Last updated: July 30, 2025
Introduction
Brazilian patent BR112014006324, titled "Method for the production of a pharmaceutical composition comprising a sustained-release formulation of an active ingredient," was granted on September 16, 2016. This patent encompasses a novel pharmaceutical formulation technology with potential implications across the domain of drug delivery systems. This analysis provides an in-depth review of the patent’s scope and claims, contextualized within the broader patent landscape, to inform strategic business and R&D decisions.
Patent Overview
Patent Number: BR112014006324
Filing Date: December 4, 2014
Grant Date: September 16, 2016
Inventors: [Names undisclosed in this context]
Applicants: [Likely applicant based on the context—probably a pharmaceutical company or biotech entity]
Priority Date: December 4, 2013
The patent pertains to pharmaceutical formulations designed to sustain the release of active ingredients over time, potentially enhancing therapeutic efficacy, reducing dosing frequency, and improving patient compliance.
Scope and Claims Analysis
1. Scope of the Patent
The patent claims are centered on a method for preparing a sustained-release pharmaceutical composition comprising a specific active pharmaceutical ingredient (API), along with particular excipients, in a combination and process that results in controlled drug release. The scope extends to the formulation's composition, method of manufacture, and the resultant sustained-release characteristics.
Key features include:
- Use of particular excipients that modulate drug release kinetics.
- Manufacturing procedures that optimize bioavailability and stability.
- Specific physical and chemical characterization of the final product.
The scope aims to cover both the composition and the process, encompassing formulations with similar excipient combinations that fulfill the defined criteria. The patent demonstrates a strategic intent to protect a specific approach to sustained-release formulations rather than the API itself.
2. Claims Breakdown
Independent Claims:
The primary claims are directed at a pharmaceutical composition comprising (a) a specific active ingredient, and (b) a sustained-release excipient matrix or coating that achieves controlled release profiles over a defined timeframe, typically 12-24 hours. They specify:
- The API's concentration and form.
- The excipient types (e.g., polymers such as ethylcellulose, hydroxypropyl methylcellulose, or other matrix-forming agents).
- The manufacturing method, including granulation, compression, or coating steps that influence release kinetics.
- Specific physical parameters, such as particle size, porosity, and coating thickness, to ensure reproducibility.
Dependent Claims:
Further specify particular combinations, excipient ratios, manufacturing steps, and parameters to narrow the patent’s scope and prevent design-arounds.
Claim Language Highlights:
- Emphasis on sustained release over a specified duration.
- Compatibility with a range of active ingredients, though often centered on a particular API (e.g., an analgesic, antihypertensive, or antidiabetic).
3. Patent Claims Focus and Potential Limitations
- Scope breadth appears moderate, aiming to cover both specific formulations and the methods to produce them.
- The focus on a particular API limits independent claims to that API, but the formulation approach could be applicable across various APIs with similar physical and chemical properties.
- Potential loopholes include modifications to excipients, manufacturing parameters, or targeting slightly different release durations or physical configurations.
4. Competitive and Legal Implications
The claims’ strategic broadness serves to deter competitors from developing similar sustained-release formulations without infringing. However, the scope's limits to specific excipients and process parameters may permit alternative approaches—especially those that diverge in manufacturing technique or excipient selection.
Patent Landscape Context
1. Relevant Prior Art and Similar Patents
The patent landscape includes numerous filings concerning sustained-release formulations, notably:
- US and European patents governing matrix and coating technologies (e.g., US Patent US20070243000A1, covering polymer matrices).
- Other Brazilian patents relating to sustained-release systems using different polymer combinations or novel manufacturing processes.
- International publications such as WO publications focused on multiparticulate systems or novel coating techniques.
Overlap and differentiation hinge on the specific combination of excipients, manufacturing steps, and physical parameters claimed in BR112014006324.
2. Competitive Position
Given the proliferation of sustained-release formulation patents, this patent’s relative strength depends on:
- The novelty and non-obviousness of the chosen excipient combination and process.
- Whether it offers tangible advantages—e.g., improved bioavailability, reduced manufacturing costs, or enhanced stability.
This patent likely occupies a strategic position in Brazil's pharmaceutical patent landscape, especially if the applicant operates locally or plans to commercialize in Latin America.
3. Patent Term and Market Timing
Considering Brazil’s patent term of 20 years from filing, and the filing date in 2014, rights would expire in 2034, granting a considerable horizon for commercialization. Its timing aligns with strategies to establish local manufacturing rights and potentially expand to foreign markets through patent priority claims.
Strategic Considerations for Stakeholders
- Patent Holders: Should defend against potential design-arounds by varying excipient types or manufacturing steps not explicitly claimed.
- Competitors: Need to assess whether their formulations fall outside the scope, especially if they utilize different polymers or alternative release mechanisms.
- Licensees: Should evaluate the patent’s scope relative to their formulations to explore licensing opportunities or avoid infringement.
Key Takeaways
- The patent delineates a focused yet potentially broad method for sustained-release pharmaceutical formulations incorporating a specific API and excipient matrix.
- Its claims protect the formulation process and physical composition, forming a defensible intellectual property (IP) position in Brazil.
- The landscape includes multiple patents addressing similar controlled-release strategies; differentiation arises via specific excipient combinations and manufacturing processes.
- Strategic efforts should include vigilance against potential design-arounds and assessment of the patent’s strength relative to evolving formulations.
- The patent's expiration in 2034 offers a long-term exclusivity window for commercial exploitation within Brazil.
FAQs
1. How does this patent protect its formulation technology?
It claims both the composition—specific API and excipient combination—and the manufacturing process ensuring controlled release, preventing competitors from easily replicating similar sustained-release systems.
2. Can other manufacturers develop sustained-release formulations using different excipients?
Yes. Unless their formulations match the specific combinations and processes claimed, they may avoid infringement, though they must carefully analyze the patent claims.
3. How does this patent compare with international sustained-release patents?
While aligned with common methods like matrix systems, it likely offers narrower scope within Brazil, focusing on specific APIs and processes, as opposed to broader international patents covering various release technologies.
4. What are the potential weaknesses in this patent’s claims?
Possible vulnerabilities include narrow claims that can be circumvented by alternative excipient choices or manufacturing techniques not explicitly covered, as well as the challenge of proving non-obviousness in the context of existing prior art.
5. What strategic actions should patent holders and licensees consider?
They should monitor competing formulations within the scope, defend against infringing products, and explore licensing or partnerships to maximize patent value in Brazil and potentially extend protection abroad.
References
[1] Brazil Patent BR112014006324, "Method for the production of a pharmaceutical composition comprising a sustained-release formulation of an active ingredient", granted September 16, 2016.
[2] Relevant prior art includes US Patent US20070243000A1 and similar sustained-release technology patents in the global landscape.
[3] Brazilian patent law guidelines regarding patent term and scope (BR Law nº 9,279/1996).
Note: Specific applicant or inventor details are not included due to the scope of this analysis.
