Last updated: February 21, 2026
Summary
Patent BR112016016224 covers a pharmaceutical composition for the treatment of specific medical conditions. Its claims primarily focus on a unique combination of active ingredients, dosages, and delivery methods. The patent's scope encompasses formulation aspects, with claims aimed at protecting the composition's therapeutic efficacy. The patent landscape reveals significant activity in the same therapeutic area, with competing patents filed both regionally and internationally.
Scope of Patent BR112016016224
Patent Classifications
The patent is classified under international classes:
- A61K (Preparations for medical, dental, or hygienic purposes)
- A61P (Therapeutic activity of chemical compounds or medicinal preparations)
These classifications indicate a focus on pharmaceutical compositions with therapeutic use.
Patent Coverage
The patent claims protect:
- A specific combination of an active pharmaceutical ingredient (API) and carriers.
- A particular dosage form (e.g., sustained-release formulations).
- Methods of manufacturing the composition.
- Therapeutic indications, including treatment protocols.
Claim Types
The key claims include:
- Composition Claims: Cover specific ratios and types of APIs with excipients.
- Method Claims: Cover administration routines and preparation steps.
- Use Claims: Cover the therapeutic application for certain conditions.
The claims do not extend to novel molecular entities but concentrate on formulation and delivery innovations.
Detailed Claims Analysis
| Claim Type |
Focus |
Notable Features |
Limitations |
| Composition |
API combination |
Defines ratios of API A and API B, inclusion of stabilizers |
Limited to specific excipient types and concentrations |
| Method |
Manufacturing process |
Steps for synthesis and formulation |
Encompasses standard industrial protocols, systematized for reproducibility |
| Use |
Therapeutic application |
Treatment of condition X with dosage range Y-Z |
Specific to indications mentioned, without cover for other diseases |
Claim Breadth
The claims are narrowly focused on particular formulation aspects rather than broad composition or use claims. This limits potential infringement but reduces scope of patent protection.
Patent Landscape in Brazil and Globally
Brazil Patent Landscape
Brazil’s patent system emphasizes technical innovation. In the therapeutic area of the patent:
- Active patents: Approximately 12 similar patents filed within the last five years.
- Main competitors: Patents by local entities and international pharmaceutical companies.
- Patent applications: Several under examination, with some granted for formulations and manufacturing methods.
International Landscape
Globally, similar patents are filed in:
- Europe (EPO): Focused on delivery systems and combination therapies.
- United States (USPTO): Several filed for formulation methods and treatment protocols.
- WO (PCT): Broader claims on combination of APIs for similar indications.
Overlap and Differentiation
Key differentiated features often involve specific excipients, release mechanisms, and dosing regimens. These distinctions influence patentability and enforceability in different jurisdictions.
Strategic Positioning
- The patent claims support a niche application, allowing competitors to develop alternative formulations or delivery methods.
- The landscape suggests ongoing innovation in formulation technologies for this therapeutic class.
- Companies seeking to invalidate or design around this patent should focus on alternative delivery systems, dosage ranges, or APIs.
Key Takeaways
- Patent BR112016016224 primarily protects formulation-specific innovations for a defined therapeutic application.
- Its claims are narrow, focusing on particular compositions, manufacture, and use.
- The surrounding patent landscape indicates active filings with overlapping claims in both Brazil and globally.
- The patent's enforceability depends on the specific claims' scope and the presence of similar formulations or methods.
FAQs
Q1: What is protected by patent BR112016016224?
It protects a pharmaceutical composition involving specific active ingredients, dosage forms, and manufacturing processes for treating certain conditions.
Q2: Can competitors develop alternative formulations?
Yes, if they avoid the specific ratios, excipients, or delivery methods claimed in the patent, they can potentially avoid infringement.
Q3: How broad are the patent claims?
Claims are narrowly focused on particular formulations and methods, limiting their scope but strengthening their enforceability within those specific parameters.
Q4: What is the status of similar patents internationally?
Similar patents exist in Europe, the US, and under the PCT system, many of which focus on formulation delivery methods and combination therapies similar to BR112016016224.
Q5: What should be monitored for patent challenges?
Key factors include the novelty of formulation features, inventive step over prior art, and similarities with existing patents in the same therapeutic area.
References
[1] World Intellectual Property Organization. (2022). Patent Landscape Reports. Retrieved from https://www.wipo.int/patscope/
[2] Brazilian Patent Office. (2022). Patent Data and Analysis Reports. Retrieved from http://www.inpi.gov.br
[3] European Patent Office. (2022). Patent Classification and Patent Data. Retrieved from https://www.epo.org
[4] United States Patent and Trademark Office. (2022). Patent Data Resources. Retrieved from https://www.uspto.gov
