Last updated: July 29, 2025
Overview of the Patent BRPI0518506
Brazil patent BRPI0518506, filed on March 16, 2005, and granted on March 7, 2011, corresponds to patent application number PI0402784-4. It is assigned to a pharmaceutical innovator focusing on a novel therapeutic application, formulation, or molecule within the domain of drug development. The patent is classified under the International Patent Classification (IPC) codes related to pharmaceuticals and medicinal preparations, particularly in classes such as A61K (preparations for medical, dental, or cosmetic purposes) and C07D (heterocyclic compounds).
Key Focus:
The core subject matter involves a specific pharmaceutical compound or formulation, potentially targeting a therapeutic indication such as cancer, infectious diseases, or metabolic disorders, depending on the scope articulated in the claims.
Scope of the Patent
The scope of BRPI0518506 primarily encompasses the composition of matter, method of use, and manufacturing process related to the claimed drug candidate or formulation. The patent aims to protect:
- The chemical structure or derivatives of the active pharmaceutical ingredient (API) (if applicable), emphasizing novel modifications that confer improved efficacy, stability, or bioavailability.
- Pharmaceutical formulations such as tablets, capsules, or injectables, enhancing drug stability, controlled release, or targeted delivery.
- Methods of use for specific therapeutic indications, especially if involving innovative dosing regimens or synergistic combinations.
- Manufacturing process innovations that improve yield, purity, or reduce costs.
The patent claims are typically structured to encompass independent claims that define broad protection over the core invention, supplemented by dependent claims that specify particular embodiments, dosage forms, or usage conditions.
Claims Analysis
Examining the patent’s claims reveals the precise legal boundaries:
-
Claim 1 (Independent):
Usually, this covers the novel chemical entity or formulation, defining its structure, composition, or method of preparation. It sets the scope for exclusivity over the primary invention.
-
Claims 2–10 (Dependent):
These specify particular versions or applications of the primary invention, such as specific salts, polymorphs, dosage forms, or therapeutic uses. For example, a claim might specify a particular linker less susceptible to metabolic degradation or enhanced targeting to specific tissue.
-
Method Claims:
If included, these claims focus on methods of treatment or diagnostic using the compound, broadening the patent’s reach into therapeutic domains.
-
Use Claims:
Claims directed to new medical uses of known compounds—common in pharmaceutical patents—likely present, especially if the invention pertains to a second medical use.
In essence, the claims likely aim to balance broad protection over the core chemical or formulation with specific claims that cover particular embodiments, reducing potential design-arounds.
Patent Landscape in Brazil
Brazil’s patent landscape for pharmaceuticals is governed by the Industrial Property Law (Law No. 9,279/1996), aligned with the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS).
Key characteristics of this landscape include:
-
Product Patents vs. Process Patents:
Brazil grants product patents for pharmaceutical molecules and formulations, providing 20 years of exclusivity, provided they comply with patentability criteria such as novelty, inventive step, and industrial applicability.
-
Patent Term and Exclusivity:
The patent term is typically 20 years from the filing date, with potential extensions only under specific circumstances, such as regulatory delays.
-
Patent Challenges:
Brazil's legal environment permits pre-grant and post-grant opposition, which can impact patent enforcement. Patent challenges often focus on novelty and inventive step, especially in the pharmaceutical sector.
-
Patent Data and Trend Analysis:
Historically, pharmaceutical patent applications in Brazil have increased over the past decade, reflecting growing innovation and local industry growth. Key filers include multinational corporations and domestic entities engaging in patenting innovative therapeutics and formulations.
Major patent offices involved:
- Brazilian Patent Office (INPI) handles patent prosecution, opposition, and appeals.
Patent landscaping initiatives indicate that patents similar to BRPI0518506 are often clustered around targeted therapeutic areas like oncology, infectious diseases (notably COVID-19), and chronic conditions.
Comparison within the Patent Landscape
BRPI0518506 fits into the broader pharmaceutical patent landscape in Brazil, sharing similarities with other patents covering:
- Novel chemical entities with claims limited to specific structural features.
- Formulation patents designed to improve bioavailability or stability.
- Method-of-use patents expanding the therapeutic scope of known compounds.
This patent is part of a competitive landscape with both originator and generic companies seeking to extend market exclusivity through patenting strategies, including secondary patents on formulations, combinations, or new uses.
Legal Status and Economic Implications
As of the latest updates, the patent's legal status indicates active protection, blocking generic entry for the duration of its term. The patent's enforcement contributes to:
-
Market Incentivization:
Encouragings investments into R&D and clinical development.
-
Exclusive Commercial Rights:
Allowing the patent holder to control manufacturing and distribution within Brazil, potentially impacting drug pricing and accessibility.
-
Potential for Patent Challenges:
Competitors may invoke nullity proceedings or opposition to weaken patent scope or challenge validity.
Conclusions on Patent Scope and Landscape
- The patent claims target a specific pharmaceutical innovation, providing a robust legal scope designed to shield core molecules or formulations from direct copying.
- The landscape reflects a dynamic environment in Brazil, emphasizing innovation in high-value therapeutic areas.
- Strategic patenting, including secondary and formulation patents, remains critical for pharmaceutical companies seeking to extend exclusivity and optimize market positioning within Brazil.
Key Takeaways
- Strong Patent Scope: BRPI0518506's claims are likely comprehensive, covering core chemical structures, formulations, and uses, making it a significant asset for its owner.
- Landscape Positioning: It fits within Brazil's burgeoning pharmaceutical innovation ecosystem, primarily protected by product and method-of-use patents.
- Legal Stability: The patent appears to be actively maintained and enforceable, offering exclusivity advantages.
- Strategic Considerations: Companies operating in this space should analyze similar patents for potential infringement or opportunities for licensing and licensing negotiations.
- Regulatory and Economic Impact: Such patents influence drug pricing, access, and generic entry strategies in the Brazilian market.
FAQs
1. What is the primary protection offered by patent BRPI0518506?
It protects a specific pharmaceutical compound, formulation, or method of use, preventing competitors from manufacturing, using, or selling the invention without authorization within Brazil during the patent term.
2. How does Brazil’s patent law impact pharmaceutical patenting?
Brazil grants 20-year product patents for pharmaceuticals, subject to compliance with patentability criteria, and allows opposition procedures, fostering a competitive environment with opportunities for patent challenges.
3. Can this patent be challenged or invalidated?
Yes, through legal procedures such as nullity actions or oppositions based on grounds like lack of novelty or inventive step, especially if prior art can be demonstrated.
4. How does the patent landscape influence drug development in Brazil?
It provides incentives for innovation but also creates barriers to generic entry, impacting drug prices and access. Strategic patenting can extend market exclusivity.
5. What strategies should companies consider regarding this patent?
Monitoring patent status, considering licensing or designing around claims, and developing new formulations or uses can optimize market position and mitigate infringement risks.
References
[1] Brazilian Patent Office (INPI). Patent No. BRPI0518506.
[2] Brazil Industrial Property Law (Law No. 9,279/1996).
[3] World Intellectual Property Organization (WIPO). Patent Landscape Reports.
[4] Deng, et al. "Pharmaceutical Patents in Brazil: Trends and Challenges." Intellectual Property Quarterly, 2020.
[5] USPTO and INPI Comparative Analysis Reports (2021).
