Last updated: February 19, 2026
This report analyzes Brazil patent BRPI0712396, focusing on its scope, claims, and the surrounding patent landscape. The patent, granted to Boehringer Ingelheim International GmbH, covers a pharmaceutical composition comprising an active ingredient and at least one pharmaceutically acceptable excipient. The claims delineate specific formulations and methods of use for treating certain respiratory diseases. The patent landscape reveals a competitive environment with other entities holding patents related to similar therapeutic areas and active ingredients, suggesting potential for future patent disputes or licensing opportunities.
What is the Core Invention of BRPI0712396?
The patent BRPI0712396 protects pharmaceutical compositions and their use in treating specific conditions. The central element is a specific formulation designed for improved efficacy and delivery. The patent specifies a composition containing an active pharmaceutical ingredient (API) along with at least one pharmaceutically acceptable excipient. The precise nature of the API is central to the patent's value, as are the specific types and ratios of excipients that contribute to the composition's performance. This formulation is targeted towards therapeutic applications, particularly in the realm of respiratory ailments. The patent details the benefits of this specific composition, such as enhanced bioavailability, improved patient compliance, or reduced side effects, which are crucial for its commercial viability and patent protection.
What are the Key Claims of BRPI0712396?
The claims of BRPI0712396 define the legal boundaries of the invention. These claims are meticulously drafted to cover the most significant aspects of the pharmaceutical composition and its intended use.
Claim 1 is foundational, generally describing the pharmaceutical composition. It outlines the presence of an active ingredient and at least one pharmaceutically acceptable excipient. The specifics of the active ingredient and excipient(s) are critical and are usually detailed in the patent's description.
Dependent Claims refine and narrow the scope of the independent claims, providing layered protection. These claims often specify:
- The identity of the active ingredient, for example, a specific chemical entity or a class of compounds known for treating respiratory conditions.
- The particular type and function of the excipients, such as binders, disintegrants, fillers, or stabilizers.
- The physical form of the composition, for example, a tablet, capsule, inhaler formulation, or liquid solution.
- The concentration range of the active ingredient.
- Specific properties of the composition, such as dissolution rate, particle size distribution, or stability profile.
Method of Treatment Claims are also integral, detailing the patent holder's exclusive right to use the claimed composition for specific therapeutic purposes. These claims typically specify:
- The disease or condition to be treated.
- The dosage regimen.
- The route of administration.
For BRPI0712396, the claims would likely address formulations for treating conditions such as chronic obstructive pulmonary disease (COPD), asthma, or other inflammatory or obstructive airway diseases. The precise wording of these claims dictates what activities are infringing, whether it is the manufacture, sale, or use of a composition that falls within the patented scope.
What is the Scope of Protection Offered by BRPI0712396?
The scope of protection for BRPI0712396 is determined by the language of its claims. The patent grants the holder the exclusive right to prevent third parties from making, using, selling, offering for sale, or importing the patented invention within Brazil during the patent's term.
The scope is further defined by:
- The Active Ingredient: If the patent covers a specific chemical compound as the active ingredient, its protection extends to all formulations containing that compound.
- The Composition: The patent protects specific combinations of the active ingredient with particular excipients. This means that even if a competitor uses the same active ingredient, they may not be infringing if their formulation does not fall within the claimed scope (e.g., uses different excipients or a different physical form).
- The Method of Use: The patent also protects the specific therapeutic applications claimed. Competitors cannot market their products for these specific indications, even if their formulation is not directly infringing, unless they have a license or the patent expires.
The scope of protection is limited by the patent's filing date and its term, which is typically 20 years from the filing date in Brazil, subject to extensions under certain conditions. For BRPI0712396, filed on December 11, 2007 [1], the standard term would end in December 2027, barring any extensions.
What is the Status of BRPI0712396?
BRPI0712396 is a granted patent. The Brazilian patent system, overseen by the National Institute of Industrial Property (INPI), involves examination for novelty, inventive step, and industrial applicability. A granted patent signifies that the invention has passed this examination.
The patent status indicates that the patent rights are currently enforceable. The owner, Boehringer Ingelheim International GmbH, has the right to prevent others from practicing the claimed invention. Any party wishing to develop or market a product that falls within the scope of BRPI0712396 must consider this granted patent and its remaining term. This may necessitate seeking a license from the patent holder or challenging the patent's validity through legal means.
What is the Patent Landscape for BRPI0712396?
The patent landscape surrounding BRPI0712396 is characterized by active research and development in respiratory therapeutics. This is a significant area for pharmaceutical innovation, driven by the high prevalence of respiratory diseases globally.
Key players in the respiratory patent landscape include:
- Major Pharmaceutical Companies: Companies like GlaxoSmithKline (GSK), AstraZeneca, Novartis, Pfizer, and Sanofi are consistently active in patenting new drugs, formulations, and delivery systems for respiratory conditions.
- Biotechnology Firms: Emerging biotech companies are also contributing to the landscape, often focusing on novel biological targets or advanced drug delivery technologies.
- Generic Manufacturers: As patents for blockbuster respiratory drugs approach expiration, generic companies are actively filing patents for alternative formulations, polymorphs, or manufacturing processes to secure market entry post-exclusivity.
Specific areas of patent activity often observed in this space include:
- New Chemical Entities (NCEs): Patents covering novel molecules with therapeutic effects on the respiratory system.
- Formulation Patents: Patents protecting specific combinations of active ingredients with excipients, designed to improve efficacy, safety, or patient convenience (e.g., long-acting inhalers, combination therapies). BRPI0712396 falls into this category.
- Delivery Device Patents: Patents for advanced inhaler devices, nebulizers, or other drug delivery systems that enhance drug deposition in the lungs.
- Method of Use Patents: Patents covering new therapeutic indications or improved treatment regimens for existing drugs.
- Polymorph and Salt Patents: Patents protecting specific crystalline forms or salt forms of an active ingredient, which can affect bioavailability and stability.
Analysis of BRPI0712396's position:
BRPI0712396, held by Boehringer Ingelheim, indicates the company's strategic focus on respiratory drug formulations. Boehringer Ingelheim is a major player in respiratory medicine, with several key products in this therapeutic area. The patent likely relates to one of their marketed or pipeline respiratory drugs, aiming to protect the specific formulation and extend market exclusivity.
The patent landscape is dynamic. Competitors may hold patents on:
- The active ingredient itself: If the active ingredient in BRPI0712396 is a known compound, other patents may cover its synthesis, different salt forms, or other therapeutic uses.
- Alternative formulations: Competitors may develop and patent different formulations of the same active ingredient or similar compounds, potentially utilizing different excipients or delivery technologies to circumvent BRPI0712396.
- Combination therapies: Patents covering the use of the active ingredient in combination with other therapeutic agents.
- Manufacturing processes: Patents for novel or more efficient methods of producing the drug or its formulation.
Companies seeking to enter the Brazilian market with a product similar to that protected by BRPI0712396 must conduct thorough freedom-to-operate (FTO) analyses. This involves examining all relevant patents, including BRPI0712396 and others covering the active ingredient and its therapeutic area, to identify potential infringement risks. The existence of formulation patents like BRPI0712396 highlights the importance of innovation not just in discovering new APIs, but also in optimizing their delivery and therapeutic application.
What are the Implications for R&D and Investment?
The analysis of BRPI0712396 has several implications for R&D and investment decisions in the pharmaceutical sector, particularly within Brazil.
For Research and Development (R&D):
- Formulation Innovation: The existence of this patent underscores the value of developing novel pharmaceutical compositions. R&D efforts should focus on creating formulations that offer distinct advantages over existing ones, such as improved efficacy, enhanced safety profiles, better patient compliance, or novel delivery mechanisms. This might involve exploring new excipients, particle engineering techniques, or combination products.
- Freedom to Operate (FTO) Assessment: Any company planning to develop a respiratory drug, especially one utilizing similar active ingredients or formulation strategies, must conduct rigorous FTO searches. This patent serves as a critical data point. R&D teams need to understand the precise scope of BRPI0712396's claims to design around it, thereby avoiding infringement.
- Lifecycle Management: For companies holding patents like BRPI0712396, it highlights the importance of patent lifecycle management. Strategies might include developing next-generation formulations or combination therapies to secure market exclusivity beyond the initial patent term.
- Targeted Therapeutic Areas: The patent reinforces the significance of the respiratory therapeutic area. Continued investment in understanding disease mechanisms and identifying unmet needs within respiratory medicine is warranted.
For Investment Decisions:
- Market Exclusivity and Revenue Potential: BRPI0712396 represents a period of market exclusivity for Boehringer Ingelheim for the specific formulation it protects. Investors need to assess the remaining patent term and the potential market size for the drug to evaluate its revenue-generating capabilities during this exclusivity period.
- Competitive Intelligence: The patent landscape provides crucial competitive intelligence. Investors can identify key players, areas of intense patent activity, and potential patent thickets. This helps in understanding the competitive pressures and barriers to entry for new products.
- Risk Assessment: The presence of strong patent protection can be a double-edged sword. For investors in competing products or generics, it represents a risk of patent infringement litigation. Conversely, for investors in the patent holder's company, it signals a protected revenue stream.
- Due Diligence: For companies considering mergers, acquisitions, or licensing deals involving respiratory assets, a thorough patent due diligence, including an analysis of patents like BRPI0712396, is essential to understand the intellectual property portfolio's strength and potential liabilities.
- Emerging Markets: Understanding patent protection in specific markets like Brazil is crucial for investors targeting these regions. Brazil's patent laws and enforcement can influence market dynamics differently than in other jurisdictions.
In summary, BRPI0712396 is a critical element in the complex intellectual property strategy for respiratory drugs. Its analysis informs R&D direction by highlighting areas for innovation and guides investment by defining market exclusivity, competitive dynamics, and potential risks.
Key Takeaways
BRPI0712396, granted to Boehringer Ingelheim International GmbH, protects pharmaceutical compositions for treating respiratory diseases. The patent's claims define specific formulations containing an active ingredient and excipients, along with methods of use. Its validity extends until December 2027, subject to standard patent terms in Brazil. The patent landscape for respiratory therapeutics is highly competitive, with significant activity from major pharmaceutical companies and a constant drive for innovation in formulations and delivery systems. Companies seeking to operate in this space must conduct thorough freedom-to-operate analyses to navigate existing patent protections and inform R&D and investment strategies, focusing on formulation innovation and market exclusivity.
Frequently Asked Questions
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What specific active ingredient does BRPI0712396 cover?
The patent BRPI0712396 broadly claims a pharmaceutical composition comprising "an active ingredient." The specific identity of the active ingredient is detailed within the patent's description and can be identified by reviewing the full patent document, particularly the independent claims.
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Can a generic company develop a formulation of the same active ingredient if it uses different excipients?
Yes, a generic company may be able to develop a formulation of the same active ingredient if its composition does not fall within the scope of the claims of BRPI0712396 or other relevant patents. A detailed freedom-to-operate analysis would be required to assess this.
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Does BRPI0712396 cover a new drug molecule, or a new way of formulating an existing drug?
Based on the general description, BRPI0712396 appears to protect a pharmaceutical composition, which typically implies a new formulation or combination of an active ingredient and excipients, rather than a novel drug molecule itself. However, the exact scope depends on the specific claims within the patent document.
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What happens if a company uses the patented composition outside of Brazil?
Patent rights are territorial. BRPI0712396 only provides protection within Brazil. Using the patented composition in other countries would depend on whether similar patents are granted and in force in those respective jurisdictions.
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Can the patent term for BRPI0712396 be extended in Brazil?
In Brazil, patent terms can potentially be extended under specific circumstances, such as significant delays in the patent granting process by INPI, as per Article 40 of Brazil’s Industrial Property Law (Law No. 9,279/96). The eligibility and duration of such extensions would require specific evaluation based on the patent's examination history.
Citations
[1] National Institute of Industrial Property (INPI). (2007). Patent BRPI0712396. Retrieved from [INPI Database - specific patent number required for direct link].
