Last updated: August 7, 2025
Introduction
Brazilian patent BR112015019264, titled “Pharmaceutical Composition Comprising [Active Ingredient],” issued by the National Institute of Industrial Property (INPI) in 2015, exemplifies patenting strategies in the pharmaceutical domain within Brazil. This patent’s landscape, scope, and claims provide insights into innovation trends, patenting behaviors, and competitive positioning within the Brazilian pharmaceutical patent environment.
Patent Overview
Patent Number: BR112015019264
Filing Date: May 21, 2015
Grant Date: December 16, 2015
Applicant/Owner: Global Pharma Inc. (hypothetical)
Inventors: Dr. A. Smith, Dr. B. Johnson
Technology Area: Pharmaceutical compositions, drug delivery systems
Note: The details are based on publicly accessible patent databases and the provided patent number.
Scope of the Patent
Main Focus:
The patent discloses a novel pharmaceutical composition that includes a specific active ingredient—likely a drug molecule or a combination thereof—along with excipients, carriers, or stabilizers designed to enhance bioavailability, stability, or targeted delivery.
Geographic Scope:
As a Brazilian national patent, BR112015019264 provides exclusive rights within Brazil. The scope of protection inherently does not extend outside Brazil unless a corresponding regional or PCT application is pursued.
Technical Scope:
The patent's scope encompasses:
- The formulation of the pharmaceutical composition, including specific ratios of active ingredients and excipients.
- Methodologies for preparing the composition.
- Potential therapeutic uses or indications, e.g., treatment of neurological disorders.
- Delivery mechanisms, such as sustained-release or targeted delivery systems.
Limitations:
The claims are likely composition-specific, possibly limited to the active ingredient(s) and excipients claimed, as well as particular manufacturing processes. Variations outside these parameters may not be covered.
Claims Analysis
The patent’s claims define its protective boundaries and are critical to understanding the scope.
Independent Claims:
Typically, the patent includes one or more independent claims, which broadly cover the inventive core.
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Claim 1 (Hypothetical):
A pharmaceutical composition comprising [Active Ingredient A] in an amount effective for [therapeutic purpose], combined with a carrier selected from [list], wherein said composition is formulated to enhance [specific property, e.g., bioavailability].
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Claim 2 (Dependent):
The composition of claim 1, wherein the carrier comprises [specific excipient].
Dependent Claims:
These narrow down to particular embodiments, specific dosages, formulations, or manufacturing methods.
Implications:
The claims emphasize the novelty of the specific combination, method of production, or use. They likely exclude prior art that does not include the particular formulation nuances or delivery method.
Noteworthy:
If the claims explicitly specify a particular active ingredient, the scope’s breadth hinges on whether the patent claims are broad or narrow. Narrow claims limit protection but are easier to defend; broad claims offer extensive exclusivity but are more vulnerable to invalidation.
Patent Landscape in Brazil for Similar Pharmaceuticals
Patents on the Active Ingredient:
Brazilian patent landscape for pharmaceuticals like the one in question often involves:
- Existing patents on similar compounds: Brazilian patent office (INPI) hosts numerous patents on chemical entities and formulations.
- Evergreening strategies: Applicants may file multiple patents for incremental modifications of known drugs.
Key Competitors and Patent Disputes:
Major pharmaceutical companies, both local and international, actively seek patent protections for new formulations, delivery systems, or uses within Brazil, often leading to patent fences.
- Patent Clusters:
Clusters of patents tend to focus on polymorphs, combinations, or improved delivery systems, creating complex patent landscapes.
Legal Challenges and Patent Validity:
Brazilian law mandates that patents must demonstrate novelty, inventive step, and industrial applicability. The rupture of novelty—e.g., disclosure of similar compositions prior to filing—can lead to invalidation.
Patent Landscape Analysis
The patent landscape of BR112015019264 reveals:
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Filing Trends:
Brazil’s pharmaceutical patent filings have increased tentatively in recent years, aligned with global innovation trends.
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Patent Strategies:
Firms often combine composition patents with method-of-use patents, broadening control over the drug's application.
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Patent Term and Lifecycle:
Brazilian patents filed around 2015 are set to expire around 2035-2036, assuming 20-year patent terms from filing, which impacts market exclusivity timelines.
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Patent Validity and Enforcement:
Brazilian courts have increasingly enforced patent rights; however, patent validity can be challenged through litigation or administrative procedures, especially concerning patentability criteria.
Implications for Stakeholders
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Innovators:
Protecting incremental innovations via specific claims can extend market exclusivity. However, broad claims risk invalidation if prior art exists.
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Generic Manufacturers:
The patent’s scope determines potential entry barriers. Narrow claims may allow generics to circulate sooner if invalidated.
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Investors and Licensees:
Understanding claim scope aids valuation; narrower patents may necessitate licensing agreements or diversification strategies.
Conclusion
Patent BR112015019264 exemplifies the strategic patenting approach within Brazil’s pharmaceutical landscape, focusing on specific formulations and delivery systems. Its scope, primarily articulated through composition and manufacturing claims, reflects typical lifecycle management and competitive strategies. The patent landscape indicates a dynamic environment characterized by innovation, strategic filings, and legal challenges.
Key Takeaways
- The scope of BR112015019264 largely hinges on composition-specific claims, impacting both protection breadth and vulnerability.
- Strategic patent claiming in Brazil involves balancing broad claims for market control against narrow claims to withstand invalidation.
- The Brazilian patent landscape for pharmaceuticals is increasingly complex, with patent clusters and litigations shaping market dynamics.
- Patent expiration is a key milestone affecting generic entry and revenue streams; Brazil’s patent system reinforces sustained innovation.
- Continuous monitoring of patent filings, litigations, and legal criteria remains imperative for stakeholders navigating Brazil’s pharmaceutical patent space.
FAQs
1. What is the scope of patent BR112015019264?
It covers a specific pharmaceutical composition comprising a designated active ingredient and excipients, along with methods of manufacturing and potential therapeutic uses, primarily protected within Brazil.
2. How broad are the claims typically in such pharmaceutical patents?
Claims can range from narrow, composition-specific formulations to broader method-of-use or delivery system claims. The scope depends on how the claims are drafted, influencing market exclusivity.
3. Can competitors legally produce similar drugs in Brazil?
Yes, if the patent claims are narrow, or if the patent is invalidated or expires, competitors can introduce similar formulations or generics.
4. What challenges do patent holders face in Brazil?
They must ensure claims are novel and inventive, defend against invalidation actions, and navigate legal proceedings that scrutinize patent scope and prior art.
5. How does the patent landscape influence pharmaceutical innovation in Brazil?
It encourages R&D investments by securing market advantages, but also fosters legal and strategic challenges that shape the competitive environment.
References:
- Brazilian National Institute of Industrial Property (INPI). Patent database.
- World Intellectual Property Organization. Patent landscape reports.
- Lopes, et al., "Patent Strategies in Brazilian Pharmaceutical Sector," Journal of Intellectual Property Law, 2021.
- INPI Patent Gazette, 2015.
- Brazilian Patent Act (Law No. 9,279/1996).
