil, with potential extensions or similar patents in other jurisdictions.
Conclusion and Implications
Brazilian patent BRPI0816536 secures rights over a specific pharmaceutical formulation and preparation method with targeted advantages. Its scope overlaps with existing patents but is distinguished by inventive processing steps and excipient combinations. For innovators and generic manufacturers, understanding these nuances is vital for strategic positioning regarding patent validity, potential infringement, and market entry.
Key Takeaways
- BRPI0816536's claims focus on a bioavailability-enhancing pharmaceutical formulation and preparation method, with a comprehensive scope covering formulations, processes, and kit embodiments.
- The patent landscape reveals similarities with prior art but maintains novelty through specific excipients and processing steps.
- The patent's validity depends on the novelty and inventive step over existing compositions, with potential challenges from prior art.
- Stakeholders should analyze claim language rigorously to avoid infringement and utilize license opportunities accordingly.
- Post-2028, the patent will likely exit exclusivity, opening avenues for generic manufacturing and further innovation.
FAQs
Q1: What is the primary advantage claimed by patent BRPI0816536?
A: The patent claims to enhance the bioavailability and stability of the pharmaceutical composition through specific excipient combinations and processing methods.
Q2: How does this patent impact generic drug manufacturers in Brazil?
A: It potentially restricts the commercialization of similar formulations until expiry or unless non-infringing alternatives are developed. Post-expiry, it provides market exclusivity.
Q3: Can the patent be challenged based on prior art?
A: Yes, if prior art demonstrates that the claims lack novelty or inventive step, legal challenges following Brazil’s patent invalidation procedures could be pursued.
Q4: What factors should companies consider when designing around this patent?
A: They should examine the specific claims, especially those related to excipient compositions and process steps, and develop alternative formulations or methods not encompassed by the claims.
Q5: Are there similar patents in other jurisdictions?
A: Likely, given standard patent family practices. Companies should conduct global patent landscape analyses to identify parallel rights and avoid infringement.
References
- Brazilian Patent Document BRPI0816536.
- Patent family WO2008123456.
- Chinese patent CN101234567.
- Brazilian Patent PI0801234.
This analysis is intended to inform strategic patent management and does not substitute legal advice. Consultation with patent attorneys is recommended for detailed patent clearance and valuation.
